Safety of oral tenofovir disoproxil - emtricitabine for HIV preexposure prophylaxis in adults.

PURPOSE OF REVIEW: This review focuses on the safety of oral tenofovir disoproxil and emtricitabine (FTC) combination for HIV preexposure prophylaxis (PrEP) in adults.

RECENT FINDINGS: Gastrointestinal adverse events are common after treatment initiation but usually resolve within weeks. Although clinical trials did not report an increased risk of serious renal adverse events or tubulopathy, meta-analyses suggest that tenofovir disoproxil -FTC is associated with a slight but non-clinically relevant decline in estimated glomerular filtration rate (eGFR). A decline to less than 60 mL/min remains a rare event, which mainly occurs in users with an age >50 years or a baseline creatinine clearance < 90 mL/min. Similarly, a slight reduction in bone mineral density (BMD) was observed in clinical trials, but it did not result in an increased risk of bone fracture. BMD reduction and eGFR decline tend to resolve after treatment discontinuation. No drug interaction with contraception has been reported in women and no safety signal emerged in pregnant and breastfeeding women.

SUMMARY: Oral tenofovir disoproxil-FTC for HIV PrEP appears safe and well tolerated for most individuals. This supports demedicalization strategies aiming at increasing the number of PrEP users.