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

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

Evaluation of sustained virological response defined as the proportion of patients with undetectable hepatitis C virus RNA 24 weeks after discontinuation of therapy and/or after liver transplantation in patients with genotype 1, 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

Eligibility 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