Fosamprenavir (GW433908)/ritonavir in HIV-infected patients: efficacy and safety results from the Spanish Expanded Access Program.
BACKGROUND
The use of protease inhibitors (PI) has led to a decrease in HIV-1-related mortality and morbidity. The objective of this study was to collect safety data on treatment with fosamprenavir/ritonavir (FPV/r) 700/100mg BID in HIV-infected patients through an expanded access program.


METHODS
Prospective, multicenter, noncomparative study in HIV-1 infected adults, for whom a regimen containing FPV/r 700/100mg BID was appropriate.


RESULTS
A total of 678 patients were included in the intention-to-treat (ITT) and safety population. The on-treatment (OT) population contained 587 patients: 76% male, 98% Caucasian, and median age 41 years. Median CD4 cell count was 351 cells/microL, HIV-RNA was 3 log copies/mL, and 49% of patients were in CDC class C. After 24 weeks of treatment, serum viral load decreased a median of 1.3 log copies/mL and 73% of patients had <400 copies/mL (P<.0001 vs. baseline); 48-week results were similar. CD4 cell count increased a median of 49 and 62 cells/microL at 24 and 48 weeks, respectively. Adverse events (AEs) associated with the study medication occurred in 21% of patients.


CONCLUSIONS
Ritonavir-boosted fosamprenavir as part of antiretroviral therapy is a potent, safe treatment in real-life clinical circumstances.
Pérez-Elias
M Jesús
MJ
Hospital Ramon y Cajal, Madrid, Spain.
Sánchez-Conde
María
M
Soriano
Vicente
V
Mallolas
Josep
J
Luque
Isabel
I
Rodríguez-Alcántara
Felipe
F
D000328:Adult; D018791:CD4 Lymphocyte Count; D002219:Carbamates / Q000008:administration & dosage / Q000009:adverse effects / Q000600:supply & distribution / Q000627:therapeutic use*; D015897:Comorbidity; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000139:chemically induced / Q000453:epidemiology; D005663:Furans; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000600:supply & distribution / Q000627:therapeutic use*; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics; D039682:HIV-Associated Lipodystrophy Syndrome / Q000453:epidemiology; D006801:Humans; D006937:Hypercholesterolemia / Q000139:chemically induced / Q000453:epidemiology; D015228:Hypertriglyceridemia / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D010755:Organophosphates / Q000008:administration & dosage / Q000009:adverse effects / Q000600:supply & distribution / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000600:supply & distribution / Q000627:therapeutic use*; D013030:Spain; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000600:supply & distribution / Q000627:therapeutic use*; D019562:Viral Load; D014766:Viremia / Q000188:drug therapy
D002219:Carbamates; D005663:Furans; D017320:HIV Protease Inhibitors; D010755:Organophosphates; D012367:RNA, Viral; D013449:Sulfonamides; D019438:Ritonavir; C426859:fosamprenavir