MMWR Morb Mortal Wkly Rep. 2022 Jun 24;71(25):830-833. doi: 10.15585/mmwr.mm7125e2.
Nirmatrelvir/ritonavir (Paxlovid) is a combination protease inhibitor that blocks replication of SARS-CoV-2 (the virus that causes COVID-19) and has been shown to reduce the risk for hospitalization and death among patients with mild to moderate COVID-19 who are at risk for progression to severe disease* (1). In December 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for early treatment with Paxlovid among persons with mild to moderate cases of COVID-19 who are at high risk for progression to severe disease (2). FDA and a small number of published case reports have documented recurrence of COVID-19 symptoms or a positive viral test result (COVID-19 rebound) 2-8 days after recovery or a negative SARS-CoV-2 test result among patients treated with Paxlovid (3-7); however, large-scale studies investigating severe illness after Paxlovid treatment are limited. This study used electronic health record (EHR) data from a large integrated health care system in California (Kaiser Permanente Southern California [KPSC]) to describe hospital admissions and emergency department (ED) encounters related to SARS-CoV-2 infections during the 5-15 days after pharmacy dispensation of a 5-day treatment course of Paxlovid. Among 5,287 persons aged ≥12 years who received Paxlovid during December 31, 2021-May 26, 2022, 73% had received ≥3 doses of COVID-19 vaccine, and 8% were unvaccinated. During the 5-15 days after Paxlovid treatment was dispensed, six hospitalizations and 39 ED encounters considered to be related to SARS-CoV-2 infection were identified, representing <1% of all patients to whom Paxlovid treatment was dispensed during the study period. Among these 45 persons, 21 (47%) were aged ≥65 years, and 35 (78%) had at least one underlying medical condition (8). This study found that hospitalization or ED encounters for COVID-19 during the 5-15 days after Paxlovid treatment was dispensed for mild to moderate COVID-19 illness were rarely identified. When administered as an early-stage treatment, Paxlovid might prevent COVID-19-related hospitalization among persons with mild to moderate cases of COVID-19 who are at risk for progression to severe disease.
尼马瑞韦/利托那韦(奈玛特韦/利托那韦片,Paxlovid)是一种蛋白酶抑制剂复方药物,可阻断 SARS-CoV-2(引发 COVID-19 的病毒)的复制,临床试验已证明其可降低轻症至中症 COVID-19 患者住院和死亡风险,这些患者有向重症发展的风险*(1)。2021 年 12 月,美国食品药品监督管理局(FDA)发布了一项紧急使用授权(EUA),批准在轻症至中症 COVID-19 患者中早期使用 Paxlovid,这些患者有向重症发展的风险(2)。FDA 和少数已发表的病例报告记录了在接受 Paxlovid 治疗的患者中,有 2-8 天康复后或 SARS-CoV-2 检测结果转阴后再次出现 COVID-19 症状或病毒检测结果阳性(COVID-19 反弹)(3-7);然而,关于 Paxlovid 治疗后发生重症疾病的大型研究有限。本研究利用来自加利福尼亚州一个大型综合医疗保健系统(凯撒永久南加州医疗集团 [Kaiser Permanente Southern California,KPSC])的电子健康记录(EHR)数据,描述了在接受 5 天疗程的 Paxlovid 治疗后 5-15 天期间,与 SARS-CoV-2 感染相关的住院和急诊(ED)就诊情况。在 2021 年 12 月 31 日至 2022 年 5 月 26 日期间,年龄≥12 岁且接受了 Paxlovid 治疗的 5287 人中,73%至少接种了 3 剂 COVID-19 疫苗,8%未接种疫苗(3)。在接受 Paxlovid 治疗后的 5-15 天内,发现有 6 例住院和 39 例 ED 就诊被认为与 SARS-CoV-2 感染有关,占该研究期间接受 Paxlovid 治疗的所有患者的比例不到 1%。在这 45 名患者中,21 名(47%)年龄≥65 岁,35 名(78%)至少有一种基础疾病(8)。本研究发现,在轻症至中症 COVID-19 患者接受 Paxlovid 治疗后 5-15 天内,COVID-19 住院或 ED 就诊的情况很少见。当作为早期治疗药物使用时,Paxlovid 可能会预防有向重症发展风险的轻症至中症 COVID-19 患者发生 COVID-19 相关的住院。