Evaluation of a Multi-disciplinary Approach for the Treatment of Hepatitis C in IDUs (HI-LO Study)

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Although injection drug users (IDUs) account for over 70% of new cases of HCV infection/year, there is no consensus on how to approach their medical care. In some Canadian centres, patients must be free of recreational drug use for as long as 6 months before being considered for HCV therapy. This is not consistent with current North American guidelines. Over the past 5 years, we have developed a successful program for the treatment of HIV infection in this population, based on a multi-disciplinary comprehensive program including directly observed therapy (DOT). Even though the duration of therapy for HCV is shorter than for HIV (as little as 6 months vs. life-long), we must address issues of administration of a weekly injection (interferon), twice daily pills (ribavirin) and the risk of significant side effects (including anxiety and depression) to successfully expand our program to treat this disease. Further, it may be that even if the program is successful, its benefits will be negated by HCV re-infection due to continued risk behaviors for its transmission.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Interferons; Ribavirin

Criteria

Inclusion Criteria:

• Age > 19 years;

• Serum HCV-RNA pos;

• HCV genotype 2 or 3;

• HBsAg neg;

• serum ALT > 1.5x upper limit normal > 3 months;

• Illicit drug use in the past year;

• Agreement from each participant of childbearing age to practice contraception;

• Absence of other contraindications to the initiation of therapy as determined by the health care team;

• Ability to provide informed consent.

Exclusion Criteria:

• Any cause for chronic liver disease other than HCV (including alcohol use >350 g/wk);

• Pregnant or breastfeeding women;

• Active HBV infection;

• Hemolytic anemia;

• Decompensated cirrhosis or portal hypertension or PT-INR > 1.3 or Child-Hugh class > A;

• Active suicidal ideation, psychosis, mania or hypomania;

• Serum creatinine > 180 µg/mL;

• Hemoglobin < 120 g/L in men or 110 g/L in women;

• Platelets < 90 x 109/L;

• Neutrophils < 1.5 x 109/L;

• Active autoimmune disease;

• NYHA disease > grade 2;

• Psoriasis requiring systemic therapy;

• Active malignancy apart from non melanoma skin cancer;

• Use of systemic immunosuppressant agents;

• Prior treatment of HCV with interferon or ribavirin;

• HIV positive with CD4 count <300 cells/mm3 or receiving didanosine (due to interaction with ribavirin);

• Life expectancy < 2 years.