A six-month-long treatment regimen, using bedaquiline drug and an injectable, will be effective in treating multi-drug resistant tuberculosis as compared to traditional treatment routes that stretch from nine months to two years, found a new study published in medical journal The Lancet on Tuesday.
The study was presented on the first day of the three-day long World Conference on Lung Health.
Called the STREAM trial, the study spanned across 13 hospitals in seven countries – India, Ethiopia, Georgia, Moldova, Mongolia, South Africa, and Uganda – and looked at whether shorter treatment regimens were as effective as the existing treatment methods. The randomised trial began in 2016 and studied 588 tuberculosis patients who were assigned different treatment regimens.
Of the 134 patients who were given a six-month regimen, 91% patients were cured and tested negative for tuberculosis, compared to 69% in the control arm that were provided routine treatment. The STREAM trial involved giving patients bedaquiline drug and a second-line injectable drug called kanamycin that was administered for two months.
One of the authors of the study, ID Rusen, said treatment adherence was over 90% and they “saw very little resistance overall and only one case of resistance to bedaquiline” in the trial. Rusen, who is the senior vice president of research and development at Vital Strategies that works in the public health field, also said that treatment cost would reduce in the long run if the period of treatment is cut short.
Until 2016, treatment for multi-drug resistant tuberculosis included about 7,200 pills and 240 injections, and took up to two years to complete.
The STREAM stage 1 trial first looked at a nine-month long treatment regimen using bedaquiline. Its results, published in 2017, found that the treatment was as effective as the existing ones that are longer. In stage 2 of the trial, a six-month regimen was evaluated.
The findings come at a time when incidence of multi-drug resistant tuberculosis, or MDR-TB, has grown exponentially, especially in India, during the Covid-19 pandemic.
According to the World Health Organization’s Global Tuberculosis Report 2022, 19.65 lakh new cases were notified in India in 2021, out of which 58,837 persons were diagnosed with drug-resistance.
The incidence of pulmonary MDR-TB stood at 1.19 lakh in 2021 in the country. Blessina Kumar, the chief executive officer of Global Coalition of TB Advocates, said that India holds the maximum burden of drug-resistant tuberculosis in the world.
The World Health Organization report stated that only 3.7% patients were put on shorter regimens as recommended by the global health body. Most patients continue to remain on longer regimens.
Kumar said that India lags far behind in meeting targets to eliminate tuberculosis. India had targeted 50% reduction in incidence of the disease by 2021, but it achieved only 10%. It had also failed its target of 75% reduction in deaths due to tuberculosis by 2021 but it could achieve only 5.9% decline between 2015 and 2021.
At least 5.06 lakh tuberculosis patients died in 2021 in India, amounting to one death per minute.
Globally, new MDR-TB cases increased by 3.1% from 2020 to 2021. The World Health Organization’s global tuberculosis report stated that Covid-19 reversed many years of slow decline in cases of the bacterial disease as diagnostic and treatment services were hampered by the pandemic. An estimated 1.06 crore persons fell ill with tuberculosis in 2021, a 4.5% global rise from a year ago.
Those advocating for better tuberculosis treatment have demanded improved access to bedaquiline and delamanid, two drugs that are proving effective against multi-drug resistant bacteria. Bedaquiline is manufactured by Janssen Pharmaceuticals, owned by Johnson & Johnson, and delamanid by Japan-based Otsuka Pharmaceuticals.
In the current six-month regimen of bedaquiline and kanamycin, researchers have, however, warned about a side effect of hearing loss by injectable drugs. The STREAM trial stated that while hearing loss was not eliminated, it was reduced in the six-month regimen since the injectable drug was used for a short span of two months.
“It is particularly encouraging to note that the findings in the fully-oral and six-month regimens are significantly better not only in the combined outcome measure, but also in the TB-associated outcomes, namely significantly fewer failures and relapses,” said Andrew Nunn, co-chief investigator in the trial.
The trial’s outcomes were also studied by the Liverpool School of Tropical Medicine. It found that while the shorter regimen of oral drugs is more expensive for governments to handle, it reduces patient’s overall cost of treatment.