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WHO trial results show remdesivir has little or no effect for covid-19 patients
- Remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little or no effect on hospitalized covid-19 patients, according to a pre-print of the results of the global trial
Interim results from the World Health Organization’s solidarity trial showed that Gilead Sciences Inc’s remdesivir showed little or no effect for covid-19 patients, a result which was significantly different from the positive results shown by Gilead’s own trial.
In fact, the mega trial, which also studied the effect of hydroxychloroquine, a combination of HIV drugs lopinavir and ritonavir, as well as a combination of lopinavir and interferon, showed that none of the drugs actually showed any effect, according to the study, which is yet to be peer-reviewed.
“These remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little or no effect on hospitalized covid-19 patients, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” the researchers in the global trial concluded, as per a pre-print of the trial results.
While the repurposed anti-malarial drug hydroxychloroquine and lopinavir-ritonavir combo have been shown to be ineffective in earlier trials, the results for remdesivir are surprising, especially as Gilead’s and US’ National Institute of Allergy and Infectious Diseases (NIAID) trials have shown that remdesivir significantly reduced the time to recovery in adults who were hospitalized with covid-19 and had evidence of lower respiratory tract infection.
The final results of NIAID’s Adaptive Covid-19 Treatment Trial-1 (ACTT-1) were also published in The New England Journal of Medicine earlier this month.
“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). 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,” Gilead said in a statement on Friday.
The WHO trial was an open-label trial, in which 11,266 adults from 30 were randomized, with 2,750 allocated remdesivir, 954 hydroxychloroquine, 1,411 lopinavir, 651 interferon and lopinavir, 1,412 only Interferon, and 4,088 no study drug.
On the other hand, the ACTT-1 was randomized, double-blind, and placebo-controlled clinical trial, which is considered the gold standard for clinical trials of drugs.
However, the WHO trial results will be significant as it could potentially put a major hurdle for Gilead in obtaining a full approval for remdesivir for treatment of covid-19.
Gilead had in August submitted a new drug application to the US Food and Drug Administration for getting an approval for the treatment of patients with covid-19. Remdesivir, which Gilead sells under the brand Veklury, is currently available in the US and other countries under an emergency use authorization (EUA) for treatment of hospitalized patients with severe covid-19.
The WHO trial results could potentially also be significant for seven Indian drugmakers including Cipla, Hetero Drugs and Zydus Cadila, with which Gilead is in a voluntary licensing pact for remdesivir. Under the pact, the Indian companies manufacture and sell generic versions of remdesivir and sell it without the need to pay royalty during the pandemic.
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Business NewsScienceHealthWHO trial results show remdesivir has little or no effect for covid-19 patients
First Published:16 Oct 2020, 12:07 PM IST
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