An investigational single-tablet regimen (STR) from Gilead was shown to be statistically non-inferior to multi-tablet regimens in a phase 3 trial treating adults with HIV who are virologically suppressed.
The novel HIV therapy consists of 75 mg of bictegravir and 50 mg of lenacapavir (BIC/LEN). The phase 3 Artistry-1 open-label trial met its primary endpoint, which set the proportion of participants with HIV-1 RNA levels of ≥50 copies/mL as defined by the FDA snapshot algorithm. The drug was also generally well tolerated.
Participants in the trial were previously taking between two and 11 pills per day, with around 40% taking their antiretrovirals at least twice a day. Such regimens complicate adherence, reduce quality of life, and may mean a high pill burden. BIC/LEN could provide a new option for people with HIV-1 who are currently unable to benefit from STRs due to pre-existing resistance, tolerability issues, or drug–drug interactions.
Gilead will be filing data from the trial along with data from its Artistry-2 trial, which will evaluate the safety and efficacy of switching from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) to BIC/LEN.