Saturday, February 12, 2011

Shorter course of IFN/ribavirin OK for some HCV patients

Shorter course of IFN/ribavirin OK for some HCV patients
Last Updated: 2011-02-10 17:45:06 -0400 (Reuters Health)

By Scott Baltic

NEW YORK (Reuters Health) - A 16-week course of therapy for hepatitis C virus (HCV) might be OK for selected patients under specific circumstances, new study results suggest.
Twenty-four weeks of treatment with peginterferon (PEG-IFN) alpha-2b and ribavirin is the standard of care. But the authors of the new study say the shorter course should be considered when patients with HCV genotype 2 or 3 infection have undetectable viral loads by week 4 of treatment.

In other cases, however, the shorter-duration therapy was inferior to the full six months of treatment.

The open-label, multicenter, randomized, parallel-group trial, conducted in 682 treatment-na�ve patients in Europe and Asia, was reported online January 14 in the Journal of Hepatology.
Participants were randomly assigned to three treatment arms:
-Group A received the standard treatment: PEG-IFN alpha-2b (PegIntron, Schering-Plough Corp.) 1.5 mcg/kg/wk, plus ribavirin (800-1,200 mg/day depending on body weight) for 24 weeks.

-Group B received a reduced dose: PEG-IFN alpha-2b 1.0 mcg/kg/wk plus ribavirin 800-1,200 mg/day for 24 weeks.

-Group C received same treatment as Group A, but for 16 weeks.

Rates of sustained virological response (undetectable HCV RNA 24 weeks after the last dose of therapy) were 66.5%, 64.3% and 56.6% in groups A, B and C, respectively.
In other words, the reduced-dose and reduced-duration regimens failed the test of noninferiority (the predefined margin was ?10%). Furthermore, the relapse rate was higher in the reduced-duration group.
However, the authors point out, rates of sustained virological response were "consistently high" across all three arms in patients who achieved a rapid virological response (i.e., undetectable HCV RNA at week 4). These rates were 75.3%, 75.9% and 72.4% in groups A, B, and C, respectively.

Anemia was "markedly lower" in patients receiving the reduced dose, as compared with the standard dose.

In addition, the authors say, while PEG-IFN alpha-2b 1.5 mcg/kg/wk should still be regarded as the standard, "Clinicians can feel confident that the dose can be reduced to 1.0 mcg/kg/wk in patients with safety concerns without any marked decline in efficacy."
In email to Reuters Health, researcher Dr. Michael Manns of the Medical School of Hannover, Germany said the 16-week regimen may be "particularly suitable for patients who are not otherwise predisposed to relapse, such as...those compliant with medication, those who do not have other characteristics associated with poor response (African American ethnicity, cirrhosis, or high baseline viral load) and for those in whom treatment shortening may be appropriate for other reasons like drug toxicity."

J Hepatol 2011.

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