HIV therapy could be given safely without routine laboratory tests to save more lives in Africa

HIV therapy could be given safely without routine laboratory tests to save more lives in Africa
Taking blood samples (Image from MRC DART Trial video) : Click to enlarge

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. If lab tests are not routinely used to monitor the effects of ART, this means that many more people with HIV in Africa could be treated for the same amount of money.

The Development of Anti-Retroviral Therapy in Africa (DART) clinical trial, funded by the UK Medical Research Council (MRC), the UK Department for International Development (DFID) and the Rockefeller Foundation, 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 trial, which began in 2003 and finished in 2008, involved 3316 people infected with HIV in Uganda and Zimbabwe.

DART participants were randomly allocated to one of two groups. People in the first group received ART and their doctor was given the results of blood tests done every three months to check for drug side-effects and measure their CD4 cell count (a measure of how well the immune system, which is damaged by HIV, is working). People in the second group had the same ART and the same blood tests done, but their doctors did not see CD4 count results and only saw the results of safety tests if they were seriously abnormal. People in both groups received free medical care and free diagnostic tests for episodes of illness throughout the trial.

Speaking about the results of the trial, 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. "

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. "

International Development Minister, Mike Foster of DFID said: "It’s absolutely clear that anti-retroviral treatment saves lives – but the cost of accompanying laboratory tests significantly reduces the number of people that this treatment can reach. The DART trial, for which DFID provided £2.5m in funding, shows that this life saving treatment can still be safely provided without this additional cost. "

"Crucially, the money saved from paying for these tests could enable more people to safely receive treatment, including those who for whatever reason are unable to travel to the laboratories. Such a step would be an important move towards our ultimate aim of achieving universal access to treatment for HIV/AIDS by 2010. "

More information

* For more details, and additional quotes from other co-principal investigators, please read the full MRC media release.
* Watch the YouTube video clip about the trial on the MRC YouTube channel.
* The results of the DART trial were presented at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, held in Cape Town, South Africa, on the 19-22 July 2009. For the DART presentations made at the conference please see the DART website or the outputs attached to the project record giving details of DFID's support to DART.

source:
http://www.research4development.info/news.asp?ArticleID=50487