Gilead Sciences receives FDA approval for new once-daily HIV pill

The FDA has approved Bixlenvo, a new once-daily single-pill HIV treatment developed by Gilead Sciences. The medication combines bictegravir with the capsid inhibitor lenacapavir. It is designed for adults whose HIV is already under control but who require a less complex regimen, a group that includes approximately five percent of HIV-positive individuals in the United States.

In a separate development, an international Phase 3 trial known as ISLEND-2 has shown that an experimental once-weekly pill combining Merck’s islatravir and Gilead’s lenacapavir is as effective as standard daily therapy. The trial, which involved 626 adults across 14 countries, found that the weekly regimen maintained viral suppression in nearly all participants after 48 weeks, with high levels of patient adherence.