Directly observed antiretroviral therapy-in which a health worker or other person watches as an HIV patient swallows their medication-has no effect on treatment outcome compared with self-administered treatment, in a range of high-income and low-income country settings. These are the conclusions of an Article published Online First (http://www.thelancet.com) and in an upcoming edition of The Lancet, written by Dr Nathan Ford, Medecins Sans Frontières, Cape Town, South Africa, and colleagues.

Directly observed treatment for tuberculosis is the WHO standard treatment for this condition; but it is costly and concerns have been raised about lack of effect of this treatment. Since antiretroviral treatment for HIV is lifelong, the concerns about cost-effectiveness are even greater, and clear evidence of benefit of this strategy is needed.

The authors did a meta-analysis of previous randomised controlled trials, which had been carried out on high-risk populations in the USA (drug users, homeless people, and prisoners), and a variety of settings in Africa, to calculate any difference in treatment outcome. The primary outcome was virological suppression at study completion.

The final analysis comprised 10 studies and 1862 HIV patients, and the authors found no statistically significant difference between the two treatment approaches. The authors say: “Our study shows no benefit to virological suppression of directly observed versus self-administered antiretroviral treatment in people with HIV infection. Despite expectations that directly observed therapy could be an effective intervention to promote adherence both for the general population and for groups at high risk of poor adherence, we did not find definitive evidence to support such use.”

They conclude: “Directly observed antiretroviral therapy seems to offer no benefit over self-administered treatment, which calls into question the use of such an approach to support adherence in the general patient population.”

In an accompanying Comment, Dr Julie E Myers and Dr Simon J Tsiouris, Mailman School of Public Health, Columbia University, New York, USA, say: “The conclusion that directly observed therapy might not be suitable to promote adherence in a general patient population is reasonable. Even if the data to support this intervention were more plentiful, a real world, widespread rollout of directly observed therapy would be impractical, notwithstanding further investment.”

Source
The Lancet