The Effectiveness of Ledipasvir/Sofosbuvir in Youth With Genotype 4 Hepatitis C Virus: A Single Egyptian Center Study.
Pediatr Infect Dis J
; 38(1): 22-25, 2019 01.
Article
in En
| MEDLINE
| ID: mdl-30234791
ABSTRACT
BACKGROUND:
Licensure of ledipasvir/sofosbuvir for chronic hepatitis C virus (HCV) infection in adolescents was based on clinical trials on patients mainly with genotype 1. We aimed to evaluate the effectiveness and short-term safety of this newly approved antiviral in adolescents with HCV genotype 4.METHODS:
This was a study of 51 HCV-infected adolescents, who received the adult dose of ledipasvir/sofosbuvir, once daily for 12 weeks, and were followed-up for 12 weeks post-treatment. Laboratory tests, quantitation of HCV RNA, HCV genotyping, IL-28rs gene polymorphism and transient elastography were performed at baseline. Follow-up visits were done for blood testing and adverse events recording.RESULTS:
The mean age was 14.7 ± 1.5 years (11-17.5), with a male to female ratio of 1.71. All patients were genotype 4a, and 76.5% had the CC IL-28 gene polymorphism. About 50% gave a history of HCV-infected mother, and 31% were treatment-experienced. Liver stiffness was F0 in 72.5%, F0-F1 in 13.7% and F1-F2 in 13.7%. Adverse events were mainly abdominal pain in 72.5%, headache in 64.7% and diarrhea in 53% of patients; these were mild. A reversible increase in creatinine level with a concomitant decline in estimated glomerular filtration rate was observed in the first month of treatment. By the end of week 12, a significant decline in liver enzymes was observed. All patients achieved an early, end of treatment, and a sustained virologic response.CONCLUSIONS:
Adolescent patients with genotype 4 chronic HCV infection achieved a good response rate with good ontreatment tolerability for ledipasvir/sofosbuvir therapy.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Antiviral Agents
/
Uridine Monophosphate
/
Benzimidazoles
/
Hepatitis C, Chronic
/
Fluorenes
Type of study:
Observational_studies
Limits:
Adolescent
/
Child
/
Female
/
Humans
/
Male
Country/Region as subject:
Africa
Language:
En
Journal:
Pediatr Infect Dis J
Journal subject:
DOENCAS TRANSMISSIVEIS
/
PEDIATRIA
Year:
2019
Document type:
Article
Affiliation country: