The debate about laboratory monitoring rages on. Some think that less monitoring is all right. Others worry about too little. There is no clear answer.

[him] moderator

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The Lancet Infectious Diseases, Volume 11, Issue 11, Pages 803 - 804, November 2011
doi:10.1016/S1473-3099(11)70185-2Cite or Link Using DOI
Published Online: 09 August 2011

Is laboratory monitoring of ART essential worldwide?
Catherine G Sutcliffe aEmail Address
In The Lancet Infectious Diseases, Laurent and colleagues report the results of a randomised non-inferiority trial in adults in Cameroon1 with HIV infection receiving antiretroviral therapy (ART). The trial compares the effectiveness and safety of two monitoring strategies: clinical monitoring alone and clinical monitoring plus laboratory monitoring of CD4 cell counts and viral loads. Participants in the laboratory group had increases in CD4 cell counts of more than the 25% threshold in the first 2 years of treatment and therefore non-inferiority of clinical monitoring alone was not shown. However, the proportions of participants with viral suppression, disease progression, HIV resistance, and toxic effects were much the same in both groups.
This trial1 contributes to the ongoing debate about the usefulness, value, and cost-effectiveness of laboratory monitoring of ART in low-resource settings, particularly sub-Saharan Africa. More than two-thirds of the 14·6 million individuals infected with HIV and in need of ART reside in sub-Saharan Africa, where the health-care infrastructure is restricted and there are few trained personnel.2 In this setting, the striking increase in the number of individuals with HIV infection who have access to lifesaving ART in the past decade3 has been accomplished with a public-health approach to treatment. By use of standardised and simplified regimens and guidelines for initiation and monitoring, the goal has been to provide universal access to ART for all patients who need it.3 By contrast with high-resource settings, ART is often started and monitored in sub-Saharan Africa only on the basis of clinical criteria and without guidance from immunological (CD4 cell counts and percentages) and virological (viral load) markers. This feature is especially true in rural areas where the financial, human, and technological resources for routine laboratory testing are restricted. Rural clinics might have the capability to do routine CD4 cell counts but viral-load testing is restricted to centralised laboratories in urban settings in many countries.
For individuals who are monitored on ART, clinical and immunological criteria are poor indicators of treatment failure,4, 5 but are the only option for many clinics. Therefore, several trials, in addition to the one presented by Laurent and colleagues,1 have been completed6 or are underway7 to assess the effect of different clinical and laboratory monitoring strategies and to inform policy. The trials have consistently reported routine monitoring of CD4 cell counts or viral loads (or both) to be beneficial compared with clinical monitoring alone for several outcomes in the first few years after initiation, including mortality, disease progression, and immune recovery.6 Observational studies have also reported higher rates of switching to second-line therapies, earlier switching, and lower HIV resistance in programmes with routine monitoring of viral load than has been noted without such monitoring.6, 8
The effect of ART on survival for individuals with HIV infection who have access only to clinical monitoring is striking, with 87% of such individuals alive at 5 years in the DART trial.9 The added benefits of laboratory monitoring are small, at least in the short term. Combined with the costs of routine testing and second-line therapies, laboratory monitoring is not a cost-effective strategy for many countries in sub-Saharan Africa,10 fuelling the debate about the value of this strategy given efforts to expand HIV and ART services but in the face of stagnating funding.2 Although expansion of ART needs to be the overall goal, the long-term effects of delayed detection of treatment failure and maintenance of individuals on failing first-line therapies are unknown and should not be ignored. Potential detrimental effects could include accumulation of resistance mutations that jeopardise future treatment options,8 increased mortality while on failing therapy,11 and transmission of resistant viruses to partners or children, which would increase demand for expensive second-line therapies. While interim strategies for targeted CD4 cell counts and viral-load testing are put in place to best make use of available resources,7, 12, 13 research and investments need to continue to develop low-cost and low-technology point-of-care assays for laboratory monitoring. If expansion remains the main aim, the quality of care and treatment provided to individuals with HIV infection in low-resource settings might be compromised and inequities between patients who are receiving care in rural and urban settings could be created or amplified.
I declare that I have no conflicts of interest.
References
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2 WHO. Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector. Progress Report 2010. Geneva, Switzerland: World Health Organization, 2010.
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a Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21205, USA

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