Every experienced HIV clinician will recognize the following new-patient scenario:
- At least one, but often several negative HIV antibody tests in the past, generally due to being in a "high risk" group.
- Recent non-specific viral-type illness that, in hindsight, was undoubtedly acute HIV infection, undiagnosed.
- Now completely recovered, but found to be newly HIV antibody positive.
- Physical exam normal, CD4 500 or higher, HIV RNA in the moderate range (10-100K).
How should patients like these be managed? Specifically, should antiretroviral therapy be started, or should they be observed?
Over in Journal of Infectious Diseases, the so-called Setpoint study -- a randomized strategy trial -- investigated whether a 36-week period of treatment would delay the need to go on continuous HIV therapy, compared with observation. After 130 of a planned 150 patients were enrolled, a Data Safety Monitoring Board elected to stop the study due to this key finding: "... the higher rate of progression to needing treatment in the Deferred Treatment group (50%) versus the Immediate Treatment (10%) group."
Importantly, the findings would have been even stronger in favor of Immediate Treatment if more up-to-date CD4 thresholds (500 rather than 350) were used as a criterion to start therapy. (The study was designed in the mid 2000s.)
How do these results influence practice? As I've noted before, patients diagnosed with recently-acquired HIV infection should be counseled that even if treatment is deferred, there is a high likelihood they will need to start treatment relatively soon.
It's also time to retire the "you may have 10 years before needing to go on therapy" counseling, something we might have been prone to do in the past to soften the blow of someone hearing that they're HIV positive. This kind of delay is highly unlikely, and may be limited to the small fraction of patients who have very low HIV RNA and very high CD4s.
Paul Sax is Clinical Director of Infectious Diseases at Brigham and Women's Hospital. His blog HIV and ID Observations is part of Journal Watch, where he is Editor-in-Chief of Journal Watch AIDS Clinical Care.