TY - JOUR
T1 - HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice
T2 - A Systematic Literature Review
AU - Patel, Rickesh
AU - Evitt, Lee
AU - Mariolis, Ilias
AU - Di Giambenedetto, Simona
AU - d’Arminio Monforte, Antonella
AU - Casado, José
AU - Cabello Úbeda, Alfonso
AU - Hocqueloux, Laurent
AU - Allavena, Clotilde
AU - Barber, Tristan
AU - Jha, Diwakar
AU - Kumar, Rahul
AU - Kamath, Rahul Dinesh
AU - Vincent, Tia
AU - van Wyk, Jean
AU - Koteff, Justin
N1 - Funding Information:
This research and the journal’s Rapid Service Fee were funded by ViiV Healthcare. ViiV Healthcare played a role in the study design, data collection and analysis, and preparation of the manuscript. The corresponding author had full access to all study data and had final responsibility for the decision to submit for publication.
Funding Information:
This research and the journal?s Rapid Service Fee were funded by ViiV Healthcare. ViiV Healthcare played a role in the study design, data collection and analysis, and preparation of the manuscript. The corresponding author had full access to all study data and had final responsibility for the decision to submit for publication. Editorial assistance was provided under the direction of the authors by Jeffrey Stumpf, PhD, CMPP, and Jennifer Rossi, MA, ELS, MedThink SciCom, and was funded by ViiV Healthcare. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. RP, LE, TV, JvW, and JK contributed to the conception and design of the research. DJ, RK, and RDK contributed to the acquisition and analysis of data. RP, LE, IM, TV, JvW, and JK contributed to the interpretation of data. All authors contributed to critically revising the manuscript for important intellectual content and approved the manuscript for publication. The systematic literature review methods have previously been presented in part at the 23rd International AIDS Conference; July 6?10, 2020; Virtual; Poster PDB0103. RP, LE, IM, TV, JvW, and JK are employees of ViiV Healthcare and hold stock in GlaxoSmithKline. SDG has served as a paid consultant or member of advisory boards for Gilead, ViiV Healthcare, Janssen-Cilag, Merck Sharp & Dohme, and Bristol-Myers Squibb. ADM is a professor at the University of Milan. JC has nothing to disclose. AC-U has received grants and personal fees from ViiV Healthcare, Gilead, Janssen, and Merck, outside the submitted work. LH has received personal fees and non-financial support from Gilead, Janssen, Merck Sharp & Dohme, and ViiV Healthcare, outside the submitted work. CA has received honoraria or travel/meeting grants from Gilead, Merck Sharp & Dohme, Janssen, and ViiV Healthcare, outside the submitted work. TB has received speaker fees, advisory board honoraria, and conference support from Roche, Thera, Janssen, Gilead, and ViiV Healthcare and currently holds education and research grants from Roche, Gilead, and ViiV Healthcare. DJ and RDK are employees of the GlaxoSmithKline Knowledge Centre. RK was an employee of the GlaxoSmithKline Knowledge Centre during this research and is now an employee of BITS Pilani, Pilani, Rajasthan. This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.
Funding Information:
RP, LE, IM, TV, JvW, and JK are employees of ViiV Healthcare and hold stock in GlaxoSmithKline. SDG has served as a paid consultant or member of advisory boards for Gilead, ViiV Healthcare, Janssen-Cilag, Merck Sharp & Dohme, and Bristol-Myers Squibb. ADM is a professor at the University of Milan. JC has nothing to disclose. AC-U has received grants and personal fees from ViiV Healthcare, Gilead, Janssen, and Merck, outside the submitted work. LH has received personal fees and non-financial support from Gilead, Janssen, Merck Sharp & Dohme, and ViiV Healthcare, outside the submitted work. CA has received honoraria or travel/meeting grants from Gilead, Merck Sharp & Dohme, Janssen, and ViiV Healthcare, outside the submitted work. TB has received speaker fees, advisory board honoraria, and conference support from Roche, Thera, Janssen, Gilead, and ViiV Healthcare and currently holds education and research grants from Roche, Gilead, and ViiV Healthcare. DJ and RDK are employees of the GlaxoSmithKline Knowledge Centre. RK was an employee of the GlaxoSmithKline Knowledge Centre during this research and is now an employee of BITS Pilani, Pilani, Rajasthan.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - Dolutegravir
KW - Dual therapy
KW - HIV-1 infection
KW - Lamivudine
KW - Real-world
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U2 - 10.1007/s40121-021-00522-7
DO - 10.1007/s40121-021-00522-7
M3 - Review article
AN - SCOPUS:85113336514
SN - 2193-8229
VL - 10
SP - 2051
EP - 2070
JO - Infectious Diseases and Therapy
JF - Infectious Diseases and Therapy
IS - 4
ER -