It is high time to end the experiments with HIV miracle drugs in Africa

At the recent annual International AIDS Conference, a surprise presentation of the latest miracle drug for HIV prevention was greeted with thunderous applause. Lenacapavir, a novel drug administered as an injection under the skin every six months, has been shown to prevent 100% of HIV infection in adolescent girls and young women in two African countries.

For many, it was a generational event. After years of unsuccessful vaccine trials, here was something almost as valuable – a twice-yearly vaccination that largely prevents HIV infections. The fact that the drug was so successful among young women in Africa made the discovery particularly monumental.

But some of us in the health profession are beginning to wonder what all the cheering is about. The scientific results were sound, but how those results translate into action for young women in Africa is a matter for our imagination. And if history is anything to go by, it could be a nightmare.

When the results were first released, Gilead, the maker of lenacapavir, said it was too early to talk about licensing and provided vague plans for production and availability in Africa. Just recently, a second study of men who have sex with men, conducted predominantly in the Northern Hemisphere, showed similarly promising results. While Gilead now says they have sufficient data to proceed with licensing and production worldwide, they have not provided a timeline for doing so. The urgency to publish study results does not reflect the urgency to provide access. Unanswered questions remain about why another study was needed to proceed with approval for use in African women, and whether and when lenacapavir will be made available in the African region at an affordable price.

The drug, which is estimated to cost about $40 per year to manufacture, is currently approved in the United States for more than $42,000 per year as an HIV treatment. In South Africa, public sector health spending is about $230 per person per year. Stakeholders and the study's scientists have urged Gilead to make lenacapavir available quickly and at an affordable price in sub-Saharan Africa. But with UNAIDS estimating that more than 3,000 women in the region are infected with HIV every week, there is no time to lose.

This is not the first time in recent history that a miracle HIV prevention drug has been tested on young African women, but is still unavailable to most of them. Cabotegravir, given as an injection into the muscle every two months, has also been studied in young African women and adolescents. That trial, conducted from 2017 to 2020, showed remarkably similar results: it was over 90% effective in preventing new HIV infections. Although it enrolled more than 3,000 women in southern Africa, it remains largely unavailable in the region.

ViiV, the manufacturer of cabotegravir, says it is committed to ensuring access and, after pressure from stakeholders, eventually allowed local manufacturing. But the drug will not be widely available in the region until 2027, nine years after the trial began, or an estimated 1.4 million preventable HIV infections in young women later.

Given these approval issues, why do pharmaceutical companies keep conducting trials among young women in Africa? Because HIV infection rates are extremely high there. In the lenacapavir trial, women who received HIV prevention pills instead of injections became infected at a rate about 100 times higher than the rate among adults ages 15 to 49 in the United States. The higher the infection rate, the faster a trial can show a benefit and the cheaper the trial is to conduct. In short, testing these drugs in Africa saves pharmaceutical companies a lot of time and money.

And what do pharmaceutical companies have to do in return for this time and cost saving? Surprisingly little. Although the Helsinki Declaration requires that all trials must have a plan to ensure that they benefit the communities in which they are conducted, this rule is often interpreted very narrowly. Pharmaceutical companies usually provide access to drugs only to the trial participants themselves and for a short period of time.

How can we break this pattern of testing HIV therapies on young African women and waiting with bated breath for the pharmaceutical industry to approve them while tens of thousands of new HIV infections pile up?

In principle, solutions that enable access are known. For decades, activists, scientists and global partners such as the Clinton Health Access Initiative, the Bill & Melinda Gates Foundation and Doctors Without Borders have worked successfully to ensure that life-saving therapies are also made available to low- and middle-income countries through the Medicines Patent Pool. This initiative, supported by the United Nations, secures patents, prices and billions in sales for pharmaceutical companies in high-income countries, while enabling the production of generic drugs in resource-poor environments at prices that the public sector and global health donors can afford.

But this system alone is clearly not enough to ensure that young women who take the risk of research also benefit from participation in a timely manner.

Instead, we need a new mandate for global drug and vaccine development research in low- and middle-income countries that requires a licensing, manufacturing, pricing and distribution plan. before to conduct trials. Should a trial demonstrate a benefit, local populations would be assured of access within a predetermined timeframe. The policy could be immediately added as a review criterion by the South Africa Health Products Regulatory Authority (South Africa's equivalent of the Food and Drug Administration in the US) and other similar regional regulators. These timelines and assurances could also be added to clinicaltrials.gov reporting requirements for all Phase 3 trials of unapproved drugs in such regions.

This shift could permanently maintain the balance of power between, for example, young women in Africa and drug manufacturers. Currently, these participants have all the power before drug trials because their bodies and samples are so valuable, but after these trials are over, they give up that power to the drug manufacturers.

Unfortunately, such a requirement will have no impact on the availability of lenacapavir in Africa. Only Gilead knows how this story will end. But in the not too distant future, results will undoubtedly be presented on the next miracle drug – one that has fewer side effects, requires only annual injections, or is easier to dose at home. Who will have access to this drug?

Young women in Africa and other people at high risk of HIV should not be required to participate in more HIV prevention trials right now. What they deserve is access to the trials that we already know are highly effective, because they volunteered to participate in the trials that have proven their benefit.

A new policy that sets timelines for local licensing and manufacturing in advance would ensure that the next miracle drug becomes quickly available to those who volunteer to have it tested on themselves and in their community.

We could all proudly support and applaud such policies.

Mark Siedner is an infectious disease clinician and associate professor of medicine at Harvard Medical School. Rochelle Walensky is a Hauser Leader at the Harvard Kennedy School of Government, an executive fellow at Harvard Business School, and former director of the U.S. Centers for Disease Control and Prevention.