US government sponsored study of Remdesivir showing promise

Gilead Reports Data on Virus Drug Ahead of Researchers

Source: Bloomberg

Gilead Sciences Inc. said early results from a U.S.-government-run study showed its experimental drug to treat coronavirus helped patients recover more quickly than standard care, suggesting it could become the first effective treatment for an illness that has turned modern life inside-out.

The company issued a news release early Wednesday commenting on the study from the U.S. National Institute of Allergy and Infectious Diseases without providing details of the results.

Gilead’s share price and the broader stock market have been churned in recent weeks by a series of early looks and leaks of trial data on the drug, called remdesivir. Last week, the market swooned after apparently discouraging results from a Chinese trial were accidentally posted on a World Health Organization web page. Data confirming those more downbeat results were published in the U.K. medical journal The Lancet on Wednesday.

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Dr. Zia H Shah, Chief Editor of the Muslim Times and in charge of health section

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Categories: Health

12 replies

  1. Press release by Gilead:

    April 29, 2020

    Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19
    — Study Demonstrates Similar Efficacy with 5- and 10-Day Dosing Durations of Remdesivir —

    FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 29, 2020– Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. 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 (Odds Ratio: 0.75 [95% CI 0.51 – 1.12] on Day 14). 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.

    “Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”

    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. This study sought to determine whether a shorter, 5-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies of remdesivir. Secondary objectives included rates of adverse events and additional measures of clinical response in both treatment groups. Patients were required to have evidence of pneumonia and reduced oxygen levels that did not require mechanical ventilation at the time of study entry. Clinical improvement was defined as an improvement of two or more points from baseline on a predefined seven-point scale, ranging from hospital discharge to increasing levels of oxygen support to death. Patients achieved clinical recovery if they no longer required oxygen support and medical care or were discharged from the hospital.

    In this study, 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 (5-day: 60.0%, n=120/200 vs.10-day: 52.3% n=103/197; p=0.14). At Day 14, 64.5 percent (n=129/200) of patients in the 5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-day treatment group achieved clinical recovery.

    Clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at Day 14 was 7 percent (n=23/320) across both treatment groups, with 64 percent (n=205/320) of patients experiencing clinical improvement at Day 14 and 61 percent (n=196/320) of patients discharged from the hospital.

    Impact of Earlier Treatment

    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,” said Aruna Subramanian, MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and one of the lead investigators of the study. “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.”

    Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events occurring in more than 10 percent of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests.

    Key efficacy and safety results from the study are included in the table below.

    https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19

  2. Gilead’s experimental coronavirus drug remdesivir has hit its goals in a government-sponsored trial and may be effective in just a five-day dosing regimen, the drugmaker announced Wednesday morning.

    The company “is aware of positive data” emerging from a study funded by the National Institute of Allergy and Infectious Diseases, it said, adding that the agency is expected to provide more details soon.

    https://www.politico.com/news/2020/04/29/gilead-coronavirus-remdesivir-220484

  3. Remdesivir cut the duration of symptoms from 15 days down to 11 in clinical trial at hospitals around the world.

    The full details have not been published, but experts said it would be a “fantastic result” if confirmed, but not a “magic bullet” for the disease.

    A drug would have the potential to save lives, ease pressure on hospitals and allow parts of lockdown to be lifted.

    Remdesivir was originally developed as an Ebola treatment. It is an antiviral and works by attacking an enzyme that a virus needs in order to replicate inside our cells.

    The trial was run by the US National Institute of Allergy and Infectious Diseases (NIAID) and 1,063 people took part. Some patients were given the drug while others received a placebo (dummy) treatment.

    Dr Anthony Fauci who runs the NIAID said: “The data shows remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery.”

    He said the results prove “a drug can block this virus” and were “opening the door to the fact that we now have the capability of treating” patients.

    The impact on deaths is not as clear cut. The mortality rate was 8% in people given remdesivir and 11.6% in those given a placebo, but this result was not statistically significant, meaning scientists cannot tell if the difference is real.

    https://www.bbc.com/news/health-52478783

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