Non-cirrhotic thrombocytopenic patients with hepatitis C virus: characteristics and outcome of antiviral therapy.

Background and Aim: Thrombocytopenia is frequently observed in patients with chronic hepatitis C virus (HCV) infection and cirrhosis, although it can also be observed in patients without cirrhosis by a virus-mediated phenomenon. This study assessed the prevalence, characteristics, and outcomes of antiviral therapy in patients with chronic HCV infection and thrombocytopenia not associated with cirrhosis. Methods: The study included 1268 patients with HCV infection and thrombocytopenia enrolled in the phase 3 ENABLE studies that assessed the impact of eltrombopag on achieving a sustained virologic response to pegylated interferon and ribavirin. The study population was subdivided according to baseline FibroSURE test results into patients with non-cirrhosis (FibroSURE < 0.4) and cirrhosis-related (FibroSURE 65 0.75) thrombocytopenia. Results: Compared with patients with cirrhosis-related thrombocytopenia (n = 995; 78.5%), non-cirrhotic patients with thrombocytopenia (n = 59; 4.6%) were younger (mean age [95% confidence interval (CI)]: 43.9 [40.7\u201347.2] vs 52.7 [52.2\u201353.3] years; P < 0.0001), predominantly female (64% [51\u201376] vs 30% [27\u201333]; P < 0.0001), and less frequently had a Model for End-Stage Liver Disease score 65 10 (24% [14\u201337] vs 45% [42\u201349]; P = 0.0012), low albumin levels ( 64 35 g/L; 2% [0\u20139] vs 32% [29\u201335]; P < 0.0001), and prevalence of diabetes mellitus (3% [0\u201312] vs 21% [19\u201324]; P = 0.0005). The sustained virologic response rate was higher in non-cirrhotic patients with thrombocytopenia (46% [95% CI, 33\u201359] vs 16% [14\u201318]; P < 0.0001). Conclusions: Patients with thrombocytopenia associated with HCV who have lower FibroSURE test results may have better preserved liver function and higher sustained virologic response rates than patients with cirrhosis

Combination of Tenofovir Disoproxil Fumarate and Peginterferon alfa-2a Increases Loss of Hepatitis B Surface Antigen in Patients with Chronic Hepatitis B

Background and aims Patients chronically infected with the hepatitis B virus rarely achieve loss of serum hepatitis B surface antigen (HBsAg) with the standard of care. We evaluated HBsAg loss in patients receiving the combination of tenofovir disoproxil fumarate (TDF) and peginterferon alfa-2a (peginterferon), for a finite duration, in a randomized trial Methods In an open-label, active-controlled study, 740 patients with chronic hepatitis B were randomly assigned to receive TDF plus peginterferon for 48 weeks (group A), TDF plus peginterferon for 16 weeks followed by TDF for 32 weeks (group B), TDF for 120 weeks (group C), or peginterferon for 48 weeks (group D). The primary endpoint was the proportion of patients with serum HBsAg loss at week 72. Results At week 72, 9.1% of subjects in group A had HBsAg loss, compared with 2.8% of subjects in group B, none of the subjects in group C, and 2.8% of subjects in group D. A significantly higher proportion of subjects in group A had HBsAg loss than in group C (P<.001) or group D (P=.003). However, the proportions of subjects with HBsAg loss did not differ significantly between group B and group C (P=.466) or group D (P=.883). HBsAg loss in group A occurred in hepatitis B e antigen-positive and - negative patients with all major viral genotypes. The incidence of common adverse events (including headache, alopecia, and pyrexia) and treatment discontinuation due to adverse events was similar among groups. Conclusion A significantly greater proportion of patients receiving TDF plus peginterferon for 48 weeks had HBsAg loss than those receiving TDF or peginterferon alone. ClinicalTrials.gov no: NCT01277601