The family of an 18-year-old woman is fighting in court for access to a new tuberculosis drug that doctors say may be her only hope of survival, in a case that is being closely watched by TB experts and health workers in India and around the world.
The family of the young woman, whose name her lawyer asked to keep confidential, filed a petition in Delhi’s High Court in December seeking access to bedaquiline, one of the first new tuberculosis drugs to be developed in nearly half a century.
Access in India to the drug, made by a Johnson & Johnson unit, is controlled by India’s government, which introduced it two years ago and is rolling its use out gradually. The drug is currently available to qualifying patients in five cities.
The woman, from the city of Patna, was diagnosed with drug-resistant TB in 2013, according to TB experts who have reviewed her case. The drugs she was treated with initially didn’t work, and a test in late 2014 showed that she had extensively drug-resistant TB, or XDR-TB, a rare and dangerous form of the disease indicating that the TB bacteria infecting her were impervious to multiple first and second-line drugs. By 2016, she was resistant to eight drugs, and had been told by doctors that there was nothing more that could be done for her, according to Zarir Udwadia, a TB specialist who examined her in October.
Because bedaquiline is a new drug, TB bacteria have not developed resistance to it. The World Health Organization and Indian government allow treatment with bedaquiline for XDR-TB cases like that of the 18-year-old woman.
The case is being closely watched by TB experts around the world, because India has the largest number of tuberculosis patients, with 1.7 million cases reported in 2015. Of them, 79,000 of them had drug-resistant forms of the disease. Yet only 184 patients in India have received bedaquiline, according to Treatment Action Group, a New York-based research and policy think tank that advocates on TB issues. It cited statistics from an international task force that is monitoring the scale-up of new TB drugs.
“She needs bedaquiline because she is almost but not completely therapeutically destitute,” said the TB specialist, Dr. Udwadia, who after his examination of the young woman recommended the drug in combination with five other medications “as her best and only chance of a cure.”
He called the woman, who is seeking treatment in New Delhi where the drug is being made available, an “ideal candidate” for bedaquiline and said doctors shouldn’t have told her there was nothing more they could give her. “Doing this when available drugs like BDQ (bedaquiline) were at hand stuck me as unjustifiable on not just medial but also moral grounds,” he said.
With bedaquiline, the young woman’s chances of being cured are more than 80%, but without it, her chances are under 50%, Jennifer Furin, a lecturer at Harvard Medical School and expert on treatment of XDR-TB, estimated in an opinion sought by the young woman’s lawyer and provided to the court.
“She will not survive six months” without the new drug, said the young woman’s lawyer, Anand Grover, who is representing her pro bono.
India’s government is controlling the rollout of bedaquiline in order to minimize the risk of resistance developing to a valuable new drug, said Saket Sikri, a lawyer for the National Institute of Tuberculosis and Respiratory Diseases in New Delhi, where the young woman is seeking the treatment.
The institute said that it cannot give bedaquiline to her without the results of a test, for which samples were taken in late December, to determine which drugs her TB bacteria are susceptible to. TB drugs must be given in combinations rather than alone, to minimize the risk of resistance.
“Unless the results come we will not be able to come up with an adequate drug combination, and if the combination is not correct, the drug will also be ineffective,” Mr. Sikri said. “We don’t want to lose the drug. We want the drug to be highly effective.”
Dr. Furin said that the results of that test could take weeks, and time is of the essence for the teenager.
“There is a very critical window,” she said.
The hospital is now reviewing a report presented to the court last week showing drug testing that was conducted in 2016, Mr. Sikri said.
A hearing is scheduled for Wednesday.
For breaking news, features and analysis from India, follow WSJ India on Facebook.
