Safety and efficacy of long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection: a systematic review and meta-analysis protocol

Background Current antiretroviral regimens have, for the most part, achieved optimal antiretroviral efficacy and tolerability, transforming HIV infection from a deadly disease into a manageable chronic condition. However, adherence to daily oral drug intake remains an issue, as it is the most import...

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Main Authors: Xiaodi Li, Hai Yu, Wei Cao, Xiaosheng Liu, Taisheng Li, Yuan-ni Wu, Lianfeng Lu
Format: Article
Language:English
Published: BMJ Publishing Group 2022-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/12/e063089.full
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author Xiaodi Li
Hai Yu
Wei Cao
Xiaosheng Liu
Taisheng Li
Yuan-ni Wu
Lianfeng Lu
author_facet Xiaodi Li
Hai Yu
Wei Cao
Xiaosheng Liu
Taisheng Li
Yuan-ni Wu
Lianfeng Lu
author_sort Xiaodi Li
collection DOAJ
description Background Current antiretroviral regimens have, for the most part, achieved optimal antiretroviral efficacy and tolerability, transforming HIV infection from a deadly disease into a manageable chronic condition. However, adherence to daily oral drug intake remains an issue, as it is the most important determinant for sustained viral suppression and prevention of the emergence of drug-resistant viral strains. The long-acting injection antiretroviral cabotegravir and rilpivirine combination, a novel drug delivery approach, is about to revolutionise the therapy for people living with HIV. In this protocol, we aim to generate a clinically useful summary of the interventions based on their efficacy.Methods and analysis We searched the literature for eligible studies published from inception up to 16 August 2022 through PubMed, EMBASE, Cochrane Library, Scopus and ClinicalTrials.gov. Two methodologically trained researchers will select the qualified studies for data extraction independently. Cochrane Risk of Bias tool will be used to assess the risk of bias in included studies. Statistical heterogeneity will be computed by Cochrane X2 and I2 tests. Sensitivity analysis will be conducted to evaluate the stability of the results. Publication biases will be evaluated by Begg’s and Egger’s tests. The quality of evidence will be assessed by the Grading of Recommendations Assessment, Development and Evaluation system. The RevMan V.5.3 and Stata V.14.0 software will be applied for statistical analyses.Ethics and dissemination Ethical approval will not be required for this systematic review because the data used are not linked to the individual patient. The results of this review will be disseminated by being published in a peer-reviewed journal.PROSPERO registration number CRD42022310414
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spelling doaj-art-b238624fc2f34c349addba5e4769ea162025-08-20T02:14:27ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-063089Safety and efficacy of long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection: a systematic review and meta-analysis protocolXiaodi Li0Hai Yu1Wei Cao2Xiaosheng Liu3Taisheng Li4Yuan-ni Wu5Lianfeng Lu6Department of Infectious Diseases, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China1 Department of Dermatology, The First Affiliated Hospital of Jinan University and Jinan University Institute of Dermatology, Guangzhou, China2 Disease Prevention Center, Chengdu First People`s Hospital, Chengdu, ChinaDepartment of Infectious Diseases, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, ChinaDepartment of Infectious Diseases, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, ChinaDepartment of Infectious Diseases, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, ChinaDepartment of Infectious Diseases, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, ChinaBackground Current antiretroviral regimens have, for the most part, achieved optimal antiretroviral efficacy and tolerability, transforming HIV infection from a deadly disease into a manageable chronic condition. However, adherence to daily oral drug intake remains an issue, as it is the most important determinant for sustained viral suppression and prevention of the emergence of drug-resistant viral strains. The long-acting injection antiretroviral cabotegravir and rilpivirine combination, a novel drug delivery approach, is about to revolutionise the therapy for people living with HIV. In this protocol, we aim to generate a clinically useful summary of the interventions based on their efficacy.Methods and analysis We searched the literature for eligible studies published from inception up to 16 August 2022 through PubMed, EMBASE, Cochrane Library, Scopus and ClinicalTrials.gov. Two methodologically trained researchers will select the qualified studies for data extraction independently. Cochrane Risk of Bias tool will be used to assess the risk of bias in included studies. Statistical heterogeneity will be computed by Cochrane X2 and I2 tests. Sensitivity analysis will be conducted to evaluate the stability of the results. Publication biases will be evaluated by Begg’s and Egger’s tests. The quality of evidence will be assessed by the Grading of Recommendations Assessment, Development and Evaluation system. The RevMan V.5.3 and Stata V.14.0 software will be applied for statistical analyses.Ethics and dissemination Ethical approval will not be required for this systematic review because the data used are not linked to the individual patient. The results of this review will be disseminated by being published in a peer-reviewed journal.PROSPERO registration number CRD42022310414https://bmjopen.bmj.com/content/12/12/e063089.full
spellingShingle Xiaodi Li
Hai Yu
Wei Cao
Xiaosheng Liu
Taisheng Li
Yuan-ni Wu
Lianfeng Lu
Safety and efficacy of long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection: a systematic review and meta-analysis protocol
BMJ Open
title Safety and efficacy of long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection: a systematic review and meta-analysis protocol
title_full Safety and efficacy of long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection: a systematic review and meta-analysis protocol
title_fullStr Safety and efficacy of long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection: a systematic review and meta-analysis protocol
title_full_unstemmed Safety and efficacy of long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection: a systematic review and meta-analysis protocol
title_short Safety and efficacy of long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection: a systematic review and meta-analysis protocol
title_sort safety and efficacy of long acting intramuscular cabotegravir and rilpivirine in adults with hiv 1 infection a systematic review and meta analysis protocol
url https://bmjopen.bmj.com/content/12/12/e063089.full
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