Early HIV Therapy Improves Survival
News Author: Bob Roehr
CME Author: Désirée Lie, MD, MSEd
Release Date: October 28, 2008; Valid for credit through October 28, 2009
October 28, 2008 (Washington, DC) — Initiating vs deferring highly active antiretroviral therapy (HAART) at a CD4 count between 351 and 500 cells/mm3 is associated with a 70% reduction in mortality rates. The study was a late-breaker presentation here at the 48th Annual ICAAC/IDSA 46th Annual Meeting: A Joint Meeting of the American Society for Microbiology and the Infectious Diseases Society of America.
It entailed an unusual collaboration between all 22 HIV research cohorts in North America and a standardization of data to allow their integration and analysis. Patients were those with a CD4 count between 351 and 500 cells/mm3 who were in active follow-up between 1996 and 2006. Individuals with previous antiretroviral treatment and those who already had experienced an AIDS-defining illness (1993 Centers for Disease Control and Prevention criteria) were excluded.
Some 2473 patients initiated HAART (8358 person-years), whereas 5901 (16,636 person-years) deferred treatment during the period of the study. Those who began therapy were more likely to be male sex, older, have a lower Centers for Disease Control and Prevention count, and have a higher viral load at baseline, but the median differences between the 2 groups were not large.
Those who deferred starting HAART had a mortality relative hazard 1.7 times that of patients who began therapy within that CD4 range (P < .001).
Lead author Mari Kitahata, MD, a researcher at the University of Washington Center for AIDS Research, said the observational methodology they used should approximate the findings of a randomized clinical trial. The size and characteristics of the study also means that the results likely are applicable to most settings where HAART is widely available.
“These data strongly support the use of antiretroviral treatment for patients at a CD4 count of 500 and below, regardless of the presence of symptoms,” she later said at a news conference.
The collaboration also is conducting analysis of patients with CD4 counts above 500 cells/mm3, which will be available “soon.” When asked by Medscape HIV/AIDS as to whether it will be presented in February 2009 at the Conference on Retroviruses and Opportunistic Infections (CROI), Dr. Kitahata replied “perhaps.”
“These are really important data,” said Daniel Kuritzkes, MD, a conference organizer and clinician at Brigham and Women’s Hospital in Boston, Massachusetts. Previous studies have suggested similar trends, but “they have lacked the power to find meaningful differences in strategies.” Aggregating these cohorts together created sufficient power to reach definitive conclusions.
It is unlike that a similar confirmatory analysis can be conducted in Europe because of how data is gathered in those cohorts.
Dr. Kuritzkes told Medscape HIV/AIDS that these data suggest that additional “hundreds of thousands of people” in the United States should be started with therapy. He believes the field “will get better at identifying patients at greatest risk for progression” on the basis of a matrix of factors such as host viral load, CD4 counts, host genetics, and viral factors.
However, the reality is that “at our center a quarter of the people get diagnosed with HIV for the first time because they got diagnosed with an AIDS-defining illness. They are being identified far too late.” Dr. Kuritzkes believes that “only a handful” at his clinic might be affected by these data.
Los Angeles physician Anthony Mills has a practice that cares primarily for gay men, a group that is more likely to test early for HIV as a regular part of medical care. He strongly advocates early intervention because “people who start early just do better; they suppress more quickly, their T-cells rebound better, they have fewer side effects. Now that the medications are so well tolerated, why would we wait?”
Scott Hammer, MD, the conference cochair, who is affiliated with Columbia University in New York City, is another advocate of early initiation of therapy. He told Medscape HIV/AIDS that in his practice, the discussion of treatment begins with the first visit. He is willing to have a patient with a CD4 count above 600 cells/mm3 begin therapy if the patient is committed to adherence.
“I say to people right now, the way the field is moving is away from these arbitrary thresholds. There are potential reasons to treat earlier and earlier, when ready. The preparation should begin at that first encounter as you go forward. You have to develop an individual profile of the patient. The conversation evolves over time,” Dr. Hammer said.
The study was supported by the participating reach cohorts with no industry sponsorship. None of the speakers has disclosed any relevant financial relationships.
48th Annual ICAAC/IDSA 46th Annual Meeting: Abstract H-896b. Presented October 26, 2008.
Pearls for Practice
- Current practice guidelines on the basis of observational data suggest that HAART be initiated at CD4+ counts less than 350 cells/mm3 in patients with asymptomatic HIV infection.
- In asymptomatic patients with HIV with CD4+ counts of 351 to 500 cells/mm3, deferring HAART vs initiating HAART early is associated with a mortality ratio of 1.7 (P < .001) based on observational data during 10 years from 22 HIV research cohorts in North America.
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- October 29, 2008 / 1:39 pm