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Title: R1626 Plus Standard HCV Treatment Provides Potent Antiviral Effect
URL: http://www.pslgroup.com/dg/226B76.htm
Doctor's Guide
July 31, 2008

NEW YORK -- July 31, 2008 -- Two new studies examine the use of the nucleoside polymerase inhibitor R1626 combined with the standard therapy for the hepatitis C virus (HCV). The reports appear in the August issue of Hepatology.

The first study showed that adding R1626 to standard HCV therapy -- pegylated interferon (peginterferon) alpha plus ribavirin -- leads to a synergistic antiviral effect.

This study included 104 HCV genotype 1-infected treatment-naive patients. Patients were randomised to receive either 1,500 mg of R1626 BID plus peginterferon alpha-2a (n = 21); 3,000 mg of R1626 BID plus peginterferon alpha-2a (n = 32); 1,500 mg of R1626 BID plus peginterferon alpha-2a and ribavirin (n = 31); or the standard peginterferon alpha-2a and ribavirin (n = 20).

At 4 weeks, HCV RNA was undetectable in 29%, 69%, and 74% of patients in the respective study arms, compared with 5% of patients receiving the standard of care treatment.

"The results of the present study show a marked increase in antiviral effect in patients when ribavirin is added to the combination of R1626 and peginterferon alfa-2a," the authors wrote.

"This phase 2a study has demonstrated a potent reduction in HCV RNA by R1626 and high viral responses with up to 74% rapid viral response after 4 weeks of treatment.

"The strong antiviral effect between R1626, peginterferon alfa-2a, and ribavirin suggests that the dose of 1 or both of these agents could be lowered to improve tolerability without significantly compromising efficacy," the authors concluded.

A second monotherapy study in patients with chronic HCV showed that the antiviral activity increased with the dosage. Side effects were tolerable, and there was no evidence of viral resistance.

For this study, patients were treated with R1626 doses of 500 mg BID; 1,500 mg BID; 3,000 mg BID; 4,500 mg BID; or placebo for 14 days.

"The decreases in HCV RNA from baseline observed with R1626 indicate potent antiviral activity and lack of viral load rebound in the significant majority of patients following 14 days of monotherapy," the authors wrote.

In addition, the study showed that R1626 was well tolerated up to 3,000 mg and that there was no evidence of viral resistance, perhaps reflecting the potency of R1626 as an antiviral agent.


SOURCE: Wiley-Blackwell

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