Headlines - Use of Truvada® or generic versions for HIV pre-exposure prophylaxis (PrEP)

On World AIDS Day 2017, the French National Agency for Medicines and Health Products Safety (ANSM) published the first data on the use of pre-exposure prophylaxis (PrEP) in France. This innovative treatment is part of a comprehensive prevention strategy for HIV transmission among adults at high risk of acquiring HIV through sexual contact, which also includes promoting condom use, regular testing for HIV and other STIs, knowing the HIV viral status of one’s partner(s), the use of “Treatment as Prevention (TasP)" for HIV-positive partners, and the use of post-exposure prophylaxis (PEP).Access to this treatment became available in France in January 2016 through the implementation of a temporary recommendation for use (RTU) for adults most at risk of HIV transmission. This was followed on February 28, 2017, by a Marketing Authorization (MA).The objectives of the study conducted by the ANSM using reimbursement data from the National Health Insurance System (SNIIRAM) were: 1/ to assess the number of people who initiated treatment with Truvada® or generics for HIV PrEP between January 1, 2016, and July 31, 2017, distinguishing between the TEU (14 months: January 4, 2016, to February 28, 2017) and the MA (5 months: March 1 to July 31, 2017) , 2/describe the main characteristics of the treated population (sex, age, region of affiliation, presence of CMU-C) and identify the specialty of the prescribing physician, distinguishing between the RTU and AMM periods.In total, 5,352 individuals were identified as newly exposed to HIV and treated with Truvada® or its generics for PrEP, based on SNIIRAM data (3,536 and 1,816, respectively, during the RTU and AMM periods) in France between January 1, 2016, and July 31, 2017. The treated population consisted of 97.5% men, with an average age of 38 years, and 7.3% of cases were covered by CMU-C. For 92.2% of prescriptions, the source was hospital-based (the proportion of non-hospital-based prescriptions increased during the AMM period). In Bourgogne-Franche-Comté, 37 individuals were identified during the RTU period and 34 during the AMM period (n=71 in total, representing 1.3% of cases in France). Their characteristics are comparable to those observed in France: predominantly men (98.6%), with a mean age of 38.2 years, and 93% of prescriptions were issued in a hospital setting. This innovative strategy helps reduce the risk of transmission, thereby lowering the number of new HIV-positive cases, provided that HIV infection is detected early.