Z Gastroenterol 2016; 54 - KV232
DOI: 10.1055/s-0036-1587008

Six weeks of sofosbuvir/ledipasvir (SOF/LDV) are sufficient to treat acute hepatitis C virus genotype 1 monoinfection: The HepNet Acute HCV IV Study

K Deterding 1, C Spinner 2, E Schott 3, T Welzel 4, G Gerken 5, H Klinker 6, U Spengler 7, J Wiegand 8, J Schulze zur Wiesch 9, A Pathil 10, M Cornberg 1, 11, 12, A Umgelter 2, C Zöllner 3, S Zeuzem 4, H von der Leyen 13, D von Witzendorff 11, MP Manns 1, 11, 12 H Wedemeyer 1, 11, 12, the HepNet acute HCV IV Study Group
  • 1Hannover Medical School, Hannover, Deutschland
  • 2University Hospital Klinikum rechts der Isar, Munich, Deutschland
  • 3Charité – Universitätsmedizin, Berlin, Deutschland
  • 4University Hospital, Frankfurt, Deutschland
  • 5University Hospital, Essen, Deutschland
  • 6University of Wuerzburg Medical Center, Wuerzburg, Deutschland
  • 7University Hospital, Bonn, Deutschland
  • 8University Clinic, Leipzig, Deutschland
  • 9University Hospital Hamburg-Eppendorf, Hamburg, Deutschland
  • 10University Clinic of Heidelberg, Heidelberg, Deutschland
  • 11HepNet Study-House, German Liver Foundation, Hannover, Deutschland
  • 12German Centre for Infection Research, partner side German Liver Foundation, HepNet Study-House, Hannover, Deutschland
  • 13Hannover Clinical Trial Center GmbH, Hannover, Deutschland

Background: Early treatment of acute hepatitis C virus (HCV) infection with interferon alfa monotherapy for 12 – 24 weeks is highly effective but is associated with frequent unfavorable side effects. There is no fully published study yet exploring the safety, efficacy and required treatment duration of interferon-free treatment of acute hepatitis C virus monoinfection.

Methods: The German HepNet Acute HCV IV Study was designed as a single arm, prospective multicenter pilot study to evaluate the efficacy and safety of treatment with SOF/LDV for 6 weeks without ribavirin in patients with acute genotype 1 HCV monoinfection. 20 patients were included by 10 centers between November 2014 and October 2015. Central HCV RNA testing was performed with the Cobas AmpliPrep/Cobas TaqMan assay version 2.0 (limit of quantification 15 IU/ml).

Results: Most patients were male (60%) and had a mean age of 46 ± 12 years. Risk factors for HCV infection were sexual transmission in 11 (55%) patients (including 5 men having sex with men), medical procedures/needle stick injury in 5 (25%) patients, drug use in 1 (5%) patient, nail treatment in 1 (5%) patient and unspecified in the remaining 2 (10%) patients. Mean alanine aminotransferase (ALT) and mean bilirubin levels before start of antiviral treatment were 882 U/l and 3.1 mg/dl, respectively. The mean HCV-RNA viral load was 4.9 log10 IU/ml (range 3.3 – 6.7) at screening; 11 patients were infected with HCV genotype 1a and 9 patients with genotype 1b. All 20 patients (100%) completed 6 weeks of antiviral treatment and follow-up week 12. Fatigue was the most frequent adverse event reported during antiviral treatment (30%). There was one SAE which was unrelated to the study drugs. At follow-up week 12, 18 (90%) patients had normalized ALT and bilirubin. At follow-up weeks 12, all patients had undetectable HCV RNA (SVR-12 20/20 (100%)).

Conclusion: Treatment for 6 weeks with SOF/LDV was safe, well tolerated and highly effective in HIV-negative HCV genotype 1-infected patients with acute hepatitis C. Short-duration treatment of acute hepatitis C may be cost-saving as compared to treatment of chronic hepatitis C and could prevent the spread of HCV in high risk populations.