Background: Placebo-controlled and open-label studies have demonstrated the safety and efficacy of daily oral preexposure prophylaxis (PrEP) in preventing HIV infection, but data are limited on real-world PrEP use.
Methods: We conducted a cohort study from July 2012 through June 2015 of Kaiser Permanente Northern California members initiating PrEP. We assessed pharmacy refill adherence and discontinuation, decreases in estimated glomerular filtration rate (eGFR), and sexually transmitted infection (STI)/HIV incidence.
Results: Overall, 972 individuals initiated PrEP, accumulating 850 person-years of PrEP use. Mean adherence was 92% overall. Black race/ethnicity [adjusted risk ratio (aRR) 3.0; 95% confidence interval: 1.7 to 5.1, P < 0.001], higher copayments (aRR 2.0; 1.2 to 3.3, P = 0.005), and smoking (aRR 1.6; 1.1 to 2.3, P = 0.025) were associated with <80% adherence. PrEP was discontinued by 219 (22.5%); female sex (aRR 2.6; 1.5 to 4.6, P < 0.001) and drug/alcohol abuse (aRR 1.8; 1.3 to 2.6, P = 0.002) were associated with discontinuation. Among 909 with follow-up creatinine testing, 141 (15.5%) had an eGFR <70 mL·min−1·1.73 m−2 and 5 (0.6%) stopped PrEP because of low eGFR. Quarterly STI positivity was high and increased over time for rectal chlamydia (P < 0.001) and urethral gonorrhea (P = 0.012). No HIV seroconversions occurred during PrEP use; however, 2 occurred in individuals who discontinued PrEP after losing insurance coverage.
Conclusions: PrEP adherence was high in clinical practice, consistent with the lack of HIV seroconversions during PrEP use. Discontinuation because of renal toxicity was rare. STI screening every 6 months, as recommended by current guidelines, may be inadequate. Strategies are needed to increase PrEP access during gaps in insurance coverage.
*Division of Research, Kaiser Permanente Northern California, Oakland, CA;
†Department of Adult and Family Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, CA; and
‡Division of Infectious Diseases, University of California, San Francisco, CA.
Correspondence to: Julia L. Marcus, PhD, MPH, Division of Research, Kaiser Permanente Northern California, 2000 Broadway, 2nd Floor, Oakland, CA 94612 (e-mail: email@example.com).
Supported by a Kaiser Permanente Northern California Community Benefit grant to J.L.M.
Presented in part at the 23rd Conference on Retroviruses and Opportunistic Infections, February 25, 2016, Boston, MA.
J.L.M. has received research grant support from Merck. M.J.S. has received research grant support from Pfizer and Merck. The remaining authors have no conflicts of interest to disclose.
Received May 11, 2016
Accepted June 24, 2016