FRIDAY, Oct. 15 (HealthDay News) -- An experimental oral drug combination appears to be well-tolerated and safe, showing promising antiviral activity for the treatment of patients with chronic hepatitis C virus (HCV) infection, according to a study published online Oct. 15 in The Lancet.
Edward J. Gane, M.D., of Auckland Clinical Studies in New Zealand, and colleagues systematically evaluated the safety, tolerability, and antiviral activity of an all-oral combination treatment with two experimental anti-HCV drugs, RG7128 (a nucleoside polymerase inhibitor) and danoprevir (a protease inhibitor), in patients with chronic HCV infection. The investigators randomized 88 patients to the drug treatment regimen or placebo.
At the highest combination doses tested (1,000 mg RG7128 and 900 mg danoprevir twice daily), the investigators found that the median change in HCV RNA concentration from baseline to day 14 was -5.1 log10 IU/mL in patients who had never been treated before and -4.9 log10 IU/mL in patients who had shown no response to previous standard treatment, compared with an increase of 0.1 log10 IU/mL in the placebo group. The combined treatment approach showed no evidence of resistance and was not associated with any treatment-related severe adverse events.
"This oral combination of a nucleoside analogue polymerase inhibitor and protease inhibitor holds promise as an interferon-free treatment for chronic HCV," the authors write.
The study was funded by Roche, with multiple authors disclosing financial relationships with the company. A few authors also disclosed financial relationships with other pharmaceutical companies.
Abstract
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