Touted to be a “miracle drug” for tuberculosis when it was launched, Bedaquiline has been effective in treating the disease-causing bacteria in 58.8 per cent patients suffering from extensively drug resistant strains in Mumbai’s slum Govandi, data presented at the 50th Union World Conference on Lung Health in Hyderabad has found.
Tuberculosis (TB) is an infectious disease with India reporting the highest burden globally. It also accounts for 24 per cent of drug resistant patients globally, with 58,347 cases in 2018.
Bedaquiline was introduced under a conditional access programme after much delay in 2016 in India for patients who were resistant to most TB drugs.
In Govandi, since 2016 till June 2019, a total 2,741 drug resistant patients have been recorded. While the Revised National Tuberculosis Control Programme (RNTCP) guidelines mandate at least 15 days hospitalisation for patients undergoing Bedaquiline treatment, the latest data shows that the results of the drug have been effective even on patients treated on out-patient basis.
In Govandi Shatabdi Hospital, 85 patients were put on Bedaquiline treatment on OPD basis between June till December last year. Of them, 50 tested culture negative — meaning tested negative for active bacteria — after six months of treatment.
While three patients died, two dropped out of treatment. Of those who passed away, one suffered from uncontrolled diabetes, one had low count of platelets and white blood cells, and third suffered from problem in pancreas. The data showed 16 patients suffered side-effects related to Bedaquiline, of which one had to be stopped on the drug’s treatment.
“Bedaquiline treatment can be monitored without patients requiring hospitalisation. We were able to maintain regular follow-up, and start the treatment early,” Dr Daksha Shah, head of TB Control Program in Mumbai, said.
Officials from Medicines Sans Frontieres (MSF) said the data also shows how accessibility of the drug will help treat a larger number of patients.
Across India, 7,200 patients have been enrolled on Bedaquiline since 2016 till September.
Of 620 patients monitored across six centres in Delhi, Mumbai, Chennai, Guwahati and Ahmedabad, data presented at the global conference showed 61 per cent (or 378) success rate on treatment.
While India plans to scale up Bedaquiline regimen, activists at the conference protested that the government was slow in expansion. India has announced it will eliminate TB by 2025. But with 1.7 per cent annual reduction in cases, it is falling short of reaching 10 per cent reduction rate required to meet 2025 target.
Dr Lucica Ditiu, executive director of Stop TB Partnership, a global platform working for TB elimination, said India has made progress with political commitment to control TB, but there is also need to push for accessibility of newer drugs. “India may be able to increase rate of reduction in new TB cases with increased budget and continued expansion. But they need to also provide newer regimen to drug resistant patients soon to prevent deaths,” she said.
Clinical trial for new drug in India
India is one of the 12 countries shortlisted to undergo a clinical trial of new drug Delamanid to prevent onset of drug resistant tuberculosis infection among close family contacts of already infected patients.
The United States-based National Institute of Health (NIH) is investing $70 million for 5,600 people to undergo the trial. In India, Pune and Chennai have been shortlisted for the trial.
“This is the first trial that is looking at prevention of multi-drug resistant tuberculosis among close contact of patients,” said Peter Kim, director of Therapeutics Research Programme, NIH.
NIH is tying up with Otsuka Phamrceutical — drug manufacturer of Delamanid. The trial results will take at least 5-6 years.