Tamsin K Phillips1,2, Phumla Sinxadi3, Elaine J Abrams4,5, Allison Zerbe4, Catherine Orrell6, Nai-Chung Hu2, Kirsty Brittain1,2, Yolanda Gomba2, Jennifer Norman3, Lubbe Wiesner3, Landon Myer1,2, Gary Maartens3. 1. Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa. 2. Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa. 3. Division of Clinical of Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa. 4. ICAP at Columbia University, Mailman School of Public Health, Columbia University, New York, NY. 5. Vagelos College of Physicians and Surgeons, Columbia University, New York, NY. 6. Department of Medicine, Institute of Infectious Disease and Molecular Medicine, Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Abstract
BACKGROUND: Tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) is an objective long-term adherence measure, but data are limited on its ability to predict virologic suppression (VS) in people on antiretroviral (ARV) treatment. There are also no data comparing DBS TFV-DP with plasma ARV concentrations as predictors of VS. METHODS: Women who were on a first-line regimen of tenofovir, emtricitabine, and efavirenz (EFV) were enrolled in a cross-sectional study. Plasma EFV and tenofovir (TFV), DBS TFV-DP assays, and 30-day self-reported adherence were evaluated as predictors of VS (<50 copies/mL) with the area under the curve of receiver operating characteristics and logistic regression. RESULTS: We enrolled 137 women; mean age of 33 years; median 4 years on antiretroviral therapy; 88 (64%) had VS. In receiver operating characteristics analyses: DBS TFV-DP [0.926 (95% CI: 0.876 to 0.976)] had a higher area under the curve than plasma TFV [0.864 (0.797 to 0.932); P = 0.006], whereas plasma EFV [0.903 (0.839-0.967)] was not significantly different from DBS TFV-DP (P = 0.138) or plasma TFV (P = 0.140); all ARV assays performed better than self-report. The association of TFV-DP in DBS with VS strengthened with increasing concentrations [reference <350 fmol/punch: 350-699 fmol/punch aOR 37 (8-178); 700-1249 fmol/punch aOR 47 (13-175); ≥1250 fmol/punch aOR 175 (20-1539)]. "White coat adherence" (defined as DBS TFV-DP <350 fmol/punch with detectable plasma TFV) was only detected in 4 women. CONCLUSIONS: Plasma EFV, TFV, and DBS TFV-DP were all strong predictors of VS. EFV or TFV assays have potential for development as point-of-care assays for use as objective adherence measures in resource-limited settings.
BACKGROUND:Tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) is an objective long-term adherence measure, but data are limited on its ability to predict virologic suppression (VS) in people on antiretroviral (ARV) treatment. There are also no data comparing DBSTFV-DP with plasma ARV concentrations as predictors of VS. METHODS:Women who were on a first-line regimen of tenofovir, emtricitabine, and efavirenz (EFV) were enrolled in a cross-sectional study. Plasma EFV and tenofovir (TFV), DBSTFV-DP assays, and 30-day self-reported adherence were evaluated as predictors of VS (<50 copies/mL) with the area under the curve of receiver operating characteristics and logistic regression. RESULTS: We enrolled 137 women; mean age of 33 years; median 4 years on antiretroviral therapy; 88 (64%) had VS. In receiver operating characteristics analyses: DBSTFV-DP [0.926 (95% CI: 0.876 to 0.976)] had a higher area under the curve than plasma TFV [0.864 (0.797 to 0.932); P = 0.006], whereas plasma EFV [0.903 (0.839-0.967)] was not significantly different from DBSTFV-DP (P = 0.138) or plasma TFV (P = 0.140); all ARV assays performed better than self-report. The association of TFV-DP in DBS with VS strengthened with increasing concentrations [reference <350 fmol/punch: 350-699 fmol/punch aOR 37 (8-178); 700-1249 fmol/punch aOR 47 (13-175); ≥1250 fmol/punch aOR 175 (20-1539)]. "White coat adherence" (defined as DBSTFV-DP <350 fmol/punch with detectable plasma TFV) was only detected in 4 women. CONCLUSIONS: Plasma EFV, TFV, and DBSTFV-DP were all strong predictors of VS. EFV or TFV assays have potential for development as point-of-care assays for use as objective adherence measures in resource-limited settings.
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