Pegylated Interferon and Ribavirin in Hepatitis C Patients on Opioid Pharmacotherapy
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      It is estimated that in excess of 170 million people worldwide are infected with the
      hepatitis C virus (HCV) resulting in 1.4 million deaths annually. In developed countries HCV
      is most commonly transmitted through injecting drug use (IDU) with estimates suggesting up to
      80-90% of incident cases are due to unsafe injecting practices. Infection results in chronic
      infection in around 75% of cases and it is these patients who subsequently develop the
      life-threatening complications of liver failure and hepatocellular carcinoma due to
      progressive fibrosis.

      Current standard of care consists of a combination of pegylated interferon and ribavirin
      which results in sustained virological response rates (SVR, defined as undetectable HCV RNA
      24 weeks post treatment) in 54-63% of patients. This is strongly dependent on viral genotype
      with genotype 1 patients achieving lower SVR rates compared to genotype 2 and 3. These
      therapies are however associated with significant side effects, most notably psychiatric.
      Depression, anxiety and irritability are common and of concern is the attendant risk of
      suicidality in patients with a chronic illness in which depression is particularly common.
      Mood disorders have been reported to occur in up to 50% patients on therapy and can result in
      dose reductions and discontinuation in 40% and 20% patients respectively.

      While more effective therapies have become available for the treatment of chronic HCV, they
      have not been largely utilised in patients actively injecting. This is due to concerns about
      potential poor adherence to treatment regimens, reinfection due to ongoing IDU, increased
      incidence of concomitant alcohol abuse, potential for increased side effects (especially
      psychiatric), concerns about pregnancy with ribavirin use due to non-adherence to
      contraception as well as active discrimination by practitioners. There are however
      considerable potential advantages including: improvement in the health of the infected
      individual, potential for decreasing the burden of disease to the community with its
      attendant costs as well as the potential for impact on transmission and its inherent
      potential public health benefits.

      This multicentre study was conducted to determine the response rates as well as the AE
      profile and the psychiatric impact of therapy in a population with chronic hepatitis C (CHC)
      who were receiving opiate pharmacotherapy, many of who were still injecting.
    

Intervention name(s): Pegylated interferon and ribavirin; Pegylated interferon and ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Pegylated interferon 180 ug subcutaneous per week Ribavirin 1000-1200 mg /day for genotype 1 and 800 mg /day orally for genotype non 1 Duration: 48 weeks for genotype 1 and 24 weeks for gentoype non 1; Pegylated interferon 180 ug/ week subcutaneously Ribavrin 1000-1200 mg /day for genotype 1 and 800 mg/day orally for genotype 2 and 3 Treatment duration 48 weeks for genotype 1 and 24 weeks for genotypes 2 and 3
Other intervention name(s): Pegasys and Copegus; Pegasys and Copegus
Intervention MeSH terms: Interferons; Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment