Rapid Responsive Evidence Synthesis for Decision-making for Lenacapavir: Evidence-to-decision (E2D) Collaboration
1
Health Systems Research Unit, South African Medical Research Council, Cape Town, South Africa
2
Discipline of General Surgery, Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa
3
Clinton Health Access Initiative, Pretoria, South Africa
4
Affordable Medicines Directorate, National Department of Health, Pretoria, South Africa
5
Division of Clinical Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
6
Division of Infectious Diseases, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
7
Infectious Diseases and Oncology Research Institute, University of the Witwatersrand, Johannesburg, South Africa
8
South African Medical Research Council/University of Cape Town Platform for Pharmacogenomics Research and Translation, South African Medical Research Council, Cape Town, South Africa
9
Infectious Diseases Unit, Grey's Hospital, Pietermaritzburg, South Africa
10
Centre for the AIDS Programme of Research in South Africa (CAPRISA), Doris Duke Medical Research Institute, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa
11
Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa
Popul. Med. 2026;8(Supplement Supplement 1):
ABSTRACT
BACKGROUND:
To describe the collaborative processes and results of a review that enabled evidence-informed, context-specific recommendations for the use of lenacapavir for HIV pre-exposure prophylaxis (PrEP) in South Africa.
METHODS:
Trustworthy guidance products require actionable statements (recommendations) supported by structured, transparent, evidence-informed decision-making processes. The National Department of Health Essential Medicines Programme, the South African Medical Research Council and Stellenbosch University established the Evidence-to-Decision (E2D) collaboration to facilitate timely evidence synthesis and promote broader stakeholder engagement in policy decisions. Efficacy and safety of lenacapavir, compared with oral PrEP, were prioritised for a rapid evidence review conducted according to a registered protocol specifying the population, intervention, control, and outcomes (PICO). Methodologists oversaw key review stages, including guideline and primary study searches, study selection, data extraction and analysis, critical appraisal, and GRADE assessment to determine the certainty of the evidence for each outcome. Evidence-to-decision tables summarised benefits, harms, and contextual considerations such as equity, feasibility, resource requirements, acceptability, and stakeholder values.
RESULTS:
When compared to oral PrEP, lenacapavir results in a large reduction in new HIV infections, with one HIV infection prevented for every 70 people. There was little to no difference in harms, apart from increased injection site reactions with lenacapavir. HIV incidence remains high, particularly amongst adolescent girls, young women and key populations. Barriers to adherence to oral PrEP include stigma and pill fatigue. Injectable PrEP is a discreet option. The 6-monthly dosing interval allows integration into existing reproductive health services, supporting consistent use and broader implementation in public health HIV prevention programmes.
CONCLUSIONS:
Findings from this review informed the inclusion of lenacapavir in the South African national PrEP policy. This collaborative effort employed a standardised approach to formulate recommendations across multiple stakeholders, minimising resource waste, and can serve as a model to guide health policy and health systems decision-making.
To describe the collaborative processes and results of a review that enabled evidence-informed, context-specific recommendations for the use of lenacapavir for HIV pre-exposure prophylaxis (PrEP) in South Africa.
METHODS:
Trustworthy guidance products require actionable statements (recommendations) supported by structured, transparent, evidence-informed decision-making processes. The National Department of Health Essential Medicines Programme, the South African Medical Research Council and Stellenbosch University established the Evidence-to-Decision (E2D) collaboration to facilitate timely evidence synthesis and promote broader stakeholder engagement in policy decisions. Efficacy and safety of lenacapavir, compared with oral PrEP, were prioritised for a rapid evidence review conducted according to a registered protocol specifying the population, intervention, control, and outcomes (PICO). Methodologists oversaw key review stages, including guideline and primary study searches, study selection, data extraction and analysis, critical appraisal, and GRADE assessment to determine the certainty of the evidence for each outcome. Evidence-to-decision tables summarised benefits, harms, and contextual considerations such as equity, feasibility, resource requirements, acceptability, and stakeholder values.
RESULTS:
When compared to oral PrEP, lenacapavir results in a large reduction in new HIV infections, with one HIV infection prevented for every 70 people. There was little to no difference in harms, apart from increased injection site reactions with lenacapavir. HIV incidence remains high, particularly amongst adolescent girls, young women and key populations. Barriers to adherence to oral PrEP include stigma and pill fatigue. Injectable PrEP is a discreet option. The 6-monthly dosing interval allows integration into existing reproductive health services, supporting consistent use and broader implementation in public health HIV prevention programmes.
CONCLUSIONS:
Findings from this review informed the inclusion of lenacapavir in the South African national PrEP policy. This collaborative effort employed a standardised approach to formulate recommendations across multiple stakeholders, minimising resource waste, and can serve as a model to guide health policy and health systems decision-making.
| eISSN: | 2654-1459 |
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