{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T22:10:04Z","timestamp":1790633404819,"version":"4.1.0"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2020,3,4]],"date-time":"2020-03-04T00:00:00Z","timestamp":1583280000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Janssen"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>We explored the combination of rilpivirine plus cobicistat-boosted darunavir [a two-drug regimen (2DR)] when switching from standard triple combined ART.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this randomized, open-label, non-inferiority trial, participants had an HIV-RNA &amp;lt;50\u2005copies\/mL on a stable (&amp;gt;6\u2005months) three-drug regimen. The primary endpoint was proportion with HIV-RNA &amp;lt;50\u2005copies\/mL at Week 24 (snapshot algorithm), with a \u201312% non-inferiority margin. ClinicalTrials.gov: NCT04064632.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>One hundred and sixty patients were allocated (1:1) to 2DR or to continue current ART (CAR). At Week 24, 72 (90.0%) of participants with 2DR and 75 (93.8%) with CAR maintained HIV-RNA &amp;lt;50\u2005copies\/mL [difference \u22123.75% (95% CI\u2009=\u2009\u221211.63 to 5.63)], confirming non-inferiority. Non-inferiority was confirmed considering an HIV-RNA &amp;gt;50\u2005copies\/mL (0% for 2DR; 3.7% for CAR; 95% CI\u2009=\u2009\u22120.4 to 7.9). Four patients reported adverse events not leading to treatment discontinuation (one patient in the 2DR group and three patients in the CAR group); eight subjects discontinued therapy in the 2DR group and three in the CAR group. With 2DR, lipid serum concentrations increased, but differences were statistically significant only for tenofovir disoproxil fumarate-containing CAR and in 2DR patients receiving a pre-switch regimen including tenofovir disoproxil fumarate. Median bone stiffness decreased in the CAR group from 86.1\u2005g\/cm2 (IQR\u2009=\u200974\u201398) to 83.2\u2005g\/cm2 (IQR\u2009=\u200974\u201397) and increased in the 2DR group from 84.9\u2005g\/cm2 (IQR\u2009=\u200974\u2013103) to 85.5\u2005g\/cm2 (IQR\u2009=\u200974\u2013101). The reduction within the CAR group was significant (P\u2009=\u20090.043).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Once-daily rilpivirine plus cobicistat-boosted darunavir is an effective 2DR that combines a high virological efficacy with a potential to avoid major NRTI toxicities.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkaa018","type":"journal-article","created":{"date-parts":[[2020,1,23]],"date-time":"2020-01-23T20:10:13Z","timestamp":1579810213000},"page":"1332-1337","source":"Crossref","is-referenced-by-count":12,"title":["Rilpivirine plus cobicistat-boosted darunavir as a two-drug switch regimen in HIV-infected, virologically suppressed subjects on steady standard three-drug therapy: a randomized, controlled, non-inferiority trial 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Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Nozza","sequence":"first","affiliation":[{"name":"San Raffaele Scientific Institute, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L","family":"Galli","sequence":"first","affiliation":[{"name":"San Raffaele Scientific Institute, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D","family":"Valenti","sequence":"first","affiliation":[{"name":"FROM Foundation, Bergamo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Rizzi","sequence":"first","affiliation":[{"name":"ASST Papa Giovanni XXIII, Bergamo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Castagna","sequence":"first","affiliation":[{"name":"San Raffaele Scientific Institute, Milan, Italy"},{"name":"Vita-Salute San Raffaele University, Milan, 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