Generic Ledipasvir-Sofosbuvir Treatment for Adolescents With Chronic Hepatitis C Virus Infection.

We assessed the safety and efficacy of a generic form of ledipasvir-sofosbuvir for the treatment of hepatitis C virus infection in Egyptian adolescents and compared the results with those of treatment with the brand-named form. The generic form resulted in a high response rate, significant improvement in liver function, and mild adverse effects. These results are comparable with those of the brand form at a reduced price.

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 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 1.7:1. 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 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.

Prevalence of hepatic abnormalities in a cohort of Egyptian children with type 1 diabetes mellitus.

BACKGROUND AND AIM: Children with type 1 diabetes mellitus (T1DM) are frequently investigated for hepatic abnormalities. This study was carried out to report on the prevalence of hepatic abnormalities in diabetic children and adolescents and to highlight the possible etiology and appropriate management. METHODS: The study included 692 children (333 were males) with T1DM attending the Diabetes Unit at Cairo University Pediatric Hospital. Their mean age was 9.65 ± 4.18 yr. All children were subjected to clinical examination for hepatomegaly, determination of alanine aminotransferase (ALT) and antibodies to hepatitis C virus (anti-HCV), and abdominal ultrasonography. All children with clinical, laboratory or ultrasound abnormality were counseled about proper glycemic control and followed up. If abnormalities persisted, more detailed investigations were carried out. HCV RNA was done for anti-HCV positive children. RESULTS: Sixty (8.7%) were found to have one or more abnormalities: clinical hepatomegaly in 13 (1.9%), elevated ALT in 27 (3.9%), anti-HCV in 25 (3.6%) and abnormal hepatic ultrasound in 31 (4.5%). Forty percent of anti-HCV positive children were HCV-RNA positive. Glycogenic hepatopathy was diagnosed in three cases by liver biopsy. Abnormalities were reversible in 37/60 after proper glycemic control. CONCLUSION: Although diabetic children are at risk of acquisition of HCV, poor glycemic control is the key factor that predisposes to hepatomegaly, elevated ALT and abnormal ultrasound findings. A 4 to 8-wk therapeutic trial of proper glycemic control is recommended prior to more invasive diagnostic procedures.