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HepC Newsletter
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Dema-@aol.com
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Jul 13, 2009 15:44 PDT
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NATAP http://natap.org/
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HCV Parallel Drug Development For Coinfection......
The 4th International Workshop on
Clinical Pharmacology of Hepatitis Therapy
Boston, MA June 27, 2009
4th Intrntnl Wrkshp Clncl Pharm HCV: _Meeting Report - The 4th
International Workshop on Clinical Pharmacology of Hepatitis Therapy_
(http://www.natap.org/2009/Pharm/Pharm_01.htm) - written by Jennifer J. Kiser, Pharm.D -
(07/12/09)
"These studies support that R7227 is a substrate for, and a weak inhibitor
of CYP3A and an inhibitor of the drug transporter p-glycoprotein (P-gp).
R7227 is therefore susceptible to drug interactions with CYP3A modulators,
and may increase levels of other P-gp substrates. Many HIV PIs and NNRTIs
are CYP3A and P-gp substrates, inducers, and/or inhibitors. Thus, the
interactions observed with R7227 highlight the importance of studying this and
other investigational HCV drugs in combination with HIV medications. The
dosing of the HCV and/or HIV drugs may need to be altered in combination or a
significant interaction could unfortunately preclude the use of some of these
medications in combination"
"The FDA is treating HCV drug development differently than they previously
treated HIV drug development in the early days, the 1990s....It appears
the FDA subscribes to the thinking that HCV is different, that HCV disease is
not as serious a threat for imminent death....BUT, not all patients have
the same disease pathogenesis, some patients progress more quickly.....HIV
accelerates HCV disease, coinfected patients can seriously progress within
5-10 years......Two studies with paired biopsies have reported in HCV/HIV
coinfected patients that HCV disease progressed 2 stages over 3 years in a
significant percent of coinfected patients....For patients with advanced
monoinfection disease they too are in danger of decompensation and death. So
what is needed is a full open discussion between the FDA and stakeholders, the
companies, to consider if there is a reasonable way to address these
needs:"
"we need consideration of parallel drug development for coinfection with
the goal that coinfected patients would get access to a combination regimen
as quickly as possible with safety in mind that contains at least 2 oral
HCV drugs plus peg/RBV. what is needed is access as quickly as possible to at
least 2 oral HCV drugs in combination with peg/RBV for coinfected patients
who cannot wait because their disease is progressed and they are in
serious danger of decompensated cirrhosis and death. the FDA encourages study in
special patient populations like coinfected and cirrhotics and in patients
with the greatest need, said Kim Struble of the FDA. We also need
consideration of early acess for monoinfected patients in grest need facing
decompensation/death.
4th International Workshop on Hepatitis C
Resistance and New Compounds
25-26 June 2009, Boston, MA USA
* _New HCV Drugs, Special Population (Coinfectio) Access: 4th
International Workshop on Hepatitis C, Resistance and New Compounds 25-26 June
2009, Boston, MA U _ (http://www.natap.org/2009/HCVresist/HCVresist_02.htm) -
(06/30/09)
* _FDA Loosens Up HCV Drug Development - HCV Boston Meeting June 27,
2009 _ (http://www.natap.org/2009/HCVresist/HCVresist_01.htm) - (06/30/09)
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