United States Ending the Human Immunodeficiency Virus (HIV) Epidemic Plan: Evaluation of the Role of Industry Funding in Published Pre-Exposure Prophylaxis (PrEP) Literature

Background: Pre-exposure prophylaxis (PrEP) is integral to the US End of AIDS strategy. However, low adherence, high costs, frequent testing and monitoring side effects make delivery of PrEP complicated. Gilead has sponsored PrEP-related research and access as part of its marketing efforts. We review conflict of interests (COI) in the scientific literature for the US PrEP-related articles to understand the impact of Gilead’s corporate sponsorship. Methods: We searched PubMed for US PrEP articles published in 2018 in the top 10 medical journals and top 10 HIV/AIDS journals and abstracted information on author/institutional COI, type of COI, and favorability of results and conclusions. We identified first three and senior authors from the articles and the leading institutions, defined as institution of three or more authors or participating institutions in a trial. We conducted on searches Google, PubMed, ClinicalTrials.gov, OpenPaymentsData.cms.gov, others to identify potential Gilead support to authors and institutions. Findings: Our search identified 93 articles. Of the 289 first three and senior authors in these articles, 34 (11%) declared a Gilead COI and 28 (10%) had undeclared Gilead COI. There were 51 leading institutions, of which, 12 (24%) declared Gilead COI and 22 (45%) had undeclared COI. Overall, 30 (32%) of the 93 articles had declared Gilead COI. Combining declared and undeclared COIs for authors and institutions provided an overall 83 (89%) articles with a potential Gilead COI. Declared Gilead support was significantly associated with favorable conclusions (p<.05) but combined declared/undeclared author and/or institutional Gilead support wasn’t. Interpretation: Nearly 90% of US PrEP articles had Gilead support but authors failed to report COI in 70% articles. Direct corporate support is important for scientific research. However, Gilead’s marketing push for PrEP, undeclared COI, and potential influence of Gilead supported authors are concerning given the potential impact on US’s HIV control strategy. Funding: None Declaration of Interests: None related to this work.