title: 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.
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.
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Liver Foundation, HepNet Study-House, Hannover, Germany, and German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Braunschweig, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Heidrich
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Liver Foundation, HepNet Study-House, Hannover, Germany, and German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Braunschweig, Germany.
authors.forename: Steffen B
authors.initials: SB
authors.lastname: Wiegand
authors.affiliation: IFI Institute for Interdisciplinary Medicine, Asklepios Klinik St Georg, Hamburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Buggisch
authors.affiliation: Gastroenterology, Gastroenterologische Schwerpunkt Praxis, Kiel, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Hinrichsen
authors.affiliation: St. Josefs hospital, Offenburg, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Link
authors.affiliation: Medical Practice, Berlin, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Möller
authors.affiliation: Leberpraxis, Hannover, Germany.
authors.forename: Klaus H W
authors.initials: KH
authors.lastname: Böker
authors.affiliation: Gastroenterological Practice, Frankfurt, Germany.
authors.forename: Gerlinde
authors.initials: G
authors.lastname: Teuber
authors.affiliation: Dept. of Internal Medicine II, University of Würzburg, Würzburg, Germany.
authors.forename: Hartwig
authors.initials: H
authors.lastname: Klinker
authors.affiliation: Gastroenterological Practice, Dortmund, Germany.
authors.forename: Elmar
authors.initials: E
authors.lastname: Zehnter
authors.affiliation: Center for Addiction-Medicine, Hepatology and HIV, Praxiszentrum Kaiserdamm, Berlin, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Naumann
authors.affiliation: Medical Practice, Münster, Germany.
authors.forename: Heiner W
authors.initials: HW
authors.lastname: Busch
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Liver Foundation, HepNet Study-House, Hannover, Germany, and German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Braunschweig, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Maasoumy
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Liver Foundation, HepNet Study-House, Hannover, Germany, and German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Braunschweig, Germany.
authors.forename: Undine
authors.initials: U
authors.lastname: Baum
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Liver Foundation, HepNet Study-House, Hannover, Germany, and German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Braunschweig, Germany.
authors.forename: Svenja
authors.initials: S
authors.lastname: Hardtke
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Liver Foundation, HepNet Study-House, Hannover, Germany, and German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Braunschweig, Germany.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Manns
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Liver Foundation, HepNet Study-House, Hannover, Germany, and German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Braunschweig, Germany.
authors.forename: Heiner
authors.initials: H
authors.lastname: Wedemeyer
authors.affiliation: IFI Institute for Interdisciplinary Medicine, Asklepios Klinik St Georg, Hamburg, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Petersen
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; German Liver Foundation, HepNet Study-House, Hannover, Germany, and German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Braunschweig, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Cornberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000737:chemistry / Q000627:therapeutic use*; D005260:Female; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007155:Immunologic Factors / Q000737:chemistry / Q000627:therapeutic use*; D016898:Interferon-alpha / Q000737:chemistry / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000737:chemistry; D011446:Prospective Studies; D012254:Ribavirin / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D007155:Immunologic Factors; D016898:Interferon-alpha; D011092:Polyethylene Glycols; D012254:Ribavirin