The phase II trial results of a gatifloxacin-containing regimen, a new combination treatment that could dramatically shorten the length of tuberculosis (TB) treatment demonstrated good potential. The regimen is significantly more potent than the currently recommended six-month regimen of isoniazid, rifampicin, pyrazinamide and ethambutol, and suggests that when gatifloxacin is used instead of ethambutol, the standard six-month regimen may be shortened to four months.
"We are working to bring together public and private partners to speed development for this new treatment," said Dr. Robert Ridley, director of the World Health Organisation-based special programme for research and training in tropical diseases (TDR). This is the most advanced shorter TB treatment regimen presently in development, and could be available to the public by the end of 2009 if positive results continue.
Finding options to shorten the length of treatment has been declared a public health priority by the Stop TB partnership. "The gatifloxacin fixed-dose combination responds to the new WHO Stop TB Strategy's call for new tools, in particular, new regimens that can significantly shorten the current six-month treatment time," said Dr. Mario Raviglione, Director of WHO's Stop TB.
One-third of the world's population is infected with Mycobacterium tuberculosis, the causative agent of TB, with approximately eight million people developing the active form of the disease every year. The HIV/AIDS pandemic has dramatically increased the incidence of this disease. A shorter TB regime will also help improve treatment adherence and preventing the development of multi-drug-resistant TB.
According to a WHO release, the phase II trial was conducted by the South African Medical Research Council in Durban, South Africa, in patients with newly diagnosed pulmonary tuberculosis with and without HIV co-infection. It was designed to measure the anti-tuberculosis activity of the treatment in the first two months of therapy when compared to standard WHO recommended treatment and two other similar regimens which contained either ofloxacin or moxifloxacin.
Treatment with either the gatifloxacin or moxifloxacin containing regimen was shown to be significantly more active than either the standard regimen or the ofloxacin containing regimen after two months of treatment. A multi-centre phase III clinical trial is planned to definitely assess whether the four month gatifloxacin containing regimen is equivalent to the current standard six month short course regimen.
The research is planned to continue as part of an international collaboration which is being developed between the World Health Organisation-based special programme for research and training in tropical diseases (TDR), the European Commission (EU), the OFLOTUB Consortium that is coordinated by the French Institut de Recherche pour le Dévelopement (IRD), and Lupin Pharmaceuticals, Ltd.
“The IRD is extremely proud to have significantly contributed to the foundation of this collaborative effort,” said Jean François Girard, chairman of IRD.
The special programme for research and training in tropical diseases (TDR) is a global programme of scientific collaboration established in 1975, sponsored by the World Health Organization, World Bank, United Nations Development Programme and United Nations Children's Fund. Its focus is research into neglected diseases of the poor, with the goal of improving existing approaches and developing new ways to prevent, diagnose, treat and control these diseases.
OFLOTUB is a consortium of ten partners from Europe and Africa that was initiated in 2002 to undertake phase II and phase III trials to test the safety and efficacy of a gatifloxacin-containing 4-month treatment regimen for the treatment of TB.