September 7, 2016
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).
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).
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