Pilot Study on the Efficacy of Pegylated Interferon-Ribavirin-Boceprevir Triple Therapy in Patients Infected With Genotype 1 HCV With Cirrhosis and Awaiting Liver Transplantation (ANRS HC 29 BOCEPRETRANSPLANT)

简要总结

详细描述

主要结局

次要结局

• Resistant mutations in plasma and liver samples (both explanted liver and graft)(Week 16 up to week 96)
• Survival after transplantation(Week 16 up to week 96)
• SVR prognosis factors(Week-4 up week 144)
• The mean time elapsed between registration on the transplantation list and the date of transplantation(Week16 up to week 96)
• Area Under the Plasma Concentration Time Curve (AUC) From 0-8h of Boceprevir(At week 16 and at week 24 and if the MELD score has changed by more than three points)
• Minimum Plasma Concentration (Cmin) of Boceprevir(At week 16 and at week 24 and if the MELD score has changed by more than three points)
• Compliance rate.(week 12, week 24, week 36, week 48, week 72 - after Liver transplant:Day 0)
• The percentage of virologic failure(week 4 and week 48)
• Sepsis according to Systemic Inflammatory Response System (SIRS) Criteria(From day 0 to week 72)
• Cirrhosis impairment(From day 0 to week 72)
• Measurement of the residual plasma concentration (Cres) of ribavirin(at Week 4 and Week 8)
• The predictive value of on-treatment HCV RNA on SVR(During weeks 1, 4, 5, 6, 7, 8, 12, 16, 20, and 24 (before transplantation))
• Survival rate within one year after liver transplantation(week 64 up to week 144)
• Maximum Plasma Concentration (Cmax) of Boceprevir(At week 16 and at week 24 and if the MELD score has changed by more than three points)
• Time of Maximum Plasma Concentration (Tmax) of Boceprevir(At week 16 and at week 24 and if the MELD score has changed by more than three points)
• Number of participants with adverse events as a measure of safety and tolerability(From week 0 to week 144)
• Perceived symptoms(at day 0, week 24, week 48 and every 24 week up liver transplant - post liver transplant: day 0, week 24 and week 48)
• The percentage of relapse after transplantation(Between week 16 and week 144)
• Boceprevir resistant mutations(From week 5 to week 48 or after week 48)
• Virological Response in participants with and without Insulin Resistance(At week 4, 8, 16, 28 and 48 during therapy)
• Relationship between the presence of a polymorphism to the ITPA gene and the onset of hemolytic anemia(After week 144)
• Correlation study between the presence of an elevated level of IP-10 during triple therapy and the absence of sustained virologic response(From week 4 to week 48)
• Insulin Resistance (HOMA-IR)(At baseline, week 48 and at the last follow-up visit)
• Relationship between the presence of a polymorphism in the IL28B gene (donor and recipient) and SVR(After week 144)
• Histological severity of HCV recurrence after liver transplantation(At week 20 up to week 100, at week 40 up to week 120, at week 64 up to week 144)