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Article

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

by
Maria Pokorska-Śpiewak
1,2,*,
Anna Dobrzeniecka
2,
Małgorzata Aniszewska
1,2 and
Magdalena Marczyńska
1,2
1
Department of Children’s Infectious Diseases, Regional Hospital of Infectious Diseases in Warsaw, Medical University of Warsaw, Wolska Str. 37, 01-201 Warsaw, Poland
2
Department of Pediatric Infectious Diseases, Regional Hospital of Infectious Diseases in Warsaw, 01-201 Warsaw, Poland
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2021, 10(18), 4176; https://doi.org/10.3390/jcm10184176
Submission received: 12 August 2021 / Revised: 13 September 2021 / Accepted: 14 September 2021 / Published: 15 September 2021
(This article belongs to the Special Issue Chronic HCV Infection: Clinical Advances and Eradication Perspectives)

Abstract

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.
Keywords: children; hepatitis C; ledipasvir/sofosbuvir; real-life; sustained virological response children; hepatitis C; ledipasvir/sofosbuvir; real-life; sustained virological response

Share and Cite

MDPI and ACS Style

Pokorska-Śpiewak, M.; Dobrzeniecka, A.; Aniszewska, M.; Marczyńska, M. 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. J. Clin. Med. 2021, 10, 4176. https://doi.org/10.3390/jcm10184176

AMA Style

Pokorska-Śpiewak M, Dobrzeniecka A, Aniszewska M, Marczyńska M. 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. Journal of Clinical Medicine. 2021; 10(18):4176. https://doi.org/10.3390/jcm10184176

Chicago/Turabian Style

Pokorska-Śpiewak, Maria, Anna Dobrzeniecka, Małgorzata Aniszewska, and Magdalena Marczyńska. 2021. "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" Journal of Clinical Medicine 10, no. 18: 4176. https://doi.org/10.3390/jcm10184176

APA Style

Pokorska-Śpiewak, M., Dobrzeniecka, A., Aniszewska, M., & Marczyńska, M. (2021). 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. Journal of Clinical Medicine, 10(18), 4176. https://doi.org/10.3390/jcm10184176

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