AIDS is a serious disease caused by human immunodeficiency virus (HIV) infection. With the establishment of cocktail therapy and the gradual optimization of treatment plan, AIDS has become a controllable chronic disease, but prevention is better than treatment.
Recently, Gilead Scientific announced that its new indication for pre exposure prophylaxis (PrEP) with Dakevone (Enrofloxacin Propranolovir Tablets (II)) has been approved by the National Medical Products Administration (NMPA) of China, making it Gilead's second approved PrEP indication drug. Previously, Enqutabine Norfovir Tablets (Shufatai) were approved in 2020, becoming the first drug in China approved for pre exposure prevention of HIV in uninfected populations.
It is reported that Dakovic was previously approved for marketing in China in 2018, and is suitable for combined use with other antiretroviral drugs to treat HIV-1 infections in adults and adolescents (aged 12 years and above and weighing at least 35kg); The newly approved new indications are for pre exposure prophylaxis (PrEP) for adults and adolescents weighing at least 35kg who are at risk of human immunodeficiency virus type 1 (HIV-1) infection, excluding those at risk due to vaginal intercourse.
At present, AIDS prevention strategies are mainly divided into two categories. One is behavioral intervention measures, including partner education, needle exchange, promotion of condom use, etc. Another type is biomedical intervention measures, including circumcision, sexually transmitted disease treatment, mother infant blockade, pre exposure prophylaxis (PrEP), post exposure prophylaxis (PEP), and treatment as a preventive measure (TasP).
PrEP is a novel and effective biological prevention method that prevents HIV infection by taking antiviral drugs. It is suitable for high-risk individuals with HIV-1 negative, who start taking medication before engaging in high-risk behaviors for pre prevention.
The World Health Organization (WHO) recommends that high-risk individuals for HIV should undergo pre exposure prevention, combined with safe sexual behavior, to form a comprehensive set of HIV prevention measures.
Professor Wang Hui, chief expert of the AIDS Medical Center of Shenzhen Third People's Hospital (the second affiliated hospital of South University of Science and Technology), said: "HIV high-risk groups maintain a certain concentration of drugs in the blood by insisting on taking antiviral drugs, so as to prevent HIV from establishing long-term infection in the body. Both efficacy and safety are important considerations for HIV high-risk groups to take preventive drugs before long-term exposure."
According to Gilead Science, the approval of Dakvos in China was based on a randomized, double-blind, multicenter, phase III clinical study (DISCVER), which evaluated the effectiveness of Dakvos (Entracitabine 200mg/propofol tenofovir 25mg, F/TAF) in engaging in sexual activity with men compared to Shufatai (Entracitabine 200mg/fumarate tenofovir dipivoxime 300mg, F/TDF) The safety and effectiveness of pre exposure prevention in men and transgender women at risk of HIV infection through sexual activity.
The research results show that Dafovir has shown no inferior efficacy in preventing HIV compared to Shufatai, and the number of adverse events in both regimens is very low. In terms of safety, the 96 week data shows that Dafovir has a relatively small impact on bone, kidney function, and blood lipids.
Currently, PrEP has become one of the key measures to block the spread of HIV in countries such as Europe and America.
However, in China, PrEP cognition is still in its early stages. According to a survey conducted in March 2020 in the Chinese Journal of Epidemiology on the cognition of PrEP among male male sexual actors in China, among the 600 male sexual actors who participated in the survey, the awareness rate of PrEP was 56.4%, with 20.3% having good knowledge related to PrEP, and only 10.6% having an absolute willingness to use it.
As early as 2016, the United Nations called on all countries to achieve the goal of ending the AIDS epidemic by 2030. In order to achieve this goal, China has also continued to achieve scientific breakthroughs and improve clinical diagnosis and treatment capabilities. HIV prevention and treatment work has achieved remarkable results. However, according to statistics in 2021, AIDS is still the infectious disease with the highest death toll in China.
At present, sexual transmission has become the main route of HIV transmission in China. More than 95% of newly diagnosed HIV infected individuals in our country are infected through sexual means, and unsafe sexual behavior is the main cause of HIV sexual transmission.
Unsafe sexual behaviors with a higher risk of HIV infection include unprotected male same-sex sex, non fixed sexual partners, paid sex, etc. The population with a higher risk of infection includes but is not limited to men who have sex with men (MSM), injecting drug users, drug addicts, sex workers, sexually active individuals (young adults and adolescents), HIV negative partners in single positive partners, and those who have recently been infected with sexually transmitted diseases.
Jin Fangqian, Global Vice President and General Manager of Gilead Science in China, said, "To end the spread of HIV, prevention and treatment are indispensable. Gilead is not only committed to quickly introducing and continuously expanding the accessibility of innovative therapies in China, but also will continue to work together with the government, medical institutions, and all sectors of society to promote the high-quality development of HIV prevention and treatment work."
It is reported that Dakovan is used for pre exposure prevention once a day, one tablet at a time. Before starting to use it for pre exposure prevention of HIV-1, the HIV-1 test results of the user must be negative. It should be noted that this drug is a prescription drug and specific use needs to be carried out under the guidance of a doctor.