{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T04:42:04Z","timestamp":1789533724158,"version":"build-2803163510"},"reference-count":31,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,12,21]],"date-time":"2024-12-21T00:00:00Z","timestamp":1734739200000},"content-version":"vor","delay-in-days":20,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Mpox, formerly known as monkeypox, has re\u2010emerged as a significant global health concern, particularly during the widespread outbreak of 2022. As an orthopoxvirus related to the eradicated smallpox virus, mpox has been primarily managed with smallpox vaccines and treatments, including the antiviral agent Tecovirimat. This systematic review aims to evaluate the effectiveness and safety of Tecovirimat in treating mpox, focusing on its use during the 2022 outbreak, especially among high\u2010risk populations, including men who have sex with men and people living with HIV. We conducted a comprehensive search across databases, such as Embase, PubMed, and Web of Science, up to August 30, 2024. The selection involved a two\u2010stage review process utilizing the Nested Knowledge platform, which helped streamline the screening and data extraction. We included studies that focused on the clinical efficacy and safety of Tecovirimat in human patients with confirmed mpox infections. Our analysis mainly synthesized data narratively due to the heterogeneity of study designs and outcomes. Fifteen studies met the inclusion criteria, providing data on 1031 mpox cases. The preliminary analysis of the PALM 007 RCT indicated that tecovirimat did not significantly outperform placebo in lesion resolution for all patients. Lesions healed faster than expected, regardless of tecovirimat or placebo treatment. A lower mortality rate of 1.7% among those enrolled in the PALM 007 RCT was observed, compared to the general mpox mortality rate of 3.6% or higher in the DRC. Observational studies revealed that early administration of Tecovirimat, especially within the first week of symptom onset, significantly improves symptom resolution, reduces the severity of the disease, and decreases the likelihood of hospitalization and complications in observational studies. However, the impact on viral clearance was inconsistent, and some studies suggested limited efficacy in severely immunocompromised patients. Regarding safety, Tecovirimat was generally well\u2010tolerated as indicated by the RCT; however, mild adverse effects such as fatigue, headache, and nausea were commonly reported among observational studies. Serious adverse events were rare but included elevated liver enzymes and psychiatric symptoms, particularly in patients with pre\u2010existing conditions. Tecovirimat demonstrates some potential benefits in treating mpox, particularly when administered early. The PALM 007 RCT failed to meet the efficacy point. Tecovirimat is generally well\u2010tolerated with a favorable safety profile, although monitoring is advisable for those with existing liver or renal conditions. Despite promising results, further large\u2010scale randomized controlled trials are needed to fully ascertain the drug's effectiveness across diverse populations and to explore its impact on viral clearance and transmission dynamics.<\/jats:p>","DOI":"10.1002\/jmv.70122","type":"journal-article","created":{"date-parts":[[2024,12,21]],"date-time":"2024-12-21T11:49:26Z","timestamp":1734781766000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Effectiveness of Tecovirimat in Mpox Cases: A Systematic Review of Current Evidence"],"prefix":"10.1002","volume":"96","author":[{"given":"Muhammed","family":"Shabil","sequence":"first","affiliation":[{"name":"University Center for Research and Development Chandigarh University Mohali Punjab India"},{"name":"Medical Laboratories Techniques Department AL\u2010Mustaqbal University Hillah Babil Iraq"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahalaqua Nazli","family":"Khatib","sequence":"additional","affiliation":[{"name":"Division of Evidence Synthesis, Global Consortium of Public Health and Research Datta Meghe Institute of Higher Education Wardha India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suhas","family":"Ballal","sequence":"additional","affiliation":[{"name":"Department of Chemistry and Biochemistry, School of Sciences JAIN (Deemed to be University) Bangalore Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pooja","family":"Bansal","sequence":"additional","affiliation":[{"name":"Department of Allied Healthcare and Sciences Vivekananda Global University Jaipur Rajasthan India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Balvir S.","family":"Tomar","sequence":"additional","affiliation":[{"name":"Institute of Pediatric Gastroenterology and Hepatology NIMS University Jaipur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayash","family":"Ashraf","sequence":"additional","affiliation":[{"name":"Chandigarh Pharmacy College, Chandigarh Group of College Mohali Punjab India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Ravi","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Chemistry Raghu Engineering College Visakhapatnam Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aashna","family":"Sinha","sequence":"additional","affiliation":[{"name":"School of Applied and Life Sciences, Division of Research and Innovation Uttaranchal University Dehradun India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pramod","family":"Rawat","sequence":"additional","affiliation":[{"name":"Department of Biotechnology Graphic Era (Deemed to be University) Dehradun India"},{"name":"Department of Allied Sciences Graphic Era Hill University Dehradun India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abhay M.","family":"Gaidhane","sequence":"additional","affiliation":[{"name":"School of Epidemiology and Public Health, Datta Meghe Institute of Higher Education, Jawaharlal Nehru Medical College, and Global Health Academy Wardha India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ganesh","family":"Bushi","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences Lovely Professional University Phagwara India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahendra Pratap","family":"Singh","sequence":"additional","affiliation":[{"name":"Center for Global Health Research, Saveetha Institute of Medical and Technical Sciences, Saveetha Medical College and Hospital Saveetha University Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiran","family":"Bhopte","sequence":"additional","affiliation":[{"name":"IES Institute of Pharmacy IES University Bhopal Madhya Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manvi","family":"Pant","sequence":"additional","affiliation":[{"name":"New Delhi Institute of Management New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nagavalli","family":"Chilakam","sequence":"additional","affiliation":[{"name":"Noida Institute of Engineering and Technology (Pharmacy Institute) Greater Noida India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sakshi","family":"Pandey","sequence":"additional","affiliation":[{"name":"Centre of Research Impact and Outcome Chitkara University Rajpura Punjab India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manvinder","family":"Brar","sequence":"additional","affiliation":[{"name":"Chitkara Centre for Research and Development Chitkara University  Himachal Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashok Kumar","family":"Balaraman","sequence":"additional","affiliation":[{"name":"Research and Enterprise University of Cyberjaya Cyberjaya Selangor Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4771-4089","authenticated-orcid":false,"given":"Rachana","family":"Mehta","sequence":"additional","affiliation":[{"name":"Clinical Microbiology, RDC, Manav Rachna International Institute of Research and Studies Faridabad Haryana India"},{"name":"Dr. Lal Pathlabs Nepal Kathmandu Nepal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zahir Ali","family":"Shaikh","sequence":"additional","affiliation":[{"name":"St. Elizabeth Medical Centre Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harapan","family":"Harapan","sequence":"additional","affiliation":[{"name":"Department of Microbiology, School of Medicine Universitas Syiah Kuala Banda Aceh Indonesia"},{"name":"School of Medicine, Tropical Disease Center Universitas Syiah Kuala Banda Aceh Indonesia"},{"name":"Medical Research Unit, School of Medicine Universitas Syiah Kuala Banda Aceh Indonesia"},{"name":"Tsunami &amp; Disaster Mitigation Research Centre (TDMRC) Universitas Syiah Kuala Banda Aceh Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2695-8714","authenticated-orcid":false,"given":"Ranjit","family":"Sah","sequence":"additional","affiliation":[{"name":"SR Sanjeevani Hospital Kalyanpur Siraha Nepal"},{"name":"Department of Paediatrics, Dr. D. 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Patil Vidyapeeth University Pune Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,12,21]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/hsr2.1603"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.61505\/evidence.2024.2.3.82"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11904-023-00661-1"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph20042963"},{"issue":"1","key":"e_1_2_12_6_1","first-page":"13","article-title":"Overview of Case Definitions and Contact Tracing Indications in the 2022 Monkeypox Outbreak","volume":"31","author":"Guarducci G.","year":"2022","journal-title":"Le Infezioni in Medicina"},{"issue":"1","key":"e_1_2_12_7_1","first-page":"12","article-title":"Monkeypox Virus Infections in Low\u2010Risk Groups During the 2022\u201023 Global Outbreak: An Analysis of the WHO Global Report","volume":"32","author":"Ram\u00edrez\u2010Soto M. 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National Institutes of Health \u201d2024 accessed September 10 2024 https:\/\/www.nih.gov\/news-events\/news-releases\/antiviral-tecovirimat-safe-did-not-improve-clade-i-mpox-resolution-democratic-republic-congo."},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.3390\/v16050784"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.7326\/M22-3132"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofae294"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofae029"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.28868"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n71"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jiac.2023.11.025"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2023.7696"},{"key":"e_1_2_12_21_1","doi-asserted-by":"crossref","DOI":"10.1177\/1357633X231194796","article-title":"Implementation and Early Outcomes of a Telehealth Visit Model to Deliver Tecovirimat for Mpox Infection in New York City","author":"Chan J.","year":"2023","journal-title":"Journal of Telemedicine and Telecare"},{"key":"e_1_2_12_22_1","first-page":"55","article-title":"Treatment of Severe Human Mpox Virus Infection With Tecovirimat","volume":"5","author":"Demir K. 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