Post-exposure Lopinavir-Ritonavir Prophylaxis versus Surveillance for Individuals Exposed to SARS-CoV-2: The COPEP Pragmatic Open-Label, Cluster Randomized Trial
MD Niklaus D Labhardt, PhD Mikaela Smit, MD Ianis Petignat, MD, PhD Thomas Perneger, MD Annalisa Marinosci, MD Pilar Ustero, Maria Pia Diniz Ribeiro, MD Silvio Ragozzino, MD Giovanni Jacopo Nicoletti, Pietro Benedetto Faré, MD, PhD Diego O Andrey, MD Frederique Jacquerioz, MD Dan Lebowitz, MD Thomas Agoritsas, PhD Benjamin Meyer, MD Hervé Spechbach, MD Julien Salamun, MD Idris Guessous, MD François Chappuis, MD Laurent Kaiser, PhD Laurent Arthur Decosterd, MD, PhD Beatriz Grinsztejn, MD Enos Bernasconi, MD, PhD Sandra Wagner Cardoso, MD, PhD Alexandra Calmy, For The Copep Study Team
eClinicalMedicine, doi:10.1016/j.eclinm.2021.101188
which was 3-fold more frequent in the LPV/r arm (34/209 [16.3%] vs 6/109 [5.5%], respectively). During 21day follow-up, 48/318 (15.1%) participants developed in the LPV/r group and 13/ 109 (11.9%) in the surveillance group (unadjusted hazard ratio 1.44; 95% CI, 0.76-2.73). In the primary endpoint analysis, which was adjuted for baseline imbalance, the hazard ratio for developing COVID-19 in the LPV/r group vs surveillance was 0.60 (95% CI, 0.29-1.26; p =0.18). Interpretation: The role of LPV/r as PEP for COVID-19 remains unanswered. Although LPV/r over 5 days did not significantly reduce the incidence of COVID-19 in exposed individuals, we observed a change in the directionality of the effect in favour of LPV/r after adjusting for baseline imbalance. LPV/r for this indication merits further testing against SARS-CoV-2 in clinical trials.
Author contributions AC and TP had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Data sharing statement Anonymized data set with core-data from the trial will be made available on Zenodo upon publication of the manuscript. The full dataset will be available upon reasonable request to the corresponding author.
Declaration of Competing Interest Dr. Niklaus D Labhardt reports support for attending CROI conference 2020 and AIDS conference 2020 by Gilead Sciences, support for attending CROI Conference 2021 by ViiV healthcare, and participation on a Data Safety Monitoring Board for the C1 6201 PROTECT trial by Pharming Group NV. Dr. Mikaela Smit reports scientific grants at Imperial College London by CDRF (prime is PEPFAR) and NIH, and consulting fees for modeling consulting by Gilead Sciences, IAS, Maple Health. Dr. Enos Bernasconi reports grants from Merck & Co. and Swiss National Science Foundation, consulting fees and support for attending meeting by Gilead Sciences, Merck & Co., ViiV healthcare, Pfizer AG, Abbvie, paid to the Lugano Regional Hospital. Dr. Alexandra Calmy reports grant from MSD for qualitative research on women and clinical trials, and unrestricted grant from Gilead, ViiV Healthcare, MSD and SIDAIDE foundation related to the funding support to LIPO and metabolims Day Hospital at Geneva University Hospitals. All other authors have nothing to disclose.
..
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