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Hepatic safety profile of raltegravir in HIV patients with chronic hepatitis C
A. Mena, F. Blanco, M. Córdoba, F. Guevara, S. González-Novoa, E. Álvarez, C. Esteve, V. Soriano
Hospital Carlos III, Infectious Diseases Department, Madrid, Spain
Background: Raltegravir (RAL) has shown good tolerability and safety in clinical trials,which generally have recruited HIV+ patients with not underlying serious conditions. HIV patients with chronic viral hepatitis represent a large group of patients in whom the tolerability of RAL has to be assessed.
Methods: A total of 311 antiretroviral-experienced HIV patients initiated RAL from Dec 2005 to Jan 2009 at our institution. Clinical data, laboratory parameters and liver stiffness (Fibroscan) were analyzed at baseline, month 1 and every 3 months. Hepatotoxicity was defined according to baseline ALT values. Any degree: >1.25-fold the upper limit of normality (31 IU/L) in patients with normal ALT and the baseline value in those with elevated ALT. For grade 3-4 hepatotoxicity, ALT increases >3.5-fold or >5-fold, respectively. HIV monoinfected and HIV/HCV co-infected (pos HCV-RNA) patients were compared.
Results: Data from 218 HIV patients were examined (126 HIV-mono and 92 HIV-HCV coinfected). Mean age 46±8 years; male 80%; median CD4 400 (22%)cells/µL; 64% plasma HIV-RNA< 50 copies/mL.
Any degree of hepatotoxicity developed in 10 (7.9%) HIV-mono and 23 (25%) coinfected patients (p< 0.001). Grade 3 or 4 hepatotoxicity was seen in only 3 patients, all co-infected. Occurred at months 1 (one) and 15 (two), in all other liver damage factors were involved. Multivariate analysis revealed HCV co-infection as the only independent variable associated with any degree of hepatotoxicity (p=0.03). The main reasons for RAL discontinuation were poor adherence (n=5), virological failure (n=3) and headache (n=1).
Conclusions: Elevations in liver enzymes are rarely seen in HIV patients treated with RAL-containing regimens. They are uniformly mild and no cases of grade 3-4 hepatotoxicity could be attributed to RAL in our patients, 40% of whom were coinfected. The good hepatic safety profile of RAL should be added to its overall good tolerability. RAL may be an interesting option in HIV/HCV co-infected patients.
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