A global alliance of public and private health experts is marking this year's World TB Day March 24 by launching human clinical trials of a new anti-tuberculosis drug regimen in South Africa, Tanzania, and Brazil. Senior government officials in the United States have welcomed the trial, which promises to help control a disease that is becoming increasingly resistant to existing treatments.
With nearly 4000 people dying of tuberculosis each day around the world, public health officials say TB control efforts urgently need new drugs.
The clinical trials being launched by the TB Alliance - at eight sites in Africa and South America - will test a new drug regimen against this deadly and highly contagious respiratory infection. This new regimen deploys a new anti-bacterial drug that promises to kill the TB bacillus more quickly - in combination with a known, frequently used drug. Dr. Anthony Fauci - director of the National Institute for Allergy and Infectious Diseases, says the regimen will be tested against both drug-sensitive and drug-resistant strains of TB.
“So this is an important step forward in the broad quest that we have now for several years to develop not only new individual drugs but drug regimens for TB,” Fauci said.
Dr. Mel Spigelman is President of the Global Alliance for TB Drug Development. He believes the new regimen could transform worlwide TB treatment efforts. He says the new treatment cycle would be shorter and less costly than the existing six-to-30-month regimen of today's multi-drug cocktail.
“It means that we have gotten to the next step and much closer to the time when we can ultimately treat TB just like any other ordinary infection which means over a period of just maybe a few weeks at the most with simple drugs,” Spigelman said.
Dr. Janet Woodcock, of the U.S. Food and Drug Administration says TB can be better controlled if there is a robust pipeline of new drugs against the disease - because over time, the bacterium becomes resistant to different drug combinations.
“Regulators around the world need to really think long and hard about what the pathways are to get drugs on the market - both new combinations of TB drugs and new single-TB drugs,” Woodcock said.
“I think one of the biggest challenges is to find the right drug and improve the right drug and the diagnostic regime, as well as having the capacity in the country to deliver it to the key population affected,” said Robert Clay of the U.S. Agency for International Development. He notes there are currently 10 experimental TB drugs in clinical trials - research largely supported by funding from the U.S. and other donor countries.
But experts say even after the drugs are approved, it can be years before they become part of regular TB treatment regimens. The entire chain - from drug development to delivery - must be streamlined, experts say, if the battle against TB is to be won.