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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.
| Content Provider | Europe PMC |
|---|---|
| Author | Zarębska-Michaluk, Dorota Piekarska, Anna Jaroszewicz, Jerzy Klapaczyński, Jakub Sitko, Marek Tudrujek-Zdunek, Magdalena Tomasiewicz, Krzysztof Belica-Wdowik, Teresa Pabjan, Paweł Lorenc, Beata Czauż-Andrzejuk, Agnieszka Tronina, Olga Krygier, Rafał Dobracki, Witold Buczyńska, Iwona Simon, Krzysztof A. Dybowska, Dorota Halota, Waldemar Pawłowska, Małgorzata Citko, Jolanta Laurans, Łukasz Mazur, Włodzimierz Janczewska, Ewa Socha, Łukasz Deroń, Zbigniew Berak, Hanna Flisiak, Robert |
| Copyright Year | 2019 |
| Abstract | IntroductionNon-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 methodsData 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.ResultsAmong 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.ConclusionsWe 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. |
| ISSN | 17341922 |
| Journal | Archives of Medical Science : AMS |
| Volume Number | 18 |
| PubMed Central reference number | PMC9710286 |
| Issue Number | 6 |
| PubMed reference number | 36457986 |
| e-ISSN | 18969151 |
| DOI | 10.5114/aoms.2019.86569 |
| Language | English |
| Publisher | Termedia Publishing House |
| Publisher Date | 2019-07-11 |
| Access Restriction | Open |
| Rights License | This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license. Copyright: © 2019 Termedia & Banach |
| Subject Keyword | hepatitis C sofosbuvir genotype 1 ledipasvir treatment-naïve |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
