CROI 2017 Abstract e-Book

Abstract eBook

Poster and Themed Discussion Abstracts

Poster and Themed Discussion Abstracts

460 LONG-TERM EFFICACY OF DOLUTEGRAVIR 50 MG BID IN INI-RESISTANT FAILING HIV-1 SUBJECTS Antonella Castagna 1 , Micol Ferrara 2 , Laura Galli 3 , Laura Comi 4 , Gaetana Sterrantino 5 , Giovanni Cenderello 6 , Mauro Zaccarelli 7 , Emanuele Focà 8 , Andrea Roncadori 9 , Adriano Lazzarin 10 1 Univ Vita-Salute San Raffaele, Milan, Italy, 2 Univ di Torino, Torino, Italy, 3 Ospedale San Raffaele, Milano, Italy, 4 Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy, 5 Azienda Ospedaliero Univ Careggi, Firenze, Italy, 6 Galliera Hosp, Genoa, Italy, 7 Natl Inst for Infectious Diseases, Rome, Italy, 8 ASST Spedali Civili di Brescia, Brescia, Italy, 9 CINECA, Casalecchio di Reno, Italy, 10 San Raffaele Vita-Salute Univ, Milan, Italy Background: No data are available on long-term efficacy of dolutegravir (DTG, 50 mg twice daily) as rescue therapy in treatment-experienced patients (pts) infected with HIV strains with resistance mutations to raltegravir or elvitegravir. Here we evaluated long-term efficacy of DTG 50 mg twice daily in combination with optimized background therapy (OBT) using data from clinical practice. Methods: The Italian Medicines Agency (AIFA) prospectively collects since 2014 demographic, clinical, virological and immunological data associated with DTG 50 mg BID prescription from all the Italian Infectious Diseases Centers (www.progettoprestigio.it). Highly treatment-experienced failing patients, with integrase inhibitor resistant virus, who started DTG 50 mg twice daily plus OBT were included in the analyses. Patients’ follow-up accrued from the start of DTG 50mg+OBT until DTG discontinuation or last visit. Virological efficacy was defined by a viral load [VL] <50 cps/mL at last observed visit. Results were described as median (IQR) or frequency (%). Results: 174 HIV-1 infected failing patients: 71%males, age 51 (47-55) years, 93% Italian, HIV-infection since 22 (16-26) years, 35% HCV positive, baseline (BL) VL 3.81 (2.75-4.64) log 10 cps/mL, BL CD4+ 295 (138-509) cells/µL. At baseline, OBT included >3 drugs in 29% of the pts; 78%were PI-based regimens, 29% NNRTI-based, 47% included NRTIs in the regimen, 6% included enfuvirtide. 37% participated to the VIKING studies or Early Access Program. Twenty-five (14%) pts discontinued (9 virological failure, 9 clinical reasons, 3 patient’s decision, 2 lost to follow-up, 2 deaths due to disease progression). At last follow-up visit, 70% had VL<50 cps/mL, with a median CD4+ of 456 cells/µL (267-733) and a CD4+ change from BL of +100 (8-270) cells/µL. 52 (30%) subjects at last visit had VL≥50 cps/ml, 31 (18%) of whom>200 cps/ml. Efficacy results according to DTG exposure are reported in the Table. Up to date, BL and follow-up genotypic drug-resistance tests are available in 9 subjects with VL>200 cps/mL at last visit; new INI mutations were selected as follows: G140S (+2 pts), Q148H (+1 pt), E138K (+6 pts), S147G (+1 pt), N155H (+1 pt), T97A (+6 pts), G140N (+1 pt), Q148R (+1 pt), L74M (+1 pt), H51Y (+1 pt), N165I (+1 pt). Conclusion: Remarkable long-term efficacy of DTG 50 mg BID in association with OBT was observed in this setting. Joint efforts are needed to set out suitable therapeutic interventions in subject failing this regimen.

CROI 2017 193