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Fosamprenavir (GW433908)/ritonavir in HIV-infected patients: efficacy and safety results from the Spanish Expanded Access Program.
Enferm Infecc Microbiol Clin. 2009 Jan; 27(1):28-32.EI

Abstract

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.

Authors+Show Affiliations

Hospital Ramon y Cajal, Madrid, Spain.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

19218000

Citation

Pérez-Elias, M Jesús, et al. "Fosamprenavir (GW433908)/ritonavir in HIV-infected Patients: Efficacy and Safety Results From the Spanish Expanded Access Program." Enfermedades Infecciosas Y Microbiologia Clinica, vol. 27, no. 1, 2009, pp. 28-32.
Pérez-Elias MJ, Sánchez-Conde M, Soriano V, et al. Fosamprenavir (GW433908)/ritonavir in HIV-infected patients: efficacy and safety results from the Spanish Expanded Access Program. Enferm Infecc Microbiol Clin. 2009;27(1):28-32.
Pérez-Elias, M. J., Sánchez-Conde, M., Soriano, V., Mallolas, J., Luque, I., & Rodríguez-Alcántara, F. (2009). Fosamprenavir (GW433908)/ritonavir in HIV-infected patients: efficacy and safety results from the Spanish Expanded Access Program. Enfermedades Infecciosas Y Microbiologia Clinica, 27(1), 28-32. https://doi.org/10.1016/j.eimc.2008.05.002
Pérez-Elias MJ, et al. Fosamprenavir (GW433908)/ritonavir in HIV-infected Patients: Efficacy and Safety Results From the Spanish Expanded Access Program. Enferm Infecc Microbiol Clin. 2009;27(1):28-32. PubMed PMID: 19218000.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fosamprenavir (GW433908)/ritonavir in HIV-infected patients: efficacy and safety results from the Spanish Expanded Access Program. AU - Pérez-Elias,M Jesús, AU - Sánchez-Conde,María, AU - Soriano,Vicente, AU - Mallolas,Josep, AU - Luque,Isabel, AU - Rodríguez-Alcántara,Felipe, AU - ,, Y1 - 2009/01/09/ PY - 2007/11/16/received PY - 2008/05/08/accepted PY - 2009/2/17/entrez PY - 2009/2/17/pubmed PY - 2009/5/22/medline SP - 28 EP - 32 JF - Enfermedades infecciosas y microbiologia clinica JO - Enferm Infecc Microbiol Clin VL - 27 IS - 1 N2 - 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. SN - 0213-005X UR - https://www.unboundmedicine.com/medline/citation/19218000/Fosamprenavir__GW433908_/ritonavir_in_HIV_infected_patients:_efficacy_and_safety_results_from_the_Spanish_Expanded_Access_Program_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0213-005X(08)00004-9 DB - PRIME DP - Unbound Medicine ER -