Document Type

Article

Disciplines

Medicine and Health Sciences

Abstract

Background and Aims

The HALT-C trial demonstrated that low-dose peginterferon maintenance therapy was ineffective in preventing clinical outcomes in patients with chronic hepatitis C, advanced fibrosis and failure to achieve a sustained virologic response during lead-in phase treatment with standard dose peginterferon/ribavirin. This analysis was performed to determine if suppressing HCV RNA during the trial was associated with a reduction in clinical outcomes.

Methods

764 patients treated during the lead-in phase of HALT-C were randomized to either peginterferon alfa-2a (90 mcg/week) maintenance therapy or no treatment (control) for 3.5 years. Clinical outcomes included an increase in Child-Turcotte-Pugh score, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, variceal hemorrhage, hepatocellular carcinoma and mortality.

Results

During the lead-in, ≥4 log10 decline in serum HCV RNA occurred in 178 patients; 82% of whom lost detectable HCV RNA and later broke through or relapsed. These patients had significantly (p=0.003) fewer clinical outcomes whether randomized to maintenance therapy or control. Following randomization serum HCV RNA increased significantly in all 90 control patients and 58/88 receiving maintenance therapy. Only 30 patients had persistent suppression of HCV RNA by ≥4 log10 during maintenance therapy. No significant reduction in clinical outcomes was observed in these patients.

Conclusions

Viral suppression by ≥4 log10 with full dose peginterferon/ribavirin is associated with a significant reduction in clinical outcomes. Continuing low dose peginterferon maintenance therapy, even in patients with persistent viral suppression, does not lead to a further decline in clinical outcomes.

Comments

Gastroenterology. Author manuscript; available in PMC 2013 September 16. Published in final edited form as: Gastroenterology. 2009 December; 137(6): 1986–1994. Published online 2009 September 10. doi: 10.1053/j.gastro.2009.08.067 PMCID: PMC3774149 NIHMSID: NIHMS502604 The publisher's final edited version of this article is available at Gastroenterology This article has been corrected. See the correction in volume 138 on page 1215.

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