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HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review
The two-drug regimen dolutegravir plus lamivudine demonstrated durable efficacy for up to 3 years in phase III studies and a high barrier to resistance in treatment-naive and virologically suppressed people with HIV (PWH). This systematic literature review summarizes real-world evidence evaluating e...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8572911/ https://www.ncbi.nlm.nih.gov/pubmed/34426899 http://dx.doi.org/10.1007/s40121-021-00522-7 |
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author | Patel, Rickesh Evitt, Lee Mariolis, Ilias Di Giambenedetto, Simona d’Arminio Monforte, Antonella Casado, José Cabello Úbeda, Alfonso Hocqueloux, Laurent Allavena, Clotilde Barber, Tristan Jha, Diwakar Kumar, Rahul Kamath, Rahul Dinesh Vincent, Tia van Wyk, Jean Koteff, Justin |
author_facet | Patel, Rickesh Evitt, Lee Mariolis, Ilias Di Giambenedetto, Simona d’Arminio Monforte, Antonella Casado, José Cabello Úbeda, Alfonso Hocqueloux, Laurent Allavena, Clotilde Barber, Tristan Jha, Diwakar Kumar, Rahul Kamath, Rahul Dinesh Vincent, Tia van Wyk, Jean Koteff, Justin |
author_sort | Patel, Rickesh |
collection | PubMed |
description | The two-drug regimen dolutegravir plus lamivudine demonstrated durable efficacy for up to 3 years in phase III studies and a high barrier to resistance in treatment-naive and virologically suppressed people with HIV (PWH). This systematic literature review summarizes real-world evidence evaluating effectiveness and safety of dolutegravir plus lamivudine. We searched Ovid MEDLINE(®), Embase(®), PubMed, Cochrane library, and relevant international conference proceedings from 2013 to 2020. Qualitative synthesis of virologic suppression at Week 48, treatment-emergent resistance, discontinuation rates, and comorbidities was undertaken, with no statistical analyses conducted. Linked publications and potential for duplication in reporting of outcomes for cohorts and populations were identified, and the publication reporting the highest number of PWH receiving dolutegravir plus lamivudine was included in the analysis. Thirty-four studies reporting on cohorts of PWH not suspected to be linked or to include duplicate data receiving dolutegravir plus lamivudine were identified (N = 5017). Of 3744 virologically suppressed PWH who switched to dolutegravir plus lamivudine, 603 (16%) reported history of virologic failure. Nineteen studies included effectiveness data (n = 3558), four of which included data from treatment-naive PWH (n = 69). In studies with > 100 PWH, high rates of virologic suppression (Week 48, 97–100%) were maintained with dolutegravir plus lamivudine, with low rates of virologic failure (0–3.3 per 100 person-years of follow-up); one instance of emergent integrase strand transfer inhibitor resistance was reported in a complex treatment-experienced individual. Rates of discontinuation due to adverse events were low and consistent with previously observed trial data. Dolutegravir plus lamivudine minimally impacted renal function and had minimal impact on or improved lipid profiles and bone mineral density. This systematic review demonstrates that effectiveness and safety of dolutegravir plus lamivudine in clinical practice support data from randomized controlled trials with regard to high rates of virologic response, low rates of discontinuation, and a high barrier to resistance. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-021-00522-7. |
format | Online Article Text |
id | pubmed-8572911 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-85729112021-11-15 HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review Patel, Rickesh Evitt, Lee Mariolis, Ilias Di Giambenedetto, Simona d’Arminio Monforte, Antonella Casado, José Cabello Úbeda, Alfonso Hocqueloux, Laurent Allavena, Clotilde Barber, Tristan Jha, Diwakar Kumar, Rahul Kamath, Rahul Dinesh Vincent, Tia van Wyk, Jean Koteff, Justin Infect Dis Ther Review The two-drug regimen dolutegravir plus lamivudine demonstrated durable efficacy for up to 3 years in phase III studies and a high barrier to resistance in treatment-naive and virologically suppressed people with HIV (PWH). This systematic literature review summarizes real-world evidence evaluating effectiveness and safety of dolutegravir plus lamivudine. We searched Ovid MEDLINE(®), Embase(®), PubMed, Cochrane library, and relevant international conference proceedings from 2013 to 2020. Qualitative synthesis of virologic suppression at Week 48, treatment-emergent resistance, discontinuation rates, and comorbidities was undertaken, with no statistical analyses conducted. Linked publications and potential for duplication in reporting of outcomes for cohorts and populations were identified, and the publication reporting the highest number of PWH receiving dolutegravir plus lamivudine was included in the analysis. Thirty-four studies reporting on cohorts of PWH not suspected to be linked or to include duplicate data receiving dolutegravir plus lamivudine were identified (N = 5017). Of 3744 virologically suppressed PWH who switched to dolutegravir plus lamivudine, 603 (16%) reported history of virologic failure. Nineteen studies included effectiveness data (n = 3558), four of which included data from treatment-naive PWH (n = 69). In studies with > 100 PWH, high rates of virologic suppression (Week 48, 97–100%) were maintained with dolutegravir plus lamivudine, with low rates of virologic failure (0–3.3 per 100 person-years of follow-up); one instance of emergent integrase strand transfer inhibitor resistance was reported in a complex treatment-experienced individual. Rates of discontinuation due to adverse events were low and consistent with previously observed trial data. Dolutegravir plus lamivudine minimally impacted renal function and had minimal impact on or improved lipid profiles and bone mineral density. This systematic review demonstrates that effectiveness and safety of dolutegravir plus lamivudine in clinical practice support data from randomized controlled trials with regard to high rates of virologic response, low rates of discontinuation, and a high barrier to resistance. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-021-00522-7. Springer Healthcare 2021-08-24 2021-12 /pmc/articles/PMC8572911/ /pubmed/34426899 http://dx.doi.org/10.1007/s40121-021-00522-7 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Review Patel, Rickesh Evitt, Lee Mariolis, Ilias Di Giambenedetto, Simona d’Arminio Monforte, Antonella Casado, José Cabello Úbeda, Alfonso Hocqueloux, Laurent Allavena, Clotilde Barber, Tristan Jha, Diwakar Kumar, Rahul Kamath, Rahul Dinesh Vincent, Tia van Wyk, Jean Koteff, Justin HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review |
title | HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review |
title_full | HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review |
title_fullStr | HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review |
title_full_unstemmed | HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review |
title_short | HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review |
title_sort | hiv treatment with the two-drug regimen dolutegravir plus lamivudine in real-world clinical practice: a systematic literature review |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8572911/ https://www.ncbi.nlm.nih.gov/pubmed/34426899 http://dx.doi.org/10.1007/s40121-021-00522-7 |
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