Monday, August 6, 2012

Vaniprevir with peginterferon, ribavirin effectively treated chronic HCV

Vaniprevir with peginterferon, ribavirin effectively treated chronic HCV

Manns MP. Hepatology. 2012;doi:10.1002/hep.25743.

Patients with chronic HCV who received vaniprevir in addition to pegylated interferon and ribavirin were more likely to experience rapid response than those only receiving interferon and ribavirin in a recent study.

In a multicenter, double blind, open-label, dose-ranging trial, 94 patients with HCV genotype 1 randomly received pegylated interferon alfa-2a and ribavirin with either blinded placebo or protease inhibitor vaniprevir for 28 days, followed by 44 weeks of interferon and ribavirin, with 6 months of subsequent follow-up. Patients received vaniprevir doses of 300 mg or 600 mg twice daily, or 600 mg or 800 mg once daily. Rapid viral response (RVR), defined as undetectable plasma HCV RNA levels after 4 weeks, was the primary endpoint.

Incidence rates of RVR were significantly greater among all vaniprevir groups compared with those receiving placebo (68.8%-83.3% of patients vs. 5.6%, P<.001 for all comparisons). HCV RNA levels were approximately 3log10 IU/mL lower among patients in the vaniprevir groups than the placebo groups during treatment. Patients receiving vaniprevir also experienced early and sustained virologic response more frequently, but the difference from those receiving placebo was not statistically significant.

Investigators evaluated resistance sequence data at baseline from 84 participants. Resistance to treatment was detected in patients with variants at R155 and D168. IL28B genotyping also was performed on samples from 67 patients, with no significant association determined between the genotype and treatment results.

Adverse events were similarly frequent among vaniprevir and placebo patients, with the exception of vomiting, which occurred more often among treated patients receiving a higher vaniprevir dose (40% of patients receiving 600 mg twice a day vs. 0% of placebo patients). Common reported events included nausea (34.7% of treated patients vs. 26.3% receiving placebo), headache (33.3% vs. 36.8%), influenza-like illness (22.7% vs. 21.1%) and fatigue (21.3% vs. 36.8%). No serious adverse events related to treatment were reported.

“Vaniprevir is a highly potent second-wave HCV protease inhibitor with a predictable resistance and a favorable safety profile that is suitable for QD or BID administration,” the researchers concluded. “Based on the results of this study, vaniprevir should be further developed for HCV protease inhibitor-based triple therapies. Vaniprevir is also a promising candidate for inclusion within future all-oral anti-HCV strategies.”

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