Gilead Sciences announced that the FDA has granted Priority Review to the company’s New Drug Application (NDA) for a once-daily, oral, fixed-dose combination of bictegravir and lenacapavir for the treatment of HIV in adults who are virologically suppressed on a stable antiretroviral regimen. The investigational single-tablet regimen combines the integrase strand transfer inhibitor bictegravir with the capsid inhibitor lenacapavir.
The NDA is supported by results from the Phase 3 ARTISTRY‑1 and ARTISTRY‑2 trials, which evaluated the safety and efficacy of the bictegravir/lenacapavir combination in people living with HIV who had previously achieved virological suppression on existing antiretroviral therapies. In these studies, participants were randomized either to switch to the once‑daily bictegravir/lenacapavir tablet or to continue their baseline regimen, including complex multi‑tablet regimens or the single‑tablet regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). The primary endpoint in both trials was the proportion of participants with HIV‑1 RNA ≥50 copies/mL at Week 48, assessed using the FDA snapshot algorithm.
According to Gilead, the Phase 3 data showed that switching to the bictegravir/lenacapavir regimen maintained virological suppression and met the predefined primary endpoints versus control regimens. The company reported that the safety profile of the investigational regimen was consistent with the known profiles of its individual components, with no new safety signals identified.
Gilead stated that the Priority Review designation is intended to expedite the FDA’s evaluation of the NDA, and that the company is working with regulators to potentially make the once‑daily bictegravir/lenacapavir regimen available as an additional treatment option for adults living with HIV who are virologically suppressed.
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