A Matti

F Gatti

G Carosi

G Cologni

M Monia

P Nasta

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

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Journal of the International AIDS 
Society
Open AccessPoster presentation
Hepatic tolerability of fosamprenavir/ritonavir (FPV/RTV) in 
HIV/hepatitis C co-infected subjects with severe hepatic fibrosis
P Nasta*, F Gatti, G Cologni, A Matti, M Monia and G Carosi
Address: Institute of Infectious and Tropical Diseases, Brescia, Italy
* Corresponding author    
Background
Few data are available in HIV/hepatitis C co-infected sub-
jects 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.
Methods
HIV/HCV-RNA positive co-infected subjects, treated with
FPV/rtv for at least 6 months have been enrolled in a ret-
rospective observational study. Baseline socio-demo-
graphic 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 [cal-
culated 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 with-
out cirrhosis using a Student's t-test for normal distribu-
tion parameters or the Mann-Whitney U test. A Kaplan
Meier analysis has been used to assess the risk of develop-
ing 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 Kap-
lan Meier analysis, the risk to develop a grade 1–2 LEE in
patients with or without cirrhosis was similar (Log Rank p
= 0.42).
Conclusion
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.
from Ninth International Congress on Drug Therapy in HIV Infection
Glasgow, UK. 9–13 November 2008
Published: 10 November 2008
Journal of the International AIDS Society 2008, 11(Suppl 1):P282 doi:10.1186/1758-2652-11-S1-P282
<supplement> <title> <p>Abstracts of the Ninth International Congress on Drug Therapy in HIV Infection</p> </title> <note>Meeting abstracts – A single PDF containing all abstracts in this Supplement is available <a href="http://www.biomedcentral.com/content/files/pdf/1758-2652-11-S1-full.pdf">here</a>.</note> <url>http://www.biomedcentral.com/content/pdf/1758-2652-11-S1-info.pdf</url> </supplement>
This abstract is available from: http://www.jiasociety.org/content/11/S1/P282
© 2008 Nasta et al; licensee BioMed Central Ltd. 


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

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