Kampala, Uganda | By Michael Wandati | A recent study on HIV prevention has revealed promising results, suggesting that biannual injections of a novel antiviral medication called lenacapavir offer complete protection against HIV transmission among women.
The findings from the PURPOSE 1 HIV prevention study, conducted among adolescent girls and young women in Uganda and South Africa, were unveiled on Thursday 20, June 2024 by Gilead Sciences, the pharmaceutical company behind lenacapavir.
In this study, none of the 2,134 women who received lenacapavir contracted HIV. In comparison, among those who received the long-standing daily pill Truvada, 16 out of 1,068 women became infected with HIV, while 39 out of 2,136 women who received a newer daily pill called Descovy developed HIV.
An independent data and safety monitoring board (DSMB) conducted a scheduled review of the trial data and concluded that the lenacapavir regimen is not only safe but also highly effective. No infections were reported among trial participants who received injectable lenacapavir. The trial, which enrolled over 5,300 individuals across 28 sites, compared lenacapavir with Gilead’s daily oral PrEP drugs, Descovy and Truvada.
During the trial period, no infections were observed among the lenacapavir group, while the Descovy group reported an incidence rate of 2.02 per 100 person-years and the Truvada group reported 1.69 per 100 person-years. These findings underscore the potential of lenacapavir as a groundbreaking HIV prevention strategy, offering hope for further advancements in the fight against the HIV/AIDS epidemic.
“While we know traditional HIV prevention options are highly effective when taken as prescribed, twice-yearly lenacapavir for PrEP could help address the stigma and discrimination some people may face when taking or storing oral PrEP pills, as well as potentially help increase PrEP adherence and persistence given its twice-yearly dosing schedule,” Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town in South Africa.
“This is one of the most important results we’ve seen to date in an HIV prevention study,” said Mitchell Warren, AVAC’s Executive Director.
AVAC is an international non-profit organization that leverages its independent voice and global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity.
Mitchell Warren said additional HIV prevention options means more people may find an option that is right for them. “ Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most – from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit,” he said.
“We are incredibly excited about this result, especially about what it can mean for women in Africa,” says Nandisile Sikwana, Regional Stakeholder Engagement Manager for AVAC, and a member of the PURPOSE 1 Global Community Advisory Group. Gilead’s plans for submission to regulatory agencies and future access, including the US Food and Drug Administration (FDA), are not yet clear. But the results make this urgent.
“We expect to see a timeline that takes into account a full analysis of PURPOSE 1 data and the coming data from PURPOSE 2 from Gilead as soon as possible, and we urge regulatory agencies to prepare to fast track regulatory review.”
Warren called on WHO to be prepared to quickly include lenacapavir, if approved by regulatory agencies, in HIV prevention guidelines.
“There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact and expand the toolbox of HIV prevention choices,” he added “We now know that lenacapivir for PrEP is safe and highly effective among women,” Sikwana added.
“Even as we await the results of the trial among other essential populations and for regulatory submission and review, there is urgent work to be done now by communities, policy makers, funders and program implementers to design and build HIV prevention programs and prepare health systems to deliver the growing array of biomedical PrEP options, including the addition of twice-yearly injectable lenacapavir.
All individuals requiring HIV prevention options should have access to a comprehensive array of PrEP products, including oral PrEP.”
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Insights gained from the implementation of daily oral PrEP, as well as the recent introduction of the dapivirine vaginal ring and injectable cabotegravir, can expedite regulatory approval and guideline formulation in pivotal nations. Furthermore, they can inform the development of impactful programs and enhance community awareness and acceptance of lenacapavir as a PrEP option.
“AVAC and a cadre of international partners have been working together to plan for successful, accelerated introduction of lenacapavir.
Since oral PrEP was first shown to be safe and effective 14 years ago, the global health community has failed in delivering PrEP at scale and with equity – and we have, therefore, not seen the impact that we need.
The lessons from the past are clear, and we now must act on them and move with speed, scale and urgency. There can be no excuses and no delays,” said Warren.
“We look forward to working with civil society partners, Gilead, international donors, normative agencies and national governments to ensure that this groundbreaking HIV prevention option is made available as quickly as possible and that we don’t squander this opportunity to drive down new HIV infections.”
