New Delhi: US pharmaceutical company Gilead Sciences has raised concerns over the data released by World Health Organization’s Solidarity trial, which concluded the company’s drug remdesivir showed negligible benefits on Covid-19 patients.
The interim findings of the multi-country trial revealed that none of the four repurposed drugs that it examined — remdesivir, hydroxychloroquine (HCQ), lopinavir and interferon — have any benefits on Covid patients.
Gilead Sciences issued a statement in response to these findings Thursday, saying: “We are concerned that the data from this open label global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”
It added: “The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury (remdesivir).”
Remdesivir is sold by the American drug company and is marketed as Veklury. It is also a part of India’s current clinical management protocol for Covid.
Solidarity trial vs US study
Gilead Sciences, in its statement, recognised that the Solidarity trial is a multi-centre, open-label global trial that provided early access to Veklury, among other Covid-19 treatments under investigation, to patients around the world.
However, the drug company alleged that due to the trial design, generating conclusive findings from the study could be difficult.
The trial, it said, “prioritized broad access, resulting in significant heterogeneity in trial adoption, implementation, controls and patient populations and consequently, it is unclear if any conclusive findings can be drawn from the study results”.
The company also supported continuing the use of remdesivir in Covid patients based on the results from other smaller trials where the benefits of the drug were demonstrated.
In particular, the company highlighted the results from the National Institute for Allergy and Infectious Diseases (NIAID)’s ACTT-1 trial, which was conducted primarily in the US and Europe and published in October this year. The trial concluded that Covid therapy using Veklury resulted in clinically meaningful improvements in hospitalised patients.
“These data were peer-reviewed and published in the New England Journal of Medicine (NEJM) and have supported Veklury’s inclusion in multiple treatment guidelines,” the statement read.
Gilead’s charges ‘easily refutable’
Dr K.S. Reddy, president of the Public Health Foundation of India and member of the executive group of the International Steering Committee of the Solidarity trial, however, said the concerns highlighted by the company are “easily refutable”.
“They have highlighted ‘heterogeneity’ of patients in the trial design as one of the factors leading to inconsistent results. But in reality, the drug has to be applied to ‘heterogeneous’ patients and it has to be universally applicable, or atleast to the majority of the patients. It cannot be tested on a homogenous set of patients,” he told ThePrint.
He added that the important thing to note “is whether the intervention and control groups were comparable in many features at baseline”.
About the other smaller trials that Gilead Sciences cited in its statement, Reddy said, “The large Solidarity trial provided for much better inter-group similarity than the smaller trial in the baseline characteristics and also provides greater assurance of a match even in unknown factors that may influence the outcome.”
According to him, the NIAID’s ACTT-1 trial “had more unintended bias as it was a small trial with just 1,000 people randomised”. It is non-comparable to WHO’s trial where the remdesivir arm has more than 5,000 patients, he said.
“Also, the Solidarity trial focused on deaths since the beginning whereas ACTT-1 changed its objective mid way and changed its priority from noting deaths to time-to-recover. The believable trial is one where large enough numbers are randomised properly with a greater the balance between treatment group and comparison group,” Reddy added.