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 Until now, evidence on when to begin the treatment of asymptomatic
patients has not been clear, and there's been concern that giving
antiretroviral therapy earlier might increase patients’ risk of
cardiovascular and renal disease.
“It has been controversial for two decades over whether to start
treatment” when levels of so-called CD4-positive white blood cells
are above 350 cells per cubic millimeter, the coauthor of the larger
of the two studies, Dr. Jens Lundgren of Rigshospitalet at the
University of Copenhagen, told Reuters Health in a telephone
interview.
"It's clear that with early treatment there's obviously a
transmission benefit, a public health benefit, but that's not a
benefit to individuals," he said. "This controversy has been going
on for so many years, we thought it was important to settle it."
In his team’s study, known as START and reported Monday afternoon at
the International AIDS Society 2015 Conference in Vancouver, 4,685
HIV-positive adults were followed for an average of three years.
Half were randomly assigned to start taking antiretroviral drugs
immediately, while their CD4-positive counts were still higher than
500. In the remaining volunteers, treatment was delayed until their
counts dropped to 350.
The findings were so dramatic, the test was terminated prematurely
and all patients were put on antiretroviral therapy.
While 1.8 percent of patients in the immediate-treatment group
reached a composite end point of death from any cause, a serious
AIDS-related event or a serious non-AIDS related event, 4.1 percent
of people in the deferred-therapy group reached that end point. When
treatment was delayed, it typically took three years for the counts
to drop low enough to begin antiretroviral therapy.
Side effects from early therapy were not a major problem, the
researchers said. The odds of having a grade 4 (serious) event or an
unscheduled hospital admission were comparable in the two groups,
and early treatment didn't seem to significantly increase the risk
of cardiovascular or renal disease during the study.
"We are demonstrating a benefit from treatment with what we could
consider to be a normal CD4-positive count," said Lundgren. "From
that logic, everybody (who is HIV positive) should be treated
because in any patient who is HIV infected but with a high
CD4-positive count there is some immune deficiency that
antiretroviral treatment can essentially repair."
The benefit for patients who received early treatment seemed to come
from lower rates of tuberculosis and in lower rates of cancer,
including types of cancer not associated with AIDS.
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"It really opens up a whole new discussion around what are actually
the factors driving cancer development in people with impaired
immune systems, which is obviously an issue in HIV patients," said
Lundgren.
The study, initiated in 2009, was done by the International Network
for Strategic Initiatives in Global HIV Trials (INSIGHT) and
involved volunteers treated at 215 sites in 35 countries.
The second study, by Xavier Anglaret of INSERM in Bordeaux, France
and colleagues, reached a similar conclusion. It followed 2,056
infected patients at nine care centers in Abidjan, the economic
capital of Ivory Coast. That research team looked at volunteers
whose CD4-positive counts were above or below 500, the standard set
by the World Health Organization.
Antiretroviral therapy "provides substantial clinical benefits in
patients who have higher CD4+ counts at the time of initiation than
those previously recommended for the initiation of ART," the
researchers concluded.
"My sense is that this will galvanize the efforts to put more people
on treatment and that most, if not all, guidelines will change to
recommending treatment irrespective of CD4-positive count," said
Lundgren. "That's our recommendation. We feel these results are
definitive and it would be unethical to repeat the study. I think we
have resolved the controversy that has persisted for the last two
decades."
SOURCES: http://bit.ly/1ebVVUf
and http://bit.ly/1Kgli5D The
New England Journal of Medicine, online July 20, 2015.
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