title: Belgian experience with triple therapy with boceprevir and telaprevir in genotype 1 infected patients who inject drugs.
abstract: No data have been reported yet on treatment outcome in persons who inject drugs (PWID) infected with hepatitis C virus treated with boceprevir or telaprevir in combination with peginterferon (Peg IFN) and ribavirin (RBV). Additionally, there are concerns about the safety of boceprevir and telaprevir in some subgroups of patients with hepatitis C (HCV). In a cohort of HCV patients infected with genotype 1 in Belgium, treatment outcome of patients infected due to IV drug use was analyzed and compared with patients who have no history of substance use. The study population consisted of 179 patients: 78 PWID and 101 controls treated with boceprevir (n = 79) or telaprevir (n = 100) additional to Peg IFN and RBV; 53 (30%) had advanced disease (F3, F4) and 79 (44%) had an antiviral therapy previously. There were no significant differences in the baseline characteristics between both groups, except that PWID patients were more frequently infected with genotype 1a (67% vs 21%), were younger and were predominantly male. Psychiatric complaints during follow-up occurred more frequently in the PWID patients: 24% versus 11% (P = .02). Treatment failure for other reasons than absence of viral response was 70% and 64% in PWID and non-PWID respectively. The sustained viral response (SVR) rates were similar in both groups (71% in PWID vs 72% in non-PWID); with a non-inferiority test with -5% margin there is a difference of -1% (95% CI [-15%, 13%]) and P = 0.30. There are no reasons to exclude PWID from treatment with boceprevir, telaprevir and novel antiviral therapies.
authors.affiliation: Department of Gastroenterology and Hepatology, Ziekenhuis Oost-Limburg, Genk, Belgium.|Faculty of Medicine and Life Sciences, Hasselt University, Martelarenlaan 42, 3500 Hasselt, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Arain
authors.affiliation: Department of Gastroenterology and Hepatology, ZNA Stuyvenberg, Antwerp, Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Bourgeois
authors.affiliation: Department of Gastroenterology and Hepatology, Hôpitaux Iris Sud Bracops, Brussels, Belgium.
authors.forename: C
authors.initials: C
authors.lastname: de Galocsy
authors.affiliation: Department of Gastroenterology and Hepatology, Hôpital de Jolimont, Haine-Saint-Paul, Belgium.
authors.forename: J
authors.initials: J
authors.lastname: Henrion
authors.affiliation: Department of Gastroenterology and Hepatology, Hôpital de Jolimont, Haine-Saint-Paul, Belgium.|Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: Deltenre
authors.affiliation: Department of Gastroenterology and Hepatology, AZ Groeninge, Kortrijk, Belgium.
authors.forename: F
authors.initials: F
authors.lastname: d'Heygere
authors.affiliation: Department of Gastroenterology and Hepatology, AZ Groeninge, Kortrijk, Belgium.
authors.forename: C
authors.initials: C
authors.lastname: George
authors.affiliation: Department of Gastroenterology and Hepatology, Clinique Saint-Joseph, Clinique de l'Espérance, Liège, Belgium.
authors.forename: B
authors.initials: B
authors.lastname: Bastens
authors.affiliation: Department of Gastroenterology and Hepatology, AZ St-Maarten, Mechelen, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: Van Overbeke
authors.affiliation: Medisch Sociaal Opvangcentrum Limburg, Genk, Belgium.
authors.forename: R
authors.initials: R
authors.lastname: Verrando
authors.affiliation: Center for Statistics (CenStat), Hasselt University, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: Bruckers
authors.affiliation: Free Clinic, Antwerp, Belgium.|Department of Public Health and Primary Care KU Leuven, Leuven, Belgium.
authors.forename: C
authors.initials: C
authors.lastname: Mathei
authors.affiliation: Department of General Practice, KU Leuven, Belgium and Maastricht University, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Buntinx
authors.affiliation: Department of Gastroenterology and Hepatology, Ghent University Hospital, Belgium.
authors.forename: H
authors.initials: H
authors.lastname: Van Vlierberghe
authors.affiliation: Department of Gastroenterology and Hepatology, UZ Antwerp, Antwerp, Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Francque
authors.affiliation: Department of Hepatology, University Hospitals KULeuven, Belgium.
authors.forename: W
authors.initials: W
authors.lastname: Laleman
authors.affiliation: Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Belgium.
authors.forename: C
authors.initials: C
authors.lastname: Moreno
authors.affiliation: Department of Gastroenterology and Hepatology, Jessa Hospital, Hasselt, Belgium.
authors.forename: F
authors.initials: F
authors.lastname: Janssens
authors.affiliation: Department of Hepatology, University Hospitals KULeuven, Belgium.
authors.forename: F
authors.initials: F
authors.lastname: Nevens
authors.affiliation: Department of Gastroenterology and Hepatology, Ziekenhuis Oost-Limburg, Genk, Belgium.|Faculty of Medicine and Life Sciences, Hasselt University, Martelarenlaan 42, 3500 Hasselt, Belgium.|Department of Hepatology, University Hospitals KULeuven, Belgium.
authors.forename: G
authors.initials: G
authors.lastname: Robaeys
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D001530:Belgium; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage*; D011392:Proline / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011446:Prospective Studies; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage; D015819:Substance Abuse, Intravenous / Q000150:complications*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D009842:Oligopeptides; D012254:Ribavirin; C486464:telaprevir; 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
keywords: boceprevir; direct acting antivirals; hepatitis C; persons who inject drugs; telaprevir