General Information

Genvoya is a four-drug combination of elvitegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), cobicistat, a CYP3A inhibitor, and emtricitabine and tenofovir alafenamide (TAF), both HIV 1 nucleoside analog reverse transcriptase inhibitors (NRTIs).

Genvoya is specifically indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya.

Genvoya is supplied as tablets for oral administration. Prior to initiation of Genvoya patients should be tested for hepatitis B infection. The recommended dose is one tablet taken orally once daily with food.

Clinical Results

FDA Approval

The FDA approval of Genvoya was based on a Phase 3 HIV clinical program in more than 3,500 patients across 21 countries, including treatment-naïve, virologically suppressed, renally impaired and adolescent patients. The approval was supported by 48-week data from two Phase III double-blind studies (Studies 104 and 111) among 1,733 treatment-naïve patients in which the regimen met its primary objective of non-inferiority compared to Stribild (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF). In the combined analysis of the studies, 92.4% of Genvoya patients and 90.4% of Stribild patients had HIV-1 RNA levels less than 50 copies/mL at Week 48. Tests of certain renal and bone laboratory parameters also favored Genvoya over Stribild. Approval was supported by a Phase III study (Study 109) evaluating Genvoya among virologically suppressed patients who switched from TDF-based regimens. The study enrolled 1,436 subjects and 1,196 had reached the 48-week time point at the time of filing. Among those patients, Genvoya was found to be statistically non-inferior to the TDF-based regimens based on the percentages of patients with HIV-1 RNA levels less than 50 copies/mL at Week 48. Patients receiving Genvoya also demonstrated improvements in certain bone and renal laboratory parameters compared to those treated with the TDF-based regimens. In addition, data from Phase III studies evaluating Genvoya among adolescents and patients with mild-to-moderate renal impairment supported the approval.

Side Effects

The most common adverse effect associated with the use of Genvoya is nausea.

Genvoya comes with the following black box warning:

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs. Genvoya is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with Genvoya. Hepatic function should be monitored closely in these patients. If appropriate, initiation of anti-hepatitis B therapy may be warranted.