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

NCT00399672 | Completed

• 1 other identifier: C06-0192
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C Virus Infection

Keywords

HCV; injection drug users; ribavirin; pegylated interferon; illicit drug users

Outcome Measures

Primary Outcomes (1)

• Rate of sustained virologic response (SVR) six months after completion of treatment.

Secondary Outcomes (3)

• Adherence to therapy

• Cost

• Quality of life

Study Arms (2)

1

ACTIVE COMPARATOR

The 4 participating sites are designated either High Intensity or Low Intensity. High Intensity sites have access to: full time specialist physicians, access to full time nurses and counselors. All weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.

Drug: Interferon injections and ribavirin

2

ACTIVE COMPARATOR

The 4 participating sites are designated either High Intensity or Low Intensity. In the Low intensity group, all patients will have access to: full time primary care physicians, specialist physicians and access to part time nurse or counselor by appointment. Patients will be offered the option of self or nurse administered pegylated interferon injections on an appointment basis. Ribavirin will be dispensed biweekly. The treatment medication cannot be stored at the clinic; it must be the subjects responsibility.

Drug: Interferon injections and ribavirin

Interventions

Interferon injections and ribavirin DRUG

Weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.

1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Pender Community Health Centre

Vancouver, British Columbia, V6B 1R3, Canada

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Brian Conway, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2006
• First Posted: November 15, 2006
• Study Start: June 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2012
• Last Updated: November 30, 2016

Record last verified: 2016-11

Locations

CA (1)