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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

2019; Termedia Publishing House; Linguagem: Inglês

10.5114/aoms.2019.86569

1896-9151

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 Simon, Dorota Dybowska, Waldemar Halota, Małgorzata Pawłowska, Jolanta Citko, Łukasz Laurans, Włodzimierz Mazur, Ewa Janczewska, Łukasz Socha, Zbigniew Deroń, Hanna Berak, Robert Flisiak,

Liver Disease Diagnosis and Treatment

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.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.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.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.