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GLG News by Maraviroc Experts

July 28, 2008
Bigger concerns about Abacavir than HLA testing
By a GLG Expert Contributor
Analysis of: F.D.A. Urges Genetic Test Before Giving AIDS Drug (www.nytimes.com)
The HLAB5701 test  is inexpensive and uncomplicated to perform  It reduces risk of the hypersenitivity reaction.  Two recent studies have raised  concerns about abacavir. -ACTG 5202 study has indicated that in persons with high viral loads epzicom (the main brand of abacavir)...
July 28, 2008
HLA screening for ABV hypersensitivity reaction
By a GLG Expert Contributor
Analysis of: F.D.A. Urges Genetic Test Before Giving AIDS Drug (www.nytimes.com)
After the extensive studies published (Mallal et al), it becomes mandatory to perform a genetic HLA screening before starting abacavir-containing antiretroviral associations. Problems are recognizable in these points: - laboratories are not capable to front an exaggerated request of HLA typing; - ad-hoc...
March 26, 2008
Impressive results in competitive environment
By a GLG Expert Contributor
Analysis of: Ardea Biosciences Reports Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating up to 2.0 Log Reduction in Plasma Viral Load (www.pipelinereview.com)
Impressive 7 day antiviral effects Potential for QD naive and BD experienced approaches Potential for coformulations Revised formulation moving into next phase of testing No critical safety issues in volunteers or patients Metabolit may be anti-gout agent
February 27, 2008
To consider the possible role of the new NNRTI etravirine in the treatment of HIV infection
By a GLG Expert Contributor
Analysis of: Promising phase I/II data in HIV with once-daily NNRTI from Idenix (www.pipelinereview.com)
Etravirine is a novel and very promising NNRTI since it has not cross-resistance with the existing NNRTIs (efavirenz and nevirapine), and also encompasses excellent efficacy, convenience, and a good tolerability.
February 26, 2008
NNRTIs are not obsolete
By a GLG Expert Contributor
Analysis of: Promising phase I/II data in HIV with once-daily NNRTI from Idenix (www.pipelinereview.com)
A new NNRTI that overcomes class resistance and with a low threshold for development of resistance will be a useful addition to our antiretroviral armamentarium.
January 30, 2008
In phase 3 ACHIEVE study, Albuferon at 1200 mcg/2 weeks is switched to 900 mcg
By a GLG Expert Contributor
Analysis of: Human Genome Sciences Modifies Dosing In Achieve Trials of Albuferon(R) (www.pipelinereview.com)
In the two large phase 3 registration trials of albinterferon alfa-2b (Albuferon, Human Genome Sciences), called ACHIEVE-1 and ACHIEVE-2/3, several patients in the arm using Albuferon 1200 mcg per 2 weeks + RBV were found to have serious pulmonry adverse events.  Such serious events were not...
January 17, 2008
IDEAL study shows equivalent efficacy of Ribavirin + PEG-Intron 1.5 vs. 1.0 mcg/kg vs. Pegasys for HCV genotype 1
By a GLG Expert Contributor
Analysis of: Schering-Plough Reports Top-Line Results of the IDEAL Study (www.sch-plough.com)
   The IDEAL study compared combination therapy of ribavirin (RBV) plus PEG-Intron (Schering) at 1.5 mcg/kg weekly vs. 1.0 mcg/kg vs. Pegasys (Roche) 180 mcg weekly in treatment-naive HCV genotype 1 patients.  The primary outcome of SVR rate was similar:  40% vs. 38% vs. 41%. ...
January 17, 2008
Hepatitis C: little-recognized nitazoxanide (Alinia, Romark) shows remarkable activity in combination therapy for HCV genotype 4
By a GLG Expert Contributor
Analysis of: Phase II Study Shows that Nitazoxanide Significantly Improves Response to Standard of Care in Patients with Chronic Hepatitis C (www.romark.com)
A phase 2 study in Egypt of hepatitis C genotype 4 showed that the viral cure or SVR rate (here actually SVR12 = %HCV RNA negative at post-Rx week 12, real SVR is at week 24) is much improved when nitazoxanide is added to standard therapy.  SVR12 was 79% in nitazoxanide + Pegasys + ribavirin...
January 17, 2008
First announcement of data (very limited) from InterMune's HCV protease inhibitor ITMN-191
By a GLG Expert Contributor
Analysis of: InterMune Announces Continuing Progress on ITMN-191 (R7227) (phx.corporate-ir.net)
In the phase 1a (single ascending dose, SAD) trial, ITMN-191 was found to be safe in the first doses tested, and more cohorts will be tested with higher doses.  Details of the study will be presented later in quarter 1 of 2008.  Multiple ascending doses (MAD) in a 2-week monotherapy phase...
January 14, 2008
New Approach for an Influenza Vaccine
By a GLG Expert Contributor
Analysis of: Universal flu vaccine shows early promise (www.fiercebioresearcher.com)
If early results are confirmed, this vaccine will revolutionize influenza immunization          

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