The recent identification of the hepatitis C virus and development of assays to detect antibodies to hepatitis C virus has allowed assessment of the prevalence of hepatitis C virus infection in patients with a variety of liver and other diseases. The aim of this study was to investigate the prevalence of hepatitis C virus antibodies and severity of liver injury in patients with porphyria cutanea tarda. Sixty-two patients were studied. Serum samples were analyzed for liver function parameters and markers of hepatitis B virus infection. Frozen serum samples from 34 patients with porphyria cutanea tarda, obtained when patients were seen at the hospital for the first time, were analyzed for hepatitis C virus antibodies with enzyme-linked immunosorbent assays (first- and second-generation) and a recombinant immunoblot assay. As controls, serum samples from 19,788 blood donors, 40 patients with alcoholic liver disease and 138 hospitalized patients without liver disease were also tested for hepatitis C virus antibodies. Liver biopsy was performed in 42 porphyria cutanea tarda patients. Specimens were evaluated for steatosis, siderosis, fibrosis, severity of inflammation and the presence of cirrhosis. In addition, the degree of necroinflammatory change and fibrosis were quantitated with the histologic activity index described by Knodell et al. The prevalence of hepatitis C virus antibodies in patients with porphyria cutanea tarda (62%) was higher than that in blood donors (0.79%), patients with alcoholic liver disease (17.5%) or hospitalized patients without liver disease (5.8%).(ABSTRACT TRUNCATED AT 250 WORDS)

Summary In randomized controlled trials of patients with chronic HCV infection, elbasvir/grazoprevir (EBR/GZR) demonstrated high cure rates and a good safety profile. This study assessed the effectiveness and safety of EBR/GZR, with and without ribavirin, in a real‐world HCV patient cohort. HEPA‐C is a collaborative, monitored national registry of HCV patients directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases. Patients entered into HEPA‐C between December 2016 and May 2017, and treated with EBR/GZR with at least end‐of‐treatment response data, were included. Demographic, clinical and virologic data were analysed, and adverse events (AEs) recorded. A total of 804 patients were included in the study. The majority were male (57.9%), with a mean age of 60 (range, 19‐92) years. Genotype (GT) distribution was GT 1, 86.8% (1a, 14.3%; 1b, 72.5%); GT 4, 13.2% and 176 patients (21.9%) were cirrhotic. Overall, among 588 patients with available data, 570 (96.9%) achieved sustained virologic response at 12 weeks post‐treatment (SVR12). SVR12 rates by genotype were GT 1a, 97.7%; GT 1b, 98.6%; and GT 4, 98.1%. No significant differences in SVR12 according to fibrosis stage were observed. Eighty patients experienced an AE, resulting in treatment discontinuation in three. In this large cohort of patients with chronic HCV managed in a real‐world setting in Spain, EBR/GZR achieved high rates of SVR12, comparable to those observed in randomized controlled trials, with a similarly good safety profile.

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