Enfermedades infecciosas y microbiologia clinica · 2009
Fosamprenavir (GW433908)/ritonavir in HIV-infected patients: efficacy and safety results from the Spanish Expanded Access Program.
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Pérez-Elias M Jesús, Sánchez-Conde María, Soriano Vicente, Mallolas Josep, Luque Isabel, Rodríguez-Alcántara Felipe, Fosamprenavir Expanded Access Program Group
Аннотация
INTRODUCTION: 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.
PATIENTS AND 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.
PATIENTS AND 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.
Предметные рубрики MeSH
AdultCD4 Lymphocyte CountCarbamatesComorbidityDrug Therapy, CombinationFemaleFeverFuransGastrointestinal DiseasesHIV InfectionsHIV Protease InhibitorsHIV-1HIV-Associated Lipodystrophy SyndromeHumansHypercholesterolemiaHypertriglyceridemiaMaleOrganophosphatesRNA, ViralRitonavirSpainSulfonamidesViral LoadViremia