Safe and effective sofosbuvir-based therapy in patients with mental health disease on hepatitis C virus treatment
Lydia Shuk Yee Tang, Jack Masur, Amy Nelson, Sarah Kattakuzhy, Shyam Kottilil, Institute of Human Virology, Division of Infectious Diseases, University of Maryland School of Medicine, Baltimore, MD 21201, United States
Zayani Sims, Critical Care Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD 20892, United States
Anu Osinusi, Gilead Sciences Inc, Foster City, CA 94404, United States
Anita Kohli, Creighton University School of Medicine, St Joseph’s Hospital, Phoenix, AZ 85013, United States
Michael Polis, Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, United States
Author contributions: Tang LSY, Masur J, Sims Z, Polis M and Kottilil S designed the research; Tang LSY, Masur J, Sims Z, Nelson A, Osinusi A, Kohli A and Kattakuzhy S performed the research; Tang LSY, Masur J, Sims Z and Kattakuzhy S analyzed the data; Tang LSY, Masur J, Sims Z and Kottilil S wrote the paper; all authors contributed critical revisions related to important intellectual content of the manuscript and had final approval of the version of the article to be published.
Institutional review board statement: Each study was approved by the institutional review board of NIAID and was conducted in compliance with the Good Clinical Practice guidelines, the Declaration of Helsinki and regulatory requirements. An independent safety monitor participated in the interim safety and efficacy analysis for SPARE. The Regulatory Compliance and Human Participants Protection Branch of NIAID served as the study sponsor and medical monitor.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Dr. Lydia Shuk Yee Tang receives funding from Gilead Sciences’ Frontlines of Communities in the United States (FOCUS) program. Dr. Anu Osinusi is an employee of Gilead Sciences Inc. None of the other authors have any conflict of interest.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Shyam Kottilil, MD, PhD, Professor of Medicine, Institute of Human Virology, Division of Infectious Diseases, University of Maryland School of Medicine, 725 West Lombard Street, Baltimore, MD 21201, United States. email@example.com
Telephone: +1-410-7068614 Fax: +1-410-7061952
Received: May 29, 2016
Peer-review started: May 29, 2016
First decision: July 29, 2016
Revised: August 19, 2016
Accepted: September 8, 2016
Article in press: September 9, 2016
Published online: November 8, 2016