EACS2023: 419 Intermittent three-drug regimens (i-3DR) as maintenance ART: a meta-analysis including individual participant data J.-J. Parienti , R. Palich , J.E. Haberer , L. Assoumou , A.R. Briant , R. Calin , D. Luise , M. Lanzafame , K. Amat , L. Hocqueloux , P. de Truchis , R. Landman Caen University Hospital, Caen, France, Sorbonne University, Pitié-Salpêtrière Hospital, Paris, France, Harvard Medical School, Boston, United States, Sorbonne Université, INSERM, Paris, France, Tenon Hospital, Sorbonne Université, Paris, France, Ospedale San Bortolo, Vicenza, Italy, Ospedale Santa Chiara, Trento, Italy, Institut de Médecine et Epidémiologie Appliquée, Hôpital Bichat-Claude Bernard, Paris, France, Orléans University Hospital, Orléans, France, Hôpital Raymond Poincaré APHP, Garches, France, Université de Paris, Hôpital Bichat-Claude Bernard, Paris, France General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Intermittent three-drug regimens (i-3DR) are not currently recommended in the European AIDS Clinical Society guidelines but they are occasionally used, particularly in Europe. Our objective was to investigate the potential impact of antiretroviral drug classes and patient characteristics on the virological outcome of i-3DR. Method: We conducted a meta-analysis of randomized controlled trials and cohorts using i-3DR as a maintenance strategy in virologically controlled people with HIV (PWH) published during the last decade. The primary endpoint was on-treatment confirmed virological failure (VF, HIV-RNA > 50 copies/mL) at week 48. We computed a two-stage single-arm meta-analysis using random-effects models to estimate proportions and a Wilson score 95% confidence interval (CI). When data were available, we performed a one-stage individual meta-analysis of i-3DR participants to identify factors associated with VF. Results: We identified seven studies of i-3DR (Table 1). Among 728 PWH exposed to i-3ART (Figure 1), 16 individuals experienced VF at week 48 (1.0%, 95% CI [0.2% to 2.5%]. The breakdown of VF cases by antiretroviral class is depicted in the forest plot (Figure 1) for second generation (G) INSTI (Dolutegravir or Bictegravir, INSTI-2G); INSTI-1G (Raltegravir or Elvitegravir); NNRTI-1G (Efavirenz or Rilpivirine); NNRTI-2G (Etravirine or Doravirine) and boosted protease inhibitor (Darunavir, Lopinavir, Atazanavir) with significant heterogeneity overall (I-squared, 53%, p<0.01). The risk of VF was significantly lower for INSTI-2G versus other i-3DR: 0/184 (0.0%) versus 16/544 (2.9%), respectively (p=0.03). Age, gender (all n=651) baseline CD4 T-cell count (n=630) and CD4 T-cell count nadir (n=615) were not associated with VF. Higher proviral DNA at baseline (n=164) was significantly associated (Figure 2) with VF (odds ratio for 1 log copies/million cells increase, 6.8; 95% CI, 1.5 to 43.7, p=0.018). Study Country Design i-3DR third agent Schedule Individual data Turkova 2016 UK RCT EFV 5-day/7 No de Truchis 2018 France Prospective Cohort bPI or NNRTI 4-day/7 Yes Calin 2020 France Retrospective Cohort INSTI 4 or 5-day/7 Yes Luise 2021 Italy Retrospective Cohort RPV 4-day/7 Yes Landman 2022 France RCT INSTI, NNRTI or bPI 4-day/7 Yes Sellem 2023 France Retrospective Cohort BIC 4 or 5-day/7 Yes Palich 2023 France Retrospective Cohort DOR 4 or 5-day/7 Yes Conclusions: i-3DR is associated with high virological efficacy at week 48. Using INSTI-2G-based i-3DR and low proviral DNA were associated with better virological outcomes. General conditions 1. I confirm that I previewed this abstract and that all information is correct. I accept that the content of this abstract cannot be modified or corrected after the submission deadline and I am aware that it will be published exactly as submitted.: Yes 2. I confirm that the submission of the abstract constitutes my consent to publication (e.g. conference website, programmes, other promotions, etc.). : Yes 3. I herewith confirm that the contact details saved in this system are those of the corresponding author, who will be notified about the status of the abstract. The corresponding author is responsible for informing the other authors about the status of the abstract.: Yes 4. I agree that all data provided may be used (saved, stored, processed, transmitted and deleted) in compliance with the privacy policy to provide the services described.: Yes 1 2 3 4 1 5 6 7 8 9 10 11 1 2 3 4 5 6 7 8 9 10 11 119
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