Efficacy of 8- versus 12-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C patients eligible for 8-week regimen in a real-world setting.

Abstract

Introduction:

Non-cirrhotic treatment-naive hepatitis C patients infected with genotype 1 can be treated with ledipasvir/sofosbuvir (LDV/SOF) for 8 weeks, but in practice this regimen is frequently extended up to 12 weeks at least in part due to insufficient real-world data supporting shortening of treatment. The aim of our study was to compare 8- and 12-week regimens' efficacy in patients eligible for 8-week therapy in a real-world setting.

Material and methods:

Data of HCV genotype 1 infected patients treated with LDV/SOF between 2015 and 2018 included in the EpiTer-2 database were analyzed with respect to patients' characteristics and length of treatment.

Results:

Among a total of 1718 patients treated with LDV/SOF, 679 were included in the analysis, 238 (35%) received 8-week regimen, whereas 441 were treated for 12 weeks although they fulfilled the criteria for a shorter course. The majority of patients were infected with genotype 1b (89%) and demonstrated minimal fibrosis (55%). The 12-week regimen was assigned significantly more frequently to patients with comorbidities, concomitant medications and advanced liver fibrosis. The sustained virologic response rate was similar after 8 (98%) and 12 (97%) weeks of therapy according to intent-to-treat analysis and reached 99% in both groups after exclusion of patients lost to follow-up.

Conclusions:

We confirmed high effectiveness regardless of treatment duration with LDV/SOF in non-cirrhotics infected with HCV genotype 1 eligible for the 8-week regimen according to the current label. This real-world study also demonstrated no need for addition of ribavirin (RBV) in this population and showed that shortening of treatment significantly improves the safety profile of LDV/SOF medication.

• Authors: Dorota Zarębska-Michaluk, Anna Piekarska, Jerzy Jaroszewicz, Jakub Klapaczyński, Marek Sitko, Magdalena Tudrujek-Zdunek, Krzysztof Tomasiewicz, Teresa Belica-Wdowik, Paweł Pabjan, Beata Lorenc, Agnieszka Czauż-Andrzejuk, Olga Tronina, Rafał Krygier, Witold Dobracki, Iwona Buczyńska, Krzysztof A Simon, Dorota Dybowska, Waldemar Halota, Małgorzata Pawłowska, Jolanta Citko, Łukasz Laurans, Włodzimierz Mazur, Ewa Janczewska, Łukasz Socha, Zbigniew Deroń, Hanna Berak, Robert Flisiak
• Journal: Archives of medical science : AMS (Arch Med Sci) Vol. 18 Issue 6 Pg. 1460-1466 ( 2022) ISSN: 1734-1922 [Print] Poland
• PMID: 36457986 (Publication Type: Journal Article)
• Copyright: Copyright: © 2019 Termedia & Banach.