title: Sofosbuvir and Ledipasvir for 8 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in HCV-Monoinfected and HIV-HCV-Coinfected Individuals: Results From the German Hepatitis C Cohort (GECCO-01).
abstract: Shortening the duration of treatment with HCV direct-acting antivirals (DAAs) leads to substantial cost reductions. According to the label, sofosbuvir and ledipasvir can be prescribed for 8 weeks (SL8) in noncirrhotic women or men with HCV genotype 1 and low viral loads. However, real-world data about the efficacy and safety of SL8 are largely missing.
  
  
  
  Interim results from an ongoing prospective, multicenter cohort of 9 treatment centers in Germany (GECCO). All patients started on treatment with HCV DAAs since January 2014 were included. This report describes safety and efficacy outcomes in 210 patients with HCV monoinfection and 35 with human immunodeficiency virus (HIV)-HCV coinfection given SL8 in a real-world setting.
  
  
  
  Of 1353 patients included into the GECCO cohort until December 2015, a total of 1287 had complete data sets for this analysis; 337 (26.2%) fulfilled the criteria for SL8 according to the package insert, but only 193 (57.2%) were eventually treated for 8 weeks. Another 52 patients did not fulfill the criteria but were treated for 8 weeks. SL8 was generally well tolerated. The overall sustained virologic response rate 12 weeks after the end of treatment was 93.5% (186 of 199). The on-treatment response rate was 99.4% (159 of 160) in HCV-monoinfected and 96.4% (27 of 28) in HIV-HCV-coinfected patients. Ten patients were lost to follow-up.
  
  
  
  SL8 seems highly effective and safe in well-selected HCV-monoinfected and HIV-HCV-coinfected patients in a real-world setting.
authors.affiliation: Center for Infectiology Berlin.
authors.forename: Patrick
authors.initials: P
authors.lastname: Ingiliz
authors.affiliation: Center for Interdisciplinary Medicine Muenster.
authors.forename: Stefan
authors.initials: S
authors.lastname: Christensen
authors.affiliation: Faculty of Medicine, Department of Surgery and Cancer, Imperial College London, United Kingdom.
authors.forename: Torben
authors.initials: T
authors.lastname: Kimhofer
authors.affiliation: Gastroenterology Practice, Herne.
authors.forename: Dietrich
authors.initials: D
authors.lastname: Hueppe
authors.affiliation: Infektiologikum, Frankfurt.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lutz
authors.affiliation: Infectiology Center in Hamburg.
authors.forename: Knud
authors.initials: K
authors.lastname: Schewe
authors.affiliation: Center for Interdisciplinary Medicine Muenster.
authors.forename: Heiner
authors.initials: H
authors.lastname: Busch
authors.affiliation: Center for HIV and Hepatogastroenterology, Duesseldorf.
authors.forename: Günther
authors.initials: G
authors.lastname: Schmutz
authors.affiliation: Ambulanzzentrum Virushepatologie, University Medical Center Hamburg-Eppendorf and DZIF Partner Site, Hamburg.
authors.forename: Malte H
authors.initials: MH
authors.lastname: Wehmeyer
authors.affiliation: Medical Department I, University Hospital, Bonn.|Klinische Arbeitsgemeinschaft AIDS, Bonn.
authors.forename: Christoph
authors.initials: C
authors.lastname: Boesecke
authors.affiliation: Gastroenterology Practice, Leverkusen, Germany.
authors.forename: Karl-Georg
authors.initials: KG
authors.lastname: Simon
authors.affiliation: Center for HIV and Hepatogastroenterology, Duesseldorf.
authors.forename: Florian
authors.initials: F
authors.lastname: Berger
authors.affiliation: Medical Department I, University Hospital, Bonn.
authors.forename: Jürgen K
authors.initials: JK
authors.lastname: Rockstroh
authors.affiliation: Ambulanzzentrum Virushepatologie, University Medical Center Hamburg-Eppendorf and DZIF Partner Site, Hamburg.
authors.forename: Julian
authors.initials: J
authors.lastname: Schulze zur Wiesch
authors.affiliation: Center for Infectiology Berlin.
authors.forename: Axel
authors.initials: A
authors.lastname: Baumgarten
authors.affiliation: Center for HIV and Hepatogastroenterology, Duesseldorf.
authors.forename: Stefan
authors.initials: S
authors.lastname: Mauss
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001562:Benzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use; D060085:Coinfection / Q000188:drug therapy*; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage / Q000627:therapeutic use; D005858:Germany / Q000453:epidemiology; D015658:HIV Infections / Q000150:complications*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000627:therapeutic use; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D000069474:Sofosbuvir
keywords: 8 weeks; HIV coinfection; ledipasvir; short course treatment; sofosbuvir