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A single pill of the study drug molnupiravir taken twice daily for five days eliminated SARS-CoV-2 from the nasopharynx of 49 participants.
As a result, Carlos del Rio, MD, a senior professor of medicine at Emory University in Atlanta, Georgia, suggested a future in which a drug such as molnupiravir could be taken in the first few days of symptoms to treat serious illnesses. occurs, similar to Tamiflu for flu. .
“I think it’s critical,” he said. Medscape Medical News of the data. Emory University was involved in the trial of molnupiravir, but del Rio was not part of the team. “This drug provides the first antiviral oral drug that can then be used in an outpatient setting.”
Del Rio nevertheless said that it is too early to call this particular remedy the breakthrough that clinicians need to keep people out of the ICU.
‘It has the potential to be exercise-changing; it is not currently changing in practice. ‘
Wendy Painter, managing director, of Ridgeback Biotherapeutics, who presented the data at the virtual conference on retroviruses and opportunistic infections, agrees. Although the data are promising, we need to see if people get better as a result of illness, to determine the true value of the drug in clinical care.
“This is a Phase 3 goal that we need to prove,” she told Medscape Medical News.
Phase 2/3 efficacy and safety studies of the drug are now underway in patients admitted to the hospital and non-hospitalized.
In a brief preview of the data, Painter outlined what researchers know so far: preclinical studies suggest that molnupiravir is effective against a number of viruses, including coronaviruses and specifically SARS-CoV-2. This prevents a virus from repeating by causing catastrophic viral errors – essentially overloading the virus with replication and mutation until the virus burns itself out and cannot produce copies.
In this phase 2a, randomized, double-blind control trial, researchers recruited 202 adults treated in an outpatient setting with fever or other symptoms of a respiratory virus and they confirmed SARS-CoV-2 infection by day 4. Participants were randomly assigned to three different groups: 200 mg molnupiravir, 400 mg; or 800 mg. The 200 mg arm was linked one-to-one to a placebo-controlled group, and the other two groups had three participants in the active group for each control.
Participants took the pills five times twice a day, after which they were followed for a total of 28 days to see if they had any complications or side effects. On days 3, 5, 7, 14, and 28, researchers also took nasopharyngeal swabs for PCR tests, to sequence the virus, and to grow SARS-CoV-2 cultures to see if the virus present in able to infect others. .
The pills do not have to be in the fridge at any stage in the process, which alleviates the cold chain challenges that plague the vaccines.
“There is an urgent need for an antiviral agent that can be easily manufactured, transported, stored and administered against SARS-CoV-2,” Painter said.
Of the 202 people recruited, 182 had evaluations that could be evaluated, of which 78 showed infection at baseline. The results are based on laboratories of the 78 participants.
On day 3, 28% of the patients in the placebo arm had SARS-CoV-2 in their nasopharynx, compared with 20.4% of the patients who received any dose of molnupiravir. But on day 5, none of the participants who received the active drug had evidence of SARS-CoV-2 in their nasopharynx. By comparison, 24% of people in the placebo arm still have detectable viruses.
Halfway through the course of treatment, there was already a difference in the presence of infectious viruses. On day 3 of the 5-day course, 36.4% of participants in the 200 mg group had detectable virus in the nasopharynx, compared to 21% in the 400 mg group and only 12.5% in the 800 mg -group. And although the reduction in SARS-CoV-2 in the 200 mg and the 400 mg arms was noticeable, it was only statistically significant in the 800 mg arm.
In contrast, by the end of the five days, the infectious virus in the placebo groups ranged from 18.2% in the 200 mg placebo group to 30% in the 800 mg group. This points to the variability of the disease course of SARS-CoV-2.
“You just do not know” what infections will lead to serious illnesses, Painter said Medscape Medical News. “And don’t you want us to do it?”
Seven participants discontinued treatment, although only four experienced adverse events. Three of those stopped the trial due to adverse events. The study is still blinded, so it is unclear what the events were, but Painter said it is not expected to be related to the study medium.
The conclusion, according to Painter, was that people treated with molnupiravir had strongly different outcomes in laboratory measures during the study.
“On average ten days after the onset of the symptom, 24% of the placebo patients remained culture positive” for SARS-CoV-2, which means that not only was there a virus in the nasopharynx, but it could also recur, Painter. “In contrast, no infectious virus could be recovered on study day 5 in any patients treated with molnupiravir.”
Conference on Retroviruses and Opportunistic Infections 2021: Abstract SS777. Presented on March 6, 2021.
Heather Boerner is a scientific and medical reporter in Pittsburgh, PA, and can be found on Twitter at @HeatherBoerner. Her book, Positively Negative: Love, Sex, and Science’s Surprising Victory Over HIV, appeared in 2014.
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