Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C

Phase 3

Completed

• Conditions: HIV Infections; Hepatitis C, Chronic
• Interventions: Biological: Peginterferon alpha-2a (Pegasys®); Drug: Ribavirin; Drug: HIV antiretroviral therapy

• Registration Number: NCT00122616
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief Summary

The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with liver disease caused by hepatitis C virus (HCV) when the treatment to eradicate the virus failed. This scientific proof needs a comparative study to be done including two groups of patients randomly allocated: one with the treatment (peginterferon) and the other without any treatment against HCV with a duration of 2 years. To conclude, two liver biopsies are needed; one before the study and a second 2 years after.

Detailed Description

C hepatitis in HIV infected patient becomes a major issue although the survival of patients, has improved in the last decades regarding to the advent of HAART, the mortality related to liver disease has increased in this population. Sustained virological response for HCV can be obtained with peg-interferon and ribavirin treatment but more or less 50% of patients experienced failure to this treatment and liver fibrosis due to HCV infection progress and may lead to cirrhosis and hepato-carcinoma. To demonstrate the efficacy of peginterferon therapy to reduce the liver damage causes by HCV infection, a randomised controlled study is needed comparing one group of patient treated by peginterferon and one group without any treatment against HCV infection. In order to show 30% difference between the two groups in reducing one point of fibrosis score (METAVIR scale), 150 patients are needed. The duration of the study is 96 weeks

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-07-19
• Study First Submitted QC: 2005-07-19
• Study First Posted: 2005-07-22
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• HIV infection (Western Blot +)
• C hepatitis (RNA viral hepatitis C [VHC] +)
• Chronic active C hepatitis on liver histological score METAVIR (A over or equal to 1 and F over or equal to 2) on biopsy performed at least 18 months before the expected date of inclusion
• Previous treatment for C hepatitis for at least 3 months including peg-interferon and ribavirin or peg-interferon alone if counterindication for ribavirin occurred
• Failure to eradicate C hepatitis virus after well conducted treatment
• The liver biopsy should have been realised at least 18 months before inclusion :

Either before treatment for C hepatitis in patients treated at most 7 months Or at least 6 months after anti HCV treatment in patient treated for more than 7 months (wash out period)

• Regular follow up in an outpatient clinic for HIV
• Unchanged antiretroviral treatment the last 3 months before inclusion
• Inform consent

Exclusion Criteria

• History of transplantation or clinical hepatic failure
• Opportunistic infection in the past three months before inclusion
• Any hepatic disease not related to HCV (B hepatitis, hemochromatosis, Wilson disease)
• Diabetes mellitus
• Immunocompromised treatment
• Active intravenous drug addiction
• Alcohol consumption of more than 50 g per day
• Counterindication for the use of interferon

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy	Peginterferon alpha-2a (Pegasys®)	Day0 to week 96:Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy
Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy	HIV antiretroviral therapy	Day0 to week 96:Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy
HIV antiretroviral therapy	HIV antiretroviral therapy	Day0 to week 96: HIV antiretroviral therapy
Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy	Ribavirin	Day0 to week 96:Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy

Primary Outcome Measures

Name	Time	Method
Percentage of patients who experienced one point decreases of their fibrosis histological score (Metavir).	Week 96

Secondary Outcome Measures

Name	Time	Method
Distribution of the change of fibrosis Metavir score in each group	Week 96
Distribution of fibrosis score from Chevallier classification	Week 96
Plasmatic fibrosis markers dosages	Week 96
Viral load quantification for HIV and HCV	Week 96
Number and percentage of CD4/CD8 cell count throughout the study	Day 0 to week 96
Number and percentage of patient had more thand 200 copies/ml throughout the study	Day 0 to week 96
Occurrence of hepatic complication related to HCV	Day0 to week 96
Survival throughout the study	Day 0 to week 96
Quality of life questionnaire	Day 0 to week 96
Fibrotest (plasmatic fibrosis marker)	Day 0, week 48 and week 96
Histological improvement according to the total interferon dose received	Day 0 to week 96

Trial Locations

Locations (1)

Service de Maladies Infectieuses et de Réanimation Médicale; 🇫🇷 Rennes, France