In
the June 2007 issue of AIDS, researchers reported data from a study to
assess the antiviral activity, pharmacokinetic properties, and safety of another
drug in this class which is further back in the development pipeline, Schering-Plough's
vicriviroc.
The
present study was an ascending, multiple-dose, placebo-controlled trial randomized
within treatment group. A total of 48 HIV positive patients were enrolled sequentially
into dose groups receiving 10 mg, 25 mg, or 50 mg oral vicriviroc twice daily
as monotherapy or else placebo for 14 days.
Results
•
Significant
reductions in HIV RNA from baseline were achieved after 14 days in all active
treatment groups (i.e., all 3 dose groups).
•
Suppression
of HIV RNA persisted 2-3 days beyond the end of treatment.
•
45%,
77%, and 82% of subjects in the 10 mg, 25 mg, and 50 mg dose groups, respectively,
achieved HIV RNA reductions of 1.0 log10 or greater.
•
18%,
46%, and 45%, respectively, achieved HIV RNA decreased of at least 1.5 log10.
•
Vicriviroc
was rapidly absorbed, with a half-life of 28-33 hours, supporting once-daily dosing.
•
Pharmacokinetic
parameters were dose linear, and steady state was achieved by day 12.
Vicriviroc
was generally well tolerated in all dose groups.
•
The
frequency of adverse events was similar in the vicriviroc and placebo groups,
at 72% and 62%, respectively.
•
The
most frequently reported adverse events included headache, pharyngitis (sore throat),
nausea, and abdominal pain, which were not dose related.
Conclusion|
In
conclusion, the authors wrote, "Whereas all doses were well tolerated and
produced significant declines in plasma HIV RNA, total oral daily doses of 50
or 100 mg vicriviroc monotherapy for 14 days appeared to provide the most potent
antiviral effect in this study."
06/15/07
Reference D
Schurmann, G Fatkenheuer, J Reynes, and others. Antiviral activity, pharmacokinetics
and safety of vicriviroc, an oral CCR5 antagonist, during 14-day monotherapy in
HIV-infected adults. AIDS 21(10): 1293-1299. June 2007.
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