Background: Truvada (FTC/TDF) for PrEP has been approved for use in adults (≥18 years of age) at high risk of sexually acquired HIV infection in the US, EU, and other countries. Regulatory reviews are ongoing to expand the indication to include adolescents. There are limited data on the efficacy of FTC/TDF for PrEP in adolescents and there are no data on drug utilization in US or EU. This study describes FTC/TDF for PrEP use in adolescents in US from January 2012 through September 2017.
Methods: We used a nationally representative sample of de-identified data from a US prescription claims database to quantify the number of unique individuals who received a FTC/TDF for PrEP prescription, representing >80% of retail pharmacies in the US. Data included medical claims, diagnosis, diagnostic procedures and both patient and provider demographics. A validated algorithm was used to exclude FTC/TDF for non-PrEP use (e.g. chronic HIV treatment, post-exposure prophylaxis and chronic Hepatitis B treatment).
Results: From January 2012 to September 2017, 148,147 unique individuals began FTC/TDF for PrEP: 2,388 (1.6%) were 12-17 yrs; 20,409 (13.8%) were 18-24 yrs; 114,279 (77.1%) were 25-54, and 11,071 (7.5%) were ≥ 55 yrs. The total number of adolescents increased annually from 266 in 2012 to 805 in 2015, but decreased to 216 in 2016. Females given FTC/TDF for PrEP accounted for 86.0% of adolescents while comprising only 18.4% of adults given prescriptions (p < 0.0001). Medicaid provided coverage for FTC/TDF in 59.1% of adolescents as compared to 13.5% of adults. Adolescents received FTC/TDF for PrEP prescriptions most commonly from pediatricians (31.6%), emergency medicine (22.6%), and family medicine physicians (12.3%).
Conclusions: While adolescent use of FTC/TDF for PrEP is not approved in the US, 1.6% of FTC/TDF PrEP users were < 18 years of age. In contrast to adults on FTC/TDF for PrEP, adolescents on FTC/TDF for PrEP were predominantly female and commonly used Medicaid coverage. Pediatricians and emergency medicine doctors were most common prescribers in adolescents. Adolescents and young adults are disproportionately affected by HIV and efforts to increase access to PrEP for adolescents at high risk are important, including expanding the indication.