The results from both trials, published today in the New England Journal of Medicine, found that novel drug combinations including the antibiotic moxifloxacin in TB treatment plans can approximately halve the number of pills that patients need to take but cannot shorten treatment time.
Most TB cases are curable after a six-month treatment regimen, providing patients stick to the treatment plan. Problems can arise if patients do not take their medication regularly, as the disease can recur or develop drug resistance.
Standard treatment plans require patients to take a cocktail of drugs every day for six months, which can be challenging and burdensome for patients to keep up with. The researchers found that with a new drug combination including moxifloxacin, taking daily medication for the first two months and then weekly high-dose medication for the last four months was equally effective at curing TB.
These results were from the RIFAQUIN phase III trial of 827 new cases of tuberculosis, led by researchers at UCL and St George’s, University of London, working with colleagues in Botswana, South Africa, Zambia and Zimbabwe. The trial found that drug combinations with moxifloxacin could help to reduce the number of pills needed but treatment could not be effectively shortened to four months.
New treatment strategies are urgently needed to battle the growing problem of drug resistance in TB.
Professor Andrew Nunn
The REMoxTB trial, a phase III trial of 1,931 patients at 50 sites in nine countries, also found that treatments could not be shortened from six to four months by using novel combinations including moxifloxacin.
Both trials involved researchers from the UCL Centre for Clinical Microbiology and Medical Research Council Clinical Trials Unit (MRC CTU) at UCL.
Professor Andrew Nunn, Scientific Programme Leader at the Medical Research Council Clinical Trials Unit, said: “New treatment strategies are urgently needed to battle the growing problem of drug resistance in TB. Resistant strains can develop when patients stop taking medication or take their treatment erratically because they start to feel better, allowing resistant TB bacteria to multiply. For example, an increasing number of TB strains are now resistant to the drug isoniazid, which has been a mainstay of treatment for over half a century. Strategies that make it easier for patients to complete treatments, such as the weekly treatments in RIFAQUIN, will help us to not only fight resistance but also to improve the quality of patients’ lives.”
Professor Tim McHugh, Director of the UCL Centre for Clinical Microbiology, said: “Our rigorous approach to conducting the REMoxTB trial and standardising the laboratory methods are firsts for such a broad global study. We found minimal variation in the results between 50 trial sites on three different continents. We would therefore expect the RIFAQUIN findings from Africa to be applicable in other regions. Further work is now needed to establish the effectiveness of the once-weekly regimen in HIV positive patients, who are especially vulnerable to TB, and the cost-effectiveness of the programme.”
- REMoxTB Research paper in New England Journal of Medicine
- RIFAQUIN Research paper in New England Journal of Medicine
- Professor Andrew Nunn’s academic profile on IRIS
- Professor Tim McHugh’s academic profile on IRIS
- MRC Clinical Trials Unit at UCL
- UCL Infection & Immunity
- Mycobacterium tuberculosis bacteria, the cause of TB (courtesy of NIAID on Flickr)