PDF(Pubmed)
Abstract：
UNASSIGNED: Viral SARS-CoV-2 rebound (viral RNA rebound) is challenging to characterize in large cohorts due to the logistics of collecting frequent and regular diagnostic test results. Pharmacy-based testing data provide an opportunity to study the phenomenon in a large population, also enabling subgroup analyses. The current real-world evidence approach complements approaches focused on smaller, prospective study designs.
UNASSIGNED: We linked real-time reverse transcription quantitative polymerase chain reaction test data from national pharmacy-based testing to health care claims data via tokenization to calculate the cumulative incidence of viral RNA rebound within 28 days following positive test results in nirmatrelvir/ritonavir (NMV-r)-treated and untreated individuals during the Omicron era (December 2021-November 2022) and prior to the Omicron era (October 2020-November 2021).
UNASSIGNED: Among 30 646 patients, the rate of viral RNA rebound was 3.5% (95% CI, 2.0%-5.7%) in NMV-r-treated infections as compared with 1.5% (95% CI, 1.3%-1.7%) in untreated infections during the Omicron era and 1.9% (95% CI, 1.7%-2.1%) prior to the Omicron era. Viral RNA rebound in patients who were vaccinated (n = 8151), high risk (n = 4411), or older (≥65 years, n = 4411) occurred at comparable rates to the overall cohort (range, 1.1%-4.8%). Viral rebounds to high RNA levels in NMV-r-treated infections occurred in 8% of viral rebounds as compared with 5% to 11% in untreated infections. Rates of hospitalization were comparable between patients with NMV-r-treated infections with viral RNA rebound (0%) and untreated patients with viral RNA rebound (0%-1.2%).
UNASSIGNED: Our findings suggest viral RNA rebound is rare (< 5%), with rates that were consistent with those from the EPIC-HR trial (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients). Most occurrences of viral RNA rebound were associated with low viral RNA levels, and viral RNA rebound progression to severe disease was not observed.
UNASSIGNED: We linked real-time reverse transcription quantitative polymerase chain reaction test data from national pharmacy-based testing to health care claims data via tokenization to calculate the cumulative incidence of viral RNA rebound within 28 days following positive test results in nirmatrelvir/ritonavir (NMV-r)-treated and untreated individuals during the Omicron era (December 2021-November 2022) and prior to the Omicron era (October 2020-November 2021).
UNASSIGNED: Among 30 646 patients, the rate of viral RNA rebound was 3.5% (95% CI, 2.0%-5.7%) in NMV-r-treated infections as compared with 1.5% (95% CI, 1.3%-1.7%) in untreated infections during the Omicron era and 1.9% (95% CI, 1.7%-2.1%) prior to the Omicron era. Viral RNA rebound in patients who were vaccinated (n = 8151), high risk (n = 4411), or older (≥65 years, n = 4411) occurred at comparable rates to the overall cohort (range, 1.1%-4.8%). Viral rebounds to high RNA levels in NMV-r-treated infections occurred in 8% of viral rebounds as compared with 5% to 11% in untreated infections. Rates of hospitalization were comparable between patients with NMV-r-treated infections with viral RNA rebound (0%) and untreated patients with viral RNA rebound (0%-1.2%).
UNASSIGNED: Our findings suggest viral RNA rebound is rare (< 5%), with rates that were consistent with those from the EPIC-HR trial (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients). Most occurrences of viral RNA rebound were associated with low viral RNA levels, and viral RNA rebound progression to severe disease was not observed.
摘要：
■由于收集频繁和定期的诊断测试结果的后勤，病毒SARS-CoV-2反弹（病毒RNA反弹）在大型队列中具有挑战性。以药学为基础的测试数据提供了一个在大量人群中研究这种现象的机会，还可以进行子组分析。当前的真实世界证据方法补充了专注于较小，前瞻性研究设计。
■我们通过标记化将来自国家基于药学的测试的实时逆转录定量聚合酶链反应测试数据与医疗保健声明数据相关联，以计算在Omicron时代（2021年12月至2022年11月）和Omicron时代（2020年10月至2021年11月）之前，在nirmatrelvir/ritonavir（NMV-r）治疗和未经治疗的个体中阳性测试结果
■在30646名患者中，在NMV-r治疗的感染中,病毒RNA反弹率为3.5%(95%CI,2.0%-5.7%),而在Omicron时代未治疗的感染中,病毒RNA反弹率为1.5%(95%CI,1.3%-1.7%),在Omicron时代之前为1.9%(95%CI,1.7%-2.1%).接种疫苗的患者的病毒RNA反弹（n=8151），高风险（n=4411），或以上(≥65岁，n=4411)的发生率与整体队列(范围，1.1%-4.8%）。在NMV-r处理的感染中,病毒反弹至高RNA水平发生在8%的病毒反弹中,与未处理的感染中的5%至11%相比。NMV-r治疗的病毒RNA反弹感染患者（0％）和未经治疗的病毒RNA反弹患者（0％-1.2％）之间的住院率相当。
■我们的研究结果表明，病毒RNA反弹是罕见的（<5％），其发生率与EPIC-HR试验(高风险患者对COVID-19蛋白酶抑制的评估)一致。大多数病毒RNA反弹事件与低病毒RNA水平有关，未观察到病毒RNA反弹进展为严重疾病。
■我们通过标记化将来自国家基于药学的测试的实时逆转录定量聚合酶链反应测试数据与医疗保健声明数据相关联，以计算在Omicron时代（2021年12月至2022年11月）和Omicron时代（2020年10月至2021年11月）之前，在nirmatrelvir/ritonavir（NMV-r）治疗和未经治疗的个体中阳性测试结果
■在30646名患者中，在NMV-r治疗的感染中,病毒RNA反弹率为3.5%(95%CI,2.0%-5.7%),而在Omicron时代未治疗的感染中,病毒RNA反弹率为1.5%(95%CI,1.3%-1.7%),在Omicron时代之前为1.9%(95%CI,1.7%-2.1%).接种疫苗的患者的病毒RNA反弹（n=8151），高风险（n=4411），或以上(≥65岁，n=4411)的发生率与整体队列(范围，1.1%-4.8%）。在NMV-r处理的感染中,病毒反弹至高RNA水平发生在8%的病毒反弹中,与未处理的感染中的5%至11%相比。NMV-r治疗的病毒RNA反弹感染患者（0％）和未经治疗的病毒RNA反弹患者（0％-1.2％）之间的住院率相当。
■我们的研究结果表明，病毒RNA反弹是罕见的（<5％），其发生率与EPIC-HR试验(高风险患者对COVID-19蛋白酶抑制的评估)一致。大多数病毒RNA反弹事件与低病毒RNA水平有关，未观察到病毒RNA反弹进展为严重疾病。
