Effectiveness of Molnupiravir Treatment in Patients with COVID-19 in Korea: A Propensity Score Matched Study
2
조회
0
다운로드
3
인용
0
참고문헌
키워드
초록
Background: The MOVe-OUT (efficacy and safety of molnupiravir [MK-4482] in non-hospitalized adult participants with COVID-19 [MK-4482-002]) trial reported that the administration of molnupiravir in unvaccinated patients with coronavirus disease 2019 (COVID-19) before the Omicron epidemic showed a preventive effect of 31% against hospitalization and death. However, studies on the preventive effect of molnupiravir against progression to severe disease and death in patients with COVID-19 during the Omicron epidemic are limited. This study aimed to evaluate the preventive effect of molnupiravir against severe/critical illness or death and death in Korean patients with COVID-19 who were vaccinated mostly during the Omicron epidemic. Materials and Methods: This study used large-scale retrospective cohort data to select patients with COVID-19 who were either treated or not treated with molnupiravir, between August 2022 and March 2023, at a ratio of 1 : 4 using the propensity score matching method. In total, 762,768 patients comprised the non- administered group, and 190,692 patients comprised the molnupiravir-administered group. The preventive effect of molnupiravir against severe/ critical illness or death and death was analyzed using logistic regression analysis. Results: The preventive effect of molnupiravir against severe/critical illness or death and death, represented by the odds ratio (OR) and 95% confidence interval (CI), in the molnupiravir-administered and non-administered group was (OR: 0.714; CI: 0.667 - 0.764) and (OR: 0.749; CI: 0.682 - 0.823), respectively. As age increased, the preventive effect against severe/critical illness or death and death increased. The preventive effect against severe/critical illness or death at ≥60 years was (OR: 0.669; CI: 0.624 - 0.717), at ≥70 years was (OR: 0.614; CI: 0.570 - 0.661), and at ≥80 years was (OR: 0.563; CI: 0.515 - 0.615). The preventive effect against death at ≥60 years was (OR: 0.729; CI: 0.663 - 0.802), at ≥70 years was (OR: 0.676; CI: 0.612 - 0.747), and at ≥80 years was (OR: 0.622; CI: 0.554 - 0.698). Conclusion: Although molnupiravir showed a relatively weak preventive effect against severe/critical illness or death (29%) and death (25%) among patients with COVID-19, it exhibited a stronger protective effect in older patients than in younger patients. In particular, the preventive effect against severe/critical illness or death (44%) and death (38%) in those aged ≥80 years was pronounced. This study strongly suggests that molnupiravir administration can alleviate the burden on the medical system, and treat patients with COVID-19 effectively by reducing its progression to severe disease and death.
Abstract
Background: The MOVe-OUT (efficacy and safety of molnupiravir [MK-4482] in non-hospitalized adult participants with COVID-19 [MK-4482-002]) trial reported that the administration of molnupiravir in unvaccinated patients with coronavirus disease 2019 (COVID-19) before the Omicron epidemic showed a preventive effect of 31% against hospitalization and death. However, studies on the preventive effect of molnupiravir against progression to severe disease and death in patients with COVID-19 during the Omicron epidemic are limited. This study aimed to evaluate the preventive effect of molnupiravir against severe/critical illness or death and death in Korean patients with COVID-19 who were vaccinated mostly during the Omicron epidemic. Materials and Methods: This study used large-scale retrospective cohort data to select patients with COVID-19 who were either treated or not treated with molnupiravir, between August 2022 and March 2023, at a ratio of 1 : 4 using the propensity score matching method. In total, 762,768 patients comprised the non- administered group, and 190,692 patients comprised the molnupiravir-administered group. The preventive effect of molnupiravir against severe/ critical illness or death and death was analyzed using logistic regression analysis. Results: The preventive effect of molnupiravir against severe/critical illness or death and death, represented by the odds ratio (OR) and 95% confidence interval (CI), in the molnupiravir-administered and non-administered group was (OR: 0.714; CI: 0.667 - 0.764) and (OR: 0.749; CI: 0.682 - 0.823), respectively. As age increased, the preventive effect against severe/critical illness or death and death increased. The preventive effect against severe/critical illness or death at ≥60 years was (OR: 0.669; CI: 0.624 - 0.717), at ≥70 years was (OR: 0.614; CI: 0.570 - 0.661), and at ≥80 years was (OR: 0.563; CI: 0.515 - 0.615). The preventive effect against death at ≥60 years was (OR: 0.729; CI: 0.663 - 0.802), at ≥70 years was (OR: 0.676; CI: 0.612 - 0.747), and at ≥80 years was (OR: 0.622; CI: 0.554 - 0.698). Conclusion: Although molnupiravir showed a relatively weak preventive effect against severe/critical illness or death (29%) and death (25%) among patients with COVID-19, it exhibited a stronger protective effect in older patients than in younger patients. In particular, the preventive effect against severe/critical illness or death (44%) and death (38%) in those aged ≥80 years was pronounced. This study strongly suggests that molnupiravir administration can alleviate the burden on the medical system, and treat patients with COVID-19 effectively by reducing its progression to severe disease and death.
참고문헌 (40)
- "WHO coronavirus (COVID-19)dashboard"[URL]
- "Coronavirus disease 19 (COVID-19)"[URL]
- Guan WJ, "Comorbidity and its impact on 1590 patients with COVID-19 in China : a nationwide analysis", Eur Respir J, 55, pp.2000547~ (2020)
- Yang J, "Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2 : a systematic review and meta-analysis", Int J Infect Dis, 94, pp.91~95 (2020)
- Wu C, "Risk factors associated with acute respiratory distress syndrome and death in patients with coronavirus disease 2019 pneumonia in Wuhan, China", JAMA Intern Med, 180, pp.934~943 (2020)
- Ito K, "Relative instantaneous reproduction number of Omicron SARS-CoV-2 variant with respect to the Delta variant in Denmark", J Med Virol, 94, pp.2265~2268 (2022)
- Bestetti RB, "Pharmacological Treatment of Patients with Mild to Moderate COVID-19 : a comprehensive review", Int J Environ Res Public Health, 18, pp.7212~ (2021)
- Siddiqi HK, "COVID-19 illness in native and immunosuppressed states : a clinical-therapeutic staging proposal", J Heart Lung Transplant, 39, pp.405~407 (2020)
- Gandhi RT, "Mild or moderate Covid-19", N Engl J Med, 383, pp.1757~1766 (2020)
- Lv Z, "Clinical characteristics and analysis of risk factors for disease progression of COVID-19 : a retrospective Cohort Study", Int J Biol Sci, 17, pp.1~7 (2021)
- Ying-Hao P, "Clinical characteristics and analysis of risk factors for disease progression of patients with SARS-CoV-2omicron variant infection : a retrospective study of 25207cases in a Fangcang hospital", Front Cell Infect Microbiol, 12, pp.1009894~ (2022)
- Soy M, "Pathogenesis and treatment of cytokine storm in COVID-19", Turk J Biol, 45, pp.372~389 (2021)
- Wen W, "Efficacy and safety of three new oral antiviral treatment(molnupiravir, fluvoxamine and Paxlovid)for COVID-19 : a meta-analysis", Ann Med, 54, pp.516~523 (2022)
- Jayk Bernal A, "Molnupiravir for oral treatment of Covid-19 in nonhospitalized patients", N Engl J Med, 386, pp.509~520 (2022)
- Hammond J, "Oral nirmatrelvir for high-risk, nonhospitalized adults with Covid-19", N Engl J Med, 386, pp.1397~1408 (2022)
- Lee CC, "Molnupiravir-A novel oral anti-SARSCoV-2 agent", Antibiotics(Basel), 10, pp.1294~ (2021)
- Painter WP, "Human safety, tolerability, and pharmacokinetics of molnupiravir, a novel broad-spectrum oral antiviral agent with activity against SARSCoV-2", Antimicrob Agents Chemother, 65, pp.e02428-20~ (2021)
- "Fact sheet for healthcare providers: Emergency use authorization for Lagevrio™ (molnupiravir) capsules"[URL]
- "Guide to use of coronavirus infectious diseases-19 treatment in South Korea (edition 11)"[URL]
- Takashita E, "Efficacy of antibodies and antiviral drugs against Covid-19 omicron variant", N Engl J Med, 386, pp.995~998 (2022)
- Takashita E, "Efficacy of antibodies and antiviral drugs against omicron BA. 2. 12. 1, BA. 4, and BA. 5 subvariants", N Engl J Med, 387, pp.468~470 (2022)
- "Press reference data"[URL]
- Butler CC, "Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes(PANORAMIC) : an open-label, platform-adaptive randomised controlled trial", Lancet, 401, pp.281~293 (2023)
- Najjar-Debbiny R, "Effectiveness of molnupiravir in highrisk patients : a propensity score matched analysis", Clin Infect Dis, 76, pp.453~460 (2023)
- Wong CKH, "Real-world effectiveness of early molnupiravir or nirmatrelvirritonavir in hospitalised patients with COVID-19 without supplemental oxygen requirement on admission during Hong Kong’s omicron BA. 2 wave : a retrospective cohort study", Lancet Infect Dis, 22, pp.1681~1693 (2022)
- Wong CKH, "Real-world effectiveness of molnupiravir and nirmatrelvir plus ritonavir against mortality, hospitalisation, and in-hospital outcomes among community-dwelling, ambulatory patients with confirmed SARS-CoV-2 infection during the omicron wave in Hong Kong : an observational study", Lancet, 400, pp.1213~1222 (2022)
- Bajema KL, "Effectiveness of COVID-19 treatment with nirmatrelvir-ritonavir or molnupiravir among U. S. Veterans : Target trial emulation studies with one-month and six-month outcomes", Ann Intern Med, 176, pp.807~816 (2023)
- Xie Y, "Molnupiravir and risk of hospital admission or death in adults with covid-19 : emulation of a randomized target trial using electronic health records", BMJ, 380, pp.e072705~ (2023)
- Suzuki Y, "Real-world clinical outcomes of treatment with molnupiravir for patients with mild-to-moderate coronavirus disease 2019 during the Omicron variant pandemic", Clin Exp Med, 23, pp.2715~2723 (2023)
- Paraskevis D, "Real-world effectiveness of molnupiravir and nirmatrelvir", ritonavir as treatments for COVID-19 in high-risk patients, 2023, jiad324~
- Park Hanul, "The effectiveness of Paxlovid treatment in long-term care facilities in South Korea during the outbreak of the Omicron variant of SARS-CoV-2", Osong Public Health and Research Perspectives, 13(6), pp.443~447 (2022), 질병관리청[DOI]
- Kim Jong Mu, "Effectiveness of Paxlovid, an Oral Antiviral Drug, Against the Omicron BA.5 Variant in Korea: Severe Progression and Death Between July and November 2022", Journal of Korean Medical Science, 38(27), pp.1~10 (2023), 대한의학회[DOI]
- "Coronavirus disease 2019 response and management guidelines for local governments in South Korea (edition 13-1)"[URL]
- Rosenbaum PR, "The central role of the propensity score in observational studies for causal effects", Biometrika, 70, pp.41~55 (1983)
- Fiolet T, "Comparing COVID-19 vaccines for their characteristics, efficacy and effectiveness against SARS-CoV-2 and variants of concern : a narrative review", Clin Microbiol Infect, 28, pp.202~221 (2022)
- Watson OJ, "Global impact of the first year of COVID-19 vaccination : a mathematical modelling study", Lancet Infect Dis, 22, pp.1293~1302 (2022)
- "Press reference data"[URL]
- "Share of people who received at least one dose of COVID-19 vaccine"[URL]
- Hoertel N, "Prevalence of contraindications to nirmatrelvir-ritonavir among hospitalized patients with COVID-19 at risk for progression to severe disease", JAMA Netw Open, 5, pp.e2242140~ (2022)
- Ross SB, "Drug interactions with nirmatrelvirritonavir in older adults using multiple medications", JAMA Netw Open, 5, pp.e2220184~ (2022)
