Scale-up Of Viral Load Testing Research Articles

Cost and Impact of Dried Blood Spot Versus Plasma Separation Card for Scale-up of Viral Load Testing in Resource-limited Settings.

BackgroundRoutine plasma viral load (VL) testing is recommended for monitoring human immunodeficiency virus–infected patients on antiretroviral therapy. In Zambia, VL scale-up is limited due to logistical obstacles around plasma specimen collection, storage, and transport to centralized laboratories. Dried blood spots (DBSs) could circumvent many logistical challenges at the cost of increased misclassification. Recently, plasma separation cards (PSCs) have become available and, though more expensive, have lower total misclassification than DBSs.MethodsUsing a geospatial model created for optimizing VL utilization in Zambia, we estimated the short-term cost of uptake/correct VL result using either DBSs or PSCs to increase VL access on equipment available in-country. Five scenarios were modeled: (1) plasma only (status quo); (2) plasma at high-volume sites, DBS at low-volume sites; (3) plasma at high-volume sites, PSC at low-volume sites; (4) PSC only; (5) DBS only.ResultsScenario 1 resulted in 795 342 correct results due to limited patient access. When allowing for full and partial adoption of dried specimens, access increases by 19%, with scenario 3 producing the greatest number of correct results expected (929 857). The average cost per correct VL result was lowest in the plasma + DBS scenario at $30.90 compared to $31.62 in our plasma + PSC scenario. The cost per correct result of using dried specimens only was dominated in the incremental analysis, due primarily to fewer correct results.ConclusionsAdopting the partial use of dried specimens will help achieve improved VL access for patients at the lowest cost per correct result.

HIV viral load scale-up: multiple interventions to meet the HIV treatment cascade.

In 2015, the WHO urged countries to provide ART to all people living with HIV, irrespective of their CD4 cell count, this new recommendation supports the Joint United Nations Programme on HIV/AIDS elimination targets. However, to meet these aims, urgent scale-up of viral load testing is critical. The multiple interventions in the healthcare system required to support scale-up of viral load testing are reviewed here. It is estimated that 18.2 million individuals are accessing antiretroviral therapy, consequently this will cause significant demand for viral load monitoring; however, at the current rate of implementation, demand will not meet the required target by 2020. To change this trajectory, multiple stakeholders must be involved, communities and key populations need increased treatment literacy to create demand and greater numbers of healthcare workers will require training. In addition, laboratories and point-of-care testing sites will need to be expanded, and adequate monitoring and evaluation tools will need to be put in place to identify gaps in the system, to institute prompt corrective actions and to direct resources where needed. Sufficient scale-up of viral load may well be possible if innovations in mHealth are used to support healthcare workers and patients with regard to the scale-up and effective use of viral load monitoring; new laboratory technologies are implemented, both at a centralized level and point-of-care, to manage higher volumes and improve coverage; and there is careful coordination between implementing partners and funders.

Short Communication: Impact of Viral Load Use on Treatment Switch in Perinatally HIV-Infected Children in Asia.

We sought to assess the impact of routine HIV viral load (VL) monitoring on the incidence of switching from a first- to a second-line antiretroviral therapy (ART) regimen, and to describe factors associated with switch. Data from a regional cohort of 16 clinical programs in six Asian countries were analyzed. Second-line switch was defined as a change from a non-nucleoside reverse transcriptase inhibitor (NNRTI) to a protease inhibitor (PI) or vice versa, and ≥1 of the following: (1) reported treatment failure by local criteria, (2) switch of ≥1 additional drug, or (3) a preceding HIV VL ≥1,000 copies/ml. Routine VL was having ≥1 test after ≥24 weeks of ART and ≥1 time/year thereafter. Factors associated with time to switch were evaluated with death and loss to follow-up as competing risks. A total of 2,398 children were included in this analysis. At ART initiation, the median (interquartile range) age was 6.0 (3.3-8.9) years, more than half had WHO stage 3 or 4, the median CD4 was 189 (47-456) cells/mm3, 93% were on NNRTI-based first-line ART, and 34% had routine VL monitoring. Treatment switch occurred in 17.6% of patients, at a median of 35 (22-49) months. After adjusting for country, sex, first ART regimen, and CD4% at ART initiation, children with routine VL monitoring were 1.46 (95% confidence interval 1.11-1.93) times more likely to be switched (p = .007). Scale-up of VL testing will lead to earlier identification of treatment failure, and it can help guide earlier switches to prevent resistance.

Genital Shedding of Resistant Human Immunodeficiency Virus-1 Among Women Diagnosed With Treatment Failure by Clinical and Immunologic Monitoring.

Background. The accumulation of human immunodeficiency virus (HIV) resistance mutations can compromise treatment outcomes and promote transmission of drug-resistant virus. We conducted a study to determine the duration and evolution of genotypic drug resistance in the female genital tract among HIV-1-infected women failing first-line therapy. Methods. Treatment failure was diagnosed based on World Health Organization (WHO) clinical or immunologic criteria, and second-line therapy was initiated. Stored plasma and genital samples were tested to determine the presence and timing of virologic failure and emergence of drug resistance. The median duration of genital shedding of genotypically resistant virus prior to regimen switch was estimated. Results. Nineteen of 184 women were diagnosed with treatment failure, of whom 12 (63.2%) had confirmed virologic failure at the switch date. All 12 women with virologic failure (viral load, 5855-1 086 500 copies/mL) had dual-class resistance in plasma. Seven of the 12 (58.3%) had genital HIV-1 RNA levels high enough to amplify (673-116 494 copies/swab), all with dual-class resistance. The median time from detection of resistance in stored samples to regimen switch was 895 days (95% confidence interval [CI], 130-1414 days) for plasma and 629 days (95% CI, 341-984 days) for genital tract secretions. Conclusions. Among women diagnosed with treatment failure using WHO clinical or immunologic criteria, over half had virologic failure confirmed in stored samples. Resistant HIV-1 RNA was shed in the genital tract at detectable levels for ≈1.7 years before failure diagnosis, with steady accumulation of mutations. These findings add urgency to the ongoing scale-up of viral load testing in resource-limited settings.

The 90 90 90 strategy to end the HIV Pandemic by 2030: Can the supply chain handle it?

IntroductionUNAIDS “90-90-90” strategy calls for 90% of HIV-infected individuals to be diagnosed by 2020, 90% of whom will be on anti-retroviral therapy (ART) and 90% of whom will achieve sustained virologic suppression. Reaching these targets by 2020 will reduce the HIV epidemic to a low-level endemic disease by 2030. However, moving the global response towards this universal test and treat model will pose huge challenges to public health systems in resource-limited settings, including global and local supply chain systems. These challenges are especially acute in Africa, which accounts for over 70% of the persons affected by HIV.DiscussionFrom a supply chain perspective, each of the “90's” has possible complications and roadblocks towards realizing the promise envisioned by 90-90-90. For instance, ensuring that 90% of HIV-infected persons know their status will require a large increase in access to HIV tests compared with what is currently available. To ensure that there are enough anti-retrovirals available to treat the nearly 25 million people that will require them by 2020 represents a near doubling of the ARV supplied to treat the 13 million currently on treatment. Similarly, to monitor those on treatment means an unprecedented scale-up of viral load testing throughout Africa.ConclusionsLarger issues include whether the capacity exists at the local level to handle these commodities when they arrive in the most severely affected countries, including considerations of the human resources and costs needed to make this strategy effective. We believe that such “real world” analysis of proposed strategies and policies is essential to ensure their most effective implementation.

Antiretroviral treatment strategies in resource-limited settings

To date, a minority of persons living with HIV worldwide has benefited from the advances in HIV therapeutics fueled by the scientific community, policy-makers, advocates, and the pharmaceutical industry in the global North. A growing body of evidence demonstrates that access to highly active antiretroviral therapy can be successfully scaled-up in less wealthy nations in the South. High rates of adherence correspond with clinical, immunologic, and virologic outcomes similar to those seen in wealthier nations. Recent reports of successful programs highlight the provision of free care, reliance on the international funding sources, and proactive adherence counseling. As access to antiretroviral therapy has improved, there is an urgent need to develop better strategies for initiating and monitoring therapy, including the scale-up of viral load testing.