SA to participate in TB trials

2005-10-18 11:07

Johannesburg - South Africa is to take part in a major global drug trial for tuberculosis (TB).

The trials are part of a partnership between the Global Alliance for TB Drug Development (TB Alliance) and Bayer Healthcare AG to co-ordinate a global clinical trial programme to study the potential of an existing antibiotic, moxifloxacin, to shorten the standard six-month treatment of TB.

Other countries participating are Brazil, Canada, Spain, Tanzania, Uganda, the United States and Zambia.

If the trials are successful, the partnership aims to register moxifloxacin for a TB indication and is committed to making it affordable and accessible in developing countries where patients need it most, the parties said on Monday.

The clinical trial programme will involve close to 2 500 patients with TB. Bayer will donate moxifloxacin for each trial site and will cover the costs of regulatory filings.

The TB Alliance will co-ordinate and help cover the costs of the trials.

Shorter regimen could ease economic burden

The trials will evaluate whether the substitution of moxifloxacin for one of the standard TB drugs (ethambutol or isoniazid) eliminates TB infection faster than the current standard therapy.

Current TB therapy is based on four drugs discovered more than 40 years ago that must be administered for six to eight months. Preclinical studies showed moxifloxacin reduced treatment time by two months when substituted for isoniazid, a cornerstone drug of TB treatment.

Moxifloxacin is approved in 104 countries to treat certain bacterial respiratory and skin infections.

Mycobacterium TB infects one-third of the world's population, resulting in nine million new cases of active TB and two million deaths each year.

Public health experts note that a shorter TB regimen would help ease the economic burden, estimated at $16bn a year, and enable healthcare workers to treat more patients.

Current projections of TB incidence and mortality reflect the need for shorter, more effective TB therapy. An estimated one billion people will be newly infected between 2000 and 2020, 200 million will fall ill and 35 million will die.

TB is a leading cause of death among people living with HIV/Aids, and multi-drug resistant strains are spreading at a rate of 300 000 newly diagnosed cases a year, the statement said.

To reverse TB as a major global health pandemic by 2015 is part of the Millennium Development Goal.

- I-Net Bridge (News24)