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Background: Truvada (TVD) for pre-exposure prophylaxis (PrEP) was approved by the FDA in July 2012 to reduce the risk of sexually acquired HIV-1 in adults at high risk.
In this study we describe the changes over time in TVD for PrEP utilization in the United States and characteristics of the individuals who started TVD from January 2012 through September 2016.
Methods: We used a nationally representative sample of blinded data from a US prescription claims database to assess individuals who received a TVD prescription, representing >80% of retail pharmacies in the US. The data warehouse also contains medical claims, including diagnosis, procedures and patient and provider demographics. We utilized a validated algorithm to identify the use of TVD for the PrEP indication by excluding use for HIV treatment, post-exposure prophylaxis and off-label chronic Hepatitis B treatment. Logistic regression with linear splines was used to identify changes over time and compare HIV and PrEP characteristics.
Results: Between January 2012 and September 2016, a total of 98,731 unique individuals were identified as starting TVD for PrEP: 5,853 in 2012; 6,547 in 2013; 16,117 in 2014; 33,484 in 2015 and 36,732 in the first three quarters of 2016. Three distinct periods have been observed, the first from 1Q2012 to 1Q2014 of slow growth (9% per quarter); the second of rapid growth from 2Q2014 to 4Q2015 (17% per quarter) and a stabilization period from 1Q2016 to 3Q2016 (growth < 1% per quarter). The first and second periods had statistically significant (p< 0.001) increases (positive slopes), but not the third. In the first period, there were a greater proportion of women (41.6%), which declined to 11.5% and 9.8% in the second and the third periods respectively. When compared to HIV positive patients, uninfected individuals receiving TVD for PrEP were 2.59 times less likely to be female (95% CI 2.5-2.6), and 1.17 times more likely to be younger than 25 years old (95% CI 1.16-1.17).
Conclusions: There has been a steady and substantive uptake in starts of TVD for PrEP across the US with more than 11,000 subjects initiating therapy in every quarter of 2016.