Hepatic Decompensation Likely Attributable to Simeprevir in Patients with Advanced Cirrhosis

Digestive Diseases and Sciences

Volumn 60, Issue 4, 2015, Pages 1031-1035

  Stine, Jonathan G ^a   Intagliata, Nicolas ^a   Shah, Neeral L ^a   Argo, Curtis K ^a   Caldwell, Stephen H ^a   Lewis, James H ^b   Northup, Patrick G ^a  

^a UNIVERSITY OF VIRGINIA   (United States)

^b GEORGETOWN UNIVERSITY HOSPITAL   (United States)

Author keywords

Cholestasis; Drug induced liver injury; Hepatitis C; Liver transplantation; Protease inhibitors

Indexed keywords

FUSED HETEROCYCLIC RINGS; PROTEINASE INHIBITOR; SIMEPREVIR; SULFONAMIDE;

ADULT; CASE REPORT; COMPLICATION; DRUG-INDUCED LIVER INJURY; HEPATITIS C, CHRONIC; HUMAN; LIVER CIRRHOSIS; MALE; MIDDLE AGED;

ADULT; DRUG-INDUCED LIVER INJURY; HEPATITIS C, CHRONIC; HETEROCYCLIC COMPOUNDS, 3-RING; HUMANS; LIVER CIRRHOSIS; MALE; MIDDLE AGED; PROTEASE INHIBITORS; SULFONAMIDES;

EID: 84934281205     PISSN: 01632116     EISSN: 15732568     Source Type: Journal    
DOI: 10.1007/s10620-014-3422-x     Document Type: Article

References (29)

1. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368:1878–1887.
2. Fried MW, Buti M, Dore GJ, et al. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naive genotype 1 hepatitis C: the randomized PILLAR study. Hepatology. 2013;58:1918–1929.
3. Zeuzem S, Berg T, Gane E, et al. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroenterology. 2014;146:430.e436–441.e436.
4. Gilead. In: Sofosbuvir Drug Package Insert. http://www.olysio.com/shared/product/olysio/prescribing-information.pdf. Accessed May 29, 2014.
5. FDA. Simeprevir Hearing. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM375113.pdf; 2013. Accessed June 20, 2014.
6. Sitole M, Silva M, Spooner L, Comee MK, Malloy M. Telaprevir versus boceprevir in chronic hepatitis C: a meta-analysis of data from phase II and III trials. Clin Ther. 2013;35:190–197. doi:10.1016/j.clinthera.2012.12.017.
7. Tischer S, Fontana RJ. Drug-drug interactions with oral anti-HCV agents and idiosyncratic hepatotoxicity in the liver transplant setting. J Hepatol. 2014;60:872–884. doi:10.1016/j.jhep.2013.11.013.
8. Simeprevir prescribing information. http://www.olysio.com/shared/product/olysio/prescribing-information.pdf. Accessed June 14, 2014.
9. Lawitz E, Sulkowski MS, Ghalib R, et al. 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 randomised study. Lancet. 2014. doi:10.1016/S0140-6736(14)61036-9.
10. AASLD Practice Guidlines. Recommendations for Testing, Managing, and Treating Hepatitis C. New York: AASLD; 2014.
11. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2014;60:392–420. doi:10.1016/j.jhep.2013.11.003.
12. Stine JG, Lewis JH. Hepatotoxicity of antibiotics: a review and update for the clinician. Clin Liver Dis. 2013;17:609–642, ix.
13. Stine JG, Lewis JH. Drug-induced liver injury: a summary of recent advances. Expert Opin Drug Metab Toxicol. 2011;7:875–890.
14. Lewis JH. Drug-induced liver injury throughout the drug development life cycle: where we have been, where we are now, and where we are headed perspectives of a clinical hepatologist. Pharm Med. 2013;27:165–191.
15. Poveda E, Wyles DL, Mena A, Pedreira JD, Castro-Iglesias A, Cachay E. Update on hepatitis C virus resistance to direct-acting antiviral agents. Antiviral Res. 2014;108:181–191. doi:10.1016/j.antiviral.2014.05.015.
16. Manns M, Marcellin P, Poordad F, et al. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2014;384:414–426.
17. Schneider MD, Sarrazin C. Antiviral therapy of hepatitis C in 2014: do we need resistance testing? Antiviral Res. 2014;105:64–71.
18. Jacobson IM, Dore GJ, Foster GR, et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2014;384:403–413.
19. Forns X, Lawitz E, Zeuzem S, et al. Simeprevir with peginterferon and ribavirin leads to high rates of SVR in patients with HCV genotype 1 who relapsed after previous therapy: a phase 3 trial. Gastroenterology. 2014;146:1669.e1663–1679.e1663.
20. Lenz O, Verbinnen T, Lin TI, et al. In vitro resistance profile of the hepatitis C virus NS3/4A protease inhibitor TMC435. Antimicrob Agents Chemother. 2010;54:1878–1887.
21. Russmann S, Grattagliano I, Portincasa P, Palmieri VO, Palasciano G. Ribavirin-induced anemia: mechanisms, risk factors and related targets for future research. Curr Med Chem. 2006;13:3351–3357.
22. Lewis JH, Stine JG. Review article: prescribing medications in patients with cirrhosis—a practical guide. Aliment Pharmacol Ther. 2013;37:1132–1156.
23. Reesink HW, Fanning GC, Farha KA, et al. Rapid HCV-RNA decline with once daily TMC435: a phase I study in healthy volunteers and hepatitis C patients. Gastroenterology. 2010;138:913–921.
24. Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370:1889–1898. doi:10.1056/NEJMoa1402454.
25. Kojima H, Nies AT, Konig J, et al. Changes in the expression and localization of hepatocellular transporters and radixin in primary biliary cirrhosis. J Hepatol. 2003;39:693–702.
26. Chalasani N, Gorski JC, Patel NH, Hall SD, Galinsky RE. Hepatic and intestinal cytochrome P450 3A activity in cirrhosis: effects of transjugular intrahepatic portosystemic shunts. Hepatology. 2001;34:1103–1108.
27. Juneja M, Euliano R, Satoskar R, Lewis JH. Polypharmacy and comorbidity are associated with a lower early virologic response in hepatitis C patients treated with first generation protease inhibitor triple therapy: a preliminary analysis. Dig Dis Sci. 2013;58:3348–3358. doi:10.1007/s10620-013-2812-9.
28. Sarin SK, Kumar A, Almeida JA, et al. Acute-on-chronic liver failure: consensus recommendations of the Asian Pacific Association for the study of the liver (APASL). Hepatol Int. 2009;3:269–282.
29. Hezode C, Fontaine H, Dorival, C, et al. Effectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis. Gastroenterology. 2014;147(1):132.e4–142.e4. doi:10.1053/j.gastro.2014.03.051.