Gang

 

I just want to make sure that everyone understands that Pfizer (Maraviroc) and Schering (Vicriviroc) are still continuing their studies with their CCR5 inhibitors. Fortunately, it seems that the liver enzyme problems seen with the Glaxo CCR5 inhibitor is only compound specific and NOT drug class specific.

 

I also want to inform all of you who are struggling with lower T cells and wide range resistance to all or most medications that the new protease inhibitor Aptivus has been in the market for a few months and that another new one, TMC 114, is now available in expanded access. Also, Roche is making the bioinjector more widely available before they get it approved by the FDA for its use with Fuzeon. Another very exciting thing is that next month, Tibotec will start their combination study of their protease (TMC 114) plus their new non nuke (TMC 125) before both drugs get approved. This is the first time in history that something like this will happen and I am proud and happy to say that it was the result of a lot of activism from the AIDS Treatment Activists Coalition (www.atac-usa.org)

 

I will post the sites for this combo study soon.

*************************************

 

This is GSK's email:

 

Dear Community Members,


GlaxoSmithKline (GSK) announced today that it is terminating patient
enrollment into Phase 3 studies for the investigational HIV entry
inhibitor, aplaviroc (GW873140).  Due to safety data observed in these
and
the Phase 2b studies, GSK has taken immediate steps to protect the
safety
and health of patients in these clinical studies.

Aplaviroc is a CCR5 entry inhibitor which entered Phase 3 development
in
July 2005 for the treatment of HIV-1 infection in
treatment-experienced
patients.  In September 2005, all Phase 2b clinical trials in HIV
treatment-naïve patients, as well as studies in healthy volunteers,
were
terminated due to cases of severe hepatotoxicity.  Phase 3 studies in
treatment-experienced patients with multi-drug resistant virus and
limited
treatment options remained open, although further enrollment was on
hold
while data from the Phase 2b studies were reviewed.  Patients who were
already in the Phase 3 studies had the option to continue therapy and
were
closely monitored for any adverse events during that time.

GSK recently received a report of a patient in one of the Phase 3
trials
who experienced elevated liver enzymes (AST, ALT) and total bilirubin.
Based on a review of this case in the context of the previous reports
from
the Phase 2b studies, GSK has stopped all Phase 3 studies of
aplaviroc. No
further clinical studies of the compound are planned at this time.


Attached is the full press release issued this morning



Please let me know if you have any questions.

Michael N. Joyner
HIV Communications and Advocacy