With the press release shared by a US-based pharmaceutical company, all the eyes were turned to the drug with the active ingredient molnupiravir, which has a potential to be a candidate for the treatment of COVID-19.
In the release, it was shared that the rate of hospitalization and death of individuals was reduced by half in the molnupiravir group compared to those who took a placebo.
Molnupiravir had been administered within 5 days after the COVID-19 symptom onset in the clinical trials.
Let’s have a close eye on MOLNUPIRAVIR,which seems to be a new hope for the treatment of COVID-19:
The drug with the active ingredient of molnupiravir is also named as MK-4482 and EIDD-2801 in clinical studies.
The molecule targets viral polymerase, the enzyme necessary for the virus to make copies of itself.
By the way, the drug prevents the virus replicating itself with the added “error codes” to the coronavirus genes.
In other words,
As the virus genome is copied, this drug molecule enters instead of the cytidine nucleoside,
In other words, a “Trojan Horse” is introduced into the genetic structure of the virus.
As a result, this process negatively affects the genome replication of the virus.
A Different Mode of Action For Molnupiravir Compared to Vaccines:
Spike protein is the the target of all currently avaible COVID-19 vaccines.
Unlike vaccines, molnupiravir does not bind to spike protein.
It targets viral polymerase, an enzyme necessary for the virus to make copies of itself.
Since differences between variants are driven by spike protein, molnupiravir is expected to be equally effective against all variants due to the difference in its mechanism of action.
Molnupiravir Clinical Study Results:
Molnupiravir (MK-4482 or EIDD-2801) is an unlicensed therapeutic agent that potently inhibits the proliferation of SARS-CoV-2, which causes COVID-19.
Several pre-clinical studies have shown the drug’s efficacy in SARS-CoV-2, including prophylaxis (disease prevention), treatment, and prevention of transmission.
In addition, preclinical and clinical data support that molnupiravir is effective against the most common SARS-CoV-2 variants.
Phase IIa data have shown that molnupiravir can reduce the patient’s viral load.
According to the Phase IIa pre-print, virus isolation was found to be 1.9% in the 800 mg molnupiravir group compared to 16.7% in the placebo group on day 3, indicating that the results represent a statistically significant difference.
Inclusion criteria for the study are:
- Being older than 18 years of old
- Not being pregnant
- Not breastfeeding
- Those with mild or moderate COVID-19 infection
- And in additionto above, those with at least one additional condition that will increase the risk of COVID-19 disease
Obesity, advanced age (+60), diabetes mellitus, and heart disease were determined as the most common risk factors to worsen the COVID-19 disease state.
However, hospitalization due to COVID-19 was exclusion criteria in this study.
Patients from 170 sites in USA, Canada, Germany, UK, France, Russia, Spain, Italy, Argentina, Brazil, Chile, Colombia, Egypt, Guatemala, Israel, Japan, Mexico, Philippines, Poland, South Africa, Sweden, Taiwan, and Ukraine had been enrolled in this study.
Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent in Mild or Moderate COVID-19 Patients in the Phase 3 Study Interim Analysis:
In the interim analysis, 7.3% of patients receiving molnupiravir remained hospitalized for 29 days, compared with 14.1% of patients treated with placebo who were hospitalized or died.
So, molnupiravir halves the need for hospitalization or death!!!
During the 29 days of follow-up time, 8 deaths were observed in patients receiving placebo, while no deaths were reported in patients receiving molnupiravir.
Due to these positive results, the study was completed earlier than planned, following the recommendation of an independent data monitoring committee and discussions with the US Food and Drug Administration (FDA).
A drug’s safety is as important as its effectiveness:
The rate of any adverse event observed during the study was 35% in the molnupiravir arm and 40% in the placebo arm.
Similarly, the rate of drug-related adverse events were also comparable between the two groups. (Molnupiravir 12% – Placebo 11%)
The rate of discontinuation due to any side effect was 3.4% in the placebo group and 1.3% in the molnupiravir arm.
The company declared that they will apply for regulatory approval as soon as possible;
Molnupiravir will be the first oral anti-viral treatment agent for COVID-19.
Important Take Home Messages:
As mentioned at the beginning, all these developments are only a new hope for the treatment of COVID-19;
Although very valuable data is coming, there is no licensed treatment agent yet…
Since there is nothing more than good news and good will for now, it would be a deadly mistake to deny vaccination, or delaying it.
Even though the product will be ready to use, a therapeutic agent with 50% effectiveness can never replace a vaccine with over 90% effectiveness…
Do not match apples and pineapples!!!
Vaccines are a kind of health insurance for the upcoming potential infections ;
And they provide protection for the future before the disease picture appears.
To make a long story short, the matter is not to be sick & being protected under the shield of vaccines!!!
Since no vaccines may provide 100% protection, COVID-10 treatment should be considered for breakthrough infections…
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