Bictegravir Maintains High Efficacy in Phase 3 HIV Clinical Trials

In 2 randomized, double-blind phase 3 studies of bictegravir (Biktarvy, Gilead Sciences), the treatment demonstrated high rates of virologic suppression through week 144 and was found to be well-tolerated and .

Bictegravir is indicated as a complete regimen for the treatment of HIV-1 infection in patients who have no antiretroviral treatment history or to replace the current antiretroviral regimen in patients who are virologically suppressed on a stable antiretroviral regimen for at least 3 months. The US product label contains a boxed warning related to the risk of post-treatment acute exacerbation of hepatitis B.

In studies 1489 and 1490, 1274 treatment-free patients were randomized to receive either bictegravir, dolutegravir/abacavir/lamivudine, or DTG + emtricitabine/tenofovir alafenamide. Noninferior efficacy was achieved in both studies at the primary endpoint, along with virologic suppression, defined as the proportion of participants who were virologically suppressed at week 48. Across all treatment groups, no participants developed treatment failure with treatment-emergent resistance.

No discontinuations because of Fanconi syndrome, proximal renal tubulopathy, or renal events were reported in the bictegravir treatment group. Similar median changes in proteinuria and mean percentage changes in hip and spine bone mineral density from the baseline were seen in both treatment groups.

Bictegravir was well tolerated through week 144, with all groups showing low levels of discontinuations from adverse events. The proportion of drug-related adverse events was 26% in the bictegravir arm, versus 42% and 29% in the other groups. The most commonly reported treatment-emergent adverse events in all groups included diarrhea, headache, and nasopharyngitis.

Beyond week 144, study participants have the option to receive bictegravir in an open-label extension for up to 96 weeks.

Reference

Gilead’s biktarvy maintained high efficacy with no cases of treatment-emergent resistance through three years in phase 3 clinical trials [news release]. Foster City, CA; Gilead Sciences: November 6, 2019. gilead.com/news-and-press/press-room/press-releases/2019/11/gileads-biktarvy-maintained-high-efficacy-with-no-cases-of-treatment-emergent-resistance-through-three-years-in-phase-3-hiv-clinical-trials. Accessed December 4, 2019.