These data were just presented at the HIV Drug Therapy in the Americas conference, 8–10 May 2014, Rio de Janeiro, Brazil.
Silva Anita; Mera Robertino; Ng Leslie; Magnuson David and Rawlings Keith
1Public Health & Medical Affairs, Gilead Sciences, Sao Paulo, Brazil. 2Epidemiology, Gilead Sciences, Foster City, CA, USA. 3Drug Safety and Public Health, Gilead Sciences, Foster City, CA, USA. 4Medical Affairs, Gilead Sciences, Foster City, CA, USA.
Introduction: Truvada® (TVD) was approved in July 2012 by the U.S. FDA for the pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk. Registration studies in the United States accrued only males while serodiscordant couple studies were carried out in Africa. The objective of this study is to explore the characteristics of the U.S. PrEP population and their prescribers.
Materials and methods: A standard algorithm was used to identify TVD for PrEP by excluding use for HIV treatment, post-exposure prophylaxis and off-label treatment for chronic hepatitis B. National electronic patient level data from ~55% of all U.S. retail pharmacies that dispensed TVD between January 2012 and September 2013 was used. De-identified patient-level data including detailed drug information, medical claims and patient demographics were analyzed. Logistic regression was used to estimate the odds of change over time.
Results: A total of 2319 unique individuals who started TVD for PrEP after 1 January 2012 were included in the analysis. As high as 48.8% of PrEP users were women. Mean age was 38.2+12.2 years, with males being significantly older (39.5+12.0) than females (36.8+12.3) and 12.3% of individuals were under 25 years old. Proportion of males under 25 was 8.0%, 95% CI 6.5–9.5; significantly lower than that of women, 16.8%, 95% CI 14.6–18.9. Distribution of TVD for PrEP prescriptions by specialty: family practice (18%), internal medicine (16%), infectious diseases (11%), nurse practitioners and physician assistants (9%) each. Among women who initiated TVD for PrEP, 49% received it from nurse practitioners and 43% infectious diseases specialists. When compared to HIV positive patients, uninfected individuals receiving TVD for PrEP were 1.8 times more likely to be female (95% CI 1.6–1.9), 1.4 times more likely to be younger than 25 years old (95% CI 1.3–1.7) and 3.6 times more likely to be treated by a non-ID physician (95% CI 3.2–4.1).
Conclusions: The population of TVD for PrEP users in the United States is quite different from HIV+ subjects. They are more likely to be women, younger and be treated by Primary care clinicians.