Two week dummy run can predict who will adhere to HIV medication

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Taking part in a trial of mock medication before starting HAART does not improve the chances of achieving viral suppression, but adherence to this dummy regimen does predict how well people will adhere to their HAART regimen, and people who manage high levels of adherence to a two week course of dummy medication showed a trend towards better levels of viral suppression at 24 weeks according to a study presented to the 40th Annual Meeting of the Infectious Diseases Society of America last month in Chicago.

Investigators recruited 60 people at two hospitals in South Carolina to participate in the dummy medication trial between November 1999 and June 2001. Trial participants were randomised to either receive two weeks of practice medication comprising methycellulose-filled capsules, or to start HAART without having a ‘dry-run.’

Both arms of the trial received advice from a pharmacist about their likely HAART treatment. A target of 90% adherence to the mock medication (thought to be the minimum necessary to obtain sustained benefit from HAART) was set by the investigators and this was assessed after two weeks, and people in both arms of the trial then started HAART if both the patients and their doctor agreed.

Glossary

virological suppression

Halting of the function or replication of a virus. In HIV, optimal viral suppression is measured as the reduction of viral load (HIV RNA) to undetectable levels and is the goal of antiretroviral therapy.

trend

In everyday language, a general movement upwards or downwards (e.g. every year there are more HIV infections). When discussing statistics, a trend often describes an apparent difference between results that is not statistically significant. 

replication

The process of viral multiplication or reproduction. Viruses cannot replicate without the machinery and metabolism of cells (human cells, in the case of HIV), which is why viruses infect cells.

control group

A group of participants in a trial who receive standard treatment, or no treatment at all, rather than the experimental treatment which is being tested. Also known as a control arm.

To determine if taking dummy medication had any effect on a person’s likelihood of adhering to HAART, viral load was tested at 24 weeks in both trial arms to see if HIV replication had been suppressed to below 400 copies/mL.

More people in the control arm (20 or 68%) achieved viral suppression than in the mock medication group (58.6%). However, when the results from the group taking mock medication were analysed further it was established that those who had managed to take at least 90% of their dummy doses achieved viral suppression (75% against 50%).

The investigators conclude that the use of dummy medication prior “to initiating HAART did not improve subsequent HIV…viral suppression” adding “patients who adhered to the m(ock) a(ntiretroviral) trial were more likely to achieve viral suppression compared to those who did not adhere”.

The draft adherence guidelines prepared by the British HIV Association can be read by clicking here and a booklet on adherence in the NAM Information Series for HIV-Positive People series is being prepared.

References

Eggleston ST et al. Mock antiretorivral trial prior to highly active antiretroviral therapy: does a placebo trial enhance adherence as measured by durable HIV-1 viral suppression?IDSA 40th Annual Meeting, Chicago, abstract 488, 2002.