Colagrossi, Luna
,
Hermans, Lucas E.
Salpini, Romina
Di Carlo, Domenico
Pas, Suzan D.
Alvarez, Marta
Ben-Ari, Ziv
Boland, Greet
Bruzzone, Bianca
Coppola, Nicola
Seguin-Devaux, Carole
Dyda, Tomasz
Garcia, Federico
Kaiser, Rolf
Köse, Sukran
Krarup, Henrik
Lazarevic, Ivana
Lunar, Maja M.
Maylin, Sarah
Micheli, Valeria
Mor, Orna
Paraschiv, Simona
Paraskevis, Dimitros
Poljak, Mario
Puchhammer-Stöckl, Elisabeth
Simon, François
Stanojevic, Maja
Stene-Johansen, Kathrine
Tihic, Nijaz
Trimoulet, Pascale
Verheyen, Jens
Vince, Adriana
Lepej, Snjezana Zidovec
Weis, Nina
Yalcinkaya, Tülay
Boucher, Charles A. B.
Wensing, Annemarie M. J.
Perno, Carlo F.
Svicher, Valentina http://orcid.org/0000-0002-2377-504X
Funding for this research was provided by:
FIRB project (RBAP11YS7K_001)
InterOmics (PB05)
Article History
Received: 4 August 2017
Accepted: 23 May 2018
First Online: 1 June 2018
Ethics approval and consent to participate
: Approval was provided by:UnorderedList removedIn accordance with National Guidelines and/or legislature, approval by Ethic Committee was not necessary since the study was based on a retrospective analysis of anonymized viral sequences obtained for clinical routine practice for the following centers: Italy (as outlined in art. 6 and art. 9 from the legislative decree 211/2003), The Netherlands (as outlined in 7:467 of the Dutch Civil Code [WMO] and 7:457 [WGBO]), Denmark (as outlined in the Act on Research Ethics Review of Health Research Projects), Turkey (as outlined in art. 2 from Regulations on Clinical Research, Official Gazette, Number 28617 at Apr 13, 2013), Luxembourg (as outlined in art. 25 of 28th august 1998 law on hospitals establishments), Poland (as outlined in the Polish Act from on December 5, 1996, on “physician professions and dentists” and in art. 37.1 Act of September 6, 2001 with changes on April 20, 2004 “Pharmaceutical Law”), Norway (as outlined in the Regional comittees of medical and health research ethics in Norway, reference nr 2012/896), France (as outlined in French Public Health Law CSP Art. L 1121–1.1), Rumenia (as outlined in leg. 46/2003), Slovenia (as outlined in 26 Direktive 98/44/EC). For Croatia, specific national guidelines/legislatives on this issue are currently not available, thus approval was deemed unnecessary according the Internal Regulation of the University Hospital for Infectious Diseases, in Zagreb. For Germany, at the time of sequences submission, there was no specific requirement concerning retrospective studies, legislations covered only clinical trials involving drugs or medical device. Part of the samples derived from our RESINA-cohort which is approved by the ethics “Cologne-16-460”.
: IL received a grant from the Ministry of Education, Science and Technological Development, Republic of Serbia, (Grant No. 175073), during the conduct of the study. SP received a grant from project BESTHOPE, (Grant No. 4–003/2012 (UEFISCDI)), during the conduct of the study. NW received a grant from The Danish Council for Independent Research (Grant No. 12–127,717), during the conduct of the study, and received fees for advisory board participation, lectures and chairing meetings from Abbvie, Bristol-Myers Squibb, Glaxo Smith Kline, Janssen, MSD and Medivir. AMJW received consultancy fees, travel and/or research grants from Bristol-Myers Squibb, Gilead, Janssen, MSD and Viiv Healthcare. None of these were related to this work. DP received funding by the Hellenic Scientific Society for the study of AIDS and STDs, during the conduct of the study. VS and CFP received educational and research grants from BMS and Gilead, during the conduct of this study. The other authors have no conflict of interests.Results reported in this manuscript have been presented in part at the 51st International Liver Congress 2016, promoted by EASL and at the 14th European Meeting of HIV & Hepatitis 2016.
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