PMID- 35033092 OWN - NLM STAT- MEDLINE DCOM- 20220203 LR - 20220203 IS - 1742-6405 (Electronic) IS - 1742-6405 (Linking) VI - 19 IP - 1 DP - 2022 Jan 15 TI - Raltegravir 1200 mg once daily as maintenance therapy in virologically suppressed HIV-1 infected adults: QDISS open-label trial. PG - 4 LID - 10.1186/s12981-022-00428-5 [doi] LID - 4 AB - BACKGROUND: Raltegravir (RAL) has favorable tolerability and safety profile, with few and manageable drug interactions. The use of RAL 1200 mg once daily (qd) for first-line therapy is well established. We assessed efficacy and safety of RAL 1200 mg qd, as part of triple combined antiretroviral therapy (cART), for maintenance strategy. METHODS: The QDISS trial (NCT03195452) was a 48-week multicenter, single-arm, open-label study designed to evaluate the ability of 2 NRTIs + RAL 1200 mg qd to maintain virological suppression in HIV-1 infected subjects on a stable cART with 2 NRTIs and a third agent for at least 6 months. The primary endpoint was the proportion of participants with HIV-1 RNA < 50 copies/mL at week 24, by the FDA snapshot algorithm. RESULTS: Of 100 participants 91% maintained viral suppression (95% CI: 83.6-95.8) at week 24 and 89% (81.2-94.4) at week 48. At week 24, there was one virological failure, without emergence of resistance-associated mutation and 10 participants had discontinued, 4 because of adverse events (AEs). Over 48 weeks, 7 AEs of grade 3-4 were reported, one possibly study-drug related (spontaneous abortion). BMI remained stable regardless of previous therapy or baseline BMI category. Over 48 weeks, total cholesterol (p = 0.023) and LDL-cholesterol (p = 0.009) decreased, lifestyle and ease subscale significantly improved (p = 0.04). The quality of life and Patients Reported Outcomes (PROs) also improved at W12 (p = 0.007). CONCLUSION: RAL 1200 mg qd as part of a maintenance triple therapy showed a high efficacy in virologically suppressed HIV-1 infected subjects, with good safety profile and improved lipid profile and patient reported outcomes. TRIAL REGISTRATION: Clinical trials.gov NCT03195452 and EudraCT 2016-003702-13. CI - (c) 2022. The Author(s). FAU - Hall, Nolwenn AU - Hall N AD - Public Health Center, CH Quimper, Quimper, France. FAU - Allavena, Clotilde AU - Allavena C AD - Department of Infectious Diseases, CHU Nantes, INSERM UIC 1413, CHU Nantes, Hotel-Dieu University Hospital, 1 Place Alexis-Ricordeau, 44000, Nantes, France. FAU - Katlama, Christine AU - Katlama C AD - Department of Infectious Diseases, Assistance Publique-Hopitaux de Paris, Pitie-Salpetriere University Hospital, Paris, France. FAU - Jobert, Alexandra AU - Jobert A AD - Sponsor Department, CHU Nantes, Nantes, France. FAU - Molina, Jean-Michel AU - Molina JM AD - Department of Infectious Diseases, Hopital Saint-Louis, Assistance Publique-Hopitaux de Paris, Universite de Paris Diderot, Sorbonne Paris Cite, INSERM UMR 941, Paris, France. FAU - Cua, Eric AU - Cua E AD - Department of Infectious Diseases, Hopital de l'Archet, Centre Hospitalier de Nice, Nice, France. FAU - Bani-Sadr, Firouze AU - Bani-Sadr F AD - Department of Internal Medicine, Infectious Diseases, and Clinical Immunology, Reims Teaching Hospitals, University of Reims, Reims, France. FAU - Hocqueloux, Laurent AU - Hocqueloux L AD - Department of Infectious Diseases, CHR d'Orleans, Orleans, France. FAU - Duvivier, Claudine AU - Duvivier C AD - AP-HP-Necker Hospital, Infectious Diseases Department, Necker-Pasteur Infectiology Centre, Paris, France. FAU - Merrien, Dominique AU - Merrien D AD - Department of Infectious Diseases, CHD Vendee, La Roche sur yon, France. FAU - Hikombo, Hitoto AU - Hikombo H AD - Infectious and Tropical Diseases Department, Le Mans General Hospital, Le Mans, France. FAU - Andre-Garnier, Elisabeth AU - Andre-Garnier E AD - Virology Laboratory CHU Hotel Dieu and INSERM CIC 1413 Nantes University, Nantes, France. FAU - Gaultier, Aurelie AU - Gaultier A AD - Department of Biostatistics, CHU de Nantes, Direction de la recherche, Nantes, France. FAU - Raffi, Francois AU - Raffi F AD - Department of Infectious Diseases, CHU Nantes, INSERM UIC 1413, CHU Nantes, Hotel-Dieu University Hospital, 1 Place Alexis-Ricordeau, 44000, Nantes, France. francois.raffi@wanadoo.fr. CN - QDISS Study Group LA - eng SI - ClinicalTrials.gov/NCT03195452 SI - EudraCT/2016-003702-13 PT - Journal Article PT - Multicenter Study DEP - 20220115 PL - England TA - AIDS Res Ther JT - AIDS research and therapy JID - 101237921 RN - 43Y000U234 (Raltegravir Potassium) SB - IM MH - Adult MH - *HIV Infections/drug therapy MH - *HIV Seropositivity MH - *HIV-1 MH - Humans MH - Quality of Life MH - Raltegravir Potassium/adverse effects MH - Treatment Outcome MH - Viral Load PMC - PMC8760827 OTO - NOTNLM OT - HIV-1 infection OT - Integrase inhibitor OT - Maintenance OT - Once daily OT - Quality of life OT - Raltegravir OT - Switch COIS- All authors declare that they have no competing interests in relation to this work. FIR - Bollengier, Olivier IR - Bollengier O FIR - Guimard, Thomas IR - Guimard T FIR - Leautez, Sophie IR - Leautez S FIR - Blanchi, Sophie IR - Blanchi S FIR - Becker, Agathe IR - Becker A FIR - Cotte, Laurent IR - Cotte L FIR - Ferry, Tristan IR - Ferry T FIR - Perpoint, Thomas IR - Perpoint T FIR - Trabaud, Marie-Anne IR - Trabaud MA FIR - Biron, Laetitia IR - Biron L FIR - Ferre, Virginie IR - Ferre V FIR - Flet, Laurent IR - Flet L FIR - Reliquet, Veronique IR - Reliquet V FIR - Rodalec, Audrey IR - Rodalec A FIR - Volteau, Christele IR - Volteau C FIR - Breaud, Sophie IR - Breaud S FIR - Pugliese, Pascal IR - Pugliese P FIR - Rosenthal, Eric IR - Rosenthal E FIR - De Dieuleveult, Barbara IR - De Dieuleveult B FIR - Prazuck, Thierry IR - Prazuck T FIR - Bachelard, Antoine IR - Bachelard A FIR - Legac, Sylvie IR - Legac S FIR - Yazdanpanah, Yazdan IR - Yazdanpanah Y FIR - Ghosn, Jade IR - Ghosn J FIR - Kalambay, Myriam IR - Kalambay M FIR - Slama, Laurence IR - Slama L FIR - Viard, Jean-Paul IR - Viard JP FIR - Lourenco, Jeremy IR - Lourenco J FIR - Ktorza, Nadine IR - Ktorza N FIR - Palich, Romain IR - Palich R FIR - Schneider, Luminita IR - Schneider L FIR - Aslan, Alexandre IR - Aslan A FIR - Tateo, Mariagrazia IR - Tateo M FIR - Zeggagh, Jeremy IR - Zeggagh J FIR - Brodard, Veronique IR - Brodard V FIR - Hentzien, Maxime IR - Hentzien M FIR - Kmiec, Isabelle IR - Kmiec I FIR - N'Guyen, Yohan IR - N'Guyen Y FIR - Ajana, Faiza IR - Ajana F FIR - Bocket, Laurence IR - Bocket L FIR - Huleux, Thomas IR - Huleux T FIR - Meybeck, Agnes IR - Meybeck A EDAT- 2022/01/17 06:00 MHDA- 2022/02/04 06:00 PMCR- 2022/01/15 CRDT- 2022/01/16 20:31 PHST- 2021/08/18 00:00 [received] PHST- 2022/01/04 00:00 [accepted] PHST- 2022/01/16 20:31 [entrez] PHST- 2022/01/17 06:00 [pubmed] PHST- 2022/02/04 06:00 [medline] PHST- 2022/01/15 00:00 [pmc-release] AID - 10.1186/s12981-022-00428-5 [pii] AID - 428 [pii] AID - 10.1186/s12981-022-00428-5 [doi] PST - epublish SO - AIDS Res Ther. 2022 Jan 15;19(1):4. doi: 10.1186/s12981-022-00428-5.