Journal Article

Opportunistic Disease and Mortality in Patients Coinfected with Hepatitis B or C Virus in the Strategic Management of Antiretroviral Therapy (SMART) Study

Ellen Tedaldi, Lars Peters, Jacquie Neuhaus, Massimo Puoti, Jürgen Rockstroh, Marina B. Klein, Gregory J. Dore, Amanda Mocroft, Vincent Soriano, Bonaventura Clotet and Jens D. Lundgren

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 47, issue 11, pages 1468-1475
Published in print December 2008 | ISSN: 1058-4838
Published online December 2008 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/593102
Opportunistic Disease and Mortality in Patients Coinfected with Hepatitis B or C Virus in the Strategic Management of Antiretroviral Therapy (SMART) Study

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Background. In the Strategic Management of Antiretroviral Therapy (SMART) study, the risk of opportunistic disease (OD) and/or death due to any cause was elevated in the drug conservation (i.e., interrupt antiretroviral therapy until the CD4+ cell count is <250 cells/µL) group, compared with the viral suppression (continued use of antiretroviral therapy) group. We assessed whether participants with concurrent hepatitis had an increased risk of the end points evaluated in the SMART study.

Methods. Participants were classified as being positive for hepatitis B virus (HBV) if they had positive hepatitis B surface antigen results for >6 months and positive for HCV if they tested HCV antibody positive. The rate and hazard ratio (HR) of OD and/or death and its 2 components were compared by hepatitis status and drug conservation versus the viral suppression group.

Results. Among 5472 participants enrolled from 8 January 2002 through 11 January 2006, 930 (17%) were HBV positive and/or HCV positive. The relative risk of non-OD death in participants randomized to the drug conservation group versus the viral suppression group was comparable regardless of hepatitis status (HR for coinfected and HIV-monoinfected participants, respectively, 1.9 [95% confidence interval {CI}, 1.0–3.9 and 1.8 [95% CI, 0.9–3.4]). The rate of OD or death was 3.9 events per 100 person-years in the coinfected group and 2.0 per 100 person-years in the HIV-monoinfected group. This excess risk was due to a higher risk of non-OD death among the coinfected participants (HR, 3.6; 95% CI, 2.3–5.6), whereas the risk of OD was comparable (HR, 1.1; 95% CI, 0.7–1.8). The 3 leading causes of non-OD death in coinfected participants were unknown cause, substance abuse, and non–acquired immunodeficiency disease cancer.

Conclusions. Interruption of antiretroviral therapy is particularly unsafe in persons with hepatitis virus coinfection. Although HCV- and/or HBV-coinfected participants constituted 17% of participants in the SMART study, almost one-half of all non-OD deaths occurred in this population. Viral hepatitis was an unlikely cause of this excess risk.

Clinical trials registration. ClinicalTrials.gov registration no. NCT00027352.

Journal Article.  4440 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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