Study Protocol - Accurate assessment of kidney function in Indigenous Australians: aims and methods of the eGFR Study |
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Authors: | Louise J Maple-Brown Paul D Lawton Jaquelyne T Hughes Suresh K Sharma Graham RD Jones Andrew G Ellis Wendy Hoy Alan Cass Richard J MacIsaac Ashim K Sinha Mark AB Thomas Leonard S Piers Leigh C Ward Katrina Drabsch Sianna Panagiotopoulos Robyn McDermott Kevin Warr Sajiv Cherian Alex Brown George Jerums Kerin O'Dea |
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Institution: | 1. Institut de Santé Publique épidémiologie Développement (ISPED), Université Victor Segalen Bordeaux 2, Bordeaux, France 2. Centre de recherche INSERM U897, Bordeaux, France 3. Laboratoire d'Epidémiologie et de Santé Publique, Centre Pasteur du Cameroun, Yaoundé, Cameroun 4. Centro Nacional de Investigaciones en Salud Materno Infantil, Santo Domingo, Dominican Republic 5. Prayas Health Group, Pune, India 6. Maternal and Child Care Union, Neoclinic, Tbilisi, Georgia 7. Institut de Recherche pour le Développement, UMR 912 IRD-INSERM-U2 Marseille, France 8. Institut de Recherche pour le Développement, UMR 196 CEPED, Paris, France
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Abstract: | Background Coinfection with hepatitis B virus (HBV) or hepatitis C virus (HCV) in HIV-infected patients receiving a commonly used nevirapine-based antiretroviral therapy is a major concern for African clinicians owing to its high prevalence, the infrequent testing and treatment of viral hepatitis, and the impact of liver disease on the tolerability and effectiveness of anti-HIV treatment. We compared the hepatotoxicity and the immunological, virological and clinical effectiveness of a nevirapine-based antiretroviral therapy between patients infected with HIV only and patients coinfected with hepatitis B or C virus in Cameroon. Methods A retrospective cohort study was conducted among HIV-1-infected patients. Plasma HBV DNA and HCV RNA were tested in positive or indeterminate samples for HBsAg or HCV antibodies, respectively. All patients received nevirapine and lamivudine plus stavudine or zidovudine. Results Of 169 HIV-1-infected patients with a median baseline CD4 count of 135 cells/mm3 (interquartile range IQR] 67-218), 21% were coinfected with HBV or HCV. In coinfected patients, the median viral load was 2.47 × 107 IU/mL for HBV (IQR 3680-1.59 × 108) and 928 000 IU/mL for HCV (IQR 178 400-2.06 × 106). Multivariate analyses showed that the risk of hepatotoxicity was 2-fold higher in coinfected patients (p < 0.01). The response to antiretroviral therapy was however comparable between monoinfected and coinfected patients in terms of CD4 cell count increase (p = 0.8), HIV-1 viral load below 400 copies/mL (p = 0.9), death (p = 0.3) and death or new AIDS-defining event (p = 0.1). Nevirapine was replaced by a protease inhibitor in 4 patients owing to hepatotoxicity. Conclusion This study suggests that the nevirapine-based antiretroviral therapy could be used safely as first-line treatment in patients with low CD4 cell count in Africa despite frequent coinfections with HBV or HCV and infrequent testing of these infections. Although testing for HBV and HCV should be systematically performed before initiating antiretroviral therapy, transaminases elevations at baseline or during treatment should be a decisive argument for testing when hepatitis status is unknown. |
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