Personal View
Early antiretroviral therapy initiation: access and equity of viral load testing for HIV treatment monitoring

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Summary

Scaling up access to HIV viral load testing for individuals undergoing antiretroviral therapy in low-resource settings is a global health priority, as emphasised by research showing the benefits of suppressed viral load for the individual and the whole population. Historically, large-scale diagnostic test implementation has been slow and incomplete because of service delivery and other challenges. Building on lessons from the past, in this Personal View we propose a new framework to accelerate viral load scale-up and ensure equitable access to this essential test. The framework includes the following steps: (1) ensuring adequate financial investment in scaling up this test; (2) achieving pricing agreements and consolidating procurement to lower prices of the test; (3) strengthening functional tiered laboratory networks and systems to expand access to reliable, high-quality testing across countries; (4) strengthening national leadership, with prioritisation of laboratory services; and (5) demand creation and uptake of test results by clinicians, nurses, and patients, which will be vital in ensuring viral load tests are appropriately used to improve the quality of care. The use of dried blood spots to stabilise and ship samples from clinics to laboratories, and the use of point-of-care diagnostic tests, will also be important for ensuring access, especially in settings with reduced laboratory capacity. For countries that have just started to scale up viral load testing, lessons can be learnt from countries such as Botswana, Brazil, South Africa, and Thailand, which have already established viral load programmes. This framework might be useful for guiding the implementation of viral load with the aim of achieving the new global HIV 90-90-90 goals by 2020.

Introduction

In 2014 the Joint UN Programme on HIV/AIDS (UNAIDS) announced ambitious new global treatment targets for 2020: 90% of people with HIV will know their status, 90% of people living with HIV will have access to treatment, and 90% of people on treatment will have suppressed viral load.1 These targets are supported by WHO recommendations from 20162 for universal access to antiretroviral therapy (ART) and routine viral load testing to monitor treatment efficacy, and unequivocal evidence from the TEMPRANO ANRS 12136 study,3 the Strategic Timing of Antiretroviral Treatment (START) study,4 and the HIV Prevention Trials Network 0525 study showing that ART with sustained viral suppression should be started early in the clinical course of HIV infection.2

The UNAIDS 90-90-90 goals present great challenges to national governments, donors, and technical partners, and bring focus to the need to expand access to diagnostic tests. An urgent priority is the introduction of routine viral load monitoring within large-scale ART programmes. Although CD4 monitoring has been essential in clinical decisions around treatment initiation and monitoring of immune reconstitution immediately following treatment initiation, viral load monitoring enables the detection of early signs of adherence problems to treatment before immunological decline.6, 7, 8 This information is crucial for informing adherence interventions and timely switching to second-line drug regimens, before drug resistance develops. Approximately 17 million people living with HIV (PLHIV) were on ART by 2015, reflecting an increase from 7·5 million in 2010.9 As ART coverage expands, investments in the global response are shifting towards ensuring the long-term effectiveness of ART through sustained suppression of the virus to improve survival, reduce HIV transmission, and prevent large-scale HIV drug resistance.10

This goal cannot be met without a substantial effort towards ensuring minimal attrition in each step of the care continuum. Without optimal retention in care, sustained adherence to medication, and effective monitoring of therapeutic response to ART, the escalating treatment response could result in a rapid decaying of regimen efficacy and the spread of drug resistance.11 Achieving long-term viral suppression within the context of early ART initiation will require a shift in both patient management and governmental policies to offer routine viral load monitoring and improved access to viral load testing capabilities in low-income and middle-income countries (LMICs).

Section snippets

Access to viral load testing

In sub-Saharan Africa, where 70% of PLHIV reside, more than 6 million people who are on ART do not have access to viral load testing, and more than 10 million viral load tests are estimated to be needed in total every year.12, 13 As national treatment programmes implement the recommendations in the 2016 WHO guidelines2—ie, immediate HIV treatment not just for sick patients, but for all HIV-infected individuals—the need for viral load testing globally will grow to as much as 30 million tests per

Addressing barriers to access to viral load

We propose the following framework (figure) for addressing barriers to access of viral load testing. First, substantial financial investments are needed at the outset to support the expansion of viral load monitoring, including laboratory infrastructure development, test commodities, operational costs, and downstream drug and clinical costs. In particular, increased switching to expensive second-line and third-line regimens could increase treatment budgets. Although viral load testing could

Expansion of viral load testing

Simple and innovative technologies that minimise the complexities of the viral load testing process and extend the reach of the test to PLHIV in remote locations are also needed to ensure equity in access to viral load testing. These technologies include the use of dried blood spots instead of plasma samples,24 in line with recommendations in the 2014 WHO interim technical update for implementing viral load monitoring,20 and other sample collection and preservation devices to provide equitable

Medical professionals and patients as stakeholders

For viral load monitoring to be successful, both medical professionals and patients should work together to request this test when needed. Demand for the test remains low, and although annual viral load testing is recommended for PLHIV on ART,25 many physicians, nurses, and clinical officers might not order viral load tests because they are unaware of the advantages of virological monitoring to guide patient management or they do not know that the test is readily available. Alternatively, they

Lessons from the past

Many of the existing barriers to viral load adoption are not new to LMICs and can be mitigated through renewed focus, concerted action, and novel approaches in expanding access to viral load testing to millions of patients. Using lessons learned from global initiatives in the 1990s that helped to improve access and equity of ART in developing countries, a similar approach in coordinated partnerships between country governments, implementing partners, donors, and industry will be needed to

Conclusion

HIV viral load monitoring is now the recommended standard of care for monitoring the impact of treatment and is crucial to sustain quality of care at both the patient and programmatic level. Expanding equitable access to viral load testing provides a clear path for preventing future infections and saving lives, and can be achieved by a global partnership. The suggestions we provide offer a framework for a concerted and harmonised implementation strategy that enables a rapid and cost-effective

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