Page last updated at 12:46 GMT, Wednesday, 9 December 2009

Scrap tests 'to boost HIV care'

Anti-retroviral clinic in Kwa Zulu Natal, South Africa, 2008
Many patients in Africa are denied access to drugs

Expensive routine lab monitoring of the toxic effects of drug treatment on HIV patients can be safely scrapped, a study in Africa suggests.

Researchers concluded money would be better spent on increasing access to the new generation HIV drugs.

A major study of 3,316 people in Uganda and Zimbabwe found routine lab tests for side effects made no difference to survival rates.

The Medical Research Council study appears in The Lancet.

More people could be treated for the same amount of money by not using routine laboratory tests
Researcher Professor Diana Gibb
Medical Research Council

The researchers concluded that thousands more people in Africa could be treated with anti-retroviral therapy (ART), the main treatment for HIV/Aids, if routine lab monitoring was dropped.

ART has proved highly successful at keeping people alive by depressing the amount of virus in the body, so its impact on the immune system is limited.

At least five million people in Africa need ART urgently, but limited resources mean that many are denied access.

The latest trial - named DART (Development of Anti-Retroviral Therapy in Africa ) - tested the benefits of routine testing for side effects on people with severe or advanced HIV infection who were started on ART.

Two types of tests were done: tests to measure side effects of drugs (toxicity tests) and a test measuring how well the drugs were working to help the immune system to fight HIV (CD4 test).

The results of one group of patients were given to doctors routinely after each three-monthly test.

But for a second group the results of toxicity tests were only passed on to doctors if they gave cause for concern - and this hardly ever happened.

CD4 tests were never passed on.

Medical care and diagnostic tests were given to doctors caring for people in both groups if they fell ill during the trial.

High survival rates

Survival rates overall were among the highest in any treatment programme in Africa.

The results show that 90% of people whose results were routinely passed to a doctor were alive after five years compared to 87% in the group whose results were only passed over if abnormal.

Without ART the five-year survival rate of African people, similar to those in DART with severe HIV infection, is only around 10%.

No difference in the occurrence of side effects caused by ART was found between the two groups.

The researchers concluded that ART can be delivered safely without routine lab monitoring for toxic effects.

They said monitoring levels of CD4 immune cells - the cells attacked by HIV - from the second year of treatment has a role but lack of CD4 test availability should not be a barrier to giving treatment.

Researcher Professor Diana Gibb, from the Medical Research Council said: "The survival of people who took part in the trial was remarkable.

"For health policymakers 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.''

Researcher Dr P Mugenyi, from the Joint Clinical Research Centre in Uganda said: "DART results suggest ART can be delivered safely and effectively by trained and supervised health workers in remote communities where routine laboratory services are not available."



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