Today the U.S. Food and Drug Administration announced their approval of Gilead’s new HIV drug, Genvoya, which is the first complete regime that uses a new form of tenofovir (tenofovir alafenamide) to receive FDA approval. Genvoya was developed particularly for people with HIV who have experienced side effects like bone loss and kidney problems on other HIV meds, or poz people who had those issues prior to starting HIV treatment.“As the HIV patient population ages there is an increased risk for development of age- and treatment-related comorbidities, including low bone mineral density and renal impairment,” noted lead author David Wohl, of University of North Carolina at Chapel Hill’s Division of Infectious Diseases, in a joint press relase with Gilead (which recently announced a $20 million partnership with UNC Chapel Hill). “This is due to the combination of HIV infection, antiretroviral treatments, and the natural aging process.”
A fixed-dose combination tablet, Genvoya also contains some previously approved HIV medications (elvitegravir, cobicistat, emtricitabine). The new form of tenofovir in Genvoya works in such a way that it results in lower levels of the HIV drug in a patient’s bloodstream, but higher levels within the cells (where HIV-1 replicates).“Today’s approval of a fixed dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.A complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older, Genvoya is for patients who have never been on HIV therapy before (what researchers call “treatment naive”) as well as for those with HIV whose viral load is currently suppressed.
Genvoya’s safety and effectiveness were evaluated in 3,171 participants enrolled in four clinical trials. Participants were randomly assigned to receive Genvoya or another FDA-approved HIV treatment. Results showed Genvoya was comparable to the other treatment regimens in reducing viral loads but was also associated with less kidney toxicity and fewer decreases in bone density.“Given its demonstrated efficacy and safety profile,” says Wohl. “Genvoya represents an important new treatment option for a range of patients who are either new to therapy or who choose to switch treatments.”Patients receiving Genvoya had a greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in the studies. Those with moderate renal impairment can take Genvoya but the HIV drug is not recommended for patients with severe renal impairment.