Claims-Based Algorithm to Identify Pre-Exposure Prophylaxis Indications for Tenofovir Disoproxil Fumarate and Emtricitabine Prescriptions (2012-2014): Validation Study.

Background: To monitor the use of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and related medicines for pre-exposure prophylaxis (PrEP) as HIV prevention using commercial pharmacy data, it is necessary to determine whether TDF/FTC prescriptions are used for PrEP or for some other clinical indication.

Objective: This study aimed to validate an algorithm to distinguish the use of TDF/FTC for HIV prevention or infectious disease treatment.

Methods: An algorithm was developed to identify whether TDF/FTC prescriptions were for PrEP or for other indications from large-scale administrative databases.

Small-area spatial-temporal changes in pre-exposure prophylaxis (PrEP) use in the general population and among men who have sex with men in the United States between 2012 and 2018.

Purpose: Oral emtricitabine/tenofovir disoproxil fumarate was approved for use as pre-exposure prophylaxis (PrEP) by the U.S. Food and Drug Administration in 2012.

Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care.

Background: We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe coronavirus disease 2019 (COVID-19) using data from a phase 3 remdesivir trial and a retrospective cohort of patients with severe COVID-19 treated with standard of care.

Methods: GS-US-540-5773 is an ongoing phase 3, randomized, open-label trial comparing two courses of remdesivir (remdesivir-cohort). GS-US-540-5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standard-of-care treatment (non-remdesivir-cohort).

Contrasting serum biomarker profiles in two Colombian populations with different risks for progression of premalignant gastric lesions during chronic Helicobacter pylori infection.

Background: Colombians in coastal Tumaco have a lower incidence of Helicobacter pylori-associated gastric cancer compared to individuals from Tuquerres in the high Andes. This is despite nearly universal prevalence of H. pylori infection and chronic gastritis.

Policy- and county-level associations with HIV pre-exposure prophylaxis use, the United States, 2018.

Purpose: HIV pre-exposure prophylaxis (PrEP) is highly efficacious, and yet most individuals indicated for it are not currently using it. To provide guidance for health policymakers, researchers, and community advocates, we developed county-level PrEP use estimates and assessed locality and policy associations.

Methods: Using data from a national aggregator, we applied a validated crosswalk procedure to generate county-level estimates of PrEP users in 2018.

Evidence of an Association of Increases in Pre-exposure Prophylaxis Coverage With Decreases in Human Immunodeficiency Virus Diagnosis Rates in the United States, 2012-2016.

Background: Annual human immunodeficiency virus (HIV) diagnoses in the United States (US) have plateaued since 2013. We assessed whether there is an association between uptake of pre-exposure prophylaxis (PrEP) and decreases in HIV diagnoses.

Methods: We used 2012-2016 data from the US National HIV Surveillance System to estimate viral suppression (VS) and annual percentage change in diagnosis rate (EAPC) in 33 jurisdictions, and data from a national pharmacy database to estimate PrEP uptake.

Trends in the use of oral emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis against HIV infection, United States, 2012-2017.

Purpose: Pre-exposure prophylaxis (PrEP) with oral emtricitibine/tenofovir disoproxil fumarate (TDF/FTC) reduces the risk of HIV infection by >90% when taken as prescribed. Trends in prevalence of PrEP use, which account for persons who have stopped PrEP, increased through 2016, but have not been described since.

Methods: Annual prevalence estimates of unique, TDF/FTC PrEP users (individuals with ≥1 day of a filled PrEP prescription in a given year) in the United States (US) were generated for 2012-2017 from a national prescription database.

The prevalence of pre-exposure prophylaxis use and the pre-exposure prophylaxis-to-need ratio in the fourth quarter of 2017, United States.

Purpose: The number of individuals who have started a regimen for HIV pre-exposure prophylaxis (PrEP) in the United States is not well characterized but has been on the rise since 2012. This analysis assesses the distribution of PrEP use nationally and among subgroups.

Methods: A validated algorithm quantifying tenofovir disoproxil fumarate/emtricitabine for PrEP in the United States was applied to a national prescription database to determine the quarterly prevalence of PrEP use.

Two years of Truvada for pre-exposure prophylaxis utilization in the US.

Introduction: Truvada® (TVD) was approved in July 2012 by the US FDA for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in high-risk adults. This study explores the characteristics of US PrEP users and their prescribers over the past two years.

Materials And Methods: A previously described algorithm was used to identify TVD for PrEP by excluding use for HIV treatment, post-exposure prophylaxis, and off-label treatment of chronic hepatitis B.