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AI134307"],"award-info":[{"award-number":["K23 AI134307"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["K24 AI150349"],"award-info":[{"award-number":["K24 AI150349"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,9,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>A 4-month regimen containing rifapentine and moxifloxacin has noninferior efficacy compared to the standard 6-month regimen for drug-sensitive tuberculosis. We evaluated the effect of regimens containing daily, high-dose rifapentine on efavirenz pharmacokinetics and viral suppression in patients with human immunodeficiency virus (HIV)-associated tuberculosis (TB).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In the context of a Phase 3 randomized controlled trial, HIV-positive individuals already virally suppressed on efavirenz--containing antiretroviral therapy (ART) (EFV1), or newly initiating efavirenz (EFV2) received TB treatment containing rifapentine (1200\u00a0mg), isoniazid, pyrazinamide, and either ethambutol or moxifloxacin. Mid-interval efavirenz concentrations were measured (a) during ART and TB cotreatment (Weeks 4, 8, 12, and 17, different by EFV group) and (b) when ART was taken alone (pre- or post-TB treatment, Weeks 0 and 22). Apparent oral clearance (CL\/F) was estimated and compared. Target mid-interval efavirenz concentrations were\u2005&amp;gt;\u20051\u00a0mg\/L. Co-treatment was considered acceptable if\u2005&amp;gt;\u200580% of participants had mid-interval efavirenz concentrations meeting this target.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>EFV1 and EFV2 included 70 and 41 evaluable participants, respectively. The geometric mean ratio comparing efavirenz CL\/F with vs without TB drugs was 0.79 (90% confidence interval [CI] .72\u2013.85) in EFV1 and 0.84 [90% CI .69\u2013.97] in EFV2. The percent of participants with mid-interval efavirenz concentrations\u2005&amp;gt;\u20051mg\/L in EFV1 at Weeks 0, 4, 8, and 17 was 96%, 96%, 88%, and 89%, respectively. In EFV2, at approximately 4 and 8 weeks post efavirenz initiation, the value was 98%.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>TB treatment containing high-dose daily rifapentine modestly decreased (rather than increased) efavirenz clearance and therapeutic targets were met supporting the use of efavirenz with these regimens, without dose adjustment.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT 02410772.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciab1037","type":"journal-article","created":{"date-parts":[[2021,12,14]],"date-time":"2021-12-14T20:22:14Z","timestamp":1639513334000},"page":"560-566","source":"Crossref","is-referenced-by-count":4,"title":["Efavirenz Pharmacokinetics and Human Immunodeficiency Virus Type 1 (HIV-1) Viral Suppression Among Patients Receiving Tuberculosis Treatment Containing Daily High-Dose Rifapentine"],"prefix":"10.1093","volume":"75","author":[{"given":"Anthony T","family":"Podany","sequence":"first","affiliation":[{"name":"University of Nebraska Medical Center , Omaha, Nebraska , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Pham","sequence":"additional","affiliation":[{"name":"University of Nebraska Medical Center , Omaha, Nebraska , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin","family":"Sizemore","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention , Atlanta, Georgia , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil","family":"Martinson","sequence":"additional","affiliation":[{"name":"Perinatal HIV Research Unit (PHRU), University of the Witwatersrand , Johannesburg , South 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