Response to Interferon/Ribavirin is Maintained Long-Term in Chronic HCV
Response to Interferon/Ribavirin is Maintained Long-Term in Chronic HCV
Background: There are few data in the literature regarding the long-term virological follow-up of chronic hepatitis C patients who obtain sustained virological response (SVR) to pegylated interferon (PEG-IFN) and ribavirin therapy.
Aim: To assess the durability of SVR to PEG-IFN and ribavirin therapy during long-term follow-up of chronic hepatitis C patients.
Methods: We evaluated a cohort of 231 chronic hepatitis C patients who had at least 48 weeks of follow-up after SVR to PEG-IFN and ribavirin treatment. Median duration of follow-up after SVR was 164 weeks, and exceeded 5 years in 30% of the cohort. Patients underwent consistent clinical, biochemical and virological evaluations every 6 months during follow-up.
Results: Sustained virological response was maintained in 211 patients (91%) while HCV-RNA became positive in two patients ( < 1%) within 1 year after SVR, and in 18 patients (8%) serum HCV-RNA was transiently positive in at least one follow-up evaluation. Clinical outcome was not significantly different between patients with persistently negative and transiently positive serum HCV-RNA.
Conclusions: Sustained virological response to PEG-IFN and ribavirin is maintained in 99% of patients during long-term follow-up. Late virological relapse occurred within 1 year after SVR and, from a clinical perspective, patients can be considered cured of infection after this period.
Hepatitis C virus (HCV) infection has a large prevalence worldwide. In infected patients, HCV tends to persist indefinitely and may lead to long-term sequelae such as chronic hepatitis, liver cirrhosis and hepatocellular carcinoma.
Pegylated interferon (PEG-IFN) and ribavirin association therapy is the current standard of care for patients chronically infected with HCV, and this regimen is able to determine a sustained virological response (SVR) in a proportion of patients ranging from 50% to 80%. Although from a clinical point of view patients obtaining an SVR to treatment (i.e. negative serum HCV-RNA 24 weeks after the end of treatment) are considered cured of infection, there is evidence that in a minority of patients, serum HCV-RNA may become positive after long-term follow-up. However, a majority of studies assessing the incidence of late virological relapse in patients apparently cured of HCV have been carried out in patients treated with nonpegylated formulations of IFN either with or without ribavirin have evaluated small series of patient alone and have a relatively short follow-up. Thus, little is known regarding the long-term follow-up of chronic HCV patients who have obtained an SVR to PEG-IFN and ribavirin therapy, and in particular, the eventuality of 'late' virological relapse has not been assessed in a consistent fashion.
In this study, carried out in the clinical practice, we evaluated a large cohort of chronic HCV-infected patients who were treated with PEG-IFN and ribavirin and who obtained an SVR to treatment and who had a consistent clinical and virological assessment over a long period of time. Our aim was to evaluate the durability of SVR during long-term evaluation.
Abstract and Introduction
Abstract
Background: There are few data in the literature regarding the long-term virological follow-up of chronic hepatitis C patients who obtain sustained virological response (SVR) to pegylated interferon (PEG-IFN) and ribavirin therapy.
Aim: To assess the durability of SVR to PEG-IFN and ribavirin therapy during long-term follow-up of chronic hepatitis C patients.
Methods: We evaluated a cohort of 231 chronic hepatitis C patients who had at least 48 weeks of follow-up after SVR to PEG-IFN and ribavirin treatment. Median duration of follow-up after SVR was 164 weeks, and exceeded 5 years in 30% of the cohort. Patients underwent consistent clinical, biochemical and virological evaluations every 6 months during follow-up.
Results: Sustained virological response was maintained in 211 patients (91%) while HCV-RNA became positive in two patients ( < 1%) within 1 year after SVR, and in 18 patients (8%) serum HCV-RNA was transiently positive in at least one follow-up evaluation. Clinical outcome was not significantly different between patients with persistently negative and transiently positive serum HCV-RNA.
Conclusions: Sustained virological response to PEG-IFN and ribavirin is maintained in 99% of patients during long-term follow-up. Late virological relapse occurred within 1 year after SVR and, from a clinical perspective, patients can be considered cured of infection after this period.
Introduction
Hepatitis C virus (HCV) infection has a large prevalence worldwide. In infected patients, HCV tends to persist indefinitely and may lead to long-term sequelae such as chronic hepatitis, liver cirrhosis and hepatocellular carcinoma.
Pegylated interferon (PEG-IFN) and ribavirin association therapy is the current standard of care for patients chronically infected with HCV, and this regimen is able to determine a sustained virological response (SVR) in a proportion of patients ranging from 50% to 80%. Although from a clinical point of view patients obtaining an SVR to treatment (i.e. negative serum HCV-RNA 24 weeks after the end of treatment) are considered cured of infection, there is evidence that in a minority of patients, serum HCV-RNA may become positive after long-term follow-up. However, a majority of studies assessing the incidence of late virological relapse in patients apparently cured of HCV have been carried out in patients treated with nonpegylated formulations of IFN either with or without ribavirin have evaluated small series of patient alone and have a relatively short follow-up. Thus, little is known regarding the long-term follow-up of chronic HCV patients who have obtained an SVR to PEG-IFN and ribavirin therapy, and in particular, the eventuality of 'late' virological relapse has not been assessed in a consistent fashion.
In this study, carried out in the clinical practice, we evaluated a large cohort of chronic HCV-infected patients who were treated with PEG-IFN and ribavirin and who obtained an SVR to treatment and who had a consistent clinical and virological assessment over a long period of time. Our aim was to evaluate the durability of SVR during long-term evaluation.