Pegylated Interferon and Ribavirin in Hepatitis C Patients on Opioid Pharmacotherapy

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if treatment of chronic hepatitis C in people who are on opiate replacement therapy such as methadone or buprenorphine (including patient who still inject drugs) is safe and effective.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melbourne Health
• Collaborators: Hoffmann-La Roche; Monash University; St Vincent's Hospital, Sydney; The University of New South Wales; Western Hospital, Australia
• Treatments: Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

1. 18 years of age or older

2. on opioid substitution therapy (methadone or buprenorphine)

3. serologic evidence of chronic hepatitis C infection determined by a detectable anti-HCV antibody for 6 months or greater with evidence of detectable HCV RNA

4. elevated ALT on at least two occasions at least one month apart within the past 6 months, with at least one during the screening period preceding the initiation of study drug dosing.

5. HCV treatment-naïve

6. Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection (unless contraindicated due to a bleeding disorder)

7. Compensated liver disease (Child-Pugh Grade A clinical classification).

8. All fertile males and females receiving ribavirin were required to be using two forms of effective contraception during treatment and during the 6 months after treatment

9. Women of child bearing potential were required to have a negative urine or blood pregnancy test documented within the 24-hour period prior to the first dose of study drug

Exclusion Criteria:

1. Women who were pregnant, breastfeeding or planning a pregnancy

2. Male partners of women who were pregnant

3. Patients who had previously received therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug

4. Recipients of any investigational drug 4 weeks or 5 half lives, whichever was longer, prior to the first dose of study drug

5. A positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab

6. A history or other evidence of a medical condition associated with chronic liver disease other than HCV

7. Haemoglobin <12 g/dL in women or <13 g/dL in men, a neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening and serum creatinine level >1.5 times the upper limit of normal at screening.)

8. A history of a severe seizure disorder or current anticonvulsant use

9. Patients with a history of immunologically-mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, coronary artery disease, cerebrovascular disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study

10. Patients with a history of thyroid disease which is poorly controlled on prescribed medications

11. Evidence of severe retinopathy

12. Evidence of excessive substance abuse as judged by the investigator

13. Patients with an increased baseline risk for anaemia (e.g. thalassaemia, spherocytosis, history of gastrointestinal bleeding, etc) or for whom anemia would be medically problematic.

14. Patients with a history of severe psychiatric disease (defined as acute phase of schizophrenia or bipolar disorder manic, mixed or depressive phase, severe anorexia, history of severe multiple episodes of self harm, currently screening as high or moderate suicide risk, current major depressive episode or current psychosis of any cause at screening)