A new way to prevent HIV transmission is generating a lot of buzz -- and more than a little controversy -- at the AIDS 2024 conference in Munich this week.
Teatment consists of twice-yearly injections of a drug called lencapavir.
Initial trial results were released in June and showed 100% efficacy, generating great excitement. Confirming preliminary data, the full peer-reviewed results were presented at the AIDS 2024 conference on Wednesday, July 24.
The trial was sponsored by California-based drugmaker Gilead Sciences.
The treatment offers an alternative to the current standard for HIV prevention efforts for more than a decade: taking a pill like Truvada every day.
In clinical trials, this type of preventive medicine, called pre-exposure prophylaxis (PrEP), can be 99% effective in preventing new HIV infections from sex. In the real world, however, that is not always the case.
People don't always take their pills. In a study in South Africa, women said they felt there was a stigma to the pill -- sexual partners assumed they were taking it because they already had HIV or had other partners.
New trial results, published Wednesday, point to a new preventive strategy.
In a double-blin, randomized study of 5,300 cisgender women in South Africa and Uganda, 2,134 received the injection and the others took one of two types of daily PrEP pills. The trial began in August 2021 and, so far, not a single woman who received the injection has contracted HIV. Participants who received one of the oral PrEP options, Truvada and Descovy, had an infection rate of about 2% -- consistent with infection rates for oral PrEPs in other clinical trials.
The results wee significant enough for the Data Monitoring Committee — an independent group of experts appointed to evaluate the progress of clinical trials — to recommend that Gilead stop its blinded trial and offer lencapavir to all study participants. On June 20, Gilead announced these results, and now, all participants can choose to receive the injection.
The focus of the study on women in sub-Saharan Africa is based on HIV data. Despite accounting for 10% of the world's population, sub-Saharan Africans account for two-thirds of people living with HIV -- 25.7 million out of 38.4 million. And, every week, nearly 4,000 adolescent girls and young women in Africa become newly infected with HIV.
An enthusiastic response
An atmosphere of enthusiasm was seen among the people when the results were declared early.
Assitant Professor of Medicine and Infectious Disease Specialist at Columbia University Vagelos College of Physicians and Surgeons Dr. "It's amazing," says Jason Zucker. “It is difficult to take medicine every day. The medicine [given] every 6 months has a lot of potential.
Dr. Philip Grant, clinical associate professor and director of the HIV Clinic at Stanford University School of Medicine, agrees that lencapavir can help fill a gap in prevention options. "That would be a huge advantage in populations that have compliance challenges," he says.
Although 99% effective in some trials, oral PrEP effectiveness drops significantly in the real world. One study shows that PrEP effectiveness is as low as 26% in certain populations—for example, men under 30.
Objective 1 data published today in the New England Journal of Medicine show that adherence to oral medication in the study was low -- that is, the 10% of women in the sample for whom medication levels were measured, mostly took fewer than 2 pills. per week. But the better the adherence, the lower the rate of HIV infection. On the other hand, about 92% of participants received lencapavir injections on time.
"Drugs work when you take them," Zucker says. "The drug given every six months has a lot of potential because, essentially, if you can get two visits a year, you're protected for the whole 12 months."
Advocacy groups have also expressed enthusiasm about the early results of lencapavir as a PrEP option. The People's Medicine Alliance - a global coalition of more than 100 organizations spanning 33 countries - said "lenacapavir" would be a "truly game-changer" for people facing stigma and discrimination, especially in low- and middle-income countries. Advocates for making medicines more accessible.
Drugs work when you take them," Zucker says. "The drug given every six months has a lot of potential because, essentially, if you can get two visits a year, you're protected for the whole 12 months.
ReplyDelete