Published online Aug 8, 2016. doi: 10.4254/wjh.v8.i22.949
Peer-review started: February 24, 2016
First decision: April 15, 2016
Revised: June 23, 2016
Accepted: July 20, 2016
Article in press: July 22, 2016
Published online: August 8, 2016
AIM: To check the safety and efficacy of boceprevir/telaprevir with peginterferon/ribavirin for hepatitis C virus (HCV) genotype 1 in the real-world settings.
METHODS: This study was a non-randomized, observational, prospective, multicenter. This study involved 47 centers in Italy. A database was prepared for the homogenous collection of the data, was used by all of the centers for data collection, and was updated continuously. All of the patients enrolled in this study were older than 18 years of age and were diagnosed with chronic infection due to HCV genotype 1. The HCV RNA testing was performed using COBAS-TaqMan2.0 (Roche, LLQ 25 IU/mL).
RESULTS: All consecutively treated patients were included. Forty-seven centers enrolled 834 patients as follows: Male 64%; median age 57 (range 18-78), of whom 18.3% were over 65; mean body mass index 25.6 (range 16-39); genotype 1b (79.4%); diagnosis of cirrhosis (38.2%); and fibrosis F3/4 (71.2%). The following drugs were used: Telaprevir (66.2%) and PEG-IFN-alpha2a (67.6%). Patients were naïve (24.4%), relapsers (30.5%), partial responders (14.8%) and null responders (30.3%). Overall, adverse events (AEs) occurred in 617 patients (73.9%) during the treatment. Anemia was the most frequent AE (52.9% of cases), especially in cirrhotic. The therapy was stopped for 14.6% of the patients because of adverse events or virological failure (15%). Sustained virological response was achieved in 62.7% of the cases, but was 43.8% in cirrhotic patients over 65 years of age.
CONCLUSION: In everyday practice, triple therapy is safe but has moderate efficacy, especially for patients over 65 years of age, with advanced fibrosis, non-responders to peginterferon + ribavirin.
Core tip: This study describes the role of antiviral therapy for chronic hepatitis C virus infections in everyday practice. Boceprevir or telaprevir, in combination with pegylated interferon and ribavirin, were used in this multicenter study organized by the Italian Association of Hospital Hepatologists (CLEO). A total of 834 patients were enrolled with this first available combination of direct-acting antiviral drugs. The data on the efficacies were quite similar to those produced by the registration studies; however, in the real world experience, patients were older and had more advanced liver disease. In this category of patients, the sustained virological response was less than 50%.