Phase I and II Study of the Safety, Virologic Effect, and Pharmacokinetics/Pharmacodynamics of Single-Dose 3-O-(3′,3′-Dimethylsuccinyl)Betulinic Acid (Bevirimat) against Human Immunodeficiency Virus Infection
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| Published in | Antimicrobial Agents and Chemotherapy Vol. 51; no. 10; pp. 3574 - 3581 |
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| Main Authors | , , , , , , , |
| Format | Journal Article |
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United States
American Society for Microbiology
01.10.2007
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| AbstractList | Bevirimat [3-O-(3',3'-dimethylsuccinyl)betulinic acid] is the first in a new class of anti-human immunodeficiency virus (HIV) drugs that inhibit viral maturation by specifically blocking cleavage of the Gag capsid (CA) precursor, CA-SP1, to mature CA protein, resulting in defective core condensation and release of immature noninfectious virions. Four cohorts of six HIV-infected adults, with CD4 counts of >200 and plasma viral loads of 5,000 to 250,000 transcripts/ml and not currently receiving antiretroviral therapy, were randomized to receive a single oral dose of placebo, 75, 150, or 250 mg of bevirimat. Thirty blood samples for drug concentrations and 20 HIV RNA measures were collected from each subject over a 20-day period. Candidate pharmacokinetic/pharmacodynamic models were fit to individual subjects by maximum likelihood followed by Bayesian estimation; model discrimination was by corrected Akaike's Information Criterion. The bevirimat pharmacokinetics was well described by an oral two-compartment linear model (r(2), 0.98), with a mean (percent coefficient of variation) half-life of 60.3 (13.6) h and apparent oral clearance of bevirimat from the plasma compartment of 0.17 (18) liters/h. HIV RNA was modeled as being produced in infected CD4 cells, with bevirimat inhibiting infection of new CD4 cells thru a Hill-type function (r(2), 0.87). Single oral doses of bevirimat were well tolerated and demonstrated a dose-dependent reduction in viral load. The average maximum reduction from baseline following the 150- and 250-mg doses was greater than 0.45 log(10), with individual patients having reductions of greater than 0.7 log(10). No bevirimat resistance mutations were detected during the course of the study. Bevirimat [3-O-(3′,3′-dimethylsuccinyl)betulinic acid] is the first in a new class of anti-human immunodeficiency virus (HIV) drugs that inhibit viral maturation by specifically blocking cleavage of the Gag capsid (CA) precursor, CA-SP1, to mature CA protein, resulting in defective core condensation and release of immature noninfectious virions. Four cohorts of six HIV-infected adults, with CD4 counts of >200 and plasma viral loads of 5,000 to 250,000 transcripts/ml and not currently receiving antiretroviral therapy, were randomized to receive a single oral dose of placebo, 75, 150, or 250 mg of bevirimat. Thirty blood samples for drug concentrations and 20 HIV RNA measures were collected from each subject over a 20-day period. Candidate pharmacokinetic/pharmacodynamic models were fit to individual subjects by maximum likelihood followed by Bayesian estimation; model discrimination was by corrected Akaike's Information Criterion. The bevirimat pharmacokinetics was well described by an oral two-compartment linear model (r2, 0.98), with a mean (percent coefficient of variation) half-life of 60.3 (13.6) h and apparent oral clearance of bevirimat from the plasma compartment of 0.17 (18) liters/h. HIV RNA was modeled as being produced in infected CD4 cells, with bevirimat inhibiting infection of new CD4 cells thru a Hill-type function (r2, 0.87). Single oral doses of bevirimat were well tolerated and demonstrated a dose-dependent reduction in viral load. The average maximum reduction from baseline following the 150- and 250-mg doses was greater than 0.45 log10, with individual patients having reductions of greater than 0.7 log10. No bevirimat resistance mutations were detected during the course of the study. Bevirimat [3- O -(3′,3′-dimethylsuccinyl)betulinic acid] is the first in a new class of anti-human immunodeficiency virus (HIV) drugs that inhibit viral maturation by specifically blocking cleavage of the Gag capsid (CA) precursor, CA-SP1, to mature CA protein, resulting in defective core condensation and release of immature noninfectious virions. Four cohorts of six HIV-infected adults, with CD4 counts of >200 and plasma viral loads of 5,000 to 250,000 transcripts/ml and not currently receiving antiretroviral therapy, were randomized to receive a single oral dose of placebo, 75, 150, or 250 mg of bevirimat. Thirty blood samples for drug concentrations and 20 HIV RNA measures were collected from each subject over a 20-day period. Candidate pharmacokinetic/pharmacodynamic models were fit to individual subjects by maximum likelihood followed by Bayesian estimation; model discrimination was by corrected Akaike's Information Criterion. The bevirimat pharmacokinetics was well described by an oral two-compartment linear model ( r 2 , 0.98), with a mean (percent coefficient of variation) half-life of 60.3 (13.6) h and apparent oral clearance of bevirimat from the plasma compartment of 0.17 (18) liters/h. HIV RNA was modeled as being produced in infected CD4 cells, with bevirimat inhibiting infection of new CD4 cells thru a Hill-type function ( r 2 , 0.87). Single oral doses of bevirimat were well tolerated and demonstrated a dose-dependent reduction in viral load. The average maximum reduction from baseline following the 150- and 250-mg doses was greater than 0.45 log 10 , with individual patients having reductions of greater than 0.7 log 10 . No bevirimat resistance mutations were detected during the course of the study. Classifications Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue AAC About AAC Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy AAC RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 0066-4804 Online ISSN: 1098-6596 Copyright © 2014 by the American Society for Microbiology. For an alternate route to AAC .asm.org, visit: AAC Bevirimat [3-O-(3',3'-dimethylsuccinyl)betulinic acid] is the first in a new class of anti-human immunodeficiency virus (HIV) drugs that inhibit viral maturation by specifically blocking cleavage of the Gag capsid (CA) precursor, CA-SP1, to mature CA protein, resulting in defective core condensation and release of immature noninfectious virions. Four cohorts of six HIV-infected adults, with CD4 counts of >200 and plasma viral loads of 5,000 to 250,000 transcripts/ml and not currently receiving antiretroviral therapy, were randomized to receive a single oral dose of placebo, 75, 150, or 250 mg of bevirimat. Thirty blood samples for drug concentrations and 20 HIV RNA measures were collected from each subject over a 20-day period. Candidate pharmacokinetic/pharmacodynamic models were fit to individual subjects by maximum likelihood followed by Bayesian estimation; model discrimination was by corrected Akaike's Information Criterion. The bevirimat pharmacokinetics was well described by an oral two-compartment linear model (r(2), 0.98), with a mean (percent coefficient of variation) half-life of 60.3 (13.6) h and apparent oral clearance of bevirimat from the plasma compartment of 0.17 (18) liters/h. HIV RNA was modeled as being produced in infected CD4 cells, with bevirimat inhibiting infection of new CD4 cells thru a Hill-type function (r(2), 0.87). Single oral doses of bevirimat were well tolerated and demonstrated a dose-dependent reduction in viral load. The average maximum reduction from baseline following the 150- and 250-mg doses was greater than 0.45 log(10), with individual patients having reductions of greater than 0.7 log(10). No bevirimat resistance mutations were detected during the course of the study.Bevirimat [3-O-(3',3'-dimethylsuccinyl)betulinic acid] is the first in a new class of anti-human immunodeficiency virus (HIV) drugs that inhibit viral maturation by specifically blocking cleavage of the Gag capsid (CA) precursor, CA-SP1, to mature CA protein, resulting in defective core condensation and release of immature noninfectious virions. Four cohorts of six HIV-infected adults, with CD4 counts of >200 and plasma viral loads of 5,000 to 250,000 transcripts/ml and not currently receiving antiretroviral therapy, were randomized to receive a single oral dose of placebo, 75, 150, or 250 mg of bevirimat. Thirty blood samples for drug concentrations and 20 HIV RNA measures were collected from each subject over a 20-day period. Candidate pharmacokinetic/pharmacodynamic models were fit to individual subjects by maximum likelihood followed by Bayesian estimation; model discrimination was by corrected Akaike's Information Criterion. The bevirimat pharmacokinetics was well described by an oral two-compartment linear model (r(2), 0.98), with a mean (percent coefficient of variation) half-life of 60.3 (13.6) h and apparent oral clearance of bevirimat from the plasma compartment of 0.17 (18) liters/h. HIV RNA was modeled as being produced in infected CD4 cells, with bevirimat inhibiting infection of new CD4 cells thru a Hill-type function (r(2), 0.87). Single oral doses of bevirimat were well tolerated and demonstrated a dose-dependent reduction in viral load. The average maximum reduction from baseline following the 150- and 250-mg doses was greater than 0.45 log(10), with individual patients having reductions of greater than 0.7 log(10). No bevirimat resistance mutations were detected during the course of the study. Bevirimat [3-O-(3',3'-dimethylsuccinyl)betulinic acid] is the first in a new class of anti-human immunodeficiency virus (HIV) drugs that inhibit viral maturation by specifically blocking cleavage of the Gag capsid (CA) precursor, CA-SP1, to mature CA protein, resulting in defective core condensation and release of immature noninfectious virions. Four cohorts of six HIV-infected adults, with CD4 counts of >200 and plasma viral loads of 5,000 to 250,000 transcripts/ml and not currently receiving antiretroviral therapy, were randomized to receive a single oral dose of placebo, 75, 150, or 250 mg of bevirimat. Thirty blood samples for drug concentrations and 20 HIV RNA measures were collected from each subject over a 20-day period. Candidate pharmacokinetic/pharmacodynamic models were fit to individual subjects by maximum likelihood followed by Bayesian estimation; model discrimination was by corrected Akaike's Information Criterion. The bevirimat pharmacokinetics was well described by an oral two-compartment linear model (r super(2), 0.98), with a mean (percent coefficient of variation) half-life of 60.3 (13.6) h and apparent oral clearance of bevirimat from the plasma compartment of 0.17 (18) liters/h. HIV RNA was modeled as being produced in infected CD4 cells, with bevirimat inhibiting infection of new CD4 cells thru a Hill-type function (r super(2), 0.87). Single oral doses of bevirimat were well tolerated and demonstrated a dose-dependent reduction in viral load. The average maximum reduction from baseline following the 150- and 250-mg doses was greater than 0.45 log sub(10), with individual patients having reductions of greater than 0.7 log sub(10). No bevirimat resistance mutations were detected during the course of the study. |
| Author | Karl Salzwedel Alan Forrest Patrick F. Smith John Wilton Judy Doto Graham P. Allaway David E. Martin Abayomi Ogundele |
| AuthorAffiliation | University at Buffalo, School of Pharmacy and Pharmaceutical Sciences, Buffalo, New York, 1 Roswell Park Cancer Institute, Buffalo, New York, 2 Emprexe Analytical, LLC, Buffalo, New York, 3 Panacos Pharmaceuticals, Gaithersburg, Maryland 4 |
| AuthorAffiliation_xml | – name: University at Buffalo, School of Pharmacy and Pharmaceutical Sciences, Buffalo, New York, 1 Roswell Park Cancer Institute, Buffalo, New York, 2 Emprexe Analytical, LLC, Buffalo, New York, 3 Panacos Pharmaceuticals, Gaithersburg, Maryland 4 |
| Author_xml | – sequence: 1 givenname: Patrick F. surname: Smith fullname: Smith, Patrick F. organization: University at Buffalo, School of Pharmacy and Pharmaceutical Sciences, Buffalo, New York, Roswell Park Cancer Institute, Buffalo, New York – sequence: 2 givenname: Abayomi surname: Ogundele fullname: Ogundele, Abayomi organization: University at Buffalo, School of Pharmacy and Pharmaceutical Sciences, Buffalo, New York, Roswell Park Cancer Institute, Buffalo, New York – sequence: 3 givenname: Alan surname: Forrest fullname: Forrest, Alan organization: University at Buffalo, School of Pharmacy and Pharmaceutical Sciences, Buffalo, New York – sequence: 4 givenname: John surname: Wilton fullname: Wilton, John organization: Emprexe Analytical, LLC, Buffalo, New York – sequence: 5 givenname: Karl surname: Salzwedel fullname: Salzwedel, Karl organization: Panacos Pharmaceuticals, Gaithersburg, Maryland – sequence: 6 givenname: Judy surname: Doto fullname: Doto, Judy organization: Panacos Pharmaceuticals, Gaithersburg, Maryland – sequence: 7 givenname: Graham P. surname: Allaway fullname: Allaway, Graham P. organization: Panacos Pharmaceuticals, Gaithersburg, Maryland – sequence: 8 givenname: David E. surname: Martin fullname: Martin, David E. organization: Panacos Pharmaceuticals, Gaithersburg, Maryland |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/17638699$$D View this record in MEDLINE/PubMed |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Corresponding author. Mailing address: Hoffman-La Roche, Inc., Clinical Pharmacology, 340 Kingsland Street, Nutley, NJ 07110-1199. Phone: (973) 562-2890. Fax: (973) 562-3411. E-mail: Patrick.smith@roche.com |
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| PublicationTitle | Antimicrobial Agents and Chemotherapy |
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| Publisher | American Society for Microbiology |
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| References | (e_1_3_1_13_2) 1997; 11 (e_1_3_1_5_2) 2002; 4 e_1_3_1_8_2 (e_1_3_1_16_2) 2004; 9 e_1_3_1_7_2 e_1_3_1_12_2 e_1_3_1_11_2 e_1_3_1_9_2 e_1_3_1_10_2 e_1_3_1_4_2 e_1_3_1_17_2 e_1_3_1_3_2 e_1_3_1_6_2 e_1_3_1_15_2 e_1_3_1_14_2 e_1_3_1_2_2 e_1_3_1_18_2 15456084 - Antivir Ther. 2004 Aug;9(4):529-36 12152519 - AIDS Rev. 2002 Apr-Jun;4(2):59-63 15242535 - AIDS Res Hum Retroviruses. 2004 Jun;20(6):595-9 14573704 - Proc Natl Acad Sci U S A. 2003 Nov 11;100(23):13555-60 17576843 - Antimicrob Agents Chemother. 2007 Sep;51(9):3063-6 17596104 - Clin Pharmacokinet. 2007;46(7):589-98 16583266 - J Pharmacokinet Pharmacodyn. 2006 Aug;33(4):399-419 12819516 - AIDS. 2003 May 23;17(8):1151-6 15942889 - J Infect Dis. 2005 Jul 1;192(1):16-23 14694123 - J Virol. 2004 Jan;78(2):922-9 14637059 - J Theor Biol. 2004 Jan 7;226(1):95-109 9451962 - AIDS. 1997;11 Suppl A:S17-24 9144290 - Nature. 1997 May 8;387(6629):188-91 |
| References_xml | – ident: e_1_3_1_6_2 doi: 10.1093/biomet/76.2.297 – ident: e_1_3_1_4_2 doi: 10.1089/0889222041217518 – ident: e_1_3_1_9_2 doi: 10.1097/00002030-200305230-00006 – ident: e_1_3_1_12_2 doi: 10.1038/387188a0 – volume: 9 start-page: 529 year: 2004 ident: e_1_3_1_16_2 publication-title: Antivir. Ther. doi: 10.1177/135965350400900410 – ident: e_1_3_1_8_2 doi: 10.1073/pnas.2234683100 – ident: e_1_3_1_10_2 doi: 10.1128/AAC.01391-06 – ident: e_1_3_1_11_2 doi: 10.2165/00003088-200746070-00004 – ident: e_1_3_1_7_2 doi: 10.1086/430741 – ident: e_1_3_1_14_2 – ident: e_1_3_1_3_2 doi: 10.1016/j.jtbi.2003.09.002 – volume: 4 start-page: 59 year: 2002 ident: e_1_3_1_5_2 publication-title: AIDS Rev. – volume: 11 start-page: S17 year: 1997 ident: e_1_3_1_13_2 publication-title: AIDS – ident: e_1_3_1_18_2 doi: 10.1128/JVI.78.2.922-929.2004 – ident: e_1_3_1_15_2 – ident: e_1_3_1_2_2 – ident: e_1_3_1_17_2 doi: 10.1007/s10928-006-9006-4 – reference: 9144290 - Nature. 1997 May 8;387(6629):188-91 – reference: 16583266 - J Pharmacokinet Pharmacodyn. 2006 Aug;33(4):399-419 – reference: 9451962 - AIDS. 1997;11 Suppl A:S17-24 – reference: 14573704 - Proc Natl Acad Sci U S A. 2003 Nov 11;100(23):13555-60 – reference: 14637059 - J Theor Biol. 2004 Jan 7;226(1):95-109 – reference: 12152519 - AIDS Rev. 2002 Apr-Jun;4(2):59-63 – reference: 14694123 - J Virol. 2004 Jan;78(2):922-9 – reference: 17576843 - Antimicrob Agents Chemother. 2007 Sep;51(9):3063-6 – reference: 15242535 - AIDS Res Hum Retroviruses. 2004 Jun;20(6):595-9 – reference: 12819516 - AIDS. 2003 May 23;17(8):1151-6 – reference: 15456084 - Antivir Ther. 2004 Aug;9(4):529-36 – reference: 15942889 - J Infect Dis. 2005 Jul 1;192(1):16-23 – reference: 17596104 - Clin Pharmacokinet. 2007;46(7):589-98 |
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Reddit... Bevirimat [3- O -(3′,3′-dimethylsuccinyl)betulinic acid] is the first in a new class of anti-human immunodeficiency virus (HIV) drugs that inhibit viral... Bevirimat [3-O-(3',3'-dimethylsuccinyl)betulinic acid] is the first in a new class of anti-human immunodeficiency virus (HIV) drugs that inhibit viral... Bevirimat [3-O-(3′,3′-dimethylsuccinyl)betulinic acid] is the first in a new class of anti-human immunodeficiency virus (HIV) drugs that inhibit viral... |
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| StartPage | 3574 |
| SubjectTerms | Adult Algorithms Anti-HIV Agents Anti-HIV Agents - adverse effects Anti-HIV Agents - pharmacokinetics Anti-HIV Agents - therapeutic use Bayes Theorem Calibration CD4 Lymphocyte Count Clinical Therapeutics Double-Blind Method Drug Resistance, Viral HIV Infections HIV Infections - drug therapy HIV-1 HIV-1 - genetics Human immunodeficiency virus Humans Male Models, Statistical RNA, Viral - blood Succinates Succinates - adverse effects Succinates - pharmacokinetics Succinates - therapeutic use Triterpenes Triterpenes - adverse effects Triterpenes - pharmacokinetics Triterpenes - therapeutic use Viral Load Virus Replication - drug effects |
| Title | Phase I and II Study of the Safety, Virologic Effect, and Pharmacokinetics/Pharmacodynamics of Single-Dose 3-O-(3′,3′-Dimethylsuccinyl)Betulinic Acid (Bevirimat) against Human Immunodeficiency Virus Infection |
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