title: Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients.
abstract: OBJECTIVE
  Acute hepatitis C virus infections (AHCV) are prevalent among HIV positive men having sex with men and generally treated with pegylated interferon-alpha (PegIFN) and ribavirin (RBV) during 24weeks. The addition of a protease inhibitor could shorten therapy without loss of efficacy.
  
  
  METHODS
  We performed an open-label, single arm study to investigate the efficacy and safety of a 12-week course of boceprevir, PegIFN and RBV for AHCV genotype 1 infections in 10 Dutch HIV treatment centers. The primary endpoint of the study was achievement of sustained virological response rate at week 12 (SVR12) in patients reaching a rapid viral response at week 4 (RVR4) and SVR12 in the intent to treat (ITT) entire study population was the most relevant secondary endpoint.
  
  
  RESULTS
  One hundred twenty-seven AHCV patients were screened in 16 months, of which 65 AHCV genotype 1 patients were included. After spontaneous clearance in six patients and withdrawal before treatment initiation in two, 57 started therapy within 26 weeks after infection. RVR4 rate was 72%. SVR12 rate was 100% in the RVR4 group. SVR12 rate in the ITT group was 86% and comparable to the SVR12 rate of 84% in 73 historical controls treated for 24 weeks with PegIFN and RBV in the same study centers.
  
  
  CONCLUSIONS
  With the addition of boceprevir to PegIFN and RBV, treatment duration of AHCV genotype 1 can be reduced to 12 weeks without loss of efficacy. Given the high drug costs and limited availability of interferon-free regimens, boceprevir PegIFN and RBV can be a considered a valid treatment option for AHCV. ClinicalTrials.gov, number NCT01912495.
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Erasmus MC, Rotterdam, The Netherlands. Electronic address: b.hullegie@erasmusmc.nl.
authors.forename: Sebastiaan J
authors.initials: SJ
authors.lastname: Hullegie
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Mark A A
authors.initials: MA
authors.lastname: Claassen
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Guido E L
authors.initials: GE
authors.lastname: van den Berk
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Academisch Medisch Centrum, Amsterdam, The Netherlands.
authors.forename: Jan T M
authors.initials: JT
authors.lastname: van der Meer
authors.affiliation: Department of Internal Medicine and Department of Medical Microbiology, Maastricht Universitair Medisch Centrum, Maastricht, The Netherlands.
authors.forename: Dirk
authors.initials: D
authors.lastname: Posthouwer
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Slotervaart Ziekenhuis, Amsterdam, The Netherlands.
authors.forename: Fanny N
authors.initials: FN
authors.lastname: Lauw
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Medisch Centrum Haaglanden, Den Haag, The Netherlands.
authors.forename: Eliane M S
authors.initials: EM
authors.lastname: Leyten
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Radboud Universitair Medisch Centrum, Nijmegen, The Netherlands.
authors.forename: Peter P
authors.initials: PP
authors.lastname: Koopmans
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Rijnstate Ziekenhuis, Arnhem, The Netherlands.
authors.forename: Clemens
authors.initials: C
authors.lastname: Richter
authors.affiliation: DC Klinieken, Amsterdam, The Netherlands.
authors.forename: Arne
authors.initials: A
authors.lastname: van Eeden
authors.affiliation: Department of Internal Medicine, Infectious Diseases Service, University of Groningen, Universitair Medisch Centrum Groningen, Groningen, The Netherlands.
authors.forename: Wouter F W
authors.initials: WF
authors.lastname: Bierman
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Academisch Medisch Centrum, Amsterdam, The Netherlands; Department of Infectious Diseases Research and Prevention, Public Health Service of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Astrid M
authors.initials: AM
authors.lastname: Newsum
authors.affiliation: Department of Internal Medicine Division of Infectious Diseases, Universitair Medisch Centrum Utrecht, Utrecht, The Netherlands.
authors.forename: Joop E
authors.initials: JE
authors.lastname: Arends
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Bart J A
authors.initials: BJ
authors.lastname: Rijnders
mesh_terms: D000208:Acute Disease; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D006526:Hepatitis C / Q000188:drug therapy* / Q000523:psychology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011392:Proline / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins / Q000008:administration & dosage; D012254:Ribavirin / Q000008:administration & dosage*
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline; C417083:peginterferon alfa-2b
keywords: Acute hepatitis C; HIV; Treatment