Time to reduce CD4+ monitoring for the management of antiretroviral therapy in HIV-infected individuals

Stevens, Wendy; Ford, Nathan

doi:10.7196/samj.8299

Cited by 9 publications

(6 citation statements)

References 9 publications

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“…This longer turnaround time on results impacts on patient retention in care [ 3 – 5 ]. It should also be noted that the need for such testing and the thresholds of CD4 counts that clinicians deem relevant for treatment initiation are moving targets [ 6 ]. In addition to ART initiation, CD4 counts are also being used as a screening tool for reflex testing to screen for and prevent Cryptococcal meningitis in patients with a CD4 count <100 cells/μl [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

A meta-analysis of the performance of the PimaTM CD4 for point of care testing

Scott

Campbell

Westerman

et al. 2015

BMC Med

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BackgroundThe Alere point-of-care (POC) Pima™ CD4 analyzer allows for decentralized testing and expansion to testing antiretroviral therapy (ART) eligibility. A consortium conducted a pooled multi-data technical performance analysis of the Pima CD4.MethodsPrimary data (11,803 paired observations) comprised 22 independent studies between 2009–2012 from the Caribbean, Asia, Sub-Saharan Africa, USA and Europe, using 6 laboratory-based reference technologies. Data were analyzed as categorical (including binary) and numerical (absolute) observations using a bivariate and/or univariate random effects model when appropriate.ResultsAt a median reference CD4 of 383 cells/μl the mean Pima CD4 bias is -23 cells/μl (average bias across all CD4 ranges is 10 % for venous and 15 % for capillary testing). Sensitivity of the Pima CD4 is 93 % (95 % confidence interval [CI] 91.4 % - 94.9 %) at 350 cells/μl and 96 % (CI 95.2 % - 96.9 %) at 500 cells/μl, with no significant difference between venous and capillary testing. Sensitivity reduced to 86 % (CI 82 % - 89 %) at 100 cells/μl (for Cryptococcal antigen (CrAg) screening), with a significant difference between venous (88 %, CI: 85 % - 91 %) and capillary (79 %, CI: 73 % - 84 %) testing. Total CD4 misclassification is 2.3 % cases at 100 cells/μl, 11.0 % at 350 cells/μl and 9.5 % at 500 cells/μl, due to higher false positive rates which resulted in more patients identified for treatment. This increased by 1.2 %, 2.8 % and 1.8 %, respectively, for capillary testing. There was no difference in Pima CD4 misclassification between the meta-analysis data and a population subset of HIV+ ART naïve individuals, nor in misclassification among operator cadres. The Pima CD4 was most similar to Beckman Coulter PanLeucogated CD4, Becton Dickinson FACSCalibur and FACSCount, and less similar to Partec CyFlow reference technologies.ConclusionsThe Pima CD4 may be recommended using venous-derived specimens for screening (100 cells/μl) for reflex CrAg screening and for HIV ART eligibility at 350 cells/μl and 500 cells/μl thresholds using both capillary and venous derived specimens. These meta-analysis findings add to the knowledge of acceptance criteria of the Pima CD4 and future POC tests, but implementation and impact will require full costing analysis.

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Section: Introductionmentioning

confidence: 99%

A meta-analysis of the performance of the PimaTM CD4 for point of care testing

Scott

Campbell

Westerman

et al. 2015

BMC Med

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“…Further, CD4 measurement in a virally suppressed patient rarely contributes to clinical decision-making. 8 Studies among adult patients in the USA, 9 the United Kingdom, 10 Australia, 8 Kenya, 11 and South Africa 12 have all estimated substantial programme cost savings if routine CD4 monitoring is reduced or stopped. Guidelines issued by the Southern African HIV Clinicians Society in 2013 recommend that for adult patients with routine viral load monitoring, there is no need to continue CD4 testing once CD4 is >200 cells/mm3 and viral load is suppressed.…”

Section: Introductionmentioning

confidence: 99%

Reducing CD4 Monitoring in Children on Antiretroviral Therapy With Virologic Suppression

Davies

Ford

Rabie

et al. 2015

Pediatric Infectious Disease Journal

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Background Ongoing CD4 monitoring in patients on antiretroviral therapy (ART) with viral suppression has been questioned. We evaluated the probability of CD4 decline in children with viral suppression and CD4 recovery after 1 year on ART. Methods We included children from 8 South African cohorts with routine HIV-RNA monitoring if: (1) they were “responders” (HIV-RNA <400 copies/ml and no severe immunosuppression after ≥1 year on ART [time 0]) and (2) ≥1 HIV-RNA and CD4 measurement within 15 months of time 0. We determined the probability of CD4 decline to WHO-defined severe immunosuppression for 3 years after time 0 if viral suppression was maintained. Follow-up was censored at the first of: day before first HIV-RNA measurement >400 copies/ml; day before a >15 month gap in testing; date of death, loss to follow-up, transfer out or database closure. Results Among 5984 children (median age at time 0: 5.8 years [IQR:3.1-9.0]), 270 experienced a single CD4 decline to severe immunosuppression within 3 years of time 0 with probability of 6.6% (95%CI:5.8-7.4). A subsequent CD4 measurement within 15 months of the first low measurement was available for 63% of children with CD4 decline and 86% showed CD4 recovery. The probability of CD4 decline was lowest (2.8%) in children ≥2 years with no/mild immunosuppression and on ART for <18 months at time 0. This group comprised 40% of children. Conclusion This finding suggests that it may be safe to stop routine CD4 monitoring in children aged ≥2 years and rely on virologic monitoring alone.

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“…In addition to simplifying clinical care, the cost implications of reducing the frequency of CD4 measurement in our setting are considerable [10,46]; Botswana currently maintains approximately 15% of its entire population on lifelong ART, and each of these individuals should undergo at least one CD4 measurement a year according to current guidelines [23]. Modelled data from South Africa estimate that stopping routine CD4 monitoring beyond the first year of ART reduced CD4 measurement costs by 51% and led to potential savings of ZAR 740 million (equivalent to approximately US$70 million) [47].…”

Section: Discussionmentioning

confidence: 99%

Utility of CD4 count measurement in the era of universal antiretroviral therapy: an analysis of routine laboratory data in Botswana

et al. 2020

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National guidelines in Botswana recommend baseline CD4 count measurement and both CD4 and HIV viral load (VL) monitoring post-antiretroviral therapy (ART) initiation. We evaluated the utility of CD4 count measurement in Botswana in the era of universal ART. Methods CD4 and VL data were analysed for HIV-infected adults undergoing CD4 count measurement in 2015-2017 at the Botswana Harvard HIV-Reference Laboratory. We determined (1) the proportion of individuals with advanced HIV disease (CD4 count < 200 cells/µL) at initial CD4 assessment, (2) the proportion with an initial CD4 count ≥ 200 cells/µL experiencing a subsequent decline in CD4 count to < 200 cells/µL, and (3) the proportion of these immunologically failing individuals who had virological failure. Logistic regression modelling examined factors associated with advanced HIV disease. CD4 count trajectories were assessed using locally weighted scatterplot smoothing (LOWESS) regression. Results Twenty-five per cent (3571/14 423) of individuals with an initial CD4 assessment during the study period had advanced HIV disease at baseline. Older age [≥ 35 years; adjusted odds ratio (aOR) 1.9; 95% confidence interval (CI) 1.8-2.1] and male sex were associated with advanced HIV disease. Fifty per cent (7163/14 423) of individuals had at least two CD4 counts during the study period. Of those with an initial CD4 count ≥ 200 cells/µL, 4% (180/5061) experienced a decline in CD4 count to < 200 cells/µL; the majority of CD4 count declines were in virologically suppressed individuals and transient. Conclusions One-quarter of HIV-positive individuals in Botswana still present with advanced HIV disease, highlighting the importance of baseline CD4 count measurement to identify this at-risk population. Few with a baseline CD4 count ≥ 200 cells/µL experienced a drop below 200 cells/µL, suggesting limited utility for ongoing CD4 monitoring.

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Time to reduce CD4+ monitoring for the management of antiretroviral therapy in HIV-infected individuals

Cited by 9 publications

References 9 publications

A meta-analysis of the performance of the PimaTM CD4 for point of care testing

A meta-analysis of the performance of the PimaTM CD4 for point of care testing

Reducing CD4 Monitoring in Children on Antiretroviral Therapy With Virologic Suppression

Utility of CD4 count measurement in the era of universal antiretroviral therapy: an analysis of routine laboratory data in Botswana

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