CROI 2015 Program and Abstracts

Abstract Listing

Oral Abstracts

Conclusions: The performance of each of the three assays varied by HIV subtype and subtype D had the highest false recent rates. These results highlight the need to optimize and validate testing algorithms for cross-sectional HIV incidence estimation in populations with the relevant HIV subtype distributions 646 German Cohort on Sofosbuvir-Based Therapy for HIV/HCV and HCV Infection (GECOSO) Stefan Christensen 2 ; Ingiliz Patrick 3 ; Dietrich Hueppe 7 ;Thomas Lutz 4 ; Karl Georg Simon 6 ; Knud Schewe 5 ; Heiner Busch 2 ; Axel Baumgarten 3 ; Guenther Schmutz 1 ; Stefan Mauss 1 1 Center for HIV and Hepatogastroenterology, Duesseldorf, Germany; 2 CIM Infectious Diseases, Muenster, Germany; 3 Medizinisches Infektiologie Zentrum Berlin, Berlin, Germany; 4 Infektiologikum, Frankfurt, Germany; 5 Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany; 6 Practice for Gastroenterology Leverkusen, Leverkusen, Germany; 7 Practice for Gastroenterology Herne, Herne, Germany Background: Sofosbuvir (SOF) was approved in Europe in January 2014 with limited study data. In particular, interferon based triple therapy in HIV/HCV coinfection and pretreated patients were not systematically studied. Here, we present real-life data on SOF-based treatments from Germany. Methods: In this multicenter cohort, all patients who were started on the following treatment regimens were documented: SOF/ribavirin (RBV), SOF/daclatasvir, SOF/simeprevir, and SOF/PegIFN/RBV. For the current analysis due to the limited observational period only patients treated with PegIFN/RBV/SOF were analysed. In February 2015 complete data sets for the first three therapy regimen will be available. Results: Overall, 266 patients were enrolled so far. Of those, 193 were HCV-monoinfected and 73 HIV/HCV-coinfected. The genotype (GT) pattern was: GT1 n=156, GT2 n=17, GT3 n=68, GT4 n=24. Liver cirrhosis was present in 85/266 (32%) patients. Pretreated patients were 134/266 (50%). 161 (61%) patients were treated with SOF/PegIFN/RBV. The SVR12 rate overall was 78%.The viral response under therapy did not substantially differ between HIV/HCV coinfection and HCV-monoinfection (see figure). In addition SVR 4 and 12 were comparable. One patient showed a non-response (HCV) and one got re-infected under therapy with a different genotype (HIV/HCV). So far <5% of patients discontinued therapy prematurely or were lost to follow up.

Oral Abstracts

Conclusions: In this preliminary analysis, response rates for HIV/HCV-coinfected and HCV-monoinfected patients treated with SOF/PegIFN/RBV were similar. The SVR12 rate seems to be lower than in the NEUTRINO study despite a low discontinuation rate. The lower SVR rate may be attributable to the cohort population containing more difficult-to- treat patients. 649 Successful HCV Treatment With Direct Acting Antivirals in HIV/HCV Patients Jennifer L. Grant 1 ;Valentina Stosor 1 ; Frank J. Palella 1 ; Richard M. Green 1 ; GuajiraThomas 1 ; DonnaV. McGregor 1 ; Milena M. McLaughlin 2 ; Sudhir Penugonda 1 ; Michael Angarone 1 ; Claudia Hawkins 1 1 Northwestern University, Feinberg School of Medicine, Chicago, IL, US; 2 Midwestern University, Chicago, IL, US Background: IFN-free combinations of direct acting antivirals (DAA) are associated with high cure rates in HCV-infected patients. The SOF/SMV combination has not yet been studied in HIV/HCV co-infected persons. We evaluated outcomes in HIV/HCV patients receiving IFN-free DAA therapy in a large urban clinic in Chicago. Methods: In a prospective observational analysis of HCV treatment experienced and treatment naïve co-infected adults (>18 years) enrolled in the Northwestern University Viral Hepatitis Registry from Jan-Sep 2014, we evaluated the efficacy and safety of SOF/RBV (24 weeks) and SOF/SMV (12 weeks). HCV virologic responses were assessed at week 2 and then monthly during therapy (Rx) and 4 and 12 weeks after completion of Rx (SVR 4 and 12). HCV relapse was defined as a detectable HCV-RNA (lower limit of detection 15 IU/mL) at 4 or 12 weeks after Rx completion. We used chi-square and students’ T-test (SPSS version 22.0, Armonk, NY; IBM Corp.) for between group comparisons. Results: We evaluated 42 HIV/HCV patients [median age 53 years (IQR 47, 60); 81%male; 50% Caucasian; median CD4+ T cell count 522 cells/mm 3 (IQR 292, 660)] for HCV Rx. Risk factors for HCV included MSM (41%) and IDU (41%). Rx was initiated in 32/42 (76%) patients with either SOF/SMV (28, 87.5%) or SOF/RBV (4, 12.5%). Males (85.3% vs. 25% (females); p<0.01) and patients with higher mean FibroSure™ scores (0.70 vs. 0.46; p=0.047) were more likely to receive HCV Rx. There were 21 (66%) with genotype (GT) 1a, 8 (25%) with GT 1b, and 1 each (3%) with GT 2, 3 and undifferentiated. 14/32 (44%) had previously received either PEG/RBV (12/14) or PEG/RBV+BOC (2/14). Median pre-Rx HCV-RNA was 1,384,532 copies/ml (IQR 798,853, 3,772,827) and 23/32 (72%) had advanced liver fibrosis (> F3). All patients received indicated ART. HCV-RNA responses are shown in Figure

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CROI 2015