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SMART Study
Strategies for Management of Antiretroviral Therapy Study
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Late breaker 106
Wafaa El-Sadr and James Neaton for the SMART Study Team
Author Summary:
The interruption (discontinuation) strategy, compared to the virologic suppression group (patients who remained on therapy, did not interrupt therapy), is associated with increased risk of:
-- HIV disease progression or death
-- death
-- serious HIV disease progression
-- severe complications (cardiac, renal, hepatic)
Risk of disease progression or death in the discontinuation group versus the viral suppression group:
-- did not differ by nadir CD4 count
-- was 3-fold higher for patients on ART with baseline HIV RNA <400 copies/ml compared to those with ART with baseline HIV RNA >400 copies/ml.
For all the other subgroups examined, risk was always greater in the discontinuation group than the viral suppression group (patients who remained on therapy, did not interrupt).
Author Conclusion
Episodic use of ART based on CD4 cell count levels as per the SMART Study design is inferior to continuous ART for the management of treatment experienced patients. Thus, this strategy should not be recommended.
As you can see in the graph immediately below, the percent of time patients in the discontinuation group spent below 200 CD4s was 3.1% and below 250 CD4s was 8.2%, and below 350 was 31.7%. So the amount of time with CD4s below 250 was not very long, El-Sadr said this was an important point to bear in mind.
It was hypothesized before the study that with therapy interruptions & less exposure to HAART, fewer of these types of events observed immediately below (cardiovascular, hepatic events, renal events). But the study findings did not confirm this, El-Sadr said. But surprisingly the findings for the severe complications endpoints and components of the endpoints found more of these events occurred for patients in the discontinuation group.
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