The health authorities said they would amend tuberculosis (TB) treatment guidelines to treat patients with multidrug-resistant (MDR) TB better. However, the government’s addition of new drugs raised concerns of safety among experts.

The Korea Centers for Disease Control and Prevention (KCDC) and the Korea Academy of Tuberculosis and Respiratory Diseases (KATRD) held a public hearing on revised TB treatment guidelines to combat MDR-TB at Samsung Medical Center on Monday.

The Korea Centers for Disease Control and Prevention and the Korea Academy of Tuberculosis and Respiratory Diseases hold a public hearing on revised tuberculosis treatment guidelines to combat multidrug-resistant tuberculosis at Samsung Medical Center on Monday.

MDR-TB is caused by mycobacterium tuberculosis that is resistant to isoniazid and rifampin, the two anti-tuberculosis agents.

The number of MDR-TB patients in Korea has steadily declined to 618 (2.3 percent) out of 26,433 in 2018. However, the treatment success rate was only 66.6 percent in 2017. This is lower than 70-80 percent in developed countries.

The revised guidelines changed the criteria for the use of new drugs to diagnose MDR-TB patients rapidly and shorten the medication period to increase treatment success.

Under the guidelines, doctors should test all TB patients with isoniazid and rifampin on the first culture strain. If MDR-TB is confirmed, they are to check resistance to additionally available drugs such as quinolone to provide timely treatment. To shorten the treatment period, the guidelines state that doctors must use new medicines such as bedaquiline and linezolid.

In March, the World Health Organization categorized new TB drugs levofloxacin (moxifloxacin), bedaquiline, and linezolid in Group A as essential drugs, and included cycloserine and clofazimine in Group B.

Under the WHO’s recommendation, the Korean health authorities agreed to put new TB drugs under Group A and B. However, they accepted agents in Group C only partially to reflect the local situation. The local treatment guidelines categorized delamanid in Group C2 and allowed to replace bedaquiline with delamanid. The guidelines also allowed the use of amikacin instead of kanamycin until the evidence for the safety of kanamycin accumulates.

Experts at the public hearing pointed out that physicians need to monitor side effects and resistance of the new drugs.

Choi Hong-jo, research head of the Korean National Tuberculosis Association, said experts might say the diagnosis and treatment of MDR-TB were essential, but the revised treatment guideline did not state who should follow the resistance of the new drugs. “The monitoring should be included in the guidelines because this is very important for patients,” he said.

Another expert said physicians need an expert committee’s discussion before the use of new drugs for MDR-TB patients aged five or less, considering the safety concern.

Kim Ye-jin, planning and research director at the Korean Society of Pediatric Infectious Diseases, said grounding the drug and feeding it for children could make the dose inaccurate.

“We have no experience of using new drugs for young children with MDR-TB aged five or less. We don’t know if we can use the drugs for them. We need advice from an expert group,” she said.

Experts also proposed that they could designate a representative institution for TB screening, and said that the government should provide support and operation of the institution as part of a national TB management.

In response, the government said it would improve regulations so that MDR-TB patients can complete the treatment.

Park Mi-seon, director of TB Epidemic Investigation Division at KCDC, said the government reflected strengthened strategies in the guidelines to help patients receive MDR-TB treatment fully. “We need to designate an MDR-TB treatment institution. We plan to establish criteria for designating 70 specialized treatment institutions,” Park said.

Government officials said they would include the opinions collected at the public hearing in the final treatment guidelines. They have not set the timing of the announcement of the final guidelines.

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