| 000 | 03207nam a2200301 4500 | ||
|---|---|---|---|
| 001 | ESSALUD | ||
| 005 | 20260902160450.0 | ||
| 007 | ta | ||
| 008 | t pe ||||| |||| 00| 0 spa d | ||
| 040 | _aBMG | ||
| 041 | _aeng | ||
| 100 |
_aHayden, Frederick G. _954466 |
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| 245 | _aEnsitrelvir for Covid-19 postexposure prophylaxis in household contacts | ||
| 300 | _apáginas: 1905-1915 | ||
| 520 | _aBackground: Ensitrelvir, an oral inhibitor of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 3C-like protease, is approved in Japan for the treatment of mild-to-moderate coronavirus disease 2019 (Covid-19). Previously, no antiviral agents were approved for postexposure prophylaxis in household contacts of patients with Covid-19. Methods: In this double-blind, randomized, placebo-controlled trial, we randomly assigned persons who were SARS-CoV-2–negative on local diagnostic testing but were household contacts of a patient with Covid-19 (the index patient) to receive either ensitrelvir (375 mg on day 1 and 125 mg daily on days 2 through 5) or placebo within 72 hours after symptom onset in the index patient. The primary end point was Covid-19 (defined by a central laboratory–confirmed positive reverse-transcriptase–polymerase-chain-reaction assay and the presence of ≥1 of 14 prespecified Covid-19 symptoms lasting ≥48 hours) by day 10 in a household contact in the modified intention-to-treat population (all the participants who underwent randomization, had a central laboratory–confirmed negative RT-PCR test for SARS-CoV-2 at baseline, and received at least one dose of the trial drug or placebo). Results: The modified intention-to-treat population included 1030 participants in the ensitrelvir group and 1011 in the placebo group. The mean age of the participants was 42.4 years; 71.1% had undergone randomization within 48 hours after symptom onset in the index patient, and 37.0% had at least one risk factor for severe Covid-19. The incidence of Covid-19 was lower in the ensitrelvir group than in the placebo group (2.9% vs. 9.0%; risk ratio, 0.33; 95% confidence interval [CI], 0.22 to 0.49; P<0.001). The incidence of adverse events during the trial was similar in the two groups (15.1% in the ensitrelvir group and 15.5% in the placebo group), as was the incidence of serious adverse events (0.2% in each group). No Covid-19–related hospitalizations or deaths were reported. Conclusions: Ensitrelvir administered to household contacts of a patient with Covid-19 within 72 hours after symptom onset in the index patient was effective in preventing Covid-19 in the contacts. | ||
| 650 |
_aCORONAVIRUS _939659 |
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| 650 |
_aSALUD GLOBAL _910472 |
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| 650 |
_aENFERMEDADES INFECCIOSAS GENERALES _954087 |
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| 650 |
_aINFECCIONES VIRALES _953766 |
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| 700 |
_aShinkai, Masaharu _954467 |
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| 700 |
_aClark, Tristan W. _954468 |
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| 700 |
_aLuetkemeyer, Anne F. _954469 |
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| 700 |
_aSax, Paul E. _954470 |
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| 700 |
_aHanage, William P. _954471 |
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| 700 |
_aGebo, Kelly A. _954472 |
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| 773 | 0 |
_022717 _922669 _dMassachusetts NEJM Group _oNEJM014 _tThe New England Journal of Medicine _wESSALUD _x0028-4793 |
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| 942 |
_cARTICULOS _e2026-08-31 _zsqb |
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| 999 |
_c22902 _d22902 |
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