Document is current

Article History

Accepted: 2 September 2021

First Online: 21 September 2021

Declarations

:

: This work was supported by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

: LB, JSF and GPF are employees of Epividian, Inc. Epividian has had research funded by Merck & Co., ViiV Healthcare, Janssen Pharmaceuticals, Gilead Sciences, and AIDS Healthcare Foundation. PM has received research grants from ViiV Healthcare, Gilead Sciences and Janssen Cilag; speaker honoraria from ViiV Healthcare, Gilead Sciences, Janssen Cilag, BMS. and MSD; and advisory board participation from ViiV Healthcare, Gilead Sciences, Janssen Cilag, BMS and MSD. MBW has participated in post-conference advisory boards for the Conference on Retroviruses and Opportunistic Infections (CROI) and International AIDS Conference (IAC) and also serves as a principal investigator on ViiV Healthcare clinical trials but does not receive personal compensation for this work, which goes directly to the AIDS Healthcare Foundation. MBW is also a member of the Epidemiology and Clinical Advisory Board for Epividian. AB and GP are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

: OPERA® complies with all HIPAA and HITECH requirements and receives annual institutional review board approval by Advarra IRB, including a waiver of informed consent and authorization for use of protected health information.

: Not applicable

: Not applicable

: The datasets generated and analyzed during the current study are not publicly available due to their proprietary nature, but access may be granted with parties agreeing to privacy restrictions and technological specifications and requirements.

: Access to codes may be granted upon request with parties agreeing to privacy restrictions and technological specifications and requirements.

: LB, PM, JSF, GP and AB contributed to the study conception and design. JSF, MBW and GPF contributed to the acquisition of data. LB performed the statistical analyses. All authors contributed to the interpretation of results. LB wrote the first draft of the manuscript. All authors read and approved the final manuscript.