Oral antiviral may halve COVID-19 hospitalisation risk, claims manufacturer

Interim results from a trial using data from 775 patients with mild-to-moderate COVID-19 show that no deaths were reported in those given molnupiravir, compared with eight deaths in those who were given a placebo.
The Merck Cherokee Plant, Riverside, United States

An investigational antiviral treatment may significantly reduce the risk of hospitalisation or death in at-risk non-hospitalised patients with COVID-19, according to a statement released by the pharmaceutical company, Merck.  

In what could become the first oral antiviral treatment for COVID-19, molnupiravir — which is being developed by Merck in collaboration with Ridgeback Biotherapeutics — may reduce the risk of hospitalisation or death from COVID-19 by around 50%.

In results taken from a planned interim analysis of a global, phase III, randomised controlled trial, 7.3% of patients who received molnupiravir were either hospitalised or had died by day 29 compared with 14.1% of placebo-treated patients.

The study, which has not been peer reviewed, involved 775 non-hospitalised adult patients with laboratory-confirmed mild-to-moderate COVID-19 and at least one risk factor associated with poor disease outcomes, such as obesity or heart disease.

The primary objective of the study was to evaluate the efficacy of molnupiravir compared with placebo as assessed by the percentage of participants who were hospitalised and/or had died from the time of randomisation through day 29.

Overall, no deaths were reported in patients who received molnupiravir, compared with eight deaths in the group that received the placebo. The incidence of any adverse events was comparable across the two groups.

A press release issued by Merck on 1 October 2021 stated that it planned to submit an application for an ‘Emergency use authorisation’ to the United States Food and Drug Administration “as soon as possible” based on the findings and also planned to submit marketing applications to other regulatory bodies worldwide.

Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD — a global, multicentre, randomised, double-blind, placebo-controlled Phase III study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. 

The MHRA could not confirm if it was considering approval of molnupiravir, for commercial reasons, but chief executive Dr June Raine said: “We are committed to providing safe, timely access to treatment for UK patients, and will continue to prioritise any COVID-19 evaluations. As with vaccines, COVID-19 treatments would only be authorised once satisfactory quality, safety and efficacy standards have been met.”

On 29 September 2021, The Pharmaceutical Journal revealed that NHS England had begun working with the government’s antivirals taskforce to scope out the deployment of oral antivirals to treat COVID-19 in the community.

A spokesperson for NHS England told The Pharmaceutical Journal that Keith Ridge, chief pharmaceutical officer for England, has taken on the role of senior responsible officer for oral antiviral deployment and is currently working with the taskforce to decide on the next steps.

The deployment will be informed by evidence from clinical trials of antiviral treatment in the UK and from overseas, some of which have shown promising results on shortening COVID-19 infection time.

READ MORE: NHS prepares for antiviral deployment to treat COVID-19

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Citation
The Pharmaceutical Journal, PJ, October 2021, Vol 307, No 7954;307(7954)::DOI:10.1211/PJ.2021.1.108151