An ongoing dialogue on HIV/AIDS, infectious diseases,
June 24th, 2009
An Irrational Fear of IRIS?
One of the most important recent studies in HIV has just been “published” in (on?) PLoS ONE. It’s ACTG 5164, led by Andrew Zolopa, which compared “early” versus “deferred” antiretroviral therapy in 282 patients presenting with acute opportunistic infections.
(Full disclosure: I am on the protocol study team — but am not an author on this paper.)
Take home message: Starting antiretroviral therapy within 2 weeks of the OI diagnosis significantly reduced the risk of further AIDS complications or death, compared to the group that started 6-12 weeks later. (For additional details of the study, here’s a nice summary in AIDS Clinical Care.)
When I discussed 5164 with some of my less clinically-inclined colleagues, they wonder why the study was even done — of course starting these severely immunocompromised patients on ART as soon as possible would be better than waiting.
But the clinicians, they were not so sure, and raised appropriate concerns about drug-drug interactions, pill burden, overlapping toxicities, reduced adherence, and — drum roll — the immune reconstitution inflammatory syndrome, or IRIS.
Some of us are terrified of IRIS, and I’m not quite sure why. Yes, it can be difficult to manage (my sense is that we’re too reluctant to use steroids), and sometimes it’s very confusing exactly what is going on. And of course there are occasional case reports of severe IRIS, some even leading to death — but always with such cases, I wonder whether the outcome would have been just as poor without ART, just with a different clinical manifestation.
So that’s why it’s particularly gratifying to see this finding in 5164:
IRIS was reported in 23 cases and confirmed in 20: 8 subjects in the immediate arm and 12 in the deferred arm.
In other words, no significant difference in IRIS rates between early and deferred therapy, and only about a 7% incidence overall. As the authors note, this is likely to be closer to the true incidence of IRIS in patients starting therapy than the 15% or so widely reported in the literature, as the latter estimate often comes from retrospective studies.
So don’t let a fear of IRIS delay starting ART. The alternative — opportunistic infections, advanced HIV disease, no ART — is “old fashioned AIDS”, and we all know how that turned out.
Categories: Health Care, HIV, Patient Care, Policy
Tags: actg, adherence, aids clinical care, aids complications, antiretroviral, antiretroviral therapy, ART, case reports, clinical manifestation, clinicians, drug interactions, HIV, immune reconstitution inflammatory syndrome, immunocompromised patients, IRIS, opportunistic infections, pill burden, plos one, reconstitution, steroids
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Paul E. Sax, MD
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