Simeprevir with PegIFN/ribavirin for chronic HCV infection shortens time with patient-reported symptoms and impairment in QoL: ATTAIN study results

was 54 years (range, 32–73; n = 56), 44/56 were male, 50/53 white, and 23/29 IL28B non-CC. Most were infected with HCV GT1 (24 1a; 21 1b), with 1 GT2, 7 GT3, and 2 GT4; 12/51 had HIV coinfection, of whom 3 had HIV/HBV coinfection; 4/51 were liver transplant recipients. 31 and 16 of 47 patients were classified as ChildPugh A and B, respectively; of the few (22) with METAVIR scores, 18 had F4. Of 40 patients with prior treatment data, 10 had failed with boceprevir or telaprevir regimens, 8/10 due to lack of efficacy. Of 49 patients with complete study drug data, 48 received DCV+SOF with RBV and 1 received DCV+SOF without RBV. At baseline, HCV RNA levels were high (>800,000 IU/mL) in 10 of 33 patients with available data. Among 11 patients with data at Week 4, HCV RNA was undetectable in 7 and ≤25 IU/mL in another 3; 4 of these 10 patients had previously failed with telaprevir or boceprevir regimens. Adverse events (AEs) were reported in 13 patients; 4 had AEs considered drug-related (opiate withdrawal symptoms, soft tissue infection, vertigo, nausea); none of these drug-related AEs, for which data were available, was serious or led to discontinuation. One patient died due to liver disease progression. Additional data (including updated safety data) for these patients and others will be available for presentation. CONCLUSION: In this preliminary analysis, DCV+SOF RBV demonstrated antiviral activity at Week 4 and was well tolerated in difficult-to-treat patients with severe liver disease and significant risk of hepatic decompensation or death.