MUMBAI: While India is still to make newer anti-tuberculosis drugs such as bedaquiline and delamanid widely available to patients suffering from drug-resistant TB, the World Health Organisation (WHO) has announced that these drugs can now be safely given to children as young as six and three years old, respectively.
India’s access to these drugs is so stringent that an 18-year-old girl from Patna got bedaquiline only after she moved the Delhi high court in 2017. She got the medicine so late in her battle against drug-resistant TB that her lungs were severely scarred and she died in Mumbai in November despite turning sputum negative.
On December 21, the WHO issued a statement that based on results of clinical trials running since 2011, “bedaquiline may now be given to children aged six years and more and delamanid from three years of age”. In August, the WHO drastically changed its recommendations for treatment of MDR TB: eight-month courses of daily injections were rejected in favour of oral medicines and the newer medicines with fewer side effects were added as the first line of treatment.
While India has not yet implemented WHO’s August directive, there are indications that the government will soon make a statement, said officials in the know.
Shailly Gupta of Médecins Sans Frontières (MSF; Doctors Without Borders) said the NGO has written to the Indian authorities to scale up access to the new drugs.
At present, patients can get access to the drugs from the government’s special programme in certain cities only. While bedaquiline has been given to roughly 300 patients with drug-resistant TB in Mumbai, delamanid is not available in Mumbai. Patients can, however, get delamanid directly from the pharmaceutical company on compassionate grounds.
In Mumbai, Dr Vikas Oswal, who is the head of unit (MDR TB DOTS-PLUS site) at the BMC-run Shatabdi Hospital, said that of his 27 patients on delamanid, most are under 18 years of age. “Delamanid works very well on pediatric patients,” he said. None of his pediatric patients are on bedaquiline.
After the WHO’s new directive, MSF has called on countries to start implementing the new treatment guidelines by September 2019. “The new WHO recommendations offer the best opportunity in a long time to finally start improving treatment for people with drug-resistant TB, using better drugs that cause fewer debilitating side effects,” said Dr Naira Khachatryan with MSF.
An estimated 5.58 lakh people developed DR-TB in 2017, but only 25% were treated. Experts in India have said that less than 4% of drug-resistant patients who need bedaquiline get it. Standard DR-TB treatment used by most countries up to now has required people to take more than 14,000 pills over a period of nearly two years, including up to eight months of painful daily injections, with severe side effects. Just over half of the patients are cured, said MSF.