China's first pre-exposure prevention drug approved for HIV

On August 11th, Gilead Sciences announced that Shufatai (emtricitabine tenofovir tablets, emtricitabine 200mg/ tenofovir disoproxil fumarate 300mg, FTC/TDF) has been approved by the Chinese National Drug Administration Approved by the Administration, it is suitable for pre-exposure prevention (PrEP) combined with safe sex measures to reduce the risk of adults and adolescents (weight at least 35kg or more) acquiring HIV-1 through high-risk 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.

Sufatai is China's first drug approved for pre-exposure prevention of HIV in uninfected people. Previously, Shufatai has been approved in China for use in combination with other antiretroviral drugs to treat HIV-1 infection in adults and children over 12 years of age (inclusive).

Human immunodeficiency virus (HIV, also known as HIV) infects immune system cells, destroying or impairing their functions. Viral infection causes a progressive decline in the immune system, and finally "immune deficiency". When the immune system cannot play a role in fighting infections and diseases, it is considered immune deficiency. Infections associated with severe immunodeficiency are called "opportunistic infections" because these infections can only occur when the immune system is weakened. Acquired immunodeficiency syndrome (AIDS, also known as AIDS) is a term that refers to the final stage of HIV infection. Any one of more than 20 kinds of opportunistic infections, or any kind of tumors related to HIV, can be defined as AIDS.

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 infected persons, 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.

Currently, HIV antiretroviral therapy as an effective prevention method has produced three new concepts: pre-exposure prevention (PrEP), post-exposure prevention (PEP), and treatment is prevention (TasP). As early as 2012, the US FDA approved Sufatai (emtricitabine tenofovir tablets) combined with safe sex for HIV pre-exposure prevention (PrEP), which is the first HIV prevention drug in history. In the same year, Shufatai (emtricitabine tenofovir tablets) was approved in China, and it entered the national medical insurance catalog in 2017.

In the new round of national medical insurance drug catalogue adjustments, the star anticancer drug icoen baptide (E/C/F/TAF), as the only single-tablet compound treatment drug, entered the 2019 national medical insurance catalogue for Adults and adolescents infected with HIV-1 have dropped by more than 50%, greatly improving the accessibility of innovative drug treatments and alleviating the medication pressure of patients.

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 2,499 HIV seronegative men or transgender women who have sex with men. The partner PrEP trial included 4,758 heterosexual HIV-1 single positive couples. In total, 2,834 adults who are not infected with HIV-1 have used Sufatai. Compared with the placebo group, the number of new HIV-1 seroconversions in the population using Sufatai was significantly lower.