A new treatment for HIV has been approved by the U.S. Food and Drug Administration.
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“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, MD, the director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Genvoya was studied in a Phase III HIV clinical trial in more than 3,500 patients across 21 countries, including treatment-naive, virologically suppressed, renally impaired and adolescent patients.
The tablet is not recommended for patients with severe renal impairment, but is safe for patients with moderate renal impairment.
The combination, like Stribild, carries a Boxed Warning alerting patients and healthcare providers that the medication can cause lactic acidosis and severe hepatomegaly with steatosis, both of which can be fatal. Depending on the trial, participants were randomly assigned to receive Genvoya or another FDA approved HIV treatment.
Genvoya, a combination pill developed by Gilead Sciences Inc. that only has to be taken once a day, is the first if its kind to get the agency’s green light. The company offers financial assistance to patients unable to afford that. The company already has two other combination medicines that include TAF under review by the FDA.
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Three-drug HIV regimens including tenofovir disoproxil are widely used, but the drug results in high plasma levels of tenofovir itself, which leads in turn to bone and renal side effects. They showed Genvoya reduced blood levels of the HIV virus by about the same amount as the comparison treatments.
