Abstract
Evidence based clinical guidelines are implemented to treat patients efficiently that include efficacy, tolerability but also health economic considerations. This is of particular relevance to the new direct acting antiviral agents that have revolutionized treatment of chronic hepatitis C. For hepatitis C genotypes 2/3 interferon free treatment is already available with sofosbuvir plus ribavirin. However, treatment with sofosbuvir-based regimens is 10–20 times more expensive compared to pegylated interferon alfa and ribavirin (PegIFN/RBV). It has to be discussed if PegIFN/RBV is still an option for easy to treat patients. We assessed the treatment of patients with chronic hepatitis C genotypes 2/3 with PegIFN/RBV in a real world setting according to the latest German guidelines. Overall, 1006 patients were recruited into a prospective patient registry with 959 having started treatment. The intention-to-treat analysis showed poor SVR (GT2 61%, GT3 47%) while patients with adherence had excellent SVR in the per protocol analysis (GT2 96%, GT3 90%). According to guidelines, 283 patients were candidates for shorter treatment duration, namely a treatment of 16 weeks (baseline HCV-RNA <800.000 IU/mL, no cirrhosis and RVR). However, 65% of these easy to treat patients have been treated longer than recommended that resulted in higher costs but not higher SVR rates. In conclusion, treatment with PegIFN/RBV in a real world setting can be highly effective yet similar effective than PegIFN± sofosbuvir/RBV in well-selected naïve G2/3 patients. Full adherence to guidelines could be further improved, because it would be important in the new era with DAA, especially to safe resources.
Highlights
More than 150 million people world-wide and 8–11 million people in Europe are chronically infected with the hepatitis C virus (HCV) [1,2]
The CobasTaqMan assay with a lower limit of quantification (LoQ) of 15 IU/mL was used in 57%, the Abbott RealTime assay in 8% with a LoQ of 12 IU/mL and the Roche Amplicor assay with LoQ of 50 IU/mL in 5%
Since the approval of sofosbuvir (SOF), interferon free treatment is already available for genotypes 2 and 3 patients and suggested as standard of care by the new AASLD [17] and EASL guidelines [18]
Summary
More than 150 million people world-wide and 8–11 million people in Europe are chronically infected with the hepatitis C virus (HCV) [1,2]. The first generation protease inhibitors boceprevir and telaprevir were only approved for genotype 1 and combination with PegIFN and RBV was still necessary because monotherapy resulted in rapid emergence of drug resistance [5]. Combinations of different DAA from different classes will allow very potent treatments even without PegIFN [6]. SOF is a new NS5B polymerase inhibitor with pangenotypic efficacy and extensive data were acquired in the treatment of GT2- and GT3-infected patients, which were the basis for the approval for the first interferon-free treatment of hepatitis C [7,8,9]. Treatment with PegIFN/RBV dual therapy may be still considered depending on the health care system, especially for easy-to-treat GT2/3 patients. Treatment with SOF/RBV therapy for 12 to 24 weeks or SOF in combination PegIFN and RBV in HCV genotype 2 or 3 can be 10–20 times more expensive compared to PegIFN and RBV treatment [10]
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