CROI 2019 Abstract eBook
494 EFFECTS OF ART SIMPLIFICATION IN THE SPANISH AIDS RESEARCH NETWORK, CORIS Sergio Serrano-Villar 1 , Inma Jarrin 2 , Pompeyo Viciana 3 , Federico Pulido 4 , Francesc Vidal 5 , Enrique Bernal 6 , Carlos Galera 7 , Santiago Moreno 1 , for the CoRIS 1 Hospital Ramón y Cajal, Madrid, Spain, 2 Institute of Health Carlos III, Madrid, Spain, 3 Hospital Universitario Virgen del Rocio, Sevilla, Spain, 4 Hospital Universitario 12 de Octubre, Madrid, Spain, 5 Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain, 6 Hospital Universitario Reina Sofia, Murcia, Spain, 7 Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain Background: The number of drugs needed to maintain lifelong HIV RNA suppression is currently debated. We aimed to compare the effects of ART simplification strategies on the risk of virological failure in CoRIS. Methods: We selected ART-naive patients initiating triple ART from 2004 to 2017 in CoRIS who achieved undetectable viral load in the first 48 weeks of ART and either remained in triple therapy during their entire follow-up or were subsequently simplified to dual or monotherapy. The outcome was virological failure, defined as at least two consecutive viral loads >50 copies/ml. The type of regimen (triple, dual or mono) and time on regimen were analyzed as time-varying covariates. We calculated cause-specific cumulative incidence curves and used multivariate Cox proportional hazards models adjusted for potential confounders to estimate hazard ratios (HR). The proportional hazards assumption was checked graphically and by tests based on Schoenfeld residuals. HR were calculated for <24 and ≥24 months of ART to meet the proportional hazards assumptions. Results: From 14458 patients, 8416 met the inclusion criteria; 7665 remained in triple therapy, 424 switched to dual therapy and 327 to monotherapy. At baseline, subjects who remained in triple therapy were more likely to be men, younger, HCV negative, HBs antigen positive, showed higher pre-ART CD4 counts and initiated ART more recently than those who switched to dual or monotherapy (all P<0.05). The median time from enrolment to censoring date was 4.9, 6.9 and 8.4 years in the triple, dual and monotherapy groups, respectively (P<0.001). In the dual and monotherapy groups, the median time of regimen maintenance was 1 and 1.3 years, and 15% and 34% switched to triple therapy during follow-up, respectively. After adjustment for potential confounders, ART simplification was associated with greater risk of virological failure after 24 months from simplification (P=0.003), which was driven by higher risk in the monotherapy group. Conclusion: Conclusions: In this large cohort representative of a real-life setting, we found that the durability of the simplified ART regimens was limited and, compared to triple therapy, monotherapy was associated with greater risk of virological failure in the monotherapy group, with no significant differences between dual and triple therapy. While additional information on long-term outcomes is needed, our results are consistent with the data reported in clinical trials.
493 FACTORS ASSOCIATED WITH THERAPEUTIC FAILURE OF 2-DRUG REGIMENS, DAT’AIDS COHORT Clotilde Allavena 1 , Colin Deschanvres 1 , Gilles Peytavin 2 , David Rey 3 , Marc- Antoine Valantin 4 , Firouze Bani-Sadr 5 , Olivier Robineau 6 , Claudine Duvivier 7 , André Cabié 8 , Laurent Hocqueloux 9 , Lise Cuzin 8 , Veronique Joly 2 , Antoine Chéret 10 , Jacques Reynes 11 , for the Dat’AIDS 1 CHU de Nantes, Nantes, France, 2 AP–HP, Hôpital Bichat-Claude Bernard, Paris, France, 3 Hôpitaux Universitaires de Strasbourg, Strasbourg, France, 4 AP–HP, Hôpitaux Universitaires Pitié Salpêtrière, Paris, France, 5 CHU de Reims, Reims, France, 6 Centre Hospitalier de Tourcoing, Tourcoing, France, 7 Necker Hospital, Paris, France, 8 CHU Fort de France, Fort de France, Martinique, 9 Centre Hospitalier Régional d’Orléans, Orléans, France, 10 Hôpital Bicêtre, Le Kremlin-Bicetre, France, 11 CHU de Montpellier, Montpellier, France Background: 2 Drug Regimens (2DRs) are becoming a key strategy in maintenance therapy to spare antiretroviral (ARV) classes, decrease toxicities and minimize drug-drug interactions. Data in real life setting are scarce and most often limited to small sample size and short time follow-up. We investigated factors associated with therapeutic failure on the most frequently prescribed 2DRs in the large French National Dat’AIDS cohort (NCT02898987). Methods: HIV1-infected adult patients starting a 2DR as a switch strategy (plasma HIV RNA (pVL) <50c/ml) between 2010 and 2017 were included in a retrospective analysis. Most frequent 2DRs were selected: dolutegravir/ rilpivirine (DTG/RPV), raltegravir/etravirine (RAL/ETR), DTG/xTC, darunavir/ ritonavir/RAL (DRV/RAL) and DRV/xTC. Primary objective was to investigate the associated factors with virologic failure (VF) defined as 2 consecutive pVL>50c/ ml and occurrence of adverse events (AE). A Cox proportional hazards model adjusted on socio-demographic, immuno-virologic and ARV history-related variables was used for analyses. Results: Overall, 3484 patients receiving 2DR were included: DTG/RPV (n=974, 28%), RAL/ETR (n=869, 25%), DTG/xTC (n=677, 19%), DRV/RAL (n=604, 18%) and DRV/xTC (n=360, 10%). Characteristics of patients on 2DR are presented in the table. Treatment interruptions occurred in 1178 cases due to AE (n=417, 12%), simplification (n=245, 7%), VF (n=122, 3.5%) and miscellaneous reasons (n=394, 11.3%). Treatment interruptions for AE and VF occurred in 12% and 2% of cases in the DTG/RPV group, 10% and 12% in RAL/ETR, 9% and 6% in DTG/ xTC, 17% and 6% and in DRV/r/RAL and 14% and 3% in DRV/r/xTC, respectively. In multivariate analysis, factors associated with VF were zenith pVL> 5 log10 c/mL (HR 1.85 [CI95 1.27-2.74], duration of undetectable pVL < 12 months (HR 2.29 [1.45-3.63]), history of VF (HR 1.63 [1.09-2.46]), and treatment with RAL/ ETR (HR 1.85 [1.05-3.27]). Conclusion: In this large cohort, 2DRs were prescribed mostly to an aging and highly experienced population and show a high efficacy as a switch strategy with a low rate of virologic failure. These results confort the place of 2DRs in maintenance strategies.
495 DISCONTINUATIONS & VIROLOGIC RESPONSE IN LATE PRESENTERS WITH InSTI- OR PI-BASED ART Gundolf Schuettfort 1 , Lena Boekenkamp 1 , Alfonso Cabello 2 , Aoife G. Cotter 3 , Marta Del Palacio Tamarit 2 , Miguel Górgolas 2 , Lisa Hamzah 4 , Eva Herrmann 1 , Pavel Khaykin 1 , Patrick W. Mallon 3 , Alvaro Mena 5 , Caroline Sabin 6 , Timo Wolf 1 , Christoph Stephan 1 , Annette E. Haberl 1
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