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 of the University of KwaZulu-Natal and Caprisa director.

The results have been welcomed by UNAIDS executive director Dr Peter Piot, who said that they proved that ‘€œan 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 first cure their patients of TB then start them on antiretroviral (ARV) medication. This is because one of the TB drugs interacts with some ARVs and reduces their effectiveness and also to spare patients from taking up to seven pills a day.

Until now, there was no clinical trial evidence worldwide to prove that treating people with HIV and TB at the same time saved lives.

However, based on doctors’€™ observation, the World Health Organisation recommends that people with CD4 of under 50 (measure of immunity) should get TB treatment and ARVs as soon as possible, those with CD4 of 50-200 should start ARVs after two months’€™ of TB treatment and those with CD4 over 200 should first complete TB treatment.

The Caprisa study involved 645 patients with CD4 of less than 500. In the public health system, only people with CD4 of 200 are put on to ARVs.

But researcher Dr Kogie Naidoo explained: ‘€œHIV 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 of under 500 should:

  • be given both TB medicine and ARVs together as soon as possible;
  • be treated intensively for TB for two months then started on ARVs or
  • only be given ARVs after completing TB treatment (a wait of six to eight months).

Twice as many patients died in the group that waited for ARVs until they had completed TB treatment than those in the two groups where ARVs and TB treatment were integrated.

In the light of these findings, the trial’€™s safety committee immediately ordered researchers to stop the arm of the trial in which patients first finished TB treatment then got ARVs. The other two arms are continuing.

However, this was not before 26 people had died in this group of 214 people  ‘€“  a mortality rate that was 55 percent higher than the other two groups combined (which had a death rate of 24 people out of 431 people).

When asked about the ethics of enrolling 10 sick patients with clinical Stage Four AIDS (advanced AIDS) into the study arm where ARV treatment was delayed, Professor Abdool Karim said that ‘€œany patients in the study could be started on ARVs at any time if judged clinically necessary’€ by the doctors who were monitoring them.

The study’€™s statistician Anneke Grobler confirmed that patients who had died generally had low CD4 counts, but that this was the case in all three study arms.

Patient Vuyokazi (who did not want her surname revealed) said she had taken TB medication and ARVs together ‘€“ seven pills in all ‘€“ and ‘€œdidn’€™t have any problems’€.

Vuyokazi, aged 26, had a CD4 of 14 when she joined the study a year ago. Her CD 4 is now 167, her TB has been cured and she says she feels ‘€œjust alright’€.

Dr Francois Venter, head of the SA HIV Clinicians Society, said that the Durban study had ‘€œbegun to answer one of the most important questions for the HIV field ‘€“ when we can start antiretrovirals safely in people with TB’€.

Given the ‘€œstriking mortality differences’€ even in people with CD4 counts of over 200, doctors would need to ‘€œre-look at the way we treat these patients, which has traditionally been to complete the full TB course before starting antiretrovirals’€, he said.

‘€œWe need to quickly diagnose HIV in our TB clinics, where over 60 percent 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 strengthening, should be a priority,’€ added Venter. ‘€“ health-e news.


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