24 April, 2014 - Seattle/New York - The world’s first drug regimen to treat both conventional and drug-resistant forms of tuberculosis is about to enter the final stage of clinical testing after receiving a significant amount of funding from the Bill and Melinda Gates Foundation. The new trial was announced by the TB Alliance and will be carried out by partners around the world.
The regimen, known as PaMZ, has produced positive results in clinical studies and, if successful, would eliminate the need for injectable drugs and reduce the cost of MDR-TB therapy in some countries by more than 90 percent in those patients whose TB organisms are sensitive to the three drugs. It will be tested in a Phase 3 clinical trial named STAND (Shortening Treatments by Advancing Novel Drugs). It also promises to be compatible with commonly-used HIV drugs, helping the millions of people co-infected with TB/HIV.
Bill Gates, co-chair of the Gates Foundation, who announced the new funding at a product developers meeting in Seattle said the treatment could "reduce the time required to cure drug-resistant TB from two years to just six months" and sharply cut the cost of a cure in low-income countries from thousands of dollars to just a fraction of that cost. He called on other funding groups to back the trial, which is estimated to cost $58 million.
The new medications are being added to existing regimens because TB patients must always take drugs in combination with other drugs to prevent the development of resistance. However, PaMZ would be a new regimen on its own, according to Mel Spigelman, TB Alliance’s president and chief executive.
Introducing new drugs individually, "you still have the same duration of therapy, increased cost, and more toxicities," he said. "We looked at starting with somewhat of a blank slate and said what are the best combinations of drugs whether old or new that give us the greatest impact" in shortening treatment and making it less painful and harmful for patients. Many current drugs for drug-resistant TB have side effects such as hearing loss and nausea.
Along with the Bill and Melinda Gates Foundation, the UK’s Department for International Development, the United States Agency for International Development and other have contributed to this trial, although additional funding is needed to sustain the new and expanded commitments for the STAND trial.