{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,12]],"date-time":"2025-07-12T22:48:06Z","timestamp":1752360486499,"version":"3.40.5"},"reference-count":41,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,12,12]],"date-time":"2019-12-12T00:00:00Z","timestamp":1576108800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["K23AI108355","UM1 AI068634","UM1 AI068636","UM1 AI106701","UM1AI069415","UM1AI069424","UM1AI069432","UM1AI069471","UM1AI069481","UM1AI069501","UM1AI069503","UM1AI069511"],"award-info":[{"award-number":["K23AI108355","UM1 AI068634","UM1 AI068636","UM1 AI106701","UM1AI069415","UM1AI069424","UM1AI069432","UM1AI069471","UM1AI069481","UM1AI069501","UM1AI069503","UM1AI069511"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>AIDS Clinical Trials Group study A5334s evaluated the pharmacokinetics of raltegravir before and during combined administration of ombitasvir, paritaprevir\/ritonavir, plus dasabuvir (OBV\/PTV\/r + DSV) and weight\u2010based ribavirin in human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfected adults. The pharmacokinetics of OBV\/PTV\/r + DSV during raltegravir coadministration were also characterized.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adults living with HIV\/HCV coinfection receiving steady\u2010state raltegravir (400 mg twice daily) with 2 nucleos(t)ide analogues were enrolled. Pharmacokinetics of raltegravir were assessed prior to HCV therapy, and 4 weeks later following initiation of OBV\/PTV\/r (25\/150\/100 mg) once daily + DSV (250 mg) twice daily. Geometric mean ratios (GMRs) and 90% confidence intervals (CIs) were used to compare the following: raltegravir pharmacokinetics with HCV therapy (week 4) <jats:italic>vs<\/jats:italic> before HCV therapy (week 0); OBV\/PTV\/r and DSV pharmacokinetics <jats:italic>vs<\/jats:italic> historical healthy controls; raltegravir pharmacokinetics at week 0 <jats:italic>vs<\/jats:italic> historical control adults living with HIV.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Eight of 11 participants had decreased raltegravir exposures after initiation of HCV therapy. The GMRs (90% CI) for maximum concentration and area under the concentration\u2013time curve of raltegravir with <jats:italic>vs<\/jats:italic> without HCV therapy were 0.68 (0.38\u20131.19) and 0.82 (0.58\u20131.17), respectively. Comparing OBV\/PTV\/r pharmacokinetics in healthy controls, A5334s study participants demonstrated generally lower maximum concentration and area under the concentration\u2013time curve values by 41\u201382% and 4\u201373%, respectively. Raltegravir exposures tended to be higher in A5334s study participants compared to adults living with HIV.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The majority of participants' plasma raltegravir exposures were lower after initiation of HCV therapy in coinfected adults; however, confidence intervals were wide.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.14148","type":"journal-article","created":{"date-parts":[[2019,10,27]],"date-time":"2019-10-27T10:04:40Z","timestamp":1572170680000},"page":"132-142","source":"Crossref","is-referenced-by-count":4,"title":["Raltegravir pharmacokinetics before and during treatment with ombitasvir, paritaprevir\/ritonavir plus dasabuvir in adults with human immunodeficiency virus\u20101 and hepatitis C virus coinfection: AIDS Clinical Trials Group sub\u2010study A5334s"],"prefix":"10.1111","volume":"86","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2394-9513","authenticated-orcid":false,"given":"Charles S.","family":"Venuto","sequence":"first","affiliation":[{"name":"University of Rochester  Rochester NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoninah S.","family":"Cramer","sequence":"additional","affiliation":[{"name":"Harvard TH Chan School of Public Health  Boston MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan L.","family":"Rosenkranz","sequence":"additional","affiliation":[{"name":"Harvard TH Chan School of Public Health  Boston MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Sulkowski","sequence":"additional","affiliation":[{"name":"Johns Hopkins University  Baltimore MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David L.","family":"Wyles","sequence":"additional","affiliation":[{"name":"Denver Health Medical Center  Denver CO USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel E.","family":"Cohen","sequence":"additional","affiliation":[{"name":"AbbVie, Inc  North Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey","family":"Schmidt","sequence":"additional","affiliation":[{"name":"AbbVie, Inc  North Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beverly L.","family":"Alston\u2010Smith","sequence":"additional","affiliation":[{"name":"National Institutes of Health  Bethesda MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gene D.","family":"Morse","sequence":"additional","affiliation":[{"name":"University at Buffalo  Buffalo NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,12,12]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(15)00485-5"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-2667(16)30020-2"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001646"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvh.12866"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/COH.0000000000000187"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciw219"},{"key":"e_1_2_10_8_1","unstructured":"Panel on Antiretroviral Guidelines for Adults and Adolescents.Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. 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