HIV Testing WHO Launches Guideline Development Group to Establish New HIV Prevention and Testing Standards for Lenacapavir
The World Health Organization (WHO) has announced the formation of a new Guideline Development Group (GDG) tasked with creating updated guidelines for the use of injectable lenacapavir as a pre-exposure prophylaxis (PrEP) for HIV prevention. The group will also focus on optimizing HIV testing services to accommodate long-acting prevention products. This important move underscores WHO’s commitment to adapting to the changing landscape of global public health, particularly in responding to the needs of populations that are disproportionately impacted by HIV. These updates aim to improve both access to high-quality HIV prevention tools and testing services worldwide, ensuring that public health systems can better address evolving HIV challenges.
Lenacapavir, a novel injectable drug, represents a significant advancement in HIV prevention. Its long-acting formulation provides an alternative to daily oral PrEP, offering convenience and potentially greater adherence for individuals at high risk of HIV infection. The new guidelines will also reflect WHO’s ongoing commitment to simplifying and enhancing HIV testing models, particularly for individuals using long-acting prevention products like lenacapavir.
The Guideline Development Group (GDG): A Global Effort
To develop these new guidelines, WHO has convened a diverse group of experts from around the world. The GDG members will play a crucial role in reviewing systematic reviews, evidence summaries, and technical updates to formulate evidence-based recommendations. These guidelines will not only aim to optimize the use of lenacapavir as a PrEP option but will also focus on improving the delivery of HIV testing services in a way that is both accessible and effective, particularly in low-resource settings.
The GDG meeting is scheduled to take place virtually from January 28 to 30, 2025. During this meeting, members will deliberate on key questions regarding the efficacy, safety, and acceptability of injectable lenacapavir for populations at substantial risk of HIV infection. They will also discuss the role of HIV testing in the context of long-acting prevention methods, such as lenacapavir, to ensure that these products are both effective and safely integrated into existing prevention strategies.
Objectives of the Guidelines
The overarching goal of this meeting and subsequent guideline development is to produce WHO guidelines that will serve as a global reference for the implementation of injectable lenacapavir and other long-acting HIV prevention products. These guidelines will also focus on simplifying HIV testing models to ensure that they are feasible, especially in resource-limited environments where healthcare access may be limited.
1. Evaluating Lenacapavir’s Role in HIV Prevention
One of the primary objectives is to evaluate the efficacy, safety, and acceptability of injectable lenacapavir as an additional option for PrEP. Lenacapavir is already showing promise as a highly effective tool in preventing HIV transmission, and the guidelines will assess its potential to complement existing prevention strategies, particularly in high-risk populations.
For populations such as men who have sex with men, people who inject drugs, sex workers, and other vulnerable groups, injectable PrEP offers an innovative solution. Unlike oral PrEP, which requires daily adherence, injectable PrEP could be administered less frequently, reducing the likelihood of missed doses and improving overall adherence. The GDG will review data from clinical trials, as well as feedback from healthcare providers and affected communities, to make a comprehensive assessment of lenacapavir’s effectiveness in reducing HIV risk.
2. Providing Evidence-Based Guidance on HIV Testing Protocols
The second critical objective of the GDG is to provide evidence-based guidance on HIV testing protocols for individuals using long-acting PrEP options, including injectable lenacapavir. Current HIV testing protocols, which focus on individuals using daily oral PrEP, may need to be adjusted for new long-acting products. The GDG will review existing testing models and consider how they can be simplified and optimized for long-acting prevention methods.
Testing is a critical component of any PrEP strategy, as it ensures that individuals are HIV-negative at the time of initiation, monitors adherence, and helps detect HIV infections early if they occur. As more people turn to long-acting prevention products, HIV testing models must be adapted to suit this shift. For example, less frequent visits may be required for long-acting PrEP users, but these visits should still involve appropriate testing to ensure the prevention method is working as intended.
The GDG will also consider the implementation challenges in low-resource settings, where access to healthcare may be limited. The recommendations will provide a roadmap for how to conduct HIV testing for those using injectable PrEP products, even in settings with limited infrastructure. This might include strategies such as leveraging community health workers or integrating testing with other routine healthcare visits to minimize barriers to care.
Composition of the Guideline Development Group
WHO’s approach to guideline development is grounded in rigorous scientific and technical expertise. As per WHO standards, the GDG is composed of a group of independent experts drawn from across the globe, representing a broad array of experiences and areas of knowledge. These members are selected based on their technical expertise, role as end-users (such as healthcare providers, program managers, and community representatives), and their capacity to contribute to the development of guidelines that reflect the needs of the populations most affected by HIV.
The GDG members serve in their personal capacity rather than as representatives of any affiliated organizations, ensuring that the guidelines developed are impartial and based solely on the available evidence. Furthermore, members of the GDG do not receive financial compensation for their participation in the guideline development process, ensuring the integrity of the process.
This international and multidisciplinary approach ensures that the guidelines developed will be comprehensive, relevant to the global HIV response, and adaptable to a variety of settings, from high-income countries to low-resource environments.
A Global Commitment to HIV Prevention
WHO’s announcement is a significant step forward in the global fight against HIV. The organization has long been at the forefront of advocating for comprehensive HIV prevention strategies, and the development of these new guidelines demonstrates its continued commitment to evolving with the changing landscape of HIV care.
Injectable lenacapavir has the potential to revolutionize HIV prevention, offering an additional tool for individuals at high risk of infection. By optimizing HIV testing services to accommodate long-acting prevention methods, WHO aims to ensure that these new interventions are effectively integrated into global HIV prevention strategies.
Moreover, as HIV continues to disproportionately affect certain populations, including key populations such as sex workers, men who have sex with men, and people who inject drugs, these guidelines will ensure that these groups have access to the most effective and appropriate prevention methods. WHO’s focus on making these interventions available in low-resource settings reflects its commitment to equity and global health justice.
