[Press release] FDA approves Gilead’s Bixlenvo™, a new once-daily single tablet option for virologically suppressed adults with HIV, including those on complex regimens

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Gilead Sciences press release

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed. Bixlenvo is now the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs.

This novel HIV treatment pairs bictegravir, a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor that has a novel mechanism of action with no cross-resistance to other antiretrovirals.

Bixlenvo requires a two-day initiation dose with Sunlenca® (lenacapavir), thereafter only Bixlenvo is taken orally once a day.

Read the full press release here.

 

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