Concerns about the effect of HIV drug holidays have emerged after a major international trial was aborted because participants taking medication breaks reported markedly higher health risks than those on uninterrupted treatment.
The trial, known as Strategies for Management of Anti-Retroviral Therapy (SMART), involved about 5,500 participants in 33 countries, including around 200 people in Australia and New Zealand.
Half the participants followed a continuous course of anti-HIV medication. The remainder took antiretrovirals only when key immune cell levels dropped below a set level, stopping treatment if their immune cell count increased again.
Volunteers were required only to be HIV-positive and have an immune cell count above a certain level at entry to qualify for the study, which began in 2002.
Researchers had hoped to find lower rates of disease progression and toxicity in people taking less HIV medication.
But they called off the trial last week after results indicated participants taking the drugs intermittently were about twice as likely to report AIDS-related illnesses or die than those on consistent treatment.
The group on irregular medication intake also reported higher rates of kidney, liver and cardiovascular disease.
We had predicted that this study would continue to follow people for six to nine years and these results became clear after a period of around two years, associate professor Sean Emery from the National Centre in HIV Epidemiology and Clinical Research told Sydney Star Observer.
Emery, who supervised the HIV trial in Australia and several other countries, said the study’s clear and very meaningful outcome suggested people already on antiretrovirals should think carefully before taking a break in treatment.
It’s quite likely that some people might have started [treatment] because they sort of thought they could have a brief period on the drugs and once they got their CD4 [immune cell] count a bit higher they could come off them, he said.
I think that’s not really supported by the data.
People Living with HIV/AIDS (NSW) executive officer Geoff Honnor told the Star SMART reinforced the organisation’s position that continuous treatment was better than intermittent therapy.
But we also know that people do take -˜drug holidays’. What we always say to people is that you should always do that under clinical supervision.
PLWHA (NSW) clients gave various reasons for wanting a treatment break, including drug side effects and preferring not to take medication while travelling, Honnor said.