Vaccine Info

Remdesivir

Remdesivir Antiviral Treatment Description

Remdesivir (GS-5734) is an investigational nucleotide analog with broad-spectrum antiviral activity – it is not approved anywhere for any use. 

As of  May 1, 2020, remdesivir had been issued an Emergency Use Authorization (EUA) in the U.S. for those hospitalized with severe disease. New data indicates it may shorten the time it takes to recover from the infection.

And on May 26, 2020, the UK Department of Health announced that adults and teenagers with severe COVID-19 disease will be allowed to be treated with remdesivir, if they fit specific criteria. The criteria for who will get it have not been laid out by the UK government, but doctors will be expected to decide on a case-by-case basis who is most likely to benefit.

Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19 disease. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19.

Remdesivir was originally developed to treat the Ebola and Marburg virus diseases but was ineffective for these viral infections.

Gilead Science first received a patent (US9724360B2) for the drug as a treatment for Ebola in 2017. In fall 2015, Gilead applied for two patents for remdesivir, one for combating coronaviruses and another for filoviruses, the family of pathogens that includes Ebola. Both were approved in spring 2019. 

Remdesivir Antiviral Delivery

Treatment is given by injection into a vein. The dosage is being evaluated in various clinical studies.

In one NIH clinical trial, remdesivir is administered as one 200-milligram (mg) IV dose followed by a 100-mg once-daily IV dose for the duration of hospitalization up to a 10-day total course of treatment. 

Remdesivir Antiviral Treatment News

  • May 28, 2020 - Roche announced the initiation of a global phase III, randomized, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra, plus the investigational antiviral remdesivir in hospitalized patients with severe COVID-19 pneumonia.

  • May 26, 2020 - The UK Department of Health announced that adults and teenagers with severe COVID-19 disease will be allowed to be treated with remdesivir if they fit specific criteria. The criteria for who will get it have not been laid out by the UK government, but doctors will be expected to decide on a case-by-case basis who is most likely to benefit.

  • May 22, 2020 - Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.

  • May 15, 2020 - Gilead Sciences Inc’s two clinical studies of its potential coronavirus treatment remdesivir will wind down by the end of May, closing off a path of patient access to the antiviral medication, according to U.S. researchers involved in the studies.

  • May 13, 2020 - Inside Gilead’s COVID-19 Response Efforts.

  • May 12, 2020 - Gilead Sciences announced on it has signed non-exclusive voluntary licensing agreements with 5 generic pharmaceutical manufacturers based in India and Pakistan to further expand the supply of the experimental antiviral remdesivir. These agreements enable these companies to manufacture remdesivir for distribution in 127 countries.

  • May 9, 2020 - The U.S. Department of HHS announced the allocation plan for the drug remdesivir. The donated doses by Gilead Sciences, Inc., which received a EUA from the U.S. FDA, will be used to treat hospitalized COVID-19 disease patients in areas of the country hardest hit by the pandemic.

  • May 8, 2020 - NIH clinical trial testing antiviral remdesivir plus anti-inflammatory drug baricitinib for COVID-19 begins.

  • May 3, 2020 - Gilead Sciences announced it would donate its entire supply of the Remdesivir IV-delivered drug to the U.S. government. 

  • May 1, 2020 - The U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.

  • May 1, 2020 - ICER Presents Alternative Pricing Models for Remdesivir as a Treatment for COVID-19. ICER constructed two models, one estimating cost-recovery pricing ($9.32/10-day course of treatment) and one its cost-effectiveness, estimated at ~$4,500 per course.

  • April 29, 2020 - Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19. Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received a placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059).

  • April 23, 2020 – Gilead Sciences issued the following statement from Merdad Parsey, MD, Ph.D., Chief Medical Officer, Gilead Sciences: “Today, information from the first clinical study evaluating the investigational antiviral remdesivir in patients with severe COVID-19 disease in China was prematurely posted on the World Health Organization website. This information has since been removed, as the study investigators did not provide permission for the publication of the results."

  • April 15, 2020 - Gilead’s remdesivir study in China for mild-moderate COVID-19 patients has just been suspended due to poor enrollment. The news comes as the pandemic continues to wane in China, and follows the recently announced termination of the study for severe COVID-19 patients for similar reasons. According to reports, the mild-moderate study had planned to enroll 308 patients from Wuhan- but it remains unclear exactly how many enrolled to date. 

  • April 10, 2020 - Gilead Sciences announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis. The majority of patients in this international cohort demonstrated clinical improvement and no new safety signals were identified with remdesivir treatment. The detailed results of this analysis were published today in The New England Journal of Medicine.

  • On April 9, 2020 - Gilead Sciences increased the number of participants in 2 ongoing clinical trials for remdesivir, its experimental treatment for COVID-19 disease. According to ClinicalTrials.gov, Gilead increased the number of study participants in a Phase 3 trial for people with moderate forms of the disease to 1,600 from 600. It did the same for a similar trial evaluating remdesivir in patients with severe COVID-19, to 2,400 participants from 400. The first results from these clinical trials are expected in May 2020.

  • April 4, 2020 - An Update on COVID-19 from our Chairman & CEO, Daniel O’Day.
  • February 25, 2020 - A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center in Omaha.

Gilead Clinical Trials

Gilead has initiated Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 following the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing.

Topline results from the open-label, Phase 3 SIMPLE trial, reported the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group, and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by Day 14.

The Adaptive COVID-19 Treatment Trial (ACTT), sponsored by the NIAID, the preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery (11 days) than those who received placebo.

“We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with COVID-19,” said NIAID Director Anthony S. Fauci, M.D. “ACTT 2 will examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes.”

  • Clinical Trial NCT04292899: Phase 3 Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
    • The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to the normalization of temperature and oxygen saturation through Day 14 in participants with severe coronavirus disease (COVID-19).
  • Clinical Trial NCT04292730: Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment
    • The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to the time to discharge in participants with moderate coronavirus disease (COVID-19).
  • Clinical Trial NCT04280705: Adaptive COVID-19 Treatment Trial (ACTT)
    • A total of 1,063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed a shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo.
  • Clinical Trial NCT04257656: Severe 2019-nCoV Remdesivir RCT
  • Clinical Trial NCT04252664: Mild/Moderate 2019-nCoV Remdesivir RCT
  • INSERM French study: 2020-000936-23: DisCoVeR
Updated
05/28/2020 - 19:50