Evidence Based Medicine on FHIR Implementation Guide
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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

Example Citation: Delany-Moretlwe 2022 clinical trial

Active as of 2024-12-19

Generated Narrative: Citation 153881

version: 1; Last updated: 2023-08-10 21:44:41+0000

url: Citation Delany-Moretlwe 2022 clinical trial

identifier: FEvIR Object Identifier/153881, https://pubmed.ncbi.nlm.nih.gov/35378077, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.26

version: 2.0.0-ballot

title: Delany-Moretlwe 2022 clinical trial

status: Active

date: 2024-12-19 14:29:51+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.

UseContexts

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jurisdiction: World

copyright:

https://creativecommons.org/licenses/by-nc-sa/4.0/

approvalDate: 2022-05-10

lastReviewDate: 2023-03-17

author: Brian S. Alper: , Computable Publishing®: MEDLINE-to-FEvIR Converter:

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period: ?? --> 2022-05-11 06:00:00+0000

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period: ?? --> 2022-04-04 20:10:00+0000

citedArtifact

identifier: https://pubmed.ncbi.nlm.nih.gov/35378077, https://www.ncbi.nlm.nih.gov/pmc//PMC9077443, https://doi.org/10.1016/S0140-6736(22)00538-4, pii/S0140-6736(22)00538-4

relatedIdentifier: https://clinicaltrials.gov/NCT03164564

Titles

-TypeLanguageText
*Primary titleEnglish

Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial.

Abstracts

-TextCopyright
*

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.

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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

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Lancet. 2022 May 7;399(10337):1754-1755

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Lancet. 2022 May 7;399(10337):1778

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Nature. 2022 Aug;608(7923):460-461

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Nature. 2022 Aug;608(7922):239

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contributor: Delany-Moretlwe S

forenameInitials: S

affiliation: Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: sdelany@wrhi.ac.za.

entry

contributor: Hughes JP

forenameInitials: JP

affiliation: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.

entry

contributor: Bock P

forenameInitials: P

affiliation: Desmond Tutu TB Centre, University of Stellenbosch, Stellenbosch, South Africa.

entry

contributor: Ouma SG

forenameInitials: SG

affiliation: Kisumu Clinical Research Site, Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.

entry

contributor: Hunidzarira P

forenameInitials: P

affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.

entry

contributor: Kalonji D

forenameInitials: D

affiliation: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.

entry

contributor: Kayange N

forenameInitials: N

affiliation: Blantyre Clinical Research Site, College of Medicine, University of Malawi, Blantyre, Malawi.

entry

contributor: Makhema J

forenameInitials: J

affiliation: Botswana Harvard AIDS Institute Partnership (BHP), Gaborone, Botswana.

entry

contributor: Mandima P

forenameInitials: P

affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.

entry

contributor: Mathew C

forenameInitials: C

affiliation: Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.

entry

contributor: Spooner E

forenameInitials: E

affiliation: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.

entry

contributor: Mpendo J

forenameInitials: J

affiliation: International AIDS Vaccine Initiative, Uganda Virus Research Institute, Entebbe, Uganda.

entry

contributor: Mukwekwerere P

forenameInitials: P

affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.

entry

contributor: Mgodi N

forenameInitials: N

affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.

entry

contributor: Ntege PN

forenameInitials: PN

affiliation: Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.

entry

contributor: Nair G

forenameInitials: G

affiliation: Desmond Tutu Health Foundation, University of Cape Town, Cape Town, South Africa.

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contributor: Nakabiito C

forenameInitials: C

affiliation: Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.

entry

contributor: Nuwagaba-Biribonwoha H

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

contributor: Panchia R

forenameInitials: R

affiliation: Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.

entry

contributor: Singh N

forenameInitials: N

affiliation: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.

entry

contributor: Siziba B

forenameInitials: B

affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.

entry

contributor: Farrior J

forenameInitials: J

affiliation: FHI 360, Durham, NC, USA.

entry

contributor: Rose S

forenameInitials: S

affiliation: FHI 360, Durham, NC, USA.

entry

contributor: Anderson PL

forenameInitials: PL

affiliation: Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.

entry

contributor: Eshleman SH

forenameInitials: SH

affiliation: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

entry

contributor: Marzinke MA

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

contributor: Hendrix CW

forenameInitials: CW

affiliation: Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

entry

contributor: Beigel-Orme S

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

contributor: Hosek S

forenameInitials: S

affiliation: Department of Psychiatry, Stroger Hospital of Cook County, Chicago, IL, USA.

entry

contributor: Tolley E

forenameInitials: E

affiliation: FHI 360, Durham, NC, USA.

entry

contributor: Sista N

forenameInitials: N

affiliation: FHI 360, Durham, NC, USA.

entry

contributor: Adeyeye A

forenameInitials: A

affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.

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contributor: Rooney JF

forenameInitials: JF

affiliation: Gilead Sciences, Foster City, CA, USA.

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contributor: Rinehart A

forenameInitials: A

affiliation: ViiV Healthcare, Durham, NC, USA.

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contributor: Spreen WR

forenameInitials: WR

affiliation: ViiV Healthcare, Durham, NC, USA.

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contributor: Smith K

forenameInitials: K

affiliation: ViiV Healthcare, Durham, NC, USA.

entry

contributor: Hanscom B

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

contributor: Cohen MS

forenameInitials: MS

affiliation: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA.

entry

contributor: Hosseinipour MC

forenameInitials: MC

affiliation: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA; UNC Project-Malawi, Lilongwe, Malawi.

entry

contributor: 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: Citation Delany-Moretlwe 2022 clinical trial

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