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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

1
Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University, Indianapolis, IN.
2
Atlanta Gastroenterology Associates, Atlanta, GA.
3
Rutgers University, Robert Wood Johnson Medical School, New Brunswick, NJ.
4
Hofstra North Shore Long Island Jewish School of Medicine, Manhasset, NY.
5
Borland-Groover Clinic, Jacksonville, FL.
6
National Research Institute, Los Angeles, CA.
7
University of Miami Schiff Center for Liver Disease, Miami, FL.
8
Digestive CARE-South Florida Center of Gastroenterology, Wellington, FL.
9
Ruane Medical and Liver Health Institute, Los Angeles, CA.
10
GASTRO ONE, Germantown, TN.
11
Janssen Research and Development LLC, Titusville, NJ.
12
Janssen Infectious Diseases BVBA, Beerse, Belgium.
13
Janssen Global Services LLC, Titusville, NJ.
14
Janssen 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
PMCID:
PMC5412860
DOI:
10.1002/hep.28467
[Indexed for MEDLINE]
Free PMC Article

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