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Durability of Response in Children Treated With Pegylated Interferon alfa [corrected] 2a ± Ribavirin for Chronic
Kathleen B Schwarz1, Jean P Molleston, Maureen M Jonas
1*Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD†Department of Pediatrics, Indiana University School of Medicine, Indianapolis‡Department of Medicine, Boston Children's Hospital, Boston, MA§Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia||Department of Pediatrics, Seattle Children's Hospital, Seattle, WA¶Department of Pediatrics, University of California, San Francisco, San Francisco#Department of Pediatrics, University of Florida College of Medicine, Gainesville**Department of Pediatrics, Columbia University Medical Center, New York, NY††Roche Products Limited, Welwyn Garden City, UK‡‡Clinical Trials and Surveys Corporation, Owings Mills, MD.
Insights
Long-term follow-up confirms excellent durability of sustained virological response (SVR) after pegylated interferon treatment in children with chronic hepatitis C. Higher SVR rates were observed in patients with the IL28B CC genotype.
Area of Science:
- Hepatology
- Virology
- Pediatric Gastroenterology
Background:
- Limited long-term data exist on sustained virological response (SVR) durability after pegylated interferon (PegIFN) treatment in pediatric chronic hepatitis C.
- PegIFN alfa-2a ± ribavirin (RBV) was used in the PEDS-C trial for treatment.
Purpose of the Study:
- To assess the long-term durability of SVR following PegIFN treatment in children.
- To evaluate the long-term safety and tolerability of the treatment.
- To investigate the association between IL28B genotype and treatment response.
Main Methods:
- Prospective, multicenter, long-term follow-up (LTFU) study.
- 38 children previously treated in the PEDS-C trial were enrolled.
- Patients attended follow-up visits 5 and 6 years after treatment cessation, with medical history, physical exams, and lab tests.
Main Results:
- The LTFU cohort (38 patients) was representative of the original PEDS-C cohort.
- All 21 responders maintained undetectable hepatitis C virus RNA during LTFU (4.4-7.0 years post-SVR).
- The IL28B CC genotype was significantly associated with achieving SVR (67% vs 30% in non-CC, P=0.028).
Conclusions:
- Sustained virological response (SVR) after PegIFN alfa-2a treatment in children with chronic hepatitis C demonstrates excellent long-term durability.
- SVR rates are higher in children with the IL28B CC genotype compared to non-CC genotypes.
Objectives:
No long-term data have been published on the durability of response following pegylated interferon (PegIFN) treatment in children with chronic hepatitis C. This prospective, multicenter, long-term follow-up (LTFU) study aimed to assess long-term durability of sustained virological response (SVR), long-term safety and tolerability, and the association between IL28B genotype and treatment response, in children previously treated with PegIFN alfa-2a ± ribavirin (RBV) in the PEDS-C trial.
Methods:
A total of 93 patients were assessed for enrollment, and 38 enrolled in the study. Patients attended 2 study visits: 5 (mean 5.6, range 4.1-6.6) and 6 (6.6, 5.1-7.7) years after treatment cessation. Standardized medical history, physical examination, and laboratory testing were performed at these visits. Reminder telephone calls were conducted at 4 and 8 months after the initial visit.
Results:
The LTFU cohort was the representative of the original PEDS-C cohort because both baseline and treatment characteristics were comparable. Of the 38 participants, 21 achieved SVR (responders) during the PEDS-C trial and 17 had not (nonresponders). All 21 responders maintained undetectable hepatitis C virus RNA during the LTFU (4.4-7.0 years after achieving SVR) in contrast to the nonresponders who demonstrated persistent viremia. IL28B CC genotype was associated with SVR (67% vs 30% in non-CC, P = 0.028).
Conclusion:
Long-term durability of SVR is excellent following PegIFN alfa-2a treatment in children with chronic hepatitis C; SVR is higher in those with IL28B CC versus non-CC.
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