RUKOBIA, the only gp120 attachment inhibitor, was developed specifically for MDR HIV-1 and received Breakthrough Therapy designation from the FDA in 20151†
Approaching 7 years of data2
Long-term data through 336 weeks of follow-up (see study details below)
Unique MOA3
Novel, first-in-class mechanism of action that directly targets HIV-1 and prevents HIV-1 from attaching to protect CD4+ T-cells3,4
†The FDA’s Breakthrough Therapy designation is a process designed to expedite the development and review of drugs intended to treat a serious condition where preliminary evidence suggests a substantial improvement over available therapies.
‡Based on BRIGHTE 336-week data.
BRIGHTE trial summary2,3,6-8
BRIGHTE is an ongoing 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. At Week 336, 80 participants were still enrolled in BRIGHTE (randomized cohort, n=72; nonrandomized cohort, n=8).
Primary endpoint (randomized cohort): 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 (96% CI; -0.810, -0.441; P<0.0001).
Additional endpoints (randomized cohort, RUKOBIA + OBT): Mean CD4+ cell count increases from baseline (Observed Analysis): +91 cells/mm3 at Week 24 (N=248) and +357 cells/mm3 at Week 336 (N=68).
Results are descriptive.
Due to attrition, analyses after Week 240 used observed data only.
Observed analyses included only participants with available CD4+ data at each visit, which may favor those who benefited from treatment.
When it's time to re-evaluate your patients' regimen, consider RUKOBIA
If your patients with MDR HIV-1 are on ARV regimens that are no longer successful due to RESISTANCE, INTOLERANCE, or SAFETY CONCERNS, they may be appropriate for RUKOBIA.
ViiVConnect Savings
See if your patients can save on their RUKOBIA prescriptions
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§Subject to eligibility and program terms and conditions. ViiVConnect Savings Programs do not constitute health insurance. Restrictions apply.
Edge of Yesterday: A podcast series by ViiV Healthcare
“When RUKOBIA was available through the BRIGHTE trial, patients were extremely excited…This was definitely a beacon of hope for them.”
—Dr. Cathy Creticos, BRIGHTE clinical trial investigator. Compensated by ViiV Healthcare.
Dosing and drug administration
Get more information about prescribing RUKOBIA as part of an optimized ARV regimen
ARV=antiretroviral; BID=twice daily; CI=confidence interval; FDA=US Food and Drug Administration; gp120=glycoprotein 120; HIV-1=human immunodeficiency virus type-1; MDR=multidrug-resistant; MOA=mechanism of action; OBT=optimized background therapy; RNA=ribonucleic acid.
References:
- Center for Drug Evaluation and Research. RUKOBIA new drug application. June 22, 2020. Accessed December 12, 2023. https://www.accessdata.fda.gov/
drugsatfda_docs/ nda/ 2020/ 212950Orig1s000RiskR.pdf - Aberg JA, Mendo Urbina F, Katlama C, et al. 7-year sustained efficacy, safety, and immunological improvement with fostemsavir-based regimens in individuals with HIV and limited treatment options. Poster presented at: 20th European AIDS Conference; October 15-18, 2025; Paris, France. Poster eP125.
- 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, 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.
- ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available. Press release. December 5, 2019. Accessed May 28, 2025. https://viivhealthcare.com/en-us/media-center/news/press-releases/2019/december/viiv-healthcare-submits-new-drug-application-to-the-fda-for-fost/
- 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
- 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
- Data on file, ViiV Healthcare.
PMUS-FSTWCNT260004
