| HIV therapy could be given safely without routine laboratory tests to save more lives in Africa |
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The largest clinical trial of anti-retroviral therapy (ART) for people with HIV infection ever run in Africa has found that regular laboratory tests offer little additional clinical benefit to populations when compared to careful clinical monitoring. The results suggest that many more people with HIV in Africa could be treated for the same amount of money as is currently spent if lab tests are not routinely used to monitor the effects of ART. The evidence from the Development of Anti-Retroviral Therapy in Africa (DART) clinical trial will be of value to low income or resource poor countries that are prioritising ART access over investment in expensive laboratory facilities.
The DART trial aimed to find out whether the lab-based strategies used to deliver ART to people with HIV infection in resource rich countries were essential in Africa, where around 4 million people still need ART urgently and resources are limited. The DART team believes governments and policymakers, as well as people living with HIV/AIDS, can now be confident that ART can be delivered safely and effectively by trained and supervised health workers in remote communities where routine laboratory services are not available. DART co- principal investigator Professor Peter Mugyenyi of the Joint Clinical Research Centre in Uganda said: ‘‘It is estimated that two-thirds of people who need treatment for HIV in Africa currently don’t have access to antiretroviral therapy. Thanks to DART, Governments now have evidence that expensive blood tests aren’t needed routinely for HIV treatment to be successful and safe. It also means that treatment could be delivered locally as long as health care workers have the right training, support and supervision. This could make a huge difference to people who live in remote areas that are many days’ walk from the nearest hospital or laboratory.’’ DART was sponsored and funded by the UK Medical Research Council. Further funding was provided by the UK Department for International Development and the Rockefeller Foundation. Antiretroviral drugs given to trial participants were donated by GlaxoSmithKline, Gilead Sciences, Abbott Laboratories and Boehringer Ingelheim. These pharmaceutical companies also provided funding for some of the sub-studies that were part of the DART trial. Scientists and health care workers from Africa and the UK collaborated closely to run the trial. Healthcare and research centres in Uganda were the Joint Clinical Research Centre, Kampala, the Infectious Diseases Institute at Mulago Hospital, Kampala and the MRC/Uganda Virus Research Institute Uganda Research Unit on AIDS, Entebbe. In Zimbabwe, researchers were based at the University of Zimbabwe Medical School Clinical Research Centre, Harare. The MRC Clinical Trials Unit in London provided overall coordination and the secretariat was provided by the International HIV Clinical Trials Research Management Office at Imperial College London. DART co-principal investigator Professor James Hakim of the University of Zimbabwe Medical School Clinical Research Centre in Harare explains the impact the DART results could have for people with HIV who don’t have access to a clinic with lab facilities: ‘‘The health economists in the DART team who have analysed the trial data have concluded that a third more people could be successfully treated for HIV in Africa if expensive lab tests weren’t used routinely. DART has shown that giving ART without these routine tests is safe and effective and suggests how the limited funding available could be used most effectively as by treating more people the number of deaths and disease related to HIV infection can be reduced. The challenge now is for policy-makers to widen availability of ART.’’ Co-principal investigator Professor Charles Gilks of Imperial College London and now UNAIDS, noted that: “The results provide compelling evidence for planners and policy-makers that, until universal access is achieved, the priority should be getting untreated patients on to ART, provided by well-trained and well-supported health workers who can deliver high quality clinical care.” Co-principal investigator Professor Diana Gibb of the MRC Clinical Trials Unit in London said: ‘‘The survival of people who took part in the trial was remarkable; without treatment only about 10% of HIV-infected African people like those in DART would be expected to survive for five years. In DART, 87% of those receiving treatment without routine blood test monitoring were still alive and well after five years, only 3 percentage points less than in the group that had routine blood test monitoring. For health policy-makers in Africa, DART provides evidence that more people could be treated for the same amount of money by not using routine laboratory tests. This would substantially reduce the number of people dying with serious disease due to HIV infection.’’ A webcast of the results of the DART trial being presented at the International AIDS Society (IAS) Conference 2009 in Cape Town on the 21st July is available on the conference website. More information about the trial can be found on the DART website . |