Interim results from the radical nine-month treatment course showed an 80.9 per cent cure rate among patients with MDR-TB in nine African countries.
At present the standard treatment for MDR-TB is 24 months, and has a global cure rate of only 50 per cent, according to the France-headquartered International Union Against Tuberculosis and Lung Disease (The Union), which is coordinating the study.
“Any successful treatment that is shorter will be an important step forward.”
Paul van Helden, Stellenbosch University, South Africa
If implemented, the shorter regime could create massive savings in countries hard hit by MDR-TB. It would also reduce the amount of time patients would have to put their lives on hold to undergo the gruelling regime, which can have severe side effects such as hearing loss and vomiting, the researchers add in a statement released last week (3 December) by The Union at the 46th Union World Conference on Lung Health in Cape Town, South Africa.
The researchers say a total of 1,022 patients have been enrolled in the trial in Benin, Burkina Faso, Burundi, Cameroon, Central African Republic, Cote d’Ivoire, Democratic Republic of Congo, Niger and Rwanda.
The interim results draw on data from 507 patients who have already completed the nine-month treatment under strict daily observation.
The statement adds: “80.9 per cent had treatment success, 7.7 per cent died, 6.5 per cent were lost to follow-up and 4.9 per cent were failures.” About one-fifth of the patients were HIV positive, and the fatality rate was higher among these than among the HIV negative patients.
The results add confidence to the nine-month regime, which was first trialled in a smaller study in Bangladesh which was published in the International Journal of Tuberculosis and Lung Disease last year (1 October). The Bangladeshi study looked at 515 patients with MDR-TB, and measured success rates of 84.5 per cent.
When it was announced many viewed the results from the Bangladeshi trial as an anomaly, says Arnaud Trebucq, one of the lead investigators of the Francophone study.
“Nobody could believe it worked. People said things like ‘Bangladesh is not normal’,” he told SciDev.Net on the sidelines of the Cape Town conference.
Trebucq and his colleagues at The Union started by testing a 12-month regimen at three sites in Cameroon, Benin and Niger. When this trial showed good results, other countries were keen to join a nine-month trial, he says.
It is important to test new treatment regimes in many different settings, and especially in countries where there is a lot of HIV-TB co-infection, The Union said in the statement. Another trial of the nine-month regimen is being carried out in Ethiopia, Mongolia, South Africa and Vietnam involving 420 MDR-TB patients, the statement adds. Results from the so-called STREAM trial are expected in early 2017.
Independent TB scientists have welcomed the results. “Any successful treatment that is shorter will be an important step forward,” says Paul van Helden, a researcher based at Stellenbosch University in South Africa.
It would be important to wait for the final results because only then will it be clear how the nine-month regimen stacks up against the longer treatment options, van Helden adds.
However, if those final results are promising he does not see big impediments to introducing the regimen into clinics. “As long as the antibiotics can be provided, I don’t see a major hurdle,” he says.
The complete results of the Francophone Africa trial are expected in the middle of 2016.
This piece was produced by SciDev.Net’s Sub-Saharan Africa English desk.