The safety, plasma pharmacokinetics, and antiviral activity of subcutaneous enfuvirtide (T-20), a peptide inhibitor of gp41-mediated virus fusion, in HIV-infected adults
| Autor: | Fred T. Valentine, J. Michael Kilby, Robert L. Murphy, Margrit Carlson, Alex Dusek, Jeffrey Goodgame, Emily L. Nelson, Joseph J. Eron, Calvin J. Cohen, Michael S. Saag, Paul A. Volberding, Jacob Lalezari, Roberto C. Arduino, Joel E. Gallant, Prakash R. Sista |
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| Rok vydání: | 2002 |
| Předmět: |
Adult
Enfuvirtide Anti-HIV Agents medicine.medical_treatment Injections Subcutaneous Immunology Pharmacology Gp41 Virus Pharmacokinetics Virology medicine Humans Chemotherapy Acquired Immunodeficiency Syndrome biology Dose-Response Relationship Drug business.industry Middle Aged biology.organism_classification HIV Envelope Protein gp41 Peptide Fragments CD4 Lymphocyte Count Regimen Infectious Diseases Lentivirus HIV-1 RNA Viral business Viral load medicine.drug |
| Zdroj: | AIDS research and human retroviruses. 18(10) |
| ISSN: | 0889-2229 |
| Popis: | 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 (p0.001) 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. |
| Databáze: | OpenAIRE |
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