Overall Survival in Patients with Hepatocellular Carcinoma Treated with Sorafenib: A Polish Experience.

BACKGROUND The mortality caused by hepatocellular carcinoma is expected to rise in the upcoming decade. Sorafenib has become the preferred systemic treatment option in patients with unresectable HCC. This study aimed to present the median overall survival (OS) in a group of patients with advanced HCC, treated with sorafenib in Poland between 2011 and 2019. MATERIAL AND METHODS The analyzed group of patients was qualified for treatment with sorafenib, financed by the National Health Fund, based on the guidelines of the Polish Drug Program. Kaplan-Meier method was used to plot the OS curves, and the log-rank test was used for testing. Multivariate assessment of factors (sex and age) related to the time to death of the patient was done using Cox regression. RESULTS Of the 2072 treated patients, 75% were men (1556) and 25% were women (516). The minimum age of patients in the trial group was 18 years and the maximum age was 90 years. Among the 1556 analyzed cases in males, 27.44% (427) did not end with death (by the date of completing the analysis). The percentage of one-year survival for this population was 58.16%, and the 2-, 3-, and 5-year survival rates were 34.45%, 21.81%, and 9.72%, respectively. The percentage of censored cases in the 516 females was 25.78% (133). The 1-2-, 3-, and 5-year survival for this population was 59.30%, 36.27%, 22.47%, and 11.34%, respectively. Statistical tests did not reveal a significant difference in the curve profiles by sex. There were no associations between OS and age. CONCLUSIONS Systemic treatment with sorafenib in accordance with the presented criteria allows for very good results, comparable to the results of selected groups of patients presented by other authors.

Is Interferon-Based Treatment of Viral Hepatitis C Genotype 3 Infection Still of Value in the Era of Direct-Acting Antivirals?

The aim of the study is to analyze treatments available for patients infected with genotype (G) 3 hepatitis C virus (HCV) in Poland at the beginning of the interferon (IFN)-free era and evaluate the efficacy and safety of different therapeutic options administered in a real-world setting. We analyzed data of 198 patients who started antiviral therapy after July 1, 2015, and completed it before December 31, 2016; 57.6% of them had liver cirrhosis and 46% were treatment experienced. Fifty percent of patients were assigned to sofosbuvir (SOF)+pegylated IFN alfa (PegIFNa)+ribavirin (RBV), 9% to PegIFNa+RBV, 36% received SOF+RBV, and 5% SOF+daclatasvir (DCV)±RBV. Cirrhotic patients were assigned more frequently to IFN-free regimens. Overall, a sustained virological response was achieved by 84.3% of patients in intent-to-treat (ITT) analysis and 87% in modified ITT analysis. For SOF+PegIFNa+RBV and SOF+DCV±RBV regimens, the sustained virologic response (SVR) rate reached at least 90%, whereas the two other therapeutic options demonstrated efficacy <80%. The SVR rate in noncirrhotics was higher than in cirrhotics, irrespective of regimen. Adverse events were documented in 52.5%, with the most common being weakness/fatigue and anemia. We confirmed effectiveness and safety of the SOF-based treatment in a real-world cohort of patients with chronic HCV G3 infection. Most notably, we demonstrated good tolerability and high efficacy of the SOF+PegIFNa+RBV regimen.