Revisions to the GENVOYA Label Approved

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.

Click here for the complete label.

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