{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T15:23:03Z","timestamp":1785424983214,"version":"3.56.0"},"reference-count":20,"publisher":"American Society for Microbiology","issue":"6","license":[{"start":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T00:00:00Z","timestamp":1780444800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T00:00:00Z","timestamp":1780444800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2026,6,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      GST-HG171 (also known as atilotrelvir) is a novel, orally administered 3CL protease inhibitor approved in China for treating mild-to-moderate COVID-19. In this study, we assessed the drug-drug interaction between GST-HG171 (boosted with ritonavir) and itraconazole (a strong CYP3A inhibitor) in healthy Chinese adult volunteers. A total of 12 healthy subjects were enrolled in this two-period study. In period 1, all subjects received 150 mg GST-HG171\/100 mg ritonavir twice daily (BID) on Days 1\u20133 (with a single dose on Day 3); after a 5-day washout period, subjects proceeded to period 2. In period 2, subjects orally took 200 mg itraconazole once daily (QD) on Days 8\u201316. On Days 12\u201314, subjects were co-administered 150 mg GST-HG171\/100 mg ritonavir (BID, with a single dose on Day 14) and itraconazole. Serial blood samples were collected after administration of GST-HG171\/ritonavir alone and co-administration of itraconazole for the measurement of pharmacokinetic parameters. Co-administration of itraconazole with GST-HG171\/ritonavir resulted in a mild increase in the\n                      <jats:italic toggle=\"yes\">C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      of GST-HG171 and ritonavir by approximately 8% and 28%, respectively, while systemic exposure (area under the plasma concentration-time curve [AUC]) was elevated by approximately 45% and 33%, respectively. There was no apparent increase in the incidence or severity of AEs during the co-administration period. In conclusion, co-administration of itraconazole, a strong CYP3A4 inhibitor, with GST-HG171\/ritonavir resulted in a moderate increase in exposure of GST-HG171 and mild increase in exposure of ritonavir, and it had an acceptable safety profile and was well tolerated in this study.\n                    <\/jats:p>\n                    <jats:sec>\n                      <jats:title>CLINICAL TRIALS<\/jats:title>\n                      <jats:p>\n                        This study is registered with ClinicalTrials.gov as\n                        <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT06087055\" xlink:type=\"simple\">NCT06087055<\/jats:ext-link>\n                        .\n                      <\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/aac.00285-26","type":"journal-article","created":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T12:54:32Z","timestamp":1778504072000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic drug-drug interaction between the COVID-19 3CL protease inhibitor GST-HG171 and itraconazole in healthy subjects"],"prefix":"10.1128","volume":"70","author":[{"given":"Xiaojiao","family":"Li","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/034haf133","id-type":"ROR","asserted-by":"publisher"}],"name":"The First Hospital of Jilin University, Phase I Clinical Research Center","place":["Jilin, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bing","family":"Li","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/034haf133","id-type":"ROR","asserted-by":"publisher"}],"name":"The First Hospital of Jilin University, Phase 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Center","place":["Jilin, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Mao","sequence":"additional","affiliation":[{"name":"Fujian Akeylink Biotechnology Co., Ltd.","place":["Fuzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tianxiang","family":"Zhang","sequence":"additional","affiliation":[{"name":"Fujian Akeylink Biotechnology Co., Ltd.","place":["Fuzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanan","family":"Tang","sequence":"additional","affiliation":[{"name":"Fujian Akeylink Biotechnology Co., Ltd.","place":["Fuzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenhao","family":"Yan","sequence":"additional","affiliation":[{"name":"Fujian Akeylink Biotechnology Co., Ltd.","place":["Fuzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chuanjing","family":"Li","sequence":"additional","affiliation":[{"name":"Fujian Akeylink Biotechnology Co., Ltd.","place":["Fuzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Zhang","sequence":"additional","affiliation":[{"name":"Fujian Akeylink Biotechnology Co., Ltd.","place":["Fuzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2320-4404","authenticated-orcid":true,"given":"Yanhua","family":"Ding","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/034haf133","id-type":"ROR","asserted-by":"publisher"}],"name":"The First Hospital of Jilin University, Phase I Clinical Research Center","place":["Jilin, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(20)30120-1"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-020-2012-7"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41579-022-00841-7"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1002\/rmv.2398"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.3390\/biom13091339"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.1c00409"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics16020217"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.3390\/v17081064"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.3390\/arm92010009"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2024.107096"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1128\/aac.00539-24"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1128\/aac.01115-23"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2024.102582"},{"key":"e_1_3_3_15_2","unstructured":"FDA. 2023. FDA drug label: ritonavir tablet. Available from: https:\/\/dailymed.nlm.nih.gov\/dailymed\/drugInfo.cfm?setid=db633374-6d8e-4622-9fe1-f9d68baa59bb"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.562"},{"key":"e_1_3_3_17_2","unstructured":"FDA. 2025. FDA drug label: itraconazole capsule. Available from: https:\/\/dailymed.nlm.nih.gov\/dailymed\/drugInfo.cfm?setid=23126370-8d6a-4027-bd8f-860e2776ba3a"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-019-04015-w"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199512073332303"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2008.168"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-013-1530-8"}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/aac.00285-26","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/aac.00285-26","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T13:04:09Z","timestamp":1781787849000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/aac.00285-26"}},"subtitle":[],"editor":[{"given":"Zhaohui","family":"Qian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,6,3]]},"references-count":20,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,6,3]]}},"alternative-id":["10.1128\/aac.00285-26"],"URL":"https:\/\/doi.org\/10.1128\/aac.00285-26","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,3]]},"assertion":[{"value":"2026-03-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-04","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00285-26"}}