Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial
Daily oral antiretroviral preexposure prophylaxis (PrEP) is a promising strategy for prevention of HIV-1 acquisition. Three clinical trials demonstrated PrEP efficacy; however, two PrEP trials among women did not find protection against HIV-1. One hypothesis proposed for these divergent results is t...
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Veröffentlicht in: | AIDS (London) 2013-08, Vol.27 (13), p.2155-2160 |
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creator | MURNANE, Pamela M CELUM, Connie BAETEN, Jared M MUGO, Nelly CAMPBELL, James D DONNELL, Deborah BUKUSI, Elizabeth MUJUGIRA, Andrew TAPPERO, Jordan KAHLE, Erin M THOMAS, Katherine K |
description | Daily oral antiretroviral preexposure prophylaxis (PrEP) is a promising strategy for prevention of HIV-1 acquisition. Three clinical trials demonstrated PrEP efficacy; however, two PrEP trials among women did not find protection against HIV-1. One hypothesis proposed for these divergent results is that PrEP efficacy may be reduced in populations with higher HIV-1 incidence.
Using data from the Partners PrEP Study, a randomized, placebo-controlled trial of daily oral tenofovir (TDF) and emtricitabine/tenofovir (FTC/TDF) PrEP among heterosexual HIV-1 serodiscordant couples from Kenya and Uganda, we assessed PrEP efficacy among subgroups at higher risk for HIV-1 acquisition, including subgroups of women with high HIV-1 incidence.
The overall placebo arm HIV-1 incidence was 2.0 per 100 person-years. Among higher risk subgroups, placebo arm HIV-1 incidence ranged from 3.9 to 6.6 per 100 person-years. In all subgroups, PrEP was protective against HIV-1 acquisition, with efficacy point estimates ranging from 64 to 84%. Among subgroups of women with placebo-arm HIV-1 incidence more than 5.0, efficacy estimates ranged from 64 to 84%. Monthly visit attendance for PrEP refills and tenofovir detection in plasma were high.
Among higher-risk subgroups in the Partners PrEP Study, including groups solely of higher-risk women, both TDF alone and combined FTC/TDF PrEP had consistently high efficacy for HIV-1 protection. PrEP, when used with high adherence, is a highly effective prevention strategy for higher risk heterosexuals. Prioritizing PrEP for persons at high risk of HIV-1 will maximize its prevention impact. |
doi_str_mv | 10.1097/QAD.0b013e3283629037 |
format | Article |
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Using data from the Partners PrEP Study, a randomized, placebo-controlled trial of daily oral tenofovir (TDF) and emtricitabine/tenofovir (FTC/TDF) PrEP among heterosexual HIV-1 serodiscordant couples from Kenya and Uganda, we assessed PrEP efficacy among subgroups at higher risk for HIV-1 acquisition, including subgroups of women with high HIV-1 incidence.
The overall placebo arm HIV-1 incidence was 2.0 per 100 person-years. Among higher risk subgroups, placebo arm HIV-1 incidence ranged from 3.9 to 6.6 per 100 person-years. In all subgroups, PrEP was protective against HIV-1 acquisition, with efficacy point estimates ranging from 64 to 84%. Among subgroups of women with placebo-arm HIV-1 incidence more than 5.0, efficacy estimates ranged from 64 to 84%. Monthly visit attendance for PrEP refills and tenofovir detection in plasma were high.
Among higher-risk subgroups in the Partners PrEP Study, including groups solely of higher-risk women, both TDF alone and combined FTC/TDF PrEP had consistently high efficacy for HIV-1 protection. PrEP, when used with high adherence, is a highly effective prevention strategy for higher risk heterosexuals. Prioritizing PrEP for persons at high risk of HIV-1 will maximize its prevention impact.</description><identifier>ISSN: 0269-9370</identifier><identifier>EISSN: 1473-5571</identifier><identifier>DOI: 10.1097/QAD.0b013e3283629037</identifier><identifier>PMID: 24384592</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject><![CDATA[Adenine - administration & dosage ; Adenine - analogs & derivatives ; Adult ; AIDS/HIV ; Anti-Retroviral Agents - administration & dosage ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Biological and medical sciences ; Chemoprevention - methods ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Emtricitabine ; Female ; Heterosexuality ; HIV Infections - prevention & control ; HIV Infections - transmission ; HIV Infections - virology ; HIV-1 - isolation & purification ; Human immunodeficiency virus 1 ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; Incidence ; Infectious diseases ; Kenya ; Male ; Medical sciences ; Organophosphonates - administration & dosage ; Pharmacology. Drug treatments ; Placebos - administration & dosage ; Tenofovir ; Treatment Outcome ; Uganda ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids]]></subject><ispartof>AIDS (London), 2013-08, Vol.27 (13), p.2155-2160</ispartof><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c319t-53110396eabd5eebdda91f31aec532849b67a7892e0576bd53496b156eec46c53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27677643$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24384592$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>MURNANE, Pamela M</creatorcontrib><creatorcontrib>CELUM, Connie</creatorcontrib><creatorcontrib>BAETEN, Jared M</creatorcontrib><creatorcontrib>MUGO, Nelly</creatorcontrib><creatorcontrib>CAMPBELL, James D</creatorcontrib><creatorcontrib>DONNELL, Deborah</creatorcontrib><creatorcontrib>BUKUSI, Elizabeth</creatorcontrib><creatorcontrib>MUJUGIRA, Andrew</creatorcontrib><creatorcontrib>TAPPERO, Jordan</creatorcontrib><creatorcontrib>KAHLE, Erin M</creatorcontrib><creatorcontrib>THOMAS, Katherine K</creatorcontrib><creatorcontrib>Partners PrEP Study Team</creatorcontrib><title>Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial</title><title>AIDS (London)</title><addtitle>AIDS</addtitle><description>Daily oral antiretroviral preexposure prophylaxis (PrEP) is a promising strategy for prevention of HIV-1 acquisition. Three clinical trials demonstrated PrEP efficacy; however, two PrEP trials among women did not find protection against HIV-1. One hypothesis proposed for these divergent results is that PrEP efficacy may be reduced in populations with higher HIV-1 incidence.
Using data from the Partners PrEP Study, a randomized, placebo-controlled trial of daily oral tenofovir (TDF) and emtricitabine/tenofovir (FTC/TDF) PrEP among heterosexual HIV-1 serodiscordant couples from Kenya and Uganda, we assessed PrEP efficacy among subgroups at higher risk for HIV-1 acquisition, including subgroups of women with high HIV-1 incidence.
The overall placebo arm HIV-1 incidence was 2.0 per 100 person-years. Among higher risk subgroups, placebo arm HIV-1 incidence ranged from 3.9 to 6.6 per 100 person-years. In all subgroups, PrEP was protective against HIV-1 acquisition, with efficacy point estimates ranging from 64 to 84%. Among subgroups of women with placebo-arm HIV-1 incidence more than 5.0, efficacy estimates ranged from 64 to 84%. Monthly visit attendance for PrEP refills and tenofovir detection in plasma were high.
Among higher-risk subgroups in the Partners PrEP Study, including groups solely of higher-risk women, both TDF alone and combined FTC/TDF PrEP had consistently high efficacy for HIV-1 protection. PrEP, when used with high adherence, is a highly effective prevention strategy for higher risk heterosexuals. Prioritizing PrEP for persons at high risk of HIV-1 will maximize its prevention impact.</description><subject>Adenine - administration & dosage</subject><subject>Adenine - analogs & derivatives</subject><subject>Adult</subject><subject>AIDS/HIV</subject><subject>Anti-Retroviral Agents - administration & dosage</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>Biological and medical sciences</subject><subject>Chemoprevention - methods</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Emtricitabine</subject><subject>Female</subject><subject>Heterosexuality</subject><subject>HIV Infections - prevention & control</subject><subject>HIV Infections - transmission</subject><subject>HIV Infections - virology</subject><subject>HIV-1 - isolation & purification</subject><subject>Human immunodeficiency virus 1</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunodeficiencies</subject><subject>Immunodeficiencies. Immunoglobulinopathies</subject><subject>Immunopathology</subject><subject>Incidence</subject><subject>Infectious diseases</subject><subject>Kenya</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Organophosphonates - administration & dosage</subject><subject>Pharmacology. Drug treatments</subject><subject>Placebos - administration & dosage</subject><subject>Tenofovir</subject><subject>Treatment Outcome</subject><subject>Uganda</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><issn>0269-9370</issn><issn>1473-5571</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU9v1DAQxS0EokvhG1SVL0i9pNjxv7i3qi20UiWEBFyjiTPZdZvEqZ1Uu9z45rjqAhIXTjOH33ujeY-QI85OObPmw5fzy1PWMC5QlJXQpWXCvCArLo0olDL8JVmxUtvCCsMOyJuU7hhjilXVa3JQSlFJZcsV-XnVdd6B29HQ0SkibqeQloh5D9Nm18PWJ9qFSK9vvhf8iXjEcfZhpDCEcU03fr0pok_3dIMzxpBwu0CfzmhamnUMy0RhhH6XMLvEMFCgEcY2DP4HtnSOHvq35FWXFfhuPw_Jt49XXy-ui9vPn24uzm8LJ7idCyU4Z8JqhKZViE3bguWd4IBO5QCkbbQBU9kSmTI6M0Ja3XClEZ3UmTkkJ8---bOHBdNcDz457HsYMSyp5kbkREplq_-j0jKTk1c6o_IZdfn3FLGrp-gHiLuas_qppzr3VP_bU5Yd7y8szYDtH9HvYjLwfg9ActB3OTXn01_OaGO0FOIXVeOddw</recordid><startdate>20130824</startdate><enddate>20130824</enddate><creator>MURNANE, Pamela M</creator><creator>CELUM, Connie</creator><creator>BAETEN, Jared M</creator><creator>MUGO, Nelly</creator><creator>CAMPBELL, James D</creator><creator>DONNELL, Deborah</creator><creator>BUKUSI, Elizabeth</creator><creator>MUJUGIRA, Andrew</creator><creator>TAPPERO, Jordan</creator><creator>KAHLE, Erin M</creator><creator>THOMAS, Katherine K</creator><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope></search><sort><creationdate>20130824</creationdate><title>Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial</title><author>MURNANE, Pamela M ; CELUM, Connie ; BAETEN, Jared M ; MUGO, Nelly ; CAMPBELL, James D ; DONNELL, Deborah ; BUKUSI, Elizabeth ; MUJUGIRA, Andrew ; TAPPERO, Jordan ; KAHLE, Erin M ; THOMAS, Katherine K</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c319t-53110396eabd5eebdda91f31aec532849b67a7892e0576bd53496b156eec46c53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adenine - administration & dosage</topic><topic>Adenine - analogs & derivatives</topic><topic>Adult</topic><topic>AIDS/HIV</topic><topic>Anti-Retroviral Agents - administration & dosage</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiviral agents</topic><topic>Biological and medical sciences</topic><topic>Chemoprevention - methods</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Emtricitabine</topic><topic>Female</topic><topic>Heterosexuality</topic><topic>HIV Infections - prevention & control</topic><topic>HIV Infections - transmission</topic><topic>HIV Infections - virology</topic><topic>HIV-1 - isolation & purification</topic><topic>Human immunodeficiency virus 1</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunodeficiencies</topic><topic>Immunodeficiencies. Immunoglobulinopathies</topic><topic>Immunopathology</topic><topic>Incidence</topic><topic>Infectious diseases</topic><topic>Kenya</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Organophosphonates - administration & dosage</topic><topic>Pharmacology. Drug treatments</topic><topic>Placebos - administration & dosage</topic><topic>Tenofovir</topic><topic>Treatment Outcome</topic><topic>Uganda</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>MURNANE, Pamela M</creatorcontrib><creatorcontrib>CELUM, Connie</creatorcontrib><creatorcontrib>BAETEN, Jared M</creatorcontrib><creatorcontrib>MUGO, Nelly</creatorcontrib><creatorcontrib>CAMPBELL, James D</creatorcontrib><creatorcontrib>DONNELL, Deborah</creatorcontrib><creatorcontrib>BUKUSI, Elizabeth</creatorcontrib><creatorcontrib>MUJUGIRA, Andrew</creatorcontrib><creatorcontrib>TAPPERO, Jordan</creatorcontrib><creatorcontrib>KAHLE, Erin M</creatorcontrib><creatorcontrib>THOMAS, Katherine K</creatorcontrib><creatorcontrib>Partners PrEP Study Team</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>AIDS (London)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>MURNANE, Pamela M</au><au>CELUM, Connie</au><au>BAETEN, Jared M</au><au>MUGO, Nelly</au><au>CAMPBELL, James D</au><au>DONNELL, Deborah</au><au>BUKUSI, Elizabeth</au><au>MUJUGIRA, Andrew</au><au>TAPPERO, Jordan</au><au>KAHLE, Erin M</au><au>THOMAS, Katherine K</au><aucorp>Partners PrEP Study Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial</atitle><jtitle>AIDS (London)</jtitle><addtitle>AIDS</addtitle><date>2013-08-24</date><risdate>2013</risdate><volume>27</volume><issue>13</issue><spage>2155</spage><epage>2160</epage><pages>2155-2160</pages><issn>0269-9370</issn><eissn>1473-5571</eissn><abstract>Daily oral antiretroviral preexposure prophylaxis (PrEP) is a promising strategy for prevention of HIV-1 acquisition. Three clinical trials demonstrated PrEP efficacy; however, two PrEP trials among women did not find protection against HIV-1. One hypothesis proposed for these divergent results is that PrEP efficacy may be reduced in populations with higher HIV-1 incidence.
Using data from the Partners PrEP Study, a randomized, placebo-controlled trial of daily oral tenofovir (TDF) and emtricitabine/tenofovir (FTC/TDF) PrEP among heterosexual HIV-1 serodiscordant couples from Kenya and Uganda, we assessed PrEP efficacy among subgroups at higher risk for HIV-1 acquisition, including subgroups of women with high HIV-1 incidence.
The overall placebo arm HIV-1 incidence was 2.0 per 100 person-years. Among higher risk subgroups, placebo arm HIV-1 incidence ranged from 3.9 to 6.6 per 100 person-years. In all subgroups, PrEP was protective against HIV-1 acquisition, with efficacy point estimates ranging from 64 to 84%. Among subgroups of women with placebo-arm HIV-1 incidence more than 5.0, efficacy estimates ranged from 64 to 84%. Monthly visit attendance for PrEP refills and tenofovir detection in plasma were high.
Among higher-risk subgroups in the Partners PrEP Study, including groups solely of higher-risk women, both TDF alone and combined FTC/TDF PrEP had consistently high efficacy for HIV-1 protection. PrEP, when used with high adherence, is a highly effective prevention strategy for higher risk heterosexuals. Prioritizing PrEP for persons at high risk of HIV-1 will maximize its prevention impact.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>24384592</pmid><doi>10.1097/QAD.0b013e3283629037</doi><tpages>6</tpages></addata></record> |
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source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Ovid Autoload |
subjects | Adenine - administration & dosage Adenine - analogs & derivatives Adult AIDS/HIV Anti-Retroviral Agents - administration & dosage Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Biological and medical sciences Chemoprevention - methods Deoxycytidine - administration & dosage Deoxycytidine - analogs & derivatives Emtricitabine Female Heterosexuality HIV Infections - prevention & control HIV Infections - transmission HIV Infections - virology HIV-1 - isolation & purification Human immunodeficiency virus 1 Human viral diseases Humans Immunodeficiencies Immunodeficiencies. Immunoglobulinopathies Immunopathology Incidence Infectious diseases Kenya Male Medical sciences Organophosphonates - administration & dosage Pharmacology. Drug treatments Placebos - administration & dosage Tenofovir Treatment Outcome Uganda Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids |
title | Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial |
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