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 weeks1,2*
 
UNIQUE MOA 3
Novel mechanism of action that directly targets HIV-1 and prevents HIV-1 from attaching to protect CD4+ cells3,4
 
ROBUST CD4+ RECOVERY 1
Proven through ~5 years1†
*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
LEARN MORE
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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A Podcast Series by ViiV Healthcare

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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.”

James, living with HIV.

Compensated by ViiV Healthcare.

DISCOVER RUKOBIA

BRIGHTE CLINICAL
TRIAL

Learn about the efficacy and safety of RUKOBIA in BRIGHTE

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DOSING AND DRUG
INTERACTIONS

Learn about administering RUKOBIA

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ViiV MEDICAL
INFORMATION

View our medical information library if you have a question about RUKOBIA

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A DEEPER LOOK AT RUKOBIA

RISKS & SIDE EFFECTS

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

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MOA

A NOVEL
MECHANISM
OF ACTION

Learn what makes RUKOBIA a first-in-class HIV-1 attachment inhibitor1,2

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EDUCATIONAL RESOURCES

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

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References:

  1. 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.
  2. Data on file ViiV Healthcare.
  3. 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.
  4. Gartland M, et al. J Antimicrob Chemother. 2021;76(3):648-652.

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