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Clinical Trial
. 2022 May 1;74(5):626-630.
doi: 10.1097/MPG.0000000000003406. Epub 2022 Feb 10.

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

Manal Hamdy El-Sayed  1   2 , Fatma S Elsayed Ebeid  1   2 , Abdel-Rahman Zekri  3 , Benedetta Massetto  4 , Kathryn Kersey  4 , Fangqiu Zhang  4 , Anuj Gaggar  4 , Walaa Elsayed  5 , Alaa El-Haddad  5
Affiliations
Clinical Trial

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

Manal Hamdy El-Sayed et al. J Pediatr Gastroenterol Nutr. .

Abstract

Objectives: In children with hematological malignancies, chronic hepatitis C virus (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 12weeks in these patients.

Methods: In a phase 2, open-label study, at one site in Egypt, patients ages 12-<18years with chronic HCV genotype 1 or 4 infection undergoing maintenance chemotherapy for hematological malignancies received ledipasvir-sofosbuvir (90 mg/400 mg) once daily for 12weeks. 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 alanine aminotransferase >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% confidence interval, 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 (two patients), and osteoarthritis and diarrhea (one 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.

Trial registration: ClinicalTrials.gov NCT02868242.

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Conflict of interest statement

Conflicts of Interest: ManalHamdy El-Sayedhas servedas a speaker forAbbott, Gilead Sciences, and Biotest. Fatma S. Elsayed Ebeid, Abdel-Rahman Zekri, Walaa Elsayed, and Alaa El-Haddad declare no conflicts of interest. Benedetta Massetto, Kathryn Kersey, Fangqiu Zhang, and Anuj Gaggar are employees and own stock in Gilead Sciences.

References

    1. Ministry of Health and Population [Egypt] E-ZaAE, and ICF International. Egypt Health Issues Survey 2015. Cairo, Egypt and Rockville, MD, USA: Ministry of Health and Population and ICF International; 2015.
    1. Said ZN, El-Sayed MH, El-Bishbishi IA, et al. High prevalence of occult hepatitis B in hepatitis C-infected Egyptian children with haematological disorders and malignancies. Liver Int 2009; 29:518–524.
    1. Schmelzer J, Dugan E, Blach S, et al. Global prevalence of hepatitis C virus in children in 2018: a modelling study. Lancet Gastroenterol Hepatol 2020; 5:374–392.
    1. Firpi RJ, Nelson DR. Management of viral hepatitis in hematologic malignancies. Blood Rev 2008; 22:117–126.
    1. Gigliotti AR, Fioredda F, Giacchino R. Hepatitis B and C infection in children undergoing chemotherapy or bone marrow transplantation. J Pediatr Hematol Oncol 2003; 25:184–192.

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