Chen, Guan-JhouGuan-JhouChenLee, Yu-LinYu-LinLeeLee, Chen-HsiangChen-HsiangLeeHSIN-YUN SUNCheng, Chien-YuChien-YuChengTsai, Hung-ChinHung-ChinTsaiHuang, Sung-HsiSung-HsiHuangLee, Yi-ChiehYi-ChiehLeeHsieh, Min-HanMin-HanHsiehSUI-YUAN CHANGYU-CHUNG CHUANGSu, Li-ShinLi-ShinSuChang, Sui-FangSui-FangChangTang, Hung-JenHung-JenTangCHIEN-CHING HUNG2020-12-292020-12-2920200305-7453https://www.scopus.com/inward/record.uri?eid=2-s2.0-85091324104&doi=10.1093%2fjac%2fdkaa287&partnerID=40&md5=7dc83753a06df5680b36cf81184d42e2https://scholars.lib.ntu.edu.tw/handle/123456789/535186Objectives: Real-world experience regarding the effectiveness of co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (EVG/C/FTC/TAF) as a switch regimen is sparse among people living with HIV (PLWH) harbouring the M184V/I mutation with or without thymidine analogue-Associated mutations (TAMs). Methods: In this retrospectivemulticentre study, PLWH whowere switched to EVG/C/FTC/TAF after having achieved viral suppression (plasma HIV RNA 200 copies/mL) for 6months or longer were included. Patients with archived M184V/Imutation (case patients) were matched to controls without M184V/I mutation at a 1:4 ratio. Patients with a history of virological failure or resistance to elvitegravir were excluded. The primary endpoint was virological nonsuccess (plasma HIV RNA_50 copies/mL) at Week 48 of switch usingamodifiedFDA snapshot analysis. Results: Overall, 100 case patients with the M184V/I mutation were identified, including 6 (6.0%) with K65R and 13 (13.0%) with at least one TAM, and were matched to 400 controls in terms of gender, age (mean = 40.3 versus 39.7 years) and cumulative exposure duration to tenofovir disoproxil fumarate (median = 146 versus 143weeks). At Week 48, the rate of virological non-success for the case patients and controls was 5.0% (5/100) and 3.3% (13/400), respectively (difference = 1.7%; 95% CI =#2.9%-6.3%), while the rate of virological success was 88.0% and 89.5% for the case patients and controls, respectively. The presence of the K65R mutation or TAMs was not associated with virological non-response. Conclusions: Among virally suppressed PLWH, EVG/C/FTC/TAF is effective in maintaining viral suppression at Week 48 despite archived M184V/I mutation with or without TAMs. ? 2020 Oxford University Press. All rights reserved.[SDGs]SDG3abacavir; atazanavir; atazanavir plus ritonavir; cobicistat plus elvitegravir plus emtricitabine plus tenofovir alafenamide; darunavir plus ritonavir; dolutegravir; efavirenz; emtricitabine; etravirine; lamivudine; lopinavir plus ritonavir; nevirapine; raltegravir; rilpivirine; tenofovir disoproxil; virus RNA; zidovudine; adenine; anti human immunodeficiency virus agent; cobicistat; elvitegravir; emtricitabine; GS-7340; quinolone derivative; adult; antiretroviral therapy; antiviral resistance; Article; CD4 lymphocyte count; cohort analysis; constipation; controlled study; diarrhea; dizziness; drug efficacy; drug substitution; drug withdrawal; female; follow up; gastrointestinal symptom; gene mutation; human; human cell; Human immunodeficiency virus 1 infection; Human immunodeficiency virus infected patient; insomnia; major clinical study; male; patient compliance; retrospective study; survival time; time to treatment; treatment duration; treatment response; virus load; clinical trial; genetics; Human immunodeficiency virus 1; Human immunodeficiency virus infection; multicenter study; mutation; Adenine; Adult; Anti-HIV Agents; Cobicistat; Emtricitabine; HIV Infections; HIV-1; Humans; Mutation; Quinolones; Retrospective StudiesImpact of archived M184V/I mutation on the effectiveness of switch to co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide among virally suppressed people living with HIVjournal article10.1093/jac/dkaa28732737511