Clinical safety and efficacy of enfuvirtide (T-20) , a new fusion inhibitor. A review of the presentation at the satellite symposium "New hope: advancing care in HIV infection" at the 15th annual Association of Nurses in AIDS Care conference, November 2002
Lalezari, J.P.
Aids Reader 13(3 Suppl): S9-13
2003
ISSN/ISBN: 1053-0894 PMID: 12765160 Document Number: 557763
Proof of the concept that a fusion inhibitor could mediate clinically significant antiviral responses came from the demonstration that patients receiving 100 mg of enfuvirtide daily as monotherapy for 14 days achieved a mean reduction in viral load of 1.5 log10 copies/mL. Phase 2 studies established subcutaneous injection of 100 mg of enfuvirtide twice daily as the dosage of choice. In pivotal phase 3 trials, enfuvirtide was added to an optimized background regimen in heavily treatment-experienced patients. Virologic and immunologic responses were significantly better in patients receiving enfuvirtide in addition to optimized background regimens than in those receiving optimized background alone, with the incremental reduction in viral load between arms being 0.934 log10 copies/mL after 24 weeks of therapy. Subgroup analyses demonstrated this benefit to be similar regardless of age, sex, race, and baseline viral load. Enfuvirtide was well tolerated, with injection site reactions being the most common adverse event, although they were rarely treatment-limiting.