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A single pill of the investigational drug molnupiravir administered twice daily for 5 days eliminated SARS-CoV-2 from the nasopharynx of 49 participants.
This prompted Carlos del Rio, MD, a distinguished professor of medicine at Emory University in Atlanta, Georgia, to suggest a future in which a drug like molnupiravir could be taken in the first few days of symptoms to prevent severe, similar illnesses. with Tamiflu for the flu. .
“I think it’s extremely important,” he said Medscape medical news of data. Emory University was involved in the molnupiravir trial, 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.
However, del Rio said it is too early to call this particular drug, doctors who need breakthroughs to keep people out of the ICU.
“It has potential to change the practice; the practice is not changing at the moment “.
Wendy Painter, MD, of Ridgeback Biotherapeutics, who presented the data at the Virtual Conference on Retroviruses and Opportunistic Infections, agreed. While the data are promising, “We’ll have to see if people get better from the real disease” to assess the real value of the drug in clinical care.
“This is a phase 3 goal that we will have to prove,” she told Medscape Medical News.
Studies on the efficacy and safety of phase 2/3 of the drug are ongoing in hospitalized and non-hospitalized patients.
In a brief pre-recorded presentation of the data, Painter presented what the researchers know so far: preclinical studies suggest that molnupiravir is effective against a number of viruses, including coronaviruses and specifically SARS-CoV-2. It prevents the replication of a virus by inducing a catastrophe of viral error – essentially overloading the virus with replication and mutation until the virus burns itself and cannot produce replicable copies.
In this phase 2a, randomized, double-blind study, the researchers recruited 202 adults who were treated on an outpatient basis with fever or other symptoms of a respiratory virus and 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 associated one-on-one 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, then were followed for a total of 28 days to monitor for complications or adverse events. On days 3, 5, 7, 14, and 28, the researchers took nasopharyngeal swabs for PCR testing, to sequence the virus, and to culture SARS-CoV-2 to see if the virus present was actually capable of infecting others. .
In particular, the pills should not be refrigerated at any point in the process, mitigating the cold chain challenges that have affected the vaccines.
“There is an urgent need for a lightweight antiviral drug to be produced, transported, stored and administered against SARS-CoV-2,” Painter said.
Of the 202 people recruited, 182 had tampons that could be evaluated, of which 78 had an infection at baseline. The results are based on laboratories of the 78 participants.
On day 3, 28% of patients in the placebo arm had SARS-CoV-2 in the nasopharynx, compared with 20.4% of patients receiving any dose of molnupiravir. But by day 5, none of the participants who received the active drug had evidence of SARS-CoV-2 in the nasopharynx. In comparison, 24% of people in the placebo arm still had a detectable virus.
Halfway through the course of treatment, the differences in the presence of the infectious virus were already evident. On day 3 of the 5-day course, 36.4% of participants in the 200 mg group had detectable virus in the nasopharynx, compared with 21% in the 400 mg group and only 12.5% in the 800 mg group. And, although the reduction in SARS-CoV-2 was visible in the 200 mg and 400 mg arms, it was only statistically significant in the 800 mg arm.
In contrast, by 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 underscores the variability in the course of SARS-CoV-2 disease.
“You just don’t know what infections will lead to serious illness,” Painter said Medscape medical news. “And you don’t want us to do it?”
Seven participants discontinued treatment, although only four had adverse events. Three of them discontinued the study due to adverse events. The study is still blind, so it is not clear what those events were, but Painter said it was not thought to be related to the drug being studied.
The conclusion, Painter said, was that people treated with molnupiravir had very different results in laboratory measures during the study.
“On average, 10 days after the onset of symptoms, 24% of placebo patients remained positive in culture” for SARS-CoV-2 – meaning that there was not only a virus in the nasopharynx, but it was able to replicate , said Painter. In contrast, no infectious virus could be recovered on study day 5 in any patient 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 based in Pittsburgh, PA and can be found on Twitter at @HeatherBoerner. Her book, Positively Negative: Love, Sex, and Science’s Surprising Victory over HIV, was published in 2014.
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