Remdesivir Potentially Most Effective For Coronavirus: China Investigator
Executive Summary
Although AbbVie’s Kaletra has shown promising efficacy in COVID-19 patients, Gilead’s remdesivir has stronger antiviral activity, says one Chinese investigator leading studies in the coronavirus outbreak epicenter Wuhan.
One month after several antiviral drugs were expedited into clinical tests in the coronavirus outbreak epicenter, some promising results are now emerging from Wuhan.
Among several such products screened and selected by front-line physicians in the central Chinese city, lopinavir and its combination with ritonavir is one of the front-runners. Marketed by AbbVie Inc. as Kaletra and originally indicated for anti-HIV use, the combo was among the first antivirals selected by Bin Cao, a leading respiratory expert and vice president of the Sino-Japan Friendship Hospital in Wuhan. Cao is also the primary investigator in several other studies ongoing around the clock in the city.
“Despite Kaletra being used widely for HIV patients, it has never been used for coronavirus,“ noted Cao in an interview with local media. ”But they are all RNA viruses, maybe they share the same shortcomings that we can overcome. In China, Kaletra is only approved for HIV…so I have to get the ethics committee clearance,” he explained.
Currently, there are two arms to the study, one for single use and the other for Kaletra plus standard care, which is interferon alpha. So far, in the nearly two months since the registration of the study, which was on 10 January according to China clinical trial registry site (http://www.chictr.org.cn/index.aspx), Cao said that he and his team have “successfully treated 199 cases” under the protocol. The patients are those with severe symptoms.
Two major medical facilities in Wuhan are conducting the study, Jinyingtan Hospital and Zhongnan Hospital of Wuhan University, while outside the city, similar studies are being conducted in Zhejiang No.1 Hospital and Chongqing No.2 Hospital. These have also been successful so far, Cao said.
Remdesivir Potential
Besides this, there are two trials for Gilead Sciences Inc.’s front-runner antiviral remdesivir, one for mild-to-moderate patients with the COVID-10 respiratory disease caused by the SARS-CoV-2 virus, and another for severe and critical ill patients.
“According to an antiviral accessibility study, remdesivir shows even stronger antiviral activity against coronavirus compared to Kaletra. If we have positive results from Kaletra, we could have even better clinical outcomes, better virology results for remdesivir,” claimed Cao.
There are two study cohorts for remdesivir: cohort 1 had enrolled 64 patients and cohort 2 had 233 patients as of 5 March when the media interview took place. However, the figures are far below those planned for the Phase III study, which had intended to enroll 453 patients, according to clinicaltrials.gov, although recruitment is ongoing.
Cao’s assessment seems to confirm the World Health Organization’s previous views on remdesivir. During a recent joint press briefing in Beijing after a week-long trip visiting multiple sites in Wuhan, Sichuan and Guangdong, “There is only one drug right now that we think has real efficacy. And that’s remdesivir,” said Bruce Aylward, the head of the WHO-China joint delegation.
But patient enrollment in general may be harder given that hospitals and institutes are rushing to register trials with their competing therapies, although most of them are traditional Chinese medicines or a combination of such therapies with chemical drugs. Since 6 February, clinical trials have surged by as many as seven-fold and there are currently 365 studies logged with the Chinese clinical trial registry.
Gilead is also expanding its remdesivir studies to a global scale, enrolling patients across Asian medical facilities, and the initial results could be out as early as April. Cao also hopes to enroll more Chinese patients, saying “We should we have more patients for the studies.”
(Scrip's rolling coverage of the coronavirus outbreak and the biopharma industry's response is aggregated here.)