Pre-exposure Prophylaxis Outcomes in High-Risk Individuals in Saudi Arabia: A 48-Week Observational Cohort Study

Background Human immunodeficiency virus (HIV) continues to pose a substantial global health challenge, with an increasing burden observed in the Middle East and North Africa (MENA) region despite advancements in preventive measures. Pre-exposure prophylaxis (PrEP) has demonstrated high efficacy globally; however, data from real-world settings within the MENA region, particularly Saudi Arabia, remain limited. This study aims to evaluate the effectiveness, safety, adherence, and implementation outcomes of PrEP among a high-risk population. Methods This prospective, single-center, observational cohort study was conducted at Dammam Medical Complex, Saudi Arabia. A total of 50 HIV-negative adults at high risk of HIV infection were enrolled and followed for 48 weeks. Participants received tenofovir alafenamide/emtricitabine (TAF/FTC) as either daily or on-demand PrEP. The primary outcome was HIV incidence per 100 person-years. Secondary outcomes included retention in care, visit adherence, safety (renal, hepatic, and bone), adherence levels, sexually transmitted infection (STI) incidence, and implementation challenges. Descriptive statistics and paired analyses were performed. Results Human immunodeficiency virus seroconversions were not observed over 48 weeks, yielding an incidence of 0 per 100 person-years (95% CI: 0.0-0.071). Retention in care was high (94%), with similar visit adherence (94%). Adherence exceeded 90% in 92% of participants, with 100% adherence among daily PrEP users. Adverse events were infrequent (6%) and mild, with no discontinuations due to safety concerns. Small but statistically significant changes in renal function and bone mineral density were observed, without clinical relevance. STI incidence was 35.4 per 100 person-years, with 30% of participants acquiring at least one STI. High-risk behaviors persisted, including condomless sex (68%). Conclusion Tenofovir alafenamide/emtricitabine-based PrEP demonstrated excellent effectiveness, safety, and adherence in a real-world setting in Saudi Arabia. Despite these favorable outcomes, high STI incidence and ongoing risk behaviors highlight the need for integrated prevention strategies. These findings support the expansion of PrEP programs in MENA while emphasizing the importance of comprehensive sexual health interventions and larger multicenter studies.