{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,10,7]],"date-time":"2024-10-07T04:11:12Z","timestamp":1728274272266},"reference-count":12,"publisher":"SAGE Publications","issue":"3-5","license":[{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p> Primary analysis at 24\u00a0weeks showed that switching to rilpivirine plus darunavir\/cobicistat was non-inferior to continuing a standard three-drug antiretroviral regimen in virologically suppressed people with HIV. We present efficacy and safety data from the 48-week analysis. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p> PROBE 2 is a randomized, open-label trial. Adults who were on a three-drug therapy and had had &lt;50 HIV-1 RNA copies\/mL for at least 6\u00a0months were randomly assigned (1:1) to 25\u00a0mg rilpivirine plus 800\/150 darunavir\/cobicistat once daily (early switch group) or to continue their regimen for 24\u00a0weeks before switching (late switch group). In the 48-week analysis, the efficacy endpoint was the proportion of participants with &lt;50 copies\/mL of HIV-RNA (US Food and Drug Administration snapshot algorithm). The trial is registered with ClinicalTrials.gov , number NCT04064632. <\/jats:p><\/jats:sec><jats:sec><jats:title>Findings<\/jats:title><jats:p> 160 participants were recruited and randomized. At week 48, 70 (87.5%) in the early switch group and 76 (94.8%) in the late switch group maintained HIV-RNA &lt;50 copies\/mL. Virological failure (\u226550 HIV-RNA copies\/mL) was not seen in any patient of the early switch group and in 2 subjects in the late switch group none of which had treatment emergent resistance-associated mutation. Adverse events leading to treatment discontinuation occurred in 7 (8.7%) participants in the early switch group and in none in the late switch group. <\/jats:p><\/jats:sec><jats:sec><jats:title>Interpretation<\/jats:title><jats:p> The combination of rilpivirine plus darunavir\/cobicistat sustained virological suppression, was associated with a low frequency of virological failure, and had a favorable safety profile, which support its use as a nucleoside reverse transcriptase inhibitor-sparing and integrase inhibitor-sparing alternative to three-drug regimens. <\/jats:p><\/jats:sec>","DOI":"10.1177\/13596535211042226","type":"journal-article","created":{"date-parts":[[2021,10,27]],"date-time":"2021-10-27T12:33:11Z","timestamp":1635337991000},"page":"51-57","update-policy":"http:\/\/dx.doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Rilpivirine plus cobicistat-boosted darunavir as alternative to standard three-drug therapy in HIV-infected, virologically suppressed subjects: Final results of the PROBE 2 trial"],"prefix":"10.1177","volume":"26","author":[{"given":"Franco","family":"Maggiolo","sequence":"first","affiliation":[{"name":"ASST Papa Giovanni XXIII, Bergamo, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicola","family":"Gianotti","sequence":"additional","affiliation":[{"name":"San Raffaele Scientific Institute, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Comi","sequence":"additional","affiliation":[{"name":"ASST Papa Giovanni XXIII, Bergamo, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisa","family":"Di Filippo","sequence":"additional","affiliation":[{"name":"ASST Papa Giovanni XXIII, Bergamo, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Fumagalli","sequence":"additional","affiliation":[{"name":"San Raffaele Scientific Institute, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvia","family":"Nozza","sequence":"additional","affiliation":[{"name":"San Raffaele Scientific Institute, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura.","family":"Galli","sequence":"additional","affiliation":[{"name":"San Raffaele Scientific Institute, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniela.","family":"Valenti","sequence":"additional","affiliation":[{"name":"FROM Foundation, Bergamo, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Rizzi","sequence":"additional","affiliation":[{"name":"ASST Papa Giovanni XXIII, Bergamo, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonella","family":"Castagna","sequence":"additional","affiliation":[{"name":"San Raffaele Scientific Institute, Milan, Italy"},{"name":"Vita-Salute San Raffaele University, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2021,10,27]]},"reference":[{"volume-title":"Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV","year":"2019","author":"US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents","key":"bibr1-13596535211042226"},{"key":"bibr2-13596535211042226","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-015-0515-6"},{"key":"bibr3-13596535211042226","doi-asserted-by":"publisher","DOI":"10.109\/cid\/ciz1243\/569794"},{"key":"bibr4-13596535211042226","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)33095-7"},{"key":"bibr5-13596535211042226","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-017-2311-2"},{"key":"bibr6-13596535211042226","doi-asserted-by":"crossref","first-page":"785","DOI":"10.1016\/S1473-3099(15)00096-1","volume":"15","author":"Arribas JR","year":"2015","journal-title":"Lancet 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