HCV Combination Treatment Effective in Hard-to-Treat Population

A fixed dose of elbasvir-grazoprevir, with or without ribavirin, is well tolerated in patients with hepatitis C virus (HCV) genotypes 1,4, or 6, according to new research.

Because patients with HCV who have failed peg-interferon and ribavirin treatment are challenging to treat, the researchers conducted an open-label trial to assess a fixed-dose combination treatment.
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They recruited 420 patients with HCV genotypes 1,4, or 6, with or without cirrhosis, who were previously treated with peg-interferon and ribavirin from 65 study centers in 15 countries in Europe, Asia, and Central and North America.

Patients were randomly assigned to receive a combination treatment of once-daily elbasvir (50 mg) and grazoprevir (100 mg), with or without twice-daily ribavirin, for 12 or 16 weeks.

The primary end point was a sustained viral response after 12 weeks (SVR12) of an HCV RNA level below 15 IU/mL.

After 12 weeks of treatment, 92.4% of patients taking elbasvir-grazoprevir and 94.2% of patients taking elbasvir-grazoprevir plus ribavirin achieved an SVR12.

For those not taking ribavirin, 6.8% of patients with HCV genotype 1a, 0% of those with genotype 1b, and 12.5% of those with genotype 4 experienced virologic failure.

Among patients who relapsed after or had a null/partial response to peg-interferon and ribavirin treatment, 0% of patients with genotype 1 and 7.5% of patients with genotype 4 experienced virologic failure after 12 weeks.

After 16 weeks of treatment, 92.4% of patients taking elbasvir-grazoprevir and 98.1% of patients taking elbasvir-grazoprevir plus ribavirin achieved an SVR12. No incidences of virologic failure were reported in patients taking ribavirin for 16 weeks, and only mild adverse events were reported.

“The combination tablet of elbasvir and grazoprevir, with or without ribavirin, was highly efficacious in inducing an SVR12 in patients with HCV genotype 1, 4, or 6 infection failed by previous treatment with peg-interferon and ribavirin, including patients with cirrhosis and/or a prior null response,” the researchers concluded. “The treatment was generally well tolerated.”

—Amanda Balbi

Reference:

Kwo P, Gane E, Peng C-Y, et al. Effectiveness of elbasvir and grazoprevir combination, with or without ribavirin, for treatment-experienced patients with chronic hepatitis C infection [published online October 5 2016]. Gastroenterology.