OASIS

Presentation Abstract

Session Number:	073
	Monday, Sep 10, 2012, 8:30 AM -11:00 AM
Presentation Title:	H-554 - Albuvirtide, the First Long-acting HIV Fusion Inhibitor, Suppressed Viral Replicaiton in HIV-Infected Adults
Location:	Room 104
Presentation Number:	H-554
Pres. Time:	Monday, Sep 10, 2012, 9:30 AM - 9:45 AM
Category:	H2
Keywords:	fusion; long-acting; HIV
Author(s):	H. Wu, MD - Division Chief ¹, C. Yao, PhD - Medical Manager ², R. J. Lu, PhD - Vice President ², T. Zhang, MD - Professor ¹, M. X. Wang, PhD - Professor ¹, H. X. Zhao, MD - Professor ³, H. Y. Peng, MS - Research Assistant ⁴, Y. Xie, BS - Research Assistant ², W. J. Min, MS - Research Assistant ², H. Jiang, PhD - Professor ², C. J. Wang, PhD - Professor ², D. Xie, PhD (Doctor of Philosophy) - Chief Scientific Officer², R. H. Jin, MD - Professor ¹; ¹Beijing You'an Hosp., Capital Med. Univ., Beijing, China, ²Chongqing Frontier Biotechnologies Co. Ltd., Chongqing, China, ³Beijing Ditan Hosp., Capital Med. Univ., Beijing, China, ⁴Beijing Kao Ke Rui Co., Beijing, China.
Financial Disclosures:	H. Wu, None. C. Yao, Chongqing Frontier Biotechnologies Co. Ltd. Role(s): Employee. R. J. Lu, Chongqing Frontier Biotechnologies Co. Ltd. Role(s): Employee. T. Zhang, None.. M. X. Wang, None.. H. X. Zhao, None.. H. Y. Peng, None.. Y. Xie, None.. W. J. Min, None.. H. Jiang, None.. C. J. Wang, None. D. Xie, Chongqing Frontier Biotechnologies Co. Role(s): Board Member, Employee. R. H. Jin, None.
Abstract:	Background: The emergence of multi-drug class resistant HIV-1 viruses and poor patient compliance continue to be the major cause of treatment failure. A long-acting drug of a new molecular mechanism that can reduce treatment frequency is highly desirable. Previously, we reported that albuvirtide, a maleimide modified peptide derived from the HIV-1 gp41 sequence, showed long plasma half life and potent anti-HIV activity in vitro and in vivo. Here we report proof-of-concept clinical data of albuvirtide in HIV-1 infected adults. Methods: Treatment-naïve HIV-1-infected adults with a plasma HIV-1 RNA of at least 5000 copies/ml were enrolled. The study included a single dose escalation, randomized, placebo controlled trial of albuvirtide by intravenous injection of 20 mg to 640 mg, and an open-label multiple dose trial with two dose levels of 160mg or 320 mg albuvirtide respectively. Results: Albuvirtide was well tolerated by all subjects. No injection site reactions were observed, and no anti-albuvirtide antibody was detected in patient plasma samples after multiple injections in 42 days. Albuvirtide exhibited a plasma half-life of 10-13 days. Patient HIV RNA level was suppressed for 6-10 days by a single administration. There was a clear correlation (p<0.001) between albuvirtide plasma concentration and the HIV viral load decrease. In the multiple dose study, all patients exhibited decline of plasma HIV RNA level up to 1.67 Log₁₀, with a mean maximum decline of 0.68 log₁₀ copies/ml (0.22-1.04) and 1.05 log₁₀ copies/ml (0.69-1.67) at 160 mg and 320mg albuvirtide, respectively. Conclusions: The data warrants further clinical investigation that combines albuvirtide with other antiretrovirals in treatment-experienced HIV infected patients.


	The Online Abstract Submission and Invitation System © 1996 - 2013 Coe-Truman Technologies, Inc. All rights reserved.