Results of a phase 3 PURPOSE 1 HIV prevention study done among adolescent girls and young women in South Africa and
Uganda show that there were no HIV infections in HIV-negative women who received 6 monthly (twice yearly) injectable
investigational drug Lenacapavir - an injectable form of PrEP (pre-exposure prophylaxis) drug developed by Gilead
Sciences. In other words, an HIV negative woman will need just two injections a year of this long acting drug to remain
safe from acquiring HIV through the sexual route.
An independent Data and Safety Monitoring Committee found this new regimen to be safe and 100% effective, with no
infections seen among study participants, and recommended that Gilead stop the blinded phase of the trial and offer
open-label lenacapavir to all participants.
Mitchell Warren, Executive Director of AVAC, calls this as one of the most important results we have seen to date in an
HIV prevention study. “Adding 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.
PURPOSE 1 is a phase-3, double-blinded, multi-centre, randomised study to evaluate safety and efficacy of twice yearly
long-acting injectable lenacapavir, and daily oral Descovy (emtricitabine and tenofovir alafenamide) for pre-exposure
prophylaxis in adolescent girls and young women at risk of HIV infection.
The study enrolled over 5,300 cis-gender adolescent girls and young women aged 16-26 years across 25 sites in South
Africa and 3 sites in Uganda. The participants were randomised into 3 groups in a 2:2:1 ratio.
- The 1st group received twice-yearly Lenacapavir,
- The 2nd group took once-daily oral Descovy (emtricitabine and tenofovir alafenamide), and
- The 3rd group was given once-daily oral Truvada (emtricitabine and tenofovir disoproxil fumarate).
There were zero incident cases of HIV infection among 2,134 women in the Lenacapavir group and 16 incident cases among
1,068 women in the Truvada group. HIV incidence in the Descovy group was numerically similar (39 incident cases among
2,136 women) to that in the Truvada group.
The results demonstrated superiority of twice-yearly injectable Lenacapavir over once-daily oral Truvada or Descovy.
In the study, Lenacapavir, Descovy and Truvada - all were generally well-tolerated and no new safety concerns were
identified.Access barriers need to be dismantled if the best of health services have to reach everyone equitably
Deep rooted gender and structural inequalities and poverty deny many women and adolescent girls their sexual rights,
deprive them of their bodily autonomy, and expose them to various forms of physical and emotional violence, as well as
heighten the risk of HIV - especially in low- and middle-income countries.
As per UNAIDS data, globally 4000 adolescent girls and young women (aged 15–24 years) were infected with HIV every week
in 2022, and more than 80% of them live in sub-Saharan Africa. In this region, there were 210,000 new HIV infections
among adolescent girls and young women in 2022. The new long acting PrEP can go a long way in controlling new HIV
infections in young women and girls - provided we also dismantle patriarchy and remove all other access barriers.
A companion phase 3 study, PURPOSE 2, is underway in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US,
testing twice-yearly lenacapavir for PrEP among cis-gender men who have sex with men, transgender women, transgender
men, and gender non-binary people. Results from this study are expected by early 2025.
The regulatory filing for lenacapavir for PrEP will include the results of both PURPOSE 1 and currently-underway study
PURPOSE 2 (if positive) to ensure that Lenacapavir can be approved for multiple populations and communities that are
most in need of additional HIV prevention options.Eliminate delays in rolling out new health technologies
Many countries have not yet fully rolled out existing PrEP (or not rolled it out at all in public services). Every new
HIV infection that occurs, is a grim reminder we could have done better in terms of prevention - and more importantly -
in making prevention services accessible to all with equity and dignity.
Regulatory agencies must start preparing to fast track regulatory review and introduction plans for the twice yearly
long acting injectable Lenacapavir. Also, communities, policy makers, funders and programme implementers must start to
re-design HIV prevention programmes and prepare health systems to be able to deliver the new drug- once it is approved-
to the people for whom it is intended, without unnecessary delays.
Lessons learned from the rollout 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, as well as community
understanding and acceptance of Lenacapavir for PrEP.
"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," says Mitchell Warren of AVAC.
For the unversed, PrEP helps prevent people from getting HIV. It is for people who are HIV-negative, but are at risk of
getting HIV. It means taking prescription medicine routinely before exposure to HIV to prevent getting it. The most
common way to get HIV is through sex or injection drug use. PrEP can reduce the chance of getting HIV through sex by
99%. It also reduces getting HIV from injection drug use by at least 74%. However, PrEP medication does not protect
against other sexually transmitted infections.
Shobha Shukla - CNS (Citizen News Service)
(Shobha Shukla is the award-winning founding Managing Editor and Executive Director of CNS (Citizen News Service) and is
a feminist, health and development justice advocate. She is a former senior Physics faculty of prestigious Loreto
Convent College and current Coordinator of Asia Pacific Regional Media Alliance for Health and Development (APCAT Media)
and Global AMR Media Alliance (GAMA). Follow her on Twitter @shobha1shukla or read her writings here www.bit.ly/ShobhaShukla