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A Protocol for Analyzing Hepatitis C Virus Replication
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A Protocol for Analyzing Hepatitis C Virus Replication

Published on: June 26, 2014

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Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: A phase 3

Eric Lawitz1, Gary Matusow2, Edwin DeJesus3

  • 1Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.

Hepatology (Baltimore, Md.)
|December 26, 2015
PubMed

Insights

Hepatitis C virus (HCV) patients with cirrhosis achieved high sustained virologic response (SVR12) rates with 12 weeks of simeprevir plus sofosbuvir. This effective treatment regimen demonstrated superiority over historical controls in difficult-to-treat populations.

Area of Science:

  • Hepatology
  • Virology
  • Clinical Trials

Background:

  • Hepatitis C virus (HCV) infection in patients with cirrhosis presents significant treatment challenges.
  • Cirrhosis increases the risk of hepatic decompensation in HCV-infected individuals.
  • Previous studies indicated potential efficacy of simeprevir and sofosbuvir in HCV patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of a 12-week regimen of simeprevir plus sofosbuvir in HCV genotype 1-infected patients with cirrhosis.
  • To determine if the treatment regimen achieves a superior sustained virologic response 12 weeks post-treatment (SVR12) compared to a historical control.
  • To assess safety and patient-reported outcomes in this specific patient population.

Main Methods:

  • A phase 3, open-label, single-arm study (OPTIMIST-2) was conducted.
  • 103 treatment-naive or treatment-experienced patients with chronic HCV GT1 infection and cirrhosis received oral simeprevir 150 mg once daily and sofosbuvir 400 mg once daily for 12 weeks.
  • The primary efficacy endpoint was the proportion of patients achieving SVR12, compared against a historical control SVR12 rate of 70%.

Main Results:

  • The simeprevir + sofosbuvir regimen achieved an 83% SVR12 rate (95% CI 76%-91%), demonstrating superiority over the 70% historical control.
  • SVR12 rates were 88% for treatment-naive and 79% for treatment-experienced patients.
  • 70% of patients experienced adverse events, mostly mild (grade 1 or 2); serious adverse events were rare and unrelated to treatment.

Conclusions:

  • Twelve weeks of simeprevir plus sofosbuvir is a safe and effective treatment for HCV GT1-infected patients with cirrhosis.
  • The regimen achieved superior SVR12 rates in both treatment-naive and treatment-experienced patients.
  • Patient-reported outcomes improved during the study, indicating a positive impact on quality of life.
Abstract

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