The soaring number of novel coronavirus cases in the United States and European Union in March has propelled the global battle against the highly contagious disease into a new phase. 

Similarly soaring are the expectations for remdesivir, an experimental anti-viral drug offering the most hope of being able to treat the disease, known officially as COVID-19, that originated in China but has enveloped the world.

While stock markets in the U.S. have tumbled amid fears of a drawn-out recession caused by the pandemic, including a 16.4 percent fall in the Dow Jones Industrial Average from the beginning of March to March 17, shares of Gilead Sciences, the U.S.-based maker of remdesivir, were up 6.9 percent during the same period.    

May Be Available to 3 Hospitals in Taiwan

The company is planning to test the drug on 1,000 patients in Asian countries outside of China as it enters phase III clinical trials, and Taiwan will be one of them. 

Chang Shan-chwen, a convener of Taiwan’s Central Epidemic Command Center and executive vice president of National Taiwan University, said Taiwan has obtained the right to participate in the clinical trial, and a total of three hospitals in northern, central and southern Taiwan will likely be involved.

Remdesivir’s potential gained currency as a possible COVID-19 treatment in early March when the New England Journal of Medicine described the first case of the novel coronavirus in the U.S. and indicated that the drug mitigated the patient’s symptoms.

                               

According to the study, the 35-year-old man returned home on Jan. 15, 2020 after visiting his family in Wuhan, China, the outbreak’s epicenter. He then went to an urgent care clinic in the state of Washington four days later, having coughed and run a fever since being back in the U.S.

He was diagnosed with the novel coronavirus and admitted to a hospital, and on the evening of day 7 of his hospitalization, doctors gave him remdesivir. The following day, his fever, vomiting and diarrhea disappeared and his coughing and oxygen saturation values improved, according to the study. 

But is the optimism generated by the use of remdesivir to treat that patient actually warranted?

Getting Rid of Fever in a Day?

Hard to tell, said Chang Hong-jen, a former director-general of Taiwan’s Centers for Disease Control and a professor in National Yang-Ming University’s Institute of Hospital and Health Care Administration. 

One issue is that other potential treatments for the new coronavirus that could supplant remdesivir exist, including the anti-flu medications Avigan (favipiravir) and Arbidol and a drug used to treat HIV and malaria, chloroquine, he said. 

In fact, according to Japanese media NHK, a Chinese official said on March 17 that Avigan has been found effective in clinical trials of patients infected with the new coronavirus. A Guardian report indicated, however, that the drug was not as effective in people with more severe symptoms, citing a Japanese health ministry source.

Another problem, Chang cautioned, is that remdesivir “still has to undergo rigorous, random, double-blind [clinical trials]” before it can be deemed effective.

Chou Pai-chien, the director of Thoracic Medicine at Taipei Medical University Hospital, explains that Remdesivir acts by disrupting the virus’ RNA polymerase (an enzyme used by many viruses to copy themselves) to prevent the virus from proliferating, but it has to get into cells to be effective. 

There are two major challenges to overcome if remdesivir is to go mainstream – the timing of when to administer the drug and testing in clinical trials. 

Challenge No. 1: When to Take the Drug

It usually takes most anti-viral medications at least seven days to clearly be effective in bringing down a fever. “To say it can break a fever in one day is overestimating its capability,” Chou said, suggesting that the results described in the New England Journal of Medicine study may have been because the drug was administered at just the right time.

As with many experts, Chou believes about 80 percent of novel coronavirus cases are relatively mild and would not require the use of remdesivir, and the drug may lead to side effects that are not yet known.

The problem is, however, that patients with severe bouts of COVID-19 can quickly develop pneumonia, have trouble clearing phlegm, and can have large amounts of mucus enter their bronchial tubes, and if remdesivir is administered too late, its effectiveness will be diminished.

So when should the drug be given to patients? Should it be used as soon as COVID-19 diagnosed or when pneumonia appears? The answers to these questions will influence dosages, but they can only be obtained from clinical trials, which will determine whether or not the drug can, in fact, suppress the virus.

Challenge No. 2: Insufficient Trials

Another issue is whether remdesivir can actually reach the 1,000 tests in clinical trials. The patients in the trials not only have to meet strict screening conditions, such as not using other medications, their lung ailments also must be caused exclusively by the novel coronavirus. If participants are not recruited quickly enough, it would delay when participants are “unblinded,” or told what treatments they received during the trial, and push back the timing of the results.

The original plan for clinical trials in Wuhan was to recruit 308 patients with mild cases of COVID-19 and 452 more seriously ill patients for clinical trials, but fewer than 200 people enrolled after 10 days.

According to a Wall Street Journal report in mid-February, the screening criteria were particularly strict, slowing down the recruitment process. “Severely ill patients had to be within 12 days of the illness’s onset and couldn’t have taken other treatments within the past 30 days to qualify,” the report said, while mildly ill participants had to have gotten sick within the previous eight days. 

If clinical trials do in fact show the remdesivir is effective in treating COVID-19, and the disease were to reach epidemic proportions in Taiwan (which had 100 confirmed cases as of March 18), would Taiwan have to worry about not having access to the drug?

National Yang-Ming University’s Chang said that even if Gilead refused to license the drug’s production to others, Taiwan could file a public health appeal based on the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) to force Gilead to issue a license. Because of that, Taiwan should not have any concerns, Chang argued. 

Source: Shutterstock/REUTERS

The clinical trials for remdesivir being done at Wuhan Jinyintan Hospital and China-Japan Friendship Hospital (though it was unclear if they hit their patient targets) are expected to conclude on April 27. Only then will we have any idea whether a drug that did not work against the Ebola virus could in fact offer a ray of hope in treating the newest virus that has brought the world to a standstill.  

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Translated by Luke Sabatier
Uploaded by Sharon Tseng