Highly effective new antiviral

Protectors from hospitalization, the story so far

Oral meds than can be prescribed from home with onset of symptoms

Molnupiravir, approved by MHRA

https://www.gov.uk/government/news/first-oral-antiviral-for-covid-19-lagevrio-molnupiravir-approved-by-mhra

The antiviral was found to be safe and effective following a stringent review of the available evidence.

https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/

Public domain data, Merck press release

$ 700 per 5-day course

Under 50% reduction in deuteriation

Effect of early treatment with fluvoxamine

Together Trial group

Public domain data, Peer reviewed trial in the Lancet

https://clinicaltrials.gov/ct2/show/NCT04727424

https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00448-4/fulltext

Adults with a risk factor

$4 for a 10-day course

32% protection against hospitalization

32% protection against death

Fluvoxamine is approved by the Food and Drug Administration as an antidepressant

Doctors already can prescribe it off-label — using their clinical judgment

https://www.washingtonpost.com/science/2021/10/28/antidepressant-fluvoxamine-coronavirus-lancet/?

https://bnf.nice.org.uk/drug/fluvoxamine-maleate.html

https://www.togethertrial.com

Ivermectin, Together trial results not yet released


PFIZER’S NOVEL COVID-19 ORAL ANTIVIRAL TREATMENT CANDIDATE REDUCED RISK OF HOSPITALIZATION OR DEATH BY 89% IN INTERIM ANALYSIS OF PHASE 2/3 EPIC-HR STUDY

https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate

Public domain data, Pfizer press release

PAXLOVID™ (PF-07321332; ritonavir)

Found to reduce the risk of hospitalization or death by 89%

Compared to placebo in non-hospitalized high-risk adults with COVID-19

Through Day 28

PAXLOVID group

No deaths

Placebo group

10 deaths

Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible

Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients)

Randomized, double-blind study of non-hospitalized adult patients with COVID-19,

who are at high risk of progressing to severe illness

Scheduled interim analysis

89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo

In patients treated within 3 days of symptom onset

PAXLOVID group

0.8% of patients hospitalized

3/389 hospitalized with no deaths

Placebo group

7.0% of patients hospitalized or died

27/385 hospitalized

with 7 subsequent deaths

(p less than 0.0001) 1 in 10,000 chance

In patients treated within 5 days of symptom onset

PAXLOVID group

1.0% of patients hospitalized

6/607 hospitalized with no deaths

Placebo group

6. 7% of patients hospitalized or died

41/612 hospitalized,

with 10 subsequent deaths

p less than 0.0001

At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), Pfizer will cease further enrollment into the study

due to the overwhelming efficacy demonstrated in these results

About the Phase 2/3 EPIC-HR Study Interim Analysis

1,219 adults enrolled out of 3,000 planned

North and South America, Europe, Africa, and Asia

Enrolled individuals had a laboratory-confirmed diagnosis of SARS-CoV-2 infection

Mild to moderate symptoms

At least one characteristic or underlying medical condition

Randomized (1:1) to receive PAXLOVID™ or placebo orally every 12 hours for five days

About the Phase 2/3 EPIC-HR Study Safety Data

Safety data, n = 1881

Treatment-emergent adverse events

PAXLOVID™group

19%

Placebo group

21%

Most of which were mild in intensity

Fewer serious adverse events

PAXLOVID™group

1.7%

Placebo group

6.6%

Discontinuation of study drug due to adverse events

PAXLOVID™group

2.1%

Placebo group

4.1%

Pharmacology

Specifically designed SARS-CoV-2-3CL protease inhibitor,

an enzyme that the coronavirus needs to replicate

Co-administration with a low dose of ritonavir helps slow the metabolism of PF-07321332

PF-07321332 inhibits viral replication at a stage known as proteolysis,

which occurs before viral RNA replication

In preclinical studies, PF-07321332 did not demonstrate evidence of mutagenic DNA interactions.

EPIC-SR includes a cohort of vaccinated patients who have an acute breakthrough symptomatic COVID-19 infection and who have risk factors for severe illness.