Final analysis confirms efficacy of Pfizer’s COVID-19 antiviral
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A final analysis confirmed that Pfizer’s investigational oral antiviral, Paxlovid, reduced the risk for severe COVID-19 outcomes by almost 90% when given within days of symptom onset, as first reported last month, the company said.
Final data from the phase 2/3 EPIC-HR study demonstrated a reduction in the risk for COVID-19-related hospitalization and death by 89% among patients who received the antiviral within 3 days of experiencing symptoms and 88% among participants who received it within 5 days, Pfizer announced in a press release.
Evidence from the study indicated that the antiviral will retain activity against SARS-CoV-2 variants, including omicron, the company said.
“Laboratory data show our COVID-19 antiviral candidate is a potent inhibitor of the omicron protease, which, combined with existing data from other variants of concern, indicates it will likely retain robust antiviral activity against current variants and other coronaviruses,” Pfizer CEO and Chairman Albert Bourla, DVM, PhD, tweeted.
On Nov. 16, Pfizer announced it was seeking an emergency use authorization from the FDA for Paxlovid, which contains the protease inhibitor nirmatrelvir and a low dose of ritonavir. If authorized or approved for use, it will be administered at a dose of 300 mg of nirmatrelvir in two 150 mg tablets with one 100 mg tablet of ritonavir, given twice-daily for 5 days.
Among 2,246 adults enrolled in the study, 0.7% who received the antiviral were hospitalized (n = 5) and none died through day 28 compared with a hospitalization rate of 6.5% (n = 44) and nine deaths in the placebo arm.
Among patients aged 65 years or older, one patient who received Paxlovid was hospitalized (1.1%) and none died. Sixteen patients who received a placebo (16.3%) were hospitalized and six died.
Perspective
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These are impressive findings and will be a welcome addition to the toolbox we have for COVID-19 treatment. The drug will be used to keep high-risk individuals from needing hospitalization when they contract COVID-19. It is going to be important that we have testing infrastructure to identify these cases quickly, so we get the maximum benefit.
This is not just a Tamiflu equivalent — an antiviral for influenza. It is much better than Tamiflu is for influenza. The medication targets the protease of SARS-CoV-2 and will not be impacted by the omicron variant’s mutations.
The appearance of omicron underscores the need to move rapidly — much faster than the current pace — on its approval and distribution.
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Pfizer. Pfizer announces additional phase 2/3 study results confirming robust efficacy of novel COVID-19 oral antiviral treatment candidate in reducing risk of hospitalization or death. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results. Accessed Dec. 14, 2021.
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