A new HIV combination therapy for the treatment of adults and children aged over 12 years has been approved in the United States by the US Food and Drug Administration (FDA).
The fixed-dose tablet contains a combination of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide and is marketed in the United States as Genvoya.
The tablet includes a new form of tenofovir designed to reduce the drug’s side effects: it offers lower levels of the drug in the patient’s bloodstream compared with tenofovir disoproxil but higher levels in the cells where HIV-1 replicates. The combination therapy, which provides patients with a single daily treatment, is associated with less kidney toxicity and decreases in bone density than previously approved tenofovir-containing regimens, the FDA says.
The drug is restricted to children who weigh at least 35kg who have never taken an HIV therapy or adults whose HIV infection is suppressed. It is not recommended for patients with severe renal impairment.
The FDA’s decision was based on the results of four clinical trials involving 3,171 patients who were randomly given Genvoya or another FDA-approved HIV therapy. Genvoya was found to be as effective as other treatments, the FDA says.
The drug — marketed by Gilead Sciences — comes with a boxed warning as it can trigger a build-up of lactic acid in the blood and can cause severe liver problems, both of which can be fatal.
The drug received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2015. The recommendation is awaiting ratification by the European Commission.