A prospective cohort study of renal function and bone turnover in adults with hepatitis B virus (HBV)-HIV co-infection with high prevalence of tenofovir-based antiretroviral therapy use.

"CONFLICTS OF INTEREST AG: nothing to disclose. WCK: grant from Abbvie. ASH: nothing to disclose. RTC: research grants to institution from Abbvie, Gilead Sciences, BMS, Roche, Boehringer, Merck, Janssen and GSK. ML‐M: speaker bureau AbbVie, Gilead. MGG: nothing to disclose. MK: recipient of research grant (to her institution) from Gilead Sciences Inc. and Intercept Pharmaceuticals, and served as a consultant for Gilead Sciences Inc. MKJ: research grant to institution from Gilead Sciences, Janssen and Merck. JG: nothing to disclose. TS‐S: nothing to disclose. DEK: nothing to disclose. MS: consultant Gilead, ViiV, AbbVie, Assembly Bío, Antios Therapeutics, Virion Therapeutics and GSK. DKW: Gilead, BMS, Vertex and Boehringer. RKS: research grants from Gilead, Abbott, Abbvie and Roche to the University. He also has served on Data Safety Monitoring Boards for Pfizer and AskBio."

"Funding information National Institute of Diabetes and Digestive and Kidney Diseases"

"Adult patients in the HBV‐HIV Cohort (N = 139) were recruited from eight sites to participate in this prospective observational cohort study, regardless of type of ART used for HBV or HIV []. While the current analysis was part of the pre‐planned objectives of the study, the target sample size was based on the primary aim to evaluate liver fibrosis progression. The study was not designed or powered to examine the impact of TDF on renal function and bone turnover. The study protocol specified study participants be at least 18 years old, chronically infected with HIV (anti‐HIV‐positive), hepatitis B surface antigen (HBsAg)‐positive for at least 6 months, on cART including an anti‐HBV nucleoside or nucleotide analogue, and agreeable to a liver biopsy within 1 year of study entry and ~3–4 years later [] (Appendix ). Those with decompensated cirrhosis, hepatitis C RNA and hepatocellular carcinoma were excluded. ART could be stopped, initiated or changed at any time per standard of care at the discretion of a treating physician. The institutional review board at each centre approved the protocol, and participants gave written informed consent. Study staff followed detailed manuals of operations to ensure consistency between sites. Data were entered by study coordinators or central laboratories and transmitted the Data Coordinating Center at the University of Pittsburgh, where they were was centrally managed and analysed. The study is registered at ClinicalTrials.gov (NCT01924455)."