Durban - The second stage of clinical trials to test shortened treatment regimes for drug-resistant TB to as short as six months, is expected to take place in 10 countries, including at four hospitals in South Africa.
This was in efforts to fight drug resistance which José Luis Castro – executive director of the International Union Against Tuberculosis and Lung Disease – labelled a crisis.
Speaking at the International TB Conference at the Durban ICC on Sunday (July 17), Castro called for this crisis to be confronted.
“Drug resistance is an indictment against us – a crisis that has arisen from our failure to ensure quality TB care everywhere,” he said.
The Union’s senior vice president – Research and Development, I.D. Rusen, said stage two of the STREAM clinical trial would test two additional regimes which both included bedaquiline.
This was a newly approved drug for the treatment of drug-resistant TB. It could reduce or eliminate the risk of hearing loss, a side effect of the current 24-month regime.
Clinical trial patients on the six-month regime to be tested would only receive injections for two months, instead of six on the current two-year treatment.
The second regime would be completely oral and last a period of nine months.
This reduction in the injection period should help address the hearing loss problem.
On the current treatment, Castro said: “For hundreds of thousands of people who have been treated for multi-drug resistant tuberculosis (MDR-TB), only to lose their hearing because of the medicines… becoming deaf has forever changed their lives… People should not have to choose between being deaf and being cured of TB.”
Rusen said 424 patients in four countries had participated in the first stage of the trial, which sought to confirm if the nine-month treatment regimen that demonstrated cure rates exceeding 80% during a pilot programme in Bangladesh, could achieve similar success in other settings.
These results are expected to be available in early 2018.
The second stage would include more than 1 000 patients, including at Sizwe Tropical Disease and Helen Joseph Hospitals in Johannesburg, and King Dinuzulu and Doris Goodwin Hospitals in Durban and Pietermaritzburg respectively.
Rusen said South Africa was among the countries chosen for this trial to ensure patients co-infected with HIV were properly evaluated.
“Each injection is painful, and because it’s given for so many months, it’s quite a difficult thing for patients to tolerate. We hope shorter regimes will contribute to adherence. The trial will also be measuring the cost of regimens to patients and to the health system,” he said.
Dr Tony Moll, clinical manager, Church of Scotland Hospital in KwaZulu-Natal, said a reduction in TB treatment period would be “absolutely incredible”.
“The MDR and extensively drug-resistant tuberculosis (XDR) treatment course is really a cruel and tough regimen. It involves six months of injections five days a week, followed by a heap of tablets every day to be taken for another 18 months. It’s very heavy going; to patients it’s a painful, long, drawn-out regime.”
He said the difference would not only be felt by patients, but also their families and healthcare providers.
“It could mean that they could get back to work earlier; it would mean that families would be able to resume normal interactions with each other without having to worry about transmission. It would have a huge impact,” said Moll.
Also speaking at the opening of the TB Conference, which preceded this week’s Aids Conference, Health Minister Dr Aaron Motsoaledi said the South African government was expanding access to “one of the few new TB drugs in decades”, bedaquiline.
He said the country currently accounted for about 60% of the global uptake of the drug.
“Preliminary reviews of outcomes of drug resistant-TB patients on bedaquiline in South Africa are really impressive, with substantial increases in treatment success and decreases in mortality rates.”
Motsoaledi is also the chairman of the Stop TB Partnership Board and the co-chair of the Global TB Caucus.
Source: IOL