Presentation Abstract

Session: 073-New Antiretroviral Therapy: Bench to Bedside
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.

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