Durability of Response in Children Treated With Pegylated Interferon alfa [corrected] 2a ± Ribavirin for Chronic Hepatitis C.
OBJECTIVE
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).


CONCLUSIONS
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.
*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.
Kathleen B
KB
Schwarz
Jean P
JP
Molleston
Maureen M
MM
Jonas
Jessica
J
Wen
Karen F
KF
Murray
Philip
P
Rosenthal
Regino P
RP
Gonzalez-Peralta
Steven J
SJ
Lobritto
Douglas
D
Mogul
Vedran
V
Pavlovic
Charles
C
Warne
Cynthia
C
Wat
Bruce
B
Thompson
D000293:Adolescent; D000998:Antiviral Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis / Q000187:drug effects; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014766:Viremia / Q000821:virology
D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a