Imperial paper voted a “must read” of 2009

The Lancet journal’s Paper of the Year Award sees Imperial research voted runner-up <em>– News</em>

Thursday 4 March 2010
By Colin Smith

A study explaining how thousands more people in Africa could be treated for HIV if routine expensive lab tests were abandoned has been highlighted as one of the “must read” papers of 2009 by readers of the medical journal The Lancet.

The study, which was co-authored by Imperial’s Professor Charles Gilks, was runner-up out of eight international research papers shortlisted for The Lancet’s Paper of the Year Award, which celebrates new directions in practice and investigation in clinical research. More than 3500 subscribers to The Lancet took part in the nomination process to select their favourite paper of 2009 and to then vote the most popular from a final shortlist of eight. Professor Gilks’s study received the second highest number of votes.

The HIV paper, published online in The Lancet on December 9 2009, was authored by the Development of Anti-Retroviral Therapy in Africa (DART) trial team, which included Professor Gilks, from Imperial’s Infectious Diseases Section and now UNAIDS.

Entitled “Routine versus clinically driven laboratory monitoring of HIV antiretroviral therapy in Africa (DART): a randomised non-inferiority trial”, the paper revealed the results from one of the largest ever trials of HIV therapy in Africa. It found that with existing funding levels, up to a third more people could be effectively treated for HIV if expensive laboratory tests are used only when there is a clinically indicated need. A present, these tests are routinely used for monitoring Antiretroviral Therapy (ART) toxicity, patient side effects and disease progression.

Professor Peter Piot, who is the Director of the College’s Institute for Global Health, said:

Researchers say more people could be treated for HIV if routine expensive lab tests were abandoned

“The DART trial shows excellent science can be done in Africa. We can now be confident that antiretroviral treatment can effectively delivered by health workers in remote communities. The results show the importance of funding primary care training and it demonstrates how well-run trials can help build capacity in resource-poor settings. I hope the trial will influence HIV programme policies so that patients in rural areas have access to treatment and therefore adhere to drug regimens despite living far from a clinical laboratory. It is vital to scale-up access to antiretroviral treatment as well as maintaining the current level of HIV treatment.”

ART involves patients taking drugs every day for the rest of their lives. It is not a cure, but it can stop people from developing AIDS for many years. The aim of ART is to keep the amount of HIV in the body at a low level. This helps to stop any weakening of the immune system and allows it to recover from any damage that HIV might have caused already.

The study involved more than 3000 Africans who had not previously had ART. All had severe or advanced HIV infection and had been assessed for ART eligibility using clinical staging and laboratory tests including CD4 cell count, which is a measure of how well the body’s immune system is working.

The paper concluded that ART can be delivered effectively without routine laboratory monitoring for toxic effects. Routine CD4-cell count monitoring from the third year of treatment resulted in a small but significant reduction in disease progression.

The DART study was funded by the UK Medical Research Council, the Rockefeller Foundation and the UK Department for International Development.