PMID- 31283942 OWN - NLM STAT- MEDLINE DCOM- 20200707 LR - 20201209 IS - 1872-9096 (Electronic) IS - 0166-3542 (Linking) VI - 169 DP - 2019 Sep TI - Efficacy and safety of dolutegravir-based regimens in advanced HIV-infected naive patients: results from a multicenter cohort study. PG - 104552 LID - S0166-3542(19)30118-4 [pii] LID - 10.1016/j.antiviral.2019.104552 [doi] AB - The aims were to describe efficacy and tolerability of regimens containing dolutegravir (DTG) in advanced ART-naive people living with HIV (PLHIV) from the clinical practice. The frequency of Immune Reconstitution Inflammatory Syndrome (IRIS), the estimated time of discontinuation of the first ART regimen and the time to reach virological suppression in a multicenter cohort of AIDS-presenters or late-presenters with CD4 <350/muL were assessed. We included 272 PLHIV: 120 (44%) AIDS-presenters and 152 (56%) late-presenters. The most frequent AIDS-defining event was Pneumocystis jirovecii pneumonia in 41 (34%). One hundred-thirty-two PLHIV (48%) started first-line cART regimens including DTG and 140 PLHIV (52%) were treated with cART regimens without DTG. One-hundred-eighty-two (67%) individuals discontinued their first-line regimen: 109 (60%) for simplification, 32 (18%) for toxicities, 4 (2%) for drug-drug interactions, 37 (20%) for other reasons. DTG was interrupted in 19/132 (14%) PLHIV: 13 (68%) for adverse events (5 intolerance, 4 gastrointestinal disorders and 4 neurological symptoms), 2 (11%) for proactive switch and 4 (21%) for medical/individual choice. IRIS was reported in 13 (5%) AIDS-presenters without differences between arms. During a median observation time of 16 months (IQR 5-24), HIV-1 RNA<50 copies/mL was achieved in 95/132 (72%) individuals on DTG-based regimen and in 92/140 (66%) individuals with other regimens. The 12-month estimated probability of DTG interruption was 14% (95% CI 11-17). The results demonstrated the low risk for IRIS and the high potency, good tolerability and safety of DTG in our population of advanced naive PLHIV. CI - Copyright (c) 2019 Elsevier B.V. All rights reserved. FAU - Rossetti, Barbara AU - Rossetti B AD - Infectious Diseases Unit, Azienda Ospedaliera Universitaria Senese, Viale Bracci 16, 53100, Siena, Italy. Electronic address: brossetti1982@gmail.com. FAU - Baldin, Gianmaria AU - Baldin G AD - Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart, Largo Agostino Gemelli, 8, 00168, Rome, Italy. Electronic address: gian.baldin@gmail.com. FAU - Sterrantino, Gaetana AU - Sterrantino G AD - Department of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50134, Florence, Italy. Electronic address: sterrantinok@gmail.com. FAU - Rusconi, Stefano AU - Rusconi S AD - Infectious Diseases Unit, DIBIC Luigi Sacco, University of Milan, Via G.B. Grassi 74, 20157, Milan, Italy. Electronic address: stefano.rusconi@unimi.it. FAU - De Vito, Andrea AU - De Vito A AD - Unit of Infectious Diseases, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Viale San Pietro 43, 07100, Sassari, Italy. Electronic address: andreadevitoaho@gmail.com. FAU - Giacometti, Andrea AU - Giacometti A AD - Infectious Diseases, Department of Biological Sciences and Public Health, Marche Polytechnic University, Via Conca, 71, 60200, Ancona, Italy. Electronic address: andrea.giacometti1@gmail.com. FAU - Gagliardini, Roberta AU - Gagliardini R AD - Department of Medical Biotechnologies, University of Siena, Viale Bracci 16, 53100, Siena, Italy. Electronic address: roberta_gagliardini@yahoo.it. FAU - Colafigli, Manuela AU - Colafigli M AD - Infectious Dermatology and Allergology Unit, IFO S. Gallicano Institute (IRCCS), via Elio Chianesi, 53, 00144, Rome, Italy. Electronic address: manuela.colafigli@gmail.com. FAU - Capetti, Amedeo AU - Capetti A AD - First Division of Infectious Diseases, Department of Infectious Diseases, Luigi Sacco University Hospital, Via G.B. Grassi 74, 20157, Milan, Italy. Electronic address: amedeo.capetti@asst-fbf-sacco.it. FAU - d'Ettorre, Gabriella AU - d'Ettorre G AD - Department of Infectious Diseases and Public Health, Sapienza University of Rome, Piazzale Aldo Moro 5, 00185, Rome, Italy. Electronic address: gabriella.dettorre@uniroma1.it. FAU - Celani, Luigi AU - Celani L AD - Department of Infectious Diseases and Public Health, Sapienza University of Rome, Piazzale Aldo Moro 5, 00185, Rome, Italy. Electronic address: luigi.celani@uniroma1.it. FAU - Lagi, Filippo AU - Lagi F AD - Department of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50134, Florence, Italy. Electronic address: filippo.lagi@gmail.com. FAU - Ciccullo, Arturo AU - Ciccullo A AD - Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart, Largo Agostino Gemelli, 8, 00168, Rome, Italy. Electronic address: arturo.ciccullo@gmail.com. FAU - De Luca, Andrea AU - De Luca A AD - Infectious Diseases Unit, Azienda Ospedaliera Universitaria Senese, Viale Bracci 16, 53100, Siena, Italy; Department of Medical Biotechnologies, University of Siena, Viale Bracci 16, 53100, Siena, Italy. Electronic address: deluca.andrea2308@icloud.com. FAU - Di Giambenedetto, Simona AU - Di Giambenedetto S AD - Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart, Largo Agostino Gemelli, 8, 00168, Rome, Italy; IRCCS Fondazione Policlinico Universitario Agostino Gemelli,Largo Agostino Gemelli, 8, 00168, Rome, Italy. Electronic address: simona.digiambenedetto@unicatt.it. FAU - Madeddu, Giordano AU - Madeddu G AD - Unit of Infectious Diseases, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Viale San Pietro 43, 07100, Sassari, Italy. Electronic address: giordano@uniss.it. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20190705 PL - Netherlands TA - Antiviral Res JT - Antiviral research JID - 8109699 RN - 0 (Anti-HIV Agents) RN - 0 (Heterocyclic Compounds, 3-Ring) RN - 0 (Oxazines) RN - 0 (Piperazines) RN - 0 (Pyridones) RN - DKO1W9H7M1 (dolutegravir) SB - IM MH - Adult MH - Anti-HIV Agents/*administration & dosage/adverse effects/therapeutic use MH - Antiretroviral Therapy, Highly Active/methods MH - CD4 Lymphocyte Count MH - Cohort Studies MH - Drug Interactions MH - Drug Therapy, Combination/adverse effects/methods MH - Drug-Related Side Effects and Adverse Reactions MH - Female MH - HIV Infections/*drug therapy MH - Heterocyclic Compounds, 3-Ring/*administration & dosage/adverse effects/therapeutic use MH - Humans MH - Immune Reconstitution Inflammatory Syndrome/chemically induced MH - Male MH - Middle Aged MH - Oxazines MH - Piperazines MH - Pneumocystis carinii MH - Pneumonia/complications MH - Pyridones MH - Viral Load/drug effects OTO - NOTNLM OT - Antiretroviral therapy OT - Dolutegravir OT - HIV OT - Immune reconstitution inflammatory syndrome (IRIS) OT - Recent HIV infection EDAT- 2019/07/10 06:00 MHDA- 2020/07/08 06:00 CRDT- 2019/07/09 06:00 PHST- 2019/03/11 00:00 [received] PHST- 2019/06/21 00:00 [revised] PHST- 2019/07/04 00:00 [accepted] PHST- 2019/07/10 06:00 [pubmed] PHST- 2020/07/08 06:00 [medline] PHST- 2019/07/09 06:00 [entrez] AID - S0166-3542(19)30118-4 [pii] AID - 10.1016/j.antiviral.2019.104552 [doi] PST - ppublish SO - Antiviral Res. 2019 Sep;169:104552. doi: 10.1016/j.antiviral.2019.104552. Epub 2019 Jul 5.