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Recommendations from the European guidelines on Clinical Management of HIV-1 Tropism Testing

European guidelines on the clinical management of HIV-1 tropism testing.

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Recommendations from the European guidelines on Clinical Management of HIV-1 Tropism Testing

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  1. European guidelines on the clinical management of HIV-1 tropism testing Vandekerckhove LPR*, Wensing AMJ*, Kaiser R, Brun-Vézinet F, Clotet B, De Luca A, Dressler S, Garcia F, Geretti AM, Klimkait T, Korn K, Masquelier B, Perno CF, Schapiro JM, Soriano V, Sönnerborg AM, Vandamme AM, Verhofstede C, Walter H , Zazzi M and Boucher CAB on behalf of the European Consensus Group on clinical management of tropism testing *These authors contributed equally to these guidelines. Introduction CCR5-antagonists such as maraviroc (MVC) specifically inhibit the entry into host cells and subsequent replication of CCR5-tropic HIV variants (R5) by an allosteric mechanism after binding to the transmembrane CCR5-co-receptor cavity. The European Medicine Agency (EMA) has approved MVC for use in treatment-experienced adults in whom only CCR5-tropic virus is detected. The US Food and Drug Administration (FDA) but not the EMA has also approved MVC for use in treatment naïve R5-only individuals. Pre-assessment of viral tropism is required for clinical use of the drug. In the registration trials the original Trofile-assay (OTA, Monogram Biosciences) was used for this purpose. Today, an enhanced version of the Trofile assay (ESTA) with improved sensitivity for the detection of HIV variants capable of using the CXCR4 receptor (X4) has replaced the OTA. In addition, several other phenotypic and genotypic approaches for tropism determination have been developed by academic groups and diagnostic companies. As the number of tropism evaluation methods is growing, guidelines for optimal use of these methods and their interpretation are required. This poster summarises the consensus statement of the European guidelines group on clinical management of tropism testing. The recommendations of the panel comprise clinical indications for tropism testing, selection of the appropriate tropism determination method and adequate interpretation of results using these methods. Recommendations from the European guidelines on Clinical Management of HIV-1 Tropism Testing SummaryHIV tropism testing is required to select patients who will benefit from antiretroviral agents targeting the CCR5 co-receptor. To date, in most European countries HIV tropism has been determined using a phenotypic tropism test. The European guidelines on the clinical management of HIV-1 tropism testing provide evidence-based recommendations for the clinical use of tropism testing and expert guidance on unresolved issues and current developments. Current data support both the use of V3 genotypic population sequencing and the commercially available ESTA for co-receptor tropism determination. For practical reasons genotypic population sequencing is the preferred method in Europe. PanelAlbert Jan (Sweden), Alexiev Ivailo (Bulgaria), Åsjö Birgitta (Norway), Balotta Claudia (Italy), Beshkov Danail (Bulgaria), Boucher Charles (the Netherlands), Braun Patrick (Germany), Brun-Vézinet Françoise (France), Camacho Ricardo (Portugal), Cane Pat (UK), Clotet Bonaventura (Spain), Coughlan Suzie (Ireland), Daeumer Martin (Germany), De Luca Andrea (Italy), Dressler Stephan (European AIDS Treatment Group), Ene Luminita (Romania), Garcia Federico (Spain), de Gascun Cillian (Ireland), Geretti Anna Maria (UK), Griskevicius Algirdas (Lithuania), Grossman Zehava (Israel), Horban Andrzej (Poland), Kaiser Rolf (Germany), Klimkait Thomas (Switserland), Kolupajeva Tatjana (Latvia), Korn Klaus (Germany), Kostrikis Leon (Cyprus), Liitsola Kirsi (Finland), Linka Marek (Czech Republic), Zidovec Lepej Snjezana (Croatia), Masquelier Bernard (France), Minarovits Janos (Hungary), Nielsen Claus (Denmark), Obermeier Martin (Germany), Otelea Dan (Romania), Paraskevis Dimitrios (Greece), Paredes Roger (Spain), Perno Carlo Federico (Italy), Pillay Deenan (UK), Poljak Mario (Slovenia), Poveda, Eva (Spain), Puchhammer-Stöckl Elisabeth (Austria), Rusconi Stefano (Italy), Schapiro Jonathan (Israel), Schmit Jean-Claude (Luxembourg), Schuurman Rob (Netherlands), Soriano Vincent (Spain), Sönnerborg Anders (Sweden), Stanékova Danica (Slovakia), Stanojevic Maja (Serbia), Svicher Valentina (Italy), Vandamme Anne-Mieke (Belgium), Vandekerckhove Linos (Belgium), Van Laethem Kristel (Belgium), Verhofstede Chris (Belgium), Walter Hauke (Germany), Wensing Annemarie (the Netherlands), Yerly Sabine (Suisse), Zazzi Maurizio (Italy), Zilmer Kai (Estonia) The Tropism guidelines are available as epublication on the website of The Lancet Infectious Diseases. These guidelines are an initiative of the EuropeHIVResistance network, EC contract number: LSHP-CT-2006-518211, which has now evolved into the European Society for Antiviral Resistance (ESAR). For more information please send an e-mail to info@esar-society.eu.

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