TY - JOUR
T1 - Impact of early antiretroviral therapy on detection of cell-associated HIV-1 nucleic acid in blood by the Roche Cobas TaqMan test
AU - on behalf of the RV254/SEARCH010 Study Team
AU - Jagodzinski, Linda L.
AU - Manak, Mark M.
AU - Hack, Holly R.
AU - Liu, Ying
AU - Malia, Jennifer A.
AU - Freeman, Joanna
AU - Phanuphak, Nittaya
AU - De Souza, Mark
AU - Kroon, Eugène D.
AU - Colby, Donn J.
AU - Chomchey, Nitiya
AU - Lally, Michelle A.
AU - Michael, Nelson L.
AU - Ananworanich, Jintanat
AU - Peel, Sheila A.
N1 - Publisher Copyright:
© 2019 American Society for Microbiology. All rights reserved.
PY - 2019/5
Y1 - 2019/5
N2 - The Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test, v2.0 (the CAP/ CTM assay), was used to quantify cell-associated HIV-1 (CAH) nucleic acid in peripheral blood mononuclear cells (PBMC) from well-characterized clinical specimens from HIV-1-infected individuals on antiretroviral therapy (ART). Chronically infected individuals on ART with no detectable plasma HIV-1 RNA demonstrated average CAH burdens of 3.2 HIV-1 log10 copies/million cells. Assay sensitivity and specificity were 98.9% and 100%, respectively, with the positive and negative predictive values being 100% and 98.6%, respectively. The CAH burden was also measured at weeks 0, 1, 2, 8, and 60 in 37 participants (RV254/SEARCH010, Bangkok, Thailand) stratified by Fiebig stage (Fiebig stage I [FI] to FVI) at ART initiation. Prior to ART initiation, the average CAH burden was 1.4, 4.1, and 3.6 log10 copies/million PBMCs for individuals who initiated ART at FI, FII, and FIII to FVI, respectively. Initiation of ART resulted in a rapid decline of CAH in all individuals, with the greatest decrease being observed in individuals who initiated ART at FI to FIII. By week 60, 100% (FI), 71.8% (FII/FIII), and 20.5% (FIV to FVI) of samples from individuals initiating treatment were at or near the limit of quantitation. Residual CAH was detectable at 60 weeks in most individuals who initiated ART at later stages (FIV to FVI) and averaged 1.9 0.7 log10 copies/ million PBMCs. The modified Roche CAP/CTM assay provides a convenient, standardized approach to measure residual HIV in blood and may be useful for monitoring patients under therapy or those participating in HIV remission studies.
AB - The Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test, v2.0 (the CAP/ CTM assay), was used to quantify cell-associated HIV-1 (CAH) nucleic acid in peripheral blood mononuclear cells (PBMC) from well-characterized clinical specimens from HIV-1-infected individuals on antiretroviral therapy (ART). Chronically infected individuals on ART with no detectable plasma HIV-1 RNA demonstrated average CAH burdens of 3.2 HIV-1 log10 copies/million cells. Assay sensitivity and specificity were 98.9% and 100%, respectively, with the positive and negative predictive values being 100% and 98.6%, respectively. The CAH burden was also measured at weeks 0, 1, 2, 8, and 60 in 37 participants (RV254/SEARCH010, Bangkok, Thailand) stratified by Fiebig stage (Fiebig stage I [FI] to FVI) at ART initiation. Prior to ART initiation, the average CAH burden was 1.4, 4.1, and 3.6 log10 copies/million PBMCs for individuals who initiated ART at FI, FII, and FIII to FVI, respectively. Initiation of ART resulted in a rapid decline of CAH in all individuals, with the greatest decrease being observed in individuals who initiated ART at FI to FIII. By week 60, 100% (FI), 71.8% (FII/FIII), and 20.5% (FIV to FVI) of samples from individuals initiating treatment were at or near the limit of quantitation. Residual CAH was detectable at 60 weeks in most individuals who initiated ART at later stages (FIV to FVI) and averaged 1.9 0.7 log10 copies/ million PBMCs. The modified Roche CAP/CTM assay provides a convenient, standardized approach to measure residual HIV in blood and may be useful for monitoring patients under therapy or those participating in HIV remission studies.
KW - CAP/CTM assay
KW - Cell-associated HIV
KW - Early treatment
KW - Fiebig stage
KW - HIV reservoir
KW - HIV-1 nucleic acid
KW - PBMC
UR - http://www.scopus.com/inward/record.url?scp=85065290102&partnerID=8YFLogxK
U2 - 10.1128/JCM.01922-18
DO - 10.1128/JCM.01922-18
M3 - Article
C2 - 30842229
AN - SCOPUS:85065290102
SN - 0095-1137
VL - 57
JO - Journal of Clinical Microbiology
JF - Journal of Clinical Microbiology
IS - 5
M1 - e01922-18
ER -