| So
treatment guidelines keep changing—ain’t that a good thing?
New research, new recommendations.
The International AIDS Society-USA
(IAS-USA) in July changed its recommendation that antiviral
therapy could be started at less than 350 CD4 cells. They
now say at 200, although, the society guidelines state, “It
is known that therapy should not be delayed until the CD4+
count declines to 200 cells/microliter, because of the increased
risk of death if therapy is started this late.”
For all HIV doctors, as with
this panel of experts, the real issue is the imperfection
of the medications. If there were no toxicities and no drug
resistance, putting people on meds would be a no-brainer.
But there’s no HIV “cocktail.”
There’s only HIV chemotherapy. In fact, a lower and lower
T-cell count has been expected from different HIV guidelines
in the U.S. and Europe, thanks in part to the onerous effects
of many of the drug regimens while the benefits are debated
by experts.
Although they’re downshifting
to 200 T-cells, a reading of the guidelines shows that the
panel is never anti-therapy. Nor does the panel ever suggest
that delaying HIV therapy is preferred. Rather, the guidelines
go back and forth about the pros and cons of therapy, including
when to start.
So what are some of these
considerations?
• Since the last time
the guidelines were updated in January 2000, two cohort studies
have pointed to the greater importance of CD4 count for considering
when to start therapy, showing “an increased mortality when
antiretroviral therapy is initiated in patients with CD4 cells
counts below 200 compared with initiation at higher levels.”
• However, cohort studies—which
are based on observational data with short-term follow-up
rather than controlled clinical trials—are not the best sources
of medical information.
• Nevertheless, “these
are the best available data.” Also, “there is general consistency
across most studies, and it is questionable whether a randomized
trial to study the issue of when to start therapy will ever
be feasible.”
• “The CD4 cell level
above 200 at which to initiate therapy remains unclear. Some
serious illnesses, especially active tuberculosis and bacteremic
pneumonia, may occur when the CD4 cell count is above 200.
• In addition, the
immune reconstitution syndrome and its associated [illnesses]
may be observed in some patients starting antiretroviral therapy
at low CD4 cell counts.”
Criticism
The guidelines were published
in the July 10th issue of The Journal of the American Medical
Association (JAMA), during the XIV International AIDS
Conference held in Barcelona. Some doctors shuddered at the
idea of waiting until their patients “deteriorated” to the
point of 200 T-cells. One HIV specialist and researcher also
wondered if the door was open for insurance companies to deny
therapy for people with more than 200 T-cells. But others
sided with the commonsensical idea of choosing to wait if
that’s desirable.
Dr. Joseph Gathe, of the
Montrose Clinic and the Houston Clinical Research Network,
wasn’t thrilled. “People hear what they want to hear,” he
said. “If you tell them they don’t need medication, they hear
that they’re okay. Then they stay away from care. By the time
they come back, they’re down to 200 T-cells or have opportunistic
infections.”
These people may not get
the message that they have to be monitored on a regular basis,
or that T-cell count and viral load measurement aren’t the
only things that have to be considered for going on therapy.
He said he’s also had patients turned away from getting the
HIV medications he prescribed after public health clinic personnel
told them they didn’t “need” to be on antivirals based on
their T-cell counts, according to treatment guidelines.
Gathe also pointed out that
there’s no mention of hepatitis C, a common co-infection among
people with HIV. HIV treatment is known to help keep hep C
disease in check. “There’s no mention of hep C in any of the
guidelines,” he said. (There are also guidelines from the
U.S. Department of Health and Human Services and from the
European Union.)
Other highlights
• “Viral load remains
an important marker of response to antiretroviral therapy.”
• “Newer formulations
of drugs and the availability/approval of new drugs have resulted
in effective and more convenient regimens (e.g., once-daily
dosing regimens, smaller pill size, protease inhibitor “boosting”
strategies).”
• “Viruses resistant
to an increasing number of drugs raise challenges… Several
new recently released drugs are active against such viruses.”
For people who’ve already
been on therapy when they had more than 200 T-cells, who have
had durable viral load suppression without adverse effects,
“it is not clear whether it is safe to discontinue therapy.”
For women, there’s no documented difference from men in terms
of T-cell count and risk of infections, so there’s no separate
recommendation for them. Visit www.iasusa.org
to see the entire document.
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