{"id":21320,"date":"2022-02-21T05:20:00","date_gmt":"2022-02-20T21:20:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=21320"},"modified":"2022-02-21T05:36:31","modified_gmt":"2022-02-20T21:36:31","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e5%8f%a3%e6%9c%8dnirmatrelvir-paxlovid%e6%b2%bb%e7%96%97%e6%96%b0%e5%86%a0%e8%82%ba%e7%82%8e%e9%97%a8%e8%af%8a%e9%ab%98%e5%8d%b1%e6%82%a3%e8%80%85","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=21320","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1a\u53e3\u670dNirmatrelvir (Paxlovid)\u6cbb\u7597\u65b0\u51a0\u80ba\u708e\u95e8\u8bca\u9ad8\u5371\u60a3\u8005"},"content":{"rendered":"\n

ORIGINAL ARTICLE<\/a><\/p>\n\n\n\n

Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19<\/h1>\n\n\n\n

Jennifer Hammond, Heidi Leister-Tebbe, Annie Gardner,\u00a0et al<\/h3>\n\n\n\n

N Engl J Med February 16, 2022
DOI: 10.1056\/NEJMoa2118542<\/h3>\n\n\n\n

Abstract<\/h2>\n\n\n\n

BACKGROUND<\/h2>\n\n\n\n

Nirmatrelvir is an orally administered severe acute respiratory syndrome coronavirus 2 main protease (Mpro<\/sup>) inhibitor with potent pan\u2013human-coronavirus activity in vitro.<\/p>\n\n\n\n

METHODS<\/h2>\n\n\n\n

We conducted a phase 2\u20133 double-blind, randomized, controlled trial in which symptomatic, unvaccinated, nonhospitalized adults at high risk for progression to severe coronavirus disease 2019 (Covid-19) were assigned in a 1:1 ratio to receive either 300 mg of nirmatrelvir plus 100 mg of ritonavir (a pharmacokinetic enhancer) or placebo every 12 hours for 5 days. Covid-19\u2013related hospitalization or death from any cause through day 28, viral load, and safety were evaluated.<\/p>\n\n\n\n

RESULTS<\/h2>\n\n\n\n

A total of 2246 patients underwent randomization; 1120 patients received nirmatrelvir plus ritonavir (nirmatrelvir group) and 1126 received placebo (placebo group). In the planned interim analysis of patients treated within 3 days after symptom onset (modified intention-to treat population, comprising 774 of the 1361 patients in the full analysis population), the incidence of Covid-19\u2013related hospitalization or death by day 28 was lower in the nirmatrelvir group than in the placebo group by 6.32 percentage points (95% confidence interval [CI], \u22129.04 to \u22123.59; P<0.001; relative risk reduction, 89.1%); the incidence was 0.77% (3 of 389 patients) in the nirmatrelvir group, with 0 deaths, as compared with 7.01% (27 of 385 patients) in the placebo group, with 7 deaths. Efficacy was maintained in the final analysis involving the 1379 patients in the modified intention-to-treat population, with a difference of \u22125.81 percentage points (95% CI, \u22127.78 to \u22123.84; P<0.001; relative risk reduction, 88.9%). All 13 deaths occurred in the placebo group. The viral load was lower with nirmaltrelvir plus ritonavir than with placebo at day 5 of treatment, with an adjusted mean difference of \u22120.868 log10<\/sub> copies per milliliter when treatment was initiated within 3 days after the onset of symptoms. The incidence of adverse events that emerged during the treatment period was similar in the two groups (any adverse event, 22.6% with nirmatrelvir plus ritonavir vs. 23.9% with placebo; serious adverse events, 1.6% vs. 6.6%; and adverse events leading to discontinuation of the drugs or placebo, 2.1% vs. 4.2%). Dysgeusia (5.6% vs. 0.3%) and diarrhea (3.1% vs. 1.6%) occurred more frequently with nirmatrelvir plus ritonavir than with placebo.<\/p>\n\n\n\n

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CONCLUSIONS<\/h2>\n\n\n\n

Treatment of symptomatic Covid-19 with nirmatrelvir plus ritonavir resulted in a risk of progression to severe Covid-19 that was 89% lower than the risk with placebo, without evident safety concerns. (Supported by Pfizer; ClinicalTrials.gov number, NCT04960202. opens in new tab<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLE Oral Nirmatrelvir for High-Risk, Nonho […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21320"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21320"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21320\/revisions"}],"predecessor-version":[{"id":21321,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21320\/revisions\/21321"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21320"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21320"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21320"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}