Gilead Sciences, Inc. (NASDAQ: GILD) today announced results of a retrospective nationwide analysis of the impact of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets) for pre-exposure prophylaxis (PrEP) use across all 50 U.S. states and the District of Columbia. Conducted in collaboration with researchers at Emory University Rollins School of Public Health and the Centers for Disease Control and Prevention (CDC), these data demonstrate that use of once-daily oral Truvada for PrEP has had an independent and significant impact on the number of new HIV infections diagnosed in the United States from 2012 to 2016. The data were presented at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam.
Truvada for PrEP is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. To take Truvada for PrEP, individuals must be confirmed to be HIV-negative and be tested for HIV immediately prior to initiating and at least every 3 months while taking Truvada for PrEP. Truvada has a boxed warning in its product label regarding the risks of drug resistance with the use of Truvada for PrEP in undiagnosed early HIV infection and post treatment acute exacerbation of hepatitis B. Further important safety information, adverse drug reactions and prescribing considerations are included below.
In the analysis, states with the highest utilization of Truvada for PrEP during this five year period (2012 to 2016) had significant declines in the average number of HIV diagnoses, while there was an average increase for the states with the lowest use. The impact of Truvada for PrEP use occurred even after controlling for the effect of antiretroviral therapy use in those living with HIV, known as treatment as prevention (TasP), in a subset of 38 states and Washington, D.C., where virologic suppression data was available.
“These data further validate the potential for significant public health impacts of Truvada for PrEP to help reduce HIV transmission in the U.S.,” said Patrick Sullivan, Professor of Epidemiology at Rollins School of Public Health, Emory University, and lead study author. “By documenting significant declines in average new cases of HIV in states where Truvada for PrEP has been most widely adopted, our analysis emphasizes the importance of improving access to HIV screening and a full range of prevention tools, including PrEP, in U.S. states.”
The analysis of state-level data was based on National HIV Surveillance System and national pharmacy data on HIV diagnoses and prevalence of use of Truvada for PrEP from 2012 to 2016. Across all 50 states and Washington, D.C., Truvada for PrEP use prevalence increased from 7.0 to 68.5 per 1,000 people at highest risk of HIV acquisition during the five-year period, and the rate of new HIV diagnoses decreased significantly from 15.7 to 14.5 per 100,000 people among the general population.
In the ten states with the highest prevalence of Truvada for PrEP use, the pooled unadjusted estimated annual percent change (EAPC) of HIV diagnoses was -4.7 percent. In the group of ten states with the lowest prevalence of Truvada for PrEP use, the EAPC of HIV diagnoses was +0.9 percent.
To evaluate the independence of the effect of Truvada for PrEP uptake from the effect of TasP, researchers analyzed data from a subset of 38 states and Washington, D.C., with viral suppression data (averaged for available years from 2012 to 2014) among people living with HIV. This analysis demonstrates that the rate of Truvada for PrEP uptake remained significantly associated with declines in new HIV diagnoses after controlling for state-level viral suppression.
“Since 2012, Truvada for PrEP has been an important component of HIV prevention strategies. We are pleased to share these additional data at AIDS 2018, correlating its uptake with declines in new diagnoses,” said Andrew Cheng, MD, PhD, Chief Medical Officer, Gilead Sciences. “Gilead remains committed to partnering with organizations that serve people at risk for HIV, as well as those living with the disease, to increase awareness of the potential impact of both Truvada for PrEP and TasP on the HIV epidemic.”
Truvada for PrEP — in combination with safer sex practices — was approved in 2012 by the U.S. Food and Drug Administration (FDA) for HIV prevention in at-risk adults, and was approved in 2018 for use in at-risk adolescents weighing at least 35 kg.
Truvada does not prevent other sexually transmitted infections or cure HIV infection or AIDS.