Gilead Sciences Inc. said its once-daily HIV-1 drug Biktarvy has been approved by the China National Medical Products Administration.
The Foster City, Calif.-based biotechnology company's Biktarvy tablet combines bictegravir and two other drugs, emtricitabine and tenofovir alafenamide — the components of Gilead's HIV drug Descovy.
Biktarvy's approval in China is based on data from four late-stage studies in 2,414 patients. Two of these phase 3 trials, dubbed 1489 and 1490, were carried out in HIV-1 infected adults who had never received any treatment.
The other two trials, known as 1844 and 1878, enrolled patients whose viral load was at an undetectable level and they had switched from another antiretroviral regimen. Undetected viral load does not mean a person is cured as HIV still remains in the body and will return to detectable levels once the treatment is discontinued.
After 48 weeks of treatment, Biktarvy showed that it worked as well as a comparator antiretroviral treatment. None of the participants in any of the four studies developed treatment-emergent virologic resistance while taking Biktarvy, and no patients discontinued Biktarvy due to renal, bone or hepatic adverse events.
The single-tablet regimen was approved to treat HIV-1 infection in the U.S. and Japan in February 2018 and March 2019, respectively. Total sales of Biktarvy for the second quarter of 2019 were $1.12 billion.