Portal de Periódicos da CAPES

Observational cohort study of rilpivirine (RPV) utilization in Europe

2022; BioMed Central; Volume: 19; Issue: 1 Linguagem: Inglês

10.1186/s12981-022-00457-0

1742-6405

Alessandro Cozzi‐Lepri, Lars Peters, Annegret Pelchen–Matthews, Bastian Neesgaard, Stéphane De Wit, Işık Somuncu Johansen, Simon Edwards, Christoph Stephan, Georgios Adamis, Thérèse Staub, Alexandra Zagalo, Peré Domingo, Daniel Elbirt, Katharina Kusejko, Johanna Brännström, Dzmitry Paduta, Tatyana Trofimova, János Szlávik, Kai Zilmer, M Losso, Veerle Van Eygen, Helen Pai, Jens Lundgren, Amanda Mocroft, Arjan Harxhi, M Losso, M Kundro, Brigitte Schmied, Igor Karpov, Anna Vassilenko, D. Paduto, В. М. Мицура, Nathan Clumeck, Stéphane De Wit, M Delforge, Vesna Hadžiosmanović, Josip Begovać, Ladislav Machala, David Jilich, Jan Gerstoft, C. Pedersen, Dalibor Sedláček, Gitte Kronborg, Thomas Benfield, Işık Somuncu Johansen, Lars Østergaard, Lothar Wiese, Nina Friis‐Møller, Lars N. Nielsen, Kai Zilmer, Jelena Šmidt, Inka Aho, Viard Jp, PM Girard, Christian Pradier, Éric Fontas, Claudine Duvivier, Jürgen K. Rockstroh, Olaf Degen, Christian Hoffmann, Hans‐Juergen Stellbrink, Christopher J. Stefan, Johannes R. Bogner, Gerd Fätkenheuer, Nikoloz Chkhartishvili, Helen Sambatakou, Georgios Adamis, N. Paissios, Vilma Uždavinienė, Thérèse Staub, S Dragas, Peter Reiss, Jasmina Trajanovska, D. H. Reikvam, A Mæland, Jonas Bruun, Brygida Knysz, Bartosz Szetela, Małgorzata Inglot, Elżbieta Bąkowska, Robert Flisiak, Anna Grzeszczuk, Miłosz Parczewski, Katarzyna Maciejewska, Bogusz Aksak‐Wąs, Marek Beniowski, E. Mularska, Elżbieta Jabłonowska, Juliusz Kamerys, Kamila Wójcik, Iwona Mozer‐Lisewska, Błażej Rozpłochowski, Alexandra Zagalo, Roxana Rădoi, Cristiana Oprea, A. V. Yakovlev, T. Trofimora, Irina Khromova, Elena Kuzovatova, Е. А. Бородулина, Е. С. Вдоушкина, Jovan Ranin, Janez Tomažič, JM Miró, Montserrat Laguno, Elisenda Martínez, Felipe García, JL Blanco, Marı́a Martı́nez-Rebollar, Josep Mallolas, Pilar Callau, R. Domínguez, Santiago Moreno, Santos del Campo, Antoni Jou, Roger Paredes, Jordi Puig, Josep M. Llibre, José Ramón Santos, Peré Domingo, María Luisa Navarro Gómez, Gràcia Mateo, A. Sambeat, J. M. Laporte, Veronica Svedhem, Anders Thalme, Anders Sönnerborg, Leo Flamholc, Katharina Kusejko, Rainer Weber, Alexandra Calmy, Hansjakob Furrer, Manuel Battegay, Peter Schmid, Anastasiia Kuznetsova, Julia Mikhalik, M Sluzhynska, Ana Milinkovic, Margaret Johnson, Emily Simons, Simon Edwards, A. M. Phillips, Margaret Johnson, Amanda Mocroft, Chloe Orkin, Anna Winston, Amanda Clarke, Clifford Leen,

HIV-related health complications and treatments

Abstract 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).