Study concept and design: Osinusi, Meissner, Heytens, Sneller, Kohli, Fishbein, Symonds, McHutchison, Polis, Fauci, Masur, Kottilil.
Acquisition of data: Osinusi, Meissner, Heytens, Nelson, Sneller, Kohli, Barrett, Kwan, Teferi, Talwani, Silk, Kotb, Wroblewski, Dewar, Highbarger, Zhang, Kleiner, Wood, Chavez, Polis, Masur, Kottilil.
Analysis and interpretation of data: Osinusi, Meissner, Lee, Bon, Nelson, Kohli, Barrett, Proschan, Herrmann, Shivakumar, Gu, Kwan, Zhang, Kleiner, Wood, Symonds, Subramanian, McHutchison, Polis, Fauci, Masur, Kottilil.
Drafting of the manuscript: Osinusi, Meissner, Lee, Bon, Nelson, Gu, Masur, Kottilil.
Critical revision of the manuscript for important intellectual content: Osinusi, Meissner, Bon, Heytens, Sneller, Kohli, Barrett, Proschan, Herrmann, Shivakumar, Teferi, Talwani, Silk, Kotb, Wroblewski, Fishbein, Dewar, Highbarger, Zhang, Kleiner, Wood, Chavez, Symonds, Subramanian, McHutchison, Polis, Fauci, Masur, Kottilil.
Statistical analysis: Osinusi, Bon, Proschan, Herrmann, Shivakumar, Gu, Polis.
Obtained funding: Masur, Kottilil.
Administrative, technical, or material support: Osinusi, Lee, Heytens, Nelson, Sneller, Kohli, Barrett, Kwan, Teferi, Silk, Kotb, Wroblewski, Fishbein, Dewar, Highbarger, Zhang, Wood, Symonds, McHutchison, Polis, Masur, Kottilil.
Study supervision: Osinusi, Kohli, Barrett, Kwan, Fishbein, Wood, McHutchison, Polis, Fauci, Masur, Kottilil.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Herrmann reported that she served as research consultant of Roche Pharma and Novartis. Dr Teferi reported that he serves on the Gilead and Merck Advisory Boards and as a speaker for Gilead. Dr Talwani reported that he has served as a speaker for Merck and performs research funded by Vertex pharmaceuticals. Dr Chavez reported that he is a member of the Regional Advisory Boards for Abbott and Gilead. Drs Symonds, Subramanian, and McHutchison are employees of Gilead Pharmaceuticals. No other disclosures were reported.
Funding/Support: This project was funded in whole by grant HHSN261200800001E from the National Cancer Institute, National Institutes of Health. This research was supported in part by the National Institute of Allergy and Infectious Diseases and by the German Research Foundation by the clinical research unit KFO 129. Pharmasset Pharmaceuticals and subsequently Gilead Sciences provided sofosbuvir and scientific advice.
Role of the Sponsor: The Regulatory Compliance and Human Participants Protection Branch of the National Institute of Allergy and Infectious Diseases (NIAID) served as the study sponsor and was involved in the review and approval of the study via the usual peer-review process as well as the study management. The Regulatory Compliance and Human Participants Protection Branch played no role in the design of the study, data collection, or analysis; interpretation of the data; preparation of the manuscript; or the decision to submit the manuscript for publication.
Disclaimer: The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does the mention of trade names, commercial products, or organizations imply endorsement by the US government.
Previous Presentations: The data from this study have been partially presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting, Boston, Massachusetts; November 13, 2012, and at the 20th Conference on Retroviruses and Opportunistic Infections, CROI 2013, Atlanta, Georgia; March 4, 2013.
Additional Contributions: We thank Katie Watkins BS, Erin Pojunas, BS, and Susan Vogel, RN, BSN (clinical monitoring support), Judith Starling, PharmD (pharmacy), Ashton Shaffer, BS (IL28B genotyping), Michelle Chakrabarti, BS, Jerome Pierson, PhD, John Tierney, BSN, MPM (regulatory support); William Ronnenberg, JD, MIP, MS, Richard Williams, PhD, and Mike Mowatt, PhD (technology transfer support); Barry Eagel, MD, CPI (sponsor medical monitor), John Powers, MD (oversight), and Kenneth Sherman, MD, PhD (independent medical monitor), for their contributions. None have received compensation for their participation.
Correction: This article was corrected on October 10, 2013, to fix a dosing error in the Figure.