FDA approved changes to the GENVOYA

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA approved changes to the GENVOYA

Information about FDA HIV product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.

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Recently, FDA approved changes to the GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), 150/150/200/10 mg fixed-dose combination tablet product labeling. The following main updates were made:

1. Longer term safety, efficacy and resistance data from 96 weeks of treatment from Study GS-US-292 0104 & GS-US-292 0111 (antiretroviral therapy (ART)-naive adults).

• GS-US-292-0104 entitled “A Phase 3, Randomized, Double-Blind Study to EvaluateThe Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1Positive, Antiretroviral Treatment- Naïve Adults”
• GS-US-292-0111 entitled “A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment- Naïve Adults”

2. Drug-drug interactions between Genvoya and the following co-administrated drugs in healthy subjects 1) ledipasvir/sofosbuvir fixed-dose combination tablet; and 2) sofosbuvir/velpatasvir fixed-dose combination tablet. No clinically significant drug interactions were observed when GENVOYA is combined with ledipasvir or velpatasvir.

3. In addition, the content of labeling was updated to include content and format revisions to the “Use in Specific Populations (Sections 8.1 and 8.2)” related to the Pregnancy and Lactation Labeling Rule (PLLR).

The updated label will soon be available drugs@fda or DailyMed

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the HIV Liaison Program visit the FDA Patient Network

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