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

Purpose

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.

Condition	Intervention
Hepatitis C Virus Infection	Drug: Interferon injections and ribavirin

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of a Multi-disciplinary Approach for the Treatment of Hepatitis C in IDUs (HI-LO Study)

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Rate of sustained virologic response (SVR) six months after completion of treatment. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adherence to therapy [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Cost [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Enrollment:	370
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2012
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 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 Weekly pegylated interferon injections will be administered by clinic staff and ribavirin will be dispensed in weekly medication pack.
Active Comparator: 2 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 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.

Arms

Assigned Interventions

Active Comparator: 1

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

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

Active Comparator: 2

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

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.

Detailed Description:

We will determine the HCV infection status of potential study subjects within a cohort of 2,000 IDUs receiving care in our centres (Appendix 1). For those who carry HCV antibodies (expected n = 1800), a test for HCV viremia and genotype will be performed. By these evaluations, we expect up to 600 individuals to be viremic and carry HCV genotype 2 or 3. Within this group, 200 consecutive patients (100/study strategy) will receive therapy for HCV, based on their eligibility to do so according to Provincial guidelines for the reimbursement of medications. Patient allocation will be according to the study site where they regularly receive care. At two sites, patients will be enrolled in a DOT program with on-site full-time nursing and counseling support (high intensity, 50 patients/site). At the other two sites, patients will receive medication on a weekly basis and will have access to part-time nursing and counseling support (low intensity, 50 patients/site). Medical follow-up will be according to current clinical standards, and the primary endpoint of the study will be the rate of sustained virologic response (SVR) six months after completion of treatment. Within the study described above, we will use standardized methodologies to calculate the total health care costs related to the treatment of HCV infection. We will also assess the effect of treatment on the quality of life (QoL) of study participants.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399672

Locations

Canada, British Columbia
Pender Community Health Centre
Vancouver, British Columbia, Canada, V6B 1R3

Sponsors and Collaborators

University of British Columbia

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:

Brian Conway, MD

University of British Columbia

More Information

No publications provided

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00399672 History of Changes
Other Study ID Numbers:	C06-0192
Study First Received:	November 14, 2006
Last Updated:	July 9, 2012
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

HCV
injection drug users
ribavirin
pegylated interferon
illicit drug users

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013