CAPE TOWN, South Africa – Preliminary results from studies looking at shorter treatment regimens for drug-resistant tuberculosis show that a revolution in treatment for the disease is possible in the near future, researchers said in a presentation here today.
The first results from an observational study in nine countries in sub-Saharan Africa show that a nine-month treatment regimen using a combination of seven drugs – the so-called Bangladesh regimen – is just as effective as the standard 24-month long treatment regimen but has a much higher success rate, with more than 80 percent of patients successfully completing the shorter regimen compared to only 50 percent of patients successfully completing the longer, standard regimen.
The first results come from 400 patients enrolled out of a total of 1,000 patients from Benin, Burkina Faso, Cote d’Ivoire, Niger, Rwanda, the Democratic Republic of Congo, Cameroon, the Central African Republic, and Burundi. Final results will be presented in June 2016, with more findings to be released in 2017 that will include information on whether or not study participants relapsed. Researchers noted that the relapse rate in the original Bangladesh study was very low.
Adverse effects were similar to the effects patients face from standard treatment, with five percent of patients enrolled in this study suffering from permanent hearing loss, Arnaud Trebucq of the Union and lead investigator for the study, said.
The treatment regimen used in this study did not include bedaquiline or delaminid – the first new drugs to treat MDR-TB in decades, Trebucq said.
But another trial looking at shorter treatment regimens will begin to use bedaquiline, said I.D. Rusen of The Union. The STREAM randomized control trial will expand to test another nine-month MDR-TB treatment using the medicine, which could eliminate the risk of severe hearing loss among patients, Rusen said. STREAM’s regimen also is all oral, without the painful injections that make the standard 24 month-long MDR-TB treatment regimen difficult for patients.
The first phase of the STREAM trial, funded by USAID, The Union and Janssen Pharmaceuticals, is currently underway in Ethiopia, South Africa, Vietnam and Mongolia, and the next phase, which will look at the effectiveness of a six month regimen, will launch next month in 10 countries with 1155 patients, Rusen said.
The TB Alliance is also investigating a possible six-month regimen using just three new and repurposed tuberculosis drugs to treat extensively-resistant tuberculosis. The first results from the trial, which has 29 patients enrolled, are encouraging, a representative from the TB Alliance said.
The preliminary results from the nine-month regimen in nine Francophone African countries are being considered by the World Health Organization in its drafting of new tuberculosis treatment guidelines, Trebucq said.
The WHO will release new, consolidated guidelines to treat drug-susceptible and drug-resistant forms of tuberculosis late next year, Giuliano Gargioni of the WHO’s global TB program said at a separate workshop. New guidelines for treating drug-resistant TB will be released on World TB Day next year, and new guidelines for drug susceptible TB will be released mid-2016, with consolidated guidelines to be released by the end of next year, Dennis Falzon of the WHO said.
Those guidelines will be important to countries that are reluctant to change national policies without global recommendations, Rusen said.