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Pre-exposure Prophylaxis Outcomes in High-Risk Individuals in Saudi Arabia: A 48-Week Observational Cohort Study
1Infectious Disease Division, Department of Internal Medicine, Dammam Medical Complex, Dammam, SAU.
Cureus
|July 23, 2026
Summary
Tenofovir alafenamide/emtricitabine pre-exposure prophylaxis (PrEP) showed excellent effectiveness and safety in Saudi Arabia, with no HIV cases observed. High adherence and retention in care were noted, but sexually transmitted infections remain a concern.
Area of Science:
- Public Health
- Infectious Diseases
- Pharmacology
Background:
- HIV remains a significant global health issue, with rising cases in the Middle East and North Africa (MENA).
- Pre-exposure prophylaxis (PrEP) is effective but understudied in real-world MENA settings, especially Saudi Arabia.
- Limited data exists on PrEP's effectiveness, safety, and adherence in high-risk populations within Saudi Arabia.
Purpose of the Study:
- To evaluate the real-world effectiveness, safety, adherence, and implementation of PrEP in Saudi Arabia.
- To assess HIV incidence, retention in care, and adverse events in participants using TAF/FTC for PrEP.
- To identify implementation challenges and ongoing risk behaviors within the study population.
Main Methods:
- Prospective, single-center, observational cohort study of 50 high-risk, HIV-negative adults in Saudi Arabia.
- Participants received daily or on-demand tenofovir alafenamide/emtricitabine (TAF/FTC) for 48 weeks.
- Primary outcome: HIV incidence; Secondary outcomes: retention, adherence, safety (renal, hepatic, bone), STI incidence, and risk behaviors.
Main Results:
- No HIV seroconversions occurred (0 per 100 person-years).
- High retention (94%) and visit adherence (94%) were observed, with over 90% adherence in most participants.
- Adverse events were infrequent (6%) and mild; statistically significant but clinically irrelevant changes in renal and bone density were noted. STI incidence was 35.4 per 100 person-years.
Conclusions:
- TAF/FTC-based PrEP demonstrated high effectiveness, safety, and adherence in a Saudi Arabian real-world setting.
- Persistent high-risk behaviors and significant STI incidence underscore the need for integrated prevention strategies.
- Findings support expanding PrEP programs in MENA, coupled with comprehensive sexual health interventions and further multicenter research.
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