EACS2023: 843 Real-world data on persons living with HIV (PLWH) switching to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) while virologically suppressed: 96-week data from the Icona cohort A. d'Arminio Monforte , A. Tavelli , A. Cingolani , L. Taramasso , C. Mussini , S. Piconi , A. Calcagno , G. Orofino , S. Cicalini , A. Castagna , F. Ceccherini-Silberstein , A. Gori , G. Guaraldi , A. Antinori Icona Foundation, Milan, Italy, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Infectious Diseases Unit, Rome, Italy, Università Cattolica del Sacro Cuore, Department of Safety and Bioethics, Rome, Italy, Ospedale Policlinico San Martino IRCCS, University of Genoa, Unit of Infectious Diseases, Genoa, Italy, AOU di Modena, University of Modena and Reggio Emilia, Infectious and Tropical Diseases Unit, Modena, Italy, ASST Lecco, Infectious Diseases Unit, Lecco, Italy, Ospedale Amedeo di Savoia, Unit of Infectious Diseases, Turin, Italy, University of Turin, Department of Medical Sciences, Turin, Italy, Ospedale Amedeo di Savoia, ASL Città di Torino, Division A of Infectious Diseases, Turin, Italy, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Clinical Department HIV/AIDS Unit, Rome, Italy, IRCCS San Raffaele Scientific Institute, Infectious Diseases Unit, Milan, Italy, Vita-Salute San Raffaele University, Milan, Italy, University of Rome Tor Vergata, Department of Experimental Medicine, Rome, Italy, ASST Fatebenefratelli-Sacco, Unit of Infectious Diseases 2, Milan, Italy, University of Milan, Milan, Italy General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: To evaluate the effectiveness of switching to BIC/FTC/TAF in ART-experienced virologically suppressed (VS) PLWH, focusing on females and PLWH ≥50 years. Method: Observational study including ART-experienced VS PLWH from Icona switching to BIC/FTC/TAF (Apr-2018/ Dec-2021). Primary endpoint treatment failure (TF): virological failure (VF: 2 consecutive HIV-RNA >200 copies/ml or 1 HIV-RNA>1000 cps/ml) or treatment discontinuation (TD) for any reason. Secondary endpoints: (i) TF excluding TD for pregnancy (TF2), (ii) TD for any reasons, (iii) TD for toxicity/intolerance (TDT), (iv) VF in ITT and (v) OT. Kaplan–Meier curves, log-rank test and Cox regression models used to estimate time to endpoints for PLWH ≥50 years old and females, with confounders tailored for each exposure/endpoint. Results: 1,233 PLWH included (44.0%>=50 years, 18.6% females) (Table1). Over a median follow-up of 125.2 weeks (IQR 83.2-145.6), 179 PLWH had TF (14.5%; 19 VF, 159 TD); 171 had TF2 (8 TD for pregnancy). 163 (13.2%) had TD (reasons for BIC/FTC/TAF discontinuation in Figure). 35 PLWH had TDT (2.8%); VF-ITT occurred in 23 (1.9%), VF-OT in 19 (1.6%) PLWH. KM probabilities of different endpoints by subgroups in Table2. In the adjusted Cox models, PLWH ≥50 years did not have a different risk of TF, while females had a 43% higher risk (Table3). After excluding 8 TD for pregnancy concerns, failure in women was comparable to men. Neither age nor sex were associated with risk of TDT. In the Cox models females had a significant 2.78-fold higher risk of VF in ITT, and aHR of 2.38 (95%CI 0.91-6.2) in the OT analysis (Table3). None of the 10 VF in women occurred during pregnancy. Table 2. Kaplan-Meier estimated 48- and 94-weeks probability of TF, TF excluding pregnancies, TFT and VF, overall and in the different groups for primary-endpoint in virologically suppressed ART-experienced patients switching to BIC/FTC/TAF 48-weeks probability 95%CI 96-weeks probability 95%CI TF (overall) 3.9% 3.0-5.2 10.3% 8.7-12.2 <50 years 4.3% 3.0-6.2 11.8% 9.5-14.6 >=50 years 3.4% 3.0-6.2 8.5% 6.3-11.3 Female 7.1% 4.4-11.3 15.2% 11.0-20.8 Male 3.2% 2.2-4.5 9.2% 7.5-11.3 TF excluding pregnancies (TF2) 3.5% 2.6-4.7 9.7% 8.1-11.6 TFT 1.8% 1.2-2.8 2.7% 1.9-3.9 VF200 ITT 0.7% 0.3-1.4 1.5% 0.9-2.4 VF200 OT 0.5% 0.2-1.1 1.2% 0.7-2.0 1 1 2,3 4 5 6 7,8 9 10 11,12 13 14,15 5 10 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
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