{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T16:24:58Z","timestamp":1792081498659,"version":"4.4.0"},"reference-count":20,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2019,2,1]],"date-time":"2019-02-01T00:00:00Z","timestamp":1548979200000},"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":[[2020,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Neuropsychiatric AEs (NPAEs) leading to dolutegravir (DTG) discontinuation were seen more frequently in real-world use than in randomized clinical trials (RCTs). The recently approved fixed-dose combination bictegravir plus emtricitabine and tenofovir alafenamide (BIC\/F\/TAF) has shown comparable NPAE rates but some favourable patient-reported outcomes in RCTs compared with DTG. We were interested in its neuropsychiatric tolerability in clinical practice.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>All patients starting BIC\/F\/TAF from June 2018 in a single centre (two subcentres) were followed retrospectively. Discontinuation rates due to any AEs and NPAEs were compared with those of patients initiating DTG-based regimens.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>As of May 2019, a total of 943 patients (852 males, 76 females, 15 transgender and gender diverse) initiated BIC\/F\/TAF outside RCTs. After a median follow-up of 6.2 months, 50 (5.3%) and 31 (3.3%) patients had discontinued BIC\/F\/TAF due to any AEs or to NPAEs, respectively. In multivariate analysis, a pre-existing depression and subcentre remained predictive for NPAEs, but not age, gender, ethnicity or prior DTG-related AEs. Compared with 1,043 patients treated with DTG-based regimens, the estimated NPAE-related discontinuation rate with BIC\/F\/TAF was comparable during the first 6 months ( P=0.36). Cross-intolerance was low, and only 5\/55 patients with prior DTG intolerability had to discontinue BIC\/F\/TAF due to NPAEs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Short-term tolerability of BIC\/F\/TAF was comparable to DTG-containing regimens. As seen with DTG, discontinuation rates were higher than in RCTs. A pre-existing depression but also physician's awareness may have an impact on tolerability and continuation of BIC\/F\/TAF. In contrast, prior intolerability of DTG was of limited predictive value.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3851\/imp3351","type":"journal-article","created":{"date-parts":[[2020,4,1]],"date-time":"2020-04-01T12:09:08Z","timestamp":1585742948000},"page":"83-90","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":26,"title":["Short-Term Neuropsychiatric Tolerability of Bictegravir Combined with Emtricitabine\/Tenofovir Alafenamide in Clinical Practice"],"prefix":"10.1177","volume":"25","author":[{"given":"Christian","family":"Hoffmann","sequence":"first","affiliation":[{"name":"ICH Study Center Hamburg, Hamburg, Germany"},{"name":"Department of Medicine II, University of Schleswig-Holstein, Campus Kiel, Kiel, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Knud","family":"Schewe","sequence":"additional","affiliation":[{"name":"ICH Study Center Hamburg, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Fenske","sequence":"additional","affiliation":[{"name":"ICH Study Center Hamburg, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Buhk","sequence":"additional","affiliation":[{"name":"ICH Study Center Hamburg, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Sabranski","sequence":"additional","affiliation":[{"name":"ICH Study Center Hamburg, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel","family":"Adam","sequence":"additional","affiliation":[{"name":"ICH Study Center Hamburg, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Hansen","sequence":"additional","affiliation":[{"name":"ICH Study Center Hamburg, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans-J\u00fcrgen","family":"Stellbrink","sequence":"additional","affiliation":[{"name":"ICH Study Center Hamburg, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2019,2,1]]},"reference":[{"key":"bibr1-IMP3351","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(19)30077-3"},{"key":"bibr2-IMP3351","doi-asserted-by":"crossref","first-page":"e364","DOI":"10.1016\/S2352-3018(19)30080-3","volume":"6","author":"Stellbrink H.J.","year":"2019","journal-title":"Lancet HIV"},{"key":"bibr3-IMP3351","doi-asserted-by":"crossref","first-page":"e347","DOI":"10.1016\/S2352-3018(18)30091-2","volume":"5","author":"Daar E.S.","year":"2018","journal-title":"Lancet HIV"},{"key":"bibr4-IMP3351","doi-asserted-by":"crossref","first-page":"e357","DOI":"10.1016\/S2352-3018(18)30092-4","volume":"5","author":"Molina J.M.","year":"2018","journal-title":"Lancet HIV"},{"key":"bibr5-IMP3351","unstructured":"Kityo C., Hagins D., Koenig E. Switching to bictegravir\/ emtricitabine\/tenofovir alafenamide (B\/F\/Taf) in women.\n                      Conference on Retroviruses and Opportunistic Infections\n                      . 4\u20137 March 2018, Boston, MA, USA. Abstract 500."},{"key":"bibr6-IMP3351","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-018-1010-7"},{"key":"bibr7-IMP3351","doi-asserted-by":"publisher","DOI":"10.1097\/COH.0000000000000388"},{"key":"bibr8-IMP3351","doi-asserted-by":"publisher","DOI":"10.24875\/AIDSRev.19000023"},{"key":"bibr9-IMP3351","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12468"},{"key":"bibr10-IMP3351","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)32340-1"},{"key":"bibr11-IMP3351","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)32299-7"},{"key":"bibr12-IMP3351","doi-asserted-by":"crossref","first-page":"561","DOI":"10.1007\/s40271-018-0322-8","volume":"11","author":"Wohl D.","year":"2018","journal-title":"Patient"},{"key":"bibr13-IMP3351","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000001269"},{"key":"bibr14-IMP3351","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.160.14.2101"},{"key":"bibr15-IMP3351","doi-asserted-by":"publisher","DOI":"10.1097\/00126334-200212153-00010"},{"key":"bibr16-IMP3351","doi-asserted-by":"publisher","DOI":"10.1007\/s12160-011-9295-8"},{"key":"bibr17-IMP3351","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.8342"},{"key":"bibr18-IMP3351","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12280"},{"key":"bibr19-IMP3351","unstructured":"Mohammed H., Marvin V., Boffito M., Asboe D. Discontinuation of dolutegravir-containing regimens due to adverse reactions: real-word data.\n                      25th British HIV Association\n                      . 2\u20135 April 2019, Bournemouth, UK. Abstract P57."},{"key":"bibr20-IMP3351","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12710"}],"container-title":["Antiviral Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3851\/IMP3351","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.3851\/IMP3351","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3851\/IMP3351","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:52:52Z","timestamp":1777380772000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.3851\/IMP3351"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,2,1]]},"references-count":20,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,2]]}},"alternative-id":["10.3851\/IMP3351"],"URL":"https:\/\/doi.org\/10.3851\/imp3351","relation":{},"ISSN":["1359-6535","2040-2058"],"issn-type":[{"value":"1359-6535","type":"print"},{"value":"2040-2058","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,2,1]]}}}