Mericitabine Plus Standard HCV Therapy Associated With Very High Rates of Virological Suppression: Presented at EASL

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Source: DGNews | Posted 5 days ago

Mericitabine Plus Standard HCV Therapy Associated With Very High Rates of

Virological Suppression

: Presented at EASL

By Berrie

BERLIN -- April 5, 2011 -- Addition of mericitabine to ribavirin plus pegylated

interferon alpha-2a (rbv/PegIFN) is well tolerated and shows strong antiviral

potency compared with rbv/PegIFN alone in treatment-naïve patients with

hepatitis C virus (HCV) genotypes 1 and 4, researchers said here at the 46th

Annual Meeting of the European Association of the Study of the Liver (EASL).

“Mericitabine, is a potent, selective nucleoside inhibitor of the hepatitis C

NS5B RNA-dependent RNA polymerase enzyme,” said J. Pockros, MD Division of

Gastroenterology/Hepatology, Liver Disease Centre, Scripps Clinic Torrey Plains,

La Jolla, California, on April 1.

For the study, patients were randomised to standard rbv/PegIFN treatment (n =

85) for 48 weeks, or to rbv/PegIFN plus mericitabine (n = 81) for 24 weeks plus

24 weeks of rbv/PegIFN alone for patients not reaching extended rapid

virological response, defined as undetectable HCV RNA from week 4 to 22.

At week 4, 14% of patients receiving rbv/PegIFN achieved rapid virological

response compared with 63% of patients receiving mericitabine.

By week 24, when no patients were receiving mericitabine, virological

suppression was achieved by 62% of patients receiving rbv/PegIFN alone versus

91% of patients who received mericitabine, with 60% of the patients in the

mericitabine arm showing extended rapid virological response, and thus having

all treatment terminated.

The remaining patients from the mericitabine arm continued blinded treatment

with rbv/PegIFN alone.

At week 36, 76% of patients who had achieved extended rapid virological response

remained with undetectable HCV RNA levels, while the other 24% relapsed.

“All of the adverse events that we have seen on the study are typical adverse

events that can be attributed to peg-interferon and ribavirin,” said Dr.

Pockros.

There were no differences in frequency of haematological and renal laboratory

analyses, and specifically no impact of mericitabine on creatinine clearance.

Dr. Pockros also indicated that their examination for resistance-associated

variants showed no evidence that these were associated with use of mericitabine.

“A good safety and tolerability profile, strong antiviral potency, and no

evidence of resistance-related breakthrough makes mericitabine highly desirable

for further study, to move forward probably in combinations with other

direct-acting antivirals,” concluded Dr. Pockros.

Funding for this study was provided by Roche.

[Presentation title: First SVR Data With The Nucleoside Analogue Polymerase

Inhibitor Mericitabine (RG7128) Combined With Peginterferon/Ribavirin in

Treatment-Naïve HCV G1/4 Patients: Interim Analysis From the JUMP-C Trial.

Abstract 1359]