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.
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.
Study Type
OBSERVATIONAL
Enrollment
50
Unnamed facility
Antwerp, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Genk, Belgium
Sustained Virologic Response at 12 weeks (SVR12)
HCV RNA \<25 IU/mL, at 12 weeks (SVR12) after the last dose of anti-HCV treatment (telaprevir, PegIFN alfa, RBV)
Time frame: Week 12
adherence to telaprevir until Week 12
adherence as measured by pill count and/or patient questionnaire (modified medication adherence self-report inventory \[M-MASRI\]
Time frame: week 12
adherence to PegIFN alfa and RBV
adherence as measured by pill/vial count and/or patient questionnaire (M-MASRI)
Time frame: at end of treatment (week 24)
on-treatment virologic response undetectable
rapid virologic response \[RVR\] and extended rapid virologic response \[eRVR\], Week 12, end of treatment) based on viral load, as measured by HCV RNA \<25 IU/mL undetectable
Time frame: week 12 and end of treatment ()
on treatment virologic response
rapid virologic response \[RVR\] and extended rapid virologic response \[eRVR\], Week 12, end of treatment) based on viral load, as measured by HCV RNA \<25 IU/mL
Time frame: week 12 and end of treatment ()
health-related quality of life based on EQ-5D
The EQ-5D consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems). A standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state is also included ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
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Unnamed facility
Haine-Saint-Paul, Belgium
Unnamed facility
Lomme, France
Unnamed facility
Montpellier, France
Unnamed facility
Perpignan, France
Unnamed facility
Berlin, Germany
Unnamed facility
Biberach, Germany
Unnamed facility
Kassel, Germany
...and 8 more locations
Time frame: 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)
Hospital Anxiety and Depression Scale (HADS)
HADS is a validated 14-item scale with 7 of the items relating to anxiety and 7 relating to depression. Each item is scored from 0 to 3, with higher scores indicating greater likelihood of depression or anxiety. Cases of anxiety or depression are each defined by subscale scores of 8 or greater, and categorized as normal (score of 0-7), mild (score of 8-10), moderate (score of 11-14), and severe (score of 15-21). The recall period is the past week.
Time frame: 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)
alcohol use disorders identification test (AUDIT)
The AUDIT questionnaire consists of 10 questions about a patient's quantity and frequency of alcohol use. The response to 8 of the questions are scored as 0 = never, 1 = monthly or less, 2 = 2 to 4 times a month, 3 = 2 to 3 times a week, 4 = 4 or more times a week. Two questions are scored as 0 = no, 2 = yes, but not in the last year, 4 = yes, during the last year. A score of 8 or more is associated with harmful or hazardous drinking
Time frame: 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)