Significant Extra Advantage Observed for Some COVID-19 Patients Treated with Remdesivir

In the ongoing battle against COVID-19, a significant development has emerged regarding the use of Remdesivir, a drug developed by Gilead Sciences. The drug has been under investigation by the German Institute for Quality and Efficiency in Health Care (IQWiG) to determine its added benefit compared to appropriate comparator therapy for COVID-19 patients.

The benefit assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. The assessment is based on the data from three randomized controlled trials (RCTs) with a total of 1,895 COVID-19 patients.

For the subpopulation of adult COVID-19 patients with pneumonia and low-flow oxygen therapy at the start of treatment, the overall consideration shows predominantly positive effects of Remdesivir compared to standard therapy. This includes a higher chance of survival and quicker recovery. Thomas Kaiser, Head of IQWIG's Drug Assessment Department, states that COVID-19 patients with pneumonia who only need low-flow oxygen therapy at the start of treatment benefit considerably from treatment with Remdesivir.

However, no added benefit was proven for adults with more severe COVID-19 disease and pneumonia who already had to be treated with high-flow oxygen or other non-invasive ventilation at the start of treatment. Usable data on the side effects of Remdesivir are lacking, but the available information does not suggest any negative effects to an extent that could call an added benefit into question.

It's important to note that the treatment of COVID-19 disease in the three studies included can only be transferred to the current care situation to a limited extent due to improvements in the treatment of hospitalized patients since the beginning of the pandemic.

The G-BA will conduct a commenting procedure and make a final decision on the extent of the added benefit of Remdesivir. More English-language information about the dossier assessment will be available soon. Interested parties can be informed when these documents are available by sending an email to [email protected].

Since July 2020, Remdesivir has been conditionally approved in Europe for the treatment of COVID-19 in adults and adolescents aged 12 and older with pneumonia who require supplemental oxygen but no invasive ventilation. Study data for adolescents with COVID-19 disease were not available, so an added benefit is not proven for this group.

The manufacturer involved in the development of Remdesivir for the treatment of COVID-19 in patients aged 12 years and older is Gilead Sciences. This development offers a glimmer of hope in the ongoing fight against the pandemic, particularly for those with moderate symptoms who can benefit significantly from the treatment.

Significant Extra Advantage Observed for Some COVID-19 Patients Treated with Remdesivir