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Methods HIV/HCV-RNA positive co-infected subjects, treated with FPV/rtv for at least 6 months have been enrolled in a retrospective observational study. Baseline socio-demographic characteristics, data on HIV, HCV and antiretroviral treatments history, immuno-virologic data, and renal and liver function parameters have been recorded at baseline and every 6 months. Liver enzymes (LE) level at baseline has been categorized as normal (LEN) or abnormal (LE-AN) using the local laboratory cut-off of 45 IU/l for females and 50 IU/l for males. The stiffness >14 Kpascal by Fibroscan® and/or a FIB-4 score >3.25 [calculated by: age ([yr] × AST [U/L])/((PLT [109/L]) × (ALT [U/L])1/2)] have been used to define the cirrhosis. LEE after 6 months of treatment has been compared between groups of patients with LE-N or LE-AN and with or without cirrhosis using a Student's t-test for normal distribution parameters or the Mann-Whitney U test. A Kaplan Meier analysis has been used to assess the risk of developing a grade 1–2 LEE.

Hepatic tolerability of fosamprenavir/ritonavir (FPV/RTV) in HIV/hepatitis C co-infected subjects with severe hepatic fibrosis