Pender Assisted Therapy (PATh) - Prospective Study of the Treatment of HCV

Hepatitis C Virus Infection Clinical Trial

Official title: Directly Observed Therapy for the Treatment of Hepatitis C Virus Infection in Injection Drug Users

Status Completed

Clinical Trial Summary

The treatment of HCV-infected IDUs presents multiple challenges, such as adherence to therapy, relapse of substance use, re-infection, and co-morbid psychiatric disease. Some guidelines recommended that IDUs not be offered HCV treatment until they had stopped all such use for > 6 months, raising some questions about fairness and discrimination. Little published data exist on HCV therapy in active IDUs. However, extensive evidence exists that, when specific programs are developed, IDUs can be successfully engaged in care. In IDUs, strategies shown to improve adherence include directly-observed therapy (DOT), cash incentives, and comprehensive case management. Weekly interferon dosing now provides a means of improving HCV treatment adherence, and makes a DOT approach more practical. Within an observational, prospective clinical cohort, we will be able to identify a group of IDUs infected with HCV genotype 2 or 3 who would most benefit from treatment for their infection. We will design a systematic approach to the determination of their appropriateness for treatment, refine the approach to their treatment within a directly observed therapy (DOT) setting, and evaluate the success of the approach (defined as the achievement of Sustained Virologic Response (SVR)). Taken together, this project will help define a systematic approach to HCV infection in the inner city. The hypothesis is that the development of a systematic approach for the diagnosis of HCV and the establishment of a directly observed therapy (DOT) program for the treatment of HCV infection in IDUs will constitute an effective means of controlling the epidemic of this infection within this population.

Clinical Trial Description

We will evaluate up to 200 IDUs receiving care in our clinics. For those found to carry genotype 2 or 3 and be eligible for treatment on medical grounds, we will evaluate the patients in a bi-weekly case conference. All physicians who are participating in this study will also be included. Nursing and counselling staff will also be present. For those who qualify to receive therapy for HCV, based on Provincial guidelines, a decision will be made regarding their appropriateness to begin treatment based on physical, mental, social and addiction-related factors. Once treatment is initiated, the primary objective of this study is to evaluate a relatively high intensity DOT program for the treatment of HCV-infected IDUs. All patients will have access to: full-time primary care physician, half-time specialist physician, immediate access to one of three full-time nurses and one of six full-time counsellors. All weekly pegylated interferon injections and one of two daily doses of oral medications will be administered/witnessed by clinic staff. The interferon will be injected at the clinic by a staff nurse, while the one daily dose of ribavirin that will be observed will be given simultaneously with methadone (if the patient is on maintenance therapy with this agent) either at the clinic site or at a community pharmacy, as has been decided in that individual's plan of care. This plan will be maintained at the time of initiation of HCV therapy. This study will evaluate 50 individuals infected with HCV genotypes 2/3 receiving up to 24 weeks of therapy. The primary outcome will be evaluation of SVR (undetectable virus at 48 weeks, 24 weeks after cessation of therapy). Patients will be enrolled at PCHC, TPHU or CCHC, according to their usual site of medical care. They will be assessed to determine if they wish to participate in the trial and meet its inclusion and exclusion criteria. They will then be asked to provide written, informed consent using the document approved by the Research Ethics Board. Once consent is granted, a medical evaluation and laboratory testing will be completed. Clinical data will consist of a medical history (to include recreational drug use history) and physical examination (to include vital signs, weight and height). Laboratory evaluations will include: confirmation of HCV antibody status, viremia and genotype; Hematology (CBC); Blood Chemistry (ALT, creatinine, alkaline phosphatase, total bilirubin (direct and indirect), urea nitrogen, albumin, glucose, sodium, potassium, chloride); ANA, TSH, HBsAg, iron studies, ceruloplasmin, AFP, PT/INR, HIV antibody test (CD4 cell count and HIV plasma viral load, if known HIV-positive); Urinalysis and Toxicology Screen; Serum pregnancy test in women of child-bearing potential. All blood work to evaluate treatment efficacy and toxicity will be collected by study personnel. This will be done at weeks 2, 4, 6, 8, 12, 16, 20 and 24 (more frequently if clinically indicated), according to the standard of care. All medical follow-up will be according to standard of care. This study will involve the prospective evaluation of HCV therapy in patients who would receive treatment regardless of their participation in the study. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

• NCT number: NCT00247884
• Study type: Observational
• Source: University of British Columbia
• Status: Completed
• Phase: Phase 4
• Start date: June 2005
• Completion date: October 2009