Efficacy and Tollerability of INI-Based 2-Drug Regimen in Virosuppressed Persons Living with HIV: A Systematic Review and Meta-Analysis
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Background The aim of this meta-analysis was to synthesize the available evidence from the literature on the efficacy and safety of integrase inhibitor-based two drug regimens compared to triple drug regimens in virosuppressed people living with HIV (PLWH) in a long-term follow-up (at 96 weeks). Materials and Methods A systematic review and meta-analysis were conducted to evaluate the efficacy, safety, and adverse drug reactions leading to discontinuation of two drug regimens compared to triple drug regimens in virosuppressed PLWH patients at 96 weeks of follow-up. We searched MEDLINE, Google Scholar, and the Cochrane Library up to March 15, 2024, and studies were selected for eligibility based on predefined criteria. Data were extracted independently by two reviewers, and risk ratios (RRs) were calculated as the measure of association between therapy and incidence of events. Results Six studies were included in the analysis, both clinical trials and observational studies. The two drug regimens included cabotegravir/rilpivirine, dolutegravir/lamivudine, and dolutegravir/rilpivirine. No significant differences were observed in treatment failure (RR, 0.77; 95% confidence interval [CI], 0.53–1.13; P=0.182), virological failure (RR, 0.79; 95% CI, 0.48–1.29; P=0.341), adverse drug reactions leading to discontinuation (RR, 1.74; 95% CI, 0.73–4.17; P=0.215), or appearance of mutation (RR, 2.48; 95% CI, 0.33–18.68; P=0.379) between two drug regimen and triple drug regimen groups at 96 weeks of follow up. Conclusion The meta-analysis provide an overview of the available evidence and supports the use of two drug regimens as an option for simplifying treatment and improving clinical outcomes in virosuppressed PLWH.
Abstract
Background The aim of this meta-analysis was to synthesize the available evidence from the literature on the efficacy and safety of integrase inhibitor-based two drug regimens compared to triple drug regimens in virosuppressed people living with HIV (PLWH) in a long-term follow-up (at 96 weeks). Materials and Methods A systematic review and meta-analysis were conducted to evaluate the efficacy, safety, and adverse drug reactions leading to discontinuation of two drug regimens compared to triple drug regimens in virosuppressed PLWH patients at 96 weeks of follow-up. We searched MEDLINE, Google Scholar, and the Cochrane Library up to March 15, 2024, and studies were selected for eligibility based on predefined criteria. Data were extracted independently by two reviewers, and risk ratios (RRs) were calculated as the measure of association between therapy and incidence of events. Results Six studies were included in the analysis, both clinical trials and observational studies. The two drug regimens included cabotegravir/rilpivirine, dolutegravir/lamivudine, and dolutegravir/rilpivirine. No significant differences were observed in treatment failure (RR, 0.77; 95% confidence interval [CI], 0.53–1.13; P=0.182), virological failure (RR, 0.79; 95% CI, 0.48–1.29; P=0.341), adverse drug reactions leading to discontinuation (RR, 1.74; 95% CI, 0.73–4.17; P=0.215), or appearance of mutation (RR, 2.48; 95% CI, 0.33–18.68; P=0.379) between two drug regimen and triple drug regimen groups at 96 weeks of follow up. Conclusion The meta-analysis provide an overview of the available evidence and supports the use of two drug regimens as an option for simplifying treatment and improving clinical outcomes in virosuppressed PLWH.
참고문헌 (31)
- Mazzitelli M, "Real-life experience on dolutegravir and lamivudine as initial or switch therapy in a silver population living with HIV", Viruses, 15, pp.1740~ (2023)
- Moreno S, "Two-drug vs. three-drug combinations for HIV-1 : Do we have enough data to make the switch?", HIV Med, 20(Suppl 4), pp.2~12 (2019)
- Hidalgo-Tenorio C, "DOLAVI real-life study of dolutegravir plus lamivudine in naive HIV-1 patients(48 weeks)", Viruses, 14, pp.524~ (2022)
- Pisaturo M, "Risk of failure in dual therapy versus triple therapy in naïve HIV patients : a systematic review and meta-analysis", Clin Microbiol Infect, 27, pp.28~35 (2021)
- Achhra AC, "Efficacy and safety of contemporary dual-drug antiretroviral regimens as first-line treatment or as a simplification strategy : a systematic review and meta-analysis", Lancet HIV, 3, pp.e351~e360 (2016)
- "EACS Guidelines"[URL]
- "Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV"[URL]
- Sequera-Arquelladas S, "DOLAMA 200 : effectiveness and safety of a dual therapy with dolutegravir plus lamivudine in treatment-experienced HIV-1 infected real world participants in Spain", Viruses, 16, pp.259~ (2024)
- Aboud M, "Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1 : 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies", Lancet HIV, 6, pp.e576~e587 (2019)
- Osiyemi O, "Efficacy and safety of switching to dolutegravir", lamivudine versus continuing a tenofovir alafenamide-based 3-or 4-drug regimen for maintenance of virologic suppression in adults living with human immunodeficiency virus type 1 : results through week 144 from the phase 3, noninferiority TANGO randomized trial, 2022, pp.75, 975~986
- Orkin C, "Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection : 96-week results of the randomised, open-label, phase 3 FLAIR study", Lancet HIV, 8, pp.e185~e196 (2021)
- Fabbiani M, "Efficacy and durability of two-vs. three-drug integrase inhibitor-based regimens in virologically suppressed HIV-infected patients : Data from real-life ODOACRE cohort", HIV Med, 22, pp.843~853 (2021)
- Trujillo-Rodríguez M, "Immunological and inflammatory changes after simplifying to dual therapy in virologically suppressed HIV-infected patients through week 96 in a randomized trial", Clin Microbiol Infect, 28, pp.1151~ (2022)
- Moher D, "Preferred reporting items for systematic reviews and meta-analyses : the PRISMA statement", BMJ, 339, pp.b2535~ (2009)
- Sterne JAC, "RoB 2 : a revised tool for assessing risk of bias in randomised trials", BMJ, 366, pp.l4898~ (2019)
- Lo CK, "Newcastle-Ottawa Scale : comparing reviewers' to authors' assessments", BMC Med Res Methodol, 14, pp.45~ (2014)
- DerSimonian R, "Meta-analysis in clinical trials", Control Clin Trials, 7, pp.177~188 (1986)
- Cheng J, "Impact of including or excluding both-armed zero-event studies on using standard meta-analysis methods for rare event outcome : a simulation study", BMJ Open, 6, pp.e010983~ (2016)
- StataCorp, "Stata statistical software: Release 16", StataCorp LLC. Texas: College Station, ~ (2019)
- De Socio GV, "Dolutegravir", lamivudine versus tenofovir alafenamide, bictegravir as a switch strategy in a real-life cohort of virogically suppressed people living with HIV, pp.J Clin Med, 2023[DOI]
- Borghetti A, "Virological outcomes with dolutegravir plus either lamivudine or two NRTIs as switch strategies : a multi-cohort study", J Antimicrob Chemother, 77, pp.740~746 (2022)
- Cento V, "Two-drug regimens with dolutegravir plus rilpivirine or lamivudine in HIV-1 treatment-naïve, virologically-suppressed patients : latest evidence from the literature on their efficacy and safety", J Glob Antimicrob Resist, 20, pp.228~237 (2020)
- Llibre JM, "Efficacy and safety of switching to the 2-drug regimen dolutegravir", lamivudine versus continuing a 3-or 4-drug regimen for maintaining virologic suppression in adults living with human immunodeficiency virus 1(HIV-1) : week 48 results from the phase 3, noninferiority SALSA randomized trial, 2023, pp.76, 720~729
- Lagi F, "Efficacy and tolerability of dolutegravir", lamivudine versus dolutegravir, J Med Virol, pp.2023, 95[DOI]
- Mendoza I, "Effectiveness, durability and safety of dolutegravir and lamivudine versus bictegravir, emtricitabine and tenofovir alafenamide in a real-world cohort of HIV-infected adults", PLoS One, 18, pp.e0291480~ (2023)
- van Wyk J, "Brief report : improvement in metabolic health parameters at week 48 after switching from a tenofovir alafenamide-based 3-or 4-drug regimen to the 2-drug regimen of dolutegravir", lamivudine : the TANGO study, 2021, pp.87, 794~800
- Taramasso L, "Durability of dolutegravir-based regimens : a 5-year prospective observational study", AIDS Patient Care STDS, 35, pp.342~353 (2021)
- Llibre JM, "Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1 : phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies", Lancet, 391, pp.839~849 (2018)
- Palacios R, "Efficacy and safety of dolutegravir", rilpivirine in real-world clinical practice. GeSIDA study 1119, 2023, pp.24, 933~937
- Ramgopal MN, "Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results(SOLAR) : a randomised, open-label, phase 3b, non-inferiority trial", Lancet HIV, 10, pp.e566~e577 (2023)
- Jaeger H, "Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection(ATLAS-2M), 96-week results : a randomised, multicentre, open-label, phase 3b, non-inferiority study", Lancet HIV, 8, pp.e679~e689 (2021)
