On August 15, 2017, the FDA approved revisions to the GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) package insert to include 144 week safety, efficacy, and resistance data from Stuides GS-US-292 0104 and GS-US-292 0111 in antiretroviral treatment-naive adults. Additionally, drug-drug interaction data were updated.
The major revisions include the following:
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice
- Clinical Trials in Treatment-Naive Adults: The primary safety assessment of GENVOYA was based on Week 144 pooled data from 1,733 subjects in two randomized, double-blind, active-controlled trials, Study 104 and Study 111, in antiretroviral treatment-naive HIV-1 infected adult subjects. A total of 866 subjects received one table of GENVOYA once daily.
Section 7: DRUG INTERACTIONS was updated with clinical comments for corticosteroids.
Section 14: Clinical Studies was update to include the Week 144 efficacy data.