Study also showed that most commonly used measure — CD4 count does not give accurate projection of illness risk
VANCOUVER, Canada – Mostly, the findings of the START trial, detailed in a session here today give rise to words of unbridled vindication and ambition. With that they have also brought a challenge.
Showing more than double the rate of serious illness and death among more than 2300 people people who did not start antiretroviral treatment for their HIV until their immune system had shown evidence of significant decline than among their counterparts who started treatment immediately upon enrolling in the study of Strategic Timing of Antiretroviral Treatment, the trial gave scientific backing to what many treatment activists, human rights advocates, researchers, clinicians and people living with the virus had long urged: Everyone should have equal access to treatment.
The findings presented by researchers here today broke down the contrast among trial participants, all of whom enrolled in the START trial with immune cell, or CD4, counts of more than 500, half of whom did not take medicine to prevent illness until those counts had dropped to 350 or below.
Dr. Jens Lundgren of the University of Copenhagen listed some of the consequences of waiting. While 14 people who started treatment immediately had serious AIDS-related illnesses over the average of three years that trial participants were followed, 50 of those who had waited for treatment did. Those illnesses included Kaposi’s sarcoma, lymphoma, pneumocystis pneumonia, herpes, and, in the greatest numbers, including a high of 62 percent in Africa, tuberculosis. While 29 of those starting immediate treatment came down with serious non-AIDS related illnesses — that included other cancers, cardiovascular disease, renal and liver diseases, 47 of those who waited for treatment did. While seven who started immediate treatment for HIV died, 13 among those who started treatment later did. As noted when the findings were released in May, starting treatment earlier did not lead to more illnesses or side effects from the drugs themselves. The numbers of serious illnesses and deaths overall exceeded researchers’ projections. Illnesses that were non-AIDS related, outnumbered AIDS-related illnesses and were largely associated with aging. And most of the illnesses occurred, among both immediate and deferred treatment starters at higher CD4 count levels.
“One of the findings of the study is how poorly CD4 counts do for predicting events,” Dr. Abdel Babiker, of the Medical Research Council Clinical Trials Unit, UCL, United Kingdom said. The counts do not fully capture damage HIV does to the immune system early in infection, he said.
In addition to proving the value of immediate treatment being offered to everyone diagnosed with HIV, Lundgren said, the findings showed a need for research to identify new ways to measure impaired immune function. They also reinforce the need for health systems to improve programs to diagnose HIV and link people diagnosed to care.
That was the challenge, and the opportunity for everyone else to celebrate and confront.
U.S. Global AIDS Coordinator Amb. Deborah Birx interrupted moderator Kenly Sikwese when he started to deliver her full title which also now includes leader of the Office of Global Health Diplomacy, citing the hurry the findings had brought,
“Times a ticking, for all of us to implement START,” she said. Noting the more than 20 million people now living with the virus who have yet to initiate treatment, she listed the diseases and death risks they are more likely to face — called “events” in research language.
“It’s hundreds of thousands of events that could be prevented month after month, day after day,” she said. On release of the initial START data in May, her office had immediately communicated with ambassadors, she said. “We have to plan now for what the World Health Organization has made very clear to us.”
That, new treatment guidelines for HIV that as WHO HIV leader Gottfried Hirnschall said, “move toward recommending immediate treatment for all,” will be released in December, but already had been strongly hinted at here. And, as Hirnschall noted, “Countries are not necessarily waiting for what the World Health Organization has to say.”
That doesn’t mean the same thing for everyone, though, Kate Thomson who represented the Global Fund to Fight AIDS, Tuberculosis and Malaria said. “There’s a danger that the access gap will actually be increased,” she said. Those left behind are likely be those with the least access now — people already marginalized by responses that have neglected the needs of men who have sex with men, people involved in sex work, people who inject drugs.