Search for an oral antiviral that can prevent disease progression and hasten recovery in Covid is on.
— SP Kalantri (@spkalantri) December 29, 2022
Today’s @NEJM reports a clinical trial from China that tested a previously unknown oral drug in symptomatic outpatients with #COVID19. n/1
Because access to nirmatrelvir is limited worldwide, the authors wondered if VV116, an oral antiviral, hasten clinical recovery, resolve symptoms, and prevent disease progression as effectively and as safely as Nirmatrelvir-Ritonavir? n/3
— SP Kalantri (@spkalantri) December 29, 2022
Study participants—symptomatic participants infected with omicron subvariants at high risk for progression to severe Covid-19—came from 7 hospitals in Shanghai, China between April 4, 2022, and May 2, 2022. n/4
— SP Kalantri (@spkalantri) December 29, 2022
They were randomly assigned in a 1:1 ratio to receive either oral VV116 or oral nirmatrelvir–ritonavir for 5 days. n/5
— SP Kalantri (@spkalantri) December 29, 2022
The median age was 53 years and half were women. Most participants had mild Covid-19, and 75% were fully vaccinated or boosted. A third had heart disease or were obese. Most participants received trial regimens within 5 days after symptom onset. n/6
— SP Kalantri (@spkalantri) December 29, 2022
What did the authors find? First, sustained clinical recovery occurred in 377 participants in the VV116 group and 378 participants in the nirmatrelvir–ritonavir group. n/7
— SP Kalantri (@spkalantri) December 29, 2022
Second, the estimated median time to sustained clinical recovery was almost similar—4 days and 5 days, respectively. n/8
— SP Kalantri (@spkalantri) December 29, 2022
Third, no participants in this trial had died or had had progression to severe Covid-19. The median time from randomization to a first negative SARS-CoV-2 test was 7 days in both groups. n/9
— SP Kalantri (@spkalantri) December 29, 2022
Fourth, participants who received VV116 reported fewer adverse events than those who received nirmatrelvir–ritonavir (67.4% vs. 77.3%). n/10
— SP Kalantri (@spkalantri) December 29, 2022
Now that VV116 has shown that it works and is safe, could it replace Nirmatrelvir-Ritonavir for prevention of disease progression in #COVID19 infected outpatients? Only time will tell. n/11 END
— SP Kalantri (@spkalantri) December 29, 2022