Abstract
Direct acting antiviral (DAA)-based treatment with ombitasvir/paritaprevir/ritonavir± dasabuvir (OBV/PTV/r± DSV) is highly effective in HCV genotype1 or 4 infection and well-tolerated with only few side effects. However, pruritus has been observed in several trials in up to 20% of patients and seems to be unique for this DAA combination. The aim of this preliminary study was to investigate the effect of OBV/PTV/r± DSV on bile acid levels and to correlate them to the emergence of pruritus during treatment. Twenty patients with chronic hepatitis C genotype1 or 4 were treated for 12 or 24weeks with OBV/PTV/r± DSV with or without ribavirin. Side effects including pruritus were assessed every 4weeks during treatment or on demand. Blood was collected in fasting state at baseline and at treatment week4 for determination of bile acid concentrations by high-resolution mass spectrometry. Pruritus developed in 5 out of 20patients during the first 4weeks of DAA treatment. Pruritus was self-limiting during DAA treatment in 4patients while one patient required cholestyramine treatment and responded well. Total bile acid levels increased approximately 4‑fold by treatment week4. Pruritus observed during OBV/PTV/r± DSV treatment of chronic hepatitisC is associated with increased on-treatment serum bile acid levels, possibly due to ritonavir-induced alterations of bile acid transport.
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