At the recent annual International AIDS Conference, a startling presentation about the newest wonder drug in HIV prevention brought a raucous standing ovation. Lenacapavir, a novel drug given as an injection under the skin every six months, was 100% successful in preventing HIV in adolescent girls and young women in two countries in Africa.
It felt to many like a generational moment. After years of failed vaccine trials, this was something nearly as valuable — a shot given twice yearly that substantially prevents HIV infections. That the drug was so beneficial in young women in Africa made the finding particularly monumental.
But some of us in the public health community are now starting to wonder what all the cheering was about. Although the scientific results were impeccable, the process for translating those results into action for young women in Africa has been left to our imaginations. And if history is any guide, this could be a nightmare.
When the results first came out, Gilead, the manufacturer of lenacapavir, stated it was too early to discuss licensing and offering vague plans about its production and availability in Africa. Just recently, a second study among men who have sex with men and predominantly conducted in the Northern Hemisphere showed similarly promising results. While Gilead now says they have sufficient data to move ahead with licensing and manufacturing worldwide, they have offered no timeline to do so. Urgency to report trial results has not been mirrored by the urgency to provide access. Unanswered questions remain about why another study was needed to move ahead with approvals for use in African women, and if and when lenacapavir will be made available at an affordable price in the African region.
The drug, which has a manufacturing cost estimated at about $40 per year, is currently licensed as an HIV treatment for more than $42,000 per year in the United States. In South Africa, health care expenditures in the public sector are approximately $230 per person per year. Advocates and the study scientists have strongly urged Gilead to make lenacapavir swiftly available in sub-Saharan Africa at an affordable price. But with over 3,000 women infected with HIV each week in the region according to UNAIDS estimates, there is no time to waste.
This is not the first time in recent history an HIV prevention wonder drug has been tested in young African women but remains unavailable for most of them. Cabotegravir, given every two months as an injection into the muscle, was also studied in young African women and adolescents. That study, conducted from 2017-2020, showed remarkably similar results: It was over 90% effective at preventing new HIV infections. Although more than 3,000 women were enrolled in Southern Africa, it remains largely unavailable in the region.
ViiV, the manufacturer of cabotegravir, states it is committed to ensuring access and, under pressure from advocates, eventually allowed for local manufacture. But it will not be widely available in the region until at least 2027, nine years after the study began, or an estimated 1.4 million preventable HIV infections in young women later.
Given these licensing issues, why do pharmaceutical companies repeatedly conduct studies among young women in Africa? Because they have extremely high rates of HIV infection. In the lenacapavir study, women who received pills for HIV prevention instead of the injection were infected at a rate that is approximately 100 times higher than the rate among adults 15-49 years in the United States. The higher the infection rate, the faster a study can show a benefit, the cheaper it is to do the study. In short, testing these drugs in Africa saves drug companies plenty of time and money.
And what do drug companies need to do in return for this time and cost saving? Surprisingly little. Although the Helsinki Declaration mandates that all trials have a plan to ensure they benefit the communities where they are conducted, this rule is often interpreted very narrowly. Drug companies typically only ensure drug access to trial participants themselves, and for a short period of time.
How do we break this pattern of testing HIV therapies in young African women and waiting with bated breath for the pharmaceutical industry to grant permission for access while tens of thousands of new HIV infections accrue?
In principle, solutions to enable access are well-known. For decades, advocates, scientists and global partners, such the Clinton Health Access Initiative, Bill and Melinda Gates Foundation, and Médecins sans Frontières, among others, have been successfully working to ensure lifesaving therapies are provided to low- and middle-income countries through the Medicines Patent Pool. This United Nations-supported initiative preserves patents, pricing, and billions of dollars in sales for pharmaceutical companies within high-income countries, while allowing generic manufacture in low-resource settings at prices that can be afforded by the public sector and global health donors.
But this system alone is clearly insufficient to ensure young women who embrace the risk of research also promptly benefit from participation.
Instead, we need a new mandate for global drug and vaccine development research in low- and middle-income settings that requires a licensing, manufacture, pricing, and distribution plan prior to the conduct of trials. Should a trial show benefit, the local population would be ensured access on a pre-specified timeline. The policy could be immediately added as a review criterion by the South Africa Health Products Regulatory Authority (South Africa’s equivalent to the Food and Drug Administration in the U.S.), and other similar regional regulatory bodies. These timelines and assurances could also be added to clinicaltrials.gov reporting requirements for all Phase 3 trials of unlicensed drugs in such regions.
This change could durably sustain the balance of power between, for example, young women in Africa and drug manufacturers. Currently, such participants hold all the power prior to drug studies when their bodies and specimens are so highly valued, but they relinquish it to drug manufacturers once those trials are completed.
Sadly, such a requirement will not impact timelines around the availability of lenacapavir in Africa. Only Gilead knows how that story will end. But in the not-too-distant future, results from the next wonder drug will undoubtedly be presented — one that has fewer side effects, needs only annual injections, or is more easily dosed at home. Who will have access to that drug?
Young women in Africa and other people at high risk for HIV should not need to be in any more HIV prevention studies right now. What they deserve is access to the ones we already know are extremely effective, because they volunteered to be in the studies that proved their benefit.
A new policy that pre-specifies timelines around local licensing and manufacturing would ensure the next wonder drug would quickly become available for those who volunteer to have it tested on them, and their communities.
Such a policy is one we could all proudly stand up and cheer for.
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 the Harvard Business School, and the former director of the U.S. Centers for Disease Control and Prevention.