Long-term Evaluation of Residual Viremia in a Clinical Trial of Dolutegravir Plus Lamivudine as Maintenance Treatment for Participants With and Without Prior Lamivudine Resistance

Abstract In this pilot clinical trial, we evaluated rates of residual replication in persons without lamivudine resistance-associated mutations in proviral DNA population sequencing who switched to dolutegravir plus lamivudine. After 144 weeks, there was no signal of changes in residual viremia base...

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Published inOpen forum infectious diseases Vol. 9; no. 11; p. ofac610
Main Authors De Miguel Buckley, Rosa, Rial-Crestelo, David, Montejano, Rocío, Pinto, Adriana, Jimenez-Gonzalez, María, Lagarde, Maria, Esteban-Cantos, Andrés, Aranguren-Rivas, Paula, Cadiñanos, Julen, Bisbal, Otilia, Castro, Juan Miguel, Santacreu-Guerrero, Mireia, Bermejo-Plaza, Laura, Moreno, Victoria, Hernando, Asunción, Martín-Carbonero, Luz, Rubio, Rafael, Delgado, Rafael, Arribas, José Ramón, Pulido, Federico
Format Journal Article
LanguageEnglish
Published US Oxford University Press 01.11.2022
Subjects
Brief Report
lamivudine resistance
HIV
next-generation sequencing
dolutegravir plus lamivudine
M184V/I
virologically suppressed
residual viremia
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ISSN2328-8957
2328-8957
DOI10.1093/ofid/ofac610

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Summary:Abstract In this pilot clinical trial, we evaluated rates of residual replication in persons without lamivudine resistance-associated mutations in proviral DNA population sequencing who switched to dolutegravir plus lamivudine. After 144 weeks, there was no signal of changes in residual viremia based on qualitative detection methods, irrespective of past lamivudine resistance. Clinical Trials Registration. NCT03539224.
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J.R.A. and F. P. contributed equally to this work as co–senior authors.
R.D.M. and D. R. contributed equally to this work.
Potential conflicts of interest. R. D. B. received grants from Fondo de Investigaciones Sanitarias (Río Hortega fellowship CM17/00064) during the conduct of the study, and speaker’s fees and nonfinancial support from Janssen, ViiV, and Gilead, outside the submitted work. D. R. received personal fees from Gilead Sciences, nonfinancial support and personal fees from Janssen Cilag, and grants and personal fees from ViiV, outside the submitted work. R. M. received grants from Instituto Salud Carlos III–Fondo Social Europeo (Juan Rodes 18/00039), during the conduct of the study, and personal fees from ViiV, Gilead, and Janssen-Cilag, outside the submitted work. A. P. received honoraria for lectures and for congress activities from ViiV and Gilead Sciences. M. L. received personal fees from Gilead, ViiV, and MSD, outside the submitted work. A. E. received a Contrato predoctoral de formación en investigación de la salud (PFIS) fellowship from Instituto de Salud Carlos III–Fondo Social Europeo (FI17/00194). P. A. received personal fees from ViiV, outside the submitted work. J. C. was supported by a Río Hortega fellowship from Instituto de Salud Carlos III–Fondo Social Europeo (CM19/00059) and received speaker’s fees from Gilead. O. B. received grants from ViiV, a scholarship for expert courses by MSD, and speaker’s fees from Gilead, outside the submitted work. M. S. received advisory fees, speaker’s fees, and grant support from ViiV. V. M. received personal fees from ViiV, Gilead Sciences, and MSD, and personal fees and nonfinancial support from Janssen-Cilag, outside the submitted work. L. M. received advisory fees and speaker’s fees from ViiV, Gilead, Janssen, and MSD. R. R. received personal fees from ViiV, Gilead Sciences, Janssen-Cilag, and MSD, outside the submitted work. R. D. received advisory fees and speaker’s fees from GSK, ViiV, and Gilead. J. R. A. received advisory fees, speaker’s fees, and grant support from ViiV, Janssen, Gilead, MSD, and Aelix. F. P. received advisory fees, speaker’s fees, and grant support from ViiV, Gilead, Janssen, MSD, and Thera. All other authors report no potential conflicts.
ISSN:2328-8957
2328-8957
DOI:10.1093/ofid/ofac610