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Opportunistic disease and mortality in patients co-infected with hepatitis C virus (HCV) and/or hepatitis B virus (HBV) in the SMART (Strategic Management of Antiretroviral Therapy) study
Presented by Ellen Tedaldi, United States.
Tedaldi E.1, Puoti M.2, Neuhaus J.3, Peters L.4, Rockstroh J.5, Klein M.6, Dore G.7, Mocroft A.8, Soriano V.9, Clotet B.10, Lundgren J.4, The SMART study group and INSIGHT
1Temple University School of Medicine, Philadelphia, United States, 2Institute of Infectious and Tropical Diseases, Brescia, Italy, 3School of Public Health, University of Minnesota, Minneapolis, United States, 4Copenhagen HIV Programme, Hvidovre University Hospital, Copenhagen, Denmark, 5Medizinische Universitaetsklinik, Bonn, Germany, 6Montreal Chest Institute, Royal Victoria Hospital, Montreal, Canada, 7National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia, 8Royal Free and University College Medical School, London, United Kingdom, 9Service of Infectious Diseases, Hospital Carlos III, Madrid, Spain, 10Hospital Universitari Germans Trias I Pujol, Badalona, Spain
Objectives: In SMART, the risk of opportunistic disease (OD) and/or death was increased in the drug conservation (DC; interrupt antiretroviral therapy (ART) until CD4<250) group as compared to the viral suppression (VS; continued use of ART) group. Co-infection with HBV and/or HCV might affect the disease processes evaluated in SMART, and could explain the increased risk in the DC group.
Methods: Participants were classified as HBV+ if HBsAg+>6 months, and HCV+ if HCV-Ab+. The rate (/100 person-year) of events of interest was compared by baseline HBV/HCV status and DC/VS arm.
Results: Among 5472 enrollees, 922 (16.8%) were HBV+ and/or HCV+; stratified as follows: HBV+ (n=110; 2.0%); HCV+ (n=798; 14.6%) or HBV+/HCV+ (n=14; 0.25%). HBV+ and/or HCV+ patients were at increased risk of non-OD death compared with the remaining cohort, whereas the relative increased risk in the DC versus VS groups for all three endpoints was comparable in HBV+ and/or HCV+ patients versus uninfected patients (table). Comparable findings were observed when HBV+ patients were excluded. The three leading causes of non-OD deaths in HBV+ and/or HCV+ participants were unknown cause, substance abuse and non-AIDS cancers.
[table 1]
Conclusions: HBV+ and/or HCV+ participants at entry had a 3.8 fold crude relative risk of non-OD death compared with the remaining cohort. Approximately half of the non-OD deaths observed in SMART occurred in this subgroup constituting 17% of the entire cohort. Interruption of ART is particularly unsafe in subgroups such as HBV+ and/or HCV+ persons with an a priori high underlying risk of non-OD death.
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