New TB Drug Trial Begins

A new drug trial aimed at faster and more effective treatment for tuberculosis started in Georgia.

The trial uses a combination of four drugs, ultimately testing whether it is possible to treat drug resistant TB in 6 months instead of 24. In addition, the trial uses oral medication instead of injections, which is a key part of the treatment.

“As resistance to current TB treatments continues to grow, we need to introduce all-oral drug regimens that can treat every person with TB in six months or less, regardless of their resistance profile,” said Mel Spigelman, president and CEO of TB Alliance.

Named SimpliciTB, the trail will test the efficacy of the drugs bedaquiline, pretomanid, moxifloxacin and pyrazinamide.

“Currently, treatment for drug-resistant TB is extremely complicated, expensive, and lengthy, involving a wide variety of medicines that have debilitating side-effects, which include injectable drugs, and are administered for nine months to two years or longer,” said the TB Alliance.  “People with MDR-TB often go untreated, and of those who do receive treatment, only about half are cured.”

The four-drug regimen has shown positive results in Phase 2b called NC-005, in which people with MDR-TB cleared TB bacteria from their lungs up to three times faster compared to patients treated with standard treatment.

NC-005 was an eight-week trial conducted at 10 sites across South Africa, Uganda and Tanzania. SimpliciTB builds on these results, testing BPaMZ over a longer duration, in more people and across more sites, and against both drug-sensitive and MDR-TB.

The first patients have been enrolled at the National Center for Tuberculosis and Lung Disease in Tbilisi, Georgia. SimpliciTB is expected to enroll 450 people with TB, including up to 150 with MDR-TB across at least 26 centers in 10 countries in Africa, Asia, Europe and Latin America.

By Shawn Wayne


28 August 2018 13:19