It is not an AIDS vaccine, but it may be the closest drug to a vaccine to date. In a large-scale study, long-acting antiretroviral drugs were injected every two months to protect people from HIV infection, Science reported. This provides a potential and easier option than other daily antiretroviral drugs, which are difficult for many people to achieve.
In 2012, the U.S. Food and Drug Administration approved a routine drug that combines two drugs, a strategy that allows uninfected people to take drugs to fight HIV, known as pre-exposure prophylaxis. In a new study, scientists compared the combination of drugs called Truvada with the efficacy of intramuscular injections of a drug called Cabotegravir or a placebo in subjects. The trial was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
The trial, which began in December 2016, recruited more than 4,500 participants worldwide who were randomly assigned to the Truvada group, the Cabotegravir group, the placebo pill group, or the placebo injection group. As of the end of April this year, there were 12 infections in the Cabotegravir group, compared with 38 in the Truvada group of the same size. This means that the incidence rate in the Cabotegravir group was 0.38%, compared with 1.21% in the Truvada group and a difference of 69% for new infections.
“It’s really exciting,” says Jared Baeten, an epidemiologist at the University of Washington in Seattle. “Baeten was not involved in the trials, but he conducted a landmark pre-study of anti-HIV pills, one of which was Truvada, in Kenya and Uganda. “It offers an alternative for people who can’t or don’t want to take their medication every day. The new study does not statistically prove that Cabotegravir is superior to Truvada. But the data make it clear that it is equally effective.
The Cabotegravir project is one of the pre-contact prevention strategies being tested by NIAID’s HIV Prevention Trial Network (HPTN), which evaluates a large number of non-vaccine interventions. “People are actively looking for long-acting anti-HIV drugs. “Cabotegravir will last for at least a few months, and we’re moving toward providing vaccines to people,” said Myron Cohen, co-principal investigator at hpTN at the University of North Carolina School of Medicine. “
HPTN 083 is the name of the Cabotegravir project and has 43 sites in the United States, South Africa, Argentina, Brazil, Peru, Vietnam, and Thailand. The new corona virus forced 11 of these sites to close, making it difficult for other sites to continue as participants became increasingly difficult to attend. In early April, researchers informed the study’s independent Data and Security Monitoring Board (DSMB) of the issue and asked to change the end of the trial to ensure there was an “uninterrupted data set,” explains UCLA’s Raphael Landovitz.
On May 14, DSMB analyzed the data and found that Cabotegravir had reached this threshold. Truvada pills and Cabotegravir injections are considered safe and well tolerated.
Based on the data, DSMB recommends that all participants, including those who receive a placebo, receive Cabotegravir injections this week.
Several studies related to Truvada have shown that, in general, people infected with HIV do not take these pills daily (blood measurements can show drug levels). It is hoped that the switch to antiretroviral drugs will be addressed. Cabotegravir targets HIV as an integrated enzyme that is essential for its replication.
The addition of long-lasting Cabotegravir adds a powerful weapon to prevent AIDS, Cohen said. “This drug can indeed contribute to the goal of eradicating AIDS by 2030. “
The study has not yet been published in a peer-reviewed journal. (Sasson)