Bictegravir Receives Expanded Indication by FDA to Treat HIV

The FDA has approved a new, expanded indication for bictegravir to treat people with HIV who have suppressed viral loads with known or suspected M184V/I resistance.

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The FDA has approved an expanded indication for bictegravir (Biktarvy; Gilead), which can be used to treat people with HIV (PWH) who have resistance to M184V/I, a pre-existing nucleoside reverse transcriptase inhibitor (NRTI), and who are virally suppressed. The medication can be used for people who have permanent treatment resistance, which affects approximately 22% to 63% of patients living with HIV.

This makes bictegravir the only integrase strand transfer inhibitor (INSTI)–based, FDA-approved, and HHS-guideline-recommended treatment for patients living with HIV who have M184V/I resistance and are virally suppressed.

“This label update builds on the established high resistance barrier of Biktarvy by showing that it’s effective in PWH who may have certain forms of pre-existing resistance or a history of past treatment failure,” Paul E. Sax, MD, Clinical Director, Division of Infectious Diseases, Brigham and Women’s Hospital, Professor of Medicine, Harvard Medical School, said in a press release.¹

Study 4030 was used as the basis of this approval, which included patients living with HIV-1 who did and did not have an NRTI resistance. The study evaluated bictegravir for its safety, efficacy, and tolerability in the target population. The double-blinded study included patients who were using dolutegravir (DTG) and either emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate at baseline. All participants either took bictegravir or DTG+F/TAF.

All patients were suppressed with their current regimen for at least 6 months if they had NRTI resistance documented or suspected and 3 months if resistance to NRTI was not documented or suspected.

A total of 47 patients taking bictegravir had HIV-1 with M184V/I resistance substitutions. The study aimed to assess how many patients had HIV RNA ≥ 50 copies/mL after 48 weeks.

After 48 weeks, 89% of the participants with M184V/I were still suppressed, with 11% not having any data at this point. All of the participants with M184V/1 who had virologic data after 48 weeks had HIV RNA below 50 copies/mL. Only 0.4% of participants in the bictegravir group had HIV-1 RNA that was 50 copies/mL or more compared with 1.1% in the DTG+F/TAF group (difference, –0.7%; 95% CI, –2.8% to 1.0%). No participant had resistance to bictegravir in the course of the treatment.

The safety profile remained consistent with the previous studies of bictegravir, which included diarrhea, nausea, and headache in 6%, 6%, and 5% of the participants, respectively.

“Clinical data have established Biktarvy as a long-term HIV treatment option for a broad range of PWH. With this label update, healthcare providers have a better understanding of the efficacy of Biktarvy in an underserved segment of PWH,” Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences, said in a press release.¹

A previous study² had shown that bictegravir could be used in combination for simplification following viral suppression. This new FDA approval could introduce bictegravir to a new population of patients living with HIV to better treat the disease past the point of treatment resistance.

References

1. U.S. FDA approves expanded indication for Gilead’s Biktarvy to treat people with HIV with suppressed viral loads, pre-existing resistance. Press release. Gilead. February 26, 2024. Accessed February 26, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/2/us-fda-approves-expanded-indication-for-gileads-biktarvy-to-treat-people-with-hiv-with-suppressed-viral-loads-preexisting-resistance
2. Klein HE. Triple therapy maintains HIV viral suppression in patients with mutation, prior virologic failure. The American Journal of Managed Care^® website. November 25, 2022. Accessed February 26, 2024. https://www.ajmc.com/view/triple-therapy-maintains-hiv-viral-suppression-in-patients-with-mutation-prior-virologic-failure