CROI 2018 Abstract eBook

Abstract eBook

Poster Abstracts

Conclusion: D/C/F/TAF achieved high virologic response rates that were overall non-inferior to control, as well as favorable bone and renal outcomes, and demonstrated consistent results across subgroups by age, gender, and race through 48 weeks in ART-naïve, HIV-1–infected patients.

Conclusion: In patients starting ART with -200 CD4+ and +5 log 10 HIV-RNA, the durability of regimens based on EFV or InSTIs was longer than that of boosted PI-based regimens.

494 SAFETY PROFILE OF DOLUTEGRAVIR:REAL-LIFE DATA OF LARGE SCALE IMPLEMENTATION IN BRAZIL Cynthia Julia B. Batista , Mariana V. Meireles, Fernanda F. Fonseca, Ana R. Pati Pascom, Fernanda Rick, Filipe d. Perini, Robério A. Júnior Carneiro, Karim Sakita, Background: Since January 2017, Brazil recommends Dolutegravir(DTG) in the first-line regimens for ART-naïve patients. A national online pharmacovigilance systemwas implemented order to record adverse events (AEs) of the drug. It is well known that only after few years of drug approval AEs, drug interaction and associated risk factors can be thoroughly assessed. In this study we aimed to describe i) the most frequent AEs reported and ii) factors associated with their occurrence in a real-life setting. Methods: A questionnaire about AEs was filled from the second dispensation of DTG by physicians, ARV dispensers or patients. All information from adults (18+) recorded in the pharmacovigilance system from January to August 2017 were included in the analysis. Data were linked with the laboratory information system, which records data on CD4 and Viral Load (VL) counts. We performed i) a descriptive analysis of the most frequent AE according to groups of systems/ major symptoms and ii) univariate and multivariate logistic regression models to assess factors associated with the occurrence of any AE. Results: We collected information on 26,070 ART-naïve patients, of whom 704 (2.7%) reported 1,016 AEs. The most frequent AEs were gastrointestinal (349, 1.3%), neurological (211, 0.8%), sleep disorders (148, 0.6%), skin disorders (128, 0.5%), mental (40, 0.2%) and systemic symptoms (40, 0.2%) and musculoskeletal (26, 0.1%). Immune reconstitution inflammatory syndrome was reported in only one patient. In the table we present the ORs and aORs of the logistic models. VL was not retained in the multivariate model. Younger (aOR 18-24 1.48 and 1.23 for 25-49, relative to 50+), female patients (aOR 1.30) with CD4 counts below 500 cells/mL (aOR 1.09) were more likely to report adverse events. Conclusion: Brazil is one of the first countries to implement DTG in a first-line regimen. This study shows data from real life in one of the biggest cohorts using DTG in the world. These data are important for a better understanding of AEs of the drug, and the results of the study demonstrate that DTG is safe and can be used in large scale. Alexsana S. Tresse, Adele Benzaken Ministry of Health, Brasilia (DF), Brazil

493 DURABILITY OF INITIAL REGIMENS WHEN STARTING ART WITH -200 CD4 AND +5 LOG HIV-RNA Nicola Gianotti 1 , Patrizia Lorenzini 2 , Alessandro Cozzi-Lepri 3 , Andrea De Luca 4 , Giordano Madeddu 5 , Laura Sighinolfi 6 , Carmela Pinnetti 2 , Carmen Santoro 7 , Paola Meraviglia 8 , Cristina Mussini 9 , Andrea Antinori 2 , Antonella D’Arminio Monforte 10 1 San Raffaele Scientific Institute, Milan, Italy, 2 Lazzaro Spallanzani National Institute for Infectious Diseases, Rome, Italy, 3 University College London, London, UK, 4 Siena University Hospital, Siena, Italy, 5 University of Sassari, Sassari, Italy, 6 S. Anna Hospital, Ferrara, Italy, 7 University of Bari, Bari, Italy, 8 ASST Fatebenefratelli, Milan, Italy, 9 University of Modena and Reggio Emilia, Modena, Italy, 10 University of Milan, Milan, Italy Background: Patients with an active opportunist disease or with -200 CD4+/ µL and +5 log 10 HIV-RNA copies/mL at antiretroviral therapy (ART) start are largely underrepresented in clinical trials; data from large observational studies may help bridging this knowledge gap. We aimed at studying the durability of different initial ART regimens in these patients. Methods: All subjects enrolled in the ICONA Study, who started ART with 1 anchor drug (ritonavir or cobicistat-boosted protease inhibitor [bPI], or non- nucleoside reverse transcriptase inhibitor [NNRTI] or integrase strand transfer inhibitor [InSTI]) plus tenofovir(TDF)/emtricitabine(FTC) or abacavir(ABC)/ lamivudine(3TC), CD4+ -200 cells/µL and HIV-RNA >5 log 10 copies/mL, and at least 1 HIV-RNA assessed both before and after the start of ART, were included in this analysis. Primary endpoint: treatment failure (TF, defined as virological failure [VF, first of 2 consecutive HIV-RNA >50 copies/mL after >6 months of treatment] or discontinuation of class of the anchor drug) as assessed by KaplanMeier method and log-rank test. Independent associations were investigated by Poisson regression analysis, in a model including variables associated with TF at a p-value <.2 at univariate analysis: anchor drug, baseline (BL) HIV-RNA, CDC C stage, HCV co-infection, CD4+, FIB-4, eGRF, ongoing opportunistic disease, nucleos(t)ide backbone. Results: 1127 patients fulfilled inclusion criteria: 729 started ART with a bPI, 305 with an InSTI and 193 with a NNRTI (95% EFV). Their median (IQR) BL CD4+, CD4+/CD8+, HIV-RNA were 63 (27-125) cells/µL, .11 (.05-.2), 5.55 (5.3-5.87) log 10 copies/mL. PYFU were 519, 1533, 264 in the NNRTI, bPI and InSTI group; incidence rates (IRs,95%CI) of TF were 18.1 (14.8-22.2), 29.1 (26.5-31.9), 20.8 (16-27.1) per 100 PYFU and IRs of VF were 5.9 (4.4-8.1), 8.0 (6.9-9.3), 5.2 (3.1-8.7) per 100 PYFU in the NNRTI, bPI and InSTI group. Cumulative probabilities of TF and VF are illustrated in figure. At multivariable analysis, compared to those based on bPIs, regimens based on NNRTIs (IRR .65 [.52-.82]; p less than.001) or InSTIs (.7 [.52-.92];p=.012) were associated with a lower risk of TF; BL HIV-RNA >500K (1.38 [1.17-1.63] compared to less than 500K; p<.001) was associated with a higher risk of TF. The type of regimens was not independently associates with VF.

Poster Abstracts

CROI 2018 178