Gilead Sciences previously submitted a marketing application for Truvada (truvada), a new AIDS prevention drug, to the US Food and Drug Administration. After a series of reviews, the US Food and Drug Administration finally approved the marketing application for the drug.
It is understood that Truvada (truvada) is mainly suitable for people who have not been infected with HIV but have had sex with HIV patients. This treatment method is called pre-exposure prevention (PrEP).
"truvada" is a pill once a day, which is suitable for homosexuals, bisexuals and high-risk people with HIV. As early as 24, this drug was introduced to the market by Gilead Technology Company in California, USA, for the treatment of HIV-infected people.
"truvada" is a mixture of two anti-HIV drugs with a long history, Emtriva and Viread, which can reduce the virus level in human body and reduce the risk of virus transmission while maintaining health. It can be used with other antiretroviral drugs in the treatment of HIV-infected patients over the age of 12.
Pharmacologically, "truvada" is an anti-retroviral drug, which can inhibit HIV replication by inhibiting virus reverse transcriptase. In order to replicate HIV, pre-viral DNA must be formed under the action of reverse transcriptase before other steps can be completed. If uninfected people take such drugs in advance, they can make the body have the ability to inhibit reverse transcriptase, so that even if HIV enters the human body, replication will be hindered in the first step, making the whole replication process difficult to complete; The virus may also be expelled from the body under the action of human metabolism and self-cleaning system, thus greatly reducing the possibility of infection.
Margelite Hamberger, director of the FDA, said that the approval of the listing of "truvada" is an important milestone in the fight against AIDS. About 5, new HIV-infected people can be infected in the United States every year, and new prevention and treatment programs are very important for the United States to fight AIDS. According to the official research results, after taking "truvada" quantitatively and cooperating with gay and bisexual men who use condoms to contact their partners with HIV, the probability of contracting the virus can be reduced by 42%; When one partner is infected with HIV and a healthy heterosexual partner takes "truvada", the probability of infection can be reduced by 75%.
FDA also requires truvada users to pay attention to sexual safety, so as to effectively reduce the risk of infection; It is also suggested that they receive an HIV test every three months to ensure that they can receive treatment as soon as possible once infected.
However, health organizations such as the AIDS Health Care Foundation (AHF) also questioned the role of "truvada". They were worried that drug abuse and traditional protective behaviors such as condom use would be reduced, and the high drug cost might also bring a big burden to ordinary families.
Margaret? Hamberger said that in the United States, about 5, adults and teenagers are diagnosed with HIV every year, so there is a great market demand for AIDS drugs and preventive drugs.
In 21, a clinical trial of truvada drugs conducted by Gilead Biotechnology Company showed that men or women who had previously had sex with HIV-infected people only took a certain dose of truvada every day, so their chances of contracting HIV decreased by 44%.
This new drug of Gilead Biotechnology Company is a collection of AIDS drugs, so its efficacy is good. For decades, experts in the pharmaceutical industry have been developing drugs that can resist HIV, but with little effect. In 29, a large-scale clinical trial was conducted in Thailand, which achieved good results, and there was a dawn in the field of AIDS treatment. The leading expert of this trial said that it is expected that new preventive drugs will be available in 219.
Debra Birnkrant, director of antiviral drugs department of the US Food and Drug Administration, said that it is estimated that the number of AIDS cases in the United States will drop by a quarter in 215, and the truvada drugs approved for marketing this time will be the main hero.
In the approval document, the US Food and Drug Administration specifically pointed out that before adding the drug to the prescription list, doctors must be familiar with the trademark information of truvada and make sure that the treatment target is those who have not been infected with HIV. The drug is only a preventive drug, not a therapeutic drug. In addition, according to the use standard of preventive drugs, the period for patients to take this drug is three months. The Food and Drug Administration suggested that Gilead Biotechnology Company set up various training courses for prescribers to ensure that prescribers are really familiar with the rules of drug use and the applicable population.
Before submitting the marketing application for truvada drugs, Gilead Biotechnology Company took samples from people who had been infected with HIV, and arranged for these patients to take truvada to test whether the infected people were resistant to truvada. In addition, Gilead Biotechnology Company also conducted an experiment among pregnant women to test whether pregnant women will have an impact on pregnancy after taking truvada drugs.
At the latest closing of Nasdaq, the share price of Gilead Biotechnology Company rose by 1.5% to close at $51.94 per share.