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Investigative Valopicitabine Shows Promise for Hepatitis C Treatment Nonresponders: Presented at DDW

By Bruce Sylvester

LOS ANGELES, C.A. -- May 25, 2006 -- A new combination therapy using an investigative antiviral drug, valopicitabine, shows promise for almost half of patients who do not respond to standard interferon therapies for treatment of hepatitis C.

Researchers reported this finding in a press briefing here on May 21^st at Digestive Diseases Week 2006 (DDW).

"This new combination might produce a viable alternative treatment for these challenging patients," said presenting investigator Paul Pockros, MD, division head, division of gastroenterology/hepatology, Scripps Clinic and Research Foundation, San Diego, California.

The ongoing phase 2b trial is comparing 5 treatment regimens in nonresponsive patients with HCV (hepatitis C)-genotype 1, who did not respond to 12 weeks or more of pegylated interferon alpha 2a (peg-IFN)/ribavirin (RBV).

Treatment response was defined as negative HCV RNA using polymerase chain reaction (PCR).

Subjects were randomized in a 1:2:2:2:2 design to 1 of the following treatment arms: 1) valopicitabine monotherapy 800 mg/day; 2) valopicitabine (400 mg/day, 800 mg/day, or dose-ramping 400-800 mg/day) plus peg-IFN; 3) peg-IFN/RBV retreatment (control).

The Peg-IFN dose is 180-mcg subcutaneous injections per week and weight-based RBV is dosed at 1000 to 1200 mg daily.

Virologic response criteria are stipulated for week 4 (>/= 0.5log reduction), week 12 (>/= 1.0log), and week 24 (>/= 2.0log). Subjects who do not achieve these criteria are classified as treatment failures and discontinued from the study.

Among the 162 subjects who have completed 24 weeks, the 2 higher-dose combinations achieved higher response rates than the control group, with an average of 2.5- to 3.0log decrease in hepatitis RNA reductions by week 24. The difference compared with the control group was significant.

The investigators have reported no viral breakthrough to date.

They reported that the highest dose of valopicitabine (800 mg) was associated with vomiting and dehydration requiring hospitalization. Use of that dosing has been stopped.

"Ongoing data from this trial will show us if these notable early results will lead to a sustained response," Dr. Pockros said.


[Presentation title: Valopicitabine (NM283), Alone or With Peg-Interferon, Compared to Peg Interferon/Ribavirin (pegIFN/RBV) Retreatment in Hepatitis C Patients With Prior Non-Response to PegIFN/RBV: Week 24 Results. Abstract 4]

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