A 75-year-old male with compensated Child–Pugh B cirrhosis initiated sofosbuvir plus simeprevir, and developed hepatic decompensation and died a few days thereafter. High exposure to simeprevir leading to hepatotoxicity most likely explained this fatal outcome. This observation, along with similar cases recently reported in the literature, should raise awareness of the potential for decompensation in patients with advanced cirrhosis treated with simeprevir.
References
1.
LawitzE., SulkowskiM., GhalibR.Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomized study.Lancet2014; 384: 1756–1765.
2.
SulkowskiM.S., GardinerD., Rodriguez-TorresM.Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.N Engl J Med2014; 370: 211–221.
3.
JensenD., O'LearyJ., PockrosP.Safety and efficacy of sofosbuvir-containing regimens for hepatitis C: real-world experience in a diverse, longitudinal observational cohort.65th Annual Meeting of the American Association for the Study of Liver Diseases, 7–11 November 2014. Boston, MA, USA. Abstract 45.
4.
DieterichD., BaconB., FlammS.Evaluation of sofosbuvir and simeprevir-based regimens in the TRIO network: academic and community treatment of a real-world heterogeneous population.65th Annual Meeting of the American Association for the Study of Liver Diseases, 7–11 November 2014. Boston, MA, USA. Abstract 46.
5.
HézodeC., FontaineH., DorivalC.Effectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis.Gastroenterology2014; 147: 132–142.
6.
FujiiY., UchidaY., MochidaS.Drug-induced immunoallergic hepatitis during combination therapy with daclatasvir and asunaprevir.Hepatology2015; 61: 400–401.
7.
StineJ.G., IntagliataN., ShahN.Hepatic decompensation likely attributable to simeprevir in patients with advanced cirrhosis.Dig Dis Sci2015; 60: 1031–1035.
8.
de KanterC.T., DrenthJ., ArendsJ.Viral hepatitis C therapy: pharmacokinetic and pharmacodynamics considerations.Clin Pharmacokinet2014; 53: 409–427.
9.
ModiA., NazarioH., GonzalezS.Safety and efficacy of simeprevir plus sofosbuvir with or without ribavirin in patients with decompensated genotype 1 hepatitis C induced cirrhosis.65th Annual Meeting of the American Association for the Study of Liver Diseases, 7–11 November 2014. Boston, MA, USA. Abstract 956.
10.
SaxenaV., TerraultN.Hepatitis C direct antiviral drugs and hepatic decompensation in patients with advanced cirrhosis: culprit or innocent bystander?Dig Dis Sci2015; 60: 806–809.
11.
AASLD/IDSA.HCV guidance: recommendations for testing, managing, and treating hepatitis C. (Accessed 25 August 2015.) Available from www.hcvguidelines.org.