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Reuters Health Information (2009-12-30): Maintenance peg-interferon no extra help in HCV non-responders


Maintenance peg-interferon no extra help in HCV non-responders

Last Updated: 2009-12-30 12:08:55 -0400 (Reuters Health)

NEW YORK (Reuters Health) - In patients with hepatitis C virus (HCV) infection who don't have sustained viral suppression with standard-dose pegylated interferon (PEG IFN) alfa-2a, there is no benefit to be gained from low-dose maintenance therapy, researchers report in the December issue of Gastroenterology.

Lead author Dr. Mitchell L. Shiffman of Virginia Commonwealth University Medical Center, Richmond, and colleagues base this conclusion on a secondary analysis of data on 764 patients with bridging fibrosis or cirrhosis who had not responded to 180 mcg/week of PEG IFN alfa-2a plus ribavirin in a randomized trial.

The nonresponders were re-randomized to receive either 90 mcg/week of PEG IFN alfa-2a as maintenance therapy (without ribavirin) or to stop treatment and act as controls during the 3.5 year maintenance phase.

Most of the current study group - 618 patients - were classified as nonresponders because they had detectable HCV RNA in serum at week 20. The other 146 did not have detectable HCV RNA at 20 weeks but had breakthrough or relapse at some point between 20 and 48 weeks.

Overall, compared to the 20-week nonresponders, the patients with relapse or breakthrough had significantly fewer clinical outcomes (increase in Child-Turcotte-Pugh score, ascites, peritonitis, encephalopathy, hepatoma, and death) regardless of whether they received maintenance therapy or not.

During the maintenance phase, serum viral levels in controls rapidly returned to baseline. In the treatment group, viral levels were linked with response during the lead-in phase. Among the 290 nonresponders at week 20 who were in the maintenance arm, 97% of those with less than a 2-log10 decline in serum HCV RNA during lead-in -- and 86% of those with a 2- to 4-log10 decline - were nonresponders to maintenance therapy.

Among the 88 patients with breakthrough/relapse who were re-randomized to maintenance therapy, 30 patients did manage to achieve and maintain HCV RNA suppression, but they had no significant reduction in clinical outcomes. In the other 58, serum HCV RNA increased significantly.

"The present study...suggests that profound viral suppression, even for a relatively brief period of time, is associated with clinical benefit," the authors said.

On the other hand, they conclude, "Continuing...maintenance therapy did not affect the development of clinical outcomes regardless of the degree of viral suppression achieved during the lead-in phase."

Gastroenterology 2009;137:1986-1994.

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