New study results have concluded that antiretroviral therapy (ART) initiation within 30 days of HIV diagnosis is associated with a significantly reduced risk of treatment dropout and failure.
The widespread uptake of antiretroviral therapy (ART) has transformed the management of HIV. With prior research pointing to benefits of early ART initiation in order to reap the most benefit, new study results have confirmed the hypothesis, finding that ART initiation within 30 days of HIV diagnosis is associated with a significantly reduced risk of treatment failure.
Researchers conducted a nationwide, observational study of 123,605 patients from China’s National Free ART Program who initiated ART between January 1, 2011 and December 31, 2014. Participants were followed from the date of first ART initiation through the date of dropout, death, or 12 months. Clinical follow ups were performed at 2 weeks, 1 month, 2 months, 3 months, and every 3 months thereafter.
Participants were stratified into 4 groups: those who initiated ART within 30 days, 31 to 90 days, 981 to 365 days, and over 1 year. Of the patients, 28,883 initiated ART within 30 days, 21,918 initiated between 31 and 90 days, 25,635 initiated between 91 and 365 days, and 47,169 initiated after 1 year.
Within the 12-month follow-up period, 11,663 participants dropped out. Of the remaining patients, a total of 9235 had viral loads of over 400 copies/mL, and the virological failure rate was 9.29%. Virological failure was lowest among those who initiated ART within 30 days (5.45%), followed by those who initiated therapy between 31 and 90 days (7.39%).
Those who initiated ART between 91 and 365 days had a 33% greater risk of treatment dropout and a 66% greater risk of virological failure. Those who initiated therapy after 1 year had a 55% greater risk of treatment dropout and an 85% greater risk of virological failure.
Notably, those who had delayed ART initiation were generally middle-aged, injecting drug users, and/or had higher CD4 counts, which are factors that may have influenced their ability to access care, according to the researchers. Those infected from heterosexual contact were 2.44 times more likely to drop out of treatment and 1.78 times more likely to have virological failure.
These study results add to a growing pile of evidence showing that there are significant benefits of early ART initiation when CD4 counts are still high. However, in real-world settings, many people living with HIV are diagnosed late and already have low CD4 counts. Because of this fact, there has been a push for immediate ART initiation, rather than early initiation.
“These results make a good case for movement to test-and-immediately treat policies,” the authors of the study wrote. “However, implementation will be challenging.”
Zhao Y, Wu Z, McGoogan J, et al. Nationwise cohort study of antiretroviral therapy timing: treatment dropout and virological failure in China, 2011-2015 [published online May 16, 2018]. Clin Infect Dis. doi: https://doi.org/10.1093/cid/ciy400.