Videos and education on RUKOBIA

Could your patients living with MDR HIV-1 be ready for RUKOBIA?

Get the answers to your questions about RUKOBIA by watching the “Ask the Expert” video series or downloading a Printable Decision Tree.

Ask the Expert Series

ONSCREEN – Text
OPTIMIZING A DRUG REGIMEN FOR MULTIDRUG-RESISTANT HIV-1

HIV-1=human immunodeficiency virus type-1.
[ViiV Healthcare logo]

AUDIO – Music

ONSCREEN – Dr. Jihad Slim + Text
Jihad Slim, MD
Assistant Professor of Medicine
New York Medical College, Valhalla, NY
Chief of Infectious Diseases
Saint Michaels Medical Center, Newark, NJ

Compensated by ViiV Healthcare.

AUDIO – Dr. Jihad Slim
Hello. It’s nice to be here with you today. My name is Jihad Slim, I’m an Assistant Professor of Medicine at New York Medical College in Valhalla, New York. I’m also Chief of Infectious Diseases at Saint Michaels Medical Center in Newark, New Jersey, where I have been taking care of people living with HIV since I started my fellowship there in 1985.

ONSCREEN – Dr. Jihad Slim

AUDIO – Dr. Jihad Slim
Today, I will discuss optimizing therapy in people with multidrug-resistant HIV-1, or MDR HIV-1.

ONSCREEN – Dr. Jihad Slim + Text + Graphic
In 2023, an estimated 1,132,739 people had HIV in the USA and 6 territories¹

CDC=Centers for Disease Control and Prevention; HIV=human immunodeficiency virus.
1. Centers for Disease Control and Prevention. Updated April 29, 2025. Accessed December 5, 2025.
https://www.cdc.gov/hiv-data/nhss/hiv-diagnoses-deaths-and-prevalence-2025.html

AUDIO – Dr. Jihad Slim
In 2023, it was estimated that 1.13 million people in the US were living with HIV-1.

ONSCREEN – Dr. Jihad Slim + Text + Bar Chart
SOME PATIENTS WITH HIV-1 CYCLE THROUGH MULTIPLE THERAPIES DUE TO RESISTANCE

Multiple Drug Resistance
Resistance to multiple ART classes due to suboptimal exposure, poor adherence, and suboptimal efficacy (eg, mono, dual, NRTI regimens).¹

People Living With HIV Who Are Resistant to Multiple Classes of Drugs, 2024²
2-class resistance: 18.3%
3-class resistance: 4.1%
4-class resistance: 1%

104,074 samples were included in the analysis, of which 32,761 (31.5%) demonstrated reduced susceptibility to at least one ARV.

ART=antiretroviral therapy; NRTI=nucleoside reverse transcriptase inhibitors.
1. Tang MW, Shafer RW. Drugs. 2012;72(9):e1-e25. 2. Henegar C, et al. ACTHIV 2025. Poster 53.

AUDIO – Dr. Jihad Slim
And data collected between 2019 and 2024 tell us that 23.4% of people living with HIV in the US had multiclass resistance, which is defined as resistance to 2 or more classes of drugs. As a result, some people with MDR HIV-1 cycle through multiple therapies due to this resistance and have limited options for their antiretroviral therapy, or ART, regimen.

ONSCREEN – Dr. Jihad Slim + Text + Graphics
PEOPLE LIVING WITH HIV-1 REQUIRE INDIVIDUALLY TAILORED REGIMENS

The choice of optimizing an ARV regimen should account for the following select factors¹:
ARV HISTORY
RESISTANCE PROFILE*
TOLERANCE
CONCOMITANT MEDICATIONS AND DRUG INTERACTIONS
COMORBIDITIES
BARRIES TO ADHERENCE

*Genotypic and phenotypic resistance (including historical resistance).
1. DHHS. Updated September 25, 2025. Accessed December 5, 2025.
https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf

AUDIO – Dr. Jihad Slim
People living with HIV-1 require individually tailored regimens.
So, it’s important to understand and consider several factors when choosing to optimize an antiretroviral (or ARV) regimen, including ARV history, resistance profile, tolerance, concomitant medications and drug interactions, comorbidities, and barriers to adherence.

ONSCREEN – Dr. Jihad Slim + Text + Graphics
CONSIDERATIONS THAT MAY INFLUENCE THE CHOICE OF OPTIMIZING A REGIMEN FOR PEOPLE WITH HIV-1

Selected guideline recommendations¹:
A regimen should preferably include at least two fully active drugs if at least one has a high resistance barrier
An ARV with a different mechanism of action and no cross-resistance with other ARVs

DHHS=Department of Health and Human Services.
1. DHHS. Updated September 25, 2025. Accessed December 5, 2025. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf

AUDIO – Dr. Jihad Slim
These factors can play an important role when selecting therapy for people living with HIV-1.
To address these factors, it’s important to choose a regimen with at least 2 fully active drugs if at least 1 has a high resistance barrier, and to use an ARV with a different mechanism of action and no cross-resistance with other ARVs.

ONSCREEN – Dr. Jihad Slim + Text + Graphics
ACCORDING TO THE DHHS GUIDELINES, THE GOALS OF THERAPY INCLUDE BOTH CLINICAL AND PATIENT-FOCUSED OUTCOMES¹

ACHIEVE AND MAINTAIN DURABLE VIRAL SUPPRESSION
RESTORE AND PRESERVE IMMUNOLOGIC FUNCTION
PREVENT HIV-1 TRANSMISSION
REDUCE HIV-ASSOCIATED MORBIDITY AND PROLONG THE DURATION AND QUALITY OF SURVIVAL

DHHS=Department of Health and Human Services.
1. DHHS. Updated September 25, 2025. Accessed December 5, 2025. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf

AUDIO – Dr. Jihad Slim
According to the US Department of Health and Human Services’ guidelines, there are key therapeutic goals that need to be achieved for people living with HIV. These goals include, first and foremost, achieving and maintaining durable virologic suppression.
The guidelines also consider other clinical and patient-focused outcomes such as restoring and preserving immunologic function, preventing HIV-1 transmission, and reducing HIV-associated morbidity, as well as prolonging the duration and quality of survival.

ONSCREEN – Dr. Jihad Slim + Text + Graphics
ACHIEVING THESE THERAPEUTIC GOALS MATTERS FOR PEOPLE LIVING WITH MDR HIV-1

MDR HIV-1 increases the risk of:
Virologic failure, particularly with persistent low-level viremia¹
Progression to AIDS and advanced immunosuppression¹
Development of multiple comorbidities, leading to poor health-related quality of life and increased healthcare costs²

AIDS=acquired immunodeficiency syndrome; MDR=multidrug-resistant.
1. DHHS. Updated September 25, 2025. Accessed December 5, 2025. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf 2. Priest J, et al. Open Forum Infect Dis. 2021;8(12):1-8.

AUDIO – Dr. Jihad Slim
MDR HIV-1 increases the risk of virologic failure, and when that happens, it could lead to advanced immunosuppression, as well as development of multiple comorbidities, which can lead to poor health-related quality of life and increased healthcare costs.

ONSCREEN – Dr. Jihad Slim

AUDIO – Dr. Jihad Slim
Now, let’s review the indication and…

ONSCREEN – Text
INDICATION
RUKOBIA, in combination with other antiretrovirals (ARVs), is indicated to treat HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen due to resistance, intolerance, or safety considerations.

IMPORTANT SAFETY INFORMATION
Contraindications

Do not use in patients with previous hypersensitivity to fostemsavir or any of the components of RUKOBIA.
Do not use RUKOBIA in patients receiving strong cytochrome P450 (CYP)3A inducers, including but not limited to enzalutamide, carbamazepine, phenytoin, rifampin, mitotane, and St John’s wort (Hypericum perforatum).

Warnings and precautions
Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of RUKOBIA.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim + Narrator
Dr. Slim:

…Important Safety Information for RUKOBIA.

Narrator:
INDICATION
RUKOBIA, used with other HIV-1 medicines, is indicated for heavily treatment-experienced adults with multidrug-resistant HIV-1 who are failing their current ARV regimen.

IMPORTANT SAFETY INFORMATION
Contraindications

Do not use in patients with previous hypersensitivity to fostemsavir or any of the components of RUKOBIA.
Do not use RUKOBIA in patients receiving strong cytochrome P450 (CYP)3A inducers, including those listed here.

Warnings and precautions
Immune Reconstitution Syndrome and autoimmune disorders have been reported with the use of RUKOBIA.

ONSCREEN – TEXT
IMPORTANT SAFETY INFORMATION (CONT’D)
Warnings and precautions (cont’d)
QTc Prolongation with Higher than Recommended Dosages: RUKOBIA at 2,400 mg twice daily has been shown to significantly prolong the QTc interval of the electrocardiogram. Use RUKOBIA with caution in patients with a history of QTc interval prolongation or in patients with relevant pre-existing cardiac disease or who are taking drugs with a known risk of Torsade de Pointes. Elderly patients may be more susceptible to drug-induced QT interval prolongation.

Elevations in Hepatic Transaminases in Patients with Hepatitis B or C Virus Co-infection:

Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
Diligence should be applied in initiating or maintaining effective hepatitis B therapy when starting RUKOBIA in patients co-infected with hepatitis B.

Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of RUKOBIA and other drugs may occur (see Contraindications and Drug Interactions).

Please see additional IMPORTANT SAFETY INFORMATION for RUKOBIA later in this video.
Please see the accompanying full Prescribing Information, also available at www.RUKOBIAHCP.com.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Narrator
QTc prolongation has occurred with higher than recommended dosages of RUKOBIA. Use RUKOBIA with caution in patients with a history of QTc interval prolongation or cardiac disease, or who are taking drugs with a known risk of Torsade de Pointes. Elderly patients may be more susceptible.
Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection. Diligence should be applied when starting RUKOBIA in patients receiving hepatitis B therapy.

Adverse reactions or loss of virologic response due to drug interactions may occur when using RUKOBIA with other drugs.

Please see additional IMPORTANT SAFETY INFORMATION for RUKOBIA later in this video. Please see the accompanying full Prescribing Information, also available at www.RUKOBIAHCP.com.

ONSCREEN – Dr. Jihad Slim + Text
AGENDA

RUKOBIA’s MOA
BRIGHTE Study
Design
Efficacy data
Safety data

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
Going forward, we will review this therapeutic option for heavily treatment experienced adults living with MDR HIV-1 and failing their current ARV regimen. We will also discuss how RUKOBIA works, and key efficacy and safety data from BRIGHTE, a registrational study of RUKOBIA.

ONSCREEN – Dr. Jihad Slim

AUDIO – Dr. Jihad Slim
Now, let’s discuss how RUKOBIA works.

ONSCREEN – Text + Graphic of HIV-1 and CD4 T-cell
RUKOBIA ADDS A DIFFERENT TYPE OF PROTECTION FOR CD4⁺

RUKOBIA
THE FIRST-IN-CLASS ATTACHMENT INHIBITOR¹

HIV-1
gp120
Temsavir
Soluble gp120*
Prevents attachment to CD4⁺ T-cells

CD4⁺ T-cell
CD4
HIV RNA
HIV DNA

Entry inhibitors²
NRTIs/NNRTIs²
INSTIs²
Protease inhibitors²
Capsid inhibitor^3,4

*Clinical significance of binding to soluble gp120 is unknown.
Diagram is for illustrative purposes only.
CD4⁺=cluster of differentiation 4; DNA=deoxyribonucleic acid; gp120=glycoprotein 120; INSTI=integrase strand transfer inhibitor; MOA=mechanism of action; NNRTI=non-nucleoside reverse transcriptase inhibitor; RNA=ribonucleic acid.

1. Lataillade M, et al. Lancet HIV. 2020;7(11):e740-e751. 2. National HIV Curriculum. Updated February 3, 2025. Accessed December 5, 2025. https://www.hiv.uw.edu/go/antiretroviral-therapy/general-information/core-concept/all 3. Link JO, et al. Nature. 2020;584(7822):614-618. 4. Bester SM, et al. Science. 2020;370(6514):360-364.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
There are many ARV, classes available, with each one specifically targeting the HIV lifecycle at a different point.
RUKOBIA’s Mechanism of Action is unique. It’s the first and only ARV that prevents attachment to the CD4⁺ T-cell, making it the first-in-class attachment inhibitor.

ONSCREEN – Text + Graphic of HIV-1 and CD4 T-cell
RUKOBIA ADDS A DIFFERENT TYPE OF PROTECTION FOR CD4⁺

RUKOBIA IS THE FIRST AND ONLY THERAPY THAT PREVENTS HIV-1 ATTACHMENT¹

PREVENTS
HIV-1 attachment to CD4⁺ T-cells by binding to the gp120 subunit^1,3

PROTECTS
uninfected CD4⁺ T-cells from HIV-1¹

PRESERVES
CD4⁺ T-cell function by preventing viral replication¹

HIV-1
gp120
Temsavir
Soluble gp120*
Prevents attachment to CD4⁺ T-cells
CD4

*Clinical significance of binding to soluble gp120 is unknown.
Diagram is for illustrative purposes only.
CD4⁺=cluster of differentiation 4; DNA=deoxyribonucleic acid; gp120=glycoprotein 120; INSTI=integrase strand transfer inhibitor; MOA=mechanism of action; NNRTI=non-nucleoside reverse transcriptase inhibitor; RNA=ribonucleic acid.

1. Lataillade M, et al. Lancet HIV. 2020;7(11):e740-e751. 2. National HIV Curriculum. Updated February 3, 2025. Accessed December 5, 2025. https://www.hiv.uw.edu/go/antiretroviral-therapy/general-information/core-concept/all 3. Link JO, et al. Nature. 2020;584(7822):614-618. 4. Bester SM, et al. Science. 2020;370(6514):360-364.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
RUKOBIA:

Prevents HIV-1 from attaching to CD4⁺ T- cells by binding to the gp120 subunit.
It protects uninfected CD4⁺ T-cells from HIV-1.
And it preserves CD4⁺ T-cell function by preventing viral replication.

13 ONSCREEN – Dr. Jihad Slim + Text
BRIGHTE
The largest trial of RUKOBIA in people living with MDR-HIV-1.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
Now, let's review key efficacy and safety data from the BRIGHTE trial.

ONSCREEN – Text + Study Design graphic
BRIGHTE: LARGEST PHASE 3 TRIAL WITH THE LONGEST REPORTED FOLLOW-UP
(336 WEEKS, APPROACHING 7 YEARS) IN THE MDR HIV-1 POPULATION

Eligible participants

Randomized cohort (RC, n=272)¹*
One or two ARV classes remaining with ≥1 fully active agent per class^†

Blinded RUKOBIA 600 mg BID + failing regimen (n=203)^‡
Blinded placebo + failing regimen (n=69)

Open-label RUKOBIA 600 mg BID + OBT^§

Nonrandomized cohort (NRC, n=99)¹
No fully active and approved ARV agents remaining

Open-label RUKOBIA 600 mg BID + OBT^§

Were on a failing current ARV regimen with VL ≥400 copies/mL
Had MDR HIV-1
Had ≤2 classes of ARVs remaining at baseline

[Timeline: D1, D8, D9, W24, W48, W96, W192², W240², W288³, W336³]

Factors influencing participant numbers and data availability

COVID-19 from Dec 2019
US approval of RUBKOBIA, July 2020
RUKOBIA available in Germany, March 2021

Primary endpoint¹

Adjusted mean plasma HIV-1 RNA log₁₀ change from Days 1-8

Additional endpoints³

Virologic suppression (HIV-1 RNA <40 copies/mL) at Weeks 24, 48, 96, 240, and 336
Mean change in CD4⁺ T-cell counts and Weeks 24, 48, 96, 240, and 336

At Week 336, 80 participants were still enrolled in BRIGHTE (RC, n=72; NRC, n=8).³

*Participants in the randomized cohort were randomly assigned 3:1 to receive fostemsavir 600 mg twice daily or placebo + current failing regimen for 8 days, after which all participants received open-label RUKOBIA.^{3
†}Fully active based on susceptibility (current or historical resistance) and availability (participant is tolerant of, eligible for, and willing to take [in the case of enfuvirtide] the antiretroviral). Use of investigational agents in OBT was permitted in the nonrandomized cohort.^{3
‡}Two participants in the RUKOBIA + failing regimen arm who had missing Day 1 HIV-1 RNA values were not included in the analysis at Day 8.¹ §Investigator-selected OBT (based on resistance testing and treatment history).²
BID=twice daily; COVID-19=coronavirus disease 2019; D=day; OBT=optimized background therapy; VL=viral load; W=week.

1. Kozal M, et al. N Engl J Med. 2020;382(13):1232-1243. 2. Aberg JA, et al. Infect Dis Ther. 2023;12(9):2321-2335. 3. Aberg JA, et al. EACS 2025. Poster eP125.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
Here, we see the study design of the BRIGHTE trial. It is the largest Phase 3 Trial in the MDR HIV-1 population with the longest follow-up, approaching 7 years.
Eligible participants were on a failing ARV regimen with a viral load of at least 400 copies per mL and had 2 or fewer remaining classes of ARVs at baseline.
Participants with at least 1 but no more than 2 remaining fully active ARVs available were enrolled in the randomized cohort.
Participants with no remaining fully active and approved ARVs were enrolled in the nonrandomized cohort.
Now let’s review the randomized and nonrandomized cohorts.
For the randomized cohort, 272 individuals were randomized to receive either RUKOBIA at 600 milligrams twice daily or placebo, each in addition to their failing regimen.
The study followed individuals on RUKOBIA over an 8-day period to evaluate the primary endpoint, which was mean change in viral load at Day 8.
Then, at Day 9, all individuals in the randomized cohort received open-label RUKOBIA 600 milligrams twice daily with optimized background therapy, or OBT, selected by the investigator based on the full ARV history and all available cumulative resistance tests.
Individuals in the nonrandomized cohort did not contribute to the primary endpoint of the BRIGHTE study. At Day 1, they received open-label RUKOBIA at 600 milligrams twice daily with OBT.
Additional data in the BRIGHTE study included viral load and mean change in CD4⁺ T-cell counts through Week 336.
At Week 336, 80 participants were still enrolled in the BRIGHTE trial.

ONSCREEN – Text + Bar Charts
BRIGHTE: LARGEST PHASE 3 TRIAL IN PEOPLE LIVING WITH MDR HIV-1
RUKOBIA WAS USED IN COMBINATION WITH OTHER ARVS TO OPTIMIZE THE ARV REGIMEN

COMMON ARVS IN THE INITIAL OBT FOR EACH COHORT IN BRIGHTE¹

Randomized Cohort (n=272)¹DTG (75% BID): 84%DRV (74% BID): 49%TFV (98% TDF): 43%ETR: 20%MVC: 19%ENF: 10%IBA: 0%Fully active^† Partially active^† Participants (%): 100; 80; 60; 40; 20; 0Participants were taking 0 (6%, n=15), 1 (52%, n=142), or 2 (42%, n=115) fully active ARVs in initial optimized background therapy.^§

Nonrandomized Cohort* (n=99)¹
(92% BID) DTG: 75%
(89% BID) DRV: 72%
(96% TDF) TFV: 75%
ETC: 21%
MVC: 8%
ENF: 11%
IBA: 15%
Fully active^†‡
Partially active^†
Participants (%): 0; 20; 40; 60; 80; 100
Participants were taking 0 (80%, n=79) or 1 (20%, n=20) fully active ARVs in initial optimized background therapy.

3TC or FTC were included in 50% and 77% of OBT in the RC and NRC, respectively.²

*For the nonrandomized cohort, experimental ARVs other than RUKOBIA were assumed to be fully active.
^†Based on the screening criteria for activity (according to screening and historical resistance measures).
^‡4 participants had 1 fully active and available ARV at screening, and 16 received ibalizumab, which was still investigational at study start.³
^§Includes participants who discontinued the study during the blinded period and never started OBT, not treated with a fully active ARV in initial OBT despite having a fully active ARV available at screening, and inadvertently assigned to the RC despite having no fully active ARV available at screening.³
3TC=lamivudine; BID=twice daily; DRV=darunavir; DTG=dolutegravir; ENF=enfuvirtide; ETR=etravirine; FTC=emtricitabine; IBA=ibalizumab; MVC=maraviroc; TDF=tenofovir disoproxil fumarate; TFV=tenofovir.

1. Lataillade M, et al. Lancet HIV. 2020;7(11):e740-e751. 2. Ackerman P, et al. IAS 2021. Poster PEB155. 3. Aberg JA, et al. EACS 2025. Poster eP125.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
Here are the ARVs included in the OBT for BRIGHTE. Some common ARVs used in the trial were dolutegravir, darunavir, and tenofovir. Both dolutegravir and darunavir were more likely to be given twice daily in this study.
A key difference between the 2 cohorts is the proportion of participants with these agents considered fully active. Due to the cohort eligibility criteria, more individuals in the randomized cohort had fully active agents compared to the nonrandomized cohort.
Of note, 15% of individuals in the nonrandomized cohort also had ibalizumab included as a fully active agent in their regimen. This reflects co-enrollment in the registrational studies of ibalizumab.

ONSCREEN – Dr. Jihad Slim + Text + Graphics
BRIGHTE: LARGEST PHASE 3 TRIAL IN PEOPLE LIVING WITH MDR HIV-1
EVALUATED A BROAD RANGE OF ADULTS LIVING WITH MDR HIV-1
RANDOMIZED COHORT^1-3

MEDIAN AGE (YEARS)
48 (range: 18-73)

Other Races: 10%
Black/African American: 22%
White: 68%
29% were Hispanic*
74% were male

HIV-1 RNA (range), median log₁₀ copies/mL
1.6; 4.7; 6.9

CD4⁺ T-cell count (range), median cells/mm³
0; 99.5; 1160

85% had a history of AIDS²

*Patients in the Hispanic ethnic group could also be included in a racial group.¹
1. Kozal M, et al. N Engl J Med. 2020;382(13):1232-1243. 2. Ackerman P, et al. AIDS. 2021;35(7):1061-1072. 3. Aberg JA, et al. EACS 2025. Poster eP125.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
Here are selected baseline demographic and clinical characteristics in the randomized cohort.
Participants were a median age of 48 years old, where 22% of the study population identified as Black or African American, 29% as Hispanic, and 74% were men. The median baseline viral load was 4.7 log with a median baseline CD4⁺ T-cell count of 99.5.
Notably, 85% of individuals in this cohort had a history of AIDS.

ONSCREEN –Text + Graphics
BRIGHTE: LARGEST PHASE 3 TRIAL IN PEOPLE LIVING WITH MDR HIV-1
EVALUATED A BROAD RANGE OF ADULTS LIVING WITH MDR HIV-1
NONRANDOMIZED COHORT^1-3

MEDIAN AGE (YEARS)
51 (range: 17*-72)

Other Races: 2%
Black/African American: 23%
White: 75%
28% were Hispanic^†

90% were male

HIV-1 RNA (range), median log₁₀ copies/mL
1.6; 4.3; 6.6

CD4⁺ T-cell count (range), median cells/mm³
0; 41; 641

90% had a history of AIDS²

*One patient was 17 years of age at enrollment and was classified as a protocol deviation.¹ ^†Patients in the Hispanic ethnic group could also be included in a racial group.¹

1. Kozal M, et al. N Engl J Med. 2020;382(13):1232-1243. 2. Ackerman P, et al. AIDS. 2021;35(7):1061-1072. 3. Aberg JA, et al. EACS 2025. Poster eP125.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
On this screen you can also see some of the baseline demographic and clinical characteristics for the nonrandomized cohort.

ONSCREEN – Dr. Jihad Slim + Text + Bar Chart
SUPERIOR ANTIVIRAL ACTIVITY AT DAY 8: RANDOMIZED COHORT
AT DAY 8, RUKOBIA + FAILING REGIMEN PRODUCED GREATER REDUCTIONS IN HIV-1 RNA THAN PLACEBO

PRIMARY ENDPOINT
[Bar Chart]
Adjusted Mean HIV-1 RNA (log₁₀ copies/mL)
Change From Day 1 to Day 8
-1.00; -0.80; -0.60; -0.40; -0.20; 0.00

PLACEBO + FAILING REGIMEN^1,2 (N=69): -0.17
Difference: -0.625 (95% CI: -0.810, -0.441) P<0.0001

RUKOBIA + FAILING REGIMEN^1,2* (N=201): -0.79

At Day 8
65% (131/203) and 46% (93/203)
of participants who received RUKOBIA + Failing Regimen had a reduction in VL from baseline of >0.5 log₁₀ copies/mL and >1 log₁₀ copies/mL, respectively, compared with 19% and 10%, respectively, of those in the placebo group.²

*Two participants who received RUKOBIA with missing Day 1 HIV-1 RNA values were not included in the analysis.¹
CI=confidence interval.

1. Kozal M, et al. N Engl J Med. 2020;382(13):1232-1243. 2. Data on file, ViiV Healthcare.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim

Now let’s move to the primary endpoint of the trial. Only participants in the randomized cohort contributed to the primary endpoint, which was the mean plasma viral load log change at Day 8.
In the placebo arm, there was a 0.17 log decline in viral load, compared to a 0.79 log decline in viral load in participants who had RUKOBIA added to their failing regimen.
The BRIGHTE study met its primary endpoint. The treatment difference was -0.625, which was statistically significant.
In the RUKOBIA plus failing regimen group, 65% of participants had a reduction in viral load from baseline of greater than 0.5 log vs 19% for placebo, and 46% had a reduction of greater than 1 log vs 10% for placebo.

ONSCREEN – Text + Line Charts
VIROLOGIC SUPPRESSION (HIV-1 RNA <40 COPIES/ML)^1-4
Virologic response (HIV-1 RNA <40 copies/mL) for RUKOBIA + OBT through Week 240 (Snapshot Analysis; ITT-E), with extended observations reported through Week 336 (Observed Analysis)

[Line chart]
Snapshot Analysis (ITT-E)*
RC; NRC

% of Participants (0; 20; 40; 60; 80; 100)
Week 0^†: RC=0; NRC=0
Week 24: RC n=272, 53%; NRC n=99, 37%
Week 48: RC n=272, 54%; NRC n=99, 38%
Week 96: RC n=272, 60%; NRC n=99, 37%
Week 144: RC n=272, 54%; NRC n=99, 35%
Week 192: RC n=272, 53%; NRC n=99, 32% - Impact of Covid 19
Week 240^‡: RC n=267, 45%; NRC n=92, 22% - Impact of Covid 19

[Line chart]
Observed Analysis
RC; NRC

% of Participants (0; 20; 40; 60; 80; 100)
Week 0^†: RC=0; NRC=0
Week 24: RC n=247, 58%; NRC n=89, 42%
Week 48: RC n=233, 62%; NRC n=83, 48%
Week 96: RC n=214, 79%; NRC n=66, 59%
Week 144: RC n=206, 78%; NRC n=57, 67%
Week 192: RC n=195, 80%; NRC n=50, 72% - Impact of Covid-19
Week 240^‡: RC n=162, 82%; NRC n=34, 65% - Impact of Covid-19
Week 288: RC n=127, 74%; NRC n=23, 74%
Week 336: RC n=72, 83%; NRC n=8, 63%

Results are descriptive. At Week 336, 80 participants were still enrolled in BRIGHTE (RC, n=72; NRC, n=8). Due to attrition, analyses after Week 240 used only observed data (participants with HIV-1 RNA measured at each visit), potentially favoring treatment successes.
The RC and NRC groups represent different populations and are not intended to be compared to one another.

At Week 240, 19 participants in the RC and 5 participants in the NRC did not have their data included in this analysis due to the impact of COVID-19.

*The ITT-E population included all randomized participants who received at least 1 dose of treatment. The FDA Snapshot algorithm was used to evaluate rates of virologic suppression among all ITT-E participants. In the ITT-E population, missing data or change in OBT was counted as virologic failure.^{1
†}Baseline values are not reported. ‡At Week 240, 12 participants had completed the study by transitioning to locally approved fostemsavir (the first fostemsavir approval was in the US in July 2020).²
FDA=US Food and Drug Administration; ITT-E=intent-to-treat–exposed.

1. Lataillade M, et al. Lancet HIV. 2020;7(11):740-751. 2. Aberg JA, et al. Infect Dis Ther. 2023;12(9):2321-2335. 3. Data on file, ViiV Healthcare. 4. Aberg JA, et al. EACS 2025. Poster eP125.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
So, these graphs show us the proportion of patients with virologic suppression over time and the results are descriptive in nature.
In the BRIGHTE trial, viral suppression was defined as a viral load of less than 40 copies/ML. The randomized cohort is shown in dark blue, and the nonrandomized cohort is shown in green. The randomized and nonrandomized cohorts represent different populations and are not intended to be compared to one another.
Looking at the graph on the left, this shows the Snapshot analysis through Week 240.
At Week 96, viral suppression was observed in 60% of individuals in the randomized cohort and 37% in the nonrandomized cohort. By Week 240, suppression was observed in 45% and 22% in the randomized and nonrandomized cohorts, respectively.
Now, looking at the graph on the right, this shows the observed analysis through Week 336.
At Week 96, viral suppression was observed in 79% of individuals in the randomized cohort and 59% in the nonrandomized cohort. At Week 240, suppression was observed in 82% and 65%, in the randomized and nonrandomized cohorts, respectively. By Week 336, viral suppression was observed in 83% of individuals in the randomized cohort and 63% in the nonrandomized cohort.
Due to attrition, analyses after Week 240 used only observed data, potentially favoring treatment success.

ONSCREEN – Text + Table
VIROLOGIC FAILURE OVER TIME¹
PDVF with RUKOBIA + OB (Snapshot analysis; ITT-E)

[Table]
RANDOMIZED COHORT RUKOBIA 600 mg BID
Week 96 (N=272) n (%): 63 (23)*
Week 240 (N=267) n (%): 80 (29)
NONRANDOMIZED COHORT RUKOBIA 600 mg BID
Week 96 (N=99) n (%): 49 (49)*
Week 240 (N=92) n (%): 53 (54)
Results are descriptive.
PDVF was defined as the following: before Week 24, confirmed HIV-1 RNA ≥400 copies/mL after confirmed (or last available before discontinuation) suppression to <400 copies/mL, or confirmed >1 log₁₀copies/mL increase in HIV-1 RNA above nadir where nadir is ≥40 copies/mL; at or after Week 24, confirmed (or last available before discontinuation) HIV-1 RNA ≥400 copies/mL.

Through Week 96 in the RC, 55% (29/53) of participants with VF who had postbaseline data had treatment-emergent gp120 resistance-associated substitutions at 4 key sites (S375H/I/M/N/T, M426L/I, M434I/L, and M475I/L/V).

*Through Week 96, the PI for RUKOBIA identifies 69 of 272 (25%) participants in the randomized cohort and 50 of 99 (51%) participants in the nonrandomized cohort as experiencing VF. The definition of VF used in the PI differs from the definition of PDVF. Per the PI, VF=confirmed ≥400 copies/mL after prior confirmed suppression to <400 copies/mL, ≥400 copies/mL at last available prior to discontinuation, or >1 log₁₀copies/mL increase in HIV-1 RNA at any time above nadir level (≥40 copies/mL).
PDVF=protocol-defined virologic failure; VF=virologic failure.

1. Aberg JA, et al. Infect Dis Ther. 2023;12(9):2321-2335.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
And here you see the virologic failure rate over time based on the criteria for protocol-defined virologic failure in the intent-to-treat–exposed population, through 5 years. These results are descriptive in nature.

ONSCREEN – Text + Line Chart
ROBUST CD4⁺ T-CELL RECOVERY APPROACHING 7 YEARS^1,2*
Change in CD4⁺ T-cells associated with RUKOBIA + OBT

[Line graph]
Observed Analysis
Mean Change From Baseline in CD4⁺ T-Cell Count (cells/mm³) (0; 50; 100; 150; 200; 250; 300; 350; 400)
RC (n=272)
NRC (n=99)
Week 0: RC=0; NRC=0
Week 24: RC n=248, +91; NRC n=87, +41
Week 48: RC n=228, +139; NRC n=83, +64
Week 96: RC n=213, +205; NRC n=65, +119
Week 144: RC n=197, +263; NRC n=53, +146
Week 192: RC n=179, +308; NRC n=45, +189 - Impact of COVID-19^†
Week 240: RC n=137, +294; NRC n=31, +240 - Impact of COVID-19^†
Week 288: RC n=117, +348; NRC n=20, +269
Week 336: RC n=68, +357; NRC n=8, +371

These results are descriptive in nature and should not be used to infer clinical significance. The RC and NRC groups represent different populations and are not intended to be compared to one another.
The Observed Analysis included only participants for whom CD4⁺ T-cell counts were measured at each study visit, potentially favoring patients who benefited from treatment.³

*Based on BRIGHTE 336 week data. †At Week 240, 19 participants did not have their data included in this analysis due to the impact of COVID-19.¹

1. Aberg JA, et al. Infect Dis Ther. 2023;12(9):2321-2335. 2. Aberg JA, et al. EACS 2025. Poster eP125. 3. Kozal M, et al. N Engl J Med. 2020;382(13):1232-1243.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
Next, let's look at CD4⁺ T-cell recovery through Week 336 in the BRIGHTE trial. These results are descriptive in nature and should not be used to infer clinical significance.
On this graph, we see CD4⁺ T-cell count changes for the randomized cohort depicted in the dark blue line, and changes for the nonrandomized cohort depicted in the green line.
This graph shows the mean CD4⁺T-cell count change over time. At Weeks 96 and 336 in the randomized cohort, RUKOBIA was associated with a mean increase of 205 and 357 cells; at the same time points, there was an observed mean increase of 119 and 371 cells in the nonrandomized cohort.
It is important to understand the patient population used in this observed analysis, as only participants from whom CD4⁺ T-cell counts were measured at each study visit were included, potentially favoring patients who benefited from treatment.

ONSCREEN – Dr. Jihad Slim + RUKOBIA Logo
Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
Now that we've talked about the efficacy data for RUKOBIA, let's turn to the cumulative safety summary.

ONSCREEN – Text + Table
CUMULATIVE SAFETY SUMMARY (SAFETY POPULATION)¹*
THE SAFETY PROFILE THROUGH WEEK 336, APPROACHING 7 YEARS, WAS CONSISTENT WITH THAT OF THE OVERALL STUDY POPULATION THROUGH WEEK 240^†

Through Week 336 in the RC, there were 12 drug-related serious AEs, including 1 fatal drug-related serious AE of IRIS; through Week 336 in the NRC, there were 4 drug-related serious AEs
Across both cohorts, the most common AEs leading to discontinuation were due to non–COVID-19 infections (RC, 8 [3%]; NRC, 6 [6%])
No deaths due to COVID-19 occurred
Within the randomized cohort, Grade 1-4 drug-related AEs occurred in 38% of participants through Week 96 and 42% of participants through Week 240²

[Table]
Randomized Cohort (n=272)
Safety outcome, n (%): Any AE; Grade 3-4 AEs; Any serious AE; AEs leading to discontinuation
Week 96: 249 (92); 78 (29); 92 (34); 14 (5)
Week 240: 259 (95); 110 (40); 122 (45); 17 (6)
Week 336: 259 (95); 125 (46); 130 (48); 19 (7)

Nonrandomized Cohort (n=99)
Safety outcome, n (%): Any AE; Grade 3-4 AEs; Any serious AE; AEs leading to discontinuation
Week 96: 98 (99); 49 (49); 48 (48); 12 (12)
Week 240: 98 (99); 60 (61); 55 (56); 13 (13)
Week 336: 98 (99); 62 (63); 58 (59); 13 (13)

*The safety population was inclusive of all participants who received ≥1 dose of study treatment. Of the 272 subjects enrolled in the randomized cohort, 1 subject who received placebo withdrew from the trial prior to receiving RUKOBIA in the open-label phase of the trial. †The primary safety assessment of RUKOBIA was based on Week 96 data from the RC.
AE=adverse event; IRIS=immune reconstitution inflammatory syndrome.

1. Aberg JA, et al. EACS 2025. Poster eP125. 2. Data on file, ViiV Healthcare.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
This includes adverse events, serious adverse events, and adverse events leading to discontinuation across both cohorts.
The safety profile through Week 336, approaching 7 years, was consistent with that observed through Week 240.
Through Week 336 in the randomized cohort, there were 12 drug-related serious adverse events, including 1 fatal event related to immune reconstitution inflammatory syndrome or IRIS.
In the nonrandomized cohort, there were 4 drug-related serious adverse events.
Adverse events leading to discontinuation were observed across both cohorts, occurring in 3% of participants in the randomized cohort and 6% in the nonrandomized cohort.
In the randomized cohort, Grade 1 to 4 drug-related adverse events occurred in 38% of participants through Week 96 and 42% of participants through Week 240.

ONSCREEN – Text + Table
ADVERSE REACTIONS THROUGH ~5 YEARS¹
AEs (GRADES 1-4) REPORTED IN ≥2% OF RANDOMIZED PARTICIPANTS TREATED WITH RUKOBIA + OBT THROUGH WEEK 240*

AE; RUKOBIA + OBT (n=271)^†
Nausea: 11%
Diarrhea: 4%
Headache: 4%
Dyspepsia: 3%
Fatigue^‡: 3%
IRIS: 2%
Somnolence: 2%
Vomiting: 2%

The safety and tolerability profile of RUKOBIA + OBT remained consistent with prior observations through Week 96, with no new safety trends²
Three additional adverse events were reported through Week 96^§: abdominal pain (3%),^¶ rash (3%),^# and sleep disturbance (3%)^‖
Through Weeks 96 and 240, the most common AEs leading to discontinuation were related to infections (3%)²
Serious drug reactions occurred in 3% of participants through Week 96, occurred in 4% of participants through Week 240, and included 3 cases of severe IRIS through Week 96²

*AEs in the nonrandomized cohort were similar to those observed in the randomized cohort. The most common AEs reported in nonrandomized patients at Week 96 were: nausea (6%), diarrhea (6%), vomiting (3%), fatigue (5%), and asthenia (2%). At Week 240, they were nausea (6%), diarrhea (6%), fatigue (5%), and asthenia (2%).^{1
†}Of the 272 participants enrolled in the randomized cohort, 1 participant who received placebo withdrew from the trial prior to receiving RUKOBIA in the open-label phase of the trial. ^‡Includes pooled terms: fatigue and asthenia.^{1
§}The primary safety assessment of RUKOBIA was based on Week 96 data from the RC.^{1,2
¶}Includes pooled terms: abdominal discomfort, abdominal pain, and abdominal pain upper. ^#Includes pooled terms: rash, rash generalized, rash maculo-papular, rash pruritic, and dermatitis allergic. ^‖Includes pooled terms: insomnia, sleep deficit, sleep disorder, and abnormal dreams.

1. Data on file, ViiV Healthcare. 2. Aberg JA, et al. Infect Dis Ther. 2023;12(9):2321-2335.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
Here we see adverse events that were reported in at least 2% of participants in the randomized cohort receiving RUKOBIA plus OBT through Week 240.
The most common adverse event was nausea, occurring in 11% of participants. Diarrhea and headache were each reported in 4%, with other adverse events occurring at lower rates, as shown here.
Three additional adverse events were reported through Week 96: abdominal pain, rash, and sleep disturbance, each occurring in 3% of participants.
Adverse events leading to discontinuation were most commonly related to infections, occurring in 3% of participants.
Serious drug reactions occurred in 3% of participants through Week 96 and in 4% of participants through Week 240, which included 3 cases of severe IRIS through Week 96.
Adverse events in the nonrandomized cohort were similar to those observed in the randomized cohort.

ONSCREEN – Dr. Jihad Slim + Text + Graphics
RUKOBIA RECOMMENDED DOSING

ONE 600 mg tablet
Do not chew, crush, or split.
Tablet shown is not actual size.

Taken twice daily

With or without food

Without dose adjustments for renal or hepatic impairment regardless of severity

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
Now let’s talk about dosing.
The recommended dosing for RUKOBIA is one 600 milligram tablet twice a day. It can be taken with or without food, and no dose adjustments are required for renal or hepatic impairment, regardless of the severity.

ONSCREEN – Dr. Jihad Slim + RUKOBIA Logo
Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
Let’s take a moment to summarize the key points from this video so far.

ONSCREEN – Dr. Jihad Slim + Text + Graphic

RUKOBIA PROVIDES A STRONG FOUNDATION FOR OPTIMIZED TREATMENT REGIMENS

UNIQUE MOA
The first-in-class attachment inhibitor that directly targets HIV-1 to protect* CD4⁺ T-cells^1,2

*Prevents HIV-1 from interacting with CD4⁺ T-cells by binding gp120.

1. Lataillade M, et al. Lancet HIV. 2020;7(11):e740-e751. 2. Gartland M, et al. J Antimicrob Chemother. 2021;76(3):648-652.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
We discussed RUKOBIA, the first and only attachment inhibitor that provides protection for the CD4⁺ T-cell by the unique mechanism of binding to viral gp120.

ONSCREEN – Dr. Jihad Slim + Text + Graphic
RUKOBIA PROVIDES A STRONG FOUNDATION FOR OPTIMIZED TREATMENT REGIMENS

DURABLE VIROLOGIC SUPPRESSION OBSERVED¹*
Results are descriptive.

Primary endpoint (RC): Adjusted mean decline in HIV-1 RNA at Day 8 was 0.79 log₁₀copies/mL (RUKOBIA 600 mg BID + failing regimen; n=201) vs 0.17 log₁₀ copies/mL (placebo + failing regimen; n=69); difference -0.625 (95% CI -0.810, -0.441); P<0.0001.
Additional endpoints (RC, RUKOBIA + OBT): Snapshot analyses (ITT‑E) virologic suppression (<40 copies/mL) was 53% at Week 24 (N=272) and 45% at Week 240 (N=267). Observed analysis virologic suppression was 58% at Week 24 (N=247) and 83% at Week 336 (N=72).
Mean CD4⁺ T-cell count increases from baseline (Observed Analysis): +90 cells/mm³ at Week 24 (N=228) and +357 cells/mm3 at Week 336 (N=68).
Due to attrition, analyses after Week 240 used observed data only.
All additional endpoint results are descriptive.
Observed analyses included only participants with available HIV-1 RNA and CD4⁺ data at each visit, which may favor those who benefited from treatment.
*Based on BRIGHTE Week 240 data.
1. Aberg JA, et al. EACS 2025. Poster eP125.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim
We also reviewed data from the registrational BRIGHTE trial, with follow-up at 336 weeks, which is approaching 7 years, providing insights into clinical trial data. Durable virologic suppression was observed through about 5 years, with extended observations approaching 7 years.

24d ONSCREEN – Dr. Jihad Slim + Text + Graphic
RUKOBIA PROVIDES A STRONG FOUNDATION FOR OPTIMIZED TREATMENT REGIMENS

ROBUST CD4⁺ T-CELL RECOVERY OBSERVED¹Results are descriptive.

Primary endpoint (RC): Adjusted mean decline in HIV-1 RNA at Day 8 was 0.79 log₁₀ copies/mL (RUKOBIA 600 mg BID + failing regimen; n=201) vs 0.17 log₁₀ copies/mL (placebo + failing regimen; n=69); difference -0.625 (95% CI -0.810, -0.441); P<0.0001.
Additional endpoints (RC, RUKOBIA + OBT): Snapshot analyses (ITT‑E) virologic suppression (<40 copies/mL) was 53% at Week 24 (N=272) and 45% at Week 240 (N=267). Observed analysis virologic suppression was 58% at Week 24 (N=247) and 83% at Week 336 (N=72).
Mean CD4⁺ T-cell count increases from baseline (Observed Analysis): +90 cells/mm³ at Week 24 (N=228) and +357 cells/mm3 at Week 336 (N=68).
Due to attrition, analyses after Week 240 used observed data only.
All additional endpoint results are descriptive.
Observed analyses included only participants with available HIV-1 RNA and CD4⁺ data at each visit, which may favor those who benefited from treatment.

1. Aberg JA, et al. EACS 2025. Poster eP125.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Dr. Jihad Slim

We also observed CD4⁺ T-cell recovery over time. Note that all these results are descriptive in nature.
RUKOBIA is the only therapy with the longest follow-up, approaching 7 yrs, for heavily treatment-experienced people living with MDR HIV-1.
Please continue watching for additional Important Safety Information.

ONSCREEN – Text
IMPORTANT SAFETY INFORMATION (cont’d)
Adverse reactions

The most common adverse reaction (all grades, randomized cohort) observed in ≥5% of subjects was nausea (10%).
81% of adverse reactions reported with RUKOBIA were mild or moderate in severity.

Drug interactions

See the full Prescribing Information for RUKOBIA for a complete list of significant drug interactions.
Temsavir may increase plasma concentrations of grazoprevir and voxilaprevir. Use an alternative hepatitis C virus regimen if possible.
Use the lowest possible starting dose for statins and monitor for statin-associated adverse events.
Patients receiving RUKOBIA should not take doses of estrogen-based therapies, including oral contraceptives, that contain more than 30 mcg/day of ethinyl estradiol. Caution is advised particularly in patients with additional risk factors for thromboembolic events.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Narrator
IMPORTANT SAFETY INFORMATION, continued.
Adverse reactions
The most common adverse reaction reported with RUKOBIA was nausea.
Drug interactions
See the full Prescribing Information for RUKOBIA for all significant drug interactions.
Temsavir may increase plasma concentrations of grazoprevir and voxilaprevir. Use an alternative hepatitis C virus regimen, if possible.
Use the lowest possible starting dose for statins with careful monitoring.
Patients receiving RUKOBIA should not take estrogen-based therapies that contain more than 30 mcg/day of ethinyl estradiol. Use RUKOBIA with caution in patients with additional risk factors for thromboembolic events.

ONSCREEN – Text
IMPORTANT SAFETY INFORMATION (cont’d)
Use in specific populations

Pregnancy: There are insufficient human data on the use of RUKOBIA during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established.
Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant.

To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at gsk.public.reportum.com or 1-877-844-8272, or FDA at 1-888-FDA-1088 or www.fda.gov/medwatch.

Please see the accompanying full Prescribing Information, also available at www.RUKOBIAHCP.com.

Rukobia (fostemsavir) extended-release tablets • 600 mg

AUDIO – Narrator
Use in specific populations
There are insufficient data on the use of RUKOBIA during pregnancy to assess drug-associated risks.
Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in the infant.
Please see the accompanying full Prescribing Information, also available at www.RUKOBIAHCP.com.

ONSCREEN – Dr. Jihad Slim + Text
Compensated by ViiV Healthcare.

Rukobia (fostemsavir) extended-release tablets - 600 mg

AUDIO – Dr. Jihad Slim
Thank you for your attention.
I hope this video has enhanced your understanding of the key clinical trial data for RUKOBIA, and you find this information useful in your practice.

ONSCREEN – Text + ViiV logo
[ViiV Healthcare logo]

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

For US HCPs only.
©2026 ViiV Healthcare or licensor.
PMUS-FSTVID260001 July 2026
Produced in USA.

AUDIO – MUSIC

Dr. Jihad Slim

Compensated by ViiV Healthcare.

In this video, Dr. Slim reviews the BRIGHTE trial, highlighting long-term RUKOBIA data in heavily treatment-experienced people living with multidrug-resistant HIV-1.

Onscreen text:
[RUKOBIA logo]

A CLOSER LOOK AT IDENTIFYING APPROPRIATE MDR HIV-1 PATIENTS

MDR HIV-1=multidrug-resistant human immunodeficiency virus type-1.

[Music]

Onscreen text:
A CLOSER LOOK AT IDENTIFYING APPROPRIATE MDR HIV-1 PATIENTS
Lower third graphic:
Dr. Charlotte-Paige Rolle
Internist, Infectious Disease Specialist
Orlando Immunology Center, Orlando, FL

Footnote at bottom of screen:
MDR HIV-1=multidrug-resistant human immunodeficiency virus type-1.

Dr. Rolle was a paid consultant for ViiV Healthcare at the time of filming.

[RUKOBIA logo]
DR. ROLLE: Hi, I’m Dr. Charlotte-Paige Rolle, an Infectious Disease Physician, board certified in Internal Medicine and Infectious Disease. In this video, we’re going to take a look at identifying appropriate patients for RUKOBIA.

Onscreen text:

Indication and Important Safety Information for RUKOBIA
My background and practice
Overview of BRIGHTE
How I identify patients for RUKOBIA
My experience treating patients living with multidrug-resistant HIV-1 with RUKOBIA

HIV-1=human immunodeficiency virus type-1.
[RUKOBIA logo]

DR. ROLLE: First, we'll review the Indication and some of the Important Safety Information for RUKOBIA, then I'll share a bit about my background and practice, followed by an overview of the BRIGHTE study patient population. Lastly, I’ll answer some key questions about how I identify patients for RUKOBIA and about my experience treating patients living with multidrug-resistant HIV-1 with RUKOBIA.

Onscreen text: Video will continue in: :40 (countdown to end of scene)

INDICATION
RUKOBIA, in combination with other antiretrovirals (ARVs), is indicated to treat HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen due to resistance, intolerance, or safety considerations.

IMPORTANT SAFETY INFORMATION
Contraindications

Do not use in patients with previous hypersensitivity to fostemsavir or any of the components of RUKOBIA.
Do not use RUKOBIA in patients receiving strong cytochrome P450 (CYP)3A inducers, including but not limited to enzalutamide, carbamazepine, phenytoin, rifampin, mitotane, and St John’s wort (Hypericum perforatum).

Please see additional Important Safety Information for RUKOBIA at the end of the video. Please click the link on this page to view the full Prescribing Information for RUKOBIA.
[RUKOBIA logo]

NARRATOR:
Indication
RUKOBIA, used with other HIV-1 medicines, is indicated for heavily treatment-experienced adults with multidrug-resistant HIV-1 who are failing their current ARV regimen.

IMPORTANT SAFETY INFORMATION
Contraindications Do not use in patients with previous hypersensitivity to fostemsavir or any of the components of RUKOBIA.

Do not use RUKOBIA in patients receiving strong cytochrome P450 (CYP)3A inducers, including those listed here.

Please see additional Important Safety Information for RUKOBIA at the end of the video. Please click on the link on this page to view the full Prescribing Information for RUKOBIA.

Onscreen text:

Trained at Brigham and Women’s Hospital
Infectious disease fellowship at Emory University
Primary or sub-investigator in over 100 clinical trials
Director of Research Operations, Orlando Immunology Center
Main site preceptor, University of Central Florida’s College of Medicine Focused Inquiry and Research Experience program
Time split roughly 70/30 between research and clinic

[RUKOBIA logo]

DR. ROLLE: So now, a little bit more about my background.
I trained at Brigham and Women’s Hospital and did an infectious disease fellowship at Emory University. I’ve been a primary or sub-investigator in over 100 clinical trials.
Currently, I’m the Director of Research Operations at the Orlando Immunology Center, where I oversee the institution’s investigator-sponsored research program. I’m also the main site preceptor for the University of Central Florida’s College of Medicine Focused Inquiry and Research Experience program. My time is split roughly 70/30 between research and clinic.

Onscreen text:
Orlando Immunology Center

Founded in 1999
Cares for ~5,000 people living with HIV-1

Population in my practice
~40% White
~30% Hispanic-Latinx
~25% African American-Black
~25% cisgender women

Large long-term, heavily treatment-experienced population

[RUKOBIA logo]

DR. ROLLE: The Orlando Immunology Center was founded in 1999 and takes care of approximately 5,000 people living with HIV. The population in my practice is roughly 40% White, 30% Hispanic-Latinx, 25% African American-Black, and 25% cisgender women.
About 40% of the people living with HIV are 50 years or older, so within that range of life experience, we have a large long-term, heavily treatment-experienced population. Many of our patients have been living with HIV since the late 1980s.

[Dr. Rolle On-screen]

DR. ROLLE: Because I’m one of 3 board-certified infectious disease physicians in our practice, many patients with complex HIV cases are sent to me, and I love taking care of this group. There is nothing more satisfying than helping a patient who’s previously been viremic for a long time due to a multitude of factors.

This is the situation in which I often find myself considering RUKOBIA.

Onscreen text:
Heavily treatment-experienced population

Multidrug resistance
Struggling to achieve or maintain viral suppression due to ARV resistance, Drug interactions, Challenging comorbidities

ARV=antiretroviral.

[RUKOBIA logo]

DR. ROLLE: I most frequently use this drug in our long-term, heavily treatment-experienced population. These patients have multidrug resistance and are struggling to achieve or maintain viral suppression due to antiretroviral resistance, drug interactions, or challenging comorbidities.

Onscreen text:

[RUKOBIA logo]

IDENTIFYING MDR HIV-1 PATIENTS

Onscreen text:
WHAT PERCENTAGE OF PATIENTS WITH HIV-1 IN THE US ARE MULTIDRUG-RESISTANT?

[RUKOBIA logo]

DR. ROLLE: So, what percentage of patients with HIV in the US are multidrug-resistant?

Onscreen text:
~29% of patients with HIV-1 in the US have been found to experience resistance to 2 or more classes of ARV therapy¹

[RUKOBIA logo]

DR. ROLLE: Research has shown that approximately 29% of patients with HIV-1 in the US experience resistance to 2 or more classes of antiretroviral therapy. You may have patients like this in your practice. While not all these patients are appropriate for RUKOBIA, those who are no longer successful on their current regimen with multidrug resistance may be.

Onscreen text:
[RUKOBIA logo]

WHO IS APPROPRIATE FOR RUKOBIA?

[Music]

Onscreen text:
INDICATION
RUKOBIA, in combination with other antiretrovirals (ARVs), is indicated to treat HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen due to resistance, intolerance, or safety considerations.

[RUKOBIA logo]

DR. ROLLE: When considering appropriate patients for RUKOBIA, we should start with the Indication.

Here we can see that we’re looking at heavily treatment-experienced adults with multidrug-resistant HIV-1 infection.

Importantly, they’re failing their current antiretroviral regimen due to any of 3 clinical factors: resistance; intolerance; or other safety considerations.

Onscreen text:

Resistance
Intolerance: Side effects of current regimen
Safety considerations: Drug interactions, Managing multiple comorbidities

[RUKOBIA logo]

DR. ROLLE: Resistance is clear. Intolerance, as you would expect, can include issues with side effects of the current regimen. Safety considerations may involve drug interactions or the need to manage multiple comorbidities.

Onscreen text:
Questions when evaluating patient’s current regimen

Is drug resistance limiting efficacy?
Is the treatment regimen unsuccessful due to tolerability issues?
Are drug interactions or new or existing comorbidities causing safety concerns?

[RUKOBIA logo]

DR. ROLLE: When patients are no longer successful on their current regimen, naturally, you’ll re-evaluate it, and the following broad questions can be helpful.
Is drug resistance limiting efficacy? Is the treatment regimen unsuccessful due to tolerability issues? Are drug interactions or new or existing comorbidities causing safety concerns?
If the patient is heavily treatment-experienced with MDR HIV-1 failing their current antiretroviral regimen, and the answer to any of these questions is “yes,” you may want to consider RUKOBIA as part of the patient’s optimized antiretroviral regimen.

Onscreen text:
[RUKOBIA logo]

BRIGHTE TRIAL

[Music]

Onscreen text:
WHO WERE THE PARTICIPANTS IN THE BRIGHTE TRIAL?

[RUKOBIA logo]

DR. ROLLE: Let’s take a closer look at the participants in BRIGHTE, the largest trial of RUKOBIA in people living with MDR HIV-1.

This was a representative population of people who are appropriate candidates for RUKOBIA.

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BRIGHTE

Total participants²:
371 individuals living with MDR HIV-1

Randomized Cohort (n=272)³
1 or 2 ARV classes remaining with ≥1 fully active agent per class

[RUKOBIA logo]

DR. ROLLE: In BRIGHTE, 371 participants were enrolled in one of two cohorts. 272 participants were enrolled in the randomized cohort. These participants had at least one, but no more than two, fully active antiretrovirals available at baseline. They were randomized to receive either fostemsavir or placebo, both added to their failing regimen, for 8 days.

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BRIGHTE

Nonrandomized Cohort (n=99)³
0 fully active and approved agents remaining
[RUKOBIA logo]

DR. ROLLE: 99 participants had no fully active antiretrovirals and entered the nonrandomized cohort. These individuals began open-label fostemsavir combined with an optimized background regimen on Day 1.

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BRIGHTE trial design²

Randomized Cohort (n=272)²
1 or 2 ARV classes remaining with ≥1 fully active agent per class

Blinded RUKOBIA 600 mg BID + failing regimen (n=203^*)
Blinded placebo + failing regimen (n=69)

Open-label RUKOBIA 600 mg BID + OBT^†

[Timeline of days and weeks noting days 01, 08, 09; and weeks 24, 48, 96, 192, and 240]

Nonrandomized Cohort (n=99)²0 fully active and approved ARV agents remaining

Open-label RUKOBIA 600 mg BID + OBT^†

Factors influencing participant numbers and data availability^3,4

COVID-19 from December 2019
US approval of RUKOBIA, July 2020
RUKOBIA available in Germany, March 2021

All participants in BRIGHTE were living with MDR HIV-1 and failing their current ARV regimens with a viral load of ≥400 copies/mL at enrollment.¹

BID=twice daily; OBT=optimized background therapy; RNA=ribonucleic acid.

*Two participants in the RUKOBIA + failing regimen arm who had missing Day 1 HIV-1 RNA values were not included in the analysis at Day 8.
^†Investigator-selected OBT (based on resistance testing and treatment history).²

[RUKOBIA logo]

DR. ROLLE: After Day 8, all participants in the randomized cohort switched to open-label fostemsavir plus an optimized background therapy tailored to their resistance profiles.

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BRIGHTE

Overall population⁵

Broad range of people living with MDR HIV-1
Age range: 18 to 73

[RUKOBIA logo]

DR. ROLLE: Consider some of the median entry or baseline characteristics of the broad range of people living with multidrug-resistant HIV-1 who participated in BRIGHTE.

They ranged in age from 18 to 73.

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BRIGHTE
Randomized cohort: baseline characteristics^2,5

Median age (years); HIV-1 RNA (range), median log₁₀copies/mL; CD4⁺T-cell count (range), median cells/mm³
18-48-73; 1.6-4.7-6.9; 0-99.5-1160

74% of overall participants were Male
68% of overall participants were White
22% of overall participants were Black/African American
10% of overall participants were Other Races

29% of the total population was Hispanic^2*

*Patients in the Hispanic ethnic group could also be included in a racial group.²

[RUKOBIA logo]

DR. ROLLE: In the randomized cohort, the median age was 48, and the median entry or baseline HIV-1 RNA level was 4.7 log. The median CD4 count was 99.5 cells.

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BRIGHTE
Nonrandomized cohort: baseline characteristics^2,5

Median age (years); HIV-1 RNA (range), median log₁₀copies/mL; CD4⁺T-cell count (range), median cells/mm³
17^*-50-72; 1.6-4.3-6.6; 0-41-641

90% of overall participants were Male
74% of overall participants were White
23% of overall participants were Black/African American
3% of overall participants were Other Races

28% of the total population was Hispanic^2†

*One patient was 17 years of age at enrollment and was classified as a protocol deviation.
^†Patients in the Hispanic ethnic group could also be included in a racial group.²

[RUKOBIA logo]

DR. ROLLE: In the nonrandomized cohort, the median age was 50, and the median entry or baseline HIV-1 RNA level was 4.3 log. At 41, the median CD4 count was much lower than that of the randomized cohort.

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Most common optimized background ARVs in BRIGHTE⁶

Dolutegravir
Darunavir
Tenofovir

[RUKOBIA logo]

DR. ROLLE: Patients in BRIGHTE were receiving RUKOBIA in combination with other antiretrovirals to optimize the antiretroviral regimen.

The most common antiretrovirals included in the background therapy were dolutegravir, darunavir, and tenofovir.

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BRIGHTE primary endpoint
Adjusted mean decline in HIV-1 RNA at Day 8 (randomized cohort):

0.79 log₁₀ copies/mL (RUKOBIA 600 mg BID + failing regimen, n=201) vs 0.17 log₁₀ copies/mL (placebo + failing regimen, n=69)

Difference: -0.625
(95% CI: -0.810, -0.441); P<0.0001

[RUKOBIA logo]

DR. ROLLE: The primary endpoint in BRIGHTE was the adjusted mean decline in HIV-1 RNA from Day 1 to Day 8 with RUKOBIA versus placebo in the randomized cohort.

The adjusted mean decline was 0.79 log with RUKOBIA twice daily plus failing regimen versus 0.17 log with placebo plus failing regimen.

The difference of -0.625 was statistically significant.

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Virologic outcomes

Virologically suppressed (HIV-1 RNA <40 copies/mL) patients in the ITT–E*
Snapshot Analysis (randomized cohort):

53% of patients at Week 24 (n=272)
60% of patients at Week 96 (n=272)
45% of patients at Week 240 (n=267)^†

Results are descriptive.

Additional Important Safety Information for RUKOBIA will be presented later in this video. Please see link on this webpage for full Prescribing Information for RUKOBIA.

*The ITT-E population included all randomized participants who received at least 1 dose of treatment. The FDA Snapshot Algorithm was used to evaluate rates of virologic suppression among all ITT-E patients. In the ITT-E population, missing data or change in OBT was counted as virologic failure.

^†At week 240, 7 participants in the randomized cohort had completed the study by transitioning to locally approved fostemsavir.

[RUKOBIA logo]

DR. ROLLE: Looking at virologic outcomes in the ITT–E Snapshot Analysis, 53% of patients were virologically suppressed at Week 24 and 60% of patients were suppressed at Week 96.

Here, virologic suppression was defined as an HIV-1 RNA less than 40 copies. The results are descriptive in nature.

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Opportunities to optimize ARV regimens if they’re no longer working in your patients with MDR HIV-1

[RUKOBIA logo]

DR. ROLLE: You may see patients with complex regimens that include entry inhibitors or twice-daily dolutegravir or darunavir.

If these regimens are no longer working for your patients with MDR HIV-1, there may be an opportunity to optimize these antiretroviral regimens.

Onscreen text:
Patients living with

Multidrug-resistant HIV-1
Who are failing their current ARV due to resistance, intolerance, or other safety considerations

[RUKOBIA logo]

DR. ROLLE: So, to summarize this section of the video: the Indication of RUKOBIA and the BRIGHTE study present us with heavily treatment-experienced adult patients living with multidrug-resistant HIV-1 who are failing their current antiretroviral therapy.

You may have patients like this in your practice who are struggling to maintain viral suppression due to resistance, intolerance, or other safety considerations.

Next, I’d like to pivot slightly and answer some questions about my experience identifying appropriate patients for RUKOBIA.

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IDENTIFYING RUKOBIA PATIENTS

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HOW DO YOU IDENTIFY APPROPRIATE PATIENTS FOR RUKOBIA?

[RUKOBIA logo]

DR. ROLLE: According to the Indication, RUKOBIA may be appropriate for individuals with MDR HIV-1 who are unsuccessful at maintaining viral suppression due to a number of clinical factors.

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If viremia is due to multidrug resistance, RUKOBIA may be an option.⁷

[RUKOBIA logo]

DR. ROLLE: For instance, when I encounter persistent viremia in a patient, I will ask myself whether the incorporation of RUKOBIA might be right for the patient in front of me.

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If regimens are failing due to safety concerns such as drug interactions or issues with other health conditions, I consider RUKOBIA.

[RUKOBIA logo]

DR. ROLLE: However, other scenarios may be more subtle. Comorbidities and drug interactions are a major consideration in the aging population, and sometimes I will even consider RUKOBIA in a patient with MDR HIV-1 failing treatment and on an antiretroviral that is causing a safety concern with other drugs or health conditions.

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[RUKOBIA logo]

HOW DO YOU KNOW WHEN A PATIENT IS FAILING THEIR REGIMEN?

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Causes of failure may include:

Resistance
Intolerance (side effects)
Safety considerations (drug interactions)

[RUKOBIA logo]

DR. ROLLE: The presence of persistent viremia is the most obvious sign of virologic failure. People with detectable, ongoing viremia for whom constructing a fully suppressive regimen has been a challenge may be candidates for the gp120-directed attachment inhibitor.

Onscreen text:
When viral loads are elevated, consider:

Repeating the viral load test
Investigating for causes of viremia

[RUKOBIA logo]

DR. ROLLE: You will only know whether a viral load is a blip or the first sign of virologic failure if you repeat it. That is why all elevated viral load tests should be repeated and investigated. Are they having any drug interactions leading to failure? Are there any tolerability or safety concerns contributing to failure?

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[RUKOBIA logo]

HOW DO YOU ADDRESS PATIENTS STRUGGLING WITH RESISTANCE, INTOLERANCE, OR SAFETY ISSUES?

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Prompted to consider RUKOBIA for MDR HIV-1 when

Patients fail ARV regimens due to tolerability, e.g., gastrointestinal concerns
Failing ARV regimen and treatment options are limited

[RUKOBIA logo]

DR. ROLLE: In patients who have been on treatment for a long time and present with viremia due to adverse events or tolerability issues, I consider RUKOBIA, as often their other treatment options are limited.

Onscreen text: PERFORM MEDICATION RECONCILIATION, INCLUDING OVER-THE-COUNTER DRUGS AND SUPPLEMENTS

[RUKOBIA logo]

DR. ROLLE: I am also very diligent with medication reconciliation, including the use of nonprescription drugs and over-the-counter supplements. Our aging patients are often on so many drugs with so many different providers, it can be overwhelming for them to tell us when new drugs are added.

So, it is our responsibility to make sure we ask. And in these instances, I have caught several drug interactions that required careful consideration.
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[RUKOBIA logo]

DR. ROLLE’S EXPERIENCE

[Music]

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WHAT PATIENT-SPECIFIC FACTORS DO YOU CONSIDER BEFORE PRESCRIBING RUKOBIA?

[RUKOBIA logo]

DR. ROLLE: Once you identify RUKOBIA may be an appropriate treatment, some factors to consider are drug interactions and adherence.

RUKOBIA is the first and only attachment inhibitor that offers a novel mechanism of action that patients may need. As I consult with my patients on adherence strategies, it's important to build an optimized routine.

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Common patient-specific factors when adding RUKOBIA

Adherence
Drug interactions with other ARVs⁶

[RUKOBIA logo]

DR. ROLLE: A significant concern providers have with any antiretroviral regimen is adherence, particularly with a twice-daily regimen. But some patients living with MDR HIV-1 are already on twice-daily antiretrovirals. In BRIGHTE, for instance, 84% of patients in the randomized cohort were on dolutegravir with 75% of that population on a twice-daily regimen.

I discuss adherence barriers with my patients, and I will often encourage them to identify other activities or drugs they might be taking twice daily and pair RUKOBIA with that.

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[RUKOBIA logo]

HOW DO YOU COUNSEL PATIENTS ABOUT THE POTENTIAL RISKS AND BENEFITS OF RUKOBIA?

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Ensure that patients

Know why RUKOBIA is being used
Understand proper adherence
Understand potential side effects of RUKOBIA

[RUKOBIA logo]

DR. ROLLE: Overall, I make sure that patients know RUKOBIA is being utilized to help them reach their HIV therapeutic goals of achieving and maintaining viral suppression. In order for the regimen to be successful, patients have to be counselled on adherence as well as the potential side effects of RUKOBIA and their OBT.

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I remind my patients starting RUKOBIA to tell me about any new

Side effects
Drugs added to their regimen
Symptoms from existing conditions

[RUKOBIA logo]

DR. ROLLE: I always remind patients to tell me about any new side effect that occurs after starting the drug, and to communicate with me any time they have new drugs added to their regimen.

I also talk to patients with advanced disease at baseline about monitoring their health, particularly if they have other conditions—and I ask them to let me know if they experience any new symptoms when they start RUKOBIA.

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[RUKOBIA logo]

HOW DO YOU INCORPORATE RUKOBIA INTO A PATIENT’S REGIMEN?

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Incorporating RUKOBIA

1) Decide RUKOBIA is the appropriate choice
2) Ensure RUKOBIA is accompanied by the right optimized background therapy before initiating

[RUKOBIA logo]

DR. ROLLE: Once you decide RUKOBIA is right for a patient, before you initiate it, you must ensure it’s being given with the right OBT. Sometimes this may require you to reconsider other components of the patient’s regimen to optimize the chances of virologic success. This requires a thorough review of the cumulative resistance tests and prior treatment history.

Hopefully you found this information useful, and you can now incorporate it into your clinical practice.

Onscreen text:
Please continue watching for Important Safety Information on RUKOBIA.

Please use the link on this webpage to view the full Prescribing Information for RUKOBIA.
[RUKOBIA logo]

DR. ROLLE: Please continue watching for Important Safety Information on RUKOBIA. Please use the link on this webpage to view the full Prescribing Information for RUKOBIA.

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[RUKOBIA logo]

IMPORTANT SAFETY INFORMATION CONT'D

NARRATOR:
Important safety information, continued.

Onscreen text:
IMPORTANT SAFETY INFORMATION (Continued)
Warnings and precautions

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of RUKOBIA.

QTc Prolongation with Higher than Recommended Dosages: RUKOBIA at 2,400 mg twice daily has been shown to significantly prolong the QTc interval of the electrocardiogram. Use RUKOBIA with caution in patients with a history of QTc interval prolongation or in patients with relevant pre-existing cardiac disease or who are taking drugs with a known risk of Torsade de Pointes. Elderly patients may be more susceptible to drug-induced QT interval prolongation.

Elevations in Hepatic Transaminases in Patients with Hepatitis B or C Virus Co-infection:

Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
Diligence should be applied in initiating or maintaining effective hepatitis B therapy when starting RUKOBIA in patients co-infected with hepatitis B.

Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of RUKOBIA and other drugs may occur (see Contraindications and Drug Interactions).

[RUKOBIA logo]

NARRATOR:
Warnings and precautions
Immune Reconstitution Syndrome and autoimmune disorders have been reported with the use of RUKOBIA.

QTc prolongation has occurred with higher than recommended dosages of RUKOBIA. Use RUKOBIA with caution in patients with a history of QTc interval prolongation or cardiac disease, or who are taking drugs with a known risk of Torsade de Pointes. Elderly patients may be more susceptible.

Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection. Diligence should be applied when starting RUKOBIA in patients receiving hepatitis B therapy.

Adverse reactions or loss of virologic response due to drug interactions may occur when using RUKOBIA with other drugs.

Onscreen text:
IMPORTANT SAFETY INFORMATION (Continued)
Adverse reactions

The most common adverse reaction (all grades, randomized cohort) observed in ≥5% of subjects was nausea (10%).
81% of adverse reactions reported with RUKOBIA were mild or moderate in severity.

Drug interactions

See the full Prescribing Information for RUKOBIA for a complete list of significant drug interactions.
Temsavir may increase plasma concentrations of grazoprevir and voxilaprevir. Use an alternative hepatitis C virus regimen if possible.
Use the lowest possible starting dose for statins and monitor for statin-associated adverse events.
Patients receiving RUKOBIA should not take doses of estrogen-based therapies, including oral contraceptives, that contain more than 30 mcg/day of ethinyl estradiol. Caution is advised particularly in patients with additional risk factors for thromboembolic events.

[RUKOBIA logo]

NARRATOR:
Adverse reactions
The most common adverse reaction reported with RUKOBIA was nausea.

Drug interactions
See the full Prescribing Information for RUKOBIA for all significant drug interactions.

Temsavir may increase plasma concentrations of grazoprevir and voxilaprevir. Use an alternative hepatitis C virus regimen, if possible.

Use the lowest possible starting dose for statins with careful monitoring.

Patients receiving RUKOBIA should not take estrogen-based therapies that contain more than 30 mcg/day of ethinyl estradiol. Use RUKOBIA with caution in patients with additional risk factors for thromboembolic events.

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IMPORTANT SAFETY INFORMATION (Continued)
Use in specific populations

Pregnancy: There are insufficient human data on the use of RUKOBIA during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established.
Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant.

To report suspected adverse reactions, contact ViiV Healthcare at gsk.public.reportum.com or 1-877-844-8272, or FDA at 1-888-FDA-1088 or www.fda.gov/medwatch.

Please see the accompanying full Prescribing Information or visit www.RUKOBIAHCP.com.

[RUKOBIA logo]

NARRATOR:
Use in specific populations
There are insufficient data on the use of RUKOBIA during pregnancy to assess drug-associated risks.

Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in the infant.

To report suspected adverse reactions, contact ViiV Healthcare at gsk.public.reportum.com or 1-877-844-8272, or FDA at 1-888-FDA-1088 or www.fda.gov/medwatch.

Please see the accompanying full Prescribing Information or visit www.RUKOBIAHCP.com.

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References:

Henegar C, Underwood M, Ragone L, et al. Trends and characteristics of HIV-1 drug resistance in the United States (2012-2018). Presented at: Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston, MA. Presentation 521.
Kozal M, Aberg J, Pialoux G, et al. Fostemsavir in adults with multidrug-resistant HIV-1 infection. N Engl J Med. 2020;382(13):1232-1243. doi:10.1056/NEJMoa1902493
Aberg JA, Shepherd B, Wang M, et al. Week 240 efficacy and safety of fostemsavir plus optimized background therapy in heavily treatment-experienced adults with HIV-1. Infect Dis Ther. 2023;12(9):2321-2335. doi:10.1007/s40121-023-00870-6
Aberg J, Shepherd B, Wang M, et al. Efficacy and safety of fostemsavir plus optimized background therapy in heavily treatment-experienced adults with HIV-1: week 240 results of the phase 3 BRIGHTE study. Poster presented at: 24th International AIDS Conference; July 29-August 2, 2022; Montreal, Canada. Poster EPB160.
Ackerman P, Thompson M, Molina JM, et al. Long-term efficacy and safety of fostemsavir among subgroups of heavily treatment-experienced adults with HIV-1. AIDS. 2021;35(7):1061-1072.
Lataillade M, Lalezari JP, Kozal M, et al. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. Lancet HIV. 2020;7(11):e740-e751. doi:10.1016/S2352-3018(20)30240-X
Pelchen-Matthews A, Borges AH, Reekie J, et al. Prevalence and outcomes for heavily treatment-experienced individuals living with human immunodeficiency virus in a European cohort. J Acquir Immune Defic Syndr. 2021;87(2):806-817.

[RUKOBIA logo]

[Music]

[ViiV Healthcare logo]

For US HCPs only.
Trademarks are property of their respective owners.
©2025 ViiV Healthcare or licensor.
PMUS-FSTVID250003 September 2025
Produced in USA.

Dr. Charlotte-Paige Rolle

Compensated by ViiV Healthcare.

Dr. Rolle talks about her experience treating patients living with MDR HIV-1 with RUKOBIA. In this video, Dr. Rolle discusses MDR HIV-1 and the BRIGHTE trial, explains how to identify a RUKOBIA patient, and shares her personal experience.

[Music]

[RUKOBIA logo]
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A CLOSER LOOK

Onscreen text:
A CLOSER LOOK

Lower third graphic:
Dr. Douglas Cunningham
Family Practitioner, Phoenix, AZ

Dr. Cunningham was a paid consultant for ViiV Healthcare at the time of filming.

[RUKOBIA logo]

DR. CUNNINGHAM:
Hello, I’m Dr. Doug Cunningham, board-certified in Family Practice and by the American Academy of HIV Medicine.

In the chapters of this video, we’ll take a closer look at 4 key topics:

Onscreen text:

The BRIGHTE trial of RUKOBIA
The efficacy profile of RUKOBIA
The unique mechanism of action of RUKOBIA, and
The safety profile of RUKOBIA

[RUKOBIA logo]

DR. CUNNINGHAM:

The BRIGHTE trial of RUKOBIA
The efficacy profile of RUKOBIA
The unique mechanism of action of RUKOBIA, and
Safety profile of RUKOBIA

As we cover each topic, we’ll walk through the basics, and then I’ll share my professional perspective as it relates to the topic at hand. First, we'll review the Indication and some of the Important Safety Information for RUKOBIA. I'll share a bit about my background and practice, and then we'll move into discussing the content.

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Video will continue in: :40 (countdown to end of scene)

INDICATION
RUKOBIA, in combination with other antiretrovirals (ARVs), is indicated to treat HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen due to resistance, intolerance, or safety considerations.

IMPORTANT SAFETY INFORMATION
Contraindications

Do not use in patients with previous hypersensitivity to fostemsavir or any of the components of RUKOBIA.
Do not use RUKOBIA in patients receiving strong cytochrome P450 (CYP)3A inducers, including but not limited to enzalutamide, carbamazepine, phenytoin, rifampin, mitotane, and St John’s wort (Hypericum perforatum).

Please see additional Important Safety Information for RUKOBIA at the end of the video. Please click the link on this page to view the full Prescribing Information for RUKOBIA.

[RUKOBIA logo]

NARRATOR:

Indication
RUKOBIA, used with other HIV-1 medicines, is indicated for heavily treatment-experienced adults with multidrug-resistant HIV-1 who are failing their current ARV regimen.

IMPORTANT SAFETY INFORMATION
Contraindications
Do not use in patients with previous hypersensitivity to fostemsavir or any of the components of RUKOBIA.

Do not use RUKOBIA in patients receiving strong cytochrome P450 (CYP)3A inducers, including those listed here.

Please see additional Important Safety Information for RUKOBIA at the end of the video. Please click on the link on this page to view the full Prescribing Information for RUKOBIA.

Onscreen text:
Dr. Douglas Cunningham
Family Practitioner, Phoenix, AZ

Practice primary healthcare with a focus on HIV/AIDS and HIV clinical research
Lecture extensively on HIV
Associate Professor, A.T. Still, Kirksville College of Osteopathic Medicine, Mesa, Arizona
35+ years providing care for patients with HIV and the LGBTQ community
Many patients with multidrug resistance and additional considerations, such as substance abuse and homelessness

[RUKOBIA logo]

DR. CUNNINGHAM:

A little bit about my background.

I currently practice primary healthcare with a focus on HIV/AIDS and HIV clinical research. I also lecture extensively on HIV both nationally and internationally, and I’m an Associate Professor at the A.T. Still, Kirksville College of Osteopathic Medicine in Mesa, Arizona.

For the past 35 years I have been providing care targeted at the specific medical and emotional needs of patients with HIV and the LGBTQ community.

Because I’ve been treating patients since the beginning of the epidemic, I have many patients with multidrug resistance. We see many patients with additional considerations, such as substance abuse and homelessness, so I have extensive experience meeting the special needs of these vulnerable populations. We take care of them just like they are family and we consider RUKOBIA when treating people living with multidrug-resistant HIV-1

Onscreen text:

We consider RUKOBIA when treating people living with multidrug-resistant HIV-1

HIV-1=human immunodeficiency virus type-1.

DR. CUNNINGHAM: We take care of them just like they are family, and we consider RUKOBIA when treating people living with multidrug-resistant HIV-1.

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WHAT DOES A CLOSER LOOK AT THE BRIGHTE TRIAL SHOW US?

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What does a closer look at the BRIGHTE trial show us?

DR. CUNNINGHAM:
In this chapter, we’ll take a closer look at the BRIGHTE trial of RUKOBIA.

I’ll take you through some essential features of BRIGHTE, the largest clinical trial of RUKOBIA in people living with multidrug-resistant HIV-1.

After that, I’ll share my perspective on the relevance of the trial design and participants to real-world treatment scenarios in people with multidrug-resistant HIV-1 who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

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WHO WERE THE TRIAL PARTICIPANTS?

DR. CUNNINGHAM: So, who were the trial participants?

Onscreen text: BRIGHTE

Total participants¹:
371 individuals living with MDR HIV-1

Failing current ARV regimen with viral load ≥400 copies/mL

ARV=antiretroviral; MDR HIV-1=multidrug-resistant human immunodeficiency virus type-1.

DR. CUNNINGHAM: In BRIGHTE, all 371 participants were living with multidrug-resistant HIV-1 and failing their current antiretroviral regimens with a viral load greater than or equal to 400 copies at enrollment.

Onscreen text:
BRIGHTE

Randomized Cohort (n=272)^1,2
1 or 2 ARV classes remaining with ≥1 fully active agent per class

Nonrandomized Cohort (n=99)^1,2
0 fully active and approved ARV agents remaining

DR. CUNNINGHAM: The 272 individuals in the randomized cohort had 1 or 2 antiretroviral classes left. The 99 individuals in the nonrandomized cohort had zero fully active and approved antiretroviral agents remaining.

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WHAT WAS THE TRIAL DESIGN?

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Randomized cohort¹
[BRIGHTEstudy design]
Nonrandomized cohort¹

BID=twice daily; OBT=optimized background therapy.

*Two participants in the RUKOBIA + failing regimen arm who had missing Day 1 HIV-1 RNA values were not included in the analysis at Day 8.
^†Investigator-selected OBT (based on resistance testing and treatment history).¹

DR. CUNNINGHAM: In the blinded phase, Days 1 through 8, participants in the randomized cohort received RUKOBIA 600 milligrams twice daily plus their failing regimen, or placebo plus their current failing regimen. In the following open-label phase, Day 9 through Week 240, they received RUKOBIA 600 milligrams twice daily plus optimized background therapy, or OBT. The OBT was investigator-selected based on resistance testing and treatment history.

Participants in the nonrandomized cohort received RUKOBIA 600 milligrams twice daily plus optimized background therapy from Day 1.

Onscreen text:
BRIGHTE
Randomized cohort: Baseline characteristics³

[Baseline characteristics, randomized cohort]

29% of the total population was Hispanic^1*

RNA=ribonucleic acid.

*Patients in the Hispanic ethnic group could also be included in a racial group.¹

DR. CUNNINGHAM: Let’s review some of the key characteristics of the broad range of people living with multidrug-resistant HIV-1 who participated in BRIGHTE.
Participants in the randomized cohort ranged in age from 18 to 73 with a median age of 48.

Onscreen text:
BRIGHTE
Nonrandomized cohort: Baseline characteristics^1,3

[Baseline characteristics, randomized cohort]

28% of the total population was Hispanic^1†

*One patient was 17 years of age at enrollment and was classified as a protocol deviation.¹
^†Patients in the Hispanic ethnic group could also be included in a racial group.¹

DR. CUNNINGHAM: In the nonrandomized cohort, the median HIV-1 RNA level was 4.3 log. The median CD4 count was 41, which was much lower than that of the randomized cohort.

Participants in the nonrandomized cohort ranged in age from 17 to 72 with a median age of 50.

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WHAT WERE THE TRIAL ENDPOINTS?

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Primary endpoint¹

Adjusted mean plasma HIV-1 RNA log10 change from Days 1 to 8 (randomized cohort)

Additional endpoints^1,2

Virologic suppression
Change in CD4+ T-cell counts
Additional endpoints were evaluated at Weeks 24, 48, 96, and 240

DR. CUNNINGHAM: The primary endpoint was adjusted mean plasma HIV-1 RNA log₁₀ change from Days 1 to 8 in the randomized cohort.

Additional endpoints included virologic suppression and change in CD4 counts.

[Music]

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WHY IS BRIGHTE IMPORTANT?

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The BRIGHTE trial¹
The largest trial of RUKOBIA in people living with MDR HIV-1

Provides critical evidence to support the use of RUKOBIA in a hard-to-treat population

DR. CUNNINGHAM: I believe that BRIGHTE is an excellent trial. With its 272 participants, it’s the largest clinical trial of RUKOBIA in people with multidrug-resistant HIV-1, and it included a broad range of patients who are representative of the populations we treat.
Importantly, patients in the randomized cohort had 1 or 2 antiretroviral classes remaining, while those in the nonrandomized cohort had zero fully active and approved antiretroviral agents remaining.

BRIGHTE is so important because it lets us know how multidrug-resistant patients could respond to RUKOBIA when they are failing their current antiretroviral regimen—whether for resistance, intolerance, or drug interactions.

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BRIGHTE gives us the evidence we need to be able to treat them confidently with RUKOBIA.

DR. CUNNINGHAM: As providers, we always do everything we can for these patients, and BRIGHTE gives us that evidence we need to be able to treat them confidently with RUKOBIA.

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WHAT DOES A CLOSER LOOK AT THE ANTIVIRAL ACTIVITY OF RUKOBIA REVEAL?

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Additional Important Safety Information for RUKOBIA will be presented later in this video. Please see link on this webpage for full Prescribing Information for RUKOBIA.

DR. CUNNINGHAM: Let’s take a closer look at the antiretroviral activity of RUKOBIA seen in BRIGHTE. Then, I’ll discuss how the antiretroviral activity of RUKOBIA helps reinforce my decision to use it in people living with multidrug-resistant HIV-1 who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

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Primary endpoint (randomized cohort):
Decline in mean plasma viral load at Day 8

[bar graph]

Additional Important Safety Information for RUKOBIA will be presented later in this video. Please see link on this webpage for full Prescribing Information for RUKOBIA.

CI=confidence interval.
*Two participants who received RUKOBIA with missing Day 1 HIV-1 RNA values were not included in this analysis.

DR. CUNNINGHAM: RUKOBIA showed superior antiretroviral activity at Day 8.

RUKOBIA added to their current failing antiretroviral regimen demonstrated significant antiretroviral activity compared with placebo, showing a mean treatment difference at Day 8 of -0.625 with a confidence interval of -0.810 to -0.441. Mean decline in HIV-1 RNA by Day 8 was 0.79 log in the randomized cohort.

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HOW DOES THE ANTIRETROVIRAL ACTIVITY SEEN IN BRIGHTE REINFORCE YOUR CONFIDENCE IN RUKOBIA?

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BRIGHTE demonstrates how RUKOBIA reduces viral load in patients with MDR HIV-1

DR. CUNNINGHAM: As you can see in these results from the BRIGHTE trial, the reduction in viral load was statistically significant, and this was achieved in a population of multidrug-resistant patients.

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WHAT CAN WE LEARN FROM A CLOSER LOOK AT RUKOBIA’S VIROLOGIC RESPONSE?

Onscreen text: What can we learn from a closer look at RUKOBIA’s virologic response?
[RUKOBIA logo]

DR. CUNNINGHAM: Let’s take a look at the virologic response RUKOBIA demonstrated in BRIGHTE.

Then, I’ll discuss how the virologic response of RUKOBIA helps affirm my choice to use it in people living with multidrug-resistant HIV-1 who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Onscreen text: Virologic response (HIV-1 RNA <40 copies/mL) for RUKOBIA + OBT through ~5 years (randomized cohort)^2,4,5

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Proportion of patients with a virological response of HIV-1 RNA <200 copies/mL at Week 20 was 50% in the Snapshot Analysis and 92% in the Observed Analysis.^4§

Results are descriptive.
At Week 240, 19 participants were unable to have their HIV-1 RNA values assessed due to the impact of COVID-19 and therefore counted as failures in the Snapshot Analysis.

*The observed analysis included only participants for whom HIV-1 RNA values were measured at each study visit, potentially favoring treatment successes.
^†The ITT–E population included all randomized participants who received at least 1 dose of treatment. The FDA Snapshot algorithm was used to evaluate rates of virologic suppression among all ITT–E participants. In the ITT–E population, missing data or change in OBT was counted as virologic failure.
^‡At Week 240, 12 participants (7 in the randomized cohort and 5 in the nonrandomized cohort) had completed the study by transitioning to locally approved fostemsavir (the first fostemsavir approval was in the US in July 2020).
^§In the randomized cohort at Week 96, the proportion of patients with HIV-1 RNA <200 copies/mL was 64% (ITT–E), Snapshot Analysis.

ITT–E=intent-to-treat—exposed.

DR. CUNNINGHAM: As you can see, at Week 24, 57% of participants in the randomized cohort achieved virologic suppression—that is, HIV-1 RNA less than 40 copies. At Week 96, 79% did so. At approximately 5 years, that is, at Week 240, 82% of participants in this population achieved virologic suppression. These results are descriptive.

Note that the observed analysis included only participants for whom HIV-1 RNA values were measured at each study visit, potentially favoring treatment successes.

The FDA Snapshot analysis was used to evaluate rates of virologic suppression among all intent-to-treat–exposed patients; patients who received at least 1 dose of treatment and missing data or change in OBT were counted as virologic failures.

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HOW DOES THE VIROLOGIC RESPONSE SEEN IN BRIGHTE REINFORCE YOUR CONFIDENCE?

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Virologic suppression of RUKOBIA^2,4,5

Has long-term clinical trial results
Enables us to help patients with MDR HIV-1 who were unable to achieve virologic suppression with previous treatment regimens

Additional Important Safety Information for RUKOBIA will be presented later in this video. Please see link on this webpage for full Prescribing Information for RUKOBIA.

DR. CUNNINGHAM: This is a case where the data speak for themselves. Even at roughly 5 years, 82% of patients in the randomized cohort achieved virologic suppression in the observed analysis. And these are, as we know, multidrug-resistant patients.

Before RUKOBIA, these patients were unable to achieve virologic suppression. Thankfully, RUKOBIA was an option for these patients in BRIGHTE.

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WHAT DOES A CLOSER LOOK AT THE CD4⁺ T-CELL RECOVERY OF RUKOBIA REVEAL?

DR. CUNNINGHAM: Let’s take a closer look at the CD4 T-cell recovery of RUKOBIA.

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WHAT IS THE RELEVANCE OF CD4⁺ T-CELLS?

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CD4⁺ T-cells play a crucial role in the immune system

Their levels relate to immunologic function

DR. CUNNINGHAM: As you know, CD4 T-cells play a crucial role in the immune system, and their levels are related to immunologic function.

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WHAT WERE THE CD4⁺ T-CELL RECOVERY RESULTS ACROSS SUBGROUPS?

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Increase in CD4⁺ T-cells with RUKOBIA + OBT through ~5 years (randomized cohort, observed analysis)^1,2,6

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Results are descriptive.
The observed analysis included only participants for whom CD4⁺ lab values were measured at each study visit, potentially favoring patients who benefited from treatment. All participant subgroups categorized by baseline CD4⁺ T-cell count experienced a mean CD4⁺ T-cell increase by Week 240, based on a subgroup analysis.

*At Week 240, 19 participants did not have their data included in this analysis due to the impact of COVID-19.
[RUKOBIA logo]

DR. CUNNINGHAM: In the randomized cohort taking RUKOBIA and OBT, observed-analysis population, robust CD4 recovery was seen across all participant subgroups categorized by baseline CD4 count. The observed analysis included only participants for whom CD4 lab values were measured at each visit, potentially favoring treatment successes.

Note that these results are descriptive.

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WHAT’S YOUR PERSPECTIVE ON THE IMPORTANCE OF CD4⁺ T-CELL RECOVERY?

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CD4⁺ T-cell recovery

At Week 240, 85% of patients (n=139) in the randomized cohort, observed analysis had CD4+ counts of ≥200 cells/mm3
Fewer AIDS-defining events and opportunistic infections

DR. CUNNINGHAM: Our closer look at the BRIGHTE trial results showed that 85% of patients in the randomized cohort, observed analysis had CD4 counts greater than or equal to 200 cells, and this was at roughly 5 years.

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WHAT DO WE SEE WITH A CLOSER LOOK AT THE MECHANISM OF ACTION OF RUKOBIA?

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What do we see with a closer look at the mechanism of action of RUKOBIA?

DR. CUNNINGHAM: Let’s take a closer look at the unique mechanism of action of RUKOBIA, the first and only attachment inhibitor. Then, I’ll share my perspective on the importance of this mechanism of action among treatments for people living with multidrug-resistant HIV-1.

Onscreen text: The three P’s

Prevent
Protect
Preserve

DR. CUNNINGHAM: An easy way to understand and remember how RUKOBIA works is through the 3 P’s. Prevent, protect, and preserve describe the essential actions of RUKOBIA’s novel mechanism of action.

Onscreen text: PREVENTS^3,7[image of RUKOBIA MOA]gp=glycoprotein.

DR. CUNNINGHAM: RUKOBIA prevents HIV-1 from attaching to CD4 T-cells by binding to the glycoprotein 120 subunit.

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PROTECTS³
[image of RUKOBIA MOA]
gp=glycoprotein.
[RUKOBIA logo]

DR. CUNNINGHAM: RUKOBIA protects uninfected CD4 T-cells from HIV-1.

Onscreen text: PRESERVES³[image of RUKOBIA MOA]

gp=glycoprotein.

DR. CUNNINGHAM: RUKOBIA preserves CD4 T-cell function by preventing viral replication.
The HIV-1 virions unable to attach to CD4 T-cells are a target for elimination by the body’s immune system.

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RUKOBIA is the first and only attachment inhibitor³

Prevents, protects, preserves
Works differently than other HIV-1 treatments

DR. CUNNINGHAM: Our closer look here shows how RUKOBIA is different: it is the first and only attachment inhibitor. It works by keeping HIV-1 from interacting with host immune cells.

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HOW DOES RUKOBIA’S MECHANISM OF ACTION REINFORCE YOUR CONFIDENCE IN THE DRUG?

Onscreen text: RUKOBIA mechanism of action^3,5,7,8

Unique
Protects CD4⁺ T-cells and preserves their function

DR. CUNNINGHAM: What I see as most important about the mechanism of RUKOBIA is that it’s an attachment inhibitor, which is unique. Nothing else works like RUKOBIA.

Also, due to this mechanism of action, we see potential protection of CD4⁺ T-cells.

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WHAT IS THE SAFETY PROFILE OF RUKOBIA?

Onscreen text:
What is the safety profile of RUKOBIA?

DR. CUNNINGHAM: Let’s take a closer look at the safety profile of RUKOBIA.

Then, I’ll discuss how the safety profile of RUKOBIA reinforces my decision to use it in people living with multidrug-resistant HIV-1 who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

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Key safety summary at Weeks 96 and 240^2,4

[safety summary table]AE=adverse event; SAE=serious adverse event.

DR. CUNNINGHAM: Let’s start by reviewing the key safety summary for RUKOBIA at Weeks 96 and 240.

Across the total population, serious drug reactions occurred in 3% of participants at Week 96 and 4% of participants at Week 240 and included 3 cases of immune reconstitution inflammatory syndrome, or IRIS.

Regarding discontinuation, across the total population of both randomized and nonrandomized cohorts, 7% and 8% of patients discontinued the study at Weeks 96 and 240, respectively. The most common adverse events leading to discontinuation were related to infections, which occurred in 3% of participants.

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Adverse reactions (grades 1-4) reported in ≥2% of randomized participants treated with RUKOBIA + OBT at Week 240⁴*

AE: Nausea; RUKOBIA + OBT (n=271)^†11%
AE: Diarrhea; RUKOBIA + OBT (n=271)^†4%
AE: Headache; RUKOBIA + OBT (n=271)^†4%
AE: Dyspepsia; RUKOBIA + OBT (n=271)^†3%
AE: Fatigue^‡; RUKOBIA + OBT (n=271)^†2%
AE: IRIS; RUKOBIA + OBT (n=271)^†2%
AE: Somnolence; RUKOBIA + OBT (n=271)^†2%
AE: Vomiting; RUKOBIA + OBT (n=271)^†2%

Three additional adverse reactions were reported at Week 96^§: abdominal pain; rash; and sleep disturbance^¶, each affecting 3% of participants.

*Adverse reactions in the nonrandomized cohort were similar to those observed in the randomized cohort. The most common adverse reactions reported in the nonrandomized patients at Week 96 were nausea (6%), diarrhea (6%), vomiting (3%), fatigue (5%), and asthenia (2%). At Week 240, they were nausea (6%), vomiting (3%), fatigue (5%), and asthenia (2%).
^†Of the 272 patients enrolled in the randomized cohort, 1 participant who received placebo withdrew from the trial prior to receiving RUKOBIA in the open-label phase of the trial.
^‡Includes pooled terms fatigue and asthenia.
^§The primary safety assessment of RUKOBIA was based on Week 96 data.
^¶Includes pooled terms insomnia, sleep deficit, sleep disorder, and abnormal dreams.

IRIS=Immune Reconstitution Inflammatory Syndrome.

DR. CUNNINGHAM: At Week 240, the safety and tolerability profiles of RUKOBIA plus optimized background therapy remained consistent with prior observations through 96 weeks, with no new safety trends.

As you can see at Week 240, the most common adverse reaction was nausea, which affected 11% of patients. Diarrhea and headache were both 4%. Also, note the additional adverse reactions reported at 3% and 2% in the chart.

Three additional adverse reactions were reported at Week 96: abdominal pain, rash, and sleep disturbance, each affecting 3% of participants.

In addition, adverse reactions in the nonrandomized cohort were similar to those observed in the randomized cohort.

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Safety profile for RUKOBIA^2,4

Characterized through ~5 years
Most common adverse event was nausea reported at 11%
Most common AEs leading to discontinuation were related to infections

DR. CUNNINGHAM: To sum up, our closer look shows that the safety profile of RUKOBIA has been characterized through approximately 5 years in the BRIGHTE trial, which included a broad range of people living with multidrug-resistant HIV-1.

The most common adverse event was nausea, reported at 11%, and the most common events leading to discontinuation were related to infections.

The safety profile was consistent with prior observations through 96 weeks, with no new safety trends.

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Summary of RUKOBIA^2,5,9

First and only attachment inhibitor that directly targets HIV-1 to protect CD4⁺ T-cells
Durable virologic suppression observed through ~5 years (Results are descriptive)
Robust CD4⁺ T-cell recovery observed through ~5 years (Results are descriptive)

DR. CUNNINGHAM: RUKOBIA is the first and only attachment inhibitor that directly targets HIV-1 to protect CD4⁺ T-cells. It has durable virologic suppression and robust CD4⁺ T-cell recovery observed through approximately 5 years.

RUKOBIA is the only therapy with approximately 5 years of clinical trial data designed specifically for people with multidrug-resistant HIV-1.

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Please continue watching for Important Safety Information on RUKOBIA. Please use the link on this webpage to view the full Prescribing Information for RUKOBIA

DR. CUNNINGHAM: Please continue watching for Important Safety Information for RUKOBIA. Please use the link on this webpage to see the full Prescribing Information for RUKOBIA.

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IMPORTANT SAFETY INFORMATION CONT'D

NARRATOR: Important safety information, continued.

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IMPORTANT SAFETY INFORMATION (Continued)
Warnings and precautions

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of RUKOBIA.

QTc Prolongation with Higher than Recommended Dosages: RUKOBIA at 2,400 mg twice daily has been shown to significantly prolong the QTc interval of the electrocardiogram. Use RUKOBIA with caution in patients with a history of QTc interval prolongation or in patients with relevant pre-existing cardiac disease or who are taking drugs with a known risk of Torsade de Pointes. Elderly patients may be more susceptible to drug-induced QT interval prolongation.

Elevations in Hepatic Transaminases in Patients with Hepatitis B or C Virus Co-infection:

Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
Diligence should be applied in initiating or maintaining effective hepatitis B therapy when starting RUKOBIA in patients co-infected with hepatitis B.

Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of RUKOBIA and other drugs may occur (see Contraindications and Drug Interactions).

NARRATOR:
Warnings and precautions
Immune Reconstitution Syndrome and autoimmune disorders have been reported with the use of RUKOBIA.

QTc prolongation has occurred with higher than recommended dosages of RUKOBIA. Use RUKOBIA with caution in patients with a history of QTc interval prolongation or cardiac disease, or who are taking drugs with a known risk of Torsade de Pointes. Elderly patients may be more susceptible.

Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection. Diligence should be applied when starting RUKOBIA in patients receiving hepatitis B therapy.

Adverse reactions or loss of virologic response due to drug interactions may occur when using RUKOBIA with other drugs.

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IMPORTANT SAFETY INFORMATION (Continued)
Adverse reactions

The most common adverse reaction (all grades, randomized cohort) observed in ≥5% of subjects was nausea (10%).
81% of adverse reactions reported with RUKOBIA were mild or moderate in severity.

Drug interactions

See the full Prescribing Information for RUKOBIA for a complete list of significant drug interactions.
Temsavir may increase plasma concentrations of grazoprevir and voxilaprevir. Use an alternative hepatitis C virus regimen if possible.
Use the lowest possible starting dose for statins and monitor for statin-associated adverse events.
Patients receiving RUKOBIA should not take doses of estrogen-based therapies, including oral contraceptives, that contain more than 30 mcg/day of ethinyl estradiol. Caution is advised particularly in patients with additional risk factors for thromboembolic events.

NARRATOR:
Adverse reactions
The most common adverse reaction reported with RUKOBIA was nausea.
Drug interactions
See the full Prescribing Information for RUKOBIA for all significant drug interactions.

Temsavir may increase plasma concentrations of grazoprevir and voxilaprevir. Use an alternative hepatitis C virus regimen, if possible.

Use the lowest possible starting dose for statins with careful monitoring.

Patients receiving RUKOBIA should not take estrogen-based therapies that contain more than 30 mcg/day of ethinyl estradiol. Use RUKOBIA with caution in patients with additional risk factors for thromboembolic events.

Onscreen text: IMPORTANT SAFETY INFORMATION (Continued)
Use in specific populations

Pregnancy: There are insufficient human data on the use of RUKOBIA during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established.
Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant.

To report suspected adverse reactions, contact ViiV Healthcare at gsk.public.reportum.com or 1-877-844-8272, or FDA at 1-888-FDA-1088 or www.fda.gov/medwatch.

Please see the accompanying full Prescribing Information or visit www.RUKOBIAHCP.com.

NARRATOR:
Use in specific populations
There are insufficient data on the use of RUKOBIA during pregnancy to assess drug-associated risks.

Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in the infant.

To report suspected adverse reactions, contact ViiV Healthcare at gsk.public.reportum.com or 1-877-844-8272, or FDA at 1-888-FDA-1088 or www.fda.gov/medwatch.

Please see the accompanying full Prescribing Information or visit www.RUKOBIAHCP.com.

Onscreen text: References:
1. Kozal M, Aberg J, Pialoux G, et al. Fostemsavir in adults with multidrug-resistant HIV-1 infection. N Engl J Med. 2020;382(13):1232-1243.
2. Aberg JA, Shepherd B, Wang M, et al. Week 240 efficacy and safety of fostemsavir plus optimized background therapy in heavily treatment-experienced adults with HIV-1. Infect Dis Ther. 2023;12(9):2321-2335, doi:10.1007/s40121-023-00870-6
3. Ackerman P, Thompson M, Molina JM, et al. Long-term efficacy and safety of fostemsavir among subgroups of heavily treatment-experienced adults with HIV-1. AIDS. 2021;35(7):1061-1072.
4. Data on file, ViiV Healthcare.
5. Lataillade M, Lalezari JP, Kozal M, et al. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. Lancet HIV. 2020;7(11):e740-e751. doi:10.1016/S2352-3018(20)30240-X
6. Aberg J, Shepherd B, Wang M, et al. Efficacy and safety of fostemsavir plus optimized background therapy in heavily treatment-experienced adults with HIV-1: week 240 results of the phase 3 BRIGHTE study. Poster presented at: 24th International AIDS Conference; July 29-August 2, 2022; Montreal, Canada. Poster EPB160.
7. Thompson M, Lalezari JP, Kaplan R, et al. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of Al438011, a Phase Ilb, randomized controlled trial. Antivir Ther. 2017;22(3):215-223.
8. Cahn P, Fink V, Patterson P. Fostemsavir: a new CD4 attachment inhibitor. Curr Opin HIV AIDS. 2018;13(4):341-345.
9. Gartland M, Zhou N, Stewart E, et al. Susceptibility of global HIV-1 clinical isolates to fostemsavir using the PhenoSense Entry assay. J Antimicrob Chemother. 2021;76(3):648-652. doi:10.1093/jac/dkaa474

[RUKOBIA logo]

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PMUS-FSTVID250002 September 2025
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