scholarly journals Real-Life Experience with Ledipasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Virus Infection with Genotypes 1 and 4 in Children Aged 12 to 17 Years—Results of the POLAC Project

2021 ◽  
Vol 10 (18) ◽  
pp. 4176
Author(s):  
Maria Pokorska-Śpiewak ◽  
Anna Dobrzeniecka ◽  
Małgorzata Aniszewska ◽  
Magdalena Marczyńska

Background: Available real-world data on the efficacy and safety of ledipasvir/sofosbuvir (LDV/SOF) in pediatric patients are limited. In this prospective, open-label, single-center study, we aimed to present our real-life experience with a fixed dose of LDV/SOF (90/400 mg) for the treatment of chronic hepatitis C (CHC) genotypes 1 and 4 in children aged 12 to 17 years. Methods: We analyzed intention-to-treat (ITT) and per-protocol (PP) rates of sustained virological response (SVR), defined as undetectable HCV viral load at posttreatment week 12, in 37 participants treated with LDV/SOF according to the HCV genotype, baseline liver fibrosis, duration of treatment, and experience of the previous ineffective antiviral treatment. There were 32 patients infected with genotype 1 and 5 with genotype 4. Fourteen (38%) participants were treatment-experienced, two were coinfected with HIV, and three were cirrhotic. Two patients qualified for 24 weeks of therapy, and the remaining 35 received 12 weeks of LDV/SOF treatment. Results: The overall ITT SVR12 rate was 36/37 (97%). One patient was lost to follow-up after week 4 of therapy when his HCV RNA was undetectable. All 36 patients who completed the full protocol achieved SVR (36/36, 100%). PP analyses of SVR12 rates according to the HCV genotype, baseline liver fibrosis, duration of the treatment, and previous ineffective treatment were all 100%. A significant decrease in aminotransferase serum levels was observed in the subsequent weeks of the treatment and at SVR assessment compared to baseline. No serious adverse events were reported. Conclusions: The results of this study confirm previous observations of a suitable efficacy and safety profile of LDV/SOF for the treatment of CHC genotypes 1 and 4 in adolescents.

2018 ◽  
Vol 12 (4) ◽  
pp. 348-355 ◽  
Author(s):  
Adel Abdel-Moneim ◽  
Alaa Aboud ◽  
Mohamed Abdel-Gabaar ◽  
Mohamed I. Zanaty ◽  
Mohamed Ramadan

2008 ◽  
Vol 48 ◽  
pp. S292
Author(s):  
M. Diago ◽  
J. Boadas ◽  
R. Planas ◽  
R. Sola ◽  
J.A. del Olmo ◽  
...  

2017 ◽  
Vol 32 (6) ◽  
pp. 1230-1233 ◽  
Author(s):  
Henry Lik‐Yuen Chan ◽  
Owen Tak‐Yin Tsang ◽  
Yee‐Tak Hui ◽  
James Fung ◽  
Grace Chung‐Yan Lui ◽  
...  

2016 ◽  
Vol 16 (4) ◽  
Author(s):  
Nadia Mohamed El-Guendy ◽  
Reham Helwa ◽  
Medhat Salah El-Halawany ◽  
Shimaa Abdel Rahman Ali ◽  
Marwa Tantawy Aly ◽  
...  

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