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South Korean Prime Minister Sye-kyun speaks during a meeting of the Central Disaster Safety Countermeasures Headquarters at the Central Government Complex in Seoul on May 3. (Yonhap News)

South Korean disease control authorities reiterated their cautious stance on the use of remdesivir, which has been drawing attention as a strong candidate for COVID-19 treatment amid its approval for emergency use by US public health authorities.

“While the US Food and Drug Administration has approved its emergency use with patients who have severe symptoms, clinical research is still being conducted by a number of countries and healthcare institutions,” said Korea Centers for Disease Control and Prevention (KCDC) Director Jung Eun-kyeong in a regular briefing on May 3.

“We will need to make a decision after viewing concrete clinical trial results showing that [remdesivir] ultimately lowers death rates or other severe conditions, as well as looking at the side effects,” she stressed.

Remdesivir has been attracting attention as a coronavirus treatment after the US FDA granted approval on May 1 for limited emergency use to treat patients with severe COVID-19 symptoms. On Apr. 29, the US National Institute of Allergy and Infectious Diseases (NIAID) published research findings that showed positive results, with initial clinical trials showing remdesivir to have shortened recovery times by 31% for patients hospitalized with COVID-19. COVID-19 patients administered with remdesivir had an average recovery period of 11 days, four fewer than the 15 days for patients who received a placebo.

Remdesivir is an antiviral agent developed by the US pharmaceutical company Gilead Science since 2009 as a treatment for the Ebola virus. It has also been reported as effective against infectious diseases in the coronavirus group, including Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).

Commenting the day before on the approval of emergency use of remdesivir, KCDC Deputy Director Kwon Jun-wook said, “Disease control authorities also recognize the significance of a prestigious US institution granting emergency use approval.”

“The matter of clinical testing results for remdesivir is an area for experts, and there have been some experts questioning the statistical significance of some of the fatality rates,” he cautioned.

The same day, the South Korean Ministry of Food and Drug Safety (MFDS) said, “The medication in question [remdesivir] is currently undergoing clinical trials, and this is not the stage for making a determination on its safety or efficacy as a COVID-19 treatment.”

“Additional information is needed regarding the number of individuals analyzed in the trials, the testing subjects, unusual responses, and other areas,” it said. Three clinical trials on remdesivir are currently being conducted in South Korea.

Experts suggested that the application of the US’ trial findings to South Korea may be unwarranted.

“While there were some differences in recovery periods, the difference between the 8% fatality rate for the group receiving remdesivir and the 11.6% rate for the group receiving a placebo was not statistically significant, and it can’t really be applied to all countries, as with the high rate observed for Italy,” said Ki Mo-ran, a professor of preventive medicine at the National Cancer Center.

“Another report indicated no difference in clinical testing conducted by the WHO [World Health Organization],” she noted.

Kim Woo-joo, a professor of infectious diseases at Korea University Guro Hospital, said, “While it is meaningful that they observed the first reduction over the treatment period in the placebo comparison, we should be cautious about interpreting that more broadly as an effect in terms of reducing fatality rates.”

Disease control authorities are currently weighing the swift adoption of remdesivir treatments as its effectiveness and security are tested.

“We are cooperating closely with the related authorities and agencies and holding discussions with experts to assess the clinical trial findings for remdesivir, while making adequate preparations for the swift implementation of special importation procedures in the event of an emergency in South Korea,” Kwon Jun-wook said.

By Kwon Ji-dam, staff reporter

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