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.

Managing multidrug-resistant HIV-1 is challenging

Reimagine their treatment journey with RUKOBIA

A first-in-class attachment inhibitor that directly targets HIV-1 to protect CD4 ⁺ T-cells*

*Prevents HIV-1 from interacting with host immune cells by binding gp120, leaving CD4⁺ T-cells untouched.

RUKOBIA IS THE ONLY gp120
ATTACHMENT INHIBITOR,
AND IT MAY GIVE PATIENTS WITH LIMITED OPTIONS THEIR NEXT OPTION

RUKOBIA IS THE ONLY gp120 ATTACHMENT INHIBITOR, AND IT MAY
GIVE PATIENTS WITH LIMITED OPTIONS THEIR NEXT OPTION

EFFICACY AND SAFETY ^1,2

Durable and sustained virologic suppression proven through 240 weeks^1,2*

UNIQUE MOA ³

Novel mechanism of action that directly targets HIV-1 and prevents HIV-1 from attaching to protect CD4+ cells^3,4

ROBUST CD4+ RECOVERY ¹

Proven through ~5 years^1†

*Based on BRIGHTE 240-week data.1 ^†BRIGHTE was a Phase 3, partially randomized, international trial in people living with MDR HIV-1 with confirmed HIV-1 RNA ≥400 copies/mL. The randomized cohort (double-blind, placebo-controlled through Day 8, then open-label) enrolled 272 participants who had 1 or 2 ARV classes remaining due to resistance, intolerability, or contraindications. The primary endpoint was the adjusted mean decline in HIV-1 RNA at Day 8: 0.79 log₁₀copies/mL (RUKOBIA 600-mg BID + failing regimen, n=201) vs 0.17 log₁₀copies/mL (placebo + failing regimen, n=69); difference: -0.625 (95% CI: -0.810, -0.441); P<0.0001. At Week 240, 45% of participants in the Snapshot Analysis (ITT-E, HIV-1 RNA <40 copies/mL) and 82% in the Observed Analysis (only participants with HIV-1 RNA measurements that were monitored at each visit) were virologically suppressed vs 53% and 57% at Week 24. The mean increase in CD4+ T-cell counts from baseline to Week 240 was 296 cells/mm³. There were 30 discontinuations due to AEs (8%). The most common AEs leading to discontinuation were related to infections (3%). The most frequent Grade 2-4 drug-related AEs occurring in ≥2% of participants (N=371) were: nausea (5%), diarrhea (2%), headache (2%), and IRIS (2%). ^1,3

AE=adverse event; BID=twice daily; gp120=glycoprotein 120; HIV-1=human immunodeficiency virus type 1; IRIS=immune reconstitution inflammatory syndrome; MDR=multidrug-resistant; MOA=mechanism of action.

Take a different
look at MDR HIV-1

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Image is not real patient. Profiles are adapted from BRIGHTE study participant characteristics

~5-Year Data is Here! ^*

*Based on BRIGHTE 240-week data

~5-Year Data is Here!*

SEE STUDY RESULTS

*Based on BRIGHTE 240-week data

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"My name is James. I’m a heavily treatment-experienced person living with HIV. I have a great deal of hopefulness. I just have to remain positive.”

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A DEEPER LOOK AT RUKOBIA

Get information about the possible risks and side effects, including warnings and precautions and rates of discontinuation

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Learn what makes RUKOBIA a first-in-class HIV-1 attachment inhibitor^1,2

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View educational library for RUKOBIA, including videos and a downloadable resource

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References:

Aberg J, Shephard B, Wang, et al. Efficacy and safety of fostemsavir plus optimized background therapy in heavily treated-experienced adults with HIV-1: Week 240 results of the Phase 3 BRIGHTE study. Poster EPB160. Poster presented at; 24th International AIDS Conference; July 29-August 2, 2022; Montreal, Canada.
Data on file ViiV Healthcare.
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):740-751.
Gartland M, et al. J Antimicrob Chemother. 2021;76(3):648-652.

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ARROW

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.

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).

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.

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: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance, and adverse reactions in a breastfed infant.

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.

Please see full Prescribing Information for RUKOBIA.

FSTWCNT220012

To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at
1-877-844-8872 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.

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June 2023 Produced in USA.

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DISCOVER RUKOBIA

BRIGHTE CLINICAL TRIAL

DOSING AND DRUG INTERACTIONS

ViiV MEDICAL INFORMATION

A DEEPER LOOK AT RUKOBIA

RISKS & SIDE EFFECTS

A NOVEL MECHANISM OF ACTION

EDUCATIONAL RESOURCES

BRIGHTE CLINICAL
TRIAL

DOSING AND DRUG
INTERACTIONS

ViiV MEDICAL
INFORMATION

A NOVEL
MECHANISM
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