The Effectiveness of Ledipasvir/Sofosbuvir in Youth with Genotype 4 Hepatitis C Virus; A Single Egyptian Center Study.

BACKGROUND: Licensure of ledipasvir/sofosbuvir for chronic hepatitis C virus (HCV) infection in adolescents, was based upon 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.

METHOD: 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 1.7:1. 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 was mild.. A reversible increase in creatinine level with a concomitant decline in eGFR 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.

CONCLUSION: Adolescent patients with genotype 4 chronic HCV infection, achieved a good response rate with good on-treatment tolerability for ledipasvir/sofosbuvir therapy.