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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic; HIV Infections

Treatments: Drug: Ribavirin; Drug: HIV antiretroviral therapy; Biological: Peginterferon alpha-2a (Pegasys®)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00122616

ANRSHC12 FIBROSTOP

Details and patient eligibility

About

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.

Full 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

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups, including a placebo group

Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy

Active Comparator group

Description:

Day0 to week 96:Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy

Treatment:

Drug: HIV antiretroviral therapy

Drug: Ribavirin

Biological: Peginterferon alpha-2a (Pegasys®)

Drug: HIV antiretroviral therapy

HIV antiretroviral therapy

Placebo Comparator group

Description:

Day0 to week 96: HIV antiretroviral therapy

Treatment:

Drug: HIV antiretroviral therapy

Drug: HIV antiretroviral therapy