Performance of Immunological Response in Predicting Virological Failure

Ingole, Nayana; Mehta, Preeti; Pazare, Amar R; Paranjpe, Supriya; Sarkate, Purva

doi:10.1089/aid.2012.0266

Cited by 18 publications

(16 citation statements)

References 15 publications

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“…2 Adjusted for age (continuous), ethnicity and gender/likely risk for HIV acquisition, and treatment regimen. 3 To calculate AIC analysis was restricted, separately for analysis of 1 and 3 month measures, to patients who had VL, pre-ART VL and CD4 count recorded.…”

Section: Resultsmentioning

confidence: 99%

“…In previous studies, baseline VL has been shown to be associated with the probability of achieving VL <500 copies/ml [5][6][7][8][9]. Early VL measures have previously been shown to be a good predictor of treatment failure by 6-12 months [3,4]. Furthermore, a handful of studies have looked at relationships between the early viral response to ART and longer-term viral response results after 6-12 months of ART [4,[7][8][9].…”

Section: Resultsmentioning

confidence: 99%

“…Several studies conducted to evaluate predictors of virological response to ART in treatment-naive patients have found an association between higher pre-ART HIV RNA viral load (VL) and increased risk of treatment failure by 6-12 months [3][4][5][6][7][8][9]. Furthermore, a few studies have evaluated the association between VL levels in the first 1-2 months of ART and subsequent virological response [3,8,9]. However, most of these studies considered the earlier ART calendar period (pre-2000), and results may not be applicable to those starting ART today, with newer, better tolerated or more effective drugs.…”

Section: Introductionmentioning

confidence: 99%

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Early virological response to HIV treatment: can we predict who is likely to experience subsequent treatment failure? Results from an observational cohort study, London, UK

Brima¹,

Lampe²,

Copas³

et al. 2017

Journal of the International AIDS Society

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Introduction: For people living with HIV, the first antiretroviral treatment (ART) regimen offers the best chance for a good virological response. Early identification of those unlikely to respond to first-line ART could enable timely intervention and increase chances of a good initial treatment response. In this study we assess the extent to which the HIV RNA viral load (VL) at 1 and 3 months is predictive of first-line treatment outcome at 6 months. Methods: All previously ART-naive individuals starting ART at two London centres since 2000 with baseline (−180 to 3 days) VL >500 c/mL had a VL measurement between 6 and 12 months after starting ART, and at least one at month 1 (4-60 days) or month 3 (61-120 days) were included. Lack of treatment response was defined as (i) VL >200 copies/mL at 6 months or (ii) VL >200 copies/mL at 6 months or simultaneous switch in drugs from at least two different drug classes before 6 months. The association with VL measurements at 1 and 3 months post-ART; change from pre-ART in these values; and CD4 count measurements at 1 and 3 months were assessed using logistic regression models. The relative fit of the models was compared using the Akaike information criterion (AIC). Results: A total of 198 out of 3258 individuals (6%) experienced lack of treatment response at 6 months (definition i), increasing to 511 (16%) for definition (ii). Those with a 1-month (day 4-60 window) VL of <1000, 1000-9999, 10,000-99,999 and >100,000 copies/ml had a 4%, 8%, 23% and 24% chance, respectively, of subsequently experiencing treatment non-response at 6 months (definition (i)). When considering the 3-month (day 61-120 window) VL, the chances of subsequently experiencing treatment non-response were, respectively, 3%, 25%, 67% and 75%. Results were similar for definition (ii). Conclusions: Whilst 3-month VL provides good discrimination between low and high risk of treatment failure, 1-month VL does not. Presence of a VL >10,000 copies/ml after 3 months of ART is a cutoff above which individuals are at a sufficiently higher risk of non-response that they may be considered for intervention.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Early virological response to HIV treatment: can we predict who is likely to experience subsequent treatment failure? Results from an observational cohort study, London, UK

Brima¹,

Lampe²,

Copas³

et al. 2017

Journal of the International AIDS Society

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“…As TAHOD participating sites were selected from major HIV referral centres, with some being the only site representing their country, it was expected that there would be variability in treatment protocols and clinical care across these sites. For example, the World Health Organization (WHO) 2013 guidelines recommend VL testing as the preferred method to monitor ART failure due to poor correlation of other monitoring methods with VL failure[4, 11, 12]. However, in resource-limited settings, VL monitoring may not form part of routine clinical care due to its high cost, or lack of resources and infrastructure.…”

Section: Discussionmentioning

confidence: 99%

The occurrence of Simpson's paradox if site-level effect was ignored in the TREAT Asia HIV Observational Database

Kerr

Chandrasekaran

Huelgas

et al. 2016

Journal of Clinical Epidemiology

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Background In multi-site HIV observational cohorts, clustering of observations often occur within sites. Ignoring clustering may lead to “Simpson's paradox” (SP) where the trend observed in the aggregated data is reversed when the groups are separated. This study aimed to investigate the SP in an Asian HIV cohort and the effects of site-level adjustment through various Cox-regression models. Methods Survival time from combination antiretroviral therapy (cART) initiation was analysed using four Cox models: (i) no site adjustment; (ii) site as a fixed effect; (iii) stratification through site; and (iv) shared frailty on site. Results A total of 6454 patients were included from 23 sites in Asia. SP was evident in the year of cART initiation variable. Model (i) shows the hazard ratio (HR) for years 2010-2014 was higher than the HR for 2006-2009, compared to 2003-2005 (HR = 0.68 vs 0.61). Models (ii)-(iv) consistently implied greater improvement in survival for those who initiated in 2010-2014 than 2006-2009 contrasting findings from Model (i). The effects of other significant covariates on survival were similar across four models. Conclusions Ignoring site can lead to SP causing reversal of treatment effects. Greater emphasis should be made to include site in survival models when possible.

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“…The WHO advise29 that VL levels of >5,000 copies/mL indicate persistent treatment failure, although these levels would not be tolerated in high-income countries where a VL of >200 copies/mL is considered a loss of virological control. In the absence of VL testing availability, immunological monitoring is considered to indicate treatment failure, although falls in CD4 count correlate less well with virological failure 43–45. In the absence of VL and CD4, syndromic management is again used to indicate the need for treatment switching.…”

Section: Tools Used To Monitor Art In High-income Countriesmentioning

confidence: 99%

Tracking the progress of HIV: the impact of point-of-care tests on antiretroviral therapy

Reid¹,

Fidler²,

Cooke³

2013

CLEP

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It is now around 30 years since the discovery of HIV, the virus that causes AIDS. More than 70 million people have been infected in that time and around 35 million have died. The majority of those currently living with HIV/AIDS are in low- and middle-income countries, with sub-Saharan Africa bearing a disproportionate burden of the global disease. In high-income countries, the introduction of antiretroviral therapy (ART) has drastically reduced the morbidity and mortality associated with HIV. Patients on ART are now predicted to have near-normal life expectancy and the role of treatment is increasingly recognized in preventing new infections. In low- and middle-income countries, treatment is now more widely available and around half of those who need ART are currently receiving it. Early diagnosis of HIV is essential if ART is to be optimally implemented. Lab-based diagnostics for screening, diagnosis, treatment initiation, and the monitoring of treatment efficacy are critical in managing the disease and reducing the number of new infections each year. The introduction of point-of-care HIV rapid tests has transformed the epidemic, particularly in low- and middle-income countries. For the first time, these point-of-care tests allow for the rapid identification of infected individuals outside the laboratory who can undergo counseling and treatment and, in the case of pregnant women, allow the timely initiation of ART to reduce the risk of vertical transmission. Although survival is markedly improved with ART even in the absence of laboratory monitoring, long-term management of people living with HIV on ART, and their partners, is essential to ensure successful viral suppression. The burden of disease in many resource-poor settings with high HIV prevalence has challenged the ability of local laboratories to effectively monitor those on ART. Diagnostics used to initiate and monitor treatment are now moving out of the laboratory and into the field. These new point-of-care tests for viral load and CD4 are poised to further transform the disease and shift the treatment paradigm in low- and middle-income countries.

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Performance of Immunological Response in Predicting Virological Failure

Cited by 18 publications

References 15 publications

Early virological response to HIV treatment: can we predict who is likely to experience subsequent treatment failure? Results from an observational cohort study, London, UK

Early virological response to HIV treatment: can we predict who is likely to experience subsequent treatment failure? Results from an observational cohort study, London, UK

The occurrence of Simpson's paradox if site-level effect was ignored in the TREAT Asia HIV Observational Database

Tracking the progress of HIV: the impact of point-of-care tests on antiretroviral therapy

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