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India may find it tough to introduce bedaquiline-based therapy for MDR-TB despite new WHO guidelines

Arun Sreenivasan, New Delhi
Wednesday, August 22, 2018, 08:00 Hrs  [IST]

While the World Health Organisation (WHO) has made key changes to the multi-drug resistant tuberculosis (MDR-TB) treatment guidelines by placing oral medication bedaquiline as the frontline drug, introducing the new regimen in India would be an uphill task, say medical professionals and healthcare activists.

In a move that could revolutionise tuberculosis treatment, the WHO last week placed the new oral drug bedaquiline in ‘Group A’ along with levofloxacin/moxifloxacin, making it the frontline medicine for treatment of all MDR-TB. It was previously placed in ‘Group C’, which indicated drugs that can be used ‘when agents in Group A and B cannot be used’. At present, MDR cases are treated with kanamycin and capreomycin injections, along with another group of drugs called fluoroquinolones. But this therapy has serious side-effects including hearing loss and kidney ailments. Moreover, patients have to visit a facility every day for six months to take injections. All these factors often lead to high dropout from treatment.

In India, though the use of bedaquiline has increased in the last two years, it is only given to patients with extensively drug-resistant TB (XDR-TB), a rare type of MDR-TB that is resistant to isoniazid and rifampin, plus any fluoroquinolone and at least one of three injectable second-line drugs.

However, most government hospitals and primary health centres currently lack facilities for additional tests that are mandatory along with the introduction of bedaquiline. “Even with the changed WHO norms, most medical professionals will hesitate to prescribe it for MDR-TB as the patient has to go for several additional monitoring including BCG and drug-susceptibility test (DST). They also have to consider the physical condition of patients to see whether they can handle potential toxicity as most of our TB patients are ill-nourished. We have qualified medical professionals and caregivers but lack equipment and infrastructure at health centres to conduct such tests and meticulous monitoring,” Qasim Sayyid of TB Alert India, a non-profit that works with the government’s Revised National Tuberculosis Control Programme, pointed out.

Janssen, an offshoot of US-based Johnson and Johnson, holds patents for producing bedaquiline until 2023 and the drug is sold globally under the brand name Sirturo. Under the Central government’s conditional access programme, bedaquiline is being imported directly from the manufacturer free of cost and, as per company estimates, around 1,000 XDR patients are on the drug. The scheme will come to an end in March 2019.

“It is indeed a miracle drug and the WHO recommendations mean MDR patients could avoid daily injections and associated side effects. But given the limited data available on bedaquiline and since the results of the Phase IIB trial showed an excess mortality, its introduction should be carefully monitored for safety. Unfortunately, most of our clinics don’t have such facilities,” an activist associated with the Tuberculosis Association of India opined.

Physicians in India will also have to deal with the high levels of flouroquinolone resistance among patients. According to available data, there is more than 70 per cent resistance already. The WHO norms clearly state that bedaquiline should be given with other second-line drugs, and fluoroquinolones are recommended for use along with it.
Besides, DST for bedaquiline has not yet been standardised. “Until a specific DST assay for bedaquiline is developed, clinicians won’t be guided by minimal inhibitory concentration (MIC) values or DST results when composing a regimen. Furthermore, MDR-TB patients may respond poorly to treatment for reasons other than drug resistance,” a senior doctor pointed out.

In most countries, bedaquiniline has received only conditional approvals. The conditions that are imposed by the American FDA include a requirement for Janssen to carry a black box warning, stating that “an increased risk of death was seen in the SIRTURO treatment group (9/79, 11.4 per cent) compared to the placebo treatment group (2/81, 2.5 per cent) in one placebo-controlled trial”. The Drug Controller General of India has also approved the drug only conditionally. The approval clearly states that bedaquiline is cleared for “multi-drug resistant mycobacterium tuberculosis when an effective treatment regimen cannot otherwise be provided”.

TB is globally the top infectious disease killer and despite being the worst-affected country, India still has little idea of the true scale of the problem. The country accounts for around one in four cases globally, according to the WHO, and close to 2.8 lakh Indians die of the disease annually. Nearly 6 per cent of TB cases in India are drug resistant.

 

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