{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T03:01:59Z","timestamp":1787022119372,"version":"build-2736575974"},"reference-count":59,"publisher":"Public Library of Science (PLoS)","issue":"5","license":[{"start":{"date-parts":[[2023,5,17]],"date-time":"2023-05-17T00:00:00Z","timestamp":1684281600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"The Mexican Congress Equity & Gender Commission","award":["The Mexican Congress Equity & Gender Commission"],"award-info":[{"award-number":["The Mexican Congress Equity & Gender Commission"]}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>High HHV-8 viral load (VL) in Kaposi Sarcoma (KS) has been associated with Severe Immune Reconstitution Inflammatory Syndrome (Severe-IRIS-KS), which can occur after initiating cART, and leads to high mortality, particularly in patients with pulmonary involvement. We investigate if valganciclovir (as an anti-HHV-8 agent) initiated before cART reduces the mortality associated with Severe-IRIS-KS and the incidence of Severe-IRIS-KS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Open-label parallel-group randomized clinical trial in AIDS cART na\u00efve patients with disseminated KS (DKS) as defined by at least two of the following: pulmonary, lymph-node, or gastrointestinal involvement, lymphedema, or \u226530 skin lesions. In the experimental group (EG), patients received valganciclovir 900 mg BID four weeks before cART and continued until week 48; in the control group (CG), cART was initiated on week 0. Non-severe-IRIS-KS was defined as: an increase in the number of lesions plus a decrease of \u2265one log10 HIV-VL, or an increase of \u226550cells\/mm3 or \u22652-fold in baseline CD4+cells. Severe-IRIS-KS was defined as abrupt clinical worsening of KS lesions and\/or fever after ruling out another infection following cART initiation, and at least three of the following: thrombocytopenia, anemia, hyponatremia, or hypoalbuminemia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>40 patients were randomized and 37 completed the study. In the ITT analysis, at 48 weeks, total mortality was the same in both groups (3\/20), severe-IRIS-KS attributable mortality was 0\/20 in the EG, compared with 3\/20 in the CG (p = 0.09), similar to the per-protocol analysis: 0\/18 in the EG, and 3\/19 in the control group (p = 0.09). The crude incidence rate of severe-IRIS-KS was four patients developed a total of 12 episodes of Severe-IRIS-KS in the CG and two patients developed one episode each in the EG. Mortality in patients with pulmonary KS was nil in the EG (0\/5) compared with 3\/4 in the CG (P = 0.048). No difference was found between groups in the number of non-S-IRIS-KS events. Among survivors at week 48, 82% achieved &gt;80% remission.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Although mortality attributable to KS was lower in the EG the difference was not statistically significant.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0280209","type":"journal-article","created":{"date-parts":[[2023,5,17]],"date-time":"2023-05-17T13:32:58Z","timestamp":1684330378000},"page":"e0280209","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":11,"title":["Impact of valganciclovir therapy on severe IRIS-Kaposi Sarcoma mortality: An open-label, parallel, randomized controlled trial"],"prefix":"10.1371","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1991-0923","authenticated-orcid":true,"given":"Patricia","family":"Volkow","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2334-0361","authenticated-orcid":true,"given":"Leslie","family":"Chavez Galan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucero","family":"Ramon-Luing","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Cruz-Velazquez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Cornejo-Juarez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabel","family":"Sada-Ovalle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rogelio","family":"Perez-Padilla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beda","family":"Islas-Mu\u00f1oz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the Kaposi Sarcoma Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2023,5,17]]},"reference":[{"issue":"2","key":"pone.0280209.ref001","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1097\/00000372-198100320-00002","article-title":"A preliminary communication on extensively disseminated Kaposi\u2019s sarcoma in young homosexual men.","volume":"3","author":"GJ Gottlieb","year":"1981","journal-title":"Am J Dermatopathol"},{"issue":"8247","key":"pone.0280209.ref002","doi-asserted-by":"crossref","first-page":"598","DOI":"10.1016\/S0140-6736(81)92740-9","article-title":"Kaposi\u2019s sarcoma in homosexual men-a report of eight cases","volume":"2","author":"KB Hymes","year":"1981","journal-title":"Lancet Lond Engl"},{"issue":"5","key":"pone.0280209.ref003","doi-asserted-by":"crossref","first-page":"744","DOI":"10.7326\/0003-4819-103-5-744","article-title":"The natural history of Kaposi\u2019s sarcoma in the acquired immunodeficiency syndrome","volume":"103","author":"B Safai","year":"1985","journal-title":"Ann Intern Med"},{"issue":"11","key":"pone.0280209.ref004","doi-asserted-by":"crossref","first-page":"1029","DOI":"10.1056\/NEJMra1615896","article-title":"HIV-Associated Cancers and Related Diseases","volume":"378","author":"R Yarchoan","year":"2018","journal-title":"N Engl J Med"},{"key":"pone.0280209.ref005","first-page":"5","article-title":"Epidemiology of Kaposi\u2019s sarcoma","volume":"10","author":"V. Beral","year":"1991","journal-title":"Cancer Surv"},{"issue":"6 Pt 1","key":"pone.0280209.ref006","doi-asserted-by":"crossref","first-page":"693","DOI":"10.7326\/0003-4819-96-6-693","article-title":"Disseminated Kaposi\u2019s sarcoma in homosexual men","volume":"96","author":"AE Friedman-Kien","year":"1982","journal-title":"Ann Intern Med"},{"issue":"4","key":"pone.0280209.ref007","first-page":"635","volume":"27","author":"JM Lacombe","year":"2013","journal-title":"Risk of Kaposi sarcoma during the first months on combination antiretroviral therapy: AIDS"},{"issue":"5","key":"pone.0280209.ref008","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1097\/QAI.0000000000000360","article-title":"Incidence Rate of Kaposi Sarcoma in HIV-Infected Patients on Antiretroviral Therapy in Southern Africa: A Prospective Multicohort Study.","volume":"67","author":"E Rohner","year":"2014","journal-title":"JAIDS J Acquir Immune Defic Syndr."},{"issue":"6","key":"pone.0280209.ref009","doi-asserted-by":"crossref","first-page":"e64392","DOI":"10.1371\/journal.pone.0064392","article-title":"Treatment response and mortality among patients starting antiretroviral therapy with and without Kaposi sarcoma: a cohort study.","volume":"8","author":"M Maskew","year":"2013","journal-title":"PloS One"},{"issue":"3","key":"pone.0280209.ref010","doi-asserted-by":"crossref","first-page":"424","DOI":"10.1093\/cid\/cir802","article-title":"Paradoxical immune reconstitution inflammatory syndrome in HIV-infected patients treated with combination antiretroviral therapy after AIDS-defining opportunistic infection","volume":"54","author":"CJ Achenbach","year":"2012","journal-title":"Clin Infect Dis Off Publ Infect Dis Soc Am"},{"issue":"5","key":"pone.0280209.ref011","doi-asserted-by":"crossref","first-page":"589","DOI":"10.1097\/QAI.0b013e3181bc476f","article-title":"Predictors of immune reconstitution inflammatory syndrome-associated with kaposi sarcoma in mozambique: a prospective study.","volume":"53","author":"E Letang","year":"2010","journal-title":"J Acquir Immune Defic Syndr 1999."},{"issue":"1","key":"pone.0280209.ref012","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1186\/s12981-017-0156-9","article-title":"Clinical characteristics, predictors of immune reconstitution inflammatory syndrome and long-term prognosis in patients with Kaposi sarcoma","volume":"14","author":"P Volkow","year":"2017","journal-title":"AIDS Res Ther"},{"issue":"22","key":"pone.0280209.ref013","doi-asserted-by":"crossref","first-page":"5224","DOI":"10.1200\/JCO.2005.14.597","article-title":"Immune Reconstitution Inflammatory Syndrome Associated With Kaposi\u2019s Sarcoma.","volume":"23","author":"M Bower","year":"2005","journal-title":"J Clin Oncol."},{"issue":"5","key":"pone.0280209.ref014","doi-asserted-by":"crossref","first-page":"841","DOI":"10.1093\/infdis\/jiz180","article-title":"The Contribution of Kaposi\u2019s Sarcoma\u2013Associated Herpesvirus to Mortality in Hospitalized Human Immunodeficiency Virus\u2013Infected Patients Being Investigated for Tuberculosis in South Africa","volume":"220","author":"MJ Blumenthal","year":"2019","journal-title":"J Infect Dis"},{"issue":"3","key":"pone.0280209.ref015","doi-asserted-by":"crossref","first-page":"342","DOI":"10.1086\/654800","article-title":"Evaluation of plasma human herpesvirus 8 DNA as a marker of clinical outcomes during antiretroviral therapy for AIDS-related Kaposi sarcoma in Zimbabwe","volume":"51","author":"M Borok","year":"2010","journal-title":"Clin Infect Dis Off Publ Infect Dis Soc Am"},{"issue":"10","key":"pone.0280209.ref016","doi-asserted-by":"crossref","first-page":"1603","DOI":"10.1097\/QAD.0b013e328360a5a1","article-title":"Immune reconstitution inflammatory syndrome associated with Kaposi sarcoma: higher incidence and mortality in Africa than in the UK","volume":"27","author":"E Letang","year":"2013","journal-title":"AIDS"},{"issue":"12","key":"pone.0280209.ref017","doi-asserted-by":"crossref","first-page":"2754","DOI":"10.1128\/AAC.41.12.2754","article-title":"Antiviral drug susceptibility of human herpesvirus 8","volume":"41","author":"J Neyts","year":"1997","journal-title":"Antimicrob Agents Chemother"},{"key":"pone.0280209.ref018","first-page":"6","author":"MM Medveczky","journal-title":"In vitro antiviral drug sensitivity of the Kaposi\u2019s sarcoma-associated herpesvirus."},{"issue":"9","key":"pone.0280209.ref019","doi-asserted-by":"crossref","first-page":"2082","DOI":"10.1172\/JCI119380","article-title":"Sensitivity of Kaposi\u2019s sarcoma-associated herpesvirus replication to antiviral drugs. 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