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In a landmark development in the fight against HIV/AIDS, a new long-acting injectable drug has shown 100% effectiveness in preventing HIV transmission among young women, offering new hope for millions in sub-Saharan Africa and beyond.
A game-changing HIV prevention drug known as lenacapavir has been found to offer complete protection against HIV infection in young women, according to findings from a major clinical trial unveiled at the International AIDS Society (IAS) Conference on HIV Science held in Kigali this week.
The drug, which only needs to be administered twice a year, is now being hailed by global health experts as a major step forward in the decades-long battle to curb new HIV infections, particularly among adolescent girls and young women in Africa, who remain disproportionately affected.
A Growing Crisis Among Young Women
Every week, the World Health Organization (WHO) reports that over 4,000 adolescent girls and young women become infected with HIV globally — 60% of whom live in sub-Saharan Africa. Deep-rooted gender inequalities, limited access to health services, and biological vulnerability continue to place young women at greater risk.
“This is more than a scientific achievement. It’s a lifeline for young women who have long carried the burden of HIV,” said Dr. Lillian Brown, an infectious disease expert with Gilead Sciences, the pharmaceutical company behind the new drug.
What is Lenacapavir?
Lenacapavir is a long-acting injectable antiretroviral medication designed to prevent HIV infection. Unlike daily oral PrEP (Pre-Exposure Prophylaxis) tablets, which require strict adherence, lenacapavir is administered via injection once every six months — a simplified regimen that is both discreet and more manageable, especially for young people.
In the Phase III "PURPOSE 1" trial, conducted in South Africa and Uganda, more than 5,300 participants aged 16 to 25 were enrolled, the vast majority being adolescent girls and young women. Not a single participant who received lenacapavir contracted HIV, a result experts have described as “remarkable.”
Inclusive Trials, Real Results
Importantly, the trial also included 500 pregnant and breastfeeding women, helping researchers evaluate the drug’s safety in maternal health contexts. No significant safety concerns were reported.
Dr. Brown emphasized the significance:
> “Preventing HIV in pregnant or breastfeeding women is critical, and lenacapavir has demonstrated excellent safety so far. This could be a turning point in protecting mothers and their babies.”
Another related study, PURPOSE 2, included a broader demographic: men who have sex with men, transgender individuals, and others across South America, South Africa, and the U.S. The results were equally promising, showing strong efficacy and low incidence of adverse effects.
Side Effects and Limitations
While generally well-tolerated, some participants reported mild pain or swelling at the injection site — the most common side effect. However, the drug is not suitable for people taking certain tuberculosis medications, particularly those containing rifampicin, as it reduces lenacapavir’s effectiveness.
Future Developments Underway
Gilead is already developing new combination therapies that merge lenacapavir with other long-acting agents like islatravir, which could allow for even more flexible dosing schedules — potentially every four months.
“These innovations could allow patients and providers to choose the best regimen for their lifestyles,” said Dr. Angela Mutesi, a Kigali-based HIV researcher who attended the conference. “We are finally seeing the field shift toward real-world solutions.”
Community-Led Research Makes the Difference
One of the most celebrated aspects of the trials was the deep collaboration with local communities, particularly in Uganda and South Africa. Community leaders, youth organizations, and healthcare workers were actively engaged, ensuring cultural sensitivity and local trust in the research process.
As a result, trial participation was high, and misinformation minimal.
Rollout Plans: Africa First
The WHO has officially endorsed lenacapavir for HIV prevention, and Gilead Sciences announced that public distribution programs will begin in Uganda and South Africa by late 2025, with plans to expand to other countries in 2026 and beyond.
Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO, said in his keynote at the Kigali summit:
> “While we still do not have a definitive vaccine for HIV, lenacapavir marks a giant leap forward in our prevention toolkit. It has the power to transform lives — especially in the Global South.”
As the global community continues to search for an ultimate cure or vaccine, lenacapavir offers a powerful, practical solution for reducing new infections right now. For young women across Africa, it represents not just a medical advancement but a chance at a healthier, more hopeful future.