VEKLURY

The Committee considers that the clinical benefit of VEKLURY (remdesivir) is:

• LOW in the treatment of COVID-19 in hospitalised patients aged 12 years and older with body weight at least 40 kg with pneumonia requiring low-flow supplemental oxygen;

Considering:

• the available clinical data limited to the results of 3 comparative studies conducted in hospitalised patients (Chinese study NCT04257656 stopped early, preliminary results of the American ACTT study, SIMPLE study without a control group) presenting numerous methodological limitations and conflicting results,
• preliminary results from the pivotal American ACTT study with the biggest population (n = 1,063 hospitalised patients with pneumonia, including 88.7% with a severe form requiring oxygen), which suggest an at best weak effect size of remdesivir versus placebo, in combination with the standard of care: 4-day reduction in the time to clinical recovery (11 days versus 15 days; HR=1.32 [1.12-1.55]), primary endpoint of debatable clinical relevance,
• and the absence of any demonstrated impact in this study on the reduction in mortality at D14 (7.1% in the remdesivir group versus 11.9% in the placebo group (HR = 0.70; 95% CI [0.47 to 1.04], NS, secondary endpoint), although the subgroup analyses suggest a positive effect on this endpoint only in the subgroup of patients receiving low-flow supplemental oxygen,
• the absence of mortality data at D28 in the ACTT study,
• the absence of data enabling a robust conclusion to be reached with respect to efficacy depending on the stage of the disease and the optimal treatment duration;
• the absence of a demonstrated impact of remdesivir in terms of the expected negative conversion of viral load;
• and despite the medical need to have access to effective and well-tolerated curative treatments for COVID-19 due to its severity, its contagiousness and its impact on healthcare organisation, particularly in intensive care units, as well as the absence of an available curative treatment;

On the basis of currently available data, the Committee considers that VEKLURY (remdesivir) provides no clinical added value (CAV V) for the treatment of COVID-19 in adults and adolescents (aged 12 years and older with body weight at least 40 kg) with pneumonia and receiving low-flow supplemental oxygen