Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study.

Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study.
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DOI:
10.3390/vaccines10101731
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发表时间:
2022-10-17
期刊:
影响因子:
7.8
通讯作者:
Federico Ii Covid Team
Federico Ii Covid Team
中科院分区:
医学3区
文献类型:
--
作者:
Gentile I;Scotto R;Schiano Moriello N;Pinchera B;Villari R;Trucillo E;Ametrano L;Fusco L;Castaldo G;Buonomo AR;Federico Ii Covid Team

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Molnupiravir和nirmatrelvir是第一种有效对抗SARS-CoV-2的口服抗病毒药物。评估OA疗效的试验涉及未接种疫苗和感染与目前流行的变体不同的变体的患者。我们对意大利omicron激增期间接受OAs治疗的确诊SARS-CoV-2感染患者进行了一项回顾性研究,以提供COVID-19大流行omicron激增期间OAs有效性和安全性的真实数据。在257名患者中,56.8%接受了莫努匹拉韦治疗,43.2%接受了Nirmatrelvir/利托那韦治疗。莫努匹韦组患者年龄较大,体重指数较低,慢性心脏病的发生率高于Nirmatrelvir/利托那韦组。莫努匹拉韦组有3例住院(2.1%),Nirmatrelvir/利托那韦组有1例住院(0.9%)。1名接受莫努匹拉韦治疗的患者死亡。Nirmatrelvir/利托那韦组至阴性的中位时间为8天,而莫努匹拉韦组为10天,p < 0.01。我们记录了31例患者(12.1%)的37例ADR(主要为味觉障碍、腹泻和恶心)。只有2例(0.8%)接受莫努匹韦治疗的患者因ADR而终止治疗。总之,在大多数接受OAs治疗的疫苗接种患者中,我们观察到住院率、死亡率和药物不良反应率较低。这些发生率低于关键性试验中报告的发生率。
Molnupiravir and nirmatrelvir were the first available oral antivirals (OAs) active against SARS-CoV-2. Trials evaluating the efficacy of OAs involved patients unvaccinated and infected with variants different from those currently circulating. We conducted a retrospective study on patients with confirmed SARS-CoV-2 infection treated with OAs during the omicron surge in Italy in order to provide real-life data on the efficacy and safety of OAs during the omicron surge of the COVID-19 pandemic. Among 257 patients, 56.8% received molnupiravir, while 43.2% received nirmatrelvir/ritonavir. Patients in the molnupiravir group were older, had a lower body mass index, and had a higher rate of chronic heart disease than those treated with nirmatrelvir/ritonavir. Three hospitalizations were recorded in the molnupiravir (2.1%) group and one in the nirmatrelvir/ritonavir (0.9%) group. One patient treated with molnupiravir died. The median time to negativity was 8 days in the nirmatrelvir/ritonavir group vs. 10 days in the molnupiravir group, p < 0.01. We recorded 37 ADRs (mainly dysgeusia, diarrhea, and nausea) in 31 individuals (12.1%). Only two patients (0.8%) treated with molnupiravir terminated treatment due to ADRs. In conclusion, in a population of mostly vaccinated patients treated with OAs, we observed a low rate of hospitalization, death, and adverse drug reactions. These rates were lower than those reported in pivotal trials.
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