New Advances in HIV PrEP: An Annual Injection of Lenacapavir May Be Sufficient

Pre-exposure prophylaxis (PrEP) has been a fundamental tool in the fight against HIV, reducing the risk of infection in people at greater risk. And a new study shows that lenacapavir might be the ideal solution.

Until now, PrEP has been available primarily in the form of daily oral treatment or long-acting injections, such as cabotegravir, which require administration every eight weeks. However, a new study published in The Lancet has yielded promising results for a new option for patients: annual injections of lenacapavir to prevent HIV.

Lenacapavir is an HIV capsid inhibitor with a long half-life, allowing for its administration in biannual injections, where it has already demonstrated its efficacy

Now, its potential for prevention has been evaluated in phase 3 clinical trials, such as the PURPOSE 1 and 2 studies, which documented a 100% and 96% risk reduction, respectively, compared to no PrEP. Furthermore, lenacapavir showed superiority over oral PrEP in high-risk groups on various continents.

The new study, conducted in the United States, evaluated the safety, tolerability, and pharmacokinetics of two once-yearly intramuscular formulations of lenacapavir. It included 40 participants without HIV or comorbidities, 65% of whom were men and 80% identified as White. The results were encouraging, with both formulations achieving higher plasma concentrations of the drug than those of biannual subcutaneous lenacapavir, suggesting effective long-term protection.

Challenges and adverse effects of lenacapavir

While the study results are encouraging, some challenges were also identified. A considerable percentage of participants (75-80%) experienced pain at the injection site, usually short-lived. Adverse effects of lenacapavir such as headache and discomfort when walking were also observed in 20-25% of cases, especially with the larger intramuscular formulation. Although these events had been documented in previous trials, their impact will need to be further evaluated in larger studies, the experts stated.

Furthermore, the current lenacapavir study was conducted in a limited and homogeneous population, making its validation in more diverse groups in terms of age, gender, and health conditions essential to determine its global applicability.

The future of PrEP: accessibility and cost-effectiveness

The success of lenacapavir will depend on its accessibility and economic viability. Currently, even the more affordable oral PrEP is not uniformly available globally , and the rollout of long-acting cabotegravir has been slow due to its high cost and need for clinical monitoring.

For lenacapavir to become a viable option, collaboration between governments, international organizations, and the pharmaceutical industry will be key to ensuring its equitable distribution. This breakthrough could mark a milestone in HIV prevention, but its impact will depend on its effective integration into health systems and its accessibility to the most at-risk populations.

__

(Featured image by Diana Polekhina via Unsplash)

DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our disclaimer for more information.

This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these important disclosures.

First published in GACETA MEDICA. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us