Videos and education on RUKOBIA

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[RUKOBIA logo]
Onscreen text:
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:

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• 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

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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.

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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
[BRIGHTE study 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.

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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.

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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.

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WHY IS BRIGHTE IMPORTANT?

Onscreen text:
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.

Onscreen text: 
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?

Onscreen text:

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. 

Onscreen text: 
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?

Onscreen text:
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

[line graph]

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?

Onscreen text: 
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?

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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

[Line graph]

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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Onscreen text:
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?

Onscreen text:
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.

Onscreen text: 
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.

Onscreen text: 
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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Onscreen text:
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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Onscreen text:

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.

Onscreen text: 
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.

Onscreen text: 
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.

Onscreen text: 
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.

Onscreen text: 
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.

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

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.

Onscreen text:
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).

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.

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.
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