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Elvucitabine Phase II 48 Week Interim Results Show Safety and Efficacy Profiles Similar to Lamivudine in Treatment Naive HIV-1 Infected Patients with a Unique Pharmacokinetic Profile
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Reported by Jules Levin
ICAAC Oct 27 2008 Wash DC
E. DeJesus1, D. Saple2, J. Morales-Ramirez3, N. Kumarasamy4, T. Jefferson5, N. Bellos6, B.H. Wade7, R. Gugliotti, H. Robison8, E. Olek8
1Orlando Immunology Ctr., Orlando, FL, 2Dr. Saple's Clinic, Mumbai, India, 3Clinical Res. Puerto Rico, San Juan, Puerto Rico, 4YRGCare VHS, Chennai, India, 5Hlth. For Life Clinic, Little Rock, AR, 6Private Practice, Dallas TX, 7Ctr. For the Prevention and Treatment of Infections, Pensacola, FL, 8Achillion Pharmaceuticals, Inc., New Haven, CT.
AUTHOR Conclusions: ELV Phase II Naive Trial
The use of ELV 10mg + EFV + TDF QD in naive patients:
--Resulted in excellent virologic and immunologic responses
--Was well tolerated, with a favorable safety profile
--Provided suitable exposure in all patients
In comparison to the LAM 300mg + EFV + TDF in naive patients both treatment groups:
--Resulted in comparable substantial and sustained viral suppression
--Demonstrated increasing CD4 cell counts
--Demonstrated similar safety profile
--No differences between frequency, type, or severity of AEs
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