Regulatory Pathways and Global Equity in Access to Injectable Cabotegravir for HIV Prevention: A Systematic Review and Meta-analysis
Published: June 2025
Abstract
Background: Biannual long-acting injectable cabotegravir has emerged as a transformative tool for HIV prevention, offering an adherence-independent alternative to daily oral PrEP. Disparities in regulatory approval and access—especially in LMICs—threaten to undermine its public health impact.
Methods: A systematic review and meta-analysis (Jan 2016–May 2025) across PubMed, Scopus, Web of Science, Embase, and regulatory databases. Meta-analysis compared uptake rates in HICs vs. LMICs. Thematic synthesis identified equity-related barriers and enablers.
Results: Of 32 eligible studies, 18 were meta-analyzed. As of May 2025, only 12 countries had approved cabotegravir for PrEP—mostly HICs. Uptake was significantly higher in HICs (36%) than LMICs (8%). Barriers included high cost, limited regulatory capacity, and stigma. Enablers included donor support, task-shifting, and community engagement.
Conclusion: Access to injectable PrEP remains inequitable. Coordinated global efforts are needed to address pricing, regulatory harmonization, and health system readiness.
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