Long-Term Histologic Improvement and Loss of Detectable Intrahepatic HCV RNA in Patients with Chronic Hepatitis C and Sustained Response to Interferon-α Therapy
- Patrick Marcellin, MD;
- Nathalie Boyer, MD;
- Anne Gervais, MD;
- Michele Martinot, BS;
- Michele Pouteau, MD;
- Corinne Castelnau, MD;
- Afef Kilani, MD;
- Jorge Areias, MD;
- Anne Auperin, MD;
- Jean Pierre Benhamou, MD;
- Claude Degott, MD; and
- Serge Erlinger, MD
- From Hopital Beaujon, Clichy, France. Acknowledgments: The authors thank Drs. C. Lemonnier and C. Langlois (Schering-Plough Corp.) for their support. Grant Support: In part by a grant from the Association pour la Recherche contre le Cancer. Requests for Reprints: Patrick Marcellin, MD, Service d'Hepatologie, Hopital Beaujon, 100 Boulevard du General Leclerc, 92118 Clichy, France. Current Author Addresses: Drs. Marcellin, Boyer, Gervais, Pouteau, Castelnau, Kilani, Areias, Auperin, Benhamou, and Erlinger and Ms. Martinot: Service d'Hepatologie and Unite de Recherches de Physiopathologie Hepatique (INSERM U24), Hopital Beaujon, 100 Boulevard du General Leclerc, 92118 Clichy, France.
Abstract
Background: Less than 20% of patients with chronic hepatitis C have a sustained response to interferon-α therapy. The long-term benefit of interferon-α with regard to hepatic viral clearance and histologic improvement remains unknown.
Objective: To determine the long-term biochemical, virologic, and histologic outcomes in patients with chronic hepatitis C who have a sustained response to interferon-α therapy.
Design: Prospective cohort study.
Setting: University hospital.
Patients: 80 patients who had chronic hepatitis C, had a sustained biochemical and virologic response to interferon-α therapy, and were followed for at least 12 months.
Measurements: Serum hepatitis C virus (HCV) RNA detected by polymerase chain reaction (PCR); HCV genotyping determined by line probe assay; liver histologic studies; liver HCV RNA detected by PCR on frozen liver tissue samples (in 27 patients); and repeated measurements of serum alanine aminotransferase (ALT) levels. Liver biopsy was done before treatment in all 80 patients, and at least one biopsy was done in 69 patients 1 to 6 years after treatment.
Results: The 80 patients had follow-up 1 to 7.6 years (mean ±SD, 4.0 ± 2.0 years) after interferon-α treatment. The follow-up period was 1, 2, 3, 4, 5, 6, and more than 6 years in 11, 13, 14, 18, 10, 12, and 2 patients, respectively, after the end of therapy. During the entire follow-up period, 93% (95% CI, 84% to 97%) of patients had persistently normal serum ALT levels. Serum HCV RNA remained undetectable in 96% (CI, 89% to 99%) of patients. A comparison of liver histologic findings before and 1 to 6.2 years after interferon-α treatment showed a clear improvement in 94% (CI, 83% to 99%) of patients. In 62% of patients, the last biopsy done showed normal or nearly normal histologic findings. Liver HCV RNA was detectable before treatment in all 13 patients tested and was undetectable 1 to 5 years after treatment in all 27 patients tested.
Conclusions: In patients with chronic hepatitis C who have persistently normal serum ALT levels and no detectable serum HCV RNA 6 months after interferon-α therapy, a long-term sustained biochemical and virologic response is generally seen. This response is associated with an absence of detectable intrahepatic HCV RNA and marked histologic improvement.
- Copyright ©2004 by the American College of Physicians
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