HIV Treatment Interruptions Don't Work
Major Study Sinks Strategy Designed to Lower Cost, Reduce Side Effects of HIV Treatment
Nov. 21, 2006 -- HIV treatment interruptions don't work, a huge
international clinical trial shows.
The strategy is known to scientists as "structured treatment
interruptions," or STI. Patients have another name for it: drug
The idea is to put HIV treatment on pause once the powerful drug combination
lets a person's CD4 T-cells – the immune cells under attack by the AIDS virus
-- return to higher levels.
Treatment starts again when CD4 counts drops toward the danger zone.
It was hoped the strategy would cut back on the side effects -- and cost --
of HIV treatment. Scientists also hoped it would help the recovering immune
system learn to fight the virus more effectively.
The new findings dash those hopes.
In a study involving 5,472 people with HIV, those on interrupted therapy had
a 2.6-fold higher risk of death from any cause or from HIV-related
"The idea of a benefit of interrupted HIV treatment for long periods of
time, where you allow the virus to bounce back, is not a valid strategy,"
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious
Diseases, said at a news conference.
Trial Stopped Early
The trial, which began in January 2002, enrolled 5,472 HIV patients with CD4
counts of more than 350.
Half took their drugs every day without fail. The other half took their HIV
drugs only when their CD4 counts dropped to less than 250, then stopped
treatment whenever their CD4 counts reached more than 350.
The trial was supposed to last six years but was stopped early when it
became clear patients getting treatment interruptions were doing significantly
Not only did they have a greater risk of death, they also had a 1.7-fold
higher risk of major heart, kidney, and liver disease.
This last finding was totally unexpected, as these events were thought to be
side effects of HIV drugs. Instead, the higher risks to the
treatment-interruption patients were due to higher blood levels of HIV and
lower CD4 T-cell counts.
"We still have much to learn regarding the detrimental effects of
uncontrolled HIV infection," write UCLA researchers Judith S. Currier, MD,
and Lindsey R. Baden, MD, in an editorial accompanying the study in the Nov. 30
issue of The New England Journal of Medicine.
The treatment-interruption strategy used in this study isn't the only one
being tried. Study researchers W.M. El-Sadr, MD, and colleagues warn that these
strategies must now be considered risky.
"The lack of benefit of our interruption strategy on major adverse
events associated with antiretroviral therapy suggests that such strategies
should be viewed as carrying a net clinical risk unless proven otherwise,"
El-Sadr and colleagues conclude.