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R/£ Clinical trial results show way forward for treating TB, HIV
September 18, 2008 Edition 1
Kerry Cullinan
Patients with tuberculosis and HIV are more likely to survive if they are treated for both conditions at the same time than those who are treated for TB first.
This is the outcome of a Durban trial conducted by the Centre for the Aids Programme of Research in SA (Caprisa), based at the University of KwaZulu Natal.
The findings could save the lives of 10 000 people a year, according to Professor Salim Abdool Karim, pro vice-chancellor (research) at the university and director of Caprisa.
The results have been welcomed by UNAids executive director Dr Peter Piot, who said they proved that "an integrated response to TB/HIV treatment would avoid unnecessary deaths from TB, the leading cause of death in people living with HIV in Africa".
At present, many doctors prefer to cure their patients of TB first, and then start them on antiretroviral (ARV) medication. This is because one of the TB drugs interacts with some ARVs and reduces their effectiveness. Another reason is to spare patients from taking up to seven pills a day.
Until now, there has been no clinical-trial evidence to prove that treating people with HIV and TB at the same time saved lives.
However, based on doctors' observations, the World Health Organisation recommends that people with CD4 counts (a measure of immunity) of under 50 should get TB treatment and ARVs as soon as possible, those with CD4 counts of 50 to 200 should start ARVs after two months of TB treatment and those with CD4 counts of more than 200 should first complete TB treatment.
The Caprisa study involved 645 patients with CD4 counts lower than 500. In the public health system, only people with CD4 counts of 200 are put on to ARVs.
But researcher Dr Kogie Naidoo said: "HIV patients who are co-infected with TB do worse than those without TB, regardless of their CD4 count."
Caprisa started its three-arm trial in 2005 to test whether patients with TB and HIV and CD4 counts of under 500 should:
In the group waiting for ARVs until they had completed TB treatment, twice as many patients died than in the two groups where ARVs and TB treatment were integrated.
In light of these findings, the trial's safety committee immediately ordered the researchers to stop the arm of the trial that involved the first group.
But this wasn't before 26 people had died in the group of 214 - a mortality rate 55% higher than the other two groups combined (a death rate of 24 people out of 431).
The other two arms of the trial are continuing.
When asked about the ethics of enrolling 10 patients with full-blown Aids into the study arm where ARV treatment was delayed, Karim said "any patients in the study could be started on ARVs at any time if judged clinically necessary" by the doctors monitoring them.
The study's statistician, Anneke Grobler, confirmed that the patients who died generally had low CD4 counts, but said this was the case in all three arms of the trial.
A patient who wanted to be identified only as Vuyokazi said she had taken TB medication and ARVs together - seven pills in all - and "didn't have any problems".
Vuyokazi (26) had a CD4 count of 14 when she joined the study a year ago.
Her CD4 count is now 167, her TB has been cured and she says she feels "just all right".
Dr Francois Venter, head of the Southern African HIV Clinicians' Society, said the Durban study had "begun to answer one of the most important questions for the HIV field - when we can start ARVs safely in people with TB".
Given the "striking mortality differences" even in people with CD4 counts of more than 200, doctors would need to reconsider the way they treated such patients, as conventional wisdom dictated that the full TB course should be completed before a patient was started on ARVs.
"We need to quickly diagnose HIV in our TB clinics, where more than 60% of patients with TB also have HIV, and get people rapidly on to antiretroviral care.
"Saving 10 000 people a year by improving a programme that desperately needs to be strengthened should be a priority," he said. - health-e news
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