Groundbreaking HIV drug is 100% effective against infection

For over a decade, taking a daily pill like Truvada has been the standard approach for preventing HIV. This method, known as pre-exposure prophylaxis (PrEP), can be up to 99% effective in clinical trials. However, in real-world settings, its effectiveness often falls short due to inconsistent use.

One study conducted in South Africa highlighted a significant challenge: women reported feeling stigmatized for taking the pill, as partners might assume they have HIV or multiple partners. This stigma can deter consistent use, reducing the drug's effectiveness.

A new approach could address these issues: a twice-yearly injection of a drug called lenacapavir. The PURPOSE 1 trial, sponsored by Gilead Sciences, aims to evaluate this method. In this double-blind, randomized study involving 5,300 cisgender women from South Africa and Uganda, 2,134 received the injection, while the rest took one of two types of daily PrEP pills. Since the trial began in August 2021, none of the women who received the injections contracted HIV. In contrast, those taking oral PrEP options, Truvada and Descovy, experienced an infection rate of about 2%, similar to other clinical trials.

These promising results led the Data Monitoring Committee, an independent group of experts, to recommend that Gilead offer lenacapavir to all study participants. On June 20, Gilead announced this recommendation, allowing all participants to opt for the injection.

The focus on women in sub-Saharan Africa is crucial, as this region represents two-thirds of the global HIV-positive population despite having only 10% of the world's population. Every week, approximately 4,000 teenage girls and young women in Africa are newly infected with HIV.

Although the trial is not yet peer-reviewed, early reactions are positive. Dr. Jason Zucker, an assistant professor of medicine and infectious disease expert at Columbia University, expressed his enthusiasm: “It’s fantastic. It’s hard to take a medication every single day. A medication that is [given] every six months has a lot of potential.”

Dr. Philip Grant, director of the HIV clinic at Stanford University, also supports the new approach. “It would be a big benefit in populations that have adherence challenges,” he said. Real-world data shows that oral PrEP's effectiveness can drop significantly; for example, it can be as low as 26% in men under 30.

“Medications work when you take them,” Zucker emphasized. “A medication that is given every six months has a lot of potential because, essentially, if you can make two visits a year, you are protected for an entire 12 months.”

Advocacy groups are equally enthusiastic about lenacapavir's potential. People’s Medicines Alliance, a global coalition advocating for medication accessibility, stated that lenacapavir could be “a real game-changer,” especially for people in low- and middle-income countries facing stigma and discrimination.

Lenacapavir is not new; it was FDA-approved in 2022 for treating multi-drug resistant HIV. However, PURPOSE 1 is the first clinical trial testing it for prevention. This trial is part of a broader initiative to improve HIV prevention globally and is one of several studies aiming to end the HIV epidemic by 2030.

Another ongoing trial, PURPOSE 2, is evaluating lenacapavir's effectiveness among diverse populations, including cisgender men, transgender individuals, and non-binary people who have sex with partners assigned male at birth in various countries, including Argentina, Brazil, and South Africa.

Despite the promising results, widespread use of lenacapavir poses challenges, particularly regarding cost. For instance, PrEP medications need to be less than $54 a year per patient for South Africa to afford them. Currently, lenacapavir costs $42,250 per new patient annually in the United States. In contrast, some oral PrEP options cost less than $4 a month.

“The biggest gap in prevention isn’t medication, it’s accessing medications,” Dr. Grant noted.

Activists in Uganda and South Africa are urging Gilead to license lenacapavir to the Medicines Patent Pool, a UN-backed organization that facilitates the production of generic drugs. This could significantly reduce costs. These activists fear a repeat of the situation with cabotegravir, another long-acting injectable PrEP approved by the FDA in 2021. Despite being more effective than oral options and requiring fewer injections, generic versions of cabotegravir are unlikely to be available in Africa until 2027 due to regulatory delays.

In response to these concerns, Gilead announced plans to ensure lenacapavir's availability in high-incidence, resource-limited countries if approved. Their strategy includes developing a voluntary licensing program to enable generic production before the patent expires. However, as Dr. Jared Baeten, Gilead's vice president of HIV Clinical Development, mentioned, the timeline will depend on further trials, regulatory reviews, and approvals.

“Cost is going to play into this dramatically,” Dr. Zucker acknowledged. “I think and hope we will do everything we can to try to reduce barriers to access.”

The development of lenacapavir as a biannual injection represents a significant advancement in HIV prevention. By addressing adherence challenges and reducing the stigma associated with daily pills, it offers a promising new strategy in the fight against HIV, particularly for women in sub-Saharan Africa.

Note: Materials provided above by the The Brighter Side of News. Content may be edited for style and length.

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