Highlights:
- WHO conducted global trials on some COVID-19 drugs and the results were shocking
- Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens have almost no effect on COVID-19 patients
- Gilead Sciences Inc’s study showed the drug was effective against COVID-19
The interim results from the solidarity trials from the World Health Organisation (WHO) showed that the Gilead Sciences Inc’s Remdesivir showed little or no effect for COVID-19 patients who are hospitalised, a result which was significantly different from the positive results shown by Gilead’s own trial.
As a matter of fact, a mega trial was conducted which also studied the effect of Hydroxychloroquine, a combination of HIV drugs Lopinavir and Ritonavir, as well as a combination of Lopinavir and Interferon, but showed that none of the drugs actually showed any effect, according to the study, which is yet to be peer-reviewed.
The researchers associated with this global trial said, “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,” as per a pre-print of the trial results.
Though the repurposed anti-Malaria drug, Hydroxychloroquine and Lopinavir-Ritonavir combo were shown to be ineffective in the 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 the drug significantly reduced the time to recovery in adults who were hospitalized with COVID-19 and had evidence of lower the 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.
On Friday, Gilead had said, “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).”
In the statement, Gilead added, “ 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,”.
The trial which was conducted by the World Health Organisation was an open-label trial in which 11,266 adults from 30 were randomized, with 2,750 were allocated remdesivir, 954 were given hydroxychloroquine, 1,411 were given lopinavir, 651 were given interferon and lopinavir, 1,412 were only given Interferon, and 4,088 no study drug.
Meanwhile, 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.
In August, Gilead submitted a new drug application for approval to the US Food and Drug Administration for the treatment of patients with COVID-19.
Remdesivir, which Gilead sells under the brand Veklury, is currently available in the US and some other countries where it is used only under an emergency use authorization (EUA) for treatment of hospitalized patients with severe Coronavirus.
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 its drug remdesivir.
Under the deal, the Indian companies manufacture and sell generic versions of remdesivir without the need to pay royalty during the pandemic.
