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Evaluating HIV Treatment As Prevention in the European Context TECHNICAL REPORT Evaluating HIV treatment as prevention in the European context www.ecdc.europa.eu ECDC TECHNICAL REPORT Evaluating HIV treatment as prevention in the European context This report was commissioned by the European Centre for Disease Prevention and Control (ECDC), coordinated by Mika Salminen, Anastasia Pharris and Marita van de Laar, and produced by the Research Department of Infection and Population Health, University College London Medical School, London, United Kingdom. Authors C Smith, University College London; V Cambiano; University College London; J O’Connor, University College London; F Nakagawa, University College London; R Lodwick, University College London; A Rodger, University College London; F Lampe, University College London; A Phillips, University College London. Suggested citation: European Centre for Disease Prevention and Control. Evaluating HIV treatment as prevention in the European context. Stockholm: ECDC; 2012. Stockholm, June 2012 ISBN 978-92-9193-372-3 doi 10.2900/59229 © European Centre for Disease Prevention and Control, 2012 Reproduction is authorised, provided the source is acknowledged. TECHNICAL REPORT Evaluating HIV treatment as prevention in the European context Contents Abbreviations ............................................................................................................................................... iv Executive summary ........................................................................................................................................1 1. Introduction ..............................................................................................................................................2 1.1 HIV in Europe – epidemiology ..............................................................................................................2 1.2 Risk of HIV acquisition through sexual intercourse ................................................................................. 2 1.3 Risk of HIV acquisition through needle stick injury ................................................................................. 2 1.4 Risk of mother-to-child transmission .....................................................................................................3 1.5 Antiretroviral therapy ...........................................................................................................................3 1.6 Objective of review..............................................................................................................................3 2. Methods ....................................................................................................................................................4 2.1 Treatment as prevention ......................................................................................................................4 2.2 Prevention of mother-to-child transmission ............................................................................................5 2.3 Post exposure prophylaxis ....................................................................................................................5 2.4 Review of treatment guidelines.............................................................................................................6 3. HIV-positive individuals receiving treatment: the impact on sexual transmission .............................................. 7 3.1 The population-level effects of antiretroviral treatment as prevention....................................................... 7 3.2 Treatment guidelines for timing of when HIV-positive individuals should receive treatment ...................... 15 3.3 Current practices in Europe – evidence from observational and surveillance studies ................................ 18 4. Pregnant HIV-positive women and their children in utero/post-delivery ......................................................... 19 4.1 The use of antiretroviral treatment as prevention ................................................................................. 19 4.2. Treatment of pregnant HIV-positive women and infants according to treatment guidelines ..................... 25 4.3 Current practices in Europe – evidence from observational and surveillance studies ................................ 28 5. Individuals exposed to HIV and treated with post-exposure prophylaxis ........................................................ 29 5.1 Evidence for the effectiveness of post-exposure prophylaxis .................................................................. 29 5.2 Treatment guidelines on post exposure prophylaxis .............................................................................. 30 5.3 Current practices of PEP in Europe – evidence from observational and surveillance studies ...................... 33 6. Other considerations ................................................................................................................................ 34 6.1 Pre-exposure prophylaxis (PrEP) ......................................................................................................... 34 6.2 Combination with non-antiretroviral interventions ................................................................................. 35 6.3 Implications of earlier treatment for the HIV positive individual ............................................................. 36 6.4 Earlier treatment – the need for earlier diagnosis ................................................................................. 36 7. Key messages and future research needs ................................................................................................... 37 8. References .............................................................................................................................................. 39 Appendix 1 Search terms .............................................................................................................................. 55 A1.1 Use of HIV treatment as prevention .................................................................................................. 55 A1.2 Mother-to-child transmission ............................................................................................................ 55 A1.3 Post Exposure Prophylaxis (PEP) ....................................................................................................... 56 Appendix 2. Summary tables of literature search ............................................................................................ 57 A2.1 Treatment as prevention A2.2 Relationship between HIV RNA in plasma and in the genital tract in adults on antiretroviral treatment A2.3 Prevention of mother to child transmission A2.4 Post exposure prophylaxis iii Evaluating HIV treatment as prevention in the European context TECHNICAL REPORT Abbreviations AI Anal intercourse AIDS Acquired immune deficiency syndrome ART Antiretroviral treatment CCR5 Chemokine receptor 5 CDC Centers for Disease Control and Prevention (United States) CI Confidence interval DHHS Department of Health and Human Services (United States) EACS European AIDS Clinical Society ECDC European Centre for Disease Prevention and Control EEA European Economic Area EU European Union HAART Highly active antiretroviral treatment HIV Human Immunodeficiency virus IAS International AIDS Society IDU Injecting drug user ILO International Labor Organization LTFU Loss to follow-up MAP Medical assisted procreation MeSH Medical subject headings MSM Men who have sex with men MTCT Mother-to-child transmission PEP Post-exposure prophylaxis pMTCT Prevention of mother-to-child transmission PrEP Pre-exposure prophylaxis PY Person-years RCT Randomised controlled trial RNA Ribonucleic acid sdNVP Single dose of nevirapine STI Sexually transmitted infection TB Tuberculosis UAI Unprotected anal intercourse UIAI Unprotected insertive anal intercourse UNAIDS Joint United Nations Programme on HIV/AIDS URAI Unprotected receptive anal intercourse VI Vaginal intercourse WHO World Health Organization ZDV Zidovudine iv TECHNICAL REPORT Evaluating HIV treatment as prevention in the European context Executive summary The goal of this project is to gather evidence regarding the population-level, and to some extent, individual-level effects of the use of antiretroviral treatment (ART) to prevent HIV infection, and to relate this to current HIV treatment guidelines. To inform the project, formal literature reviews were performed for the three main areas of interest: the effect of antiretroviral therapy in adults on preventing sexual transmission of HIV, prevention of mother-to-child transmission (pMTCT) and post exposure prophylaxis (PEP). The strongest evidence with regard to the effect of treatment of HIV positive individuals to prevent onwards sexual transmission comes from the recent randomised controlled trial (RCT), HPTN052. This study demonstrated that early versus delayed ART led to a 96% relative reduction in onwards linked transmission. Several observational studies of HIV sero-discordant heterosexual couples have also reported that transmission is rare in patients on ART, particularly in those with low HIV-RNA concentrations. However, the findings of HPTN052 and these observational studies are mainly applicable to vaginal heterosexual sex. No direct empirical evidence regarding the relationship between ART use and the risk of HIV transmission through anal intercourse is currently available. Whilst the major HIV treatment guidelines
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