Clinical trials show promise for Remdesivir as COVID-19 treatment

Ritu Jha-

It seems malaria drug hydroxychloroquine has been overtaken by the new up and coming drug Remdesivir that is considered as the first effective coronavirus treatment, according to the US top infectious disease expert.

Developed by Gilead Sciences Inc., an American biopharmaceutical company based in Foster City, California, Remdesivir has been going through its phase 3 trial evaluating 5-day and 10-day dosing durations in hospitalized patients with severe manifestations of COVID-19, announced the official press release by Gilead Sciences.

The study demonstrated that patients receiving a 10-day treatment course of Remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course. “No new safety signals were identified with Remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks,” it added.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), expressed optimism about the drug’s effectiveness.

“The data shows that Remdesivir has a clear-cut, significant positive effect in diminishing the time to recover,” Fauci told reporters, “This drug (Remdesivir) can block the virus.”

Over 1,063 patients have participated in the clinical experiment so far, Fauci said, and  the death rate is just slightly lower in the Remdesivir group, but more data remains to be analyzed.

But the scientist, who has led NIAID since 1984, said the news reminded him of the day 34 years ago when modest results for the drug AZT signaled the first potential weapon against HIV.

Dr. Aruna Subramanian, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases at the Stanford University School of Medicine, and one of the lead investigators of the study, stated through the press note that in an exploratory analysis, patients in the study who received Remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms.

Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.

“These data are encouraging as they indicate that patients who received a shorter, 5-day course of Remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” she said. “While additional data are still needed, these results help to bring a clearer understanding of how treatment with Remdesivir may be optimized, if proven safe and effective.”

Daniel O’Day, chairman and CEO at Gilead Sciences said in an open letter that the company’s drug shows significant promise.

“This work started long before we knew about the outbreak of COVID-19. Remdesivir is the result of more than a decade of research, experimentation and iteration by Gilead scientists,” O’Day said. “Over the past two months, we all have been waiting in hopeful anticipation for the science to speak on Remdesivir.”

However, as of yet, Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19.

Scientists around the world have been racing to find treatments for coronavirus that causes COVID-19, which has killed nor than 230,000 people globally as of April 30, 2020, but no drug has been definitively proven effective. President Donald Trump, though, advocated for hydroxychloroquine and got it imported from India despite experts saying it has a side effect.

Welcoming the Remdesivir news as a silver lining, Dr. Prasun Mishra, CEO and founder of the American Association for Precision Medicine (AAPM) told indica that hydroxychloroquine is the subject of a clinical experiment at present and has never been tested earlier in the US. And historically it has been known that drugs have toxicity and side effects and that  hydroxychloroquine has its side effect.

“It has cardiac side effects, and anyone with heart problems and existing conditions or organ failure they have to avoid hydroxychloroquine.

“It’s an opportunity for precision medicine, and it would be good to have a biomarker to see which patients will respond and which will not,” he said.

Mishra on why he finds Remdesivir more promising from the beginning said because Remdesivir was originally developed to fight to SARS-CoV2 and Ebola – also an RNA virus like the novel coronavirus – by inhibiting viral RNA synthesis and virus replication, and the drug has a broad-spectrum activity on inhibiting the novel coronavirus replication, in vitro and in vivo, in animals.

There was a lot of controversy from the China side, but he believes the FDA would give it an Emergency Use Authorization (EUA).

Remdesivir, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19.

The trial started on Feb. 21, and the first trial participant in the ACTT trial was an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan. That patient volunteered to participate in the study at the first study site, the University of Nebraska Medical Center/Nebraska Medicine, in February 2020. A total of 68 sites ultimately joined the study—47 in the United States and 21 in countries in Europe and Asia.

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