China News Service, Beijing, August 12 (Reporter Li Yanan) Gilead Sciences recently announced that Sufatai (emtricitabine tenofovir tablets, emtricitabine 200mg/ tenofovir disoproxil fumarate 300mg, FTC/TDF) has been approved by the National Medical Products Administration of China. It is suitable for pre-exposure prevention (PrEP) combined with safe sex measures to reduce adults and adolescents (weight at least 35kg or more) from acquiring HIV through high-risk sex. 1 risk.
Sufatai is China's first drug approved for pre-exposure prevention of HIV in uninfected people. Prior to this, Shufatai has been approved domestically for use in combination with other antiretroviral drugs to treat HIV-1 infection in adults and children over 12 years of age (inclusive). Pre-exposure prophylaxis (PrEP) is an HIV prevention strategy in which HIV-negative individuals take drugs to help reduce the risk of infection before exposure to the virus that may occur through sex. Shufatai is used for pre-exposure prevention, which requires one tablet per day, combined with safe sex measures. Before using Sufatai for pre-exposure prophylaxis, the HIV-1 test result of the user must be negative.
According to data released by the National Health Commission in November 2019, a total of 131,000 cases of HIV infection were found in a new national report from January to October 2019. Among newly reported infections, sexual transmission has become the main route of transmission. In addition to adopting safe sex and using condoms correctly, the World Health Organization (WHO) recommends pre-exposure prevention for people at high risk of HIV to form a comprehensive set of HIV prevention measures.
Professor Zhang Fujie, Director of the Infection Clinic and Research Center of Beijing Ditan Hospital of Capital Medical University, said: “Shufatai's approval as a pre-exposure prophylaxis meets the huge domestic demand in the field of HIV drug prevention and will bring a better life to people in need. It is a safe and effective new choice for prevention. As a pre-exposure prophylaxis, Shufatai will play an important role in our response to the HIV epidemic and help reduce the number of new HIV infections in China."
According to reports, the approval of Sufatai's PrEP indication is based on two randomized, double-blind, placebo-controlled clinical trials, namely the iPrEx trial and the partner PrEP trial. Among them, the iPrEx test enrolled 2499 HIV seronegative men or transgender women who have sex with men. The partner PrEP trial included 4758 heterosexual HIV-1 single positive couples. In total, a total of 2,834 adults who were not infected with HIV-1 used Sufatai. Compared with the placebo group, the number of new HIV-1 seroconversions in the population using Sufatai was significantly lower.
The pre-exposure prophylaxis effect of Sufatai is highly correlated with compliance. Among the subjects taking Sufatai, the common adverse reactions were headache, abdominal pain and weight loss.
In the United States, pre-exposure prophylaxis can be used to reduce the risk of HIV-1 in adults or adolescents (weight at least 35 kg or more) at high risk of HIV infection. Before starting the pre-exposure prophylaxis, the user must have a negative HIV-1 test result. (Finish)