The U.S. Food and Drug Administration has approved Genvoya – a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide – as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
Genvoya is approved for use in HIV-infected adults and children aged 12 years and older weighing at least 35 kg (77 pounds) who have never taken HIV therapy and HIV-infected adults whose HIV-1 virus is currently suppressed. The FDA does not recommend Genvoya for patients with severe renal impairment, but says those with moderate renal impairment can take the drug.
Genvoya, which is marketed by Gilead Sciences in Foster City, Calif., contains a new form of tenofovir that has not been previously approved. The FDA says this new form of tenofovir was developed to help reduce some drug side effects, and provides lower levels of the drug in the bloodstream but higher levels within the cells where HIV-1 replicates.
According to Gilead Sciences, Genvoya was studied in a phase III HIV clinical program in more than 3,500 patients across 21 countries, including treatment-naive, virologically suppressed, renally impaired, and adolescent patients. The approval is supported by 48-week data from two phase III double-blind studies among 1,733 treatment-naive patients in which the regimen met its primary objective of noninferiority, compared with another FDA-approved HIV treatment. In the combined analysis of the studies, 92.4% of Genvoya patients and 90.4% of patients on the other treatment had HIV-1 RNA levels less than 50 copies/mL at week 48.
The FDA says Genvoya appears to be associated with less kidney toxicity and fewer decreases in bone density than previously approved tenofovir-containing regimens, based on laboratory measures. Patients receiving Genvoya had greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in the studies.
The new treatment carries a boxed warning alerting patients and health care providers that the drug can cause a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal. The boxed warning also states that Genvoya is not approved to treat chronic hepatitis B virus infection.