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Kampala, Uganda | THE INDEPENDENT | A new HIV prevention study has found that twice-a-year injections of a new antiviral drug, called lenacapavir, completely protected women from contracting HIV.
Findings of the the PURPOSE 1 HIV prevention study among adolescent girls and young women in South Africa and Uganda was released on Thursday by Gilead Sciences. Gilead is the developer of the lenacapavir, one of the HIV prevention drugs that was being studied in the trial. In the study, none of the 2,134 women who received lenacapavir contracted HIV. By comparison, 16 of the 1,068 women who received the long-running daily pill Truvada contracted HIV. And 39 out of 2,136 women who received a newer daily pill called Descovy developed HIV.
An independent data and safety monitoring board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with no infections seen among trial participants who received injectable lenacapavir. The trial enrolled more than 5,300 individuals across 28 sites to receive lenacapavir or either one of Gilead’s daily oral PrEP drugs, Descovy and Truvada.
While no infections happened during the trial period among more than 2,000 women in the lenacapavir group, the Descovy group recorded an incidence rate of 2.02 per 100 person-years and the Truvada group 1.69 per 100 person-years.
“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.
The full range of PrEP products – including oral PrEP – must be made feasible choices for all people who need and want HIV prevention options.”
Lessons learned from roll out of daily oral PrEP, and more recently the dapivirine vaginal ring and injectable cabotegravir, can help speed regulatory approval and guideline development in key countries, design of effective programs, and community understanding of and acceptance of lenacapavir for PrEP.
“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.”
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