Researchers have announced a significant development in the fight against HIV with a new preventative drug that demonstrates 100% efficacy in clinical trials.
U.S-based Gilead Sciences Inc. announced Thursday that its experimental injection, called lenacapavir, prevented 100% of HIV cases in women and adolescent girls in Africa, when administered twice yearly.
It was the first successful big trial of what’s hoped to become a powerful new drug regimen for fending off the virus. Lenacapavir is already approved under the brand name Sunlenca to treat HIV that’s resistant to other medicines.
The trial to demonstrate its efficacy as a preventative medicine involved about 5,300 women and female adolescents ages 16 to 25 in South Africa and Uganda. Some volunteers received lenacapavir and others received existing drugs that are administered daily against HIV.
No cases of HIV occurred among women in the trial who received the twice-yearly shot, Gilead said in a statement.
The results exceeded Gilead’s expectations. “No other HIV-prevention strategy has had zero infections before in a late-stage study,” said Jared Baeten, who leads HIV development at Gilead.
Gilead is also conducting a second prevention trial of lenacapavir in men who have sex with men, as well as transgender women and men. This trial, which includes participants in the US, is expected to produce results by late 2024.
If successful, Gilead plans to seek regulatory approval for the preventive use of lenacapavir in the US and other countries.
“Cold Shivers”
The development is a rare piece of exciting news for experts who have been in the trenches in the decadeslong war against HIV.
“I got cold shivers,” Dr. Linda-Gail Bekker, an investigator in the trial of the drug, told New York Times, describing the startling sight of a line of zeros in the data column for new infections. “After all our years of sadness, particularly over vaccines, this truly is surreal.”
Yvette Raphael, the leader of a group called Advocacy for Prevention of H.I.V. and AIDS in South Africa, said it was “the best news ever.”
There are an estimated 1.3 million new HIV infections worldwide each year. Researchers are seeking to prevent the deadly disease with drugs that are better than existing ones.
Lenacapavir presents a potential option to a HIV vaccine, which has not yet been developed.
“With zero infections and 100% efficacy, twice-yearly Sunlenca has demonstrated its potential as an important new tool to help prevent HIV infections,” said Gilead chief medical officer, Merdad Parsey.
News of the trial’s outcome pushed Gilead’s stock price over 9% to roughly $69 on Thursday.
According to Bekker, who is director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, while traditional HIV prevention methods are effective when used correctly, Sunlenca as pre-exposure prophylaxis drugs, or PrEP, could mitigate stigma and discrimination associated with taking or storing oral PrEP pills.
Additionally, its biannual dosing schedule may enhance adherence and persistence with PrEP.
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