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


Few data are available in HIV/hepatitis C co-infected subjects with severe hepatic fibrosis or cirrhosis. Liver enzymes elevation (LEE) in HIV/HCV co-infected patients with or without cirrhosis on fosamprenavir/ritonavir (700/100 mg BID)-containing HAART regimen has been assessed.


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 (LE-N) 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.

Summary of results

A total of 13 HIV/HCV co-infected subjects on HAART containing FPV/rtv have been enrolled [median age 44 years (IQR 29–68); 25 females; mean time on HAART: 9.3 years; mean time on FPV/rtv: 28 months; pts with LE-AN: 70 (53%); with cirrhosis: 51(38.6%)]. Subjects with LE-AN had a significant decrease of AST/ALT from baseline through 6th month (mean ALT: 136 (DS 95) UI/l to 86 (+90) UI/l, p < 0.001; mean AST: 106 (DS 57) UI/l to 64 (DS 62) UI/l, p < 0.001). No difference in LEE was observed in subjects with or without cirrhosis. At the Kaplan Meier analysis, the risk to develop a grade 1–2 LEE in patients with or without cirrhosis was similar (Log Rank p = 0.42).


In HIV/HCV co-infected patients, LEE is frequent and it is related with liver disease progression and death. In co-infected subjects FPV/rtv at standard dose represents a safe opportunity also in cirrhotic patients.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Nasta, P., Gatti, F., Cologni, G. et al. Hepatic tolerability of fosamprenavir/ritonavir (FPV/RTV) in HIV/hepatitis C co-infected subjects with severe hepatic fibrosis. JIAS 11 (Suppl 1), P282 (2008).

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