{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T17:45:49Z","timestamp":1783446349191,"version":"3.55.0"},"reference-count":42,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2021,2,18]],"date-time":"2021-02-18T00:00:00Z","timestamp":1613606400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Int J STD AIDS"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:p>Objectives: Elvitegravir\/cobicistat\/emtricitabine\/tenofovir alafenamide (E\/C\/F\/TAF) is a recommended and widely used regimen for HIV infection. In this study, we aimed to determine the efficacy and safety of E\/C\/F\/TAF in people living with HIV (PLWH), who are either treatment-na\u00efve or switched from any tenofovir disoproxil fumarate-containing regimen. For switched patients, we aimed to determine the impact of switching from tenofovir disoproxil fumarate (TDF) to TAF on lipid profile and kidney functions. Methods: ACTHIV-IST Study Group produced a database, and five dedicated HIV centres in Istanbul entered data of PLWH who switched from any TDF-containing regimen to E\/C\/F\/TAF and treatment-na\u00efve patients who were initiated with the E\/C\/F\/TAF regimen between January 2017 and December 2019. Clinical findings, viral parameters, lipid studies, renal function tests, adverse events and adherence to the treatment were recorded in this prospective observational study. Results: The study included a total of 614 switched and treatment-na\u00efve patients. Of 430 treatment-experienced patients, 89% (382) were men, and the mean age was 42 \u00b1 12\u00a0years. Among them, 47% (181\/382) self-identified as men who have sex with men (MSM). The median duration of HIV diagnosis was 54 \u00b1 29\u00a0months. The median duration of E\/C\/F\/TAF use was 20 \u00b1 36 months and that of previous treatment was 23 \u00b1 18\u00a0months. HIV-RNA was undetectable at baseline and month 12 in 84.1% (360\/428) and 86.1% (328\/381) of patients, respectively ( p &gt; 0.05). Mean CD4 counts were 708 \u00b1 287\u00a0cells\/\u00b5L and 802 \u00b1 305 cells\/\u00b5L at baseline and month 12, respectively ( p &lt; 0.001). Serum creatinine levels remained stable during the treatment period. Mean total cholesterol levels at baseline and month 12 were 172 and 211\u00a0mg\/dL ( p &lt; 0.01), LDL-cholesterol 104 and 138\u00a0mg\/dL ( p &lt; 0.01), HDL-cholesterol 39 and 49\u00a0mg\/dL ( p &lt; 0.01) and triglycerides 134 and 174\u00a0mg\/dL ( p &lt; 0.01), respectively. The treatment was generally well tolerated. Eight patients discontinued the therapy (drug interaction: 3; lost to follow-up: 1; pregnancy: 1; pulmonary tuberculosis: 1; side effect: 1; patient\u2019s decision: 1). Of 184 treatment-na\u00efve patients, 88% (162) were men, and the mean age was 36.5\u00b1\u00a012\u00a0years. Among them, 50% (81\/162) self-identified as MSM. The mean duration of HIV infection was 21.6 \u00b1 17.1\u00a0months. The mean duration of E\/C\/F\/TAF use was 16 \u00b1 4\u00a0months. HIV-RNA was undetectable at baseline and month 12 in 1% and 89.1% of patients, respectively. Mean CD4 counts at baseline and month 12 were 469 \u00b1 223 cells\/\u00b5L and 740 \u00b1 298 cells\/\u00b5L, respectively. During the treatment period, creatinine levels remained stable. Total cholesterol, LDL-cholesterol, triglyceride and also HDL-cholesterol levels increased. Mean total cholesterol levels at baseline and month 12 were 167 and 211\u00a0mg\/dL ( p &lt; 0.01), LDL-cholesterol 108 and 143\u00a0mg\/dL ( p &lt; 0.01), HDL-cholesterol 41 and 47\u00a0mg\/dL ( p &lt; 0.01) and triglycerides 136 and 172\u00a0mg\/dL, respectively ( p &lt; 0.01). The treatment was generally well tolerated. Three patients discontinued the therapy (drug interaction: 1; non-responder: 1; patient\u2019s decision: 1). Conclusion: Starting with or switching to E\/C\/F\/TAF in PLWH effectively suppresses HIV infection, is associated with an increase in CD4 cell count and is well tolerated in a real-life setting. Renal functions remained stable during the treatment. E\/C\/F\/TAF use was associated with an increase in LDL-cholesterol and triglyceride levels along with an increase in HDL-cholesterol levels.<\/jats:p>","DOI":"10.1177\/0956462420983692","type":"journal-article","created":{"date-parts":[[2021,2,21]],"date-time":"2021-02-21T01:17:49Z","timestamp":1613870269000},"page":"562-569","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy and safety of co-formulated elvitegravir\/cobicistat\/emtricitabine\/tenofovir alafenamide in HIV-positive patients: real-world data"],"prefix":"10.1177","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8632-2825","authenticated-orcid":false,"given":"Fehmi","family":"Tabak","sequence":"first","affiliation":[{"name":"Department of Infectious Diseases and Clinical Microbiology, Cerrahpasa School of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esra","family":"Zerdali","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Clinical Microbiology, Haseki Training and Research Hospital, University of Health Sciences, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ozlem","family":"Altunta\u015f","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Clinical Microbiology, Bakirkoy Dr.Sadi Konuk Training and Research Hospital, University of Health Sciences, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alper","family":"Gunduz","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Clinical Microbiology, Sisli Hamidiye Etfal Training and Research Hospital, University of Health Sciences, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6475-3894","authenticated-orcid":false,"given":"Sibel","family":"Bolukcu","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Clinical Microbiology, Faculty of Medicine, Bezmialem Vak\u0131f University, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9091-6087","authenticated-orcid":false,"given":"Bilgul","family":"Mete","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Clinical Microbiology, Cerrahpasa School of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inci Y","family":"Nakir","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Clinical Microbiology, Haseki Training and Research Hospital, University of Health Sciences, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7716-3006","authenticated-orcid":false,"given":"Hayat","family":"Kumbasar Karaosmanoglu","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Clinical Microbiology, Bakirkoy Dr.Sadi Konuk Training and Research Hospital, University of Health Sciences, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dilek S","family":"Yildiz","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Clinical Microbiology, Sisli Hamidiye Etfal Training and Research Hospital, University of Health Sciences, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meliha","family":"Meric Koc","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Clinical Microbiology, Faculty of Medicine, Bezmialem Vak\u0131f University, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u0130lyas","family":"Dokmetas","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Clinical Microbiology, Sisli Hamidiye Etfal Training and Research Hospital, University of Health Sciences, Istanbul, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"[ACTHIV-IST (Action Against HIV in Istanbul) Study Group]","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2021,2,18]]},"reference":[{"key":"bibr1-0956462420983692","unstructured":"U.S. Department of Health and Human Services. 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