FOSTER CITY (dpa-AFX) - The U.S. Food and Drug Administration approved a
new, expanded indication for Biktarvy (bictegravir 50 mg/emtricitabine 200
mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV or PWH
who have suppressed viral loads with known or suspected M184V/I resistance, a
common form of treatment resistance, Gilead Sciences Inc. (GILD) said in a
statement.

HIV treatment resistance is permanent and irreversible, which can jeopardize
future treatment options for people with HIV.

The M184V/I resistance mutation has been found to be present in a range (22-63%)
of PWH with pre-existing resistance to nucleoside reverse transcriptase
inhibitors (NRTIs) across various HIV subtypes. This label update is supported
by Study 4030, which evaluated the efficacy, safety, and tolerability profile of
Biktarvy in a broad range of people with HIV-1 with or without pre-existing NRTI
resistance, including those with the M184V/I resistance.

The company noted that Biktarvy is now the first and only integrase strand
transfer inhibitor (INSTI)-based single-tablet regimen that is FDA approved and
U.S. Department of Health and Human Services (DHHS) guideline recommended for
PWH who are virally suppressed with M184V/I resistance.

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