ANRS HC20 Effectiveness of an Optimized Anti HCV PegIFN-alpha2a + Ribavirin on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV

ANRS HC20 Pilot Study, Multicenter, Assessing the Effectiveness of an Optimized Anti HCV (360μg/Week Induction of PegIFN-alpha2a + 18mg/kg/j of RBV for 6 Months and Then Depending on the Virological Response to S12, Elongation up S72 to the Dual Anti HCV, With Accompanying Measures) on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00901524

Acronym

ETOC

Enrollment

Registered

2009-05-13

Start date

2009-06-01

Completion date

2012-06-01

Last updated

2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis

Keywords

HCV Genotype 1, 4, Virological response, Ribavirin, PegPegIFN- alpha 2a, Viral Hepatitis (HCV)

Brief summary

The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.

Detailed description

In patients HIV infected, the success rate do not exceed 20% in genotype 1 or 4 patients. In case of treatment failure , patients are rarely re-treated, and liver fibrosis progresses rapidly. The new molecules are not yet available for patients co-infected with HIV, and patients having already undergone a first treatment will likely be among the last to be included in trials evaluating the effectiveness of these treatments. However, recent studies show that it is possible to propose a new treatment "optimized" to these patients in the hope to obtain better success rate. Provide antiretroviral treatment, use of high doses of Peg-interferon and ribavrine, and supporting patients.

Interventions

DRUGPeg-interféron alpha 2a + ribavirin

Pilot study, multicenter, open label

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age over 18 years * Weight 85 kg below the pre-inclusion visit. * Documented HIV infection (HIV positive) * HCV infection documented by a positive PCR * HCV Genotype 1 or 4 * Compensated liver disease (Child-Pugh below/equal to 6) * Lymphocytes CD4 above 200/mm3 * Patient not answering a treatment for hepatitis C. * Patient not covered by dual by Peg-IFN + riba for at least three months (wash out)

Exclusion criteria

* Co-infection with HBV (HBsAg positive) * Neutropenia below 1000/mm3 * Thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm3. * Hemoglobin below 11 g / dL (men and women) * Arguments radiological (ultrasound, CT or MRI) of hepatocellular carcinoma cell * Antiretroviral containing didanosine (ddI) and stavudine (d4T) and zidovudine (AZT) and abacavir (ABC).

Design outcomes

Primary

Measure	Time frame
Study the proportion of patients co-infected HIV-HCV, non-responders to treatment for HCV (genotype 1 and 4), with a sustained virological response (6 months after stopping treatment (W72 or W96)) at a re-optimized treatment of hepatitis C.	W72 or W96 (depending of the end of treatment)

Secondary

Measure	Time frame
Analyze rapid virological response (W4) and early (W12).	W4 and W12

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPhilippe BONNARD, MD

Hopital Tenon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026