Factors in failing to start ART

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With the goal of preventing HIV transmission and disease progression, US federal guidelines since early 2012 have suggested everyone who tests HIV positive should start on anti-retroviral treatment (ART). But, says a MD Mag report, not everyone does. A study led by Dr Terra V Fatukasi, at the department of epidemiology, University of North Carolina at Chapel Hill, concluded that its findings from data drawn from the pre-100% guideline era can be helpful in reducing the percentage of non-compliant patients now.

Unexpectedly, the study found that the demographic characteristics of patients who failed to initiate ART within 2 years of entering care were not as important as clinical factors.

“Higher CD4 count, lower viral load, and a prevalent Aids diagnosis were clinical characteristics associated with delayed ART initiation,” researchers wrote. “Gender, age, race/ethnicity, and HIV risk factors such as reported male-to-male sexual contact and injection drug use were not associated with delayed ART initiation.”

Over the 10-year study period, the only clinical factor associated with failure to initiate ART was lower viral load.

“Despite the known benefits of early antiretroviral therapy initiation, a lower viral load measurement may continue to be an important clinical characteristic in the more recent era with current ART initiation guidelines,” researchers wrote. “These findings provide a target for closer monitoring and intervention to reduce disparities in HIV care.”

The research was based on data for 4,907 HIV patients enrolled in 8 clinics across the country between January 2003 through December 2012 – for whom treatment was strongly-to-moderately recommended. All of the test subjects had not previously been on ART.

At the beginning of their inclusion in the study, these patients had CD4 counts of 350 cells/mm or below. CD4 cells are the white blood cells that kill infections like HIV. A normal count is considered to be in the 500 to 1,500 range. Aids may be diagnosed when that count drops below 200.

Those with a CD4 count of at least 200 cells/mm at the beginning of their participation in the study were 1.3 times as likely to delay ART than those with counts of less than 200. From 2003 through 2012, 54.6% of the participants with CD4 counts less than 200 did not initiate ART.

Viral load is measured by the number of HIV RNA. A viral load is 10,000 HIV RNA per millilitre of blood and high load would be 100,000. At the beginning of their participation, patients with viral loads of less than10,000 were more likely to delay ART than those with a viral load of at least a 100,000. Across the entire study period, 26.3% of those with viral loads of 10,000 or less did not start ART and 37.3% of those with viral loads of 100,000 or more also were not ART initiators.

An Aids diagnosis also was not necessarily compelling in terms of many Aids positive participants not initiating ART. In the group that started in 2003 to 2007, 64.3% did not begin ART. In the group that started participating in the study in the 2008 to 2012 period, 74.1% with Aids diagnoses were not initiators.

“Though guidelines also recommended ART initiation for patients with an Aids diagnosis, it is possible that our findings that a prevalent Aids diagnosis was associated with delayed ART initiation could have resulted from a lower engagement in care,” researchers wrote.

Enrollment date was the only demographic factor that appeared to affect the willingness to start ART, according to the study.

The study found that 6% of the participants who did not initiate ART within 2 years of enrolling died. In 2014, 12,333 people died of Aids-related causes in the US, according to the US Centres for Disease Control and Prevention (CDC). ART has been credited increased longevity for people who are HIV positive, and making it more of a chronic condition than a terminal one.

“This prolonged delay in ART intiation among patients with moderate to strong recommendation under past guidelines suggests that treatment practice under current guidelines recommending therapy initiation to all HIV-seropositive patients should be carefully scrutinised,” researchers wrote. “The tendency to delay therapy in those patients with lower viral load may still persist despite clear evidence of the benefits of immediate therapy initiation.”

Abstract
Prompt initiation of combination antiretroviral therapy (ART) is important to reduce comorbidity and mortality among people living with HIV, especially for those with a low CD4 cell count. However there is evidence that not everyone receives prompt initiation of ART after enrolling into HIV care. The current study investigated factors associated with failure to initiate ART within two years of entering into care among those with a CD4 count at or below 350 cells/mm3. The sample included 4,907 ART-naive patients with a CD4 count at or below 350 cells/mm3 enrolled between January 1, 2003 and December 31, 2012 at any of eight clinical sites in the Center for AIDS Research Network of Integrated Clinical Systems (CNICS). The two-year risk of delayed ART initiation was estimated using a log-binomial regression model with stabilized inverse probability of censoring weights for those lost to follow-up. Adjusting for other factors, an earlier enrollment date was the sole demographic characteristic associated with an increased risk of delayed ART initiation. Higher CD4 count, lower viral load, and a prevalent AIDS diagnosis were clinical characteristics associated with delayed ART initiation. Gender, age, race/ethnicity and HIV risk factors such as reported male-to-male sexual contact and injection drug use were not associated with delayed ART initiation. This study identified characteristics of patients for whom treatment was strongly to moderately recommended but who did not initiate ART within two years of entering care. Despite the known benefits of early antiretroviral therapy initiation, a lower viral load measurement may continue to be an important clinical characteristic in the more recent era with current ART initiation guidelines. These findings provide a target for closer monitoring and intervention to reduce disparities in HIV care.

Authors
Terra V Fatukasi, Stephen R Cole, Richard D Moore, William C Mathews, Jessie K Edwards, Joseph J Eron

MD Mag material
PLOS One abstract


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