Clear evidence against episodic HIV treatment
HIV-infected patients are at increased risk of opportunistic disease or death if they are treated using a strategy of episodic antiretroviral therapy guided by their CD4+ count, rather than given continuous antiretroviral therapy, say researchers in The New England Journal of Medicine (2006;355:2283).
SMART treatment groups
Patients with CD4+ counts of more than 350 cells
per cubic millimetre were randomised to episodic or continuous
antiretroviral therapy.
Patients in the episodic treatment group
had antiretroviral therapy
deferred until their CD4+ count decreased to less than 250 cells
per cubic millimetre.
Treatment was then continued until their
count rose to more than 350 cells per cubic millimetre. |
The
latest evidence against such a treatment strategy, which the researchers
describe as “clear and compelling”, is from the so-called
SMART (strategies for management of antiretroviral therapy) study. The
study was halted early in January when an analysis of interim data revealed
that subjects on episodic treatment (see Panel right) had more
than twice the risk of disease progression than those taking continuous
antiretroviral therapy (PJ, 28 January, p98).
The full report of the trial, which involved 5,472 patients followed
for an average of 16 months, shows that the hazard ratio for opportunistic
disease or death from any cause among patients treated episodically was
2.6 per cent (95 per cent confidence interval 1.9–3.7; P<0.001).
The researchers explain that interruption of antiretroviral therapy has
been advocated as a treatment strategy to enhance quality of life, limit
adverse events and allow for the emergence of wild-type virus in patients
infected with multidrug-resistant HIV.
A recent study showed that the strategy could result in significant cost
savings with no
evidence of treatment resistance (PJ, 12 August, p182).
However, the researchers conclude that the episodic treatment strategy
used in the SMART study is deleterious, and did not reduce the risk of
death from causes other than opportunistic disease as they had expected. |