Guidelines on lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis
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World Health Organization
Abstract
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xi, 47 p.
This publication provides evidence-based recommendations on the use of long-acting injectable lenacapavir for HIV prevention and on HIV testing strategies to support the delivery of long-acting pre-exposure prophylaxis (PrEP). It addresses the need to expand effective prevention options in the context of ongoing HIV transmission and barriers associated with existing PrEP modalities, such as adherence to daily oral regimens and frequent clinic visits. Developed using WHO guideline methodology and the GRADE approach, it synthesizes clinical trial evidence, modelling studies and implementation considerations to inform policy and programme decisions. The document outlines recommendations to offer lenacapavir as an additional prevention choice within combination HIV prevention and to use simplified HIV testing approaches, particularly rapid diagnostic tests, to facilitate access and continuity of PrEP services. It also examines issues related to safety, acceptability, feasibility, cost–effectiveness, equity and human rights, and discusses implementation considerations and research gaps. Intended primarily for policy-makers, programme managers and health service providers, the guidance aims to support countries in strengthening HIV prevention strategies, improving access to user-centred services and advancing progress towards global HIV targets.
This publication provides evidence-based recommendations on the use of long-acting injectable lenacapavir for HIV prevention and on HIV testing strategies to support the delivery of long-acting pre-exposure prophylaxis (PrEP). It addresses the need to expand effective prevention options in the context of ongoing HIV transmission and barriers associated with existing PrEP modalities, such as adherence to daily oral regimens and frequent clinic visits. Developed using WHO guideline methodology and the GRADE approach, it synthesizes clinical trial evidence, modelling studies and implementation considerations to inform policy and programme decisions. The document outlines recommendations to offer lenacapavir as an additional prevention choice within combination HIV prevention and to use simplified HIV testing approaches, particularly rapid diagnostic tests, to facilitate access and continuity of PrEP services. It also examines issues related to safety, acceptability, feasibility, cost–effectiveness, equity and human rights, and discusses implementation considerations and research gaps. Intended primarily for policy-makers, programme managers and health service providers, the guidance aims to support countries in strengthening HIV prevention strategies, improving access to user-centred services and advancing progress towards global HIV targets.
Keywords
WHO guideline, Pre-Exposure Prophylaxis, HIV Infections, Acquired Immunodeficiency Syndrome, Anti-HIV Agents, Injections, Intramuscular, Drug Administration Schedule, Rapid Diagnostic Tests, Self-Testing, HIV Testing, HIV Antibodies, Cost-Effectiveness Analysis, Health Equity, Patient Preference, Homosexuality, Male, Pregnancy Complications, Infectious, Drug-Related Side Effects and Adverse Reactions, Drug Resistance, Viral, Anti-Retroviral Agents, Feasibility Studies, Evidence-Based Practice, Evidence Gaps, Systematic Reviews as Topic, Guideline, prevention and control, diagnosis, drug therapy, therapeutic use, administration and dosage, adverse effects