Clinical trial NCT01980290: Telaprevir With Peginterferon Alfa & Ribavirin in Ex-People Who INject Drugs Infected by Genotype 1 Chronic Hepatitis C
Official title: Observational Multicenter Study in Ex-People Who INject Drugs (Ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis, Chronic
Keywords: HCV genotype 1
Liver Fibrosis
ex-People who INject Drugs (ex-PWIDs)
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2013-11-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men or women who have HCV infection genotype 1, a quantifiable serum HCV RNA, documentation of the degree of liver fibrosis assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan), physician decision to start triple therapy with telaprevir and PegIFN alfa/RBV, have never been treated with antiviral treatment (naïve) or who have relapsed after IFN or PegIFN plus RBV (relapsers), have a history of injecting drugs, and are currently under stable substitution therapy (eg, methadone, buprenorphine) and/or followed in an addiction center will be eligible to enter this study.

Brief summary: The purpose of this study is to collect information on the efficacy, safety and tolerability of telaprevir (in combination with other medications), in patients who have a history of intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg., methadone, buprenorphine) and/or followed in addiction centres.

Detailed description: This is a multicenter, non-interventional, observational, prospective study to evaluate the efficacy, safety, and adherence to telaprevir in ex-People Who Inject Drugs (ex-PWIDs) infected with genotype 1 chronic hepatitis C and any fibrosis stage including compensated cirrhosis, who are receiving substitution therapy (eg, methadone, buprenorphine) and/or are being followed in an addiction center. Patients may be treatment naïve or relapsers. Participating physicians are to offer enrollment in this study to all eligible patients at their site in who they plan to initiate triple therapy with telaprevir, pegylated interferon alfa (PegIFN alfa), and ribavirin (RBV). A target of 115 patients will participate in this study. The duration of each patient's participation in this study will be up to approximately 60 weeks. After obtaining the signed participation agreement or ICF, selection criteria will be reviewed to verify the patient's eligibility. Data will be recorded in the electronic case report form (CRF) at 6 time points for each patient which correspond to routine care visits: inclusion, and at the patient's routine care visit closest to Week 4, 12, and 24, end of treatment, and end-of-follow-up (e.g., approximately 12 weeks after end-of-treatment). No additional blood, urine, or other biological samples will be required, and no additional investigations, beyond the routine clinical management of the patient, will be performed.

Eligibility criteria: Inclusion Criteria:

Have HCV genotype 1, a quantifiable serum HCV RNA, recent (within 18 months of baseline) documentation of the degree of liver fibrosis (Metavir F0-F4; Ishak 0-6) assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan); Physician decision to start triple therapy with telaprevir and PegIFN alfa/RBV; Have never been treated with antiviral treatment (naïve) or who have relapsed after IFN or PegIFN plus RBV (relapsers); History of injecting drugs and are currently under stable substitution therapy (eg, methadone, buprenorphine) and/or followed in an addiction center.

Exclusion Criteria:

Infected or coinfected with HCV of a genotype other than genotype 1; Previous or current treatment with a DAA therapy; Have any contraindication specified in the SmPC for telaprevir, PegIFN alfa, or RBV; Have a history or other evidence of decompensated liver disease, or have coinfection with active hepatitis B or HIV; Currently participating in another investigational study or clinical study.

Primary outcomes:
measure: Sustained Virologic Response at 12 weeks (SVR12)
timeFrame: Week 12
Secondary outcomes:
measure: adherence to telaprevir until Week 12
timeFrame: week 12
measure: adherence to PegIFN alfa and RBV
timeFrame: at end of treatment (week 24)
measure: on-treatment virologic response undetectable
timeFrame: week 12 and end of treatment ()
measure: on treatment virologic response
timeFrame: week 12 and end of treatment ()
measure: health-related quality of life based on EQ-5D
timeFrame: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
measure: alcohol use disorders identification test (AUDIT)
timeFrame: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Brussels
country: Belgium
city: Bruxelles
country: Belgium
city: Genk
country: Belgium
city: Haine-Saint-Paul
country: Belgium
city: Lomme
country: France
city: Montpellier
country: France
city: Perpignan Cedex
country: France
city: Berlin
country: Germany
city: Biberach
country: Germany
city: Kassel
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Maastricht
country: Netherlands
city: Lausanne
country: Switzerland
city: Zürich
country: Switzerland
city: Dundee
country: United Kingdom
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
References:
citation: Robaeys G, Christensen S, Lucidarme D, Arain A, Bruggmann P, Kunkel J, Keim S, Jakel M, DeMasi R, Liu C, Lonjon-Domanec I, Foster GR. Chronic Hepatitis C Treatment in Patients with Drug Injection History: Findings of the INTEGRATE Prospective, Observational Study. Infect Dis Ther. 2017 Jun;6(2):265-275. doi: 10.1007/s40121-017-0158-x. Epub 2017 May 5.