- A new study found that the drug Sunleca (lenacapavir) has been shown to be 100% effective at preventing HIV in females.
- The drug is given via injection two times a year and is manufactured by the U.S. company Gilead.
- Health experts say the potential to reduce the number of new HIV infections is enormous if the drug can be made widely accessible.
Two shots a year of lenacapavir, a drug manufactured as Sunleca by the U.S. company Gilead, was shown to be 100% effective in preventing the transmission of HIV in females, according to a new study funded by Gilead and administered by some of its employees.
More than 5,000 females in Uganda and South Africa were part of the research; 2,134 of them were given the injections, and none of them were reported to have HIV.
The other sections of the study cohort were split into two varieties of oral prevention pills — Descovy and Truvada — on a daily basis, and around 2% of them reported HIV infections.
The results of testing in men have not yet been calculated, but experts say the potential to change the rate of new HIV infections is enormous if the pre-exposure prophylaxis (PrEP) drug can be made widely accessible.
Dr. Amit Achhra, MD, an assistant professor of medicine at Yale School of Medicine who specializes in infectious diseases, told Healthline that the future of HIV prevention was “exciting” in this light.
“While we don’t have HIV vaccine yet, injectable HIV PrEP comes close to what one might see as periodic ‘HIV vaccine,’ i.e. periodic shots that have very high efficacy in preventing HIV infection,” Achhra said. “For those who don’t wish to get the shots, very effective oral HIV PrEP pills will remain an effective option. With more HIV prevention options available, we hope the rate of HIV infections will further decline in the future.”
Approximately 39 million people worldwide live with HIV, and some of the highest numbers of diagnoses are in sub-Saharan Africa.
In 2022, according to the Foundation for Aids Research, 3,100 young women and girls (ages 15 to 24) contracted HIV every week in sub-Saharan Africa.
Lenacapavir, which is used as a treatment for HIV after it has been contracted in the U.S., Canada, and Europe, is among the group of drugs known as capsid inhibitors. These disrupt the protein shells (capsids) of the HIV virus that is essential to replication, which can interrupt the process of multiplying in the body.
Dr. Monica Gandhi, a professor of medicine and the associate division chief of the Division of HIV, Infectious Diseases, and Global Medicine at UCSF/San Francisco General Hospital, told Healthline that lenacapavir is a “first-in-class new HIV medication” with strong potency.
“The formation of a capsid around the virus is very important at multiple stages of the viral life cycle, including during nuclear transport and release,” Gandhi said. “Lenacapavir is so potent that it can be provided just twice yearly (every 26 weeks), which is its advantage over agents for PrEP (daily oral or cabotegravir, which is given once every 8 weeks).”
Rates of HIV are 7.7% higher in men who have sex with other men and 9.2% higher for transgender people, according UNAIDS.
According to Gandhi, the pathways to HIV infection work differently in females and males, but a new study should provide encouraging results for males.
“The PURPOSE 2 trial is being conducted in men, transgender women and non-binary individuals and the results are due out later this year, which is when (if favorable), Gilead will apply for regulatory approval,” Gandhi said. “Some drugs can work differently in men and women due to differential tissue levels at the site where transmission can occur (e.g. anal or vaginal mucosa), so it is important to test these preventive agents in both men and women.”
Current reports have lenacapavir running more than $40,000 for the first year, but it’s been suggested that it could be sold for as little as $40, which would instantly create an enormous path to access worldwide.
“If the drug can be more cheaply made than what the company is suggesting, that would be a huge boon for the field, especially in preventing HIV infection in low-and-middle-income countries,” Gandhi said.
“The drug is likely to be approved in the US even at a higher price point and should have benefits in controlling HIV infection in the US since the
“Currently, oral PrEP pills are significantly cheaper than shots, and in fact, the generic version of Truvada oral PrEP pill is available for very cheap, often less than $1 per pill. However, many people have a hard time keeping up with the daily pill,” Achhra said.
“It will therefore be important to have equally cheaper and accessible injectable PrEP options widely available to make a big dent in the HIV epidemic. Of note, it will be equally important for clinics and hospitals administering these shots to reduce their hospital ‘facility fees,’ which are often exorbitant and prevent access to these medications,” Achhra said.
A capsid inhibitor called lenacapavir, sold as Sunleca by the drug maker Gilead, prevented HIV infection in 100% of the cases in a recent study of more than 5,000 females in South Africa and Uganda.
Lenacapavir has been used as a treatment for HIV, but these twice-yearly shots could revolutionize HIV prevention, experts say.
Results of a study of the drug’s efficacy in males have not been published yet, but experts say full access and a cheaper price point would make an enormous difference globally.
