{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T17:07:18Z","timestamp":1753895238771,"version":"3.41.2"},"reference-count":1,"publisher":"Wiley","issue":"4S3","license":[{"start":{"date-parts":[[2014,11,2]],"date-time":"2014-11-02T00:00:00Z","timestamp":1414886400000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by\/3.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of the International AIDS Society"],"published-print":{"date-parts":[[2014,11]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Switch to Stribild (STB) was non\u2010inferior to continuation of a non\u2010nucleoside reverse transcriptase inhibitor (NNRTI) with emtricitabine and tenofovir DF (FTC\/TDF) at week 48 in virologically suppressed HIV adults [<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"#CIT0001\">1<\/jats:ext-link>]. We report the Week 48 efficacy and safety of STB versus nevirapine (NVP) or rilpivirine (RPV) with FTC\/TDF in suppressed subjects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>Virologically suppressed subjects on an NNRTI with FTC\/TDF regimens for \u22656 months were randomized (2:1) to switch to STB versus continue their NNRTI regimen. Eligibility criteria included no documented resistance to FTC and TDF, no history of virologic failure and eGFR \u226570 mL\/min. The primary endpoint was the proportion of subjects in the modified ITT population who maintained HIV\u20101 RNA &lt;50 copies(c)\/mL at Week 48 by FDA snapshot algorithm (12% non\u2010inferiority margin). Subgroup analysis by non\u2010EFV NNRTI use (NVP [74]; RPV [19]; etravirine [3]) at screening was pre\u2010specified.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The mITT population included 433 subjects who were randomized and treated. In the non\u2010EFV NNRTI subgroup, 59 switched to STB; 37 continued a non\u2010EFV NNRTI (27 NVP, 10 RPV) with FTC\/TDF. At week 48, 97% STB versus 95% non\u2010EFV NNRTI maintained HIV\u20101 RNA &lt;50 c\/mL. No emergent resistance was detected in either group. No difference in median increases from baseline in CD4 count at week 48 (cells\/\u00b5L): 25 STB versus 55 non\u2010EFV NNRTI (p=0.78). No discontinuation due to adverse events; no cases of proximal renal tubulopathy. As expected, there were no significant changes in the frequency of neuropsychiatric symptoms (i.e. anxiety, insomnia, dizziness, vivid dreams, weird\/intense dreams, and nightmares) reported on the HIV Symptom Index at week 48 compared to baseline after switching to STB. There was a greater but non\u2010progressive decrease from baseline in eGFR in the STB versus non\u2010EFV NNRTI group; median changes (mL\/min) at week 48: \u22129.1 versus \u22121.4. Switch to STB was associated with a higher treatment ease (convenience, flexibility, demand, lifestyle, understanding) score (range: \u221215 to 15) at week 4 (median: 14 vs 11; p=0.047) and week 24 (median: 14 vs 12.5; p=0.038).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In this small group of virologically suppressed subjects, switch to STB vs continuation of NVP or RPV with FTC\/TDF was safe, well\u2010tolerated, and associated with a high rate of virologic suppression at week 48. There was more treatment ease with STB use.<\/jats:p><\/jats:sec>","DOI":"10.7448\/ias.17.4.19793","type":"journal-article","created":{"date-parts":[[2014,11,3]],"date-time":"2014-11-03T08:30:34Z","timestamp":1415003434000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Switch to Stribild versus continuation of NVP or RPV with FTC and TDF in virologically suppressed HIV adults: a STRATEGY\u2010NNRTI subgroup analysis"],"prefix":"10.1002","volume":"17","author":[{"given":"Hans\u2010Juergen","family":"Stellbrink","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Antinori","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anton","family":"Pozniak","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Flamm","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fritz","family":"Bredeek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kiran","family":"Patel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Will","family":"Garner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Piontkowsky","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,11,2]]},"reference":[{"key":"e_1_2_1_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(14)70796-0"}],"container-title":["Journal of the International AIDS Society"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.7448%2FIAS.17.4.19793","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.7448\/IAS.17.4.19793","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,24]],"date-time":"2023-09-24T17:17:47Z","timestamp":1695575867000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.7448\/IAS.17.4.19793"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,11]]},"references-count":1,"journal-issue":{"issue":"4S3","published-print":{"date-parts":[[2014,11]]}},"alternative-id":["10.7448\/IAS.17.4.19793"],"URL":"https:\/\/doi.org\/10.7448\/ias.17.4.19793","archive":["Portico"],"relation":{},"ISSN":["1758-2652","1758-2652"],"issn-type":[{"type":"print","value":"1758-2652"},{"type":"electronic","value":"1758-2652"}],"subject":[],"published":{"date-parts":[[2014,11]]},"assertion":[{"value":"2014-11-02","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"19793"}}