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Hepatic decompensation and other serious adverse events were investigated in an observational cohort study of 511 patients treated with regimens containing sofosbuvir, December 2013\u2013June 2014. Among 499 previously stable patients (no history of hepatic decompensation during the previous 12 months), a nested case\u2013control study was performed to identify predictors of decompensation\/serious adverse event. Cases and controls were matched 1:5 based on treatment regimen and duration. Matched conditional logistic regression was used for analysis. Providers scored the likelihood that events were treatment\u2010related (scale = 0\u20134). The cumulative incidence of decompensation\/events was 6.4% for the total cohort. Among 499 previously stable patients, the incidence of decompensation\/events was 4.5%; the mortality rate was 0.6%. Sixteen of the 499 experienced one or more serious complications considered to be at least potentially treatment\u2010related, and the sustained virological response rate was 7\/16 (44%). Two cases, both on sofosbuvir\/simeprevir (without interferon or ribavirin), had complications consistent with autoimmune events (score 3, \u2018likely treatment\u2010related\u2019), and one experienced a flare of autoimmune hepatitis. Compared to controls, cases had higher baseline median model for end\u2010stage liver disease scores (14 vs 8, P &lt; 0.01). Decompensation\/events was independently associated with lower baseline albumin (<jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content> = 0.12\/g\/dL, P = 0.01) and higher total bilirubin (<jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content> = 4.31\/mg\/dL, P = 0.01). Reduced hepatic function at baseline increased the risk of liver decompensation\/events.<\/jats:p>","DOI":"10.1111\/jvh.12530","type":"journal-article","created":{"date-parts":[[2016,3,19]],"date-time":"2016-03-19T02:23:43Z","timestamp":1458354223000},"page":"667-676","source":"Crossref","is-referenced-by-count":4,"title":["High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in <scp>HCV<\/scp>\u2010infected patients treated with sofosbuvir\u2010containing regimens"],"prefix":"10.1111","volume":"23","author":[{"given":"P. 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