Treatment of naïve patients with chronic hepatitis C genotypes 2 and 3 with pegylated interferon alpha and ribavirin in a real world setting: relevance for the new era of DAA

PLoS One. 2014 Oct 10;9(10):e108751. doi: 10.1371/journal.pone.0108751. eCollection 2014.

Abstract

Evidence based clinical guidelines are implemented to treat patients efficiently that include efficacy, tolerability but also health economic considerations. This is of particular relevance to the new direct acting antiviral agents that have revolutionized treatment of chronic hepatitis C. For hepatitis C genotypes 2/3 interferon free treatment is already available with sofosbuvir plus ribavirin. However, treatment with sofosbuvir-based regimens is 10-20 times more expensive compared to pegylated interferon alfa and ribavirin (PegIFN/RBV). It has to be discussed if PegIFN/RBV is still an option for easy to treat patients. We assessed the treatment of patients with chronic hepatitis C genotypes 2/3 with PegIFN/RBV in a real world setting according to the latest German guidelines. Overall, 1006 patients were recruited into a prospective patient registry with 959 having started treatment. The intention-to-treat analysis showed poor SVR (GT2 61%, GT3 47%) while patients with adherence had excellent SVR in the per protocol analysis (GT2 96%, GT3 90%). According to guidelines, 283 patients were candidates for shorter treatment duration, namely a treatment of 16 weeks (baseline HCV-RNA <800.000 IU/mL, no cirrhosis and RVR). However, 65% of these easy to treat patients have been treated longer than recommended that resulted in higher costs but not higher SVR rates. In conclusion, treatment with PegIFN/RBV in a real world setting can be highly effective yet similar effective than PegIFN± sofosbuvir/RBV in well-selected naïve G2/3 patients. Full adherence to guidelines could be further improved, because it would be important in the new era with DAA, especially to safe resources.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antiviral Agents / chemistry
  • Antiviral Agents / therapeutic use*
  • Female
  • Hepacivirus / drug effects
  • Hepacivirus / genetics
  • Hepacivirus / isolation & purification
  • Hepatitis C, Chronic / diagnosis
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Immunologic Factors / chemistry
  • Immunologic Factors / therapeutic use*
  • Interferon-alpha / chemistry
  • Interferon-alpha / therapeutic use*
  • Male
  • Middle Aged
  • Polyethylene Glycols / chemistry
  • Prospective Studies
  • Ribavirin / therapeutic use*
  • Young Adult

Substances

  • Antiviral Agents
  • Immunologic Factors
  • Interferon-alpha
  • Polyethylene Glycols
  • Ribavirin

Grants and funding

This registry was financially supported by MSD Sharp & Dohme GmbH (manufacturer of pegylated interferon alpha-2b) (http://www.msd.de/). The protocol and the contracts did not intend to influence the decision to treat patients with pegylated interferon alpha-2b. The HepNet study house of the German Liver Foundation, which was supported by the German Center for Infectious Disease Research (DZIF), coordinated and formally sponsored the registry. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.