{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T07:51:02Z","timestamp":1789026662158,"version":"build-2803163510"},"reference-count":25,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2013,5,15]],"date-time":"2013-05-15T00:00:00Z","timestamp":1368576000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2013,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p>The potential impact of tesamorelin on CYP3A activity was investigated by examining its effect on the pharmacokinetics of simvastatin and ritonavir. In two randomized, two\u2010way crossover studies, subjects were administered 2\u2009mg tesamorelin on Days 1\u20137 with 80\u2009mg simvastatin or 100\u2009mg ritonavir co\u2010administered on Day 6 (Treatment A), and a single dose of simvastatin or ritonavir alone on Day 6 (Treatment B). Pharmacokinetic samples were collected on Day 6 to measure simvastatin, ritonavir and tesamorelin plasma concentrations. For simvastatin, A\/B ratios of least squares geometric means and corresponding 90% confidence intervals (CIs) for AUC<jats:sub>0\u2212t<\/jats:sub>, AUC<jats:sub>0\u2212inf<\/jats:sub> and C<jats:sub>max<\/jats:sub> were contained within the usual no effect range of 80\u2013125%. For ritonavir, ratios and 90% CIs for AUCs were within this acceptance range, but the lower CI for C<jats:sub>max<\/jats:sub> was 74.8%, suggesting a decreased rate of exposure. However, since the A\/B ratios for AUCs and C<jats:sub>max<\/jats:sub> parameters were approximately 90%, these were minor decreases and no dose adjustment of ritonavir is required in the presence of tesamorelin. These studies showed that the impact of tesamorelin on CYP3A activity appears to be minimal, if any. Either medication may be co\u2010administered with tesamorelin in patients without changing their original dosing regimen.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cpdd.27","type":"journal-article","created":{"date-parts":[[2013,5,15]],"date-time":"2013-05-15T17:19:08Z","timestamp":1368638348000},"page":"237-245","source":"Crossref","is-referenced-by-count":3,"title":["Impact of Tesamorelin, a Growth Hormone\u2010Releasing Factor (GRF) Analogue, on the Pharmacokinetics of Simvastatin and Ritonavir in Healthy Volunteers"],"prefix":"10.1002","volume":"2","author":[{"given":"Shirley","family":"Teng","sequence":"first","affiliation":[{"name":"PRACS Institute Fargo, ND USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane","family":"Potvin","sequence":"additional","affiliation":[{"name":"Theratechnologies Inc. Qu\u00e9bec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Claude","family":"Mamputu","sequence":"additional","affiliation":[{"name":"Theratechnologies Inc. Qu\u00e9bec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Genevi\u00e8ve","family":"Vincent","sequence":"additional","affiliation":[{"name":"Theratechnologies Inc. Qu\u00e9bec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monika","family":"Zoltowska","sequence":"additional","affiliation":[{"name":"Theratechnologies Inc. Qu\u00e9bec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9e","family":"Morin","sequence":"additional","affiliation":[{"name":"Theratechnologies Inc. Qu\u00e9bec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saida","family":"Hatimi","sequence":"additional","affiliation":[{"name":"Theratechnologies Inc. Qu\u00e9bec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie\u2010Elise","family":"Michaud","sequence":"additional","affiliation":[{"name":"Theratechnologies Inc. Qu\u00e9bec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"High","sequence":"additional","affiliation":[{"name":"Theratechnologies Inc. Qu\u00e9bec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murray P.","family":"Ducharme","sequence":"additional","affiliation":[{"name":"Learn and Confirm Inc. 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Poster Presented at: XVII International AIDS Conference; Aug 3\u20138 2008; Mexico City Mexico."},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2362.2002.01018.x"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.81.5.1999"},{"key":"e_1_2_6_9_1","doi-asserted-by":"crossref","first-page":"409","DOI":"10.1201\/b14095","volume-title":"Pharmacokinetics","author":"Gibaldi M","year":"1982"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01068419"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/48.4.613"},{"key":"e_1_2_6_12_1","doi-asserted-by":"crossref","first-page":"1207","DOI":"10.1093\/clinchem\/46.8.1207","article-title":"Falsely increased values for rabbit immunoglobulin\u2010based nephelometric immunoassays attributable to human anti\u2010rabbit antibodies","volume":"46","author":"Butch AW.","year":"2000","journal-title":"Clin Chem."},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1258\/0004563021901793"},{"key":"e_1_2_6_14_1","doi-asserted-by":"crossref","first-page":"348","DOI":"10.1093\/clinchem\/31.2.348","article-title":"Interference in a two\u2010site immunoradiometric assay for thyrotropin in a child","volume":"31","author":"Cusick CF","year":"1985","journal-title":"Clin Chem."},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2265.1994.tb02563.x"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/44.10.2212"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11883-010-0152-1"},{"key":"e_1_2_6_18_1","first-page":"15","article-title":"From concept to care: pharmacokinetic boosting of protease inhibitors","volume":"9","author":"Boffito M.","year":"2004","journal-title":"PRN Notebook"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/00126334-200010001-00002"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.2009.00430.x"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10565-007-9004-3"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2010.176"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2012.08.017"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1124\/mol.106.026450"},{"key":"e_1_2_6_25_1","unstructured":"MichaudSE AbolfathiZ PotvinD et al. Pharmacokinetic\/pharmacodynamic evaluation of Tesamorelin (TH9507) a growth hormone\u2010releasing factor (GRF) analog administered subcutaneously once daily for 14 consecutive days in healthy and HIV positive populations. Poster presented at: ENDO 2009; June 10\u201313 2009; Washington DC USA."},{"key":"e_1_2_6_26_1","unstructured":"Norvir [package insert]. 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