FDA approved on November 5 a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (Genvoya—Gilead Sciences) as a complete regimen for the treatment of HIV-1 infection. The combination drug is approved for adults and children with HIV who are aged 12 years and older, weighing at least 77 pounds, and are treatment-naive and for adults whose HIV-1 virus is currently suppressed. Patients with moderate renal impairment can take the new drug; however, it is not recommended for those with severe renal impairment. Four clinical trials involving more than 3,100 participants showed that the combination drug was effective in reducing viral loads and comparable to other treatment regimens. FDA notes that the tablet includes a new form of tenofovir that has not been previously approved; the drug provides lower levels of tenofovir in the bloodstream but higher levels with the cells where HIV-1 replicates. However, the new drug also includes a boxed warning alerting patients and providers that the drug can cause a buildup of lactic acid in the blood and severe liver problems. The boxed warning notes that the drug is not approved to treat chronic hepatitis B virus infection. Nausea is the most common adverse event associated with the drug; however, serious adverse events include new or worsening kidney problems, decreased bone mineral density, and immune reconstitution syndrome.
Source: FDA News Release