News - AASLD Drug Combination May Become New Treatment Paradigm for Hepatitis C
- AASLD: Drug Combination May Become New Treatment Paradigm for Hepatitis C Virus
By Mark L. Fuerst
BOSTON, MA -- November 3, 2004 -- The combination of a novel, oral polymerase inhibitor and pegylated interferon, may become the new treatment paradigm for hepatitis C virus (HCV) infections, according to results of an interim analysis presented here on November 1st at the 55th Annual Meeting of the American Association for the Study of Liver Diseases.
This new combination "may offer improved efficacy outcomes, especially for HCV patients who are nonresponders or have failed to clear the virus with standard therapy," said Nezam Afdhal, associate professor of medicine at Harvard University.
During his presentation, Dr. Afdhal said that the polymerase inhibitor, NM 283, is the first in a new class of designer drugs that specifically block a step in HCV viral replication. Unlike existing therapies, which are administered by injection, NM 283 is taken orally and appears to have fewer adverse effects than existing agents, Dr. Afdhal said.
He presented data from an ongoing, phase 2, clinical study that evaluated the combination of NM 283 and pegylated interferon. The trial includes 30 treatment-na�ve patients with compensated chronic HCV infections. They received NM 283 in escalating daily doses of 400-, 600-, and 800-mg, alone or in combination with pegylated interferon 1.0 mcg/kg subcutaneously on days 8, 15, and 22. At day 8 they reached the 800-mg dose of NM 283.
Dr. Afdhal presented results from an interim analysis of 19 patients, 12 in the combination arm and 7 in the NM283 alone arm. He said that 75% of patients treated with the combination experienced early virologic response. An early virologic response was correlated with an improved chance of sustained viral clearance, he said.
Patients receiving the combination therapy achieved a mean 2.7 log viral load reduction through week 4, representing a 99.8% reduction in HCV RNA. Dr. Afdhal said that this result is consistent with preclinical data that suggested a synergistic antiviral effect for the combination of NM 283 plus interferon-alfa.
Dr. Afdhal said the safety of the combination therapy was "satisfactory, with typical side effects expected with interferon, and a high compliance rate [more than 90%]."
"This is the first agent in the class to be effective, it has a good safety profile, and is additive with interferon. It's the start of a new paradigm for treating HCV infection," Dr. Afdhal said.
[Presentation title: "Final Phase I/II Trial Results for NM283, a New Polymerase Inhibitor for Hepatitis C: Antiviral Efficacy and Tolerance in Patients with HCV-1 Infection, Including Previous Interferon Failures." Abstract LB03]
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