Australia ’ s first real-world effectiveness study of oral antiviral ( OAV ) treatment in prevention of death or hospitalisation associated with mild to moderate COVID-19 .
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Australia ’ s first real-world effectiveness study of oral antiviral ( OAV ) treatment in prevention of death or hospitalisation associated with mild to moderate COVID-19 .
Van Heer C , Majumdar S , et al . Effectiveness of community-based oral antiviral treatments against severe COVID-19 outcomes in people 70 years and over in Victoria , Australia , 2022 : an observational study . Lancet Reg Health West Pac 2023 ; 41:100917 .
Objectives
1 . Efficacy of treatment with the following on rates of hospitalisation and death within 35 days from a COVID-19 diagnosis :
— An OAV vs no OAV treatment — LAGEVRIO vs no treatment OR nirmatrelvir-ritonavir vs no treatment
2 . The impact of initiation speed on mortality outcomes . A non-randomised , observational , retrospective cohort study .
Who
• Highly vaccinated Victorian patients (> 95 % 2-dose , 94 % 3-dose , 70 % 4-dose ) aged ≥70 years with newly diagnosed mild-to-moderate COVID-19 .
• Two study cohorts were analysed : 1 . Mortality cohort , n = 38,933 2 . Hospitalisation cohort , n = 31,133
When
During Victoria ’ s third wave of transmission in 2022 characterised by the dominance of the BA . 4 and BA . 5 Omicron subvariants . ( 11 July to 31 October 2022 )
Scan QR code for study designs : MOVe-OUT and Victorian Observational Study
Key findings
1 . Significantly lower rates of death and hospitalisation with an OAV treatment ( LAGEVRIO or nirmatrelvirritonavir ) vs no treatment
— Treatment vs no treatment was associated with an overall 57 % ( OR = 0.43 , 95 % CI 0.36 – 0.51 ; p < 0.0001 ) reduction in the odds of death and 31 % ( OR = 0.69 , 95 % CI 0.55 – 0.86 ; p < 0.0001 ) reduction in the odds of hospitalisation .
2 . Treatment with either LAGEVRIO vs no treatment OR nirmatrelvir-ritonavir vs no treatment was associated with a reduction in death and hospitalisation
— LAGEVRIO vs no treatment was associated with a 55 % ( OR = 0.45 , 95 % CI 0.38 – 0.54 ; p < 0.0001 ) reduction in the odds of death and a 29 % ( OR = 0.71 , 95 % CI 0.58 – 0.87 ; p = 0.003 ) reduction in the odds of hospitalisation .
— Nirmatrelvir-ritonavir vs no treatment was associated with a 73 % ( OR = 0.27 , 95 % CI 0.17 – 0.40 ; p < 0.0001 ) reduction in the odds of death and a 40 % ( OR = 0.60 , 95 % CI 0.43 – 0.83 ; p = 0.001 ) reduction in the odds of hospitalisation .
— Study population included in this trial differed to those in the OAV registration trials . Patients assessed in this study were aged 70 years or older and were highly vaccinated . Please refer to individual product information for registration study details .
3 . Early OAV treatment vs no treatment was associated with reduced mortality
— Patients who received OAV treatment within one day of diagnosis had a 61 % reduction in the odds of death ( OR = 0.39 , 95 % CI 0.33 – 0.46 ; p < 0.0001 )
— Receiving treatment four or more days post-diagnosis resulted in a 33 % reduction in the odds of death ( OR = 0.67 , 95 % CI 0.44-0.97 ; p = 0.044 ).
Study limitations
• These findings are limited by the observational nature of the study where unobserved confounders may bias estimates of treatment effect .
• This study was not powered to assess the difference between the two active treatments ( LAGEVRIO or nirmatrelvir-ritonavir ). No clinical inference can be made .
• Treatment was not balanced between the two available OAVs . Majority of the patients in the treated group were treated with LAGEVRIO vs nirmatrelvir-ritonavir ( Mortality cohort = 79 %, Hospitalisation cohort = 76 %)
• No safety anaylsis was performed .
Concluding statement
Treatment with both LAGEVRIO vs no treatment OR nirmatrelvir-ritonavir vs no treatment was associated with a reduction in death and hospitalisation in vaccinated ≥70 years individuals during the Omicron era . Timely , equitable treatment with OAVs is an important tool in the fight against COVID-19 .
Before prescribing either LAGEVRIO or nirmatrelvir-ritonavir , please review the full Product Information available at www . ebs . tga . gov . au . Both products are listed on the PBS , for current PBS eligibility criteria for individual products , please refer to www . pbs . gov . au .