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; Giambenedetto, Simona Di; Monforte, Antonella d’Arminio; Casado, José Luis; Úbeda, Alfonso Cabello; Hocqueloux, Laurent; Allavena, Clotilde; Barber, Tristan; Jha, Diwakar; Kumar, Rahul; Kamath, Rahul; Vincent, Tia; Wyk, Jean van; Koteff, Justin

doi:10.1007/s40121-021-00522-7

Cited by 35 publications

(33 citation statements)

References 44 publications

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“…Of the 74 records previously identified and published in a systematic literature review on dolutegravir plus lamivudine, 13 met the inclusion criteria for reporting data on markers of inflammation and atherogenesis in virologically suppressed PWH [ 31 ]. In the update to this literature search conducted on 14 July 2021, an additional 316 records were identified, 2 of which were eligible for this analysis.…”

Section: Resultsmentioning

confidence: 99%

“…In brief, Ovid Medline, Embase, PubMed, and Cochrane library databases and conference proceedings were searched for real-world observational studies evaluating the effectiveness and safety of dolutegravir plus lamivudine. The full search strategy including search terms has been previously published [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

“…For the real-world evidence, linked publications were identified based on trial identifiers in addition to reporting of population, sites, and study period [ 31 ]. Studies were reviewed to evaluate potential duplication in reporting the same biomarker outcomes for the same cohort.…”

Section: Methodsmentioning

confidence: 99%

“…Studies were reviewed to evaluate potential duplication in reporting the same biomarker outcomes for the same cohort. If duplication was suspected, the publication reporting the highest number of PWH receiving dolutegravir/lamivudine was included in the analysis [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

“…Information was extracted from published material, with no instances of personal communication with authors to confirm or retrieve data. To assess the quality of eligible real-world evidence, a single reviewer evaluated extent of loss to follow-up, methods of selecting PWH, assessment of effectiveness outcomes, and handling of missing data [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

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Changes in Inflammatory and Atherogenesis Biomarkers With the 2-Drug Regimen Dolutegravir Plus Lamivudine in Antiretroviral Therapy–Experienced, Virologically Suppressed People With HIV-1: A Systematic Literature Review

Llibre

Cahn

et al. 2022

Open Forum Infectious Diseases

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Background The 2-drug regimen dolutegravir plus lamivudine has demonstrated long-term non-inferior efficacy vs 3-/4-drug regimens (3/4DRs) in phase III trials. This systematic literature review summarizes clinical trial and real-world evidence evaluating impact of dolutegravir plus lamivudine on inflammatory and atherogenesis biomarkers in people with HIV-1 (PWH). Methods Using Ovid MEDLINE ®, Embase ®, PubMed, and Cochrane library databases and conference proceedings, we searched for studies published from January 1, 2013, to July 14, 2021, reporting changes in inflammatory and atherogenesis biomarkers with dolutegravir plus lamivudine in antiretroviral therapy–experienced, virologically suppressed PWH aged ≥18 years. Results Four records representing 2 randomized controlled trials (RCTs) and 6 records of real-world evidence met eligibility criteria. All real-world studies evaluated CD4+/CD8+ ratio, while only 1 assessed inflammatory biomarkers. Across both RCTs, no consistent pattern of change in biomarkers was observed between dolutegravir/lamivudine and 3/4DR comparators. There were significant changes in soluble CD14 favoring dolutegravir/lamivudine in TANGO at Weeks 48 and 144 and SALSA at Week 48, and in IL-6 favoring the control group in TANGO at Weeks 48 and 144. In the real-world study evaluating inflammatory biomarkers, median soluble CD14 significantly decreased 48 weeks post-switch to dolutegravir plus lamivudine (P<0.001), while other biomarkers remained stable. In all 6 real-world studies, increases in CD4+/CD8+ ratio were reported after switch to dolutegravir plus lamivudine (follow-up, 12-60 months). Conclusions Results show that dolutegravir plus lamivudine has a comparable impact on inflammatory and atherogenesis biomarkers versus 3/4DRs, with no consistent pattern of change after switch in virologically suppressed PWH.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Changes in Inflammatory and Atherogenesis Biomarkers With the 2-Drug Regimen Dolutegravir Plus Lamivudine in Antiretroviral Therapy–Experienced, Virologically Suppressed People With HIV-1: A Systematic Literature Review

Llibre

Cahn

et al. 2022

Open Forum Infectious Diseases

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Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir Plus Lamivudine for Switch Therapy in Patients with HIV-1 Infection: A Real-World Cohort Study

Gan,

Xie,

et al. 2023

Infect Dis Ther

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Two-Drug Regimens Dolutegravir/Lamivudine and Dolutegravir/Rilpivirine Are Effective with Few Discontinuations in US Real-World Settings: Results from the TANDEM Study

Schneider,

Blick,

Burke

et al. 2024

Infect Dis Ther

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Introduction Dolutegravir/lamivudine (DTG/3TC) and dolutegravir/rilpivirine (DTG/RPV) are fixed-dose, complete, single-tablet, two-drug regimens (2DRs) indicated for HIV-1. DTG/3TC is approved for antiretroviral therapy (ART)-naive people with HIV-1 and virologically suppressed individuals to replace current ART; DTG/RPV is indicated for virologically suppressed individuals as a switch option. Virologic efficacy and effectiveness of these DTG-based 2DRs have been demonstrated in phase 3 clinical trials and real-world cohorts, primarily from Europe. This study characterized real-world use of DTG-based 2DRs for HIV-1 treatment in the USA. Methods TANDEM was a retrospective medical chart review across 24 US sites. Individuals aged ≥ 18 years who initiated DTG/3TC or DTG/RPV before September 30, 2020, with ≥ 6 months of follow-up were included. One cohort included ART-naive people who initiated DTG/3TC ( n = 126), and two other cohorts included virologically suppressed (HIV-1 RNA < 50 copies/mL) people on stable ART regimens for ≥ 3 months before switch to either DTG/3TC ( n = 192) or DTG/RPV ( n = 151). Clinical characteristics, treatment history, and outcomes are described. Results Virologically suppressed individuals were older than those who were ART-naive, and the ART-naive cohort had higher proportions of individuals assigned male at birth and of Hispanic ethnicity. The most common healthcare provider-reported reason for choosing a DTG-based 2DR was avoidance of long-term toxicities (25–33% across cohorts), followed by simplification/streamlining of treatment. Among ART-naive people on DTG/3TC, 94% achieved virologic suppression after initiation, and 83% maintained suppression at last follow-up; discontinuation rate was < 1%. Among cohorts who switched to DTG-based 2DRs, 96% maintained virologic suppression on DTG/3TC and 93% on DTG/RPV; 2% on DTG/3TC and 3% on DTG/RPV discontinued. Conclusion Motivation for selecting DTG-based 2DRs was primarily driven by a desire to avoid or manage toxicities and simplify treatment. Results demonstrate that DTG/3TC and DTG/RPV are effective in real-world settings, with few discontinuations, reflecting data from clinical trials. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-024-00961-y.

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HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review

Cited by 35 publications

References 44 publications

Changes in Inflammatory and Atherogenesis Biomarkers With the 2-Drug Regimen Dolutegravir Plus Lamivudine in Antiretroviral Therapy–Experienced, Virologically Suppressed People With HIV-1: A Systematic Literature Review

Changes in Inflammatory and Atherogenesis Biomarkers With the 2-Drug Regimen Dolutegravir Plus Lamivudine in Antiretroviral Therapy–Experienced, Virologically Suppressed People With HIV-1: A Systematic Literature Review

Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir Plus Lamivudine for Switch Therapy in Patients with HIV-1 Infection: A Real-World Cohort Study

Two-Drug Regimens Dolutegravir/Lamivudine and Dolutegravir/Rilpivirine Are Effective with Few Discontinuations in US Real-World Settings: Results from the TANDEM Study

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