Generic sofosbuvir/ledipasvir for the treatment of genotype 4 chronic hepatitis C in Egyptian children (9-12 years) and adolescents.

Autor: El-Araby HA; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., Behairy BE; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., El-Guindi MA; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., Adawy NM; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., Allam AA; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., Sira AM; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt. asira@liver.menofia.edu.eg., Khedr MA; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., Elhenawy IA; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., Sobhy GA; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., Basiouny HEDM; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., Salem ME; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., Abdel-Aziz SA; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., Fouad OA; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt., Ayoub BA; Department of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Jazyk: angličtina
Zdroj: Hepatology international [Hepatol Int] 2019 Nov; Vol. 13 (6), pp. 706-714. Date of Electronic Publication: 2019 Sep 12.
DOI: 10.1007/s12072-019-09985-w
Abstrakt: Background/purpose of the Study: Worldwide and national efforts are directed against eradication of HCV. The introduction of direct-acting antivirals (DAAs) has changed dramatically the outcome of HCV treatment. In spite of the Food and Drug Administration approval of the oral drugs sofosbuvir (SOF) and ledipasvir (LED) for the treatment of HCV in adolescents more than or equal to 12 years old, sufficient real-world experience is still lacking. The aim of this study was to assess the safety and efficacy of the generic SOF/LED fixed-dose combination 400/90 (400 mg SOF + 90 mg LED) for the treatment of adolescents and children (9-12 years) with chronic hepatitis C (CHC).
Methods: In this prospective observational study, 100 cases of genotype 4 CHC were recruited consecutively from those fulfilling the inclusion and exclusion criteria. All cases received the generic fixed-dose combination SOF/LED (400/90), one tablet daily for 12 weeks. All clinical, laboratory, and virologic characteristics were evaluated at base line, and week (W) 2, 4, 8, and 12 of therapy and W12 post-treatment (SVR12).
Results: Recruited children (9-12) and adolescents weighed 28-83 and 31-90 kg, respectively. Eighty cases were naïve and 20 cases were pegylated interferon/ribavirin treatment-experienced. Very rapid virologic response (vRVR) at W2 was 96%, while at W4 response rate was 100% and maintained till the end of treatment and at W12 post-treatment (SVR12). All reported side effects were mild and did not lead to treatment termination and disappeared at W12 post-treatment.
Conclusion: The generic SOF/LED fixed-dose combination is safe and effective in children, 9-12 years, and adolescents with vRVR rate of 96%, 100% EOT response and SVR12.
Databáze: MEDLINE
Externí odkaz: