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The Safety, Plasma Pharmacokinetics, and Antiviral Activity of Subcutaneous Enfuvirtide (T-20), a Peptide Inhibitor of gp41-Mediated Virus Fusion, in HIV-Infected Adults
Abstract
Enfuvirtide (T-20) is a novel antiretroviral agent that blocks HIV-1 cell fusion. A 28-day randomized dose-comparison study was conducted to determine the safety, pharmacokinetics, and antiviral activity of enfuvirtide in 78 HIV-infected adults, most with extensive treatment experience. Patients received enfuvirtide, added to a failing regimen, either by continuous subcutaneous infusion (CSI: 12.5, 25, 50 or 100 mg/day) or by subcutaneous (SC) injection (50 or 100 mg twice daily). Dose-related decreases in viral load were observed, with a maximum mean reduction from baseline of 1.6 log(10) copies/ml (p< 0.001) seen in the 100 mg bid SC group. Most responses diminished by 28 days. Plasma pharmacokinetics and antiviral responses were more consistent for SC injection than for CSI because of technical difficulties experienced with CSI. Injection site reactions were common but generally mild. These results indicate that enfuvirtide is a promising new therapeutic agent for HIV-infected patients, including those with prior antiretroviral treatment.
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Cited by
Wei, X., Decker, J. M., Liu, H., Zhang, Z., Arani, R. B., Kilby, J. M., Saag, M. S., Wu, X., Shaw, G. M., & Kappes, J. C. (2002) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.46.6.1896-1905.2002 · Cited by 1,569
Self-citationEnfuvirtide, an HIV-1 Fusion Inhibitor, for Drug-Resistant HIV Infection in North and South America
Lalezari, J. P., Henry, K., O'Hearn, M., Montaner, J. S. G., Piliero, P. J., Trottier, B., Walmsley, S., Cohen, C., Kuritzkes, D. R., Eron, J. J., et al. (2003) · New England Journal of Medicine · doi:10.1056/nejmoa035026 · Cited by 914
Self-citationEnfuvirtide: the first therapy to inhibit the entry of HIV-1 into host CD4 lymphocytes
Matthews, T., Salgo, M., Greenberg, M., Chung, J., DeMasi, R., & Bolognesi, D. (2004) · Nature Reviews Drug Discovery · doi:10.1038/nrd1331 · Cited by 465
HIV-1 Antiretroviral Resistance: Scientific Principles and Clinical Applications
Tang, M. W., & Shafer, R. W. (2012) · Drugs · doi:10.2165/11633630-000000000-00000 · Cited by 326
Metadata
- Authors
- Kilby, J. M., Lalezari, J. P., Eron, J. J., Carlson, M., Cohen, C., Arduino, R. C., Goodgame, J. C., Gallant, J. E., Volberding, P., Murphy, R. L., Valentine, F., Saag, M. S., Nelson, E. L., Sista, P. R., & Dusek, A.
- Venue
- AIDS Research and Human Retroviruses
- Publisher
- SAGE Publications
- Published
- 2002-07
- Volume
- 18
- Issue
- 10
- Pages
- 685-693
- ISSN
- 0889-2229 (ISSN-L)
- 1931-8405
- OpenAlex
- W2112129496
- Cited by
- 198
- References
- 0
- FWCI
- 15.46
- Type
- journal article
- Language
- en
- Open access
- closed
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- Kilby, J. M., Lalezari, J. P., Eron, J. J., Carlson, M., Cohen, C., Arduino, R. C., Goodgame, J. C., Gallant, J. E., Volberding, P., Murphy, R. L., Valentine, F., Saag, M. S., Nelson, E. L., Sista, P. R., & Dusek, A. (2002). The Safety, Plasma Pharmacokinetics, and Antiviral Activity of Subcutaneous Enfuvirtide (T-20), a Peptide Inhibitor of gp41-Mediated Virus Fusion, in HIV-Infected Adults. AIDS Research and Human Retroviruses. https://doi.org/10.1089/088922202760072294
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