National Medical Products Administration in China approved Gilead’s Biktarvy for HIV-1 infection
Updated: Aug 30, 2019
Gilead has announced that National Medical Products Administration in China has approved Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) for the treatment of HIV-1 infection. The drug is once a day oral administration. Biktarvy is combination of the novel bictegravir with Descovy® (emtricitabine 200mg/tenofovir alafenamide 25mg; FTC/TAF).
In China, the drug is indicated for the adult patients those who have not demonstrated resistance to the integrase class, emtricitabine, and tenofovir.
In China, it was estimated that 150,000 new patients were diagnosed with HIV in 2018. New patients are diagnosed because of the increase in screening procedures. Chinese government is providing free drugs for the treatment of HIV-1 infection since 2003.
The approval is based on the ongoing trials Studies 1489 and 1490. The studies include adult patients with HIV-1 infection. The trial consists of 2,414 patients across different geographies, age groups, and races/ethnicities. The primary endpoint is the non-inferiority. The drug has met the primary endpoint, Diarrhea, nausea, and headache are the common side effects observed.
Biktarvy can cause exacerbation of hepatitis B.