Diagnostic Accuracy of the Rapid Xpert HIV-1 Viral Load XC, Xpert HIV-1 Viral Load, &amp; m-PIMA HIV-1/2 Viral Load in South African Clinics

Dorward, Jienchi; Naidoo, Jessica; Moodley, Pravi; Sookrajh, Yukteshwar; Samsunder, Natasha; Sayed, Fathima; Naicker, Nivashnee; Fanshawe, Thomas R; Drain, Paul K.; Lessells, Richard; Hayward, Gail; Butler, Christopher; Garrett, Nigel

doi:10.1097/qai.0000000000003037

Cited by 6 publications

(6 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Reasons for the difference in 12-week VL suppression between the point-of-care and laboratory assay are not clear because we have found the Xpert HIV-1 VL to be sensitive and specific at a VL threshold of 50 copies/mL. 16 …”

Section: Discussionmentioning

confidence: 87%

See 1 more Smart Citation

Point-of-Care Viral Load Testing to Manage HIV Viremia During the Rollout of Dolutegravir-Based ART in South Africa: A Randomized Feasibility Study (POwER)

Dorward

Sookrajh

Lessells

et al. 2023

JAIDS Journal of Acquired Immune Deficiency Syndromes

Self Cite

View full text Add to dashboard Cite

Background: Data are required regarding the feasibility of conducting a randomized trial of point-of-care viral load (VL) testing to guide management of HIV viremia and to provide estimates of effect to guide potential future trial design. Setting: Two public South African clinics during the dolutegravir-based antiretroviral therapy (ART) rollout. Methods: We randomized adults receiving first-line ART, with recent VL ≥1000 copies/mL, in a 1:1 ratio to receive point-of-care Xpert HIV-1 VL versus standard-of-care laboratory VL testing after 12 weeks. Feasibility outcomes included proportions of eligible patients enrolled and completing follow-up and VL process outcomes. Estimates of effect were assessed using the trial primary outcome of VL <50 copies/mL after 24 weeks. Results: From August 2020 to March 2022, we enrolled 80 eligible participants, an estimated 24% of those eligible. 47 of 80 (58.8%) were women, and the median age was 38.5 years (interquartile range [IQR], 33–45). 44 of 80 (55.0%) were receiving dolutegravir, and 36 of 80 (465.0%) were receiving efavirenz. After 12 weeks, point-of-care participants received VL results after median 3.1 hours (IQR 2.6–3.8), versus 7 days (IQR 6–8, P < 0.001) in standard of care. Twelve-week follow-up VL was ≥1000 copies/mL in 13 of 39 (33.3%) point-of-care participants and in 16 of 41 (39.0%) standard-of-care participants; 11 of 13 (84.6%) and 12 of 16 (75.0%) switched to second-line ART. After 24 weeks, 76 of 80 (95.0%) completed follow-up. 27 of 39 (69.2% [95% CI: 53.4 to 81.4]) point-of-care participants achieved VL <50 copies/mL versus 29 of 40 (72.5% [57.0 to 83.9]) standard-of-care participants. Point-of-care participants had median 3 (IQR, 3–4) clinical visits versus 4 (IQR, 4–5) in standard-of-care participants (P < 0.001). Conclusions: It was feasible to conduct a trial of point-of-care VL testing to manage viremia. Point-of-care VL lead to quicker results and fewer clinical visits, but estimates of 24-week VL suppression were similar between arms. Trial Registration: Pan African Clinical Trials Registry: PACTR202001785886049.

show abstract

Section: Discussionmentioning

confidence: 87%

“…To date, 2 point-of-care assays have been approved as accurate by the WHO for use in LMICs 13,14 and have been evaluated in our setting. 15,16 Clinical trials of these assays among children, 17 adolescents, 18 and adults [19][20][21] have demonstrated shorter turnaround times, but effects on clinical outcomes have been mixed.…”

Section: Introductionmentioning

confidence: 99%

Point-of-Care Viral Load Testing to Manage HIV Viremia During the Rollout of Dolutegravir-Based ART in South Africa: A Randomized Feasibility Study (POwER)

Dorward

Sookrajh

Lessells

et al. 2023

JAIDS Journal of Acquired Immune Deficiency Syndromes

Self Cite

View full text Add to dashboard Cite

show abstract

“…We conducted a prospective diagnostic accuracy sub‐study within the POwER study. POwER is an open‐label, individually randomized, feasibility study of point‐of‐care HIV viral load (VL) testing to enhance re‐suppression among people with HIV viraemia while receiving first‐line ART [16, 17].…”

Section: Methodsmentioning

confidence: 99%

“…Seventy-four (59.7%) were receiving efavirenz for a median of 4.2 years (2.1-6.0), and 50 (40.3%) were receiving dolutegravir, for a median of 0.6 years (0.5-1.0). Median time since the pre-enrolment viraemic VL was 15 days (13)(14)(15)(16)(17)(18)(19)(20)(21). In December 2020, we were informed that 1).…”

Section: Study Populationmentioning

confidence: 99%

Diagnostic accuracy of a point‐of‐care urine tenofovir assay, and associations with HIV viraemia and drug resistance among people receiving dolutegravir and efavirenz‐based antiretroviral therapy

Dorward,

Lessells,

Govender

et al. 2023

J Int AIDS Soc.

Self Cite

View full text Add to dashboard Cite

IntroductionNovel point‐of‐care assays which measure urine tenofovir (TFV) concentrations may have a role in improving adherence monitoring for people living with HIV (PLHIV) receiving antiretroviral therapy (ART). However, further studies of their diagnostic accuracy, and whether results are associated with viraemia and drug resistance, are needed to guide their use, particularly in the context of the global dolutegravir rollout.MethodsWe conducted a cross‐sectional evaluation among PLHIV receiving first‐line ART containing tenofovir disoproxil fumarate at enrolment into a randomized trial in two South African public sector clinics. We calculated the diagnostic accuracy of the Abbott point‐of‐care immunoassay to detect urine TFV compared to liquid chromatography‐tandem mass spectrometry (LC‐MS/MS). We evaluated the association between point‐of‐care urine TFV results and self‐reported adherence, viraemia ≥1000 copies/ml and HIV drug resistance, among people receiving either efavirenz or dolutegravir‐based ART.ResultsBetween August 2020 and March 2022, we enrolled 124 participants. The median age was 39 (IQR 34–45) years, 55% were women, 74 (59.7%) were receiving efavirenz and 50 (40.3%) dolutegravir. The sensitivity and specificity of the immunoassay to detect urine TFV ≥1500 ng/ml compared to LC‐MS/MS were 96.1% (95% CI 90.0−98.8) and 95.2% (75.3−100.0), respectively. Urine TFV results were associated with short (p<0.001) and medium‐term (p = 0.036) self‐reported adherence. Overall, 44/124 (35.5%) had viraemia, which was associated with undetectable TFV in those receiving efavirenz (OR 6.01, 1.27−39.0, p = 0.014) and dolutegravir (OR 25.7, 4.20−294.8, p<0.001). However, in those with viraemia while receiving efavirenz, 8/27 (29.6%) had undetectable urine TFV, compared to 11/17 (64.7%) of those receiving dolutegravir. Drug resistance was detected in 23/27 (85.2%) of those receiving efavirenz and only 1/16 (6.3%) of those receiving dolutegravir. There was no association between urine TFV results and drug resistance.ConclusionsAmong PLHIV receiving ART, a rapid urine TFV immunoassay can be used to accurately monitor urine TFV levels compared to the gold standard of LC‐MS/MS. Undetectable point‐of‐care urine TFV results were associated with viraemia, particularly among people receiving dolutegravir.Trial registrationPan‐African Clinical Trials Registry: PACTR202001785886049.

show abstract

“…We enrolled 80 eligible participants between August 2020 and March 2022, an estimated 23.7% of those who were potentially eligible at the study clinics. 8 Median age was 38.5 years (interquartile range [IQR] 33-45), 58.8% were female, and median time on ART was 3.2 years (IQR 1.0-6.0) (Table S1, Supplemental Digital Content, http://links.lww.com/QAI/C216).…”

Section: Participantsmentioning

confidence: 99%

Viremia and HIV Drug Resistance Among People Receiving Dolutegravir Versus Efavirenz-Based First-Line Antiretroviral Therapy

Dorward,

Sookrajh,

Lessells

et al. 2024

JAIDS Journal of Acquired Immune Deficiency Syndromes

Self Cite

View full text Add to dashboard Cite

show abstract

Diagnostic Accuracy of the Rapid Xpert HIV-1 Viral Load XC, Xpert HIV-1 Viral Load, & m-PIMA HIV-1/2 Viral Load in South African Clinics

Abstract: Supplemental Digital Content is Available in the Text.

Cited by 6 publications

References 24 publications

Point-of-Care Viral Load Testing to Manage HIV Viremia During the Rollout of Dolutegravir-Based ART in South Africa: A Randomized Feasibility Study (POwER)

Point-of-Care Viral Load Testing to Manage HIV Viremia During the Rollout of Dolutegravir-Based ART in South Africa: A Randomized Feasibility Study (POwER)

Diagnostic accuracy of a point‐of‐care urine tenofovir assay, and associations with HIV viraemia and drug resistance among people receiving dolutegravir and efavirenz‐based antiretroviral therapy

Viremia and HIV Drug Resistance Among People Receiving Dolutegravir Versus Efavirenz-Based First-Line Antiretroviral Therapy

Contact Info

Product

Resources

About