Pegylated Interferon and Ribavirin in Hepatitis C Patients on Opioid Pharmacotherapy
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|ClinicalTrials.gov Identifier: NCT01120795|
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : May 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Pegylated interferon and ribavirin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pegylated Interferon Alfa-2a Plus Ribavirin for Patients With Chronic Hepatitis c Virus on Opioid Pharmacotherapy: Virological and Psychological Outcomes|
|Study Start Date :||February 2004|
|Primary Completion Date :||January 2006|
|Study Completion Date :||July 2006|
Experimental: pegylated interferon and ribavirin
Anti hepatitis C agents
Drug: Pegylated interferon and ribavirin
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
Other Name: Pegasys and CopegusDrug: Pegylated interferon and ribavirin
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 Name: Pegasys and Copegus
- Sustained virological response [ Time Frame: 24 weeks post cessation of HCV therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120795
|Australia, New South Wales|
|Sydney, New South Wales, Australia|
|St Vincents Hospital|
|Sydney, New South Wales, Australia|
|Footscray, Victoria, Australia, 3011|
|Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|
|Principal Investigator:||Joseph J Sasadeusz, MBBS||Melbourne Health|