India may find it difficult to introduce bed-quiline-based therapy for MDR-TB despite new WHO guidelines



Although the World Health Organization (WHO) has made significant changes to the treatment guidelines for multidrug-resistant tuberculosis (MDR-TB) by using oral medication bedaquiline as the leading drug, introducing the new regime in India would be a hard task, say medical professionals and care activists.

In a movement that could bring about a revolution in the treatment of tuberculosis, the WHO placed last week the new oral drug bedaquiline in Group A & # 39; together with levofloxacin / moxifloxacin, making it the first line medicine for the treatment of all MDR-TB. It was previously posted in 'Group C & # 39 ;, which indicates which medicines can be used' when resources in Group A and B can not be used & # 39 ;. At present, MDR cases are treated with kanamycin and capreomycin injections, together with another group of medicines called fluoroquinolones. But this therapy has serious side effects, including hearing loss and kidney disease. In addition, patients must visit a facility every day for six months to receive injections. All these factors often lead to a high failure of the treatment.

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

However, most government hospitals and primary health centers currently do not have facilities for additional tests that are mandatory, along with the introduction of bedaquiline. "Even with the changed WHO standards, most medical professionals will hesitate to prescribe it for MDR-TB because the patient has to undergo various controls, including BCG and the drug-sensitivity test (DST), and must also consider the physical condition of patients to see if they can deal with potential toxicity, because most of our TB patients are poorly fed We have qualified medical professionals and healthcare providers, but lack equipment and infrastructure in health centers to perform such tests and to monitor monitoring. "Qasim Sayyid from TB Alert India, a non-profit organization working with the government's revised National Tuberculosis Control Program, pointed out.

Janssen, an offshoot of US-based Johnson and Johnson, has patents for producing bedaquiline until 2023 and the drug is sold worldwide under the brand name Sirturo. Under the conditional access program of the central government, bedaquiline is imported directly from the manufacturer free of charge and, according to the company's estimates, about 1,000 XDR patients are involved in the medicine. The scheme will expire in March 2019.

"It is indeed a panacea and the WHO recommendations mean that MDR patients can avoid daily injections and associated side effects, but given the limited available data on bedaquiline and as the results of the Phase IIB study showed excessive mortality, the its introduction are carefully checked for safety, but unfortunately most of our clinics do not have such facilities, "said an activist attached to the Tuberculosis Association of India.

Doctors in India will also have to deal with the high levels of flouroquinolone resistance in patients. According to available data, there is already more than 70 percent resistance. The WHO standards clearly state that bedaquiline should be given together with other second-line medicines, and fluoroquinolones are recommended for use.
In addition, DST for bedquiline is not yet standardized. "Until a specific DST test for bedaquiline has been developed, physicians will not be guided by minimal inhibitory concentration (MIC) or DST results when formulating a regimen, and MDR TB patients may respond poorly to treatment reasons other than drug resistance, "noted a senior doctor.

In most countries, bedaquiniline has only received conditional approvals. The conditions imposed by the US FDA include a requirement for Janssen to wear a black box warning stating that "an increased risk of death was seen in the SIRTURO treatment group (9/79, 11.4%). ) compared with the placebo treatment group (2/81, 2.5 percent) in one placebo-controlled study ". The Drug Controller General of India has also only conditionally approved the medicine. The approval clearly states that bedaquiline is released for "multi-drug-resistant mycobacterium tuberculosis when an effective treatment regimen can not be otherwise provided".

TBC is the largest killer of infectious diseases worldwide and despite being the worst affected country, India still has little idea of ​​the true extent of the problem. The country accounts for about one in four cases worldwide, according to the WHO, and almost 2.8 lakh Indians die of the disease every year. Almost 6 percent of TB cases in India are resistant to drugs.


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