New Oral Pharmaceutical Agents For Mild to Moderate COVID-19
As it is becoming more clear vaccines do not stop the spread of COVID-19, but may be instrumental in shortening the length of illness, symptoms, and decrease hospitalizations; two large pharmaceutical companies, Merck and Pfizer, have come forward with press releases regarding two new investigational oral antiviral agents for the possible prevention and treatment of mild to moderate COVID-19, referring to them as “game changers.”
- Clinical trials of these two agents were stopped early due to the “overwhelming efficacy” and were submitted for emergency use authorization (EUA).
- Both pharmaceuticals aim to decrease symptoms and hospitalizations from COVID -19 in mild to moderate cases. Their mechanisms of action are different.
How do these pharmaceuticals work? How are they different from each other? Are they safe? Are they “game changers”? How do they compare with known research, efficacy, and side effects of Ivermectin?
As many are exceptionally optimistic and excited about these pharmaceuticals, what is the available evidence objectively and critically, ask key questions as the FDA does the same as they will soon
Paxlovid (PF-07321332; ritonavir)
Pfizer’s pharmaceutical is for use in non-hospitalized high-risk adults with mild to moderate Covid-19 symptoms or exposure. Paxlovid is given at symptom onset or known exposure and continued twice daily for 5 days.1
It is a combination of PF-07321332 and ritonavir, an antiretroviral protease inhibitor used in HIV/AIDS 1,2, Protease inhibitors are pharmaceuticals that bind and block enzyme activity necessary for replication of the virus5,6.
Phase 2/3 trials have not yet been made available. The following data was from Pfizer’s interim analysis press release7:
- 89% reduction in hospitalization risk compared to placebo when given within 3 days of symptom onset
- Through day 28 of study, no deaths reported in treatment group compared to 10 deaths in placebo group
Is Paxlovid Safe?
Researchers determined this pharmaceutical has a “high safety margin,” is well tolerated with no observed adverse effects when administered to rats and monkeys.8
Current information on the safety profile in humans from Pfizer’s press release, states adverse events were ‘mild in nature and similar between treatment and placebo groups, 19% and 21% respectively’. There were fewer serious adverse events in the treatment group.9. It is unknown how long subjects were followed for adverse events.
Merck’s pharmaceutical blocks replication of the virus by changing its RNA genetic code. It is given within 5 days of symptom onset and continued twice daily for 5 days.
The main mechanism of this agent is through creating genetic mutations. By increasing many mutations within the viral RNA of SARS-CoV-2, replication of the virus is impaired. As the mutation rate exceeds a tolerable rate, it results in virus extinction.10,11
Phase 3 clinical trial data has not been made accessible. The following data was announced in a press release from Merck from their interim analysis12:
- Hospitalizations were reduced by 50% and entirely prevented death
- 3% of patients who received the pharmaceutical were hospitalized through day 29 in comparison with 14.1% in the placebo group
- 40% of subjects showed efficacy against viral variants
Is Molnupiravir Safe?
Merck states molnupiravir is well tolerated with the incidence of any adverse reaction being similar between treatment group and placebo, 35% and 40% respectively. Data on adverse events has not been made accessible. Pharmaceutical-related adverse effects were of similar representation at 12% and 11% respectively.12
Is it possible for molnupiravir to insert itself into and alter human DNA? Could it cause birth defects or affect RNA replication required for fetus development? These are questions being posed as this pharmaceutical comes to market because of its mechanism of action. The answers are not available at this time.
Exceptionally safe and inexpensive, ivermectin has a clean safety profile as demonstrated in its 34 years of use in humans and over 3.7 billion doses safely administered world-wide.17,18
Meta-analysis of 42 worldwide clinical studies including 15,000 patients as of February 27, 2021, indicated ivermectin’s effectiveness in treatment and prevention of COVID-19. “Since it is a meta-analysis based on 42 test results, it is estimated that the probability of this comprehensive judgment being a mistake is as low as 1 in 4 trillion.”19
Outcomes of 27 clinical trials totaling 6,612 patients demonstrated the effectiveness of ivermectin in COVID-19 exposed patients by reducing need for hospitalization, mortality and time to viral clearance.19 To date, 66 trials have been conducted for use of ivermectin in COVID-19 totaling 49,372 patients. Of these, 31 were randomized controlled trials revealing 85% effectiveness used as prophylaxis and 67% if used as early treatment.20
There were no severe adverse events reported in the aforementioned studies.19 Due to decades of clinical use, it exhibits a desirable long term safety profile.
- Important questions remain regarding the real-world efficacy and nature of adverse events of the two new oral agents, paxlovid and molnupiravir.
- Current data we have for these new pharmaceuticals is from press releases from both pharmaceutical companies. We will have to wait for the actual data from the Phase 3 trials before a final assessment can be made.
- Considering its long-term use, dozens of dedicated COVID-19 studies involving thousands of patients, over 3.5 billion doses administered, and a clean long-term safety profile of ivermectin, one might wonder if a true game changer has been right before us this entire time. Review the evidence and decide for yourself.
Reprinted with permission from Regenerative Medicine Center.