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Simeprevir, daclatasvir and sofosbuvir for hepatitis C virus-infected patients with decompensated liver disease

E Lawitz1, F Poordad1, J A Gutierrez1

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

Journal of Viral Hepatitis
|November 24, 2016
PubMed

Insights

This study shows that a 12-week treatment with simeprevir, daclatasvir, and sofosbuvir achieved a 100% sustained virologic response (SVR12) in cirrhotic hepatitis C patients. The combination therapy was safe and effective for patients with portal hypertension or decompensated liver disease.

Area of Science:

  • Hepatology
  • Virology
  • Pharmacology

Background:

  • Chronic hepatitis C virus (HCV) infection affects millions, potentially leading to liver cirrhosis.
  • Cirrhosis can progress to compensated or decompensated stages, impacting patient outcomes.
  • Direct-acting antivirals (DAAs) have revolutionized HCV treatment, but data in advanced liver disease are crucial.

Purpose of the Study:

  • To evaluate the efficacy and safety of a 12-week regimen of simeprevir, daclatasvir, and sofosbuvir in cirrhotic HCV patients.
  • To assess the treatment in patients with genotype 1 or 4 HCV infection, portal hypertension, or decompensated liver disease (Child-Pugh A or B).
  • To determine the primary endpoint of sustained virologic response 12 weeks after treatment completion (SVR12).

Main Methods:

  • Phase II IMPACT study involving 40 treatment-naïve or experienced adult patients with HCV genotype 1 or 4.
  • Patients received a 12-week combination therapy: simeprevir (150 mg), daclatasvir (60 mg), and sofosbuvir (400 mg) daily.
  • Patients were stratified by Child-Pugh (CP) score: CP A (<7) with portal hypertension or CP B (7-9).

Main Results:

  • All 40 enrolled patients (19 CP A, 21 CP B) achieved the primary endpoint of SVR12, demonstrating 100% efficacy.
  • Pharmacokinetic exposure of study drugs was higher in CP B patients compared to CP A patients.
  • The treatment was generally safe and well-tolerated, with mostly Grade 1/2 adverse events; one Grade 3 gastrointestinal hemorrhage in a CP B patient was unrelated to study drugs.

Conclusions:

  • A 12-week treatment course of simeprevir, daclatasvir, and sofosbuvir is highly effective, achieving 100% SVR12 in cirrhotic HCV patients.
  • This combination therapy is safe and well-tolerated in patients with portal hypertension or decompensated liver disease (CP A and B).
  • The findings support the use of this DAA combination for advanced HCV liver disease.

Keywords:
daclatasvirhepatitis Csimeprevirsofosbuvir

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