The World Health Organization (WHO) has shared interim results from the international, open-label trial published recently in the New England Journal of Medicine. They report that remdesivir, hydroxychloroquine, lopinavir and interferon beta-1a not only fail to reduce mortality associated with COVID-19, but also don’t lessen the need for ventilation initiation nor reduce hospitalization duration for patients infected with SARS-CoV-2. Additionally, the WHO dropped Hydroxychloroquine, lopinavir and interferon for futility while the global health organization considers taking on new drugs into the ongoing study. In the meantime, the drug that the Solidarity trial dismissed, Remdesivir, went on to generate over $2.8 billion in sales for the San Francisco Bay Area maker of the antiviral drug. They gained this blockbuster status thanks to the ACTT-1 program, backed by the National Institute of Allergy and Infectious Diseases (NIAID). TrialSite’s controversial piece “Not a Knockout Drug but Knocking it out of the Ballpark” back in July predicted up to $3 billion in sales.
The WHO Study
Including 11,266 hospitalized patients aged 18 and up from 30 countries, the study started March 22 and ended October 3, 2020. Patients were randomly assigned to remdesivir (n=2750), hydroxychloroquine (n=954), lopinavir (n=1411), interferon (n=2063) or no trial drug (n=4088) reports Estie Mermelstein, MSN, FNP-BC writing for Infectious Disease Advisor.
This study sought out to investigate the effects of these drugs on in-hospital mortality irrespective of whether a death actually occurred before or after the 28th day. Secondary outcomes measured included the need for mechanical ventilation and hospitalization duration reported Ms. Mermelstein.
The Solidarity trial also included a majority of younger patients (81% under 70); majority of males (62%) and in fact included a sizable number with diabetes (25%). 8% of the study population were already undergoing ventilation. The net results were disappointing. Overall, the drugs had a “null effect on mortality.” Moreover, the trial drugs didn’t unfortunately affect patient mortality by various subgroups (e.g. age, ventilation status at entry, comorbidity, etc.). In disappointing results, the trial drugs failed to lead to improvements in the rate of ventilation initiation or duration of hospitalization.
Although the influential global clinical trial revealed no real benefit of remdesivir, powerful health authorities such as the National Institutes of Health (NIH) didn’t seem to care about those particular results. In fact, earlier in the pandemic, TrialSite reported that NIAID played an active role in not only sponsoring the pivotal ACTT clinical trial but also actually modifying study endpoints to showcase a positive outcome of the study. They found that the drug didn’t reduce mortality but it did reduce hospitalization duration by 4 days. In “Are Politics & Power Behind the Rise of Remdesivir,” TrialSite asked some uncomfortable questions about all of this.
In fairness to Gilead, a great American biopharmaceutical company, they publicly disagreed with the findings of the Solidarity trial. Gilead suggested that the emerging data from WHO was quite inconsistent to data from what they described as better designed trials. They pointed out that Solidarity was an open-label and prioritized broad access, which led to material heterogeneity in trial adoption, implementation, controls and patient populations.
They publicly fretted that they had their demonstrated evidence produced from the three randomized controlled studies, including the double-blinded, placebo-controlled ACTT-1. The results from these studies can be viewed in the New England Journal of Health.
TrialSite cannot say which study is truly more accurate. Gilead makes a strong case, and it’s well known from numerous real world data points that remdesivir helps hospitalized patients with COVID-19. TrialSite will continue to publish study results, interviews and observations ongoing in a manner as as objective and unbiased as possible. Regardless, its consensus is that remdesivir has helped many tens of thousands of COVID-19 patients, and the marketplace has evidenced this by the company generating nearly $3 billion of sales during the pandemic.