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Usage of Antivirals and the Occurrence of Antiviral Resistance in Norway 2018 REPORT 2019 Usage of Antivirals and the Occurrence of Antiviral Resistance in Norway 2018 RAVN Resistensovervåking av virus i Norge Resistance against Antivirals in Norway Usage of Antivirals and the Occurrence of Antiviral resistance in Norway 2018 RAVN Resistensovervåkning av virus i Norge Resistance against antivirals in Norway 2 Published by the Norwegian Institute of Public Health Division of Infection Control and Environmental Health Department for Infectious Disease registries October 2019 Title: Usage of Antivirals and the Occurrence of Antiviral Resistance in Norway 2018. RAVN Ordering: The report can be downloaded as a pdf at www.fhi.no Graphic design cover: Fete Typer ISBN nr: 978-82-8406-032-3 Emneord (MeSH): Antiviral resistance Any usage of data from this report should include a specific reference to RAVN. Suggested citation: RAVN. Usage of Antivirals and the Occurrence of Antiviral Resistance in Norway 2018. Norwegian Institute of Public Health, Oslo 2019 Resistance against antivirals in Norway • Norwegian Institute of Public Health 3 Table of contents Introduction _________________________________________________________________________ 4 Contributors and participants __________________________________________________________ 5 Sammendrag ________________________________________________________________________ 6 Summary ___________________________________________________________________________ 8 1 Antivirals and development of drug resistance ______________________________________ 10 2 The usage of antivirals in Norway _________________________________________________ 16 Influenza virus 19 Human immunodeficiency virus 20 Hepatitis B virus 24 Human herpesviruses 25 Hepatitis C virus 26 3 Influenza virus _________________________________________________________________ 29 Surveillance methods 29 Surveillance data 2018 29 New flu antiviral drugs: potential for resistance 32 4 Human immunodeficiency virus ___________________________________________________ 37 Surveillance methods 37 Surveillance data 2018 38 National tenders on HIV drugs: Perspectives on antiretroviral drug resistance 41 5 Hepatitis B virus ________________________________________________________________ 44 Surveillance method 44 Surveillance data 2018 44 6 Human herpes viruses ___________________________________________________________ 47 Surveillance of cytomegalovirus drug resistance 47 Surveillance method 47 Surveillance data 2018 47 Surveillance of herpes simplex virus drug resistance 49 Surveillance method 49 Surveillance data 2018 49 7 Hepatitis C virus ________________________________________________________________ 50 Resistance against antivirals in Norway • Norwegian Institute of Public Health 4 Introduction In 2018, the rise in antimicrobial resistance (AMR) was defined by WHO as one of the greatest threats to global health. Antiviral treatment is a young, but rapidly growing field, and the number of antiviral drugs registered is constantly increasing. Better knowledge and increased awareness are essential to be able to control emerging antiviral drug resistance, and surveillance will be a key tool for management. The Norwegian Surveillance System for Virus Resistance (RAVN) was established in 2014 and is coordinated by the RAVN administration at the Norwegian Institute of Public Health. The RAVN administration works together with the RAVN Advisory council to monitor viral resistance in collaboration with participating regional laboratories. It is a pleasure to present the sixth report from the surveillance system for Resistance against Antivirals in Norway (RAVN). In this report, we present data for 2018 on resistance against agents for treatment of influenza, HIV-1 infection, hepatitis B virus infection. and human herpes virus infections. The reference laboratories at the Norwegian Institute of Public Health and at the Oslo University Hospital have submitted the data. In this year’s report, we have added a new chapter with a general introduction to antiviral treatment and drug resistance, including a presentation of the different drugs and drug classes. Hopefully, this will provide useful background knowledge when reading other parts of the report, particularly for new colleagues in the field. In addition to the surveillance data, we have selected two relevant topics that are given special attention in the report, presented by invited authors: • National tender on HIV drugs: This is a process administered by Norwegian health authorities aiming to reduce the cost of antiretroviral treatment of HIV through coordinated procurement of the drugs. The possible consequences of instructing clinicians to prescribe drugs based on an economically prioritized list of HIV treatment regimens are discussed from a drug resistance perspective. • New antiviral drugs against influenza: Currently, oseltamivir is the only drug on the market in Norway, but new drugs are in the pipeline. An overview of new treatment options is presented, and their potential for drug resistance discussed. Furthermore, we provide an update on the status of the ongoing work with resistance testing for hepatitis C virus (HCV): Drug resistance testing is currently not available in Norway. An assay based on next generation sequencing is being implemented at the NIPH. It is our hope that the report contains valuable data and interesting perspectives for clinicians, microbiologists, other colleagues with an interest in infectious diseases, and for those developing diagnostic- and treatment guidelines and strategies to prevent transmission of viral infections. RAVN would like to thank those who contributed with data and writing this report, for excellent work. Enjoy! Resistance against antivirals in Norway • Norwegian Institute of Public Health 5 Contributors and participants Editors: Anne-Marte Bakken Kran Norwegian Institute of Public Health (NIPH) Othilde Elise Håvelsrud Norwegian Institute of Public Health (NIPH) Collaborating authors: Irene Litleskare Usage of antivirals in Norway NIPH Karoline Bragstad Influenza virus NIPH Anne-Marte Bakken Kran Human Immunodeficiency virus NIPH, Oslo University Hospital Vidar Ormåsen Human Immunodeficiency virus Oslo University Hospital Kathrine Stene-Johansen Hepatitis B virus NIPH Grete Birkeland Kro Human herpesviruses Oslo University Hospital Kathrine Stene-Johansen Hepatitis C virus NIPH Rikard Rykkvin Hepatitis C virus NIPH Contributors: From RAVN advisory council: Garth Tylden, Andreas Christensen, Heidi Syre, Birgitta Åsjø RAVN administration https://www.fhi.no/hn/helseregistre-og-registre/ravn/ Institutions submitting surveillance data to RAVN: NIPH, Karoline Bragstad / Kathrine Stene-Johansen / Rikard Rykkvin. The Norwegian Prescription database (NorPD), NIPH, Irene Litleskare Oslo University Hospital, Rikshospitalet, Grete Birkeland Kro Oslo University Hospital, Ullevål, Anne-Marte Bakken Kran, Mona Holberg-Petersen RAVN advisory council 2018: Anne Marte Bakken Kran (chairperson) Oslo University Hospital, Ullevål, Oslo Bente Bergersen Oslo University Hospital, Ullevål, Oslo Kathrine Stene-Johansen Norwegian Institute of Public Health, Oslo Andreas Christensen St. Olav University Hospital, Trondheim Garth Tylden University Hospital of North Norway, Tromsø Heidi Syre Stavanger University Hospital Susanne Dudman Norwegian Institute of Public Health, Oslo Birgitta Åsjø Haukeland University Hospital, Bergen Resistance against antivirals in Norway • Norwegian Institute of Public Health 6 Sammendrag Bruk av antivirale midler Ifølge data fra Reseptregisteret, fortsetter trenden fra tidligere år, nemlig at salget av antivirale medikamenter målt i definerte døgndoser (DDD) fortsetter å øke også i 2018. Til tross for en økning av salget, både målt i antall DDD og i antall behandlede pasienter, er kostnadene i 2018 for første gang redusert. Dette kan forklares av prisreduksjon på medikamenter mot hiv og hepatitt C virus (HCV). For medikamenter mot hiv og HCV har det vært en dreining fra medikamenter med ett virkestoff til kombinasjonspreparater. Denne endringen har vært spesielt tydelig for HCV de siste to år, hvor 95 % av pasientene i 2018 ble behandlet med kombinasjonspreparater mot 27 % i 2016 og ingen i 2014. Influensavirus Det ble ikke påvist influensavirus med resistens mot oseltamivir eller zanamivir i 2017/18-sesongen. Alle sirkulerende influensavirusgrupper er for tiden resistente overfor adamantaner, og FHI har derfor sluttet å teste rutinemessig for adamantanresistens. Kun oseltamivir er nå tilgjengelig på det norske markedet. Humant immunsviktvirus-1 Resistensmutasjoner som overvåkes ble påvist i 9.2 % av prøvene fra pasienter med nydiagnostisert hiv-1 infeksjon i Norge i 2018. Dette er en noe høyere andel enn foregående år, men det var i 2018 også færre prøver som ble undersøkt for resistens, og totalt færre nye tilfeller av hiv-1 i Norge. Prevalensen av overført resistens har vært stabil de siste årene med bare små variasjoner. I 2018 var det utelukkende resistensmutasjoner assosiert med revers transkriptase- hemmere som ble påvist i overvåkningen av primærresistens (5.9 % non-nukleosid- og 5.0 % nukleosid revers transkriptasehemmere). Det ble ikke påvist noen mutasjoner assosiert med resistens mot proteasehemmere. For integrasehemmere er det ingen overvåkning av primærresistens. Hepatitt B virus I 2018 ble 20 pasientprøver sendt til referanselaboratoriet for hepatitt B virus (HBV) resistenstesting. Det ble påvist antiviral resistens i 4 av disse prøvene, og alle hadde mutasjoner assosiert med resistens mot entecavir.
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