{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T00:29:04Z","timestamp":1792801744063,"version":"4.5.0"},"reference-count":37,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2018,8,1]],"date-time":"2018-08-01T00:00:00Z","timestamp":1533081600000},"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":[[2019,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The safety and efficacy of doravirine were compared with that of efavirenz as initial treatment of adults living with HIV-1 infection (NCT01632345).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A Phase IIb double-blind trial with participants stratified by screening HIV-1 RNA (\u2264 or &gt;100,000 copies\/ml) and randomized 1:1:1:1:1 to receive once-daily doravirine (25, 50, 100 or 200 mg) or efavirenz 600 mg (Part I) for up to 96 weeks, with open-label tenofovir disoproxil fumarate 300 mg\/emtricitabine 200 mg (TDF\/FTC). After dose selection at week 24, doravirine 100 mg was provided to participants receiving the other doses of doravirine and additional participants were randomized 1:1 to receive once-daily doravirine 100 mg or efavirenz 600 mg for 96 weeks with TDF\/FTC (Part II). Primary outcomes were the proportion of participants with HIV-1 RNA &lt;40 copies\/ml at week 24, and central nervous system (CNS) adverse events (AEs) by weeks 8 and 24 (Parts I+II combined).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>210 and 132 participants were randomized in Parts I and II, respectively, and 216 (108 on doravirine 100 mg, 108 on efavirenz) were evaluable for Parts I+II combined. At week 24, the proportion of participants with HIV-1 RNA &lt;40 copies\/ml was 72.9% for doravirine 100 mg and 73.1% for efavirenz (difference \u22120.5 [95% CI \u221212.3, 11.2]). In addition, CNS AEs were reported by 26.9% and 47.2% of doravirine and efavirenz recipients, respectively (difference \u221220.4 [95% CI \u221232.6, \u22127.5]; P=0.002).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Doravirine 100 mg with TDF\/FTC demonstrated similar antiretroviral activity and superior CNS safety compared with efavirenz 600 mg with TDF\/FTC.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3851\/imp3323","type":"journal-article","created":{"date-parts":[[2019,7,29]],"date-time":"2019-07-29T11:16:41Z","timestamp":1564399001000},"page":"425-435","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":26,"title":["Doravirine dose Selection and 96-Week Safety and Efficacy versus Efavirenz in Antiretroviral Therapy-Naive Adults with HIV-1 Infection in a Phase IIb Trial"],"prefix":"10.1177","volume":"24","author":[{"given":"Jose M","family":"Gatell","sequence":"first","affiliation":[{"name":"Hospital Clinic\/IDIBAPS, University of Barcelona, Barcelona, Spain"},{"name":"Present address: ViiV Healthcare, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier O","family":"Morales-Ramirez","sequence":"additional","affiliation":[{"name":"Clinical Research Puerto Rico, San Juan, Puerto Rico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debbie P","family":"Hagins","sequence":"additional","affiliation":[{"name":"Chatham County Health Department, Savannah, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Thompson","sequence":"additional","affiliation":[{"name":"AIDS Research Consortium of Atlanta, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keikawus","family":"Arast\u00e9h","sequence":"additional","affiliation":[{"name":"EPIMED\/Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Hoffmann","sequence":"additional","affiliation":[{"name":"ICH Study Center, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Raffi","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department and INSERM CIC 1413, University Hospital of Nantes, Nantes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olayemi","family":"Osiyemi","sequence":"additional","affiliation":[{"name":"Triple O Research Institute PA, West Palm Beach, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin","family":"Dretler","sequence":"additional","affiliation":[{"name":"Infectious Disease Specialists of Atlanta, Decatur, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Harvey","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xia","family":"Xu","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Plettenberg","sequence":"additional","affiliation":[{"name":"ifi-Institute for Infections, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Don E","family":"Smith","sequence":"additional","affiliation":[{"name":"Albion Centre, Sydney, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joaqu\u00edn","family":"Portilla","sequence":"additional","affiliation":[{"name":"Hospital General Universitario de Alicante\/ISABIAL, Alicante, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sorin","family":"Rugina","sequence":"additional","affiliation":[{"name":"Ovidius University, Clinical Infectious Diseases Hospital, Constanta, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sushma","family":"Kumar","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colleen","family":"Frobose","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Wan","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Rodgers","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carey","family":"Hwang","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hedy","family":"Teppler","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2018,8,1]]},"reference":[{"key":"bibr1-IMP3323","unstructured":"Food and Drug Administration (FDA). Full prescribing information: SUSTIVA (efavirenz). 2017. (Accessed 29 April 2019.) Available from https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/021360s044,020972s0561b1.pdf"},{"key":"bibr2-IMP3323","doi-asserted-by":"publisher","DOI":"10.7326\/M14-0293"},{"key":"bibr3-IMP3323","doi-asserted-by":"publisher","DOI":"10.17265\/2159-5313\/2016.09.003"},{"key":"bibr4-IMP3323","unstructured":"Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. 2018. (Accessed 14 May 2019.) Available from https:\/\/aidsinfo.nih.gov\/contentfiles\/lvguidelines\/adultandadolescentgl.pdf"},{"key":"bibr5-IMP3323","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.107"},{"key":"bibr6-IMP3323","unstructured":"Food and Drug Administration (FDA). Full prescribing information: INTELENCE\u2122 (etravirine). 2018. (Accessed 29 April 2019.) 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Full prescribing information: TRUVADA (emtricitabine\/tenofovir disoproxil fumarate). 2018. (Accessed 29 April 2019.) Available from https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/021752s055lbl.pdf"},{"key":"bibr23-IMP3323","unstructured":"U.S. Department of Health and Human Services, National Institutues of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0. 2014. (Accessed 15 October 2018.) Available from https:\/\/rsc.tech-res.com\/clinical-research-sites\/safety-reporting\/daids-grading-tables"},{"key":"bibr24-IMP3323","unstructured":"U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Human immunodeficiency virus-1 infection: developing antiretroviral drugs for treatment. Guidance for industry. 2015-+. (Accessed 15 October 2018.) 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