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New oral analogue to remdesivir is similarly effective to nirmatrelvir-ritonavir for mild to moderate symptomatic COVID-19
Question clinique
Is the novel oral antiviral drug VV116 noninferior to nirmatrelvir-ritonavir (Paxlovid) for high-risk patients with symptomatic mild to moderate COVID-19?
L’Essentiel
A new oral analogue to remdesivir provided a similar time to sustained clinical recovery as nirmatrelvir-ritonavir (Paxlovid). There was no placebo group and the vast majority of patients had mild disease, with no patients progressing to severe disease or dying. It is good to have an alternative to Paxlovid that is easier to take than intravenous remdesivir. The drug is manufactured by a Chinese drug company and has not been submitted for FDA approval, but this study highlights the fact that more drugs for COVID-19 (and probably other viral infections) are on their way. 1b
Référence
Plan de l'etude: Randomized controlled trial (double-blinded)
Financement: Industry + govt
Cadre: Outpatient (any)
Sommaire
VV116 is an oral analogue to intravenous remdesivir, which has been shown to prevent progression to more severe disease in outpatients. This study identified 822 patients with mild or moderate symptomatic COVID-19. The mean age of participants was 53 years, 50% were men, and 75% in each group were vaccinated (presumably, in this Chinese trial, with the Sinovax vaccine). The most common risk factors for severe illness were age at least 60 years, hypertension or cardiovascular disease, and obesity, and patients started treatment a median of 4 days following diagnosis. This study took place during the omicron phase of the pandemic. Care is organized quite differently in China, and while this was a hospital-based study, 92% of the participants had disease classified as mild and 8% as moderate. Patients were randomized to receive VV116 (600 mg every 12 hours on day 1 and 300 mg every 12 hours on days 2 to 5) or nirmatrelvir 300 mg plus ritonavir 100 mg every 12 hours for 5 days. A similar number of patients (24 to 27) were withdrawn prior to the first dose of the study drug, mostly due to withdrawal of consent. The primary outcome was time to sustained clinical recovery, defined as 2 consecutive days with a score of 0 or 1 on a 33-point scale. This was achieved more quickly with VV116 (hazard ratio 1.17; 95% CI 1.01 - 1.35), which easily exceeded the noninferiority cutoff of 0.8. The median time to recovery was 4 days with VV116 and 5 days with nirmatrelvir-ritonavir. Because all patients were already hospitalized, hospitalization could not be an outcome. No patients in either group progressed to severe disease or died. There were no serious adverse events in either group that were thought to be related to the medications.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Commentaires
Impact assessment
Excellent
Oral Analogue too Remdesivir
Why would pts with mild Covid symptoms be hospitalised? Were they already hospitalised for co-morbidities & Covid was coincidental or nosocomial? Why would mild viral symptoms require intensive treatment?
The lack of a placebo group further questions the value of the study - as well as the mean age of the 53 yrs pt group not being the most likely to experience disease progression.