The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc.’s (NASDAQ:GILD) Bixlenvo, a new treatment for adults with HIV who maintain virologic suppression.
The medication combines 75 mg of bictegravir and 50 mg of lenacapavir into the smallest once-daily single-tablet regimen available on the market today.
Bixlenvo offers the first and only single-tablet option for patients managing complex regimens who cannot use other available single-tablet therapies.
Patients complete a two-day initiation dose of Sunlenca before transitioning to the once-daily Bixlenvo regimen.
Clinical Trial Efficacy And Safety
The FDA based its approval on data from the Phase 3 ARTISTRY-1 and ARTISTRY-2 clinical trials. The trials evaluated virologically suppressed adults who switched from complex multi-tablet regimens or Biktarvy.
The new medication successfully maintained virologic suppression at the 48-week mark.
Participants generally tolerated the drug well, with no new safety concerns emerging. The most common adverse reactions, affecting at least two percent of patients across the program, included headache, nausea, and diarrhea.
Patient Demographics And Treatment Benefits
The ARTISTRY-1 study enrolled the oldest population in any Phase 3 HIV-1 registrational trial, featuring a median participant age of 60 years.
These individuals possessed extensive treatment histories, averaging 28 years of prior therapy. At the beginning of the trial, participants took between two and 11 pills daily, with many requiring multiple doses throughout the day due to high antiretroviral resistance.
Switching to the Bixlenvo tablet improved participant-reported treatment satisfaction and enhanced specific fasting lipid parameters.
Finally, the ARTISTRY-2 trial demonstrated that transitioning to this medication produced no significant impact on overall patient weight.
GILD Price Action: Gilead Sciences shares were up 0.49% at $146.40 at the time of publication on Monday, according to Benzinga Pro data.
Photo by Michael Moloney via Shutterstock
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