COVIDPILLSFOR $705? WHYORAL ANTIVIRALS ARE ALL THE RAGE
Three Covid-19 pills race to the finish line: What we know, and what we don’t
Covid pills are all the rage right now, as several oral antiviral medications specifically developed against SARS-CoV-2 are about to hit the finish line. Three are in advanced stages of clinical trials, phases II/III, of which Merck’s molnupiravir is the front-runner.
The good news: People newly infected with Covid-19 might soon have access to what essentially is a pill for SARSCoV-2. Trials are promising. If, or when, approved, they could further boost the world’s fight against the pandemic, which has so far left 5 million dead.
Merck has announced molnupiravir cuts the risk of hospitalisation and death from the virus by 50 per cent, based on the initial data readout. Here’s the lowdown on the Covid pills:
What are the three Covid pills on trial?
The three candidate antivirals dashing towards the finish line are: molnupiravir, ritonavir, and AT-527.
They’re all oral medications. Among the three, the Merckdeveloped molnuvirapir is leading the pack, with initial data analysis of a trial involving 1,850 participants showing it cuts hospitalisations and deaths by half. All three are expected to complete clinical trials by November.
What are the end points of the Covid pill trials?
Molnupiravir: The study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalised and/or die through Day 29.
Ritonavir: The study seeks to determine whether PF-07321332/ ritonavir, developed by Pfizer, is safe and effective for the treatment of adults who are ill with Covid-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Study visits will be conducted at a participant’s home or another non-clinic location if available. The total study duration is up to 24 weeks.
AT-527: This study evaluates the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalised adult and adolescent participants with mild to moderate coronavirus disease 2019 (Covid-19) in the outpatient setting.
Level of effectiveness
No patients given molnupiravir died during trials.
Merck announced that 7.3 per cent of patients who received molnupiravir (28/385) were hospitalised through Day 29 of the study.
On the other hand, 14.1 per cent of patients given placebo (53/377) were either hospitalised or died as a result of Covid-19 through Day 29. That’s a 50 per cent efficacy, based on the initial data analysis.
Additionally, no patients that were given molnupiravir died, whereas eight of those given the placebo did. Merck said it was already seeking emergency-use authorisation in the United States.
What are the advantages of having Covid-19 pills?
The pills pose a number of important advantages.
First: In the early stages of the infection, the pill can be already taken at home (if available). So people who are newlyinfected with the virus could use it outside of hospitals. This could greatly help avoid health care facilities from being overwhelmed.
Second: They’re specific to the Covid virus. Until now, hospitals have been using a repurposed drug remdesivir — developed to treat Ebola — to curb the damage done by a Covid infection, but its effectiveness is limited. On the other hand, monoclonal antibodies also can attack the virus in early infection, but they’re in short supply, not easy to administer and quite pricey. They have to be given intravenously, which makes administration even more expensive.
Third: Ease of logistics and administration. The new pills, if proven safe and effective, could be the equivalent of antibiotics pills or a flu tablet that could keep people out of the hospital, curb complications, say experts.
Will vaccines become unnecessary if, and when the Covid pills are roll-out?
If regulators deem the trial data to be acceptable based on their proof of work in reducing Covid hospitalisations and deaths, the new generation of oral medications could be a game changer. The antiviral pill could offer an easy-to-swallow early-intervention tool against Covid, preventing the bulk of cases from progressing further.
That would significantly alter the fight against coronavirus. Meanwhile, approved Covid vaccines are already proven safe and effective and had been rolled out in the hundreds of millions across the world, but there’s not enough of it for the entire planet.
As the global death toll climbed past 5 million, Dr Anthony S. Fauci, adviser on the pandemic to US President Joe Biden, warned that people in his country should not wait to be jabbed just because they believe they can take the pill. While the new medicine may decrease a person’s risk, Fauci said the best way to be protected is by avoiding infection, though inoculation.
Who are the drugs makers behind them? Merck, known as MSD outside the United States and Canada, is the developer of molnupiravir. Pfizer, for its part started the early-stage clinical trial for ritonavir drug. Roche collaborated with Atea Pharmaceuticals to develop AT-527 as an oral treatment for Covid-19 patients.
Why does it take time for antiviral drugs to develop?
One reason it takes time for antiviral drugs to be developed is because they’re so specific to the viruses causing disease. Merck conducted the molnupiravir clinical trials jointly with Ridgeback Biotherapeutics (a biotech company based in Miami Florida). It has also conducted trials with Indian pharmaceutical companies.
However, work on the broadspectrum antiviral started more than 10 years ago. Any drug development effort is a time and money-intensive endeavour. Merck, for example, also tried to develop Covid vaccine, which the company abandoned in January after it failed to generate desired immune responses. Merck decided to focus on the pills instead.
How much is the cost of each molnupiravir course?
About $705 per course, based on an the $1.2 billion orders placed by the US government for 1.7 million courses of the pill from Merck. The orders were “advanced” as the clinical trials had not been completed yet, and is contingent on approval by drug regulators. US health authorities plan to give the pills for free.
How many pills will be prescribed for each course?
Merck said patients will take four capsules twice a day for five days — 40 pills over the course of the treatment. The regimen is familiar to anyone who has taken an antibiotic.
What about side effects?
Merck did not report any serious side effects among volunteers in its clinical trial. Any side effects, which typically involve mild complaints like headaches, can be hard to distinguish from feeling ill from Covid, researchers said.
Isn’t the $705 price tag per course too high?
Whether that will be the actual cost, remains unclear at this point. Merck have committed to “plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic,” said Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine.
[Merck have committed to] plans to implement a tiered pricing approach based on World Bank country income criteria …”
Prof Stephen Evans | London School of Hygiene & Tropical Medicine
No patients that were given molnupiravir died. Merck said it was already seeking emergency-use authorisation in the United States.
What’s the price of the generics version of the pill?
Nothing has been announced yet. On June 29, 2021, Reuters reported that five Indian generic drugmakers — including Cipla, Dr Reddy’s Laboratories, Sun Pharmaceutical Industries, Torrent Pharmaceuticals and Emcure Pharmaceuticals — have partnered with Merck to expand production of molnupiravir. These are “nonexclusive voluntary licensing agreements”.
Will the Covid pills be available in other countries?
The deal with Indian drugmakers gave them licence to make and supply molnupiravir to India and more than 100 low- and middle-income countries following approvals or emergency authorisation by local regulatory agencies, Merck said in late April.