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Effect of On-Demand Oral Pre-exposure Prophylaxis With Tenofovir/Emtricitabine on Herpes Simplex Virus-1/2 Incidence Among Men Who Have Sex With Men: A Substudy of the ANRS IPERGAY Trial

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      Abstract

      We evaluated the impact of on-demand oral tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) for pre-exposure prophylaxis (PrEP) on herpes simplex virus (HSV)-1/2 incidence among men who have sex with men (MSM) enrolled in the ANRS IPERGAY trial. Serum samples were tested at baseline and at the last visit for HSV-1/2 antibodies. Overall HSV-1 incidence was 11.7 per 100 person-years; 16.2 and 7.8 per 100 person-years in the TDF/FTC and placebo arm, respectively ( P = .19). Overall HSV-2 incidence was 7.6 per 100 person-years; 8.1 and 7.0 per 100 person-years in the TDF/FTC and placebo arm, respectively ( P = .75). On-demand oral PrEP with TDF/FTC failed to reduce HSV-1/2 incidence in this population.

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      Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women.

      The Centre for the AIDS Program of Research in South Africa (CAPRISA) 004 trial assessed the effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n = 445 women) with placebo gel (n = 444 women) in sexually active, HIV-uninfected 18- to 40-year-old women in urban and rural KwaZulu-Natal, South Africa. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years (person time of study observation) (38 out of 680.6 women-years) compared with 9.1 per 100 women-years (60 out of 660.7 women-years) in the placebo gel arm (incidence rate ratio = 0.61; P = 0.017). In high adherers (gel adherence > 80%), HIV incidence was 54% lower (P = 0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50 to 80%) and low adherers (gel adherence < 50%), the HIV incidence reduction was 38 and 28%, respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconverters. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.
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        On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection.

        Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have been reported among studies, probably due to challenges of adherence to a daily regimen.
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          Global and Regional Estimates of Prevalent and Incident Herpes Simplex Virus Type 1 Infections in 2012

          Background Herpes simplex virus type 1 (HSV-1) commonly causes orolabial ulcers, while HSV-2 commonly causes genital ulcers. However, HSV-1 is an increasing cause of genital infection. Previously, the World Health Organization estimated the global burden of HSV-2 for 2003 and for 2012. The global burden of HSV-1 has not been estimated. Methods We fitted a constant-incidence model to pooled HSV-1 prevalence data from literature searches for 6 World Health Organization regions and used 2012 population data to derive global numbers of 0-49-year-olds with prevalent and incident HSV-1 infection. To estimate genital HSV-1, we applied values for the proportion of incident infections that are genital. Findings We estimated that 3709 million people (range: 3440–3878 million) aged 0–49 years had prevalent HSV-1 infection in 2012 (67%), with highest prevalence in Africa, South-East Asia and Western Pacific. Assuming 50% of incident infections among 15-49-year-olds are genital, an estimated 140 million (range: 67–212 million) people had prevalent genital HSV-1 infection, most of which occurred in the Americas, Europe and Western Pacific. Conclusions The global burden of HSV-1 infection is huge. Genital HSV-1 burden can be substantial but varies widely by region. Future control efforts, including development of HSV vaccines, should consider the epidemiology of HSV-1 in addition to HSV-2, and especially the relative contribution of HSV-1 to genital infection.
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            Author and article information

            Affiliations
            [1 ]Virologie, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, France
            [2 ]Institut National de la Santé et de la Recherche Médicale (INSERM) Unité, Centre National de la Recherche Scientifique Unité Mixte de Recherche, Institut Universitaire d’Hématologie, Sorbonne Paris Cité, Université Paris Diderot, Hôpital Saint Louis, France
            [3 ]INSERM Service Commun, Villejuif, France
            [4 ]Maladies Infectieuses, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, France
            [5 ]Maladies Infectieuses, Hôpital de la Croix Rousse, Centre Hospitalier et Universitaire de Lyon, France
            [6 ]Department of Infectious Diseases, University Hospital of Nantes and Centre d’Investigation Clinique, INSERM, Nantes
            [7 ]Maladies Infectieuses, Hôpital de l’Archet, Centre Hospitalier de Nice, France
            [8 ]Maladies Infectieuses, Hôpital Tenon, Assistance Publique Hôpitaux de Paris, France
            [9 ]Maladies Infectieuses, Centre Hospitalier de l’Université de Montréal, Canada
            [10 ]Université Paris-Sud, Université Paris-Saclay, France
            Author notes
            Correspondence: M.-L. Chaix, MD, PhD, Virologie, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75010 Paris, France ( marie-laure.chaix@ 123456aphp.fr ).
            Journal
            Open Forum Infect Dis
            Open Forum Infect Dis
            ofid
            Open Forum Infectious Diseases
            Oxford University Press (US )
            2328-8957
            November 2018
            08 November 2018
            08 November 2018
            : 5
            : 11
            6286447
            10.1093/ofid/ofy295
            ofy295
            © The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

            This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

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            Pages: 5
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            Funding
            Funded by: ANRS
            Funded by: Canadian HIV Trials Network CTN268
            Funded by: 10.13039/501100007473
            Funded by: Bill and Melinda Gates Foundation OPP1106343
            Funded by: Gilead Sciences 10.13039/100005564
            Categories
            Brief Report

            prep, hsv1/2 incidence, hsv1/2 prevalence, msm, tdf/ftc

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