Interferon sensitivity and cost-effectiveness in naïve chronic Hepatitis C patients in the era of interferon-free therapies

Background: Pegylated interferon (PEG-IFN) and ribavirin (RBV) therapy results about 40% sustained virological response (SVR) rate in naïve chronic hepatitis C genotype 1 (CHC G1) subjects with numerous side-effects. Assessment of failed SVR based on interferon sensitivity may be a cost-effective method in the era of interferon-free therapies. Aim: To determine the rate of missing SVR and the costs of unnecessary PEG-IFN and RBV therapy in naïve CHC G1 patients who achieved early virological response (EVR: > 2 log decline in baseline viral load on week 12). Patients and methods: We analyzed data of 191 naïve CHC patients (85 males, 106 females), who received PEG-IFN and RBV from 2003 to 2013. Baseline parameters like age, sex, viral load, ALT, gamma-GT and cholesterol were recorded. Treatment duration was 48 weeks in whom EVR was detected; twenty-six patients without EVR were excluded from the analysis. We investigated the missing SVR rate of complete (viral load not detectable) and partial (> 2 log decline of baseline RNA) EVR patients and their therapeutical cost. EVR and SVR RNA assays were performed by PCR (polymerase chain reaction) methods. The amount of 48 weeks PEG-IFN/RBV therapy was about 20.400 USD. Results: The overall SVR rate of EVR patients was 44% (73/165). The failed SVR rate was 26% (24/91) in cEVR and 92% (68/74) in pEVR persons. Using similar data to assess the interferon sensitivity percentage of 100 naïve patients, about 50 subjects will fail SVR. Unsuccessful use of PEG-IFN/RBV drugs for 48 weeks results minimally 1.020.000 USD cost in these patients. Conclusions: About half of naïve CHC G1 patients cannot achieve SVR, but has enough interferon sensitivity to access EVR. Highly sensitive negative prediction of failed treatment success is necessary before the administration of interferon-based therapy and suggest the use of interferon-free therapeutic regimes in these patients. The unsuccessful use of PEG-IFN/RBV therapy requires large financial sources. At the same time, the cheaper PEG-IFN/RBV combination may also suitable for interferon sensitive, responder patients.