HCV Parallel Drug Development For Coinfection

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 - 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