A combination of the two new anti-tuberculosis drugs, bedaquiline and delamanid, has been found to be safe and effective in a small group of paediatric and adolescent patients suffering from the infectious disease. At least 18 minor patients who were put on these drugs at an independent Médecins Sans Frontières (MSF) clinic in Govandi have shown consistent sputum conversion (samples testing negative for the bacteria) and overall improvement.
MSF’s medical activities manager Dr. Pramila Singh said none of the 18 patients who were put on the new drugs suffered from any major side effects that required hospitalisation or led to stopping of treatment. “We have put patients suffering from the most complex form of extensively drug-resistant (XDR) TB or those in a pre-XDR stage on the newer drugs. So far, our observations and reports show the drugs have not led to any major side effects. The toxicity of these drugs was much less than the widely-used injectable drugs,” said Dr. Singh. The youngest of the patients is four years old while the oldest is 17. She said these patients are either on a combination of bedaquiline and delamanid, or just delamanid.
According to the guidelines on the Programmatic Management of Drug Resistant TB in India, delamanid can be prescribed to patients between six and 17 years of age, but bedaquiline cannot be prescribed to patients below 18. The World Health Organisation’s (WHO) latest guidelines, however, have extended bedaquiline to patients between six and 17 years of age and delamanid to children above three years.
“We have offered the newer drugs to younger patients as part of an observational cohort. These patients had no other choice of drugs available due to the complexity of their disease,” said Dr. Singh. She said a wider rollout of the newer TB drugs is essential.
Since 2016, the MSF’s independent clinic has 210 patients on the new drugs. Of these, 155 are on a combination of bedaquiline and delamanid. Nearly 60 patients are TB-free.
Chest physician Dr. Zarir Udwadia from Hinduja Hospital said till date, only 1,364 patients in India have received bedaquiline. “In South Africa, over 16,800 patients are receiving the drug and the country has already recorded a change in their drug-resistant cases,” said Dr. Udwadia. The WHO has recently pushed bedaquiline to the group A of drugs due to its efficacy and safety while delamanid was pushed lower, to group C. “It is sad that only 2% of our population is receiving bedaquiline. It appears that instead of protecting the patients, our authorities are protecting the drug,” he said.
