Gilead Sciences Announces NMPA Approval of Descovy for HIV Pre-Exposure Prophylaxis in China

China Finance and Economics News, January 8th, by reporter Du Ding: Gilead Sciences recently announced that Descovy (emtricitabine and tenofovir alafenamide tablets (Ⅱ), emtricitabine 200mg/tenofovir alafenamide 25mg, F/TAF) has been approved by the National Medical Products Administration (NMPA) for pre-exposure prophylaxis (PrEP) in adults and adolescents weighing at least 35kg who are at risk of human immunodeficiency virus type 1 (HIV-1) infection, to reduce the risk of HIV-1 infection due to high-risk sexual behavior.

Previously, Gilead's Emtricitabine and Tenofovir Alafenamide Tablets have been approved in China for use in combination with other antiretroviral drugs to treat HIV-1 infection in adults and adolescents (aged 12 years and above and weighing at least 35kg).

Pre-exposure prophylaxis (PrEP) refers to the method where individuals who have not yet been infected with HIV take specific antiretroviral drugs before engaging in behaviors that could potentially expose them to HIV, as a means to prevent HIV infection. It is an important biomedical approach for HIV prevention. The World Health Organization (WHO) recommends that populations at high risk of HIV should undergo pre-exposure prophylaxis and combine it with safe sexual practices to form a comprehensive set of HIV prevention measures. Additionally, with updates to authoritative guidelines both in China and internationally, pre-exposure prophylaxis has been further confirmed as one of the key strategies in HIV control and prevention.

Professor Wang Hui, Chief Expert of the AIDS Medicine Center at Shenzhen Third People's Hospital (Second Affiliated Hospital of Southern University of Science and Technology), stated that high-risk HIV groups can prevent the virus from establishing a long-term infection in the body by consistently taking antiviral drugs to maintain a certain concentration in the blood. "It is worth mentioning that both efficacy and safety are important considerations for the long-term use of pre-exposure prophylaxis (PrEP) drugs by high-risk HIV groups. The approval of Descovy’s new indication provides them with a new preventive option."

Descovy's approval in China this time is based on a randomized, double-blind, multicenter, Phase III clinical study (DISCOVER). The study results showed that Descovy demonstrated non-inferior efficacy compared to Truvada in preventing HIV, and both regimens had a low number of adverse events. In terms of safety, 96-week data showed that Descovy had a smaller impact on bone, kidney function, and blood lipids.

"To end the HIV epidemic, both prevention and treatment are indispensable. Gilead Sciences is not only committed to rapidly introducing and continuously expanding the accessibility of innovative therapies in China to meet the evolving needs of more populations from prevention to treatment, but will also continue to work together with the government, medical institutions, and all sectors of society to promote high-quality development in HIV prevention and treatment efforts. This supports the construction of 'Healthy China' and advances the early realization of the goal to end the HIV epidemic," said James Jin, Vice President of Gilead Sciences Global and General Manager of Gilead Sciences China.