https://pubmed.ncbi.nlm.nih.gov/35149641/ Hepatitis C

J Pediatr Gastroenterol Nutr. 2022 Feb 10.
doi: 10.1097/MPG.0000000000003406.Online ahead of print.

Ledipasvir-sofosbuvir in Adolescents with Chronic Hepatitis C and Hematological Malignancies Undergoing Chemotherapy

Manal Hamdy El-Sayed 1, Fatma S Elsayed Ebeid, Abdel-Rahman Zekri, Benedetta Massetto, Kathryn Kersey, Fangqiu Zhang, Anuj Gaggar, Walaa Elsayed, Alaa El-Haddad

Abstract

Objectives: In children with hematological malignancies, chronic HCV infection has been associated with more rapid liver disease progression and higher risk of malignancy relapse due to chemotherapy interruption. We evaluated the safety and efficacy of ledipasvir-sofosbuvir for 12 weeks in these patients.

Methods: In a phase 2, open-label study, at one site in Egypt, patients aged 12-<18 years with chronic HCV genotype 1 or 4 infection undergoing maintenance chemotherapy for hematological malignancies received ledipasvir-sofosbuvir (90 mg/400 mg) once daily for 12 weeks. The efficacy endpoint was sustained virologic response 12 weeks after treatment (SVR12). Safety was assessed by the incidence of adverse events and clinical and laboratory data, including HCV flares defined as ALT ≥3-fold increase from Day 1 and HCV RNA elevation ≥1 × log10 from Day 1.

Results: Of the 19 adolescents enrolled and treated, median age was 14 years (range 12-17), 84% (16/19) were male, and all had HCV genotype 4 and were HCV treatment naive. All patients completed treatment and achieved SVR12 (19/19, 100%, 95% CI, 82-100). Common adverse events were pyrexia (5/19, 26%), diarrhea (4/19, 21%), and headache (4/19, 21%). Three patients experienced serious adverse events of pneumonia (2 patients), and osteoarthritis and diarrhea (1 patient); none were considered related to study drug. No patient experienced HCV flares
.
Conclusions: Ledipasvir-sofosbuvir was well-tolerated and efficacious in adolescents with chronic HCV genotype 4 and leukemia undergoing maintenance chemotherapy. These data support the use of this interferon-and ribavirin-free regimen in adolescents with hematological malignancies.