Determining Who Should Start ART Immediately When Resources Are Limited

The World Health Organization (WHO)’s guidelines for the treatment of individuals with HIV include starting antiretroviral therapy (ART) right away, no matter what the patient’s CD4 count is.

In an ideal world, every individual diagnosed with HIV would have immediate access to ART. However, certain low- and middle-income locales are not as well equipped as wealthier regions to provide therapy for HIV sufferers. In situations in which ART must be rationed, it’s important to have a system that allows health care providers to identify patients who should be moved to the front of the line.

The results of a nearly 5-year international trial may help shed some light on this situation. The START trial, funded by the US National Institute of Allergy and Infectious Diseases and carried out by a group of researchers from across the globe, enrolled thousands of subjects in order to identify those with HIV who could best benefit from immediate administration of ART.

From April 2009 to December 2013, 4,684 HIV-positive subjects from 35 countries took part in the trial. The researchers randomly assigned 2,325 subjects to receive ART right away, with almost all of them beginning the regimen within a few months of trial enrollment. The other 2,359 subjects were assigned to receive ART at a later time, with 3 years being the average delay. Adherence to the regimen was found to be high in both groups, as evidenced by the study subjects’ lowered viral load levels once on ART.

The study found that HIV-positive individuals of all ages experience better outcomes if they start ART as soon as possible. Furthermore, those who are older are at greater risk of having poor health outcomes if they delay treatment.

“The risk of developing AIDS or serious non-AIDS conditions was more than 3 times higher among those aged 50 years or older compared with younger participants,” Birgit Grund, PhD, a statistician at the University of Minnesota and an author of the study, told Contagion^®. “Therefore, it is particularly urgent for older patients to start ART immediately. In our study, immediate ART decreased the incidence of AIDS or serious non-AIDS conditions by 24 per 1,000 person-years among those aged 50 and older, and by 6.7 per 1,000 person-years among those aged 30 to 49.”

The study also found that individuals with low CD4 to CD8 T-cell ratios should be prioritized, as should those whose HIV RNA counts are especially high (greater than 50,000 copies per mL).

Why are older individuals with HIV more likely to experience health problems or even death if the period before beginning ART is prolonged? “The reason for more rapid disease progression with age is likely to be multifactorial, including a role for comorbidities associated with aging and a direct role for HIV,” the authors wrote in the study.

In addition to making every effort to provide ART as soon as possible for middle-aged and older individuals living with HIV, the authors noted, providers also need to ensure that those who are older are not overlooked when it comes to testing for the disease in the first place; roughly 17% of all new HIV diagnosis occur in individuals 50 years of age and older.

Because only 553 of the study’s nearly 4,700 enrollees were 50 years or older, the researchers were unable to parse out whether gender, race, or route of infection affected the outcomes in that advanced age group. “We don’t have enough data to reliably identify further differences among those aged 50+ years only,” Dr. Grund said.

Laurie Saloman, MS, is a health writer with more than 20 years of experience working for both consumer- and physician-focused publications. She is a graduate of Brandeis University and the Medill School of Journalism at Northwestern University. She lives in New Jersey with her family.