Z Gastroenterol 2015; 53 - KG143
DOI: 10.1055/s-0035-1559169

German cohort on Sofosbuvir based therapy for HIV/HCV- and HCV-infection (GECCO) – Patients on opioid substitution therapy (OST) respond as well as non-OST patients

S Christensen 1, P Ingiliz 2, D Hüppe 3, T Lutz 4, K Simon 3, K Schewe 5, C Schwarze-Zander 6, H Busch 1, A Baumgarten 2, G Schmutz 7, S Mauss 7
  • 1Centrum für Interdisziplinäre Medizin (CIM), Infektiologische Praxisgemeinschaft, Münster, Deutschland
  • 2Medizinisches Infektiologie Zentrum Berlin, Berlin, Deutschland
  • 3Praxis für Gastroenterologie, Herne, Deutschland
  • 4Infekiologikum, Frankfurt, Deutschland
  • 5Infektionsmedizinisches Centrum Hamburg, Hamburg, Deutschland
  • 6Medizinischen Universitätsklinik I, HIV-Immunologie-Infektiologie und Tropenmedizin-Ambulanz, Bonn, Deutschland
  • 7Centrum für HIV und Hepatogastroenterologie, Düsseldorf, Deutschland

Background: Sofosbuvir (SOF) was approved in Europe in January 2014. However, outcomes of SOF based therapy in patients on OST in comparison to NON-OST were not systematically studied. Here, we present corresponding real-life data on SOF-based treatments from Germany.

Methods: Ongoing multicenter cohort on HCV patients who were started on the following HCV treatments: SOF/Ribavirin (RBV), SOF/Daclatasvir (DCV), SOF/Simeprevir (SMV), SOF/PegIFN/RBV and SOF/Ledipasvir (LDV). For the current analysis only patients with GT 1 or GT3 treated with PegIFN/RBV/SOF (12 weeks) or SOF/RBV (24 weeks) were analysed.

Results: Overall, 393 HCV-monoinfected patients and 125 HIV/HCV-coinfected patients were enrolled so far. OST patients 80/518 were more often male (82,5% vs. 66%), younger (47 vs. 53 median years), and less often HIV coinfected (12% vs. 17%). The genotype (GT) pattern was: GT1 67,4% in NON-OST, 50% in OST. GT2 6,2% in NON-OST, 1,3% in OST. GT3 16,2% in NON-OST, 46,3% in OST. GT4 7,5% in NON-OST, 1,3% in OST. Liver cirrhosis was present in 24,2% NON-OST and 32,5% in OST. 55% of non-OST and 32,5% of OST patients were pretreated. In GT 1 patient treated with SOF/PegIFN/RBV, the SVR12 rate was 86.6% in non-OST and 88.9% in OST patients. In GT 3 patients, treated with SOF/PegIFN/RBV, the SVR12 rate was 86.4% in non-OST and 72.7% in OST patients (p = ns). With SOF/RBV SVR12 rates in NON-OST were 71,4% (10/14) versus 66,7% (4/6) in OST. Lost to follow up/discontinuation rate was 3,7% in NON-OST and 12,5 in OST patients.

Discussion: In this real life cohort response rates for chronically HCV GT 1- mono-and coinfected patients on OST and NON-OST treated with SOF/PegIFN/RBV in GT 1 were comparable. The lower response rate in GT 3 patients on OST was due to drop-out, not relapses. Reasons for higher drop out rates among OST patients need to be investigated in further studies. The preliminary SVR12 rates seem to be in line with the „real world” success rates in TARGET and TRIO.