Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-29 @ 1:54 AM
Study NCT ID:
NCT01120795
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2010-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pegylated Interferon and Ribavirin in Hepatitis C Patients on Opioid Pharmacotherapy
Sponsor:
Melbourne Health
Organization:
Study Overview
Official Title:
Pegylated Interferon Alfa-2a Plus Ribavirin for Patients With Chronic Hepatitis c Virus on Opioid Pharmacotherapy: Virological and Psychological Outcomes
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: