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Gilead Sciences said it was “disappointed” with the World Health Organisation (WHO) guideline that advised against the use of antiviral remdesivir in managing hospitalised Covid-19 patients.
The WHO Guideline Development Group (GDG) panel of international experts said remdesivir was not suggested for hospitalised patients, regardless of how severely ill they were. “There was no evidence that the drug improved survival or the need for ventilation”, the WHO-panel said in The BMJ .
The advice echoed a WHO statement from October where remdesivir was among four drugs said to have little impact on mortality. The statement was based on interim data from the WHO’s Solidarity Therapeutics Trial.
However, remdesivir was the first Covid-19 treatment drug approved by the USFDA late last month. On Friday, the US regulator also gave an emergency use authorisation for baricitinib and remdesivir for the treatment of suspected or laboratory confirmed Covid-19 in hospitalised adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation etc.
Clinical benefits
Countering WHO’s statement, Gilead said, “Veklury (remdesivir) is recognised as a standard of care for treating hospitalised patients with Covid-19 in guidelines from numerous credible national organisations, including the US National Institutes of Health and Infectious Diseases Society of America, Japan, UK and Germany. These recommendations are based on the robust evidence from multiple randomised, controlled studies published in peer-reviewed journals that demonstrate the clinical benefits of Veklury, such as significantly faster recovery, which can free up limited hospital resources.”
Further, it added, “We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19 in approximately 50 countries.”
Indian companies, including Hetero, Cipla, Jubilant and Mylan, for example, have an alliance to make and sell the injectable product at reduced prices in certain markets.
Some doctors and industry-representatives pointed out that the WHO guideline was sending mixed signals on a drug that was given in moderate to severe cases and worked in the first five to nine when the virus was actively replicating.
Dharmesh Shah, Chairman and Managing Director of BDR Pharmaceuticals, told BusinessLine that he had seen patients benefiting from the drug. It improved several patients’ condition, he said, at a time when there was no other drug available. BDR Pharma makes the drug for Cipla.
The WHO-panel also supported continued enrolment into trials evaluating remdesivir, especially to provide higher certainty of evidence for specific groups of patients, the journal said.
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