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Hepatology. 2016 Aug;64(2):370-80. doi: 10.1002/hep.28467. Epub 2016 Mar 22.

Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study.

Author information

  • 1Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University, Indianapolis, IN.
  • 2Atlanta Gastroenterology Associates, Atlanta, GA.
  • 3Rutgers University, Robert Wood Johnson Medical School, New Brunswick, NJ.
  • 4Hofstra North Shore Long Island Jewish School of Medicine, Manhasset, NY.
  • 5Borland-Groover Clinic, Jacksonville, FL.
  • 6National Research Institute, Los Angeles, CA.
  • 7University of Miami Schiff Center for Liver Disease, Miami, FL.
  • 8Digestive CARE-South Florida Center of Gastroenterology, Wellington, FL.
  • 9Ruane Medical and Liver Health Institute, Los Angeles, CA.
  • 10GASTRO ONE, Germantown, TN.
  • 11Janssen Research and Development LLC, Titusville, NJ.
  • 12Janssen Infectious Diseases BVBA, Beerse, Belgium.
  • 13Janssen Global Services LLC, Titusville, NJ.
  • 14Janssen Global Services LLC, High Wycombe, UK.

Abstract

Effective antiviral therapy is essential for achieving sustained virological response (SVR) in hepatitis C virus (HCV)-infected patients. The phase 2 COSMOS study reported high SVR rates in treatment-naive and prior null-responder HCV genotype (GT) 1-infected patients receiving simeprevir+sofosbuvir±ribavirin for 12 or 24 weeks. OPTIMIST-1 (NCT02114177) was a multicenter, randomized, open-label study assessing the efficacy and safety of 12 and 8 weeks of simeprevir+sofosbuvir in HCV GT1-infected treatment-naive and treatment-experienced patients without cirrhosis. Patients were randomly assigned (1:1; stratified by HCV GT/subtype and presence or absence of NS3 Q80K polymorphism [GT1b, GT1a with Q80K, GT1a without Q80K]), prior HCV treatment history, and IL28B GT [CC, non-CC]) to simeprevir 150 mg once daily+sofosbuvir 400 mg once daily for 12 or 8 weeks. The primary efficacy endpoint was SVR rate 12 weeks after end of treatment (SVR12). Superiority in SVR12 was assessed for simeprevir+sofosbuvir at 12 and 8 weeks versus a composite historical control SVR rate. Enrolled were 310 patients, who were randomized and received treatment (n = 155 in each arm). SVR12 with simeprevir+sofosbuvir for 12 weeks (97% [150/155; 95% confidence interval 94%-100%]) was superior to the historical control (87%). SVR12 with simeprevir+sofosbuvir for 8 weeks (83% [128/155; 95% confidence interval 76-89%]) was not superior to the historical control (83%). The most frequent adverse events were nausea, headache, and fatigue (12-week arm: 15% [23/155], 14% [22/155], and 12% [19/155]; 8-week arm: 9% [14/155], 17% [26/155], and 15% [23/155], respectively). No patients discontinued treatment due to an adverse event. One (1%, 12-week arm) and three (2%, 8-week arm) patients experienced a serious adverse event (all unrelated to study treatment).

CONCLUSION:

Simeprevir+sofosbuvir for 12 weeks is highly effective in the treatment of HCV GT1-infected patients without cirrhosis, including those with Q80K. (Hepatology 2016;64:370-380).

PMID:
26799692
DOI:
10.1002/hep.28467
[PubMed - in process]
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