CROI 2015 Program and Abstracts

Abstract Listing

Poster Abstracts

Responses to SOF+SMV+/-RBV are shown in the table.

*The pt with relapse received SOF+SMV+RBV, had G1b, cirrhosis and a prior history of telaprevir-based Rx completed 14 months prior, and had no known mutations associated with resistance. Conclusions: Conclusion: SOF+SMV+/-RBV treatment may be appropriate for carefully selected PI-experienced G1 pts including those with cirrhosis. Further study is needed to confirm these findings. 645 Effectiveness of Sofosbuvir/Simeprevir for HIV/HCV Patients in Clinical Practice Jody Gilmore 1 ; Kenneth Lynn 1 ; Delisha Breen 1 ; StaceyTrooskin 2 ; Jihad Slim 3 ; Nancy Scangarello 3 ; Alvin Kingcade 4 ; Katie Hunyh 4 ;Vincent Lo Re 1 ; Jay R. Kostman 1 1 PerelmanSchoolofMedicine,Philadelphia,PA,US; 2 DrexelUniversityCollegeofMedicine,Philadelphia,PA,US; 3 StMichael’sMedicalCenter,Newark,NJ,US; 4 PhiladelphiaHealthManagementCorporation,Philadelphia,PA,US Background: HIV/HCV-coinfected patients have been underrepresented in clinical trials of all-oral therapies for chronic HCV genotype 1 infection. Our objective was to assess virologic responses and tolerability of sofosbuvir + simeprevir (sof/sim) in HIV/HCV-coinfected patients compared to those with HCV alone. Methods: We performed a cohort study among HCV-infected patients treated with sof/sim at 4 community-based and academic centers. The main outcome was end-of- treatment (EOT) HCV virologic response. HCV RNA, liver aminotransferases, and sof/sim discontinuations were evaluated over 12 weeks of treatment and 12 weeks of follow-up. Results were stratified by HIV status and by the presence of advanced hepatic fibrosis/cirrhosis. Results: Eighty-one patients (37 coinfected; 44 monoinfected) were treated with sof/sim between 12/2013 and 9/2014. Fifty-nine percent were African American, 61%were male, 73% had METAVIR stage 3/4 fibrosis, and 46% had prior HCV therapy (49% null or partial responders; 16% relapsers; 35% stopped due to toxicity). The most common HIV regimens in coinfected persons included raltegravir, dolutegravir, or rilpivirine with either tenofovir/emtrictabine or abacavir/lamivudine. Among HIV/HCV patients, 54% and 87% achieved an HCV RNA that was not quantifiable at 2 and 4 weeks of therapy, respectively, compared to 55% and 81% for HCV-monoinfected patients (p>0.5). Those with METAVIR stage 3/4 were equally likely to achieve HCV suppression by 4 weeks compared to those with less fibrosis regardless of HIV status (61% vs. 67% in coinfected patients, p=0.68; 56% vs. 75% in monoinfected patients, p=0.33). Overall, mean levels of alanine aminotransferase decreased from 54 U/L to 22 U/L within 2 weeks of sof/sim initiation. Of the 81 patients, only 5 (6%; 3 coinfected; 2 monoinfected) prematurely discontinued therapy (1 due to nonresponse; 1 for cutaneous reaction; 3 lost to follow-up). Among 42 patients completing 12 weeks of therapy, 37 (88%) achieved an EOT response (89% in coinfected patients; 88% in monoinfected patients, p>0.5). At the time of this analysis, 22 patients were followed for at least 4 weeks after the completion of therapy with 2 virologic relapses in monoinfected patients, 1 with METAVIR stage 3/4. Conclusions: An all-oral sof/sim regimen was effective for patients with chronic HCV genotype 1, regardless of HIV status, previous treatment response, and stage of fibrosis. Adverse events were rare, even in patients with advanced fibrosis/cirrhosis. 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.

Poster 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.

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CROI 2015