The effect of sorafenib on overall survival may depend on the hepatitis status of patients with advanced hepatocellular carcinoma (HCC), according to a study published in the Journal of Clinical Oncology.1

Findings from the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol (SHARP) trial led to sorafenib becoming the standard of care for patients with advanced unresectable HCC.

To assess the unclear relationship between disease etiology and survival, researchers conducted a meta-analysis of 3 large prospective randomized trials that included sorafenib as the control arm. Investigators analyzed data from 3256 patients, 50% of whom received sorafenib.

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Patients who were both hepatitis B virus (HBV) negative and hepatitis C virus (HCV) positive had a lower risk of death than patients with other viral statuses (log [hazard ratio], −0.27; 95% CI, −0.46-−0.06).

Among patients who were HBV negative and HCV positive, median overall survival for those treated with sorafenib was 12.6 months compared with 10.2 months for patients treated with other agents, which included brivanib, sunitinib, and linifanib.

Patients with other hepatitis statuses, such as HBV positive and HCV negative, did not have any improvement in overall survival attributable to sorafenib.

The authors hypothesize that HCV proteins modulate the expression of microRNAs, influencing the sensitivity of HCC cells to sorafenib.

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These findings suggest that researchers should stratify by etiology in future trials of advanced HCC, especially when sorafenib is used as the control arm.


  1. Jackson R, Psarelli E-E, Berhane S, Khan H, Johnson P. Impact of viral status on survival in patients receiving sorafenib for advanced hepatocellular cancer: A meta-analysis of randomized phase III trials. J Clin Oncol. 2017 Jan 3. doi: 10.1200/JCO.2016.69.5197 [Epub ahead of print]