Low rate of adverse hepatic events associated with fosamprenavir/ritonavir-based antiretroviral regimens.
OBJECTIVE
To appraise the incidence of liver toxicity in a population of patients receiving fosamprenavir/ritonavir (FPV/r) with a high frequency of viral hepatitis co-infection.


METHODS
636 patients, 341 (54%) with HCV antibodies and 38 (5.6%) bearing serum HBsAg, were recruited. All of them received FPV/r 700/100 twice every day. 93 (27%) patients who tested positive for HCV antibodies showed an AST to platelet ratio index (APRI) higher than 1.5, consistent with significant liver fibrosis.


RESULTS
After a median (range) follow-up time of 6.91 (0.46-20.66) months, 3 (0.47%) patients developed grade 3 ALT elevation. All the former patients were hepatitis virus co-infected, 2 with hepatitis C virus and 1 with hepatitis B virus. The frequency of grade 3 ALT elevation in patients with HCV antibodies was 0.58% and in those harbouring HBsAg it was 2.63%. 4 (0.62%) patients suffered from a liver decompensation and 1 died due to a hepatic cause while on follow-up. No patients with APRI equal to or higher than 1.5 showed grade 3 ALT elevation.


CONCLUSIONS
The incidence of adverse hepatic events in patients receiving FPV/r including combinations seems to be low, even in subjects co-infected with hepatitis virus and in those with significant liver fibrosis.
Pineda
Juan A
JA
Unit of Infectious Diseases, Hospital Universitario de Valme, Sevilla, Spain. japineda@telefonica.net
Pérez-Elías
Maria-Jesús
MJ
Peña
José M
JM
Luque
Isabel
I
Rodríguez-Alcantara
Felipe
F
D000328:Adult; D002219:Carbamates / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D005663:Furans; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology*; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010755:Organophosphates / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D013030:Spain / Q000453:epidemiology; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use
D002219:Carbamates; D005663:Furans; D017320:HIV Protease Inhibitors; D010755:Organophosphates; D013449:Sulfonamides; D019438:Ritonavir; C426859:fosamprenavir