Study Suggests Early ART in Recently HIV-Infected Patients Preferable to Delayed Treatment
DEC. 16, 2011 - Among people recently infected with HIV, immediate antiretroviral
therapy (ART) appears preferable to deferring treatment, according to a new study published in The Journal of
Infectious Diseases and now available online. Although
the benefits of ART during early HIV-1 infection remain unproven, the findings support growing evidence favoring earlier ART
Christine Hogan, MD, of the Medical College of Wisconsin in Milwaukee, led a team of researchers from various
institutions to investigate the effects of ART on individuals infected with HIV-1 within the previous six months. The
multicenter clinical trial-the AIDS Clinical Trials Group (ACTG) Setpoint Study-enrolled 130 men and non-pregnant
women who were at least 18 years old and had not received ART previously. Participants were randomized into two
groups: In the immediate treatment group, patients were to receive ART treatment for 36 weeks, after which
treatment was stopped; treatment was deferred for patients in the second group. All individuals were
followed throughout the study.
The study's primary endpoint was the patients' virologic setpoint at 72 weeks. The researchers also sought to compare
the virologic setpoint at 72 weeks for patients in the immediate treatment group with that of patients in the deferred treatment
group at 36 weeks.
Investigators found that the immediate treatment group had a better outcome than the deferred group. Individuals in the deferred
arm experienced higher than anticipated rates of disease progression, necessitating the start of HIV treatment before the study endpoint. Half
of the participants in the deferred treatment group required treatment on medical grounds within 18 months.
According to Dr. Hogan and colleagues, the results suggest that "if immediate therapy is not begun, progression to
meeting standard criteria for ART initiation may occur more rapidly than expected, especially with changing treatment
paradigms." In addition, patients who received treatment immediately appear to have been protected not only during
treatment but for a brief period of time afterward.
In an accompanying editorial, Harout Tossonian, MD, PhD, and Brian Conway, MD, of the University of British Columbia
in Vancouver, Canada, noted that "immune preservation and reduction in the latent pool of HIV-1-carrying CD4 T-cells seems to
require intervention at the earliest possible time of acute infection." They noted that the advantages of immediate
treatment appear to be achieved with little to no harm to the patient, either in terms of drug-related toxicity
or emergence of drug resistance. "The initial course of 36 weeks of treatment may delay the need for
re-starting it more than the 36 weeks spent on it from the time of initial presentation," Drs. Tossonian
and Conway wrote. "Thus over the lifetime of the patient, there will be less cumulative drug exposure."
Dr. Hogan and her team suggest that the findings may be of interest to clinicians and patients struggling with when
to begin ART. An additional sub-study is underway "to address whether immediate versus deferred treatment during primary HIV
infection results in improvements in markers of inflammation and immune activation, which may provide further insight into
potential benefits of treating primary infection," the authors wrote.
1) In a comparative randomized trial of immediate versus deferred antiretroviral therapy (ART) in early HIV infection, patients whose
therapy was deferred experienced higher than anticipated rates of disease progression.
2) Participants who received treatment immediately appear to have been protected not only during treatment but also for a brief
period of time after treatment was stopped.
The study and the accompanying editorial are available online. They are embargoed until 12:01 a.m. EST on
Friday, Dec. 16, 2011:
The Setpoint Study (ACTG A5217): Effect of Immediate Versus Deferred Antiretroviral Therapy on Virologic Set
Point in Recently HIV-1-Infected Individuals
Recent HIV-1 Infection: To Treat or Not to Treat, That Is the Question
Founded in 1904, The Journal of Infectious Diseases is the premier publication in the Western Hemisphere for original research on
the pathogenesis, diagnosis, and treatment of infectious diseases; on the microbes that cause them; and on disorders of host immune
mechanisms. Articles in JID include research results from microbiology, immunology, epidemiology, and related disciplines. JID is
published under the auspices of the Infectious Diseases Society of America (IDSA). Based in Arlington, Va., IDSA is a
professional society representing more than 9,000 physicians and scientists who specialize in infectious diseases.
For more information, visit www.idsociety.org .
"Reproduced with permission - "Infectious Diseases Society of America (IDSA)"
Infectious Diseases Society of America (IDSA)