Issue: December 2015
November 16, 2015
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TNF-alpha may predict patient reported mental health outcomes

Issue: December 2015
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SAN FRANCISCO — After adjusting for a number of factors, tumor necrosis factor-alpha was the only variable that predicted poor patient-reported mental health outcomes in a cohort of patients with genotype 1 HCV, according to findings presented at The Liver Meeting 2015.

Zobair Younossi, MD, of the Center for Liver Diseases, Inova Fairfax Hospital, and Linda Henry, PhD, with colleagues from the Center for Outcomes Research in Liver Disease, investigated possible associations between pro-inflammatory cytokines and patient reported mental health outcomes in a cohort of 100 patients. Eligible participants were treated with Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) with or without ribavirin. Half of the cohort received ribavirin, while half did not.

Zobair Younossi, MD, MPH

Zobair Younossi

Patients completed the Role Emotional (RE), Mental Health (MH) and Mental Component Summary of SF-36, Emotional Well-being of FACIT-F, and Emotional domain of CLDQ-HCV.

Clinicians analyzed frozen serum for interleukins 1, 1 ra, 8, 10, tumor necrosis factor-alpha (TNF-alpha), interferon-gamma, monocyte chemotactic protein 1/chemokine ligand 2, granulocyte colony stimulating factor, vaso-endothelial and platelet-derived growth factors, according to the Henry.

“We looked at all of these factors and compared them with how the patients reported that they were feeling,” Henry said.

In an adjusted analysis that accounted for a history of anxiety before treatment, the researchers reported that serum TNF-alpha level was the most consistent independent biomarker predictor of lower on-treatment mental health patient reported outcomes (P < .05).

On-treatment anemia was more common in the ribavirin arm, 10% vs. 0% (P = .02). Psychiatric adverse events (26% vs. 10%; P = .04) and skin events (22% vs. 6%, P = .02) also were more common among patients receiving ribavirin.

“There is increasing data that suggest that ribavirin has neuropsychiatric side effects. This research is one of the first to connect serum cytokines of HCV-infected patients to the development of these outcomes” Younossi said. “More research is underway to better understand the interaction of HCV, its treatment with cytokines and brain function.” – Rob Volansky

Reference:

Younossi ZM, et al. Abstract 316. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.

Disclosures: Henry reports no relevant financial disclosures. Younossi reports being on the advisory committees or review panels of Janssen, Salix and Vertex and consulting for Coneatus, Enterome and Gilead. Please see abstract for all other authors’ disclosures.