GILD · News · 20260827N

Product Launch and Transition

GILEAD SCIENCES, INC. · 2026-08-27 · Importance 58 · Surprise 42

The U.S. FDA approved Gilead’s Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg), a once-daily single-tablet regimen for virologically suppressed adults with HIV. Bixlenvo is positioned as the first and only single-tablet regimen for suppressed patients on complex regimens who cannot take currently available single-tablet options. The product combines bictegravir, the backbone of Biktarvy, with lenacapavir, which Gilead is also developing as a cornerstone of its longer-term HIV treatment and prevention strategy.

Key facts

• The once-daily tablet combines bictegravir, the backbone of Gilead's Biktarvy, with lenacapavir, described as a centerpiece of Gilead's long-term strategy for HIV treatment and prevention. source
• Bixlenvo™ is described as the smallest once-daily single tablet regimen (STR). source
• Bixlenvo™ is the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs. source
• Bixlenvo™ contains bictegravir 75 mg and lenacapavir 50 mg. source