An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients
This prospective, national, multicenter, non-interventional study examined the use of triple
combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and
ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection.
Dosing and treatment duration were at the discretion of the investigator in accordance with
local clinical practice and local labeling. Participants were to be observed for the duration
of their triple combination therapy and for up to 24 weeks thereafter.
Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis
comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label
combination of simeprevir+ sofosbuvir without Ribavirin.
Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis
Janssen Scientific Affairs, LLC
1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1,
cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin
(or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV).
2. Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV)
treatment using a new test of liver function, HepQuant-SHUNT.
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