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US FDA approves Gilead Sciences' single tablet regimen for HIV-1

The U.S. Food and Drug Administration approved Gilead Sciences Inc.'s new drug application for Biktarvy, a once-daily single tablet regimen for treating HIV-1 infection.

Biktarvy combines bictegravir, an integrase strand transfer inhibitor, as well as nucleoside reverse transcriptase inhibitors, emtricitabine and tenofovir alafenamide, or Descovy.

The triple-therapy is indicated to treat adults with HIV-1 infection who have not had any antiretroviral treatment.

Biktarvy can also replace current antiretroviral regimens in patients who are virologically suppressed for at least three months with no history of treatment failure and no known substitutions linked to resistance to the individual components of Biktarvy.

The label warns against initiating the therapy in patients with less than 30 mL/min of creatinine clearance, a test determining kidney function.

Biktarvy also has a boxed warning regarding the risk of post-treatment worsening of hepatitis B, a virus that infects the liver.

The application was based on four successful phase 3 studies among patients with either no prior treatment or virologically suppressed patients switching from another antiretroviral regimen.

Biktarvy is undergoing additional trials, including a dedicated study in women, as well as a study in adolescents and children living with HIV.

Gilead Sciences plans to present data from these studies at scientific conferences in 2018.

Biktarvy will compete with Juluca, a single-pill regimen from GlaxoSmithKline plc's HIV unit ViiV Healthcare, which got U.S. approval in November 2017.