Timing of ART for HIV positive adults with tuberculosis

New evidence published

TDR news item
9 May 2014

A new study suggests that antiretroviral therapy (ART) in patients with both HIV and tuberculosis (TB) infections could be delayed until after the TB treatment is completed. Published in The Lancet Infectious Diseases, the findings completed a randomized, double-blind, placebo-controlled clinical trial in 4 African countries and indicated that ART could be delayed until the completion of 6 months of TB treatment of HIV-infected TB patients with higher CD4 T cell counts.

“Coordinated treatment for TB and HIV is a key issue. Assessment of studies like this one will help us, when necessary, update guidelines based on the best science so that people are treated with maximum benefit.”

Dr Mario Raviglione, head of WHO’s Global Tuberculosis Programme

The clinical trial was initiated by TDR and took place during 2008-2013 in 26 HIV and TB treatment centres in South Africa, Uganda, United Republic of Tanzania and Zambia. Antiretroviral (ARV) treatment traditionally began after CD4 counts fell below 200. At the time, WHO had been asking for more studies on the best timing for ARV therapy on patients with higher CD4 counts, greater than 350 cells per μL.

Tuberculosis is a major health problem – according to the World Health Organization (WHO), 8.6 million incident cases of tuberculosis occurred in 2012. Of these, over 1 million (13%) were also infected by HIV. Antiretroviral therapy has significantly improved the management and outcome of HIV infection, but treatment may be complicated by side effects that are more challenging when patients have both HIV infection and TB. Therefore the goal is to reduce the amount of treatment time as much as possible.

Of the 1 675 patients enrolled, 834 were assigned early ART (starting after 2 weeks of tuberculosis treatment) and 841 delayed ART (starting ART at the end of 6 months of tuberculosis treatment). The early treatment’s effect on the composite outcomes of TB treatment failure, TB recurrence and death over a 24-month follow-up period were not enough to indicate that ART initiation within two weeks of starting TB treatment was beneficial.

The study will be evaluated jointly by the WHO’s Global Tuberculosis Programme and the HIV Department. “Coordinated treatment for TB and HIV is a key issue,” said Dr Mario Raviglione, head of WHO’s Global Tuberculosis Programme. “Careful assessment of studies like this one will help us, when necessary, update guidelines based on the best science so that people are treated with maximum benefit.”

“WHO systematically looks at methods, outcomes and public health implications of new results with consideration of all existing data,” said Dr Gottfried Hirnschall, head of WHO’s HIV Department. “We will assess this new evidence with care to determine the need for a change in existing recommendations in our next guideline revision.”

Building research capacity during the trial

The trial not only aimed to furnish biomedical data but also to further ingrain a culture of research into local and national disease control programmes. “This study was embedded within African national disease control to build local research capacities and appoint programme managers relevant to their own settings,” says Dr Mahnaz Vahedi, a TDR staff member and study investigator.

Improved lab quality assurance procedures, increased involvement of national control programme managers on research, and professional stimulus of local health care workers were among the values that comprised the study’s policy basis. The effort has also helped to integrate local doctors’ expertise and catalyse research consistent with local medical interests.

For more information, contact:

Jamie Guth
TDR Communications Manager
Telephone: +41 79 441 2289
E-mail:guthj@who.int

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