LB2. Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial
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| الحاوية / القاعدة: | Open Forum Infectious Diseases vol. 5 (Nov 2018), p. S759 |
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| المؤلف الرئيسي: | |
| مؤلفون آخرون: | , , , , , , , , , , , , |
| منشور في: |
Oxford University Press
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| الموضوعات: | |
| الوصول للمادة أونلاين: | Citation/Abstract Full Text - PDF |
| الوسوم: |
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| 024 | 7 | |a 10.1093/ofid/ofy229.2176 |2 doi | |
| 035 | |a 3171059516 | ||
| 045 | 2 | |b d20181101 |b d20181130 | |
| 100 | 1 | |a Kumar, Princy |u Division of Infectious Diseases and Travel Medicine, Medstar Georgetown University Hospital, Washington, DC | |
| 245 | 1 | |a LB2. Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial | |
| 260 | |b Oxford University Press |c Nov 2018 | ||
| 513 | |a Journal Article | ||
| 520 | 3 | |a Background Doravirine is a novel, non-nucleoside reverse-transcriptase inhibitor (NNRTI) that has demonstrated efficacy in two Phase 3 trials in treatment-naïve adults with HIV-1. Methods This open-label, active-controlled, noninferiority (NI) trial evaluated a once-daily single-tablet regimen of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF) vs. continuation of current therapy in adults with HIV-1 virologically suppressed for ≥6 months on a stable regimen of two NRTIs plus a boosted protease inhibitor (PI), boosted elvitegravir, or NNRTI. Participants with screening HIV-1 RNA <40 copies/mL, no history of virologic failure on any regimen, and no resistance to DOR/3TC/TDF were randomized (2:1) to start DOR/3TC/TDF on Day 1 (immediate switch group, ISG) or after 24 weeks (delayed switch group, DSG). The primary endpoint was the proportion (%) of participants with HIV-1 RNA <50 copies/mL (FDA snapshot approach), with the primary comparison between ISG at Week 48 and DSG at Week 24 and a secondary comparison between the groups at Week 24; the NI margin was -8%. The % of participants with HIV-1 RNA ≥50 copies/mL was also analyzed (FDA snapshot approach; NI margin 4%). Results A total of 670 participants (447 ISG, 223 DSG) were treated and included in the analyses; 84.5% were male, 76.4% were white, and mean age was 43.3 years. At Week 24, 93.7% (419/447) of ISG vs. 94.6% (211/223) of DSG had HIV-1 RNA <50 copies/mL (difference −0.9% [−4.7, 3.0]), and 1.8% of each group had HIV-1 RNA ≥50 copies/mL. At Week 48, 90.8% (406/447) of ISG maintained HIV-1 RNA <50 copies/mL (vs. 94.6% of DSG at Week 24; difference −3.8%, 95% CI [−7.9%, 0.3%]), and 1.6% of ISG had HIV-1 RNA ≥50 copies/mL. In the ritonavir-boosted PI stratum, mean changes in fasting LDL-C and non-HDL-C at Week 24 were significantly lower (P < 0.0001) in ISG vs. DSG (table). Rates of any AE and of drug-related AEs at Week 24 were higher in ISG vs. DSG. AEs were mild in most ISG participants (64% of those with any AE; 80% of those with drug-related AEs). Conclusion A once-daily single-tablet regimen of DOR/3TC/TDF demonstrated non-inferior efficacy and acceptable safety compared with continuing therapy, and is an option for maintaining viral suppression in patients considering a change in therapy. Disclosures P. Kumar, Merck, Pfizer, Janssen,: Grant Investigator and Shareholder, Research grant. GSK, Gilead, Teratechnologies, TaiMed,: Grant Investigator, Scientific Advisor and Shareholder, Consulting fee and Research grant. J. M. Molina, Merck GIlead ViiV Janssen Teva: Ad Board and Speaker’s Bureau, Consulting fee. Gilead Sciences: Grant Investigator, Research support. G. Rizzardini, ViiV, Gilead Science, MSD, Angelini, and Abbvie: Board Member and Speaker’s Bureau, Speaker honorarium. Gliead, ViiV, and MSD: Research Contractor, Research grant. P. Cahn, Abbvie: Grant, Research grant. Merck: Grant, Advisory Board. ViiV Healthcare: Grant, Advisory Board. M. Bickel, Merck & Co., Inc.: Research Contractor, Research grant. Y. Zhou, Merck & Co., Inc.: Employee, Salary. C. Morais, Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc.: Employee and Shareholder, May hold stock/stock options in the company and Salary. S. Kumar, Merck & Co., Inc.: Employee and Shareholder, Salary. P. Sklar, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.: Employee and Shareholder, Salary. G. J. Hanna, Merck Sharp & Dohme, a subsidiary of Merck & Co., inc.: Employee and Shareholder, May hold stock/stock options in the company. and Salary. C. Hwang, Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc.: Employee and Shareholder, Salary. W. Greaves, Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc.: Employee, May hold stock/stock options within the company. <graphic position="float" mimetype="image" xlink:href="ofidis_ofy229_if002.jpeg" /> | |
| 610 | 4 | |a Merck & Co Inc Food & Drug Administration--FDA Merck Sharp & Dohme | |
| 653 | |a Stock options | ||
| 653 | |a Stockholders | ||
| 653 | |a Infectious diseases | ||
| 653 | |a Infections | ||
| 653 | |a Hospitals | ||
| 653 | |a Advisors | ||
| 653 | |a Antibiotics | ||
| 653 | |a High density lipoprotein | ||
| 700 | 1 | |a Johnson, Margaret |u Royal Free Hospital, London, UK | |
| 700 | 1 | |a Molina, Jean-Michel |u University of Paris Diderot and Hôpital Saint-Louis, Paris, France | |
| 700 | 1 | |a Rizzardini, Giuliano |u ASST Fatebenefratelli Sacco, Milan, Italy | |
| 700 | 1 | |a Cahn, Pedro |u Fundación Huésped, Buenos Aires, Argentina | |
| 700 | 1 | |a Bickel, Markus |u Infektiologikum, Frankfurt, Germany | |
| 700 | 1 | |a Mallolas, Josep |u University of Barcelona, Barcelona, Spain | |
| 700 | 1 | |a Zhou, Yan |u Merck & Co., Inc., Kenilworth, New Jersey | |
| 700 | 1 | |a Morais, Cristiana |u Merck & Co., Inc., Kenilworth, New Jersey | |
| 700 | 1 | |a Kumar, Sushma |u Merck & Co., Inc., Kenilworth, New Jersey | |
| 700 | 1 | |a Sklar, Peter |u Merck & Co., Inc., Kenilworth, New Jersey | |
| 700 | 1 | |a Hanna, George J |u Merck & Co., Inc., Kenilworth, New Jersey | |
| 700 | 1 | |a Hwang, Carey |u Merck & Co., Inc., Kenilworth, New Jersey | |
| 700 | 1 | |a Greaves, Wayne |u Merck & Co., Inc., Kenilworth, New Jersey | |
| 773 | 0 | |t Open Forum Infectious Diseases |g vol. 5 (Nov 2018), p. S759 | |
| 786 | 0 | |d ProQuest |t Health & Medical Collection | |
| 856 | 4 | 1 | |3 Citation/Abstract |u https://www.proquest.com/docview/3171059516/abstract/embedded/7BTGNMKEMPT1V9Z2?source=fedsrch |
| 856 | 4 | 0 | |3 Full Text - PDF |u https://www.proquest.com/docview/3171059516/fulltextPDF/embedded/7BTGNMKEMPT1V9Z2?source=fedsrch |