Baseline characteristics Overall N=45 No ART modification N=33 ART modified N=12 p-value Male gender, frequency (%) 41 (91.1%) 29 (87.9%) 12 (100%) 0.561 Age (years), median (IQR) 42.9 [36.1;50.1] 44.8 [36.3;51.5] 42.5 [35.4;45.0] 0.472 Years from HIV diagnosis, median (IQR) 1.30 [0.69;2.51] 1.29 [0.69;2.71] 1.30 [0.72;2.00] 0.875 Nadir CD4 (cell/µL), median (IQR) 220 [62.0;359] 200 [49.0;305] 282 [106;379] 0.199 HIV-RNA (cps/mL), median (IQR) 89.0 [61.0;163] 75.0 [60.0;145] 134 [81.0;233] 0.186 CD4 (cell/µL), median (IQR) 495 [321;640] 479 [317;628] 554 [392;754] 0.521 CD8 (cell/µL), median (IQR) 1075 [869;1426] 1115 [869;1424] 1066 [905;1436] 0.959 CD4 /CD8 ratio, median (IQR) 0.44 [0.31;0.64] 0.44 [0.29;0.59] 0.48 [0.39;0.67] 0.419 Months of second-generation INSTI-based regimen, median (IQR) 14.9 [6.97;25.9] 14.9 [6.22;25.9] 15.0 [7.96;22.3] 0.867 Table1. Baseline characteristics according to antiretroviral therapy switch Baseline regimen Overall (N=45) DTG/3TC (N=1) B/F/TAF (N=11) DTG-3DR (N=33) Rescue regimen: No ART modification 33 (73.3%) 1 (100%) 6 (54.5%) 26 (78.8%) DTG+DRV/b 1 (2.22%) 0 (0.00%) 0 (0.00%) 1 (3.03%) INSTI-sparing DRV/b-based 3DR 2 (4.44%) 0 (0.00%) 1 (9.09%) 1 (3.03%) INSTI-containing 4DR 3 (6.67%) 0 (0.00%) 2 (18.2%) 1 (3.03%) INSTI-sparing 4DR 1 (2.22%) 0 (0.00%) 1 (9.09%) 0 (0.00%) INSTI-based 3DR different from baseline regimen 5 (11.1%) 0 (0.00%) 1 (9.09%) 4 (12.1%) Table2. Baseline regimens and rescue regimens EACS2023: 929 Outcomes after virological failure to first-line second-generation INSTI-based therapy in a real-life setting R. Papaioannu Borjesson , T. Clemente , S. Diotallevi , R. Lolatto , A. Forniti , M. Bottanelli , L. Galli , F. Alberton , C. Muccini , H. Hasson , A. Castagna , V. Spagnuolo Vita Salute San Raffaele University, Milan, Italy, Infectious Diseases Unit, San Raffaele Scientific Institute, Milan, Italy, Infectious Diseases Unit, Azienda Ospedaliero Universitaria Pisana, University of Florence, Florence, Italy, Vita-Salute San Raffaele University, Milan, Italy General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: To explore the efficacy of rescue-regimens introduced after virological failure (VF) to a first-line second-generation INSTI-based (SG-INSTI) therapy. Method: Retrospective, cohort study including people-living-with-HIV (PLWH), followed at IRCCS San Raffaele, Milan, failing a first-line SG-INSTI regimen [DTG/3TC, B/F/TAF, DTG-based 3-drug regimen (DTG-3DR)] between 1 /Jan/2008 and 31 /Dec/2021. Follow-up accrued from the second VL>50 copies/mL under SG-INSTI regimen (baseline, BL) until virological success [(VS) the achievement of at least one VL<50 copies/mL after BL] or last visit. Cumulative probabilities of VS estimated by Kaplan-Meier curves, compared using log-rank test. Results: Among 521 PLWH who started a first-line SG-INSTI regimen, 45 (8.6%) had VF after a median of 14.9 (IQR=6.97-25.9) months: 33/395 (8.4%) individuals failed a DTG-3DR, 11/102 (10.8%) B/F/TAF, 1/24 (4.2%) DTG/3TC. Baseline characteristics of the 45 failing PLWH reported in Table1. At BL, 12/45 (27%) PLWH changed antiretroviral therapy (ART) [median BL VL 134 (IQR=81-233) copies/mL], while 33 (73%) maintained their failing-regimen [median BL VL 75 (IQR=60-145) copies/mL] (Table2). During a median follow-up of 5.13 (IQR=3.75-7.07) months, 34 (75.6%) PLWH achieved VS: 25 (75.8%) while maintaining their failing-regimen, 9 (75%) after a regimen switch (Figure1); estimated 6- and 12-months probabilities of VS were 59% and 84%, respectively. No difference in VS curves between PLWH who maintained their failing regimen and those who switched therapy. An isolated M184I mutation occurred in one individual at BL; no emergent drug resistance mutations occurred in case of VF of the rescue regimen. Conclusions: Virologic failures of first-line second-generation INSTI-based regimens are rare, characterized by low viremia and absence of drug resistance mutations. Most individuals remained on their failing regimen and achieved spontaneous virological suppression in the majority of cases. In this setting, it is unclear whether changing the failing regimen would be of benefit. 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 1 2 2 3 1 2 4 2 2 2 2 1 2 3 4 st st + + + + + 176 19TH EUROPEAN AIDS CONFERENCE | WARSAW 2023
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