The FDA hearing on expanding access to direct-acting-antivirals (docket FDA-2010-N-107) scheduled for april 30 has its first deadline today "Submit written or electronic requests for oral presentations and comments by April 8, 2010 (see section III of this document for details). Written or electronic comments will be accepted after the hearing until June 25,"
See http://edocket.access.gpo.gov/2010/pdf/2010-5055.pdf
For the many here who have been excluded by ifn-based tx (HectorSF, Susan400, MrLiver, Trinity4, JennyPenny,Smaug48, Magnum, MerryBe and many other friends) this could be a significant opportunity. The drug regime required to reach SVR among ifn-unresponsive or ifn-intolerant could well be within reach *now*, a combination of a polymerase inhibitor (r7128) , a protease inhibitor (boceprevir or telaprevir), an ifn-enhancer (alinia) along with tolerable levels of ifn/rbv.
The available clinical data on simultaneously targeting multiple viral proteins looks very promising and the approach has demonstrated success in HIV. However, drug manufacturers will not test this combination outside their own product line. The three companies currently testing polymerase/protease combinations (abbott, vertex, roche) are only testing their own drugs. Furthermore, they are testing in trials targeted at tx naive, not those most in need.
The FDA hearing is an investigation of whether additional trials, are appropriate:
"what types of studies should be conducted to best address unmet medical needs for patients with CHC including those with the greatest risk of progression of liver disease and/ or the lowest predicted virologic response rates"
The default path will be to only pursue regimes such as the one above after both a polymerase and a protease are approved and r7128 approval is very unlikely before 2014. Expanded early access to those most in need during the next 4-5 years could make a significant impact - let them know!