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Sofosbuvir Regimens in Liver Decompensation

J Viral Hepat; ePub 2016 Mar 17; Perumalswami, et al

Reduced hepatic function at baseline increased the risk of liver decompensation/events in patients with HCV treated with sofosbuvir-containing regimens. This according to a study of 499 patients with HCV and no history of hepatic decompensation during the previous 12 months. Patients were matched 1:5 with controls, based on treatment regimen and duration. Researchers found:

• Cumulative incidence of decompensation/events was 6.4% for the total cohort.

• Among the 499 previously stable patients, incidence of decompensation/events was 4.5%; mortality rate was 0.6%.

• 16 of the 499 experienced 1 or more serious complications considered to be at least potentially treatment-related.

• Sustained virological response among those 16 patients was 44%.

• 2 cases, both on sofosbuvir/simeprevir (without interferon or ribavirin), had complications consistent with autoimmune events, and 1 experienced a flare of autoimmune hepatitis.

• Cases had higher baseline median model for end-stage liver disease scores vs controls (14 vs 8).

• Decompensation/events was independently associated with lower baseline albumin and higher total bilirubin.

Citation: Perumalswami PV, Patel N, Bichoupan K, et al. High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in HCV-infected patients treated with sofosbuvir-containing regimens. [Published online ahead of print March 17, 2016]. J Viral Hepat. doi:10.1111/jvh.12530.