PMID- 33315694 OWN - NLM STAT- MEDLINE DCOM- 20210910 LR - 20230926 IS - 1944-7884 (Electronic) IS - 1525-4135 (Print) IS - 1525-4135 (Linking) VI - 86 IP - 4 DP - 2021 Apr 1 TI - Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Adults With HIV and M184V/I Mutation. PG - 490-495 LID - 10.1097/QAI.0000000000002595 [doi] AB - BACKGROUND: The ability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) to maintain virologic suppression in participants with M184V and/or M184I resistance mutations from historical genotypic reports when switching from a tenofovir disoproxil fumarate-based or abacavir (ABC)-based regimen was investigated. SETTING: Phase IIIb, 48-week, open-label, single-arm, multicenter, clinical trial (NCT02616029). METHODS: Virologically suppressed adults with HIV and documented M184V/I on historical genotypic records switched to E/C/F/TAF from a tenofovir disoproxil fumarate-based or ABC-based regimen. The primary end point was HIV-1 RNA of <50 copies per milliliter at week 12 using pure virologic response (PVR). Secondary end points included HIV-1 RNA of <50 copies per milliliter at weeks 24/48 (PVR) and at weeks 12, 24, and 48 (Food and Drug Administration snapshot algorithm), and change in CD4+ count at weeks 12, 24, and 48. RESULTS: M184V alone was reported in 82.8% of 64 participants; 9.4% and 7.8% had M184I and M184V/I, respectively, and 43.8% had archived M184V/I (baseline DNA). All (62/62 with available data, 100%, 95% confidence interval 94.2% to 100%) participants maintained PVR at weeks 12, 24, and 48. By Food and Drug Administration snapshot algorithm, one participant had HIV-1 RNA of >/=50 copies per milliliter (week 12); confirmatory HIV-1 RNA was <50 copies per milliliter. No significant changes were observed in CD4+ cell count. Drug-related adverse events (AEs) were reported by 10 (15.6%) participants. Six (9.4%) and 5 (7.8%) participants had grade 3-4 AEs or serious AEs, respectively (none drug related). CONCLUSIONS: The presence of the resistance mutations M184V/I did not jeopardize the efficacy of switching to E/C/F/TAF in virologically suppressed adults. High rates of virologic suppression were maintained throughout 48 weeks of therapy and treatment was well tolerated. CI - Copyright (c) 2020 The Author(s). Published by Wolters Kluwer Health, Inc. FAU - Perez-Valero, Ignacio AU - Perez-Valero I AD - Unidad VIH-Hospital Universitario La Paz, Madrid, Spain. FAU - Llibre, Josep M AU - Llibre JM AD - Fundacion Lucha contra el SIDA and Infectious Diseases, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain. FAU - Castagna, Antonella AU - Castagna A AD - Vita-Salute San Raffaele University, IRCCS San Raffaele, Milan, Italy. FAU - Pulido, Federico AU - Pulido F AD - Unidad VIH, Hospital Universitario 12 de Octubre, imas12, UCM, Madrid, Spain. FAU - Molina, Jean-Michel AU - Molina JM AD - Department of Infectious Diseases, Saint-Louis Hospital and University of Paris, Paris, France. FAU - Esser, Stefan AU - Esser S AD - University Hospital Essen, Essen, Germany; and. FAU - Margot, Nicolas AU - Margot N AD - Gilead Sciences, Foster City, CA. FAU - Shao, Yongwu AU - Shao Y AD - Gilead Sciences, Foster City, CA. FAU - Temme, Lauren AU - Temme L AD - Gilead Sciences, Foster City, CA. FAU - Piontkowsky, David AU - Piontkowsky D AD - Gilead Sciences, Foster City, CA. FAU - McNicholl, Ian R AU - McNicholl IR AD - Gilead Sciences, Foster City, CA. FAU - Haubrich, Richard AU - Haubrich R AD - Gilead Sciences, Foster City, CA. LA - eng SI - ClinicalTrials.gov/NCT02616029 PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - United States TA - J Acquir Immune Defic Syndr JT - Journal of acquired immune deficiency syndromes (1999) JID - 100892005 RN - 0 (Anti-HIV Agents) RN - 0 (Drug Combinations) RN - 0 (Quinolones) RN - 4GDQ854U53 (elvitegravir) RN - 99YXE507IL (Tenofovir) RN - EL9943AG5J (tenofovir alafenamide) RN - G70B4ETF4S (Emtricitabine) RN - LW2E03M5PG (Cobicistat) RN - OF5P57N2ZX (Alanine) SB - IM MH - Adult MH - Aged MH - Alanine/administration & dosage/therapeutic use MH - Anti-HIV Agents/administration & dosage/*therapeutic use MH - Cobicistat/administration & dosage/therapeutic use MH - Drug Combinations MH - Drug Resistance, Viral/*genetics MH - Emtricitabine/administration & dosage/therapeutic use MH - Female MH - HIV Infections/*drug therapy MH - HIV-1/*drug effects/genetics MH - Humans MH - Male MH - Middle Aged MH - Mutation MH - Quinolones/administration & dosage MH - Tenofovir/administration & dosage/analogs & derivatives/therapeutic use MH - Young Adult PMC - PMC7899215 COIS- Data sharing: Gilead Sciences shares anonymized individual patient data upon request or as required by law or regulation with qualified external researchers based on submitted curriculum vitae and reflecting non conflict of interest. The request proposal must also include a statistician. Approval of such requests is at Gilead Science's discretion and is dependent on the nature of the request, the merit of the research proposed, the availability of the data, and the intended use of the data. Data requests should be sent to datarequest@gilead.com. EDAT- 2020/12/15 06:00 MHDA- 2021/09/11 06:00 PMCR- 2021/02/22 CRDT- 2020/12/14 17:13 PHST- 2020/07/30 00:00 [received] PHST- 2020/11/17 00:00 [accepted] PHST- 2020/12/15 06:00 [pubmed] PHST- 2021/09/11 06:00 [medline] PHST- 2020/12/14 17:13 [entrez] PHST- 2021/02/22 00:00 [pmc-release] AID - 00126334-202104010-00017 [pii] AID - QAIV21236 [pii] AID - 10.1097/QAI.0000000000002595 [doi] PST - ppublish SO - J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):490-495. doi: 10.1097/QAI.0000000000002595.