Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Active as of 2023-12-17 |
Resource Citation "153881" Version "1" Updated "2023-08-10 21:44:41+0000"
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url: https://fevir.net/resources/Citation/153881
identifier: FEvIR Object Identifier: 153881, id: 35378077
version: 1.0.0-ballot
title: Delany-Moretlwe 2022 clinical trial
status: active
date: 2023-12-17 16:55:23+0000
publisher: HL7 International / Clinical Decision Support
contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss
description: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.
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approvalDate: 2022-05-10
lastReviewDate: 2023-03-17
author: Brian S. Alper: , Computable Publishing®: MEDLINE-to-FEvIR Converter:
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identifier: id: 35378077, id: PMC9077443, id: 10.1016/S0140-6736(22)00538-4, pii: S0140-6736(22)00538-4
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Titles
Type Language Text Primary title (Title Type#primary) English (Tags for the Identification of Languages#en) Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Abstracts
Text Copyright **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<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 & 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 © 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. relatesTo
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affiliation: : Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: sdelany@wrhi.ac.za.
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affiliation: : Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
entry
name: Patricia Nahirya Ntege
forenameInitials: PN
affiliation: : Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.
entry
name: Gonasagrie Nair
forenameInitials: G
affiliation: : Desmond Tutu Health Foundation, University of Cape Town, Cape Town, South Africa.
entry
name: Clemensia Nakabiito
forenameInitials: C
affiliation: : Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
entry
name: Harriet Nuwagaba-Biribonwoha
forenameInitials: H
affiliation: : Eswatini Prevention Center, International Center for AIDS Care and Treatment Program at Columbia University Mailman School of Public Health, New York, NY, USA.
entry
name: Ravindre Panchia
forenameInitials: R
affiliation: : Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
entry
name: Nishanta Singh
forenameInitials: N
affiliation: : HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.
entry
name: Bekezela Siziba
forenameInitials: B
affiliation: : Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
entry
name: Jennifer Farrior
forenameInitials: J
affiliation: : FHI 360, Durham, NC, USA.
entry
name: Scott Rose
forenameInitials: S
affiliation: : FHI 360, Durham, NC, USA.
entry
name: Peter L Anderson
forenameInitials: PL
affiliation: : Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.
entry
name: Susan H Eshleman
forenameInitials: SH
affiliation: : Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
entry
name: Mark A Marzinke
forenameInitials: MA
affiliation: : Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
entry
name: Craig W Hendrix
forenameInitials: CW
affiliation: : Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
entry
name: Stephanie Beigel-Orme
forenameInitials: S
affiliation: : Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
entry
name: Sybil Hosek
forenameInitials: S
affiliation: : Department of Psychiatry, Stroger Hospital of Cook County, Chicago, IL, USA.
entry
name: Elizabeth Tolley
forenameInitials: E
affiliation: : FHI 360, Durham, NC, USA.
entry
name: Nirupama Sista
forenameInitials: N
affiliation: : FHI 360, Durham, NC, USA.
entry
name: Adeola Adeyeye
forenameInitials: A
affiliation: : Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
entry
name: James F Rooney
forenameInitials: JF
affiliation: : Gilead Sciences, Foster City, CA, USA.
entry
name: Alex Rinehart
forenameInitials: A
affiliation: : ViiV Healthcare, Durham, NC, USA.
entry
name: William R Spreen
forenameInitials: WR
affiliation: : ViiV Healthcare, Durham, NC, USA.
entry
name: Kimberly Smith
forenameInitials: K
affiliation: : ViiV Healthcare, Durham, NC, USA.
entry
name: Brett Hanscom
forenameInitials: B
affiliation: : Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
entry
name: Myron S Cohen
forenameInitials: MS
affiliation: : University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA.
entry
name: Mina C Hosseinipour
forenameInitials: MC
affiliation: : University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA; UNC Project-Malawi, Lilongwe, Malawi.
entry
name: HPTN 084 study group
Generated Narrative: Practitioner #author0
name: Sinead Delany-Moretlwe
Generated Narrative: Practitioner #author1
name: James P Hughes
Generated Narrative: Practitioner #author2
name: Peter Bock
Generated Narrative: Practitioner #author3
name: Samuel Gurrion Ouma
Generated Narrative: Practitioner #author4
name: Portia Hunidzarira
Generated Narrative: Practitioner #author5
name: Dishiki Kalonji
Generated Narrative: Practitioner #author6
name: Noel Kayange
Generated Narrative: Practitioner #author7
name: Joseph Makhema
Generated Narrative: Practitioner #author8
name: Patricia Mandima
Generated Narrative: Practitioner #author9
name: Carrie Mathew
Generated Narrative: Practitioner #author10
name: Elizabeth Spooner
Generated Narrative: Practitioner #author11
name: Juliet Mpendo
Generated Narrative: Practitioner #author12
name: Pamela Mukwekwerere
Generated Narrative: Practitioner #author13
name: Nyaradzo Mgodi
Generated Narrative: Practitioner #author14
name: Patricia Nahirya Ntege
Generated Narrative: Practitioner #author15
name: Gonasagrie Nair
Generated Narrative: Practitioner #author16
name: Clemensia Nakabiito
Generated Narrative: Practitioner #author17
name: Harriet Nuwagaba-Biribonwoha
Generated Narrative: Practitioner #author18
name: Ravindre Panchia
Generated Narrative: Practitioner #author19
name: Nishanta Singh
Generated Narrative: Practitioner #author20
name: Bekezela Siziba
Generated Narrative: Practitioner #author21
name: Jennifer Farrior
Generated Narrative: Practitioner #author22
name: Scott Rose
Generated Narrative: Practitioner #author23
name: Peter L Anderson
Generated Narrative: Practitioner #author24
name: Susan H Eshleman
Generated Narrative: Practitioner #author25
name: Mark A Marzinke
Generated Narrative: Practitioner #author26
name: Craig W Hendrix
Generated Narrative: Practitioner #author27
name: Stephanie Beigel-Orme
Generated Narrative: Practitioner #author28
name: Sybil Hosek
Generated Narrative: Practitioner #author29
name: Elizabeth Tolley
Generated Narrative: Practitioner #author30
name: Nirupama Sista
Generated Narrative: Practitioner #author31
name: Adeola Adeyeye
Generated Narrative: Practitioner #author32
name: James F Rooney
Generated Narrative: Practitioner #author33
name: Alex Rinehart
Generated Narrative: Practitioner #author34
name: William R Spreen
Generated Narrative: Practitioner #author35
name: Kimberly Smith
Generated Narrative: Practitioner #author36
name: Brett Hanscom
Generated Narrative: Practitioner #author37
name: Myron S Cohen
Generated Narrative: Practitioner #author38
name: Mina C Hosseinipour
Generated Narrative: Organization #author39
name: HPTN 084 study group
Generated Narrative: ArtifactAssessment #meshHeading0
artifact: #
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Adult (#D000328)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Anti-HIV Agents (#D019380)
freeToShare: true
Components
Type Classifier qualifier () is Major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Child (#D002648)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Diketopiperazines (#D054659)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Emtricitabine (#D000068679)
freeToShare: true
component
type: qualifier ()
classifier: is not a major topic ()
component
type: qualifier ()
classifier: therapeutic use (#Q000627)
component
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Female (#D005260)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: HIV Infections (#D015658)
freeToShare: true
component
type: qualifier ()
classifier: is Major topic ()
component
type: qualifier ()
classifier: chemically induced (#Q000139)
component
component
type: qualifier ()
classifier: epidemiology (#Q000453)
component
component
type: qualifier ()
classifier: prevention & control (#Q000517)
component
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: HIV Seropositivity (#D006679)
freeToShare: true
component
type: qualifier ()
classifier: is Major topic ()
component
type: qualifier ()
classifier: drug therapy (#Q000188)
component
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: HIV-1 (#D015497)
freeToShare: true
Components
Type Classifier qualifier () is Major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Humans (#D006801)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Infant, Newborn (#D007231)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Pregnancy (#D011247)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Pyridones (#D011728)
freeToShare: true
component
type: qualifier ()
classifier: is not a major topic ()
component
type: qualifier ()
classifier: therapeutic use (#Q000627)
component
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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