San Francisco, March 2025 – At last week’s Conference on Retroviruses and Opportunistic Infections (CROI 2025), two presentations highlighted the urgent need to simplify HIV testing requirements to ensure the future of injectable pre-exposure prophylaxis (PrEP). The discussions underscored the devastating impact of funding cuts to HIV prevention programs, particularly through the US President’s Emergency Plan for AIDS Relief (PEPFAR), and the challenges posed by the current testing protocols for long-acting PrEP.
PEPFAR Cuts Threaten Global HIV Targets
Dr. Cissy Kityo, Executive Director of Uganda’s Joint Clinical Research Centre, revealed that the number of people receiving PrEP at least once has surged from one million in 2021 to eight million by mid-2024. This growth has been driven almost entirely by PEPFAR programs, which now account for over 90% of global PrEP provision. However, the near-total defunding of PEPFAR’s PrEP initiatives has cast a shadow over this progress.
Dr. Cheryl Case Johnson of the World Health Organization (WHO) presented a stark forecast: if PEPFAR funding is not restored or replaced, up to 10.75 million additional people could acquire HIV by 2030, with 2.93 million more deaths. Even with partial funding replacement, the world could still see 4.43 million new infections and 770,000 deaths. These projections are a far cry from the United Nations’ target of reducing new HIV infections to 375,000 annually by 2030.
The Promise of Injectable PrEP
Injectable PrEP, particularly the twice-yearly drug lenacapavir, has been hailed as a game-changer in HIV prevention. With 100% efficacy in cisgender women and 96% efficacy in gay and bisexual men and transgender women, lenacapavir offers a highly effective alternative to daily oral PrEP. Generic versions of lenacapavir and ViiV’s six-times-yearly cabotegravir are expected to become available by 2026-27, potentially making these drugs more accessible.
However, the promise of injectable PrEP is being undermined by stringent and costly HIV testing requirements. Unlike HIV treatment, which typically requires six-monthly testing, PrEP protocols demand three-monthly testing. For injectable PrEP, the requirements are even more rigorous, with recommendations for HIV RNA testing at initiation and every two months thereafter.
The Cost and Complexity of HIV Testing
HIV RNA tests, which can detect infections as early as 10 days after exposure, are significantly more expensive than standard rapid tests. RNA tests cost between 33and33and85 per test, require specialized equipment, and need expert technicians to interpret results. In contrast, rapid HIV antibody tests cost as little as 0.50−0.50−3.00 and can be administered almost anywhere.
Dr. Johnson emphasized that RNA testing is unrealistic in low-income settings, where 95% of HIV testing is conducted using standard rapid tests. A study by Dr. Sara Cox of the University of Washington modeled the impact of different testing methods on PrEP initiation in Kenya. The study found that while RNA testing would result in fewer people starting PrEP inappropriately, the difference was minimal—0.18% of PrEP users. Detecting one additional HIV case using RNA testing would require testing 5,305 people, at a cost ranging from 47,000to47,000to450,000.
A Shift Toward Simpler Testing
The WHO is now advocating for the use of standard rapid tests for PrEP initiation and monitoring, including for injectable PrEP. Self-testing is also being promoted as a viable option, with studies in Africa and Brazil evaluating its effectiveness in the context of cabotegravir injections.
In high-income countries, the feasibility of RNA testing is increasingly questioned. The International Antiviral Society (IAS-USA) has updated its guidelines to recommend initiating PrEP with a standard rapid test if RNA testing is unavailable, followed by an antibody/antigen test for confirmation.
Voices from the Ground
Dr. Johnson shared testimonials from PrEP users who have embraced self-testing. Pangpond, a young man from Thailand, described his experience: “It was so simple. The clinic sent me the HIVST kit. I had to ask the clinic for advice online when I first used it, then I sent them the result, and they sent me PrEP to initiate. This was incredibly convenient, and I quickly regained control, feeling ready to enjoy life again.”
Conclusion
The future of injectable PrEP hinges on simplifying HIV testing requirements. While RNA testing offers earlier detection, its high cost and complexity make it impractical for widespread use. By embracing standard rapid tests and self-testing, the global health community can ensure that injectable PrEP reaches those who need it most, helping to realign with the UN’s ambitious HIV targets. As Dr. Johnson concluded, “We cannot afford to let perfect testing be the enemy of good prevention.”
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