Role of fatty liver in the epidemic of advanced chronic liver disease among people with HIV: protocol for the Canadian LIVEHIV multicentre prospective cohort
Cecilia T Costiniuk,
Jean-Pierre Routy,
Bertrand Lebouché,
Joseph Cox,
Marina B Klein,
Neora Pick,
Sharon L Walmsley,
Alexandra de Pokomandy,
Nadine Kronfli,
Giada Sebastiani,
Curtis Cooper,
Melanie C M Murray,
Colleen Price,
Felice Cinque,
Sahar Saeed,
Dana Kablawi,
Luz Ramos Ballesteros,
Wesal Elgretli,
Erica E M Moodie,
Ken Monteith
Affiliations
Cecilia T Costiniuk
Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada
Jean-Pierre Routy
1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada
Bertrand Lebouché
1 Faculty of Medicine and Health Sciences, Family Medicine Department, McGill University, Montreal, Québec, Canada
Joseph Cox
3 Direction régionale de santé publique, Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de-l`Île-de-Montréal du Québec, Montréal, Québec, Canada
Marina B Klein
1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada
Neora Pick
10 Department of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada
Sharon L Walmsley
9 Department of Medicine, Division of Infectious Diseases, University of Toronto, Toronto, Ontario, Canada
Alexandra de Pokomandy
Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada
Nadine Kronfli
1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada
Giada Sebastiani
1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada
Curtis Cooper
Dept of Medicine, University of Ottawa, Ottawa, Ontario, Canada
Melanie C M Murray
10 Department of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada
Colleen Price
6 Canadian HIV/AIDS and Chronic Pain Society, Ottawa, Ontario, Canada
Felice Cinque
1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada
Sahar Saeed
3 Public Health Sciences, Queen`s University, Kingston, Ontario, Canada
Dana Kablawi
1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada
Luz Ramos Ballesteros
1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada
Wesal Elgretli
4 Division of Experimental Medicine, McGill University, Montreal, Quebec, Canada
Erica E M Moodie
5 Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada
Introduction Advanced chronic liver disease (ACLD) is a major cause of death for people with HIV (PWH). While viral hepatitis coinfections are largely responsible for this trend, metabolic dysfunction-associated steatotic liver disease (MASLD) is an emerging concern for PWH. We aimed to assess the contribution of MASLD to incident ACLD in PWH.Methods and analysis This multicentre prospective observational cohort study will enrol 968 consecutive HIV monoinfected patients from four Canadian sites, excluding subjects with alcohol abuse, liver disease other than MASLD, or ACLD at baseline. Participants will be followed annually for 4 years by clinical evaluation, questionnaires, laboratory testing and Fibroscan to measure liver stiffness measurement (LSM) and controlled attenuation parameter (CAP). The primary outcome will be incidence of ACLD, defined as LSM>10 kPa, by MASLD status, defined as CAP≥285 dB/m with at least one metabolic abnormality, and to develop a score to classify PWH according to their risk of ACLD. Secondary outcomes will include health-related quality of life (HRQoL) and healthcare resource usage. Kaplan-Meier survival method and Cox proportional hazards regression will calculate the incidence and predictors of ACLD, respectively. Propensity score methods and marginal structural models will account for time-varying exposures. We will split the cohort into a training set (to develop the risk score) and a validation set (for validation of the score). HRQoL scores and healthcare resource usage will be compared by MASLD status using generalised linear mixed effects model.Ethics and dissemination This protocol has been approved by the ethics committees of all participating institutions. Written informed consent will be obtained from all study participants. The results of this study will be shared through scientific publications and public presentations to advocate for the inclusion of PWH in clinical trials of MASLD-targeted therapies and case-finding of ACLD in PWH.
