OBJECTIVES: Chronic infection with Hepatitis C virus is causing advanced liver disease in a large proportion of patients. Standard treatment is antiviral therapy with the goal of a sustained virological response (SVR). The objective of the study is to validate SVR in the chronic infection Hepatitis C as patient relevant endpoint as defined by German code of social law. METHODS: Systematic literature searches were conducted in order to find relevant methods for the validation of surrogate endpoints in general and to find studies with appropriate data to perform the validation of SVR as a surrogate parameter in Hepatitis C. The validation will be realised with the best method according to the data available from the selected studies. RESULTS: Five studies were identified as basis for validation (out of 694 papers retrieved and 36 studies selected for further analysis). Due to the lack of long-term studies fulfilling the defined inclusion criteria, no differentiation between antiviral treatment schemes and different stages of the disease were possible. Methods of Prentice were identified as applicable for validation. With the four Prentice criteria, SVR could be validated as a surrogate endpoint for the endpoints liver cancer and mortality. However, this was not possible with data from all five studies and only partly with different analysis methods (combination) of data. For regression models or meta-analysis, data is not sufficient since individual patient data was not available. For one study further analysis (proportion of treatment effect) could be performed. CONCLUSIONS: When focussing on statistical methods current data allows for a very limited validation of SVR as a patient-relevant endpoint for treatment of Hepatitis C, only. There is a lack of long-term data (going beyond 5 years of follow up), especially for individual data of treated and untreated patients, likely due to the slow-evolving character of Hepatitis C.