Gilead Sciences Inc. received the first approval for an HIV prevention medicine in China, with Truvada receiving the nod for use in adults and adolescents.
Truvada, which is a combination of emtricitabine and tenofovir disoproxil fumarate, can now be used as a pre-exposure prophylaxis, or PrEP, treatment to prevent HIV transmission in patients who weigh at least 35 kilograms.
The China National Medical Products Administration approved Truvada based on two clinical trials that showed that patients treated with the therapy had lower detectable HIV antibodies compared to the placebo arm.
Truvada is the first HIV prevention drug approved by China, Gilead said in an Aug. 11 press release. The therapy was previously approved in China in combination with other antiretroviral drugs to treat HIV-1 infection in patients ages 12 years and up.
About 131,000 new HIV infections were reported between January and October 2019 in China, according to the China National Health Commission's November 2019 report.
In the U.S., the medicine was initially approved in 2004 to treat HIV, the virus that causes AIDS, and in 2012, the U.S. Food and Drug Administration approved the use of Truvada as a PrEP treatment to prevent HIV transmission.