US Real-World Effectiveness Study of Nirmatrelvir/Ritonavir in Preventing Hospitalization of High-Risk COVID-19 Patients

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Current Therapeutic Research-clinical and Experimental Pub Date : 2024-01-01 DOI:10.1016/j.curtheres.2024.100757

Mark R. Cullen MD , Xiaofeng Zhou PhD , Scott P. Kelly PhD , Caihua Liang MD, PhD , Ling Li MS , Rongjun Shen MS , Heidi K. Leister-Tebbe BSN , Steven G. Terra PharmD , Michael Gaffney PhD , Leo Russo PhD

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Abstract

Purpose

We describe nirmatrelvir/ritonavir (NMV/r) effectiveness in preventing hospitalization among COVID-19 patients at high risk of severe disease.

Methods

An ongoing US population-based observational cohort study with retrospective and prospective collection of national electronic healthcare data collected from the US Optum® deidentified COVID-19 Electronic Health Record dataset during December 22, 2021−July 20, 2022. Participants were ≥12 years old; had a positive SARS-CoV-2 test, COVID-19 diagnosis, or NMV/r prescription; and were at high risk of severe COVID-19 based on demographic/clinical characteristics. Potential confounders between groups were balanced using propensity score matching. Immortal time bias was addressed. Hospitalization rates within 30 days from COVID-19 diagnosis were evaluated. Sensitivity analyses included 15-day hospitalization, chart review to investigate incidental hospitalization effects, and exclusion of patients identified as having COVID-19 based on NMV/r prescription alone. Outcomes were also evaluated by race, age, and COVID-19 vaccine status.

Findings

Overall, 12,440 and 234,123 patients were included in the NMV/r and non-NMV/r groups, respectively. After propensity score matching, baseline characteristics were well balanced across groups (NMV/r, n = 12,439; non-NMV/r, n = 36,490). Incidence of hospitalization (95% CI) within 30 days was 0.90% (0.74%−1.08%) for the NMV/r group and 5.91% (5.67%−6.16%) for the non-NMV/r group, with relative risk (95% CI) of 0.15 (0.13−0.18; 85% risk reduction). NMV/r was comparably effective in Black patients (relative risk, 0.19 [0.10−0.34]; 81% risk reduction). Sensitivity analyses supported the main outcomes.

Implications

Real-world NMV/r effectiveness against hospitalization during Omicron predominance among COVID-19 patients at high risk of severe disease supports demonstrated clinical trial efficacy. Black patients underutilized NMV/r despite high effectiveness.

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美国尼马瑞韦/利托那韦预防 COVID-19 高危患者住院治疗的实际效果研究

目的我们描述了尼马瑞韦/利托那韦（NMV/r）在预防COVID-19重症高危患者住院方面的有效性。方法一项正在进行的基于美国人群的观察性队列研究，该研究采用回顾性和前瞻性方法收集美国Optum®去标识化COVID-19电子健康记录数据集中的全国电子医疗保健数据，时间为2021年12月22日至2022年7月20日。参与者年龄≥12岁；SARS-CoV-2检测、COVID-19诊断或NMV/r处方呈阳性；根据人口统计学/临床特征，属于严重COVID-19高危人群。采用倾向评分匹配法平衡了组间潜在的混杂因素。解决了不朽时间偏差问题。对确诊 COVID-19 后 30 天内的住院率进行了评估。敏感性分析包括 15 天住院率、调查偶然住院影响的病历审查，以及排除仅根据 NMV/r 处方确定为 COVID-19 的患者。研究结果NMV/r组和非NMV/r组分别纳入了12,440名和234,123名患者。经过倾向评分匹配后，各组的基线特征非常均衡（NMV/r，n = 12,439；非 NMV/r，n = 36,490）。30 天内住院的发生率（95% CI），NMV/r 组为 0.90% (0.74%-1.08%)，非 NMV/r 组为 5.91% (5.67%-6.16%)，相对风险 (95% CI) 为 0.15 (0.13-0.18; 风险降低 85%)。NMV/r 对黑人患者的疗效相当（相对风险为 0.19 [0.10-0.34]；风险降低 81%）。在 COVID-19 重型疾病高风险患者中，NMV/r 对 Omicron 占主导地位期间住院治疗的实际效果支持临床试验的疗效。尽管NMV/r的有效性很高，但黑人患者对其利用不足。

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来源期刊

Current Therapeutic Research-clinical and Experimental 医学-药学

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

3 months

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