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A single pill of the investigational drug molnupiravir taken twice daily for 5 days removed SARS-CoV-2 from the nasopharynx of 49 participants.
This led Carlos del Rio, MD, a distinguished professor of medicine at Emory University in Atlanta, Georgia, to suggest a future in which a drug such as molnupiravir could be taken in the early days of symptoms to prevent serious illness. to Tamiflu for the flu.
“I think it’s very important,” he said Medscape Medical News of the data. Emory University participated in the trial against molnupiravir, but del Rio was not part of that team. “This drug provides the first oral antiviral drug that could then be used in an outpatient setting.”
Still, Del Rio said it’s too early to name this particular drug that doctors needed to keep people out of the ICU.
“You have the potential change practice; at the moment it does not change practice “.
Wendy Painter, MD, of Ridgeback Biotherapeutics, who presented the data at the Virtual Conference on Retroviruses and Opportunistic Infections, agreed. While the data is promising, “we will have to see if people improve the actual disease” to assess the real value of the drug in clinical care.
“This is a phase 3 goal that we will have to demonstrate,” he told Medscape Medical News.
Phase 2/3 efficacy and safety studies are now being conducted in hospitalized and outpatients.
In a brief pre-recorded presentation of the data, Painter set out what researchers know so far: Preclinical studies suggest that molnupiravir is effective against several viruses, including coronaviruses and specifically SARS-CoV-2. It prevents a virus from reproducing by causing a viral error catastrophe, essentially overloading the virus with replication and mutation until the virus burns and cannot produce replicable copies.
In this 2nd phase, a double-blind randomized trial, the researchers recruited 202 adults who were treated in an outpatient setting with fever or other symptoms of a respiratory virus and confirmed SARS-CoV-2 infection on day 4. participants were randomly assigned to three different groups: 200 mg molnupiravir, 400 mg; or 800 mg. The 200 mg arm was individually combined with a placebo-controlled group and the other two groups had three participants in the active group for each control.
Participants took the pills twice a day for 5 days, and then followed them for a total of 28 days to control for complications or adverse events. On days 3, 5, 7, 14, and 28, the researchers also took nasopharyngeal swabs for PCR testing, for sequencing the virus, and for culturing SARS-CoV-2 cultures to see if the virus present is capable of infecting. other people. .
It should be noted that the pills should not be refrigerated at any point in the process, to alleviate the challenges of the cold chain that vaccines have suffered.
“There is an urgent need for an antiviral drug that is easy to produce, transport, store, and administer against SARS-CoV-2,” Painter said.
Of the 202 people recruited, 182 had swabs that could be evaluated, of which 78 had infection at first. The results are based on laboratories of these 78 participants.
At day 3, 28% of placebo arm patients had SARS-CoV-2 in the nasopharynx, compared with 20.4% of patients receiving some dose of molnupiravir. But on day 5, none of the participants receiving the active drug had tests for SARS-CoV-2 in the nasopharynx. In comparison, 24% of people in the placebo arm still had detectable viruses.
By mid-course of treatment, differences in the presence of infectious viruses were already evident. On day 3 of the 5-day course, 36.4% of participants in the 200 mg group had detectable nasopharyngeal virus, compared with 21% in the 400 mg group and only 12.5% in the 800 mg group. mg. And although the reduction in SARS-CoV-2 was noticeable in the 200 mg and 400 mg arms, it was only statistically significant in the 800 mg arm.
In contrast, at the end of the 5 days in the placebo groups, the infectious virus ranged from 18.2% in the 200 mg placebo group to 30% in the 800 mg group. This points to the variability in the course of SARS-CoV-2 disease.
Painter said he “just doesn’t know” what infections will cause serious illness Medscape Medical News. “And you wouldn’t want us to do that?”
Seven participants discontinued treatment, although only four experienced adverse events. Three of these suspended the trial due to adverse events. The study remains blinded, so it is unclear what those events were, but Painter said they were not thought to be related to the study drug.
The conclusion, Painter said, was that people treated with molnupiravir had completely different results in laboratory measurements during the study.
“An average of 10 days after the onset of symptoms, 24% of placebo patients remained positive in the culture” of SARS-CoV-2, i.e., not only was there a virus in the nasopharynx, but which was able to replicate itself, Painter said. “In contrast, no infectious viruses could be recovered on day 5 of the study in any patients treated with molnupiravir.”
Conference on Retroviruses and Opportunistic Infections 2021: Abstract SS777. Filed March 6, 2021.
Heather Boerner is a scientific and medical reporter based in Pittsburgh, Pennsylvania and can be found on Twitter at @HeatherBoerner. Her book, Positively Negative: Love, Sex, and Science’s Surprising Victory over HIV, came out in 2014.
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