Format

Send to

Choose Destination
J Pediatr Gastroenterol Nutr. 2018 Jul;67(1):86-89. doi: 10.1097/MPG.0000000000001968.

Dual Sofosbuvir/Daclatasvir Therapy in Adolescent Patients With Chronic Hepatitis C Infection.

Author information

1
Internal medicine and Hepatology, Green CRC, Alexandria.
2
Paediatric Hepatology Department, Cairo Faculty of Medicine, Cairo.
3
Paediatric Hepatology Department, Alexandria Faculty of medicine.
4
Innovations & Research, Pharco Corporation.
5
Tropical medicine and Hepatology Department, Alexandria Faculty of Medicine, Alexandria.
6
Gastroenterology and Endemic Medicine Department, Theodore Research Institute, Cairo, Egypt.

Abstract

OBJECTIVES:

Dual sofosbuvir/daclatasvir (SOF/DCV) therapy is currently recommended by the European Association for Study of Liver (EASL) as an option for the treatment of chronic hepatitis C virus (HCV) infection in adults for all genotypes; however, it is still not considered for patients younger than 18 years old. We aimed to test safety and efficacy of SOF/DCV in adolescent patients 12 to 17 years old with chronic HCV, genotype 4 infection.

METHODS:

We conducted a prospective, uncontrolled, open-label multicenter study. A total of 30 chronic HCV-infected adolescents, aged from 12 to 17 years old were included and treated with dual SOF/DCV for 12 weeks. Patients were monitored throughout the treatment and follow-up period for safety and efficacy outcome measures including the sustained virologic response 12 (SVR12) rate.

RESULTS:

The intention-to-treat (ITT) SVR12 rate was 29 of 30 (96.7%; 95% confidence interval [CI] 83.3%-99.4%). The only patient who did not achieve SVR12 was lost to follow-up after showing viral negativity at the end of treatment (EOT) visit. Whereas all the remaining 29 patients (100%, 95% CI 88.3%-100%) who completed the follow-up visits achieved SVR12. All patients showed normalized liver enzymes with normal hematological, liver and renal function tests at the end of the study. No fatalities or treatment-emergent serious or severe adverse events were reported throughout the study.

CONCLUSIONS:

SOF/DCV combined therapy could be a safe and effective treatment in adolescent patients 12 to 17 years old with chronic HCV genotype 4 infection. (See Video, Supplemental Digital Content, http://links.lww.com/MPG/B348).

Supplemental Content

Full text links

Icon for Wolters Kluwer
Loading ...
Support Center