EACS2023: 681 Real-world effectiveness of Dolutegravir + Lamivudine (DTG + 3TC) in treatment-naive people with HIV-1 (PWH) and low CD4+ cell count or high viral load at baseline: a systematic literature review E. Letang , T.J. Barber , C. Allavena , L. Hocqueloux , J. Casado , S. Di Giambenedetto , A. Cabello-Úbeda , A. d’Arminio Monforte , M. Kabra , J. Priest , A. Milinkovic , B. Jones ViiV Healthcare, Madrid, Spain, Ian Charleson Day Centre, Royal Free London NHS Foundation Trust, London, United Kingdom, Institute for Global Health, University College London, London, United Kingdom, CHU Hôtel-Dieu, Nantes, France, Centre Hospitalier Universitaire d’Orléans, Orléans, France, Hospital Universitario Ramón y Cajal, Madrid, Spain, Fondazione Policlinico Universitario Agostino Gemelli IRCCS and Università Cattolica del Sacro Cuore, Rome, Italy, Fundación Jimenez Diaz University Hospital, Madrid, Spain, 'San Paolo’ Hospital, University of Milan, Milan, Italy, ViiV Healthcare, Brentford, United Kingdom, ViiV Healthcare, Durham, United States General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: Low CD4+ cell count or high viral load (VL) remain important considerations when initiating therapy in treatment-naive PWH. DTG + 3TC was effective in achieving virologic suppression among these populations in the GEMINI-1/-2 and STAT trials. To complement existing clinical trial data and support treatment decisions, we summarize real-life data on DTG + 3TC effectiveness in treatment-naive PWH with low CD4+ count or high VL. Method: A systematic literature review was conducted using PRISMA guidelines. Studies published between January 2013 and March 2023 were retrieved from Ovid MEDLINE , Embase , PubMed, Cochrane library, and international conference proceedings. Results: We identified 187 publications reporting results from 146 studies of 67 cohorts (N=36,313). Ten and 14 non-overlapping studies included treatment-naive PWH with CD4+ count <200 cells/mm (low CD4+ count; n=215) or VL ≥100,000 copies/mL (high VL; n=502) at baseline, respectively. Six and 10 studies reported virologic effectiveness for PWH with low CD4+ count (n=122) or high VL (n=315), respectively. Among the 4 studies reporting outcomes for N ≥10 PWH with baseline low CD4+ count, 88% (45/51) achieved VL <50 copies/mL at Week 24, 94% (30/32 and 16/17) at Week 48, and 70% (7/10) at Week 96. For PWH with baseline VL ≥100,000 copies/mL, 50% (5/10) and 88% (37/42) had <50 copies/mL at Week 24, 100% (14/14) and 100% (152/152) at Week 48, and 87% (39/45) at Week 96. In the 2 cohorts with N ≥10 PWH with baseline VL ≥500,000 copies/mL, 59% (13/22) and 89% (16/18) achieved suppression at Week 24 and 95% (21/22) at Week 48. Conclusions: Consistent with GEMINI-1/-2 and STAT, initial real-world evidence from treatment-naive PWH initiating DTG + 3TC shows high rates of virologic suppression regardless of CD4+ count or VL at baseline. An ongoing clinical trial will provide additional DTG + 3TC efficacy data in these subpopulations. 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 5 6 7 8 9 10 11 10 10 1 2 3 4 5 6 7 8 9 10 11 ® ® 3 149
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