Elsevier

The Lancet

Volume 380, Issue 9839, 28 July–3 August 2012, Page 325
The Lancet

World Report
FDA paves the way for pre-exposure HIV prophylaxis

https://doi.org/10.1016/S0140-6736(12)61235-5Get rights and content

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Cited by (52)

  • Cost-effectiveness of oral pre-exposure prophylaxis and expanded antiretroviral therapy for preventing HIV infections in the presence of drug resistance among men who have sex with men in China: A mathematical modelling study

    2022, The Lancet Regional Health - Western Pacific
    Citation Excerpt :

    Understanding how the HIVDR affects the effectiveness of PrEP is essential to control the transmission of HIV. Since 2012, oral PrEP based on tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) has been approved by the US Food and Drug Administration (FDA),15 and subsequently recommended by the WHO in 2015,16 and then more than 50 countries had released national guidelines following the WHO's PrEP recommendations by the end of 2019.17 Oral PrEP is not popular in China, which may be because that China has not released the PrEP guideline yet.17

  • The spatiotemporal distribution of pre-exposure prophylaxis accessibility in the United States, 2016–2020

    2021, Annals of Epidemiology
    Citation Excerpt :

    In February 2019, the U.S. Department of Health and Human Services established the Ending the HIV Epidemic: A Plan for America (EHE) Initiative to end the current HIV epidemic by 2030 [1,2] The goals of the EHE Initiative are to decrease HIV incidence by 75% in 5 years and by 90% in 10 years, with an emphasis on expanding access to and uptake of daily oral HIV pre-exposure prophylaxis (PrEP) in geographic hot spots of the U.S [1,2] PrEP is a biomedical intervention for preventing HIV transmission in persons living without HIV but who are at increased risk for HIV [3,4] PrEP is highly effective in reducing HIV infection at the individual level by up to 99% [5-14] Higher PrEP uptake has also been associated with decreases in annual HIV diagnosis rates by 1.3% at the state level [15] While PrEP is an effective antiretroviral-based HIV prevention strategy and the prevalence of PrEP use has steadily increased over time [16-21] levels of PrEP uptake remain much lower than the estimated 1.1 million persons who have indications for PrEP in the U.S [22,23] Suboptimal spatial proximity to PrEP services is a significant contributor to such low uptake of PrEP [24,25].

  • Adoption of guidelines on and use of oral pre-exposure prophylaxis: a global summary and forecasting study

    2021, The Lancet HIV
    Citation Excerpt :

    The efficacy of oral pre-exposure prophylaxis (PrEP) with tenofovir-based antiviral medication to prevent the acquisition of HIV in uninfected people has been shown in randomised controlled trials across settings and populations.1 The US Food and Drug Administration approved tenofovir disoproxil fumarate with emtricitabine for oral PrEP in 2012,2 and, in 2015, WHO recommended offering once-daily oral PrEP to people at substantial risk of HIV acquisition (provisionally defined as HIV incidence of >3 per 100 person-years in the absence of PrEP) as an additional choice in combination HIV prevention.3 WHO updated guidance in 2019 to include the option of event-driven dosing (also known as on-demand PrEP) for men who have sex with men.4

  • Prevalence and incidence of hepatitis C virus infection in men who have sex with men: a systematic review and meta-analysis

    2021, The Lancet Gastroenterology and Hepatology
    Citation Excerpt :

    For all eligible studies, extra datapoints included country of origin, year of publication, and HCV testing method used, as well as HIV PrEP use among men who were HIV-negative. Men whose follow-up finished before 2012, the year of the first regulatory approval of PrEP, were assumed not to be taking PrEP.20 The four cohort studies in HIV-negative MSM whose study follow-up finished after 2012 were all in men taking PrEP.

  • Global dynamics and cost-effectiveness analysis of HIV pre-exposure prophylaxis and structured treatment interruptions based on a multi-scale model

    2019, Applied Mathematical Modelling
    Citation Excerpt :

    These factors rekindled the interest in examining interruption strategies [13]. Tenofovir/emtricitabine was approved for use as oral pre-exposure prophylaxis (PrEP) by the US Food and Drug Administration (FDA) in July 2012 [28]. The US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) followed with guidelines to promote PrEP use in 2014 and 2015, respectively [29,30].

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