Efficacy and durability of two‐ <i>vs</i>. three‐drug integrase inhibitor‐based regimens in virologically suppressed HIV‐infected patients: Data from real‐life ODOACRE cohort

Fabbiani, Massimiliano; Rossetti, Barbara; Ciccullo, Arturo; Oreni, Letizia; Lagi, Filippo; Celani, Luigi; Colafigli, Manuela; Vito, Andrea De; Mazzitelli, Maria; Dusina, Alex; Montagnani, Francesca; Rusconi, Stefano; Capetti, Amedeo; Sterrantino, Gaetana; d’Ettorre, Gabriella; Giambenedetto, Simona Di

doi:10.1111/hiv.13146

Cited by 25 publications

(14 citation statements)

References 43 publications

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“…Instead, central nervous system events are the most frequently reported AE leading to treatment discontinuation. This data correlates with the TANGO trial [ 8 ] and other real-life studies [ 15 , 16 , 17 ].…”

Section: Discussionsupporting

confidence: 87%

Dolutegravir Plus 3TC in Virologically Suppressed PLWHIV: Immunological Outcomes in a Multicenter Retrospective Cohort in Spain during the COVID-19 Pandemic

Buzón

Dueñas

Pedrero-Tomé

et al. 2023

Viruses

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Dolutegravir (DTG) based dual therapies for treating PLWHIV are a standard of care nowadays. Switching to DTG and lamivudine (3TC) safety and efficacy were proven in TANGO randomized clinical trial. This multicenter retrospective study included 1032 HIV virologically suppressed patients switching to DTG+3TC from 13 Spanish hospitals. DTG+3TC provided high rates of undetectable viral load over 96%, corresponding to 96.6% (889/921) at 24 weeks, 97.5% (743/763) at 48 weeks, and 98.3% (417/425) at 96 weeks. No significant differences are evident when comparing the total population according to sex, presence of comorbidity, or presence of AIDS. The analysis for paired data showed an increase in CD4+ cell count. A statistically significant increase in CD4+ lymphocyte count was found in those without comorbidities in the three-time series analyzed [average increase at 24 weeks: 48.7 (SD: 215.3) vs. 25.8 (SD: 215.5), p-value = 0.050; a mean increase at 48 weeks: 75.1 (SD: 232.9) vs. 42.3 (SD: 255.6), p-value = 0.003; a mean increase at 96 weeks: 120.1 (SD: 205.0) vs. 63.8 (SD:275.3), p-value = 0.003]. In conclusion, our cohort demonstrates that DTG+3TC is an effective treatment strategy for virologically-suppressed PLWHIV independent of age, sex, and HIV stage, as well as a safe and durable strategy.

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Section: Discussionsupporting

confidence: 87%

Dolutegravir Plus 3TC in Virologically Suppressed PLWHIV: Immunological Outcomes in a Multicenter Retrospective Cohort in Spain during the COVID-19 Pandemic

Buzón

Dueñas

Pedrero-Tomé

et al. 2023

Viruses

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“…All patients had HIV RNA <50 copies/mL at the start of the study regimen, and they excluded data from PLWHIV with no prior resistance mutation available, which is a relevant difference with our cohort. In addition, data from the real‐life ODOCARE cohort showed similar efficacy of 2DR DTG‐based regimens and 3DR INSTI‐based regimens in virologically suppressed PLWHIV but with better tolerability [18]. Compared to other 2DR, similar results have been reported with DTG/RPV and DTG/3TC [17, 18], although for patients with extensive experience with ART and prior virological failures, DTG/RPV would be a better option.…”

Section: Discussionmentioning

confidence: 81%

Efficacy and safety of dolutegravir/rilpivirine in real‐world clinical practice. GeSIDA study 1119

et al. 2023

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Introduction Dolutegravir/rilpivirine (DTG/RPV) is an effective antiretroviral (ART) regimen endorsed by clinical trials as a switch therapy. The aim of our study was to analyse the efficacy and safety of DTG/RPV in real‐world clinical practice. Methods Observational, multicentre study of patients who started DTG/RPV. Efficacy, adverse events and metabolic changes at 48 weeks were analysed. Results A total of 348 patients were included; median time of HIV infection was 21.1 years, 33.7% were AIDS cases; median nadir CD4 was 160 cells/μL; 90.5% had received ≥3 lines of ART and 179 (53.8%) had prior virological failure. Convenience (43.5%), toxicity/intolerance (28.4%) and interactions (17.0%) were the main reasons for starting DTG/RPV. Previous regimens were protease inhibitors (PI) (31.6%), non‐nucleoside reverse transcriptase inhibitors (NNRTI) (20.4%) and integrase strand transfer inhibitors (INSTI) (14.9%). Efficacy (HIV‐RNA <50 copies/mL) at 48 weeks was 89.7% (95% CI 86.1–92.6) by intention‐to‐treat (ITT) and 94.2% (95% CI 91.3–96.4) by on treatment (OT); 10 patients (3.1%) were not suppressed (3 had abandoned ART). There was a mean decrease in triglycerides, total cholesterol, low‐density lipoprotein‐cholesterol, glutamic–pyruvic transaminase (GPT), gamma‐glutamyl transferase (GGT) and alkaline phosphatase; creatinine increased with a decrease in glomerular filtration rate. Conclusions This study confirms the effectiveness, tolerability and safety of DTG/RPV in real‐world clinical practice in a different population from clinical trials, with many years of infection, low CD4 nadir, several previous treatment lines, more than half with virological failures, and one‐third diagnosed with AIDS. The switch to DTG/RPV was safe with few discontinuations due to adverse effects. Modifications of the lipid and liver profiles were favourable. There were no relevant changes in kidney function.

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“…Treatment durability in real clinical practice has previously been compared between DAT and triple-drug regimens. At 96 weeks follow-up of 1666 virologically suppressed patients at baseline, significantly higher treatment durability was reported for patients on an INSTI-based dual-drug versus an INSTI-based triple-drug regimen (probability of treatment discontinuation for any reason, 11.2% vs 20.6%; p<0.001) 20. Our study also showed that being male was an independent protective factor for treatment durability, although this finding needs to be considered in the context of our small sample.…”

Section: Discussionmentioning

confidence: 96%

Real-world effectiveness and durability of dual antiretroviral therapy in HIV-infected patients

et al. 2022

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Background and objectivesWhile randomised controlled trials in HIV-infected patients have shown that certain dual antiretroviral therapy (DAT) regimens are non-inferior in terms of efficacy compared with classical triple-drug regimens, few real clinical experiences have been described. The aim of the study was to investigate, in real clinical practice, DAT effectiveness, durability, and risk factors for treatment discontinuation.MethodsThis was a prospective cohort study that included HIV-infected patients treated with DAT (2015–2020). DAT was considered effective when patients achieved or maintained virological suppression and was assessed at 24 and 48 weeks. DAT durability was evaluated using the Kaplan-Meier method. Adherence and treatment cost were compared with patients’ previous antiretroviral regimens.Results51 patients were included, 27.5% with HIV-1 RNA ≥50 copies/mL at baseline, treated with a wide range of dual combinations. At 48 weeks follow-up, 83.8% and 50.0% of patients who started DAT with HIV-1 RNA <50 copies/mL and ≥50 copies/mL, respectively, were suppressed. 39 out of 51 patients (76.5%) maintained DAT for a mean treatment duration of 40.5±14.8 weeks. Full adherence was observed in 78.4% of patients compared with 70.2% in the previous regimen. Mean daily cost was €18.6±4.3 compared with €16.1±7.9 in the previous regimen (p=0.008).ConclusionDAT effectiveness and durability were higher in patients who were virologically suppressed at baseline. DAT is a possible alternative for virologically non-suppressed patients who cannot be treated with a triple-drug regimen.

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Efficacy and durability of two‐ vs. three‐drug integrase inhibitor‐based regimens in virologically suppressed HIV‐infected patients: Data from real‐life ODOACRE cohort

Abstract: The members of the ODOACRE Study Group are given in the Appendix.

Cited by 25 publications

References 43 publications

Dolutegravir Plus 3TC in Virologically Suppressed PLWHIV: Immunological Outcomes in a Multicenter Retrospective Cohort in Spain during the COVID-19 Pandemic

Dolutegravir Plus 3TC in Virologically Suppressed PLWHIV: Immunological Outcomes in a Multicenter Retrospective Cohort in Spain during the COVID-19 Pandemic

Efficacy and safety of dolutegravir/rilpivirine in real‐world clinical practice. GeSIDA study 1119

Real-world effectiveness and durability of dual antiretroviral therapy in HIV-infected patients

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