Author: Dr Azuka Chinweokwu Ezeike, MBBS, FWACS, FMCOG, MSc (PH)
On July 14, 2025, the World Health Organization (WHO) released new guidelines introducing long-acting injectable lenacapavir as an additional option for HIV prevention. This marks a significant step forward in the global fight against HIV. The drug was earlier approved by the United States Food and Drug Administration (FDA) in June 2025.
Lenacapavir is a capsid inhibitor administered as an injection just twice a year (every 26 weeks). The drug was developed by Gilead Sciences and is marketed under the brand name Yetzugo in the United States.It is designed for HIV-negative individuals at high risk of acquiring HIV.
These groups include:
The WHO also emphasises that a person’s request for PrEP (pre-exposure prophylaxis) should be considered valid evidence of HIV risk. This makes PrEP more accessible beyond pre-defined groups.
Until now, HIV prevention options have included:
The key advantage of lenacapavir is its twice-yearly dosing. This is likely to improve adherence compared to daily pills or more frequent injections.
According to WHO, lenacapavir does not show evidence of adverse outcomes in pregnancy, similar to other pre-exposure prophylaxis methods. Its safety has also been demonstrated across different populations.
To make PrEP more accessible, WHO now recommends using flexible HIV testing methods such as rapid self-test kits. This move aims to remove barriers that have previously limited access, especially in low-resource settings.
This new recommendation is expected to:
For individuals and healthcare providers alike, this development offers a more convenient and effective prevention choice. It is a promising addition to the global HIV prevention toolkit.
Source
World Health Organization. Guidelines on lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis. Available fromhttps://iris.who.int/bitstream/handle/10665/381892/9789240111608-eng.pdf?sequence=1
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Published July 17, 2025