New Injectable Promises Complete Protection from HIV for Young Women

Last month, the biopharmaceutical company Gilead shared groundbreaking results from a recent clinical trial (PURPOSE1) for long-acting injectable HIV prevention. The twice-yearly injectable drug, lenacapavir, provided total protection from HIV for a test group of 2,134 women in Uganda and South Africa. While lenacapavir has been used to treat multi-drug resistant HIV since 2022, this trial marks the first usage as pre-exposure prophylaxis (PrEP). PrEP is one tool to prevent the virus, and refers to anti-retroviral medication taken by people who do not have HIV to reduce the risk of contracting it through sexual transmission or injection drug use. These new findings offer immense promise for the future of PrEP as a global tactic to protect young women from contracting HIV. 

Though immense global progress in reducing the spread of HIV has been made in recent decades, women and girls still face a high risk of contracting the virus. This is particularly the case in Sub-Saharan Africa, where women and girls made up 63 percent of new HIV infections in 2022. Several factors contribute to women and girls’ risk profile for HIV, including a lack of comprehensive and accurate knowledge about the virus, and high rates of child marriage. Many young women also lack the power in sexual relationships to negotiate condom use or safer sex practices, furthering their risk.  

Access to efficacious forms of PrEP is essential to reduce the incidence of HIV globally. Daily oral pills such as Truvada and Descovy are known to be effective and widely used in high-income countries, but their uptake and continuation is low in Sub-Saharan Africa, particularly for young women. Research also shows that stigma and judgement surrounding HIV prevents young women from adhering to the daily regimen and regular refills of the PrEP drugs.  

Other forms of PrEP have also been met by barriers. The long-acting injectable cabotegravir, which is administered every two months, is safe, effective, and more discreet, but lack of access and affordability have set back the rollout of the drug to low-income countries outside of global HIV programs such as the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). And while the option of the vaginal dapivirine ring, which slowly releases anti-retroviral medication over the course of a month, is proven to be safe, discreet, and effective, it has not been approved by the U.S. Food and Drug Administration (FDA), thus hindering its implementation by PEPFAR. 

A New Hope 

The clinical trial success of lenacapavir adds a safe and effective long-acting injectable option for PrEP to existing options and also may minimize the barriers for women seeking HIV prevention. The PURPOSE 1 trial included pregnant and lactating women, and allowed women to continue in the study if they became pregnant after enrollment. Pregnant and lactating people face a high risk of contracting HIV, especially in the period immediately after birth, but they have been underrepresented in clinical trials for PrEP. Research has shown that biological changes during and after pregnancy can increase the risk of contracting HIV, even after taking behavioral factors such as condom use into account.  

Global HIV programs like PEPFAR are critical to optimizing the potential of lenacapavir. In 2023, PEPFAR supported the introduction and scale up of an earlier long-acting injectable, cabotegravir, by implementing trainings for key stakeholders in eight countries in Africa—the first training for the delivery of long-acting PrEP outside of a research setting. It is anticipated that with the success of the PURPOSE 1 trial, there will be demand for lenacapavir to be delivered alongside existing options in PEPFAR.  

Yet questions on manufacturing, implementation studies, and pricing remain. In response, Gilead has committed to ensuring an efficient process for regulatory approval, and to manufacturing a sufficient volume of the drug to meet demand at affordable prices for countries with a high incidence of HIV.  

Meeting the UNAIDS goal of ending AIDS by 2030 will not be easy. But ensuring that young women have a range of safe and effective prevention options is essential to doing so. 

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