Author Contributions: Dr Holmes had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Holmes, Granich, Ryan, Moloney-Kitts, Dybul.
Acquisition of data: Holmes, Coggin, Jamieson, Mihm, Granich, Savio, Hope.
Analysis and interpretation of data: Holmes, Coggin, Jamieson, Granich, Savio, Goosby, Dybul.
Drafting of the manuscript: Holmes, Coggin, Granich, Ryan, Dybul.
Critical revision of the manuscript for important intellectual content: Holmes, Coggin, Jamieson, Mihm, Granich, Savio, Hope, Moloney-Kitts, Goosby, Dybul.
Statistical analysis: Holmes, Jamieson.
Obtained funding: Coggin, Granich, Dybul.
Administrative, technical, or material support: Holmes, Coggin, Jamieson, Mihm, Granich, Hope, Ryan, Moloney-Kitts, Dybul.
Study supervision: Coggin, Granich, Ryan, Moloney-Kitts, Goosby, Dybul.
Financial Disclosures: Dr Holmes reports that prior to serving in his current capacity of employment for the US Department of State, that he worked from July 2006-January 2008 in HIV clinical research for Gilead Sciences, a biotechnology firm that manufactures tenofovir; and that he was also a stockholder during that time. The other authors report no disclosures.
Funding/Support: This study was funded by the President's Emergency Plan for AIDS Relief (PEPFAR) of the US government.
Role of the Sponsor: PEPFAR funded this study and US government employees led all elements of design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.
Previous Presentations: This research was presented in part in a report to Congress, “Report to Congress by the US Global AIDS Coordinator on the Use of Generic Drugs in the President's Emergency Plan for AIDS Relief,” May, 2008; and at the 16th Conference on Retroviruses and Opportunistic Infections, February 8-11, 2009, Montréal, Canada, Measuring Progress in Reducing the Costs of ARV Drugs Purchased by the President's Emergency Plan for AIDS Relief, 2005 to 2007.
Additional Contributions: We would like to acknowledge the ongoing contributions of the PEPFAR country teams, implementing partners, and PEPFAR technical working groups in support of National HIV treatment programs; and Sophia Zilber, MA, Policy Analysis Inc (acting in personal capacity as a biostatistical consultant; services provided without compensation) for technical guidance.