Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Active as of 2024-11-21 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Citation 153881</b></p><a name="153881"> </a><a name="hc153881"> </a><a name="153881-en-US"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 1; Last updated: 2023-08-10 21:44:41+0000</p></div><p><b>url</b>: <a href="Citation-153881.html">Citation Delany-Moretlwe 2022 clinical trial</a></p><p><b>identifier</b>: FEvIR Object Identifier/153881, <code>https://pubmed.ncbi.nlm.nih.gov</code>/35378077, <a href="http://terminology.hl7.org/6.1.0/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt
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This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.15.26</p><p><b>version</b>: 2.0.0-ballot</p><p><b>title</b>: Delany-Moretlwe 2022 clinical trial</p><p><b>status</b>: Active</p><p><b>date</b>: 2024-11-21 14:09:14+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: </p><div><p>This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>
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</div><p><b>approvalDate</b>: 2022-05-10</p><p><b>lastReviewDate</b>: 2023-03-17</p><p><b>author</b>: Brian S. Alper: , Computable Publishing®: MEDLINE-to-FEvIR Converter: </p><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/citation-classification-type citation-source}">Citation Source</span></p><p><b>classifier</b>: <span title="Codes:">MEDLINE</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/citation-classification-type medline-owner}">MEDLINE Citation Owner</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#owner_value NLM}">National Library of Medicine, Index Section</span></p></blockquote><p><b>currentState</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type medline-medline}">Medline Citation Status of Medline</span>, <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-publication-status-ppublish}">PubMed PublicationStatus of ppublish</span></p><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-received}">PubMed Pubstatus of Received</span></p><p><b>period</b>: ?? --> 2022-02-27</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-revised}">PubMed Pubstatus of Revised</span></p><p><b>period</b>: ?? --> 2022-03-12</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-accepted}">PubMed Pubstatus of Accepted</span></p><p><b>period</b>: ?? --> 2022-03-14</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-pubmed}">PubMed Pubstatus of Pubmed</span></p><p><b>period</b>: ?? --> 2022-04-05 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-medline}">PubMed Pubstatus of Medline</span></p><p><b>period</b>: ?? --> 2022-05-11 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-entrez}">PubMed Pubstatus of Entrez</span></p><p><b>period</b>: ?? --> 2022-04-04 20:10:00+0000</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://pubmed.ncbi.nlm.nih.gov</code>/35378077, <code>https://www.ncbi.nlm.nih.gov/pmc/</code>/PMC9077443, <code>https://doi.org</code>/10.1016/S0140-6736(22)00538-4, pii/S0140-6736(22)00538-4</p><p><b>relatedIdentifier</b>: <code>https://clinicaltrials.gov</code>/NCT03164564</p><h3>Titles</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Language</b></td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/title-type primary}">Primary title</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">English</span></td><td><div><p>Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial.</p>
</div></td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td><td><b>Copyright</b></td></tr><tr><td style="display: none">*</td><td><div><p><strong>BACKGROUND:</strong> Oral pre-exposure prophylaxis has been introduced in more than 70 countries, including many in sub-Saharan Africa, but women experience considerable barriers to daily pill-taking, such as stigma, judgement, and the fear of violence. Safe and effective long-acting agents for HIV prevention are needed for women. We aimed to evaluate the safety and efficacy of injectable cabotegravir compared with daily oral tenofovir diphosphate plus emtricitabine (TDF-FTC) for HIV prevention in HIV-uninfected women.
<strong>METHODS:</strong> HPTN 084 was a phase 3, randomised, double-blind, double-dummy, active-controlled, superiority trial in 20 clinical research sites in seven countries in sub-Saharan Africa. Participants were eligible for enrolment if they were assigned female sex at birth, were aged 18-45 years, reported at least two episodes of vaginal intercourse in the previous 30 days, were at risk of HIV infection based on an HIV risk score, and agreed to use a long-acting reversible contraceptive method. Participants were randomly assigned (1:1) to either active cabotegravir with TDF-FTC placebo (cabotegravir group) or active TDF-FTC with cabotegravir placebo (TDF-FTC group). Study staff and participants were masked to study group allocation, with the exception of the site pharmacist who was responsible for study product preparation. Participants were prescribed 5 weeks of daily oral product followed by intramuscular injections every 8 weeks after an initial 4-week interval load, alongside daily oral pills. Participants who discontinued injections were offered open-label daily TDF-FTC for 48 weeks. The primary endpoints of the study were incident HIV infection in the intention-to-treat population, and clinical and laboratory events that were grade 2 or higher in all women who had received at least one dose of study product. This study is registered with ClinicalTrials.gov, NCT03164564.
<strong>FINDINGS:</strong> From Nov 27, 2017, to Nov 4, 2020, we enrolled 3224 participants (1614 in the cabotegravir group and 1610 in the TDF-FTC group). Median age was 25 years (IQR 22-30); 1755 (54·7%) of 3209 had two or more partners in the preceding month. 40 incident infections were observed over 3898 person-years (HIV incidence 1·0% [95% CI 0·73-1·40]); four in the cabotegravir group (HIV incidence 0·2 cases per 100 person-years [0·06-0·52]) and 36 in the TDF-FTC group (1·85 cases per 100 person-years [1·3-2·57]; hazard ratio 0·12 [0·05-0·31]; p<0·0001; risk difference -1·6% [-1·0% to -2·3%]. In a random subset of 405 TDF-FTC participants, 812 (42·1%) of 1929 plasma samples had tenofovir concentrations consistent with daily use. Injection coverage was 93% of the total number of person-years. Adverse event rates were similar across both groups, apart from injection site reactions, which were more frequent in the cabotegravir group than in the TDF-FTC group (577 [38·0%] of 1519 vs 162 [10·7%] of 1516]) but did not result in injection discontinuation. Confirmed pregnancy incidence was 1·3 per 100 person-years (0·9-1·7); no congenital birth anomalies were reported.
<strong>INTERPRETATION:</strong> Although both products for HIV prevention were generally safe, well tolerated, and effective, cabotegravir was superior to TDF-FTC in preventing HIV infection in women.
<strong>FUNDING:</strong> National Institute of Allergy and Infectious Diseases, ViiV Healthcare, and the Bill & Melinda Gates Foundation. Additional support was provided through the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. ViiV Healthcare and Gilead Sciences provided pharmaceutical support.</p>
</div></td><td><div><p>Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.</p>
</div></td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: </p><div><p>UNAIDS Confronting inequalities: lessons for pandemic responses from 40 years of AIDS. July 14, 2021. https://www.unaids.org/en/resources/documents/2021/2021-global-aids-update-slideset</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>citation</b>: </p><div><p>WHO . World Health Organization; Geneva: 2015. Policy brief: pre-exposure prophylaxis (PrEP): WHO expands recommendation on oral pre-exposure prophylaxis of HIV infection (PrEP)</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Celum CL, Delany-Moretlwe S, Baeten JM, et al. HIV pre-exposure prophylaxis for adolescent girls and young women in Africa: from efficacy trials to delivery. J Int AIDS Soc. 2019;22(suppl 4)</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/31328444/">https://pubmed.ncbi.nlm.nih.gov/31328444/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/31328444</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Velloza J, Khoza N, Scorgie F, et al. The influence of HIV-related stigma on PrEP disclosure and adherence among adolescent girls and young women in HPTN 082: a qualitative study. J Int AIDS Soc. 2020;23</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/32144874/">https://pubmed.ncbi.nlm.nih.gov/32144874/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/32144874</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Cottrell ML, Yang KH, Prince HM, et al. A translational pharmacology approach to predicting outcomes of preexposure prophylaxis against HIV in men and women using tenofovir disoproxil fumarate with or without emtricitabine. J Infect Dis. 2016;214:55–64.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/26917574/">https://pubmed.ncbi.nlm.nih.gov/26917574/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/26917574</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Andrews CD, Yueh YL, Spreen WR, et al. A long-acting integrase inhibitor protects female macaques from repeated high-dose intravaginal SHIV challenge. Sci Transl Med. 2015;7</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/25589630/">https://pubmed.ncbi.nlm.nih.gov/25589630/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/25589630</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Radzio J, Spreen W, Yueh YL, et al. The long-acting integrase inhibitor GSK744 protects macaques from repeated intravaginal SHIV challenge. Sci Transl Med. 2015;7</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/25589631/">https://pubmed.ncbi.nlm.nih.gov/25589631/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/25589631</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Markowitz M, Frank I, Grant RM, et al. Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ECLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial. Lancet HIV. 2017;4:e331–e340.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/28546090/">https://pubmed.ncbi.nlm.nih.gov/28546090/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/28546090</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Landovitz RJ, Li S, Grinsztejn B, et al. Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. PLoS Med. 2018;15</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/30408115/">https://pubmed.ncbi.nlm.nih.gov/30408115/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/30408115</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385:595–608.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/34379922/">https://pubmed.ncbi.nlm.nih.gov/34379922/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/34379922</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Balkus JE, Brown E, Palanee T, et al. An empiric HIV risk scoring tool to predict HIV-1 acquisition in African women. J Acquir Immune Defic Syndr. 2016;72:333–343.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/26918545/">https://pubmed.ncbi.nlm.nih.gov/26918545/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/26918545</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Eshleman SH, Fogel JM, Piwowar-Manning E, et al. Characterization of HIV infections in women who received injectable cabotegravir or tenofovir disoproxil fumarate/emtricitabine for HIV prevention: HPTN 084. J Infect Dis (in press).</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/35301540/">https://pubmed.ncbi.nlm.nih.gov/35301540/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/35301540</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Castillo-Mancilla JR, Zheng JH, Rower JE, et al. Tenofovir, emtricitabine, and tenofovir diphosphate in dried blood spots for determining recent and cumulative drug exposure. AIDS Res Hum Retroviruses. 2013;29:384–390.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/22935078/">https://pubmed.ncbi.nlm.nih.gov/22935078/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/22935078</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Anderson PL, Liu AY, Castillo-Mancilla JR, et al. Intracellular tenofovir-diphosphate and emtricitabine-triphosphate in dried blood spots following directly observed therapy. Antimicrob Agents Chemother. 2017;62:e01710–e01717.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/29038282/">https://pubmed.ncbi.nlm.nih.gov/29038282/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/29038282</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Hendrix CW, Andrade A, Bumpus NN, et al. Dose frequency ranging pharmacokinetic study of tenofovir-emtricitabine after directly observed dosing in healthy volunteers to establish adherence benchmarks (HPTN 066) AIDS Res Hum Retroviruses. 2016;32:32–43.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/26414912/">https://pubmed.ncbi.nlm.nih.gov/26414912/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/26414912</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Donnell D, Baeten JM, Bumpus NN, et al. HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention. J Acquir Immune Defic Syndr. 2014;66:340–348.</p>
</div><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/24784763/">https://pubmed.ncbi.nlm.nih.gov/24784763/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/24784763</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: cites</p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>citation</b>: </p><div><p>Marzinke MA, Grinsztejn B, Fogel JM, et al. Characterization of human immunodeficiency virus (HIV) infection in cisgender men and transgender women who have sex with men receiving injectable cabotegravir for HIV prevention: HPTN 083. J Infect Dis. 2021;224:1581–1592.</p>
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Electronic address: sdelany@wrhi.ac.za.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author1">Hughes JP</a></p><p><b>forenameInitials</b>: JP</p><p><b>affiliation</b>: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author2">Bock P</a></p><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: Desmond Tutu TB Centre, University of Stellenbosch, Stellenbosch, South Africa.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author3">Ouma SG</a></p><p><b>forenameInitials</b>: SG</p><p><b>affiliation</b>: Kisumu Clinical Research Site, Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author4">Hunidzarira P</a></p><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author5">Kalonji D</a></p><p><b>forenameInitials</b>: D</p><p><b>affiliation</b>: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author6">Kayange N</a></p><p><b>forenameInitials</b>: N</p><p><b>affiliation</b>: Blantyre Clinical Research Site, College of Medicine, University of Malawi, Blantyre, Malawi.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author7">Makhema J</a></p><p><b>forenameInitials</b>: J</p><p><b>affiliation</b>: Botswana Harvard AIDS Institute Partnership (BHP), Gaborone, Botswana.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author8">Mandima P</a></p><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author9">Mathew C</a></p><p><b>forenameInitials</b>: C</p><p><b>affiliation</b>: Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author10">Spooner E</a></p><p><b>forenameInitials</b>: E</p><p><b>affiliation</b>: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author11">Mpendo J</a></p><p><b>forenameInitials</b>: J</p><p><b>affiliation</b>: International AIDS Vaccine Initiative, Uganda Virus Research Institute, Entebbe, Uganda.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author12">Mukwekwerere P</a></p><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author13">Mgodi N</a></p><p><b>forenameInitials</b>: N</p><p><b>affiliation</b>: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author14">Ntege PN</a></p><p><b>forenameInitials</b>: PN</p><p><b>affiliation</b>: Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author15">Nair G</a></p><p><b>forenameInitials</b>: G</p><p><b>affiliation</b>: Desmond Tutu Health Foundation, University of Cape Town, Cape Town, South Africa.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author16">Nakabiito C</a></p><p><b>forenameInitials</b>: C</p><p><b>affiliation</b>: Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author17">Nuwagaba-Biribonwoha H</a></p><p><b>forenameInitials</b>: H</p><p><b>affiliation</b>: Eswatini Prevention Center, International Center for AIDS Care and Treatment Program at Columbia University Mailman School of Public Health, New York, NY, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author18">Panchia R</a></p><p><b>forenameInitials</b>: R</p><p><b>affiliation</b>: Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author19">Singh N</a></p><p><b>forenameInitials</b>: N</p><p><b>affiliation</b>: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author20">Siziba B</a></p><p><b>forenameInitials</b>: B</p><p><b>affiliation</b>: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author21">Farrior J</a></p><p><b>forenameInitials</b>: J</p><p><b>affiliation</b>: FHI 360, Durham, NC, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author22">Rose S</a></p><p><b>forenameInitials</b>: S</p><p><b>affiliation</b>: FHI 360, Durham, NC, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author23">Anderson PL</a></p><p><b>forenameInitials</b>: PL</p><p><b>affiliation</b>: Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author24">Eshleman SH</a></p><p><b>forenameInitials</b>: SH</p><p><b>affiliation</b>: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author25">Marzinke MA</a></p><p><b>forenameInitials</b>: MA</p><p><b>affiliation</b>: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author26">Hendrix CW</a></p><p><b>forenameInitials</b>: CW</p><p><b>affiliation</b>: Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author27">Beigel-Orme S</a></p><p><b>forenameInitials</b>: S</p><p><b>affiliation</b>: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author28">Hosek S</a></p><p><b>forenameInitials</b>: S</p><p><b>affiliation</b>: Department of Psychiatry, Stroger Hospital of Cook County, Chicago, IL, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author29">Tolley E</a></p><p><b>forenameInitials</b>: E</p><p><b>affiliation</b>: FHI 360, Durham, NC, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author30">Sista N</a></p><p><b>forenameInitials</b>: N</p><p><b>affiliation</b>: FHI 360, Durham, NC, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author31">Adeyeye A</a></p><p><b>forenameInitials</b>: A</p><p><b>affiliation</b>: Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author32">Rooney JF</a></p><p><b>forenameInitials</b>: JF</p><p><b>affiliation</b>: Gilead Sciences, Foster City, CA, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author33">Rinehart A</a></p><p><b>forenameInitials</b>: A</p><p><b>affiliation</b>: ViiV Healthcare, Durham, NC, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author34">Spreen WR</a></p><p><b>forenameInitials</b>: WR</p><p><b>affiliation</b>: ViiV Healthcare, Durham, NC, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author35">Smith K</a></p><p><b>forenameInitials</b>: K</p><p><b>affiliation</b>: ViiV Healthcare, Durham, NC, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author36">Hanscom B</a></p><p><b>forenameInitials</b>: B</p><p><b>affiliation</b>: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author37">Cohen MS</a></p><p><b>forenameInitials</b>: MS</p><p><b>affiliation</b>: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author38">Hosseinipour MC</a></p><p><b>forenameInitials</b>: MC</p><p><b>affiliation</b>: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA; UNC Project-Malawi, Lilongwe, Malawi.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc153881/author39">HPTN 084 study group</a></p></blockquote></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author0</b></p><a name="153881/author0"> </a><a name="hc153881/author0"> </a><a name="153881/author0-en-US"> </a><p><b>name</b>: Sinead Delany-Moretlwe </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author1</b></p><a name="153881/author1"> </a><a name="hc153881/author1"> </a><a name="153881/author1-en-US"> </a><p><b>name</b>: James P Hughes </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author2</b></p><a name="153881/author2"> </a><a name="hc153881/author2"> </a><a name="153881/author2-en-US"> </a><p><b>name</b>: Peter Bock </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author3</b></p><a name="153881/author3"> </a><a name="hc153881/author3"> </a><a name="153881/author3-en-US"> </a><p><b>name</b>: Samuel Gurrion Ouma </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author4</b></p><a name="153881/author4"> </a><a name="hc153881/author4"> </a><a name="153881/author4-en-US"> </a><p><b>name</b>: Portia Hunidzarira </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author5</b></p><a name="153881/author5"> </a><a name="hc153881/author5"> </a><a name="153881/author5-en-US"> </a><p><b>name</b>: Dishiki Kalonji </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author6</b></p><a name="153881/author6"> </a><a name="hc153881/author6"> </a><a name="153881/author6-en-US"> </a><p><b>name</b>: Noel Kayange </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author7</b></p><a name="153881/author7"> </a><a name="hc153881/author7"> </a><a name="153881/author7-en-US"> </a><p><b>name</b>: Joseph Makhema </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author8</b></p><a name="153881/author8"> </a><a name="hc153881/author8"> </a><a name="153881/author8-en-US"> </a><p><b>name</b>: Patricia Mandima </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author9</b></p><a name="153881/author9"> </a><a name="hc153881/author9"> </a><a name="153881/author9-en-US"> </a><p><b>name</b>: Carrie Mathew </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author10</b></p><a name="153881/author10"> </a><a name="hc153881/author10"> </a><a name="153881/author10-en-US"> </a><p><b>name</b>: Elizabeth Spooner </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author11</b></p><a name="153881/author11"> </a><a name="hc153881/author11"> </a><a name="153881/author11-en-US"> </a><p><b>name</b>: Juliet Mpendo </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author12</b></p><a name="153881/author12"> </a><a name="hc153881/author12"> </a><a name="153881/author12-en-US"> </a><p><b>name</b>: Pamela Mukwekwerere </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author13</b></p><a name="153881/author13"> </a><a name="hc153881/author13"> </a><a name="153881/author13-en-US"> </a><p><b>name</b>: Nyaradzo Mgodi </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author14</b></p><a name="153881/author14"> </a><a name="hc153881/author14"> </a><a name="153881/author14-en-US"> </a><p><b>name</b>: Patricia Nahirya Ntege </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author15</b></p><a name="153881/author15"> </a><a name="hc153881/author15"> </a><a name="153881/author15-en-US"> </a><p><b>name</b>: Gonasagrie Nair </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author16</b></p><a name="153881/author16"> </a><a name="hc153881/author16"> </a><a name="153881/author16-en-US"> </a><p><b>name</b>: Clemensia Nakabiito </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author17</b></p><a name="153881/author17"> </a><a name="hc153881/author17"> </a><a name="153881/author17-en-US"> </a><p><b>name</b>: Harriet Nuwagaba-Biribonwoha </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author18</b></p><a name="153881/author18"> </a><a name="hc153881/author18"> </a><a name="153881/author18-en-US"> </a><p><b>name</b>: Ravindre Panchia </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author19</b></p><a name="153881/author19"> </a><a name="hc153881/author19"> </a><a name="153881/author19-en-US"> </a><p><b>name</b>: Nishanta Singh </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author20</b></p><a name="153881/author20"> </a><a name="hc153881/author20"> </a><a name="153881/author20-en-US"> </a><p><b>name</b>: Bekezela Siziba </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author21</b></p><a name="153881/author21"> </a><a name="hc153881/author21"> </a><a name="153881/author21-en-US"> </a><p><b>name</b>: Jennifer Farrior </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author22</b></p><a name="153881/author22"> </a><a name="hc153881/author22"> </a><a name="153881/author22-en-US"> </a><p><b>name</b>: Scott Rose </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author23</b></p><a name="153881/author23"> </a><a name="hc153881/author23"> </a><a name="153881/author23-en-US"> </a><p><b>name</b>: Peter L Anderson </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author24</b></p><a name="153881/author24"> </a><a name="hc153881/author24"> </a><a name="153881/author24-en-US"> </a><p><b>name</b>: Susan H Eshleman </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author25</b></p><a name="153881/author25"> </a><a name="hc153881/author25"> </a><a name="153881/author25-en-US"> </a><p><b>name</b>: Mark A Marzinke </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author26</b></p><a name="153881/author26"> </a><a name="hc153881/author26"> </a><a name="153881/author26-en-US"> </a><p><b>name</b>: Craig W Hendrix </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author27</b></p><a name="153881/author27"> </a><a name="hc153881/author27"> </a><a name="153881/author27-en-US"> </a><p><b>name</b>: Stephanie Beigel-Orme </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author28</b></p><a name="153881/author28"> </a><a name="hc153881/author28"> </a><a name="153881/author28-en-US"> </a><p><b>name</b>: Sybil Hosek </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author29</b></p><a name="153881/author29"> </a><a name="hc153881/author29"> </a><a name="153881/author29-en-US"> </a><p><b>name</b>: Elizabeth Tolley </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author30</b></p><a name="153881/author30"> </a><a name="hc153881/author30"> </a><a name="153881/author30-en-US"> </a><p><b>name</b>: Nirupama Sista </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author31</b></p><a name="153881/author31"> </a><a name="hc153881/author31"> </a><a name="153881/author31-en-US"> </a><p><b>name</b>: Adeola Adeyeye </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author32</b></p><a name="153881/author32"> </a><a name="hc153881/author32"> </a><a name="153881/author32-en-US"> </a><p><b>name</b>: James F Rooney </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author33</b></p><a name="153881/author33"> </a><a name="hc153881/author33"> </a><a name="153881/author33-en-US"> </a><p><b>name</b>: Alex Rinehart </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author34</b></p><a name="153881/author34"> </a><a name="hc153881/author34"> </a><a name="153881/author34-en-US"> </a><p><b>name</b>: William R Spreen </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author35</b></p><a name="153881/author35"> </a><a name="hc153881/author35"> </a><a name="153881/author35-en-US"> </a><p><b>name</b>: Kimberly Smith </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author36</b></p><a name="153881/author36"> </a><a name="hc153881/author36"> </a><a name="153881/author36-en-US"> </a><p><b>name</b>: Brett Hanscom </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author37</b></p><a name="153881/author37"> </a><a name="hc153881/author37"> </a><a name="153881/author37-en-US"> </a><p><b>name</b>: Myron S Cohen </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #author38</b></p><a name="153881/author38"> </a><a name="hc153881/author38"> </a><a name="153881/author38-en-US"> </a><p><b>name</b>: Mina C Hosseinipour </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #author39</b></p><a name="153881/author39"> </a><a 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value="**BACKGROUND:** Oral pre-exposure prophylaxis has been introduced in more than 70 countries, including many in sub-Saharan Africa, but women experience considerable barriers to daily pill-taking, such as stigma, judgement, and the fear of violence. Safe and effective long-acting agents for HIV prevention are needed for women. We aimed to evaluate the safety and efficacy of injectable cabotegravir compared with daily oral tenofovir diphosphate plus emtricitabine (TDF-FTC) for HIV prevention in HIV-uninfected women.
**METHODS:** HPTN 084 was a phase 3, randomised, double-blind, double-dummy, active-controlled, superiority trial in 20 clinical research sites in seven countries in sub-Saharan Africa. Participants were eligible for enrolment if they were assigned female sex at birth, were aged 18-45 years, reported at least two episodes of vaginal intercourse in the previous 30 days, were at risk of HIV infection based on an HIV risk score, and agreed to use a long-acting reversible contraceptive method. Participants were randomly assigned (1:1) to either active cabotegravir with TDF-FTC placebo (cabotegravir group) or active TDF-FTC with cabotegravir placebo (TDF-FTC group). Study staff and participants were masked to study group allocation, with the exception of the site pharmacist who was responsible for study product preparation. Participants were prescribed 5 weeks of daily oral product followed by intramuscular injections every 8 weeks after an initial 4-week interval load, alongside daily oral pills. Participants who discontinued injections were offered open-label daily TDF-FTC for 48 weeks. The primary endpoints of the study were incident HIV infection in the intention-to-treat population, and clinical and laboratory events that were grade 2 or higher in all women who had received at least one dose of study product. This study is registered with ClinicalTrials.gov, NCT03164564.
**FINDINGS:** From Nov 27, 2017, to Nov 4, 2020, we enrolled 3224 participants (1614 in the cabotegravir group and 1610 in the TDF-FTC group). Median age was 25 years (IQR 22-30); 1755 (54·7%) of 3209 had two or more partners in the preceding month. 40 incident infections were observed over 3898 person-years (HIV incidence 1·0% [95% CI 0·73-1·40]); four in the cabotegravir group (HIV incidence 0·2 cases per 100 person-years [0·06-0·52]) and 36 in the TDF-FTC group (1·85 cases per 100 person-years [1·3-2·57]; hazard ratio 0·12 [0·05-0·31]; p&lt;0·0001; risk difference -1·6% [-1·0% to -2·3%]. In a random subset of 405 TDF-FTC participants, 812 (42·1%) of 1929 plasma samples had tenofovir concentrations consistent with daily use. Injection coverage was 93% of the total number of person-years. Adverse event rates were similar across both groups, apart from injection site reactions, which were more frequent in the cabotegravir group than in the TDF-FTC group (577 [38·0%] of 1519 vs 162 [10·7%] of 1516]) but did not result in injection discontinuation. Confirmed pregnancy incidence was 1·3 per 100 person-years (0·9-1·7); no congenital birth anomalies were reported.
**INTERPRETATION:** Although both products for HIV prevention were generally safe, well tolerated, and effective, cabotegravir was superior to TDF-FTC in preventing HIV infection in women.
**FUNDING:** National Institute of Allergy and Infectious Diseases, ViiV Healthcare, and the Bill &amp; Melinda Gates Foundation. Additional support was provided through the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. ViiV Healthcare and Gilead Sciences provided pharmaceutical support."/>
<copyright
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IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-11-21
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