Recommendations: For treatment-experienced patients: 10. Re-treatment with boceprevir or telaprevir, together with peginterferon alfa and weight-based ribavirin, can be recommended for patients who had virological relapse or were partial responders after a

prior course of treatment with standard interferon alfa or peginterferon alfa and/or ribavirin (Class 1, Level A). Adverse events occurred more frequently in patients treated with PIs than in those treated with PegIFN and RBV therapy alone. In the BOC trials, anemia and dysgeusia were the most common adverse events, whereas in the TVR trials, rash, anemia, pruritus, nausea, and diarrhea developed more commonly among those who received TVR than who received SOC therapy.12, 16 In the phase 3 TVR trials, a rash of any severity was noted in 56% of patients who received a TVR-based regimen compared to 32% of those who received a PegIFN Selleck LY294002 and RBV regimen.16

The rash was typically eczematous and maculopapular in character, consistent with a drug-induced eruption. In most patients, the rash was mild to moderate in severity but was severe (involving >50% of the body surface area) in 4% of cases. The development of rash necessitated discontinuation of TVR in 6% and of the entire regimen in 1% of the cases. The Stevens Johnson Syndrome or Drug-Related Eruption with Systemic Symptoms (DRESS) occurred in <1% of subjects but at a higher frequency than generally observed for other drugs. The response of the rash to local or systemic treatment with corticosteroids Obeticholic Acid and oral antihistamines is uncertain. Pruritus, commonly but not always associated with rash, was noted in ∼50% of patients who received TVR therapy.16 Anemia developed among recipients of both PIs. Hemoglobin decreases below 10 g/dL (grade 2 toxicity) occurred in 49% of patients Adenosine who received a BOC regimen compared to 29% of those who received the SOC regimen, whereas 9% had a hemoglobin decline of <8.5 g/dL (grade 3 toxicity).12 Among patients treated with T12PR, hemoglobin levels of <10 g/dL were observed

in 36% of patients compared to in 14% of patients who received SOC, and 9% had hemoglobin decreases to <8.5 g/dL.16 Because hematopoietic growth factors were not permitted during the TVR trials, there was a 5%-6% higher rate of treatment discontinuation among those who developed anemia than among those who did not. However, neither anemia nor RBV dose reduction adversely affected the SVR rate. Of note is that in the BOC trial, SVR rates in patients managed by RBV dose reduction alone were comparable to those in patients managed with erythropoietin therapy.23 Similarly, in the TVR trials, dose reduction of RBV had no effect on SVR rates, and therefore dose reduction should be the initial response to management of anemia.