Group Information: The PHOTON-1 investigators are listed at the end of this article.
Study concept and design: Sulkowski, Brainard, Symonds, Subramanian, McHutchison.
Acquisition, analysis, or interpretation of data: Sulkowski, Naggie, Lalezari, Fessel, Mounzer, Shuhart, Luetkemeyer, Asmuth, Gaggar, Ni, Svarovskaia, Brainard, Symonds, Subramanian, McHutchison, Rodriguez-Torres, Dieterich.
Drafting of the manuscript: Sulkowski, Gaggar, Subramanian, Rodriguez-Torres.
Critical revision of the manuscript for important intellectual content: Sulkowski, Naggie, Lalezari, Fessel, Mounzer, Shuhart, Luetkemeyer, Asmuth, Gaggar, Ni, Svarovskaia, Brainard, Symonds, Subramanian, McHutchison, Rodriguez-Torres, Dieterich.
Statistical analysis: Ni, Subramanian, McHutchison.
Obtained funding: Shuhart.
Administrative, technical, or material support: Asmuth, Svarovskaia.
Study supervision: Sulkowski, Naggie, Shuhart, Gaggar, Brainard, Symonds, Subramanian, McHutchison.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Sulkowski reports receiving research grants and personal and other fees from Gilead, AbbVie, PIPI, Bristol-Myers Squibb, Indenix, Janssen, and Merck. Dr Naggie reports that her university salary is partially supported by AbbVie, Achillion, Bristol-Myers Squibb, Vertex, and Gilead. Dr Mounzer reports receiving consultancy fees from ViiV Healthcare, Gilead, and Johnson & Johnson; grant support from Johnson & Johnson, speakers bureau fees from Gilead, Bristol-Myers Squibb, Johnson & Johnson, and Merck; and travel support for attending advisory board meetings for Gilead, Johnson & Johnson, and ViiV Healthcare. Dr Leutkemeyer reports receiving grants from Bristol-Myers Squibb, Vertex, AbbVie, Gilead, and Pfizer. Drs Gaggar, Svarovskaia, Brainard, Symonds, Subramanian, and McHutchinson reported being employed by Gilead. Dr Rodriquez-Torres reports receiving grant support and personal fees from Gilead, Akros, Boehringer Ingelheim, Bristol-Myers Squibb, Glaxo SmithKine, Indenix, Idera, Inhibitex, Medtronic, Merck, Novartis, Pharmasset, Roach, Santaris, Scynexis, Tibotec, Vertix, ViroChem Pharma, Zymogentics, and Genentech. Dr Dieterich reports receiving grants from Gilead, Bristol-Myers Squibb, Boehringer Ingelheim, Indenix, Merck, and AbbVie. No other disclosures were reported.
Funding/Support: This trial was funded by Gilead Sciences.
Role of the Sponsors: Gilead (the sponsor) provided the study drug. In collaboration with the principal investigator (M.S.S.) and the publication committee (S.N., M.R.T., D.D.), the sponsor designed and conducted the study, collected the data, monitored the conduct of the study, and performed the statistical analyses. The interpretation of the data was performed by the sponsor in concert with the principal investigators and the publication committee. The first draft of the manuscript and all subsequent drafts was prepared by the academic and industry authors, with assistance from a medical writer employed by the sponsor. The decision to submit the manuscript for publication was the responsibility of the principal investigator, the publication committee, and the sponsor. The academic authors vouch for the completeness and accuracy of the data and data analyses and for the fidelity of the study to the protocol.
PHOTON-1 Principal Investigators: (David Asmuth, MD) University of California Davis Medical Center; (Meena Bansal, MD) Mount Sinai School of Medicine; (Maurizio Bonacini, MD) Saint Luke's Hospital; (Eric Daar, MD) Harbor-UCLA Medical Center; (Douglas Dieterich, MD) Mount Sinai School of Medicine; (Craig Dietz, DO) Kansas City Care Clinic; (Richard Elion, MD) Whitman-Walker Clinic; (W. Jeffrey Fessel, MD) Kaiser Permanente; (Timothy Friel, MD) Lehigh Valley Hospital and Health Network; (Joseph Gathe, Jr, MD) Therapeutic Concepts; (David Hardy, MD) Cedars-Sinai Health Systems; (Tarek Hassanein, MD) SCTI Research Foundation; (Trevor Hawkins, MD) Southwest Care Center; (Federico Hinestrosa, MD) Orlando Immunology Center; (Gregory Huhn, MD) The Ruth M. Rothstein CORE Center; (Mamta Jain, MD) UT Southwestern Medical Center; (Dushyantha Jayaweera, MD) University of Miami School of Medicine; (Donald Kotler, MD) St. Luke's Roosevelt Hospital Center; (Jacob Lalezari, MD) Quest Clinical Research; (Anne Luetkemeyer, MD) San Francisco General Hospital; (Claudia Martorell, MD) The Research Institute; (Cynthia Mayer, DO) St. Joseph Comprehensive Research Institute; (Anthony Mills, MD) Private Practice; (Karam Mounzer, MD) Philadelphia FIGHT; (Susanna Naggie, MD) Duke University Medical Center; (Ronald Nahass, MD) I.D. Care, Inc; (Edgar Overton, MD) University of Alabama – Birmingham; (Maribel Rodriguez-Torres, MD) Fundacion De Investigacion; (Peter Ruane, MD) Private Practice; (Margaret Shuhart, MD) Harborview Medical Center; (Mark Sulkowski, MD) Johns Hopkins University; (Diana Sylvestre, MD) Oasis Clinic; (Karen Tashima, MD) The Miriam Hospital; (Pablo Tebas, MD) University of Pennsylvania; (David Wohl, MD) University of North Carolina at Chapel Hill.
Previous Presentations: Presented in part at the 64th annual meeting of the American Association for the Study of Liver Diseases; November 1-5, 2013; Washington, DC; and at the Conference on Retroviruses and Opportunistic Infections (CROI); March 3-6, 2014; Boston, Massachusetts.
Additional Contributions: We thank Maryanne Lenoci and Sherri Paxton of Gilead Sciences for providing clinical operations support and David McNeel, MA, and Kellie Chu of Gilead Sciences for providing editorial support. These persons received no compensation apart from usual salary for their contributions.
Correction: This article was corrected on July 23, 2014, to fix incorrect information in the text, in the Figure, and in Tables 1 and 3.