Immunologic Criteria Are Poor Predictors of Virologic Outcome: Implications for HIV Treatment Monitoring in Resource-Limited Settings

Rawizza, Holly; Chaplin, Beth; Meloni, Seema; Eisen, Geoffrey; Rao, T. K. Sreepada; Sankalé, Jean-Louis; Dieng-Sarr, A; Agbaji, Oche; Onwujekwe, D; Gashau, Wadzani; Nkado, Reuben; Ekong, Ernest; Okonkwo, Prosper; Murphy, Robert L.; Kanki, PJ

doi:10.1093/cid/cir729

Cited by 131 publications

(120 citation statements)

References 27 publications

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“…In our study, some of the patients who responded to therapy using clinical parameters only were already failing virologically. Other reports have suggested similar findings in resource-poor settings [20]. Similar to our study findings, these reports show that clinical criteria are poor predictors for virological outcome.…”

Section: Discussionsupporting

confidence: 92%

“…In Tanzania, Muhimbili Hospital started to provide ART earlier than many other centers. It has been demonstrated that virological failure, both in terms of insufficient suppression of viral load, and in terms of drug resistance, precedes CD4 cell decline, which ultimately leads to clinical progression and death [20]. To follow up patients using clinical parameters, thus, means that any therapy change will be delayed compared to following up using virological parameters.…”

Section: Discussionmentioning

confidence: 99%

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Clinical and virological response to antiretroviral drugs among HIV patients on first-line treatment in Dar-es-Salaam, Tanzania

Mosha

Ledwaba²,

Ndugulile

et al. 2014

J Infect Dev Ctries

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Introduction: In Tanzania, the follow-up on antiretroviral therapy (ART) response is based on clinical outcomes. We investigated virological response and ARV resistance mutations in relation to clinical response in ARV-treated patients. Methodology: A cross-sectional study of a cohort of 150 patients taking first-line ART in Dar-es-Salaam was conducted. Data were collected using standardized questionnaires and patients' blood samples. HIV viral load testing and genotyping was performed on all viremic samples. Statistical analyses compared clinical responders and non-responders. Results: The median time on ART was 20 months; 71 (47%) patients were ART clinical responders. Clinical non-responders were more likely to have started ART with advanced disease with significantly lower median percentage weight gain (6% versus 20%) with respect to pre-treatment levels. Sixty-one (86%) and 64 (81%) of clinical responders and non-responders, respectively, had undetectable viral loads. Genotyping was successful in 24 (96%) virologically failing patients, among whom 83% had resistance mutations; 67% had dual nucleoside reverse transcriptase inhibitor (NRTI)/non-NRTI (NNRTI) resistance mutations. Seventeen (71%) and 19 (79%) patients had NRTI and NNRTI resistance mutations, respectively, which were related to the ART in use, with no difference between clinical responders and nonresponders. The most prevalent subtypes were A and C, found in 9 (38%) and 7 (29%) patients, respectively. Conclusions: The observed virological response was high and did not correlate with clinical response. The prevalence of ARV resistance mutations was high in viraemic patients and was related to the ARV prescribed. We recommend use of viral load monitoring during ART in Tanzania.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Clinical and virological response to antiretroviral drugs among HIV patients on first-line treatment in Dar-es-Salaam, Tanzania

Mosha

Ledwaba²,

Ndugulile

et al. 2014

J Infect Dev Ctries

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“…In resource-limited settings, WHO recommends monitoring and detection of treatment failure using a four-stage classification system for clinical symptoms and immunological assessment with CD4 monitoring (2). However, substantial misclassification of treatment failure may occur when using only these WHO criteria, potentially leading to both treatment regimen changes and accumulation of drug resistance mutations (3,4). Therefore, for proper disease monitoring and clinical management, accurate quantification of HIV-1 RNA using PCR-based assays is essential.…”

mentioning

confidence: 99%

Evaluation of Quantification of HIV-1 RNA Viral Load in Plasma and Dried Blood Spots by Use of the Semiautomated Cobas Amplicor Assay and the Fully Automated Cobas Ampliprep/TaqMan Assay, Version 2.0, in Kisumu, Kenya

et al. 2013

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dIn Kenya, HIV-1 viral load monitoring is commonly performed with the Cobas Amplicor using plasma specimens. Interest is growing in transitioning to real-time PCR (RT-PCR), such as the Cobas Ampliprep/Cobas TaqMan (CAP/CTM), using dried blood spots (DBS). Before implementation, direct evaluation of the two assays using DBS field specimens is required. This study compares the sensitivity, specificity, negative and positive predictive values (NPV and PPV, respectively), concordance, and agreement between HIV-1 viral load measurements using plasma and DBS specimens obtained from 512 HIV-1-infected pregnant females enrolled in the Kisumu Breastfeeding Study and tested with the Cobas Amplicor and CAP/CTM assays. The sensitivity and NPV of viral load detection in DBS specimens were higher with CAP/CTM (sensitivity, 100%; 95% confidence interval [CI], 99.1 to 100.0%; NPV, 100%; 95% CI, 59.0 to 100.0%) than the Cobas Amplicor (sensitivity, 96.6%; 95% CI, 94.3 to 98.1%; NPV, 58.8%; 95% CI, 40.7 to 75.4%). The PPVs were comparable between both assays when using DBS. The specificity of viral load detection in DBS specimens was lower with CAP/CTM (77.8%; 95% CI, 40.0 to 97.2%) than that of the Cobas Amplicor (95.2%; 95% CI, 76.2 to 99.9%). Good concordance and agreement were observed when paired plasma and DBS specimens were tested with both assays. Lower specificity with the CAP/CTM is likely due to proviral HIV-1 DNA amplification and lower detection limits with RT-PCR. However, the CAP/CTM has better sensitivity and higher throughput than the Cobas Amplicor. These findings suggest that DBS may be a suitable alternative to plasma when using RT-PCR, which could increase access to viral load monitoring in resource-limited settings.

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“…(5) which found that immunological criteria has poor prediction of virological failure. The study showed the sensitivity of immunological criteria to detect viral failure was 58%, specificity was 75% and the positive-predictive value was 39%.…”

Section: Discussionmentioning

confidence: 99%

A Study of People Living With Hiv-Aids [Plha] on First Line Highly Active Antiretroviral Therapy [Haart] With Immunological Failure

Kandasamy¹,

Radhakrishnan²,

Subramanian³

et al. 2016

jemds

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BACKGROUNDFollow-up of patients with First line antiretroviral therapy, Cluster Differentiation (CD4) counts are done every 6 months. Viral load is not possible in resource poor settings like India. Non-Governmental Organisation (NGO's), Human Immunodeficiency Virus (HIV) treating physicians and international guidelines recommend viral load as the follow-up method for first line failure, so to study the impact of national program with immunological criteria and its sensitivity to identify virological failure is needed at this juncture.

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Immunologic Criteria Are Poor Predictors of Virologic Outcome: Implications for HIV Treatment Monitoring in Resource-Limited Settings

Cited by 131 publications

References 27 publications

Clinical and virological response to antiretroviral drugs among HIV patients on first-line treatment in Dar-es-Salaam, Tanzania

Clinical and virological response to antiretroviral drugs among HIV patients on first-line treatment in Dar-es-Salaam, Tanzania

Evaluation of Quantification of HIV-1 RNA Viral Load in Plasma and Dried Blood Spots by Use of the Semiautomated Cobas Amplicor Assay and the Fully Automated Cobas Ampliprep/TaqMan Assay, Version 2.0, in Kisumu, Kenya

A Study of People Living With Hiv-Aids [Plha] on First Line Highly Active Antiretroviral Therapy [Haart] With Immunological Failure

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