Efficacy of PegInterferon-Ribavirin-Boceprevir Therapy in Patients Infected With G1 HCV With Cirrhosis, Awaiting Liver Transplantation

• Status: Completed
• Trial end date: 2015-01-22
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of efficacy of triple therapy with pegylated interferon, ribavirin, and boceprevir in patients with genotype 1 chronic hepatitis C, who are treatment-naive, have relapsed, or are non-responders with cirrhosis and awaiting liver transplantation, with a MELD score less than or equal to 18

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Interferons; Ribavirin

Criteria

Inclusion Criteria:

• Adult 18 years and older

• Chronic infection with hepatitis C virus proven with positive PCR for more than 6 months

• Viral genotype 1

• Cirrhosis while awaiting liver transplantation

• MELD score < or equal to 18

• With or without hepatocellular carcinoma

• Naive to antiviral C treatment

• Failure on a previous treatment. Failure is defined as the persistence of detectable HCV RNA. The previous HCV failure treatment profile must be able to be documented according to the following terminology:- Relapsing patient: HCV RNA undetectable at the end of treatment, becoming detectable again after the discontinuation of treatment- Breakthrough: increase of viremia of 1 log or more during the treatment - Non-responding patient with partial response: HCV RNA detectable at W24 without ever having been undetectable and with a decrease in HCV RNA ≥ 2 log at W12 - Non-responding patient with nul response: decrease in HCV RNA < 2 log at W12

• No need for prior treatment wash-out

• Negative pregnancy test in women of child-bearing age

• Double method of contraception in men and women of child-bearing age during the entire duration of treatment and the 6 months following its discontinuation

• Free, informed, and written consent (signed on the day of pre-enrollment at the latest and before all exams required by the study)

• Person enrolled in or a beneficiary of a social security/Universal Health Insurance Coverage

• Inclusion approved by the Decision Support Committee

Exclusion Criteria:

• Previous HCV treatment with boceprevir or telaprevir

• Alcohol consumption > 40 g/day

• Toxicomania constituting a barrier for starting therapy according to the opinion of the investigator. Patients included in a methadone or buprenorphine replacement program may be enrolled

• MELD > 18

• Non controlled sepsis

• Platelets < 50,000/mm3

• Neutrophil granulocyte levels < 1000/mm3

• Creatinine clearance < 50 mL/min (MDRD)

• Hb < 10 g/dL

• Uncontrolled psychiatric problems

• Contraindications to boceprevir

• Contraindication to interferon or ribavirin

• Subject with major complications of cirrhosis

• HIV coinfection

• HBV coinfection (unless this is treated effectively with analogues, as proven by undetectable viremia for at least 12 months)

• Other infectious disease underway

• Neoplastic disease other than hepatocellular carcinoma during the previous year, or neoplastic disease for which the prognosis is less than 3 years

• Treatment with immunosuppressors (including corticosteroids), antivirals other than those for the study, except aciclovir

• Consumption of St. John's wort

• Associated treatments including a molecule or substance that could interfere with the pharmacokinetic characteristics of boceprevir

• History of a lactose allergy

• Person participating in another study including an exclusion period that is still underway during pre-enrollment

• So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)

• Pregnancy, breast-feeding