(RTTNews) - Gilead Sciences, Inc. (GILD) on Thursday announced that the U.S. FDA has approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), a once-daily single tablet regimen for the treatment of HIV in virologically suppressed adults.
Bixlenvo is the first single-tablet regimen (STR) indicated for virologically suppressed adults who are unable to take currently available STRs, including those on complex HIV treatment regimens.
Bixlenvo combines bictegravir, an integrase strand transfer inhibitor, with Sunlenca (lenacapavir), a capsid inhibitor with a novel mechanism of action and no cross-resistance to other antiretrovirals.
The regimen requires a two-day initiation dose with lenacapavir, followed by once-daily oral Bixlenvo.
The approval was based on results from the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials, which evaluated virologically suppressed adults who switched to Bixlenvo from complex multi-tablet regimens or Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide).
ARTISTRY-1 included adults with extensive HIV treatment experience, with participants taking two to 11 pills per day at baseline.
The trial population had a median treatment duration of 28 years, while 67% of participants had nucleoside reverse transcriptase inhibitor resistance and 81% were receiving complex regimens because of antiretroviral resistance.
In both trials, Bixlenvo maintained comparable virologic suppression at Week 48 and was well tolerated. The most common adverse reactions reported in at least 2% of participants across the ARTISTRY program were headache, nausea and diarrhea.
The Phase 3 results demonstrated that switching to Bixlenvo was associated with improvements in certain fasting lipid parameters and participant-reported treatment satisfaction. The ARTISTRY-2 trial showed that switching to Bixlenvo had no significant impact on weight.
GILD closed Thursday at $148.86, up 0.52%. In the overnight market, the stock is up 0.44% at $149.52.