Results of phase 3 trial of domestic new coronavirus oral medicine

Results of the phase 3 trial of the domestic New coronavirus oral drug: high-risk mild to moderate disease treatment effect is not inferior to Paxlovid, and less adverse reactions, as raltegravir analog

On December 28, the New England Journal of Medicine (NEJM) published the results of a clinical trial of a domestic oral drug, VV116, for the treatment of New coronavirus pneumonia, led by seven hospitals in Shanghai, China.

This is a randomized, observer-blinded and controlled Phase 3 clinical trial with nirmatrelvir/ritonavir (nirmatrelvir/ritonavir, currently marketed under the trade name Paxlovid).

A total of 822 participants, mainly infected with the Omicron B.1.1.529 mutant strain, all with mild to moderate neocoronary pneumonia (92.1% with mild disease), 75% vaccinated, 35.1% of whom had cardiovascular disease and 32.9% with a BMI over 25, were at high risk of developing severe disease in the study.

Among them, 77.3% received treatment within 5 days of symptom onset.

In the trial, 384 and 387 individuals were randomly assigned to receive either 5 days of VV116
(600 mg/per 12 hours on the first day of treatment and 300 mg/per 12 hours on the second 4 days)

OR nematavir/ritonavir treatment (300 mg nematavir + 100 mg ritonavir/every 12 hours for 5 days).

The primary endpoint of treatment was sustained clinical recovery to day 28.

Among them, sustained clinical recovery means that the sum of the patient’s total scores for the 11 clinical symptoms is 0 or 1 (each symptom score is 0 to 3, the more severe the score is) lasting for 2 days.

Results showed that the median time for patients to achieve sustained clinical recovery was 4 to 5 days.

There was no significant difference in the time to achieve sustained symptom remission (0 points for all 11 covid -19-related target symptoms on 2 consecutive days) and first negative nucleic acid test on treatment with VV116 and nematovir/ritonavir.

The first negative nucleic acid test occurred at day 7 after receiving treatment.

However, the probability of adverse events was lower for VV116 (at 67.4%) compared to nematavir/ritonavir (77.3%).

The most frequently reported adverse events in both groups were psychiatric disorders, hypertriglyceridemia, and hyperlipidemia, none of them serious.

VV116 is a structural analogue of remdesivir (deuterated remdesivir hydrobromide), the same nucleoside analogue.

It interacts with the polymerase of the new coronavirus and can integrate into the RNA of the virus and terminate the replication process of the virus.

Previously, it showed anti-NeoCoronavirus effects in animal studies and small population trials.

In September 2020, the British Medical Journal (BMJ) had published the World Health Organization (WHO) recommended treatment protocol forNew coronavirus.

This regimen prioritizes the recommendation of nematuvir/ritonavir for the treatment of high-risk patients with mild to moderate disease, followed by raltegravir, monupiravir (molnupiravir), and subsequently raltegravir for the treatment of patients with severe disease.

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