Breakthrough study demonstrates far shorter, more effective treatment for multidrug-resistant tuberculosis (MDR-TB), with majority cured
Final results demonstrated nine-month treatment had 82% success rate, compared with previous standard that required more than 20 months of treatment and achieved cure rates below 55%
Findings announced at 47th Union World Conference on Lung Health, Liverpool UK
Wednesday, 26 October, 2016 (Liverpool, UK) – Final results from an observational study conducted with 1,006 rifampicin-resistant tuberculosis (RR-TB) patients in nine francophone countries in Africa show high treatment success rates of 82 percent with limited adverse events on a nine-month treatment regimen. The study was carried out among MDR-TB patients in Benin, Burkina Faso, Burundi, Cameroon, Central African Republic, Côte d’Ivoire, Democratic Republic of the Congo, Niger and Rwanda. The results were presented at the 47th Union World Conference on Lung Health convening in Liverpool, UK, 26-29 October 2016.
“The francophone study is a breakthrough in the fight against drug-resistant TB,” said Dr Paula I Fujiwara, Scientific Director of the International Union Against Tuberculosis and Lung Disease (The Union). “These results have now been replicated in many different settings and with a large number of patients, showing conclusively that this is the most effective treatment for drug-resistant TB discovered to date.”
The previous standard regimen for treating drug-resistant TB lasted 20 months or more and achieved cure rates below 55 percent. Based on the francophone´s strong preliminary data presented in December 2015, the World Health Organization (WHO) in May 2016 recommended that the nine-month treatment regimen be used in place of the previous regimens.
“With strong evidence now showing that this regimen is the most effective available for treating multidrug-resistant forms of TB, the next step is for countries to begin widely implementing this new approach,” said Dr Arnaud Trébucq, a Senior Consultant with The Union.
Among the 1006 patients who participated in the study, treatment was successful for 821 (82 percent), of whom 734 were cured, defined as patients who completed the full course of treatment without evidence of failure, and who produced samples that tested negative for the presence of TB bacteria three times before treatment completion, using a culture test. A culture test, in which colonies of TB bacteria are cultured within a growth medium, is the most rigorous test available for identifying the presence of TB. An additional 87 patients successfully completed the full course of treatment without demonstrating any signs of treatment failure but had less than three negative culture results. An additional 54 patients (5 percent) did not respond to the treatment, 82 patients (8 percent) died, and 49 (5 percent) were lost to follow-up. The death rate was higher among patients with HIV-infection, but among patients who survived, the regimen demonstrated similar success rates in HIV-infected and non HIV-infected patients.
The study was carried out by researchers from The Union, together with the Institute of Tropical Medicine of Anvers (Belgium), the San Raffaele Scientific Institute of Milan (Italy) and the teams of each of the nine participating countries which included clinicians, National Reference Laboratories and National Tuberculosis control Programmes.
On 13 October, WHO published new data on the global TB epidemic, referring to drug-resistant TB as a “crisis.” In 2015, 580,000 people became sick with TB resistant to at least rifampicin, of whom 480,000 were diagnosed as having developed resistance to both rifampicin and isoniazid. In September 2016, the United Nations General Assembly issued a declaration committing to take worldwide action against drug-resistant TB. The declaration recognised that within the broader context of antimicrobial resistance, resistance to antibiotics “is the greatest and most urgent global risk, requiring increased attention and coherence at the international, national and regional levels.”