| Background:There are10 million people with HCV in China, which is the majority of HCV patients worldwide. In China, HCV was identified as an important role in the development of liver cancer. Peginterferon plus ribavirin therapy (P-R therapy) is the routine treatment for patients with chronic hepatitis C. However, side events including the low platelet count and liver function depreesion limit the use of sufficient dose and duration in P-R therapy for patients with HCV related cirrhosis.Aim:To assess the safety, efficacy and influencing factors of P-R therapy in Chinese patients with HCV related cirrhosis, we conducted this clinical study.Methods:Sustained virological response (SVR) is considered as end point in treatment and the efficacy and cost of optimizing protocol of antiviral therapy including boceprevir (BOC) and sofosbuvir (SOF) were assessed. In our retrospective study,122 patients with HCV related cirrhosis were enrolled. In prospective study,62 cirrhotic patients were enrolled in P-R therapy and 63 cirrhotic patients with thrombocytopenia were enrolled in splenectomy, thrombopoietin or entrobapag group.34 cirrhotic genotype lb P-R-therapy experienced patients were enrolled in BOC therapy. In totally,62 patients were treated with P-R therapy in prospective study and the main characteristics of baseline, effecicy and safety were observed. From 2009 to 2013,38 cases whose platelet count was lower than 60×109/L were enrolled in splenectomy or thrombopoietin group. The study included two stages:4-week initial treatment and 48-week antiviral treatment. During which time, platelet count, liver stiffness mesurement (LSM), ALB, Tbil, ALT, and cost-effectiveness were all detected and analyzed. From 2013 to 2014,25 patients whose platelet count was lower than 75×109/L were enrolled in eltrombopag group. During the initiation phase, patients received eltrombopag for up to 8 weeks until platelet count increased to the threshold. Antiviral therapy will last 12 weeks. A follow-up visit was scheduled for 12 weeks after the last treatment with antiviral therapy. Hematologic, biochemical, HCVRNA load and other safety assessments were performed weekly. P-R-therapy experienced 34 patients were retreated with BOC plus P-R and efficacy were evaluated. For these patients who cann’t attain SVR would be retreated with SOF plus DCV (daclatasvir).Results:SVR rate is 29% in cirrhotic patients, which is obvious lower than 44.1% in no-cirrhotic patients (P<0.05). In splenectomy group 18 of 21 cases completed 48-week P-R treatment. In thrombopoietin group,9 of 17 patients group completed P-R therapy. In eltrombopag group, only 34% patients achieved the required platelet threshold. Despite being kept on eltrombopag, only four patients did not need dose reduction or withdrawal of pegylated interferon. SVR 12 was achieved in only 1 (4%) patient. No serious or fatal adverse events happened. In the cost-effective analysis, total cost is about 8 billion yuan, but only 1 patient achieved SVR. From 2013 to 2014,34 treatment-experienced cirrhotic Chinese patients were enrolled in BOC plus P-R therapy, and 18 (52.9%) patients had SVR24. All of them were relapsers. Factors associated with SVR included HB, HCVRNA level, IL 28 variation and ALT (P=0.021,0.026,0.028,0.041). Four treatment failure patients were subsequently treated with SOF plus DCV for twelve weeks and all achieved SVR12.Conclusion:For Chinese patients with HCV related decompensated cirrhosis, if not combined with thrombocytopenia, P-R therapy was well tolerated. However, for these patients with thrombocytopenia, P-R therapy was hardly tolerated and splenectomy is better than thrombopoietin and eltrombopag. SVR rate in treatment-experienced CHC GT1b is 52.4% with BOC plus P-R therapy, but SOF-DCV therapy seems to be better. |
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