The Chinese-developed oral antiviral reportedly achieves similar outcomes to Paxlovid, but with fewer side effects and drug–drug interactions.
Results from a clinical trial in China suggest clinicians could soon have another alternative treatment for COVID-19.
The research, published in the New England Journal of Medicine, saw 771 symptomatic adults with mild-to-moderate COVID-19 who had a high risk of progression receive a five-day course of either nirmatrelvir plus ritonavir (sold as Paxlovid), or the new VV116 antiviral.
According to the results of the Phase 3, non-inferiority, observer-blinded, randomised trial, neither group recorded a death, while the time to sustained symptom resolution and a first negative SARS-CoV-2 test did not differ substantially between the two groups.
The median time to recovery, defined as the absence of symptoms for two consecutive days, was four days for VV116 recipients and five days for those who took nirmatrelvir plus ritonavir. After four weeks, approximately 98% of all participants had recovered, and none progressed to severe disease.
Additionally, the incidence of adverse events was lower in the VV116 group than in the nirmatrelvir–ritonavir group (67.4% vs 77.3%).
Dr Panagis Galiatsatos, an assistant professor of medicine at Johns Hopkins who was not involved in the study, told NBC news the results – including the difference in side effects – constitute a ‘big deal’.
‘You have a medication that looks to be just as good as Paxlovid, but less cumbersome,’ he said.
‘It looks like we might have another tool in the toolbox.’
Nirmatrelvir plus ritonavir is one of two oral antivirals subsidised for use in Australia, alongside molnupiravir (sold as Lagevrio). However, despite its greater effectiveness, the treatment has been prescribed at a far lower rate than molnupiravir due to the high number of drug–drug interactions it has with medications that are likely to be used by those most vulnerable to COVID-19.
VV116 is reportedly similar to existing intravenous antiviral remdesivir, but its formula has been adjusted by researchers from pharmaceutical companies Junshi Biosciences and Vigonvita Life Sciences to allow its use in pill form.
Study co-author Professor Ren Zhao, from Shanghai Jiao Tong University School of Medicine, called the trial a ‘great success’.
‘Our study not only provided valuable information and experience for the development and clinical application of two major anti-SARS-CoV-2 small molecule drug routes, the RdRp inhibitor and the 3CL protease inhibitor, but also showed that our self-developed anti-SARS-CoV-2 oral drugs … have similar efficacy and safety to Paxlovid,’ he said.
‘We hope that our study results can assist … efforts to combat the epidemic.’
But despite the promising initial results, Dr Galiatsatos believes regulators will want to see greater evidence before it gains approval for wider use to ensure there are no unknown rare side effects, and also to measure the drug’s efficacy against newer COVID variants.
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