PMID- 34506342 OWN - NLM STAT- MEDLINE DCOM- 20220117 LR - 20230926 IS - 1944-7884 (Electronic) IS - 1525-4135 (Print) IS - 1525-4135 (Linking) VI - 88 IP - 4 DP - 2021 Dec 1 TI - Brief Report: Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Females Living With HIV: An Integrated Analysis of 5 Trials. PG - 393-398 LID - 10.1097/QAI.0000000000002789 [doi] AB - BACKGROUND: We characterized the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in a broad population of pediatric/adolescent/adult/elderly females living with HIV (FWH). SETTING: Integrated analysis. METHODS: Available data from 5 trials were integrated. Week 48 virologic suppression (HIV-1 RNA <50 copies/mL), resistance, adverse events (AEs), and laboratory parameters were assessed. RESULTS: Three hundred and seventy-three FWH [304 virologically suppressed; 69 antiretroviral therapy (ART)-naive] received B/F/TAF [data from comparator regimens available for 306 individuals (236 virologically suppressed and 70 ART-naive participants)]. Virologic suppression rates with B/F/TAF at week 48 were high regardless of age in participants virologically suppressed at baseline (>/=95%) and in ART-naive participants (>/=87%). Virologic suppression rates were similar in B/F/TAF and comparator regimens (both virologically suppressed and ART-naive groups). Treatment-emergent resistance was not detected in the B/F/TAF group. AEs considered related to study drugs were experienced by 9.2% (B/F/TAF) and 5.5% (comparator regimen) of virologically suppressed participants and 15.9% (B/F/TAF) and 31.4% (comparator regimen) of ART-naive participants. For virologically suppressed and ART-naive FWH combined, only 1 of the 373 B/F/TAF-treated and 2 of the 306 comparator-regimen participants discontinued because of AEs (none were bone/renal/hepatic AEs); grade 3/4 AEs were experienced by 5.1% (B/F/TAF) and 7.8% (comparator regimen); and grade 3/4 elevation of low-density lipoprotein/total cholesterol occurred in 2.7%/0.3% (B/F/TAF) and 5.9%/2.0% (comparator regimen). At week 48, median changes from baseline estimated glomerular filtration rate in adults were <5 mL/min; results were similar in B/F/TAF and comparator-regimen groups. CONCLUSION: B/F/TAF treatment was effective and well tolerated over 48 weeks, confirming B/F/TAF as an option for a broad population of FWH. CI - Copyright (c) 2021 The Author(s). Published by Wolters Kluwer Health, Inc. FAU - Orkin, Chloe AU - Orkin C AD - Ambrose King Centre, The Royal London Hospital, Barts Health NHS Trust, London, United Kingdom. FAU - Ajana, Faiza AU - Ajana F AD - Centre Hospitalier de Tourcoing, Tourcoing, France. FAU - Kityo, Cissy AU - Kityo C AD - Joint Clinical Research Centre, Kampala, Uganda. FAU - Koenig, Ellen AU - Koenig E AD - Instituto Dominicano de Estudios Virologicos (IDEV), Santo Domingo, Dominican Republic; and. FAU - Natukunda, Eva AU - Natukunda E AD - Joint Clinical Research Centre, Kampala, Uganda. FAU - Gandhi-Patel, Bhumi AU - Gandhi-Patel B AD - Gilead Sciences, Foster City, CA. FAU - Wang, Hui AU - Wang H AD - Gilead Sciences, Foster City, CA. FAU - Liu, Yapei AU - Liu Y AD - Gilead Sciences, Foster City, CA. FAU - Wei, Xuelian AU - Wei X AD - Gilead Sciences, Foster City, CA. FAU - White, Kirsten AU - White K AD - Gilead Sciences, Foster City, CA. FAU - Makadzange, Tariro AU - Makadzange T AD - Gilead Sciences, Foster City, CA. FAU - Pikora, Cheryl AU - Pikora C AD - Gilead Sciences, Foster City, CA. FAU - McNicholl, Ian AU - McNicholl I AD - Gilead Sciences, Foster City, CA. FAU - Collins, Sean E AU - Collins SE AD - Gilead Sciences, Foster City, CA. FAU - Brainard, Diana AU - Brainard D AD - Gilead Sciences, Foster City, CA. FAU - Chuck, Susan K AU - Chuck SK AD - Gilead Sciences, Foster City, CA. LA - eng PT - Clinical Trial PT - Journal Article 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 (Amides) RN - 0 (Anti-HIV Agents) RN - 0 (Drug Combinations) RN - 0 (Heterocyclic Compounds, 3-Ring) RN - 0 (Heterocyclic Compounds, 4 or More Rings) RN - 0 (Piperazines) RN - 0 (Pyridones) RN - 8GB79LOJ07 (bictegravir) RN - 99YXE507IL (Tenofovir) RN - EL9943AG5J (tenofovir alafenamide) RN - G70B4ETF4S (Emtricitabine) RN - JAC85A2161 (Adenine) RN - OF5P57N2ZX (Alanine) SB - IM MH - Adenine/therapeutic use MH - Adolescent MH - Adult MH - Aged MH - Alanine/*therapeutic use MH - Amides/*therapeutic use MH - Anti-HIV Agents/adverse effects/*therapeutic use MH - Child MH - Drug Combinations MH - Emtricitabine/*therapeutic use MH - Female MH - HIV Infections/*drug therapy MH - HIV-1/*drug effects MH - Heterocyclic Compounds, 3-Ring/*therapeutic use MH - Heterocyclic Compounds, 4 or More Rings/therapeutic use MH - Humans MH - Middle Aged MH - Piperazines/*therapeutic use MH - Pyridones/*therapeutic use MH - Tenofovir/*analogs & derivatives/therapeutic use MH - Treatment Outcome MH - Young Adult PMC - PMC8547745 COIS- C.O. reports grants and personal fees from Gilead during the conduct of the included study; grants, personal fees, speaker bureau fees, and travel expenses from Gilead, and speaker bureau fees from GlaxoSmithKline, Janssen, MSD, and VIIV, outside the submitted work. C.K. reports grants to her institution from Gilead during the conduct of the included study. B.G.-P., H.W., Y.L., X.W., K.W., T.M., C.P., I.M., S.E.C., D.B., and S.K.C. are employees of and hold stocks in Gilead Sciences. The remaining authors have no conflicts of interest to disclose. Data Sharing: Gilead Sciences shares anonymized individual patient data on request or as required by law or regulation with qualified external researchers based on submitted curriculum vitae and reflecting nonconflict 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- 2021/09/11 06:00 MHDA- 2022/01/18 06:00 PMCR- 2021/10/26 CRDT- 2021/09/10 17:17 PHST- 2021/03/18 00:00 [received] PHST- 2021/08/16 00:00 [accepted] PHST- 2021/09/11 06:00 [pubmed] PHST- 2022/01/18 06:00 [medline] PHST- 2021/09/10 17:17 [entrez] PHST- 2021/10/26 00:00 [pmc-release] AID - 00126334-202112010-00011 [pii] AID - QAIV21843 [pii] AID - 10.1097/QAI.0000000000002789 [doi] PST - ppublish SO - J Acquir Immune Defic Syndr. 2021 Dec 1;88(4):393-398. doi: 10.1097/QAI.0000000000002789.