Simeprevir and Sofosbuvir (SMV-SOF) for 12 weeks for the treatment of chronic Hepatitis C Genotype 1 infection: A real world (Transplant) hepatology practice experience

American Journal of Gastroenterology

Volumn 111, Issue 2, 2016, Pages 250-260

  Pillai, Anjana A ^a   Wedd, Joel ^a   Norvell, J P ^a   Parekh, Samir ^a   Cheng, Nicole ^a   Young, Nikita ^a   Spivey, James R ^a   Ford, Ryan ^a  

^a EMORY UNIVERSITY HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BILIRUBIN; CREATININE; CYCLOSPORIN; EVEROLIMUS; MYCOPHENOLATE MOFETIL; RAPAMYCIN; RIBAVIRIN; SIMEPREVIR; SOFOSBUVIR; TACROLIMUS; ANTIVIRUS AGENT; IMMUNOSUPPRESSIVE AGENT; VIRUS RNA;

ADULT; AFRICAN AMERICAN; AGE; ANTIVIRAL THERAPY; ARTICLE; ASCITES; BILIRUBIN BLOOD LEVEL; BLACK PERSON; BODY MASS; CAUCASIAN; CHRONIC HEPATITIS C; CLINICAL PROTOCOL; COHORT ANALYSIS; COMBINATION CHEMOTHERAPY; CREATININE BLOOD LEVEL; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GENDER; GENOTYPE; GRAFT RECIPIENT; HEPATIC ENCEPHALOPATHY; HEPATITIS C VIRUS; HUMAN; INTENTION TO TREAT ANALYSIS; INTERNATIONAL NORMALIZED RATIO; LIVER CELL CARCINOMA; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RACE; RETROSPECTIVE STUDY; SUSTAINED VIROLOGIC RESPONSE; TREATMENT OUTCOME; TREATMENT RESPONSE; VIRUS LOAD; BLOOD; CARCINOMA, HEPATOCELLULAR; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPLICATION; GASTROENTEROLOGY; GENETICS; GRAFT VS HOST DISEASE; HEPACIVIRUS; HEPATITIS C, CHRONIC; LIVER NEOPLASMS; LIVER TRANSPLANTATION; MIDDLE AGED; STATISTICAL MODEL;

ANTIVIRAL AGENTS; CARCINOMA, HEPATOCELLULAR; COHORT STUDIES; DRUG THERAPY, COMBINATION; FEMALE; GASTROENTEROLOGY; GENOTYPE; GRAFT VS HOST DISEASE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LIVER CIRRHOSIS; LIVER NEOPLASMS; LIVER TRANSPLANTATION; LOGISTIC MODELS; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; RIBAVIRIN; RNA, VIRAL; SIMEPREVIR; SOFOSBUVIR; TREATMENT OUTCOME; VIRAL LOAD;

EID: 84961754971     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1038/ajg.2015.422     Document Type: Article

References (25)

1. Chak E, Talal AH, Sherman KE, et al. Hepatitis C virus infection in USA: an estimate of true prevalence. Liver Int 2011; 31: 1090-101
2. Armstrong GL, Wasley A, Simard EP, et al. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med 2006; 144: 705-14
3. Holmberg SD, Spradling PR, Moorman AC, et al. Hepatitis C in the United States. N Engl J Med 2013; 368: 1859-61
4. Davis GL, Alter MJ, El-Serag H, et al. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Gastroenterology 2010; 138: 513-21
5. Berenguer M, Prieto M, Rayon JM, et al. Natural history of clinically compensated hepatitis C virus-related graft cirrhosis aft er liver transplantation. Hepatology 2000; 32: 852-8
6. Wright TL, Donegan E, Hsu HH, et al. Recurrent and acquired hepatitis C viral infection in liver transplant recipients. Gastroenterology 1992; 103: 317-22
7. Kim WR, Smith JM, Skeans MA, et al. OPTN/SRTR 2012 Annual Data Report: liver. Am J Transplant 2014; 14 Suppl 1: 69-96
8. Gane EJ, Agarwal K. Directly acting antivirals (DAAs) for the treatment of chronic hepatitis C virus infection in liver transplant patients: a fl ood of opportunity. Am J Transplant 2014; 14: 994-1002
9. Berenguer M, Palau A, Aguilera V, et al. Clinical benefi ts of antiviral therapy in patients with recurrent hepatitis C following liver transplantation. Am J Transplant 2008; 8: 679-87
10. Gordon FD, Kwo P, Ghalib R, et al. Peginterferon-alpha-2b and ribavirin for hepatitis C recurrence postorthotopic liver transplantation. J Clin Gastroenterol 2012; 46: 700-8
11. 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: 1918-29
12. Hayashi N, Izumi N, Kumada H, et al. Simeprevir with peginterferon/ribavirin for treatment-naive hepatitis C genotype 1 patients in Japan: CONCERTO-1, a phase III trial. J Hepatol 2014; 61: 219-27
13. 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, doubleblind, placebo-controlled phase 3 trial. Lancet 2014; 384: 414-26
14. 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: 403-13
15. Dieterich D, Rockstroh JK, Orkin C, et al. Simeprevir (TMC435) with pegylated interferon/ribavirin in patients coinfected with HCV genotype 1 and HIV-1: a phase 3 study. Clin Infect Dis 2014; 59: 1579-87
16. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368: 1878-87
17. Hagan LM, Sulkowski MS, Schinazi RF. Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 hepatitis C virus in interferon-ineligible/intolerant individuals. Hepatology 2014; 60: 37-45
18. Van Der Meer AJ, Veldt BJ, Feld JJ, et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fi brosis. JAMA 2012; 308 : 2584-93
19. 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: 132-42
20. Saxena V, Nyberg L, Pauly M, et al. Safety and Efficacy of simeprevir/sofosbuvir in hepatitis C-infected patients with compensated and decompensated cirrhosis. Hepatology 2015; 62: 715-25
21. OPTN. (accessed on 6 June 2015); available at http://optn.transplant.hrsa. gov/governance/policies/
22. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C. (accessed on 8 June 2015); available at http://www. hcvguidelines.org/full-report-view
23. 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 treatmentnaive patients: the COSMOS randomised study. Lancet 2014; 384: 1756-65
24. Pearlman BL, Ehleben C, Perrys M. The combination of simeprevir and sofosbuvir is more Effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related child's class A cirrhosis. Gastroenterology 2015; 148: 762-70
25. Shiffman ML, James AM, Long AG, et al. Treatment of chronic HCV with sofosbuvir and simeprevir in patients with cirrhosis and contraindications to interferon and/or ribavirin. Am J Gastroenterol 2015 ; 110: 1179-85