New combination treatment that could dramatically shorten the length of tuberculosis treatment

Jan 10 2006

The clinical results of a new combination treatment that could dramatically shorten the length of tuberculosis treatment were presented at a recent scientific conference in the USA. This virulent disease of the lungs still infects millions every year, with a notable resurgence in Europe, especially in the East.

Delegates at the 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), held in Washington DC last month, heard that phase II trials of a gatifloxacin-containing regimen are showing positive results. It is significantly more potent than the current recommended regime of isoniazid, rifampicin, pyrazinamide and ethambutol, which may trim one-third off the six-month treatment regime.

“We are working to bring together public and private partners to speed development for this new treatment,” says Dr Robert Ridley, director of the World Health Organization-based Special Programme for Research and Training in Tropical Diseases (TDR). If the positive results continue, the new treatment could be publicly available by the end of 2009, he predicts.

One-third of the world's population is infected with mycobacterium tuberculosis, the causative agent of TB, with around 8 million people developing the active form of the disease every year (and over 1.5 million succumbing to it). The HIV/AIDS pandemic has dramatically increased the incidence of this disease. Indeed, finding ways to trim the TB treatment time is a major public health priority of the WHO’s Stop TB partnership.

The phase II trial was conducted by the South African Medical Research Council in Durban, South Africa, in patients with newly diagnosed pulmonary tuberculosis (some with HIV co-infection, others without). It was designed to assess the anti-tuberculosis activity of the treatment in the first two months of therapy and compared with standard WHO-recommended treatment and two other similar regimens which contained either ofloxacin or moxifloxacin.

Treatment containing either the gatifloxacin or moxifloxacin has proved significantly more active than either the standard regimen or the ofloxacin-containing regimen after two months. Now, a multi-centre Phase III clinical trial is planned to measure definitively whether the four-month gatifloxacin treatment is as effective as standard six-month short courses.

An EU-funded consortium of ten European and African institutions (OFLOTUB) is involved in the trial which covers sites in Benin, Guinea, Kenya, Senegal and South Africa. The four-year OFLOTUB project was launched in 2001 with nearly Euro 2.4 million in EU funding. A collaboration with the WHO is also being negotiated for developing the new short-treatment regimen.

In 2002, the European Commission initiated the European and Developing Countries Clinical Trials Programme on Poverty-related Diseases (EDCTP). In the current research Framework Programme (FP6, 2002-2006), Euro 400 million has been set aside to combat HIV/AIDS, malaria and tuberculosis, Euro 200 million of which is for the EDCTP. Another Euro 200 million comes from the scheme’s 15 signatory countries (Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the UK).