Role of fatty liver in the epidemic of advanced chronic liver disease among people with HIV: protocol for the Canadian LIVEHIV multicentre prospective cohort
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 c...
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BMJ Publishing Group
2023-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/8/e076547.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Cecilia T Costiniuk |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a34ad2f3a19c45f5ab962af75b23b9a7 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a34ad2f3a19c45f5ab962af75b23b9a72024-11-14T06:50:08ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2023-076547Role of fatty liver in the epidemic of advanced chronic liver disease among people with HIV: protocol for the Canadian LIVEHIV multicentre prospective cohortCecilia T Costiniuk0Jean-Pierre Routy1Bertrand Lebouché2Joseph Cox3Marina B Klein4Neora Pick5Sharon L Walmsley6Alexandra de Pokomandy7Nadine Kronfli8Giada Sebastiani9Curtis Cooper10Melanie C M Murray11Colleen Price12Felice Cinque13Sahar Saeed14Dana Kablawi15Luz Ramos Ballesteros16Wesal Elgretli17Erica E M Moodie18Ken Monteith19Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada1 Faculty of Medicine and Health Sciences, Family Medicine Department, McGill University, Montreal, Québec, Canada3 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, Canada1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada10 Department of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada9 Department of Medicine, Division of Infectious Diseases, University of Toronto, Toronto, Ontario, CanadaChronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, CanadaDept of Medicine, University of Ottawa, Ottawa, Ontario, Canada10 Department of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada6 Canadian HIV/AIDS and Chronic Pain Society, Ottawa, Ontario, Canada1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada3 Public Health Sciences, Queen`s University, Kingston, Ontario, Canada1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada1 Chronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, Canada4 Division of Experimental Medicine, McGill University, Montreal, Quebec, Canada5 Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada7 COCQ SIDA, Montreal, Quebec, CanadaIntroduction 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.https://bmjopen.bmj.com/content/13/8/e076547.full |
| spellingShingle | 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 Role of fatty liver in the epidemic of advanced chronic liver disease among people with HIV: protocol for the Canadian LIVEHIV multicentre prospective cohort BMJ Open |
| title | Role of fatty liver in the epidemic of advanced chronic liver disease among people with HIV: protocol for the Canadian LIVEHIV multicentre prospective cohort |
| title_full | Role of fatty liver in the epidemic of advanced chronic liver disease among people with HIV: protocol for the Canadian LIVEHIV multicentre prospective cohort |
| title_fullStr | Role of fatty liver in the epidemic of advanced chronic liver disease among people with HIV: protocol for the Canadian LIVEHIV multicentre prospective cohort |
| title_full_unstemmed | Role of fatty liver in the epidemic of advanced chronic liver disease among people with HIV: protocol for the Canadian LIVEHIV multicentre prospective cohort |
| title_short | Role of fatty liver in the epidemic of advanced chronic liver disease among people with HIV: protocol for the Canadian LIVEHIV multicentre prospective cohort |
| title_sort | role of fatty liver in the epidemic of advanced chronic liver disease among people with hiv protocol for the canadian livehiv multicentre prospective cohort |
| url | https://bmjopen.bmj.com/content/13/8/e076547.full |
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