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

Abstract

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.

Real World Experience of Chronic Hepatitis C Retreatment with Genotype Specific Regimens in Nonresponders to Previous Interferon-Free Therapy

“…They were selected from the EpiTer-2, an investigator-initiated study, supported by the Polish Association of Epidemiologists and Infectiologists, which included 22 Polish centres involved in diagnosis and treatment of HCV-infected patients. As presented in the previous publications from the EpiTer-2 study data of consecutive patients who started antiviral therapy after 1 July, 2015, and completed before December 2017 were collected retrospectively with a web-based questionnaire [ 6 – 8 ]. Patients were treated in the therapeutic programme reimbursed by the National Health Fund and consented for treatment and medical procedures according to the standard of care and their data were entered retrospectively into the EpiTer-2 database.…”

Real‐world effectiveness and safety of direct‐acting antivirals in patients with cirrhosis and history of hepatic decompensation: Epi‐Ter2 Study

“…Once cirrhosis is established, the annual risk of hepatic decompensation is 3%‐6% and after the episode of decompensation, the risk of death in the following year reaches up to 15%‐20% 2 . The introduction of highly effective direct‐acting antiviral agents (DAAs) with high sustained virologic response (SVR) rates, short duration of treatment and few side effects has revolutionized antiviral treatment for CHC and reduced the risk of progression of liver disease 3 . However, despite good safety profiles and high efficacy of DAAs, there are patients who remain at substantial risk of treatment failure, discontinuation or severe adverse events.…”

“…2 The introduction of highly effective direct-acting antiviral agents (DAAs) with high sustained virologic response (SVR) rates, short duration of treatment and few side effects has revolutionized antiviral treatment for CHC and reduced the risk of progression of liver disease. 3 However, despite good safety profiles and high efficacy of DAAs, there are patients who remain at substantial risk of treatment failure, discontinuation or severe adverse events. This holds particularly true for the most difficult-to-treat group of individuals with already decompensated cirrhosis, since although successful hepatitis C virus (HCV) treatment can improve hepatic function in the majority of patients over the short term with 60% of patients achieving improvement in model for end-stage liver disease (MELD) score, up to 23% patients may experience worsening of the disease.…”