Beijing is touting a promising new drug, VV116, as COVID-19 cases surge nationwide after the abrupt end to its "zero-COVID" policy.
Described as "superior goods of Chinese provenance" in government-affiliated media reports, a phase 3 comparative clinical trial published in the New England Journal of Medicine concluded the oral antiviral agent VV116 is as effective as Paxlovid at curbing mild to moderate illness among people at high risk of severe disease caused by COVID-19 with even lower incidence of adverse effects.
Paxlovid is an antiviral drug produced by Pfizer that was granted emergency authorization in December 2021 by the U.S. Food and Drug Administration (FDA) for treating severe disease caused by COVID-19.
The VV116 study published on December 28 said the Chinese drug was "noninferior" to nirmatrelvir–ritonavir, or Paxlovid, with fewer safety concerns.
This drug "can interfere with the replication of the virus, reduce the amount of the virus, and can be used to treat the disease," said Shin-Ru Shih, director and distinguished professor at the Research Center for Emerging Viral Infections at Chang Gung University in Taiwan.
This is the same principle as Paxlovid, which is currently used in most countries around the world. These antiviral drugs are designed to stop the virus from replicating, giving the body valuable time to build immunity to the virus. Paxlovid is currently the drug recommended by the U.S. National Institutes of Health to treat COVID-19.
The People's Daily, China's state-run newspaper, on December 29 reported that the VV116 trial is the first study of a Chinese developed COVID-19 drug published by the authoritative New England Journal of Medicine.
"We dare to directly compare the efficacy of domestically developed drugs with Paxlovid at this point, which is a bold challenge and breakthrough," Xu Huaqiang, a researcher at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, told the People's Daily.
As VV116 goes through the often-lengthy trials required for approval, epidemiologists believe that China should use existing drugs, given the surge of cases since the relaxation of zero-COVID restrictions began in early December.
China's National Health Commission stopped publishing daily reports on COVID-19 deaths on December 25. As of January 2, China's official COVID-19 death toll was 5,253 since the pandemic began in January 2020. China's population was over 1.4 billion people in 2021.
According to a forecast published December 28 by Airfinity, a London-based research firm that focuses on predictive health analytics, COVID-19 infections in China are expected to reach the first peak January 13, with 3.7 million cases a day, while deaths are estimated to peak 10 days later, at approximately 25,000 a day.
Amesh Adalja, an American infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security, told VOA Mandarin, "The Chinese government can and should increase access to Paxlovid for high-risk individuals in order to preserve their hospital capacity and minimize deaths."
Adalja said that the question that still needs to be answered about VV116 is its ability to decrease rates of hospitalization and death.
Shih said that given the current situation in China, the available vaccines and medicines should be used as soon as possible. "Because after all, there are some elderly people or people with chronic diseases. They are at high risk and may not be able to wait for new medicines. We should use available resources to help these people first," she said.
"I think the fight against this global pandemic requires a global effort," she added. "Although there are some livelihood considerations among various pharmaceutical companies and countries, after all, the lives of patients should be the top priority."
Drug trials
Shih said the VV116 study is different from a real phase 3 trial.
"This study is to compare VV116 with Paxlovid, which is a commonly used protease inhibitor. This clinical trial is a comparison of non-inferiority to show that it is no worse than Paxlovid," she told VOA Mandarin. "It's not a real phase 3 clinical trial. It's just a comparative clinical trial."
Shih said VV116 "has potential, but it will not be available to the public immediately."
Ruijin Hospital, which is affiliated with Shanghai Jiao Tong University, created VV116, which was further developed by pharmaceutical companies Junshi Biosciences and Vigonvita Life Sciences.
VV116 is similar to Remdesivir, developed by the U.S. pharmaceutical company Gilead Sciences and approved by the FDA to treat COVID-19 by intravenous injection in adults and children.
The VV116 trial was led by Ruijin Hospital and another Shanghai institution, Renji Hospital, which is also affiliated with Shanghai Jiao Tong University School of Medicine and conducted at seven other hospitals in Shanghai.
It is a single-blind study, meaning the researchers didn't know which drugs the patients were taking, but the patients did. One trial group of 377 participants took VV116 while the other control group of 378 participants took Paxlovid. Both courses of treatment are five days.
The results showed that the median time to recovery, which is two consecutive days without symptoms of COVID-19, was four days for the VV116 trial group and five days for those taking Paxlovid. After four weeks, 98% of the participants had recovered, and none had developed serious illness.
In the trial, 26% of people taking Paxlovid reported a change in their sense of taste, compared to 4% of the VV116 control group. People in both trial groups experienced elevated triglycerides, which can increase the risk of heart disease and stroke. However, 11% of people in the VV116 group reported this side effect, compared with 21% in the Paxlovid group.
Shih said that such a discovery is of great significance.
"Because Paxlovid has drug-drug interactions, people with some chronic diseases can't use Paxlovid when they take certain medicines. So, we need better medicines. VV116 has such potential, and its side effects are indeed relatively small," she told VOA Mandarin in a phone interview.
However, scientists believe that VV116 needs larger trials to confirm its efficacy and side effects. Shih said that because the trial was not double-blind and the number of participants was relatively small, the trial may be biased, so drug regulatory agencies will require pharmaceutical companies to conduct further trials. A double-blind trial is one in which neither the participants nor the researchers know which treatment participants are receiving until the clinical trial concludes.
"Especially if this drug is to be extended to more people, the ethnic group cannot only be Chinese, and it may have to be tested among all ethnic groups. When Paxlovid conducted clinical trials, different races are taken into consideration, which is more complete," Shih said.
The median age of the participants was 53 years and approximately half the participants were women.
According to FDA regulations, the third phase of clinical trials generally recruits nearly 3,000 participants. Paxlovid's latest clinical trial included more than 2200 participants.
In most countries, it takes years for drugs to go from clinical trials to approval by drug regulatory agencies. In the U.S., studies show that the average approval process of new drugs takes 12 years, according to PharmaNewsIntelligence, and costs from $985 million to $2.8 billion.
Adrianna Zhang contributed to this report.
