EACS2023: 671 Dolutegravir + lamivudine 2-drug regimen is highly effective and well-tolerated in a real-world clinical setting in Europe: data from the COMBINE-2 Study C. Mussini , C. Henegar , L. Assoumou , S. De Wit , M. Johnson , E. Quiros Roldan , L. Ragone , B. Jones , J. van Wyk , M. Aboud , C. Fletcher , A. Duffy , S. Bannoo , A. Pozniak , V. Vannappagari , COMBINE-2 Study Group University of Modena and Reggio Emilia, Modena, Italy, ViiV Healthcare, Durham, United States, INSERM, Paris, France, Centre Hospitalier Universitaire Saint-Pierre, Brussels, Belgium, Royal Free Hospital, London, United Kingdom, University of Brescia, Brescia, Italy, ViiV Healthcare, Brentford, United Kingdom, Research Organization (KC) Ltd., London, United Kingdom, Chelsea and Westminster Hospital, London, United Kingdom General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: In Europe, dolutegravir/lamivudine (DTG/3TC) is a 2-drug regimen (2DR) indicated for treatment of HIV-1 in antiretroviral therapy (ART)-naïve and ART-experienced, suppressed people living with HIV (PLWH) with no known or suspected resistance to integrase inhibitors or lamivudine. We analyzed effectiveness and safety of DTG+3TC use in real-world clinical practice in Europe. Method: Adult PLWH initiating DTG+3TC 2DR on or after 01JAN2014 with no documented baseline resistance mutations were recruited from NEAT ID Network sites across Europe. Treatment-naïve PLWH initiating first line ART and ART-experienced PLWH switching to a 2DR while suppressed [viral load (VL) <50 copies/mL] were eligible. Kaplan-Meier methods were used to estimate suppression and viral failure (VF; 2 consecutive VLs≥50 copies/mL or 1 VL ≥50 copies/mL followed by discontinuation of DTG+3TC) during 96 weeks of follow-up. Emergent resistance following VF, drug-related adverse events (AEs), and deaths were summarized. Results: A total of 399 suppressed-switch PLWH (77.4% male; 64.9% white) and 19 ART-naive PLWH (78.9% male; 63.2% white) initiated DTG+3TC. Over 96 weeks, there were 2 VF events in the suppressed switch group [1 VF with 1 VL≥50 + discontinuation: 0.3% (95% confidence interval 0.0% – 1.9%); 1 VF with 2 VL ≥50: 0.3% (0.0-1.8)]. At 96 weeks, 95.7% remained on DTG+3TC. Nineteen non-serious drug-related AEs were reported by 17 (4.3%) participants, with 1 (0.3%) serious AE of low mood. All ART-naïve PLWH taking DTG+3TC achieved suppression prior to 96 weeks and there were no events of subsequent VF; at 96 weeks, 94.7% remained on DTG+3TC. There were no documented treatment emergent resistance mutations or deaths in either treatment group. Conclusions: Real-world data from routine clinical practice in Europe indicate DTG+3TC is a highly effective and well-tolerated regimen with a high barrier to resistance for both ART-naïve and ART-experienced, suppressed PLWH over 96 weeks of follow up. 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 2 7 7 2 8 8 8 9 2 1 2 3 4 5 6 7 8 9 145
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