The UNC-based research covered the period from January 2003 to December 2012, when most patients in the study were not covered by the most recent federal guidelines pertaining to HIV treatment.
About one-third of the HIV patients with low viral loads tempted fate and avoided starting human immunodeficiency virus (HIV) medications despite recommendations to take them, according to a 10-year University of North Carolina (UNC) study.
The mass prolonged delay in antiretroviral treatment (ART) among patient necessitates scrutinization of the current guidelines for HIV therapy, the study’s authors noted.
Joseph Enron, MD, professor of medicine at the UNC Chapel Hill’s School of Medicine, discovered with a team of researchers that lower-viral load patients delaying therapy may still persist “despite clear evidence of the benefits of immediate therapy initiation."
With the increasing ability of ART to put HIV into remission, federal guidelines since early 2012 have suggested that anyone who tests positive for HIV begin therapy immediately in order to reduce disease progression and reduce transmission. Prior to that time, guidelines made moderate-to-strong recommendations to start ART. The UNC research covered the period of January 2003 to December 2012, so that most of the patients in the study were not covered by the most recent federal guidelines.
The UNC research was based on data of 4,907 HIV positive patients for whom treatment was strongly-to-moderately recommended, enrolled in 8 HIV clinics across the country during the set time frame. All of the test subjects had not previously been on ART.
Viral load is measured by the number of HIV RNA (viral load = 10,000 RNA per mL of blood; high load = 100,000). At the beginning of their participation, patients with viral loads of less than 10,000 had a .36 higher risk ratio of being more likely to delay ART than those with a viral load of at least 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 at least 100,000 had also not begun ART.
To be included in the study, patients needed infection-killing white blood cell (CD4) counts of 350 cells/mm or below. A normal count is considered to be in the range of 500 to 1,500. 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 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.
While a low viral load over the course of the study was the most statistically significant factor in delaying ART, an AIDS diagnosis also played a role. 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,” according to the study.
Enrollment date was the only demographic factor that appeared to affect the willingness to start ART, according to the study.
“For example, for each one year increase…in enrollment date, patients were 0.94 times (95% CI:0.92, 0.97) as likely to delay ART initiation,” researchers wrote.
Unexpectedly, demographic characteristics such as gender, age, race/ethnicity, and HIV risk factors such as reported male-to-male sexual contact and injection drug abuse were not significantly associated an ART delay. Enrollment date was the only demographic factor that appeared to affect the willingness of study participants to start ART, the study said. “For example, for each one year increase…in enrollment date, patients were 0.94 times (95% CI: 0.92, 0.97) as likely to delay ART initiation,” the study explained.
Six percent of the study participants who did not initiate ART died within 2 years of enrolling. In 2014 in the US, 12,333 people died of AIDS-related causes, according to the US Centers for Disease Control and Prevention. ART has been credited with increasing longevity for people who are HIV positive, making HIV more of a chronic condition than a terminal one.
“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 study, "Risk factors for delayed antiretroviral therapy initiation among HIV-seropositive patients," appeared online in PlosOne last month.