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A Next Step for Genotype 1 HCV Regimens: Eliminating Ribavirin

Summary and Comment |
February 21, 2014

A Next Step for Genotype 1 HCV Regimens: Eliminating Ribavirin

  1. Atif Zaman, MD, MPH

An interferon-free, ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 was effective in treatment-naive patients in a small phase II study.

  1. Atif Zaman, MD, MPH

As described in recent reviews, interferon-free regimens will soon likely be approved to treat genotype 1 hepatitis C virus (HCV) infection in the near future (NEJM JW Gastroenterol Jan 15 2014, NEJM JW Gastroenterol Nov 15 2013). In previous regimens, most adverse effects were related to interferon; however, ribavirin also has significant adverse effects, namely anemia.

The purpose of the current phase IIA, open-label study was to examine the efficacy and safety of an interferon- and ribavirin-free regimen for treatment of genotype 1 HCV infection. Sixty-six treatment-naive patients without cirrhosis were randomly assigned to receive either a 12-week or 24-week regimen comprising daclatasvir (an NS5A replication complex inhibitor; 60 mg daily), asunaprevir (an NS3 protease inhibitor; 200 mg twice daily), and BMS-791325 (a non-nucleoside NS5B inhibitor; 75 mg or 150 mg twice daily). The primary endpoint was sustained virologic response at 12 weeks after treatment (SVR12).

Sixty-one of 66 patients (92%) achieved SVR12. Similar response rates were achieved in genotypes 1a and 1b (94% and 88%), in IL28B host genotypes CC and non-CC (100% and 89%), with 75-mg and 150-mg doses of BMS-791325 (94% and 91%), and with durations of 12 and 24 weeks (94% and 91%). During treatment, two patients experienced virologic breakthrough, and one patient relapsed. There were no adverse events leading to discontinuation.

Comment

This small study suggests that we will soon have effective regimens for hepatitis C virus infection that are not only interferon-free, but also ribavirin-free, using the next generation of direct antiviral agents. This regimen is now moving into the next phase of clinical studies with a larger sample size that will include patients with cirrhosis as well as treatment-experienced patients.

  • Disclosures for Atif Zaman, MD, MPH at time of publication Speaker’s bureau Bristol-Myers Squibb; Genentech; Gilead; Kadmon; Merck; Salix; Vertex

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Reader Comments (1)

bernarodo frider Physician, Gastroenterology, Argerich Hospital

interesante futuro

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