Movfor

As Molnupiravir and Paxlovid, two oral COVID-19 drugs, have been approved in many countries around the world, thanks to generic drug agreements, pharmaceutical companies in India and other countries have recently launched cheap generic drugs.

Indications

Movfor is indicated for the treatment of adult patients with mild to moderate coronavirus disease 2019 (COVID-19) who have a positive SARS-COV-2 diagnostic test and at least one risk factor for progression to severe disease.

Dosage

Adults

The recommended dose of Movfor is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days.

The safety and effectiveness of molnupiravir when administered for more than 5 days has not been established.

Lagevrio should be taken as soon as possible after diagnosis of COVID-19 or within 5 days of the onset of symptoms.

Missed dose

If a patient misses a dose of Lagevrio within 10 hours of the usual dose, the patient should take it as soon as possible and then resume their normal dosing schedule. If a patient misses a dose by more than 10 hours, the patient should not take the missed dose but should take the next dose at the regularly scheduled time. Patients should not double their dose to make up for a missed dose.

Special Populations

Geriatrics

There is no need to adjust the dose of Lagevrio based on age.

Renal Impairment

No dose adjustment is required in patients with renal impairment.

Hepatic Impairment

No dose adjustment is required in patients with hepatic impairment.

Pediatric population

The safety and effectiveness of Movfor in patients under 18 years of age have not been established. No data available.

Dosage

For oral administration.

Movfor 200mg capsules can be taken with or without food.

The capsule should be swallowed whole with plenty of liquid (such as a glass of water). Do not open, crush or chew this capsule.

Strengths

Capsules, 200mg

Adverse Reactions

A Phase 3 trial studied the use of molnupiravir in subjects with mild to moderate COVID-19 (n =386), in its interim analysis, the most common adverse reactions (≥1% of subjects) during treatment and within 14 days after the last dose were diarrhea (3%), nausea (2%), dizziness (1%), and headache (1%), all of which were grade 1 (mild) or 2 (moderate).

Contraindications

Allergy to the active substance of this medicine or any excipients.

Storage

This medicine does not require any special storage conditions. Keep in original packaging.

Mechanism of action

Mechanism of action:

Molnupiravir is a prodrug that is metabolized into the ribonucleoside analog N-hydroxycytidine (NHC). It is distributed in cells and is phosphorylated in cells to form pharmacologically active ribonucleoside triphosphate (NHC-TP). NHC-TP works through a mechanism known as viral error catastrophe. Viral RNA polymerase incorporates NHC-TP into viral RNA, leading to the accumulation of errors in the viral genome and thereby inhibiting replication.

Antiviral Activity:

NHC was active in cell culture trials against the SARS-CoV-2 virus, with 50% effective concentrations (EC50) ranging from 0.67 to 2.66µM in A-549 cells and from 0.32 to 2.03µM in Vero E6 cells. NHC has similar activity against SARS-CoV-2 variant strains B.1.1.7 (Alpha), B.1351 (Beta), P.1 (Gamma) and B.1.617.2 (Delta), with EC50 values ​​of 1.59, 1.77 and 1.32 and 1.68µM respectively. No impact on the in vitro antiviral activity of NHC against SARS-CoV-2 was observed when NHC was tested in combination with abacavir, emtricitabine, hydroxychloroquine, lamivudine, nelfinavir, remdesivir, ribavirin, sofosbuvir, or tenofovir.

Pharmacodynamic effects:

The relationship between NHC and intracellular NHC-TP and antiviral efficacy has not been clinically evaluated.

Resistance:

In a Phase 2 clinical trial evaluating molnupiravir for the treatment of COVID-19, no amino acid substitutions in the SARS-CoV-2 virus associated with NHC resistance were identified. Studies assessing selection of NHC resistance in cell culture for SARS-CoV-2 viruses have not yet been completed.

Safety and Efficacy

Molnupiravir is the world’s first oral antiviral drug approved for the treatment of mild to moderate COVID-19 infection in adults. The approval was primarily based on data from the Phase III MOVe-OUT study. First-time treatment patients took molnupiravir and placebo respectively. The hospitalization/death rate within 29 days was 7.3% (28/385) in the molnupiravir treatment group and 14.1% (53/377) in the placebo control group, p=0.0012. The risk of hospitalization and death was reduced by 50% in the molnupiravir group, and no deaths were reported within 29 days, compared with eight deaths in the placebo control group.

In terms of safety, the incidence of any adverse events in the Molnupiravir treatment group was similar to that in the placebo group (35% vs 40%), and the incidence of drug treatment-related adverse events was also comparable (12% vs 11%). Moreover, the proportion of patients in the Molnupiravir group who discontinued treatment due to adverse events was lower (1.3% vs 3.4%).