Highlights
- •No significant improvement in health-related quality of life was observed among people who inject drugs (PWID) following HCV direct-acting antiviral (DAA) treatment.
- •A modest, but significant improvement in employment was observed during study follow-up.
- •This study suggests the need for HCV care models addressing a range of issues beyond HCV treatment to improve quality of life among PWID.
Abstract
Objectives
Methods
Results
Conclusions
Keywords
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Publication history
Publication stage
In Press Accepted ManuscriptFootnotes
Precis: People who inject drugs with HCV infection experienced different changes in patient reported outcomes during and following direct-acting antiviral treatment.
Author Contributions:
Concept and design: Cunningham, Shih, Amin, Powis, Hellard, Bruggmann, Marks, Stedman, Hajarizadeh, Feld, Dore, Grebely; Acquisition of data: Bruneau, Litwin, Dalgard, Hellard, Bruggmann, Marks, Lacombe, Stedman, Read, Hajarizadeh, Dunlop, Conway, Dore, Grebely
Analysis and interpretation of data: Cheng, Cunningham, Shih, Amin, Powis, Litwin, Cooper, Dalgard, Lacombe, Conway, Feld, Grebely
Drafting of the manuscript: Cheng, Cooper, Dore, Grebely
Critical revision of the paper for important intellectual content: Cheng, Cunningham, Shih, Amin, Bruneau, Artenie, Powis, Litwin, Cooper, Dalgard, Hellard, Bruggmann, Lacombe, Stedman, Read, Hajarizadeh, Conway, Feld, Grebely
Statistical analysis: Cheng, Cunningham, Artenie
Provision of study materials or patients: Bruneau, Litwin, Bruggmann, Marks, Read, Dunlop, Conway
Obtaining funding: Marks, Grebely
Administrative, technical, or logistic support: Artenie, Marks, Dunlop
Supervision: Grebely
Funding: This work was supported by funding from AbbVie and Gilead Sciences. The Kirby Institute, which sponsored this study, is funded by the Australian Government Department of Health and Ageing.
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Potential conflicts of interest: Dr Grebely reported receiving grants and personal fees from AbbVie, Camurus, Cepheid, Gilead Sciences (Gilead), Hologic, Indivior, and Merck. Dr Hellard reported receiving grants from Gilead and AbbVie. Dr Bruneau reported receiving grants and personal fees from Gilead, and consulting fees from Gilead, AbbVie and Cepheid. Dr Artenie reported receiving support from Canadian Institutes of Health Research. Dr Litwin reported receiving grants and personal fees from Gilead, and consulting fees from AbbVie, Merck and Gilead. Dr Cooper reported receiving grants and personal fees from Gilead and AbbVie. Dr Feld reported receiving grants and consulting fees from AbbVie and Gilead. Dr Dore reported receiving grants from AbbVie, Merck, Gilead. Dr Read reported receiving grants from Gilead, and fees for educational talks from Gilead and AbbVie. Dr Lacombe reported receiving fees for educational talks from Gilead, Janssen, Merck and ViiV Healthcare; travel grants from Gilead and Merck; advisory board fees from SPIKIMM and Diaccurate. Dr Dunlop reported receiving grants from National Clinical Centre for Research on Emerging Drugs and NSW Health. Dr Stedman reported receiving grants and personal fees from AbbVie, and participation on a Data Safety Monitory Board for Eisai Limited. Dr Bruggmann reported receiving grants from AbbVie and Gilead. Dr Conway reported receiving grants from AbbVie, Gilead, Indivior Canada, Merck, ViiV Healthcare; consulting fees from AbbVie, AstraZeneca, Gilead, Indivior Canada, Merck, Moderna, Sanofi Pasteur, Seqirus, ViiV Healthcare; and honoraria from AbbVie, AstraZeneca, Gilead, Indivior Canada, Merck, Sanofi Pasteur, Seqirus. No other disclosures were reported.
Acknowledgement: The authors thank the study participants for their contribution to research, as well as current and past researchers and staff. They acknowledge the following members of the study group: Protocol Steering Committee—Jason Grebely (chair, University of New South Wales [UNSW] Sydney, Sydney, Australia), Gregory Dore (UNSW Sydney, Sydney, Australia), Philippa Marks (UNSW Sydney, Sydney, Australia), Olav Dalgard (Akershus University Hospital, Oslo, Norway), Philip Bruggmann (Arud Centres for Addiction Medicine, Zurich, Switzerland), Catherine Stedman (Christchurch Hospital, Christchurch, New Zealand), Karine Lacombe (Hôpital Saint-Antoine, Paris, France), Jeff Powis (South Riverdale Community Health Centre, Toronto, Canada), Margaret Hellard (Alfred Hospital, Melbourne, Australia), Sione Crawford (Hepatitis Victoria, Melbourne, Australia), Tracy Swan (International Network on Hepatitis in Substance Users, New York, New York), Jude Byrne (Australian Injecting & Illicit Drug Users League, Canberra, Australia), and Melanie Lacalamita (Poliklinik fur Infektiologie, Inselspital, Bern, Switzerland). Coordinating Centre—Amanda Erratt (study coordinator), Evan Cunningham (associate lecturer), Behzad Hajarizadeh (lecturer), Jason Grebely (coprincipal investigator), Gregory Dore (coprincipal investigator), Pip Marks (clinical trials manager), Ineke Shaw (systems manager), Sharmila Siriragavan (data manager), Janaki Amin (statistician), Sophie Quiene (clinical pro- ject coordinator), and Kathy Petoumenos (biostatistics and databases pro- gram). Site Principal Investigators—Philip Bruggmann (Arud Centres for Addiction Medicine, Zurich, Switzerland), Patrick Schmid (Kantonsspital St Gallen, St Gallen, Switzerland), Erika Castro (Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland), Alberto Moriggia (Fondazione Epatocentro Ticino, Lugano, Switzerland), Karine Lacombe (Hôpital Saint-Antoine, Paris, France), Jean-Pierre Daulouede (Csapa Bizia, Bayonne, France), Olav Dalgard (Akershus University Hospital, Oslo, Norway), Brian Conway (Vancouver Infectious Diseases Center, Vancouver, Canada), Christopher Fraser (Cool Aid Community Health Centre, Victoria, Canada), Jeff Powis (South Riverdale Community Health Centre, Toronto, Canada), Jordan Feld (Toronto General Hospital, Toronto, Canada), Julie Bruneau (Centre Hospitalier de l’Université de Montréal, Montréal, Canada), Curtis Cooper (Ottawa Hospital, Ottawa, Canada), Ed Gane (Auckland Hospital, Auckland, New Zealand), Catherine Stedman (Christchurch Hospital, Christchurch, New Zealand), Gail Matthews (St Vincent’s Hospital, Sydney Australia), Adrian Dunlop (Newcastle Pharmacotherapy Service, Newcastle, Australia), Margaret Hellard (Alfred Hospital, Melbourne, Australia), Ian Kronborg (Footscray Hospital, Footscray, Australia), David Shaw (Royal Adelaide Hospital, Adelaide, Australia), Alain Litwin and Brianna Norton (Montefiore Medical Centre, New York, New York; Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine, New York, New York), Maria Christine Thurnheer (Poliklinik fur Infektiologie, Inselspital, Bern, Switzerland), Martin Weltman (Nepean Hospital, Kingswood, Australia), Philip Read (Kirby Institute, UNSW Sydney, Sydney, Australia; Kirketon Road Centre, Sydney, Australia), and John Dillon (Ninewells Hospital, Dundee, United Kingdom). Site Coordinators—Tina Horschik (Arud Centres for Addiction Medicine, Zurich, Switzerland), Simone Kessler and Cornelia Knapp (Kantonsspital St Gallen, St Gallen, Switzerland), Lorenza Oprandi (Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland), Paola Messina and Marzia Pantic (Fondazione Epatocentro Ticino, Lugano, Switzerland), Manuela Le Cam (Hôpital Saint-Antoine, Paris, France), Cecilia Maitre (Csapa Bizia, Bayonne, France), Jessica Andreassen, Ingunn Melkeraaen, and Merete Moen Tollefsen (Akershus University Hospital, Oslo, Norway), Hannah Pagarigan (Vancouver Infectious Diseases Center, Vancouver, Canada), Rozalyn Milne (Cool Aid Community Health Centre, Victoria, Canada), Kate Mason (South Riverdale Community Health Centre, Toronto, Canada), Diana Kaznowski and Lily Zou (Toronto General Hospital, Toronto, Canada), Rachel Bouchard and Barbara Kotsoros (Centre Hôspitalier de l’Université de Montréal, Montréal, Canada), Miriam Muir and Jessica Milloy (Ottawa Hospital, Ottawa, Canada), Victoria Oliver (Auckland Hospital, Auckland, New Zealand), Tracy Noonan (Christchurch Hospital, Christchurch, New Zealand), Alison Sevehon (St Vincent’s Hospital, Sydney, Australia), Susan Hazelwood and Michelle Hall (Newcastle Pharmacotherapy Service, Newcastle, Australia), Michelle Hagenauer (Alfred Hospital, Melbourne, Australia), Rachel Liddle (Footscray Hospital, Footscray, Australia), Catherine Ferguson (Royal Adelaide Hospital, Adelaide, Australia), Linda Agyemang, Hiral Patel, and Irene Soloway (Montefiore Medical Centre, New York, New York), Orlando Cerocchi (Toronto General Hospital, Toronto, Canada), Melanie Lacalamita (Poliklinik fur Infektiologie, Inselspital, Bern, Switzerland), Vincenzo Fragomeli (Nepean Hospital, Kingswood, Australia), Rosie Gilliver, Rebecca Lothian (Kirby Institute, UNSW Sydney, Sydney, Australia; Kirketon Road Centre, Sydney, Australia), Shirley Cleary and Linda Johnston (Ninewells Hospital, Dundee, United Kingdom), and Sarah Middleton (Auckland City Hospital, Auckland, New Zealand). The authors also thank Ronald D’Amico, Barbara McGovern, Jonathan Anderson, Ze Zhong, Fiona Keane, Fernando Tatsch, and others at AbbVie and Diana Brainard, John McHutchison, and others at Gilead Sciences for their support.
