A novel approach to develop the first new tuberculosis (TB) combination drug regimen has cleared a major hurdle when Phase II clinical trial results have proved it could kill more than 99 percent of patients' TB bacteria within two weeks and could be more effective than existing treatments, according to a study published Monday in the journal Lancet.
The findings from researchers and the nonprofit TB Alliance raise hope for a treatment breakthrough in bringing under control the growing and dangerous epidemic of drug-resistant forms of TB that, in some cases, are becoming untreatable. The results, presented Monday at the ongoing 2012 International AIDS Conference, also reveal progress in the pursuit of an antiretroviral- compatible TB treatment, which is critical to treating the millions of people with TB/HIV co-infection.
TB now remains the largest killer of people with AIDS, but very often, TB and HIV treatments cannot be given together because of drug-drug interactions and side effects.
The clinical trial tested a combination of one completely novel drug candidate, a new TB drug candidate already approved to treat other infectious diseases, and one existing TB drug. These results, along with pre-clinical data, suggest that this novel combination could treat both drug-susceptible and some forms of drug-resistant TB in only four months. Currently, people with multi-drug resistant TB (MDR-TB) require 18 to 24 months of treatment. Even those with ordinary TB need six months of taking drugs every day.
"These findings confirm the promise of novel TB regimens to be shorter, simpler, safer, and, compared with today's MDR-TB drugs, much less expensive," said Mel Spigelman, CEO and President of TB Alliance. "The next trial to advance this regimen is already underway. We now have real momentum toward bringing to market treatments that will ultimately help save millions of lives."
According to the UNAIDS, HIV-related TB remains a serious challenge. A total of 8.8 million people acquired active TB worldwide in 2010, including 1.1 million who were living with HIV.
TB Alliance is an organization dedicated to finding faster- acting and affordable drug regimens to fight tuberculosis. It operates with funding mainly from the Bill & Melinda Gates Foundation, UK aid, the United States Agency for International Development.
