#AIDS2016 Dolutegravir (DTG) plus Rilpivirine (RPV) in Suppressed Heavily Pretreated HIV-Infected Patients A. Díaz, J.L. Casado, F. Dronda, C. Gómez-Ayerbe, M.J. Vivancos, S. Bañón, C. Quereda, S. Serrano, A. Moreno, E. Navas, M.Á. Rodríguez, M.J. Pérez-Elías, S. Moreno. Hospital Universitario Ramón y Cajal, Madrid (Spain) Background: It is frequent that patients with multiple virological failures are suppressed with complex, toxic regimens. Optimization of these regimens would be desirable. DTG+RPV is a NRTI-, PI-sparing regimen that is currently being evaluated in early switching. We aimed to explore the role of DTG 50 mg plus RPV 25 mg, both once daily, in fully suppressed patients with a history of repeated treatment failures. Methods: Ongoing cohort study, based in daily clinical practice. Patients with multiple ART failures and with long-standing viral suppression are offered treatment with DTG+RPV according to the physician’s criteria. Patients are not treated with DTG+RPV if resistance to integrase inhibitors (INI) or RPV was shown. All the patients had visits recorded at 4, 12, 24, and 48 weeks after switching. The main outcome variable was persistence of undetectable HIV RNA 48 weeks after switching.

#AIDS2016 Variable Age, median53.4 years GenderWomen 34% AIDS34% Prior IDU/HCV+68%/70% Nadir CD4+ T cell count, median 179 cells/mm 3 Baseline CD4+ T cell count, median 592 cells/mm 3 VariableResults Time on ART, median19.4 years Time HIV RNA<506.7 years Number of pills Reasons for prescribing DTG + RPV DDI: 38% Toxicity: 33% Simplification: 25% NRTINNRTIPIINI Treated 2, n (%)38 (100)34 (90)37 (97)24 (62) Failure 3, n (%)38 (100)26 (68)27 (71)3 (8) Resistance mutations 4, n (%)25 (65)14 (37)12 (32)NA Number of mutations, median NA Most significant major resistance mutations M184V (59%), M41L (50%), L210W (36%), T215Y (36%), K65R (9%) K103N (43%), G190A/S (28%), H221Y (14%), A98G (7%) V179D (7%) M46I/L (50%), V82AT (42%), I54V (33%), L33F (33%), L90M (25%), I84V (16%), I50V (8%). NA 2 CCR5 inhibitors, 10%, T20 10%. Median, 3.6 drug families per patient (55%) patients failed to 3 or more drug families 4 17 (45%) patients had major resistance mutations to 2 or more drug families Characteristics of the Study Population (n=38) Previous treatment and resistance mutations 1 Regimens at the time of switching included NRTI + NNRTI + PI (85%) NRTI + NNRTI + PI + INI (53%)

#AIDS2016 Efficacy Three patients discontinued the new regimen due to gastrointestinal toxicity, DDI with omeprazole, and physician’s decision, one case each. There have been no virological failures: HIV-RNA remained below 35 copies/mL in 100% (38/38) at week 4 and 100% (35/35) at week 48. CD4 count remained stable after switching: median 708 cells/mm 3 at week 48 (95%CI , P=0.99). Safety CONCLUSIONS Switching to a simple, dual regimen of DTG plus RPV in heavily pretreated, multiply failed, suppressed HIV- infected patients, appears to be safe and efficacious. All P values < 0.05 P < 0.05 P < 0.001