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Outcomes for Cirrhotic Patients with Hepatitis C Virus 1b Treated with Asunaprevir and Daclatasvir Combination

Akihiro Tamori1, Hoang Hai1, Sawako Uchida-Kobayashi1

  • 1Osaka City University Graduate School of Medicine, Osaka, Japan Department of Hepatology.

Annals of Hepatology
|August 16, 2017
PubMed

Insights

Asunaprevir and daclatasvir combination therapy effectively treats Hepatitis C Virus (HCV) genotype 1b, achieving high sustained viral response (SVR) in cirrhotic patients. Careful management is needed due to increased adverse events and hepatocellular carcinoma (HCC) risk in this group.

Area of Science:

  • Hepatology
  • Virology
  • Pharmacology

Background:

  • Real-world efficacy and safety of asunaprevir + daclatasvir for Hepatitis C Virus (HCV) in compensated cirrhotic patients remain under-evaluated.
  • Previous studies focused on outcomes in patients achieving sustained viral response (SVR).

Purpose of the Study:

  • To assess the real-world efficacy and safety of asunaprevir + daclatasvir combination therapy in HCV genotype 1b patients with and without cirrhosis.
  • To evaluate liver function improvement and hepatocellular carcinoma (HCC) development post-treatment.

Main Methods:

  • 145 treatment-naive HCV genotype 1b patients (49 cirrhotic, 96 non-cirrhotic) without RASs at L31/Y93 were enrolled.
  • Patients received 24 weeks of asunaprevir (100 mg BID) + daclatasvir (60 mg QD).
  • Primary endpoint: SVR 24 weeks post-treatment. Secondary endpoints: liver function, HCC development/recurrence for 1 year.

Main Results:

  • SVR24 rates were high and similar in both groups (96% cirrhotic vs. 96% non-cirrhotic).
  • Grade III/IV adverse events were more frequent in cirrhotic patients (20.4% vs. 10.4%).
  • Cirrhotic patients with SVR showed improved liver function but higher rates of HCC recurrence (43%) and development (7.4%) compared to non-cirrhotics.

Conclusions:

  • RAS-oriented asunaprevir/daclatasvir therapy demonstrates potent anti-HCV activity in genotype 1b patients.
  • Cirrhotic patients require careful monitoring due to increased risks of adverse events and HCC post-treatment.
Abstract

Keywords:
Adverse eventsHepatocellular carcinomaResistance-associated substitutionSustained viral response.

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