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Interferon Free Therapy with and Without Ribavirin for Genotype 1 HCV Cirrhotic Patients in the Real World Experience

2018; Kowsar Publishing; Volume: 18; Issue: 8 Linguagem: Inglês

10.5812/hepatmon.80761

1735-3408

Dorota Zarębska‐Michaluk, Jerzy Jaroszewicz, Ewa Janczewska, Hanna Berak, Andrzej Horban, Marek Sitko, Aleksander Garlicki, Beata Dobracka, Agnieszka Czauż‐Andrzejuk, Dorota Dybowska, Waldemar Halota, Małgorzata Pawłowska, Magdalena Tudrujek‐Zdunek, Krzysztof Tomasiewicz, Włodzimierz Mazur, Zbigniew Deroń, Teresa Belica‐Wdowik, Barbara Baka‐Ćwierz, Iwona Buczyńska, Krzysztof Simon, Anna Piekarska, Jolanta Białkowska, Beata Lorenc, Rafał Krygier, A. Staniaszek, Jakub Klapaczyński, Jolanta Citko, Łukasz Socha, Marta Wawrzynowicz‐Syczewska, Łukasz Laurans, Robert Flisiak,

Hepatitis B Virus Studies

Background: In the interferon era, patients with HCV-related cirrhosis were considered hard to treat due to contraindications to therapy, safety issues, and poor response. Objectives: We investigated interferon-free regimens in cirrhotic patients in real-world practice. Methods: We analyzed data of HCV infected patients with liver cirrhosis conducted in 22 Polish hepatology centers. They were assigned to a treatment schedule based on physician decision. Data were collected retrospectively by an online questionnaire. Results: In total, 1113 patients infected with genotype 1 HCV were enrolled to the analysis, 96.6% presented GT1b infection. A total of 56% were treatment-experienced, mostly with PegIFN + RBV, 77.2% of group presented comorbidities with the most frequent hypertension and diabetes,73.2% patients were treated with concomitant medications, and 31% of cohort was assigned to RBV-free regimen, majority of them to OBV/PTV/r + DSV. Overall, 94.7% patients achieved the sustained virological response in intent-to-treat analysis, with comparable rate for RBV-free and RBV-containing options (94.2% vs. 94.9%). Treatment course was more often modified in RBV-containing group, whereas rate of discontinuation was the same for both cohorts. Adverse events were observed in 41% with the most common weakness/fatigue; more frequently in RBV-containing regimens (43% vs. 36.6%). Serious adverse events were reported in 4.1% patients. A total of 16 deaths not related to study drugs were documented, mostly in RBV-containing group. Conclusions: We confirmed effectiveness of the interferon-free regimens without ribavirin in real-world cohort of cirrhotic patients with chronic HCV infection genotype 1. Therapy was well tolerated with infrequent adverse events.