Fixed-Dose HCV Combo Drug Effective in Hard-to-Treat Patients
For patients with hepatitis C virus (HCV) genotype 1, 4, or 6 infection who have previously failed peg-interferon and ribavirin treatment, the combination of elbasvir and grazoprevir, with or without ribavrin, was effective in inducing sustained virologic response 12 weeks after the end of treatment (SVR12). Results of this study were published online in the journal Gastroenterology.
Treating patients with HCV genotype 1, 4, or 6 who have failed peg-interferon and ribavirin can be challenging. To ascertain the effectiveness of the combination of elbasvir, an HCV NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, in these patients, researchers conducted a Phase 3, randomized controlled open-label study, where the two drugs were given once daily in a fixed-dose combination tablet.
Patients with a null or partial response to peg-interferon and ribavirin (n=420) were given elbasvir/grazoprevir once daily (with or without ribavirin twice daily) for 12 or 16 weeks; the primary endpoint was HCV RNA <15 IU/mL 12 weeks after completing treatment.
With 12 weeks of treatment, 92.4% of patients in the elbasvir/grazoprevir group achieved an SVR12; for those taking the combination plus ribavirin, 94.2% achieved SVR12.
With 16 weeks of treatment, 92.4%, of patients in the elbasvir/grazoprevir group achieved an SVR12; for those taking the combination plus ribavirin, 98.1% achieved SVR12.
Virologic failure occurred in 6.8% of genotype 1a, 0% of genotype 1b, and 12.5% of genotype 4 patients with 12 weeks of therapy without ribavirin. For patients in the 12-week elbasvir/grazoprevir group, virologic failure occurred in 0% of genotype 1 and 7.5% of genotype 4 patients who relapsed after peg-interferon and ribavirin treatment or had a null or partial response. No incidences of virologic failure were noted in patients treated for 16 weeks who also received ribavirin.
Treatment was generally well-tolerated with the most common adverse effects being fatigue, headache, and nausea.
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