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Randomized Controlled Trial
. 2021 Jan 1;72(1):95-100.
doi: 10.1097/MPG.0000000000002900.

Efficacy of Sofosbuvir/Ledipasvir in Adolescents With Chronic Hepatitis C Genotypes 1, 3, and 4: A Real-world Study

Daniele Serranti  1 , Gabriella Nebbia  2 , Mara Cananzi  3 , Emanuele Nicastro  4 , Fabiola Di Dato  5 , Federica Nuti  2 , Silvia Garazzino  6 , Erika Silvestro  6 , Vania Giacomet  7 , Federica Forlanini  7 , Michele Pinon  8 , Pier Luigi Calvo  8 , Silvia Riva  9 , Icilio Dodi  10 , Antonina Marta Cangelosi  10 , Roberto Antonucci  11 , Silvia Ricci  12 , Elisa Bartolini  1 , Greta Mastrangelo  1 , Sandra Trapani  1 , Matteo Lenge  13 , Paola Gaio  3 , Pietro Vajro  14 , Raffaele Iorio  5 , Lorenzo D'Antiga  4 , Giuseppe Indolfi  15
Affiliations
Randomized Controlled Trial

Efficacy of Sofosbuvir/Ledipasvir in Adolescents With Chronic Hepatitis C Genotypes 1, 3, and 4: A Real-world Study

Daniele Serranti et al. J Pediatr Gastroenterol Nutr. .

Abstract

Objectives: Sofosbuvir/Ledipasvir (SOF/LDV) has been approved by the European Medicine Agency (EMA) for the treatment of children and adolescents (at least 3 years of age) with chronic hepatitis C (CHC) genotype 1, 3, and 4 infection. The aim of this study was to evaluate the efficacy and safety of SOF/LDV in adolescents (12 to <18 years old) with CHC in the real-world setting.

Methods: Prospective, open-label, multicentre study involving 12 Italian centres. Patients received the fixed-dose combination of SOF/LDV (400/90 mg) once daily ± ribavirin as per EMA approval and recommendations. The key efficacy endpoint was sustained virological response 12 weeks after the end of treatment (SVR12) as per intention-to-treat analysis. Safety was assessed by adverse events and clinical/laboratory data.

Results: Seventy-eight consecutive adolescents (median age 15.2 years, range 12-17.9; girls 53.8%) were enrolled and treated between June 2018 and December 2019. Genotype distribution was as follows: genotype 1 (82.1%), 3 (2.5%), and 4 (15.4%). Seventy-six (97.4%) patients completed treatment and follow-up. Overall, SVR12 was 98.7%. One patient was lost to follow-up after 4 weeks of treatment; 1 patient completed treatment and missed the follow-up visit. No virological breakthrough or relapse were observed. No patient experienced grade 3 to 4 adverse event or serious adverse event.

Conclusions: The results of this real-world study confirmed the high efficacy and the optimal safety profile of SOF/LDV for treatment of CHC in adolescents.

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References

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