Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 2, 2020
Date Accepted: Jan 19, 2021
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Subclinical and clinical outcomes in HIV and chronic hepatitis B virus co-infected patients from clinical outpatient centers in France: an ambi-spective longitudinal cohort study
ABSTRACT
Background:
Previous large-scale studies have examined the effect of chronic hepatitis B virus (HBV) infection on overall and cause-specific mortality in human immunodeficiency virus (HIV)-positive individuals. However, few have collected data on the subclinical indicators of HBV that lead up to these severe outcomes in the co-infected population.
Objective:
The aim of this study will be to identify clinical determinants of patients with persistent serum HBV-DNA replication, hepatitis B “e” antigen (HBeAg) seroclearance, and hepatitis B surface antigen (HBsAg) seroclearance and how these subclinical outcomes relate to liver fibrosis and liver-related morbidity and mortality in a recent extension of a large cohort of HIV-HBV co-infected patients.
Methods:
HIV-positive patients with chronic HBV completing follow-up in a prospective cohort study conducted in four outpatient centers (Paris and Lyon, France; 2002-2011) were invited to participate in a cross-sectional visit from November 2016-March 2018, during which a comprehensive evaluation of HIV-/HBV-related disease was undertaken. Virological and clinical data were retrospectively collected since the previous study visit.
Results:
Of the 308 enrolled in the cohort, 147 (47.7%) participated in the cross-sectional visit. Most participants were hepatitis B “e” antigen-negative (82.8%), had undetectable HBV DNA (93.9%), and were undergoing antiretroviral therapy containing tenofovir disoproxil fumarate or tenofovir alafenamide (77.6%). Of the 161 non-participating individuals, 42 (13.6%) died, 41 (13.3%) were lost to follow-up (LTFU) with recent information on vital status, and 78 (25.3%) were LTFU without information on vital status. There were no significant differences between those who did and did not complete the cross-sectional visit, except for lower proportion with an AIDS-defining illness (20.4% versus 30.4%, respectively). With this extension, median follow-up time of the overall cohort is presently 9.2 years (IQR=3.4-14.6).
Conclusions:
The extended follow-up of the French HIV-HBV cohort will provide important long-term data on the subclinical trajectory of HBV disease in the co-infected population. Despite relatively high attrition rates, there is little evidence of differential LTFU bias. Clinical Trial: clinicaltrials.gov, NCT02889094; https://clinicaltrials.gov/ct2/show/NCT02889094
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