Long-Term Follow-Up of Children Treated With Peginterferon and Ribavirin for Hepatitis C Virus Infection.
The aim of the study was to describe the 5-year follow-up of children who received peginterferon and ribavirin in a global, open-label study.



A 5-year follow-up study of 107 children and adolescents ages 3 to 17 years with chronic hepatitis C virus infection who received peginterferon and ribavirin for 24 or 48 weeks. No drugs were administered during follow-up.



Ninety-four patients were enrolled in the long-term follow-up portion of the study; the median duration of follow-up was 287 weeks (range, 73-339). Of 63 patients with sustained virologic response who were enrolled, 54 completed 5 years of follow-up; none had relapse in the 5-year follow-up period. Significant decreases in height z scores were observed during treatment. The effect of treatment on height z score was larger in patients treated for 48 weeks compared with those treated for 24 weeks (mean change from baseline to the end of treatment was -0.13 [P < 0.001] and -0.44 [P < 0.001] in the 24- and 48-week treatment groups, respectively). Among patients treated for 24 weeks, full recovery of height z scores to baseline was observed by 1 year of follow-up, whereas only partial recovery was observed during 5 years of follow-up in patients treated for 48 weeks (mean change from baseline to the final follow-up visit was -0.16 (P = NS) and -0.32 (P < 0.05) in the 24- and 48-week treatment groups, respectively). Similar patterns were observed for weight and body mass index z scores.



Impairment of growth should be considered when assessing the risk-benefit profile of peginterferon/ribavirin therapy in children with hepatitis C virus infection. In deciding to treat children with chronic hepatitis C virus, considerations should include both deferring treatment in patients during optimal growth periods, and the possibility that interferon-free regimens may be available to children in the next 5 to 10 years.
*Clinical Research Department, Merck Sharp & Dohme Corp., Kenilworth, NJ †Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL ‡Hepatologia Infantil, El Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina §University of Texas Southwestern Medical Center, Dallas, TX ||Pediatric Hepatology and Liver Transplant Section, German Hospital, Buenos Aires, Argentina ¶Service de Gastroentérologie-Hépatologie-Nutrition pédiatriques, Hôpital Necker-Enfants Malades, Paris, France #Chefarzt der Klinik für Kinder und Jugendmedizin, Kindergastroenterologe, Neonatologe, Klinikum Starnberg, Akademisches Lehrkrankenhaus der Ludwig-Maximilians-Universität, München, Germany **Hospital de Niños Sor Maria Ludovica de La Plata, La Plata, Argentina ††Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA ‡‡Chesterbrook, PA §§Merck & Co., Inc., North Wales, PA ||||Bristol-Myers Squibb Company, Princeton, NJ ¶¶Winter Park, FL.
Barbara
B
Haber
Estella
E
Alonso
Alejandra
A
Pedreira
Norberto
N
Rodriguez-Baez
Mirta
M
Ciocca
Florence
F
Lacaille
Thomas
T
Lang
Teresita
T
Gonzalez
Zachary
Z
Goodman
Zijiang
Z
Yang
Beth
B
Jackson
Stephanie
S
Noviello
Janice K
JK
Albrecht
D000293:Adolescent; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001827:Body Height / Q000187:drug effects*; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006130:Growth Disorders / Q000209:etiology* / Q000517:prevention & control; D016174:Hepacivirus / Q000187:drug effects; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D012254:Ribavirin / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use
D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin