At the recent annual International AIDS Conference, a sensational presentation on the latest miracle drug in HIV prevention drew a raucous standing ovation. Lenacapavir, a new drug given as a subcutaneous injection every six months, was 100% successful in preventing HIV in adolescent girls and young women in two countries in Africa.
It felt like a generational moment for many. After years of failed vaccine trials, here was something almost as valuable: a twice-yearly injection 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 cheer was about. While the scientific results were impeccable, the process of translating these results into action for young women in Africa was left to our imagination. And if history is any guide, this could be a nightmare.
When the results first came out, Gilead, the manufacturer of lenacapavir, stated that this was the case too early to discuss licensing and offer vague plans for its production and availability in Africa. A second study was recently conducted among men who have sex with men and was conducted mainly in the Northern Hemisphere showed similarly promising results. While Gilead now says they have enough data to move forward with licensing and manufacturing globally, they have not offered a timeline for this. The urgency to report research results is not reflected by the urgency to provide access. Unanswered questions remain about why another study was needed to move forward with approvals for use in African women, and if and when lenacapavir will become available at an affordable price in the African region.
The medicine, that one Production costs are estimated at approximately $40 per yearis currently licensed as an HIV treatment for more than $42,000 per year in the United States. In South Africa, public sector healthcare expenditure is approximately $230 per person per year. Lawyers and the study scientists strongly urged Gilead to make lenacapavir available quickly and at an affordable price in sub-Saharan Africa. But with over Every week, 3,000 women in the region are infected with HIV According to UNAIDS estimates, there is no time to lose.
This is not the first time in recent history that a miracle drug for preventing HIV has been tested in young African women, but it is still unavailable to 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 between 2017 and 2020, showed remarkably similar results: it was more than 90% effective at preventing new HIV infections. Although more than 3,000 women participated in southern Africa, it is still largely unavailable in the region.
ViiV, the manufacturer of cabotegravir, says so committed to guaranteeing access and, under pressure from proponentseventually allowed for local production. But it won’t be widely available in the region until 2027nine years after the study began, or an estimated 1.4 million preventable HIV infections in young women later.
Given these licensing issues, why are pharmaceutical companies repeatedly conducting studies on young women in Africa? Because they have extremely high HIV infection rates. In the lenacapavir study, women who were given HIV prevention pills instead of the injection were infected at a rate about 100 times higher than the rate among adults aged 15 to 49 in the United States. The higher the infection rate, the faster a study can demonstrate a benefit and the cheaper it is to conduct the study. In short, testing these drugs in Africa saves pharmaceutical companies a lot of time and money.
And what should pharmaceutical companies do in return for these time and cost savings? Surprisingly little. Although the Declaration of Helsinki stipulates that all processes must have a plan to ensure that they benefit the communities where they are carried out, this rule is often interpreted very narrowly. Drug manufacturers usually only guarantee access to medicines to trial participants themselves, and that for a short period of time.
How do we break this pattern of testing HIV therapies on young African women and waiting with bated breath for the pharmaceutical industry to approve access while tens of thousands of new HIV infections arise?
Solutions to enable access are in principle known. For decades, advocates, scientists, and global partners such as the Clinton Health Access Initiative, the Bill and Melinda Gates Foundation, and Doctors Without Borders, among others, have worked successfully to ensure that life-saving therapies are brought to low- and middle-income countries through the Drug patent pool. This United Nations-backed initiative preserves patents, awards, and billions of dollars in sales for pharmaceutical companies in high-income countries, while enabling generic manufacturing in resource-poor settings at prices that can be provided by the public sector and global healthcare donors.
But this system alone is clearly insufficient to ensure that young women who embrace the risk of research can quickly benefit from participation.
Instead, we need a new mandate for global research into drug and vaccine development in low- and middle-income settings, which requires a licensing, manufacturing, pricing and distribution plan. prior to conduct tests. Should a pilot show prove beneficial, locals would be given access on a pre-specified timeline. The policy could immediately be 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 regulatory authorities. These timelines and guarantees can also be supplemented clinicaltrials.gov reporting requirements for all Phase 3 trials of unlicensed medicines in such regions.
This change could sustainably maintain the balance of power between, for example, young women in Africa and drug manufacturers. Currently, such participants have all the power ahead of drug trials, while their bodies and specimens are so highly valued, but they relinquish that power to drug companies once those trials are completed.
Unfortunately, such a requirement will not impact the timelines surrounding the availability of lenacapavir in Africa. Only Gilead knows how that story will end. But in the not too distant future, the results of the next miracle drug will undoubtedly be presented: a drug that has fewer side effects, requires only annual injections or can be more easily dosed at home. Who has access to that medicine?
Young women in Africa and other people at high risk for HIV should no longer be required to participate in HIV prevention trials at this time. What they deserve is access to the drugs that we already know are extremely effective because they voluntarily participated in the studies that proved their benefit.
A new policy that specifies advance timelines around local permitting and manufacturing would ensure that the next miracle cure would quickly become available to those who volunteer to have it tested on them and their communities.
Such a policy is one that we can all proudly stand up for and cheer for.
Mark Siedner is an infectious disease physician 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.