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Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection

Hiromitsu Kumada1, Yoshiyuki Suzuki, Kenji Ikeda

  • 1Toranomon Hospital, Tokyo, Japan.

Hepatology (Baltimore, Md.)
|March 8, 2014
PubMed
Abstract

Insights

All-oral daclatasvir and asunaprevir achieved high sustained virologic response (SVR) rates in patients with chronic hepatitis C virus (HCV) genotype 1b infection. This interferon-free, ribavirin-free regimen demonstrated good tolerability in patients ineligible, intolerant, or nonresponsive to prior therapies.

Area of Science:

  • Hepatology
  • Virology
  • Clinical Trials

Background:

  • Direct-acting antivirals offer an alternative to interferon/ribavirin for hepatitis C virus (HCV) infection.
  • Patients ineligible, intolerant, or nonresponsive to interferon-based regimens require effective treatment options.

Purpose of the Study:

  • To evaluate the efficacy and safety of an all-oral daclatasvir plus asunaprevir regimen in patients with chronic HCV genotype 1b.
  • To determine the sustained virologic response 24 weeks after treatment (SVR24) in specific patient populations.

Main Methods:

  • An open-label, phase 3 study enrolled 135 interferon-ineligible/intolerant and 87 nonresponder patients with HCV genotype 1b.
  • Patients received daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily for 24 weeks.
  • Sustained virologic response 24 weeks after treatment (SVR24) was the primary endpoint.

Main Results:

  • SVR24 was achieved by 87.4% of interferon-ineligible/intolerant patients and 80.5% of nonresponder patients.
  • High SVR24 rates were observed across subgroups, including those with cirrhosis and different IL28B genotypes.
  • The rate of serious adverse events was low (5.9%), with nasopharyngitis and elevated liver enzymes being common side effects.

Conclusions:

  • Interferon-free, ribavirin-free all-oral therapy with daclatasvir and asunaprevir is well tolerated.
  • This 24-week regimen achieves a high SVR rate in patients with HCV genotype 1b who failed prior interferon-based therapies.

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