This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrowReprints and Permissions
Right arrow Copyright Information
Right arrow Books from ASM Press
Right arrow MicrobeWorld
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by DeJesus, E.
Right arrow Articles by Zolopa, A. R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by DeJesus, E.
Right arrow Articles by Zolopa, A. R.

 Previous Article  |  Next Article 

Antimicrobial Agents and Chemotherapy, December 2008, p. 4315-4319, Vol. 52, No. 12
0066-4804/08/$08.00+0     doi:10.1128/AAC.00467-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Safety and Efficacy of Enfuvirtide in Combination with Darunavir-Ritonavir and an Optimized Background Regimen in Treatment-Experienced Human Immunodeficiency Virus-Infected Patients: the Below the Level of Quantification Study{triangledown}

Edwin DeJesus,1* Michael S. Gottlieb,2 Joseph C. Gathe Jr.,3 Michael L. Greenberg,4 Carol Jean Guittari,5 and Andrew R. Zolopa6

Orlando Immunology Center, Orlando, Florida,1 Synergy Hematology Oncology Medical Associates, Los Angeles, California,2 Therapeutic Concepts, Houston, Texas,3 Trimeris, Inc., Morrisville, North Carolina,4 Roche Laboratories, Nutley, New Jersey,5 Stanford University School of Medicine, Palo Alto, California6

Received 8 April 2008/ Returned for modification 4 May 2008/ Accepted 13 September 2008

Enfuvirtide is the first fusion and entry inhibitor approved for use for the treatment of human immunodeficiency virus (HIV) type 1 infection and as such represents a novel class of agents. For the population of patients experienced with three antiretroviral classes, enfuvirtide provides an additional option for treatment. This prospective, open-label, 24-week, single-arm trial assessed the efficacy and safety of enfuvirtide (90 mg injected subcutaneously twice daily) in combination with darunavir-ritonavir (600/100 mg administered orally twice daily) in triple-antiretroviral-class-experienced adults failing their current regimen. The primary efficacy endpoint was the proportion of participants with plasma HIV RNA loads of <50 copies/ml. Other virological and immunological measures were also evaluated, as were the effects of the baseline viral coreceptor tropism and darunavir phenotype sensitivity scores on the outcomes. At week 24, 60.3%, 72.5%, and 84.0% of 131 participants achieved viral loads of <50 copies/ml and <400 copies/ml and a change from the baseline load of ≥1 log10 copies/ml, respectively. A baseline viral load of ≤5 log10 copies/ml was a significant predictor of achieving a viral load of <50 copies/ml at 24 weeks; however, neither background genotype sensitivity nor darunavir phenotype sensitivity was a significant predictor of the achievement of viral loads of <50 copies/ml. Although these findings are limited by the relatively small numbers of participants with darunavir susceptibility changes of ≥10-fold, they suggest that combining enfuvirtide and darunavir-ritonavir with an optimized background regimen in triple-class experienced participants naïve to these agents can result in positive virological and immunological responses regardless of most baseline parameters.

* Corresponding author. Mailing address: Orlando Immunology Center, 1701 N. Mills Avenue, Orlando, FL 32803. Phone: (407) 647-3960. Fax: (407) 367-0856. E-mail: edejesus{at}oicorlando.com

{triangledown} Published ahead of print on 22 September 2008.

Antimicrobial Agents and Chemotherapy, December 2008, p. 4315-4319, Vol. 52, No. 12
0066-4804/08/$08.00+0     doi:10.1128/AAC.00467-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Sayana, S., Prosser, P., Ricaurte, J. C., Sanchez, S., Hamwi, G., Hershey-Weber, J., Chien, C., Easley, A., Nguyen, T., Wilson, L., Khanlou, H. (2009). Analysis of a Switch From Enfuvirtide to Raltegravir in Patients With Undetectable Viral Load: Efficacy and Quality of Life at 24 Weeks. J Int Assoc Physicians AIDS Care (Chic Ill) 8: 85-86  


Copyright © 2009 by the American Society for Microbiology.   For an alternate route to Journals.ASM.org, visit: http://intl-journals.asm.org | More Info»