Observational cohort study of rilpivirine (RPV) utilization in Europe
Cozzi-Lepri, Alessandro (Centre for Clinical Research. Epidemiology. Modelling and Evaluation (CREME). Institute for Global Health. University College London)
Peters, Lars (CHIP. Rigshospitalet. University of Copenhagen)
Pelchen-Matthews, Annegret (Centre for Clinical Research. Epidemiology. Modelling and Evaluation (CREME). Institute for Global Health. University College London)
Neesgaard, Bastian (CHIP. Rigshospitalet. University of Copenhagen (Belgium))
De Wit, Stéphane (Université Libre de Bruxelles, Department of Infectious Diseases)
Johansen, Isik Somuncu (Odense University Hospital (Dinamarca))
Edwards, Simon (Mortimer Market Centre, Department of HIV (London))
Stephan, Christoph (Infectious Diseases Unit. Goethe-University Hospital)
Adamis, Georgios (General Hospital of Athens G. Gennimatas (Greece))
Staub, Therese (Centre Hospitalier de Luxembourg, Service des Maladies Infectieuses (Luxembourg))
Zagalo, Alexandra (Santa Maria University Hospital, Department of Infectious Diseases (Lisbon, Portugal))
Domingo, Pere (Institut d'Investigació Biomèdica Sant Pau)
Elbirt, Daniel (Allergy. Immunology and HIV Unit | Kaplan. Medical Center)
Kusejko, Katharina (University Hospital Zürich (Switzerland))
Brännström, Johanna (Department of Infectious Diseases. Venhälsan Södersjukhuset)
Paduta, Dzmitry (Gomel Regional Centre for Hygiene)
Trofimova, Tatyana (Novgorod Centre for AIDS Prevention and Control)
Szlavik, Janos (South-Pest Hospital Centre-National Institute for Infectiology and Haematology)
Zilmer, Kai (West-Tallinn Central Hospital, Infectious Diseases Clinic (Talinn, Estonia))
Losso, Marcello (Hospital J.M. Ramos Mejia (Buenos Aires))
Van Eygen, Veerle (Janssen Research & Development)
Pai, Helen (Janssen Research & Development)
Lundgren, Jens (CHIP. Rigshospitalet. University of Copenhagen)
Mocroft, Amanda (Rigshospitalet. University of Copenhagen (Denmark))
Harxhi, Arjan (Medical University of Tirana (Albania))
Losso, Marcelo Horacio (Hospital General de Agudos JM Ramos Mejía (Buenos Aires))
Kundro, Mariana (Hospital General de Agudos JM Ramos Mejía (Buenos Aires))
Schmied, Brigitte (Institute of Science and Technology Austria (ISTA))
Karpov, Igor Alexandrovich (Belarusian State Medical University (Minsk))
Vassilenko, Anna (Belarusian State Medical University (Minsk))
Paduto, Dmitriy (Regional AIDS Centre (Svetlogorsk, Bèlgica))
Mitsura, Victor (Gomel State Medical University)
Clumeck, Nathan (University Hospital Brussels)
De Wit, Stéphane A. (Université Libre de Bruxelles)
Delforge, Marc D. (Université Libre de Bruxelles)
Hadziosmanovic, Vesnadarjan (Clinical Center University of Sarajevo)
Begovac, Josip (University of Zagreb)
Machala, Ladislav (Charles University in Prague)
Jilich, David (Charles University in Prague)
Gerstoft, Jan (IT University of Copenhagen)
Torp-Pedersen, Christian (Aalborg Universitet)
Sedlacek, Dalibor (Fakultní nemocnice Plzeň)
Kronborg, Gitte (University of Copenhagen)
Benfield, Thomas (Copenhagen University Hospital Hvidovre)
Johansen, IS (Odense University Hospital (Dinamarca))
Ostergaard, Leif (Aarhus University)
Wiese, Lothar (Roskilde University)
Friis-Moller, Nina (Zealand University Hospital)
Nielsen, Lars Norregård (Hillerod Hospital (Hillerod, Dinamarca))
Zilmer, Kai (Kaunas University of Technology)
Smidt, Jelena (Kohtla - Jarve Jarve Gümnaasium)
Aho, Inka (Helsinki University Central Hospital)
Viard, Jean-Paul (Université Paris Cité)
Girard, Pierre-Marie (University of Paris-Est)
Pradier, Christian (Centre Hospitalier Universitaire de Nice)
Fontas, Eric (Centre Hospitalier Universitaire de Nice)
Duvivier, Claudine (Hôpital Universitaire Necker)
Rockstroh, Jurgen (Universitätsklinikum Bonn)
Degen, Olaf (University Medical Center Hamburg)
Hoffmann, C. (IPM Study Center)
Stellbrink, H.J. (IPM Study Center)
Stefan, C. (JW Goethe University Hospital (Frankfurt))
Bogner, Johannes (University Hospital München)
Fätkenheuer, Gerd (University of Cologne)
Chkhartishvili, N. (Infectious Diseases, AIDS and Clinical Immunology Research Center)
Sambatakou, Helen (Hippokration General Hospital (Athens))
Paissios, N. (Athens General Hospital "G Gennimatas")
Uzdaviniene, V. (Vilnius University Hospital Santariskiu Clinics)
Staub, T. (Centre Hospitalier de Luxembourg)
Dragas, S.
Reiss, P. (University of Amsterdam)
Trajanovska, J. (University Clinic for Infectious Diseases & Febrile Conditions (Skopje))
Reikvam, Dag Henrik (Oslo University Hospital (Oslo, Noruega))
Maeland, A. (Oslo University Hospital (Oslo, Noruega))
Bruun, Johan (University Hospital of North Norway)
Knysz, B. (WWF Poland)
Szetela, Bartosz (Nicolaus Copernicus University)
Inglot, Malgorzata (Wroclaw Medical University)
Bakowska, E. (Hospital For Infectious Diseases (Warsaw))
Flisiak, Robert (Medical University of Bialystok)
Grzeszczuk, Anna (Medical University of Bialystok)
Parczewski, Miłosz (Pomeranian Medical University in Szczecin)
Maciejewska, Katarzyna (Pomeranian Medical University in Szczecin)
Aksak-Was, Bogusz (Pomeranian Medical University in Szczecin)
Beniowski, Marek (Medical University of Silesia in Katowice)
Mularska, Elżbieta
Jablonowska, Elżbieta (University of Lodz)
Kamerys, J. (Poznan University of Medical Sciences)
Wojcik, K. (University of Lodz)
Mozer-Lisewska, Iwona (Uniwersytet Medyczny im.Karola Marcinkowskiego w Poznaniu)
Rozplochowski, Błażej (Poznan University of Medical Sciences)
Zagalo, A. (Hospital Santa Maria (Lisboa, Portugal))
Radoi, Roxana (Clinical Hospital Of Infectious Diseases "Dr. Victor Babes")
Oprea, Cris (Joint Institute for Nuclear Research)
Yakovlev, A. (Saint Petersburg State University)
Trofimora, T. (Novgorod Centre for AIDS (Novgorod))
Khromova, I. (Tomsk Regional Center of AIDS and infectious diseases prophylaxis and control" (RCAIDPC))
Kuzovatova, Elena (Blokhina Scientific Research Institute of Epidemiology and Microbiology of Nizhny Novgorod)
Borodulina, Elena (Samara State Medical University)
Vdoushkina, Elena (Samara State Medical University)
Ranin, Jovan (Klinički centar Srbije)
Tomazic, J. (Ljubljana University Medical Centre)
Miro, Josep M. (Instituto de Salud Carlos III)
Laguno, Montse (Hospital Clínic i Provincial de Barcelona)
Martinez, E. (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Garcia, F. (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Blanco, J.L. (Hospital Clínic i Provincial de Barcelona)
Martinez-Rebollar, María (Hospital Clínic i Provincial de Barcelona)
Mallolas Masferrer, Josep (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Callau, Pilar (Universitat de Barcelona)
Rojas, J. (Hospital Clínic i Provincial de Barcelona)
Moreno, Santiago (Pontifical Catholic University of Argentina)
del Campo, Santos (Hospital Universitario Ramón y Cajal (Madrid))
Jou, A. (IrsiCaixa Institute for AIDS Research)
Paredes, Roger (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Puig, Jordi (Universitat Autònoma de Barcelona)
Llibre, Josep M.. (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Santos, J.R. (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Domingo, Pere (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Gutierrez, M. (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Mateo, G.M. (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Sambeat, A. (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Laporte, J.M. (Arabako Unibertsitate Ospitalea (Vitoria, País Basc))
Svedhem, V. (Karolinska University Hospital and Karolinska Institutet (Suècia))
Thalme, Anders (Karolinska University Hospital and Karolinska Institutet (Suècia))
Sonnerborg, A. (Karolinska University Hospital)
Flamholc, L. (Skåne University Hospital (Suècia))
Kusejko, Katharina (University of Zurich)
Weber, R. (Universitäts-Herzzentrum Freiburg - Bad Krozingen)
Calmy, Alexandra (University of Geneva)
Furrer, Hansjakob (Inselspital, Universitätsspital Bern)
Battegay, Manuel (University of Basel)
Schmid, P. (Cantonal Hospital of Schwyz)
Kuznetsova, A. (Kyiv National Economic University)
Mikhalik, Julia (Crimean Republican AIDS centre)
Sluzhynska, M. (International HIV/AIDS Alliance in Ukraine)
Milinkovic, Ana (Imperial College London)
Johnson, A.M. (Mortimer Market Centre)
Simons, Edwards (Mortimer Market Centre)
Edwards, S. (Brookhaven National Laboratory)
Phillips, A.M. (Royal Free and University College Medical School)
Johnson, M.A. (Royal Free and University College Medical School)
Mocroft, A. (Royal Free and University College Medical School)
Orkin, Chloe (Queen Mary, University of London)
Winston, Alan (Imperial College London)
Clarke, A. (University of Sussex)
Leen, Clifford (The University of Edinburgh)

Data:	2022
Resum:	Introduction: Data on safety and effectiveness of RPV from the real-world setting as well as comparisons with other NNRTIs such as efavirenz (EFV) remain scarce. Methods: Participants of EuroSIDA were included if they had started a RPV- or an EFV-containing regimen over November 2011-December 2017. Statistical testing was conducted using non-parametric Mann-Whitney U test and Chi-square test. A logistic regression model was used to compare participants' characteristics by treatment group. Kaplan-Meier analysis was used to estimate the cumulative risk of virological failure (VF, two consecutive values > 50 copies/mL). Results: 1,355 PLWH who started a RPV-based regimen (11% ART-naïve), as well as 333 initiating an EFV-containing regimen were included. Participants who started RPV differed from those starting EFV for demographics (age, geographical region) and immune-virological profiles (CD4 count, HIV RNA). The cumulative risk of VF for the RPV-based group was 4. 5% (95% CI 3. 3-5. 7%) by 2 years from starting treatment (71 total VF events). Five out of 15 (33%) with resistance data available in the RPV group showed resistance-associated mutations vs. 3/13 (23%) among those in the EFV group. Discontinuations due to intolerance/toxicity were reported for 73 (15%) of RPV- vs. 45 (30%) of EFV-treated participants (p = 0. 0001). The main difference was for toxicity of central nervous system (CNS, 3% vs. 22%, p < 0. 001). Conclusion: Our estimates of VF > 50 copies/mL and resistance in participants treated with RPV were similar to those reported by other studies. RPV safety profile was favourable with less frequent discontinuation due to toxicity than EFV (especially for CNS).
Ajuts:	European Commission FP7 260694
Nota:	Altres ajuts: ViiV Healthcare LLC; Janssen Scientific Affairs; Janssen R&D; Bristol-Myers Squibb Company; Merck Sharp & Dohme Corp; Gilead Sciences; The Swiss National Science Foundation (148522); the Danish National Research Foundation and by the International Cohort Consortium of Infectious Disease (RESPOND) (DNRF126).
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Cohort Study ; Europe ; Edurant™ ; Eviplera™ ; Efavirenz ; Real-world efectiveness
Publicat a:	AIDS Research and Therapy, Vol. 19 Núm. 1 (december 2022) , p. 38, ISSN 1742-6405

DOI: 10.1186/s12981-022-00457-0
PMID: 35933352

12 p, 780.3 KB

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