Simeprevir plus peginterferon/ribavirin for HCV genotype 1-infected treatment-naïve patients in China and South Korea

Journal of Gastroenterology and Hepatology
Lai WeiTIGER team

Abstract

Approximately one-third of patients with hepatitis C virus (HCV) genotype (GT) 1 infection live in East Asia. This study evaluated the efficacy, pharmacokinetics, safety, and tolerability of simeprevir plus peginterferon alpha-2a and ribavirin (PR) in HCV GT1-infected, treatment-naïve, Asian patients with compensated liver disease. This phase III, randomized study (NCT01725529) was conducted in China and South Korea. Patients received simeprevir 150 mg once daily (QD), simeprevir 100 mg QD, or placebo, in combination with PR for 12 weeks. Patients in the simeprevir groups received PR alone for a further 12 or 36 weeks based on response-guided treatment criteria. Patients in the placebo group received a further 36 weeks of PR alone. The primary efficacy endpoint was sustained virologic response 12 weeks after planned end of treatment (SVR12). Secondary endpoints were safety, pharmacokinetics, tolerability, and patient-reported outcomes. Overall, 457 patients were treated; the majority had GT1b infection (452/457 [99%]) and IL28B CC GT (364/457 [80%]). Of the 454 patients who had liver biopsy, 26 had cirrhosis (6%). SVR12 rates were superior for both the simeprevir 100 mg (89%; P = 0.003) and 150 mg (91%; P < 0.001) groups versus...Continue Reading

References

Aug 9, 2012·Health and Quality of Life Outcomes·Leah KleinmanDennis Revicki
Nov 13, 2012·Annual Review of Pharmacology and Toxicology·Jennifer J Kiser, Charles Flexner
Jul 24, 2013·Journal of Gastroenterology and Hepatology·Yan Cui, Jidong Jia
Mar 26, 2014·Gastroenterology·Lai Wei, Anna S F Lok
Jul 30, 2014·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Jane P MessinaEleanor Barnes
Dec 20, 2014·Journal of Viral Hepatitis·A A ButtUNKNOWN ERCHIVES (Electronically Retrieved Cohort of HCV Infected Veterans) Study Team

❮ Previous
Next ❯

Citations

May 14, 2016·European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology·S RenX Chen
Feb 28, 2017·Antiviral Research·Guangdi Li, Erik De Clercq
Oct 15, 2019·Journal of Clinical and Translational Hepatology·Lai WeiJinzi J Wu

❮ Previous
Next ❯

Related Concepts

Related Feeds

Antivirals

Antivirals are medications that are used specifically for treating viral infections. Discover the latest research on antivirals here.

Antivirals (ASM)

Antivirals are medications that are used specifically for treating viral infections. Discover the latest research on antivirals here.