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Been There, Done ThatThere's a lot of us who've tried the whole treatment thing. It didn't work; either because:
o.k., o.k. ... that's enough whining. Here's what's coming down the pike.
Inhibitors(and we don't mean shy people) As you may recall from the straightup on why hep C's so hard to
get rid of
(here),
the virus gets inside of us and reproduces itself - a lot like our
normal proteins & enzymes inside of us do, except we want to keep the
good stuff . Get the picture? If not take a look at this
flash movie for a minute ...
here.
Anyway ... what these will do is make the virus stop reproducing itself, to give the interferon a chance to do its stuff. It's hoped that the inhibitors will cut out the whole ribavirin part and shorten the time on treatment. So we get less sick, more genotype 1's get cured and insurance companies and the rest of us are happy. The catch ...
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Drug Name |
Drug Type |
Drug Company |
Phase |
What Science Has
|
|
Actilon fka CPG-0101 |
Immune booster |
Coley Pharmaceutical Group |
Ib |
Hep C virus declined WITHIN 24 HOURS for the group that took the highest dose. Enrollment's closed for Phase Ib, which will be done by January 2007. |
|
Albuferon |
Immuno-modulator |
Human Genome Sciences |
III |
Albuferon is kind of like a souped-up interferon. This small company is sinking tons of effort into its success, & passed their phase II Quality of Life (QoL) study. Phase III studies will feature two studies: one for genotype 1's and one for genotypes 2 & 3. |
|
Bavituxomab |
monoclonal antibody antiviral |
Peregrine Pharmaceuticals |
II |
Pre-clinical ended early. So far … the monkey didn't die. Enrollment for Phase I is closed a little ahead of schedule, per company press release, 10/24/06. Guess they're pretty excited about that. |
|
Merimepodib fka VX-497 |
?? |
Vertex Pharmaceuticals, Johnson & Johnson |
II |
At the end of a 24-week treatment with triple therapy: Merimepodib, Pegasys & Copegus, 86% of participants went viral negative. |
|
Suvus |
?? |
Bioenvision, Inc. |
II |
Reduced viral load in hep C patients- many with cirrhosis. Press Release was pretty vague, though. Not much detail. Data will be presented Sept. 7-8, 2006 in Dublin, Ireland. |
|
Telapravir fka VX-950 |
protease inhibitor |
Vertex Pharmaceuticals, Johnson & Johnson |
II |
Data from several studies (PROVE 1) of this drug were just released, per company press release 10/27/2006. Findings are kind of a mixed bag, but still pretty good. In another, people who got the inhibitor + peg inf + riba (Roche's) stayed viral negative 12 wks POST TREATMENT; not so for the ones who did only the Telapravir. A couple people quit & no one's saying why. All the patients are genotype 1, hard-to-treat. Clinics are currently enrolling for PROVE 2, to be completed by year-end. |
|
Valopicitabine fka NM283 |
polymerase inhibitor |
Idenix Pharmaceuticals |
II |
In this large-scale trial some folks got NM283 alone, others got it with Peg-inf/riba. 72% of the people who did the combination cleared at 12 weeks, yet opted to continue the peg/riba for the full 48 weeks. |
|
Viramidine
|
Pro-drug of Ribavirin (meaning, same drug, different name) |
Valeant Pharmaceuticals (FKA Ribapharm) |
II |
Valeant's phase II study didn't get people to go SVR negative (38%, vs. 52%, regular riba). Valeant said this had to do with weight-based dosing. Returning once again from the drawing board, they have a high-dose phase IIb in the pipeline. Straight up ... this one's outta there. The SEC's even investigating company top dogs for selling stock, per company press release 9/13/2006 |
These tables are
updated as soon as we hear, and have an internet connection. The
information provided comes from primary & secondary sources, such as
Principal Investigators of the studies, or their staff, but mostly from
press releases. For the bottom line on your decisions, see
our disclaimer ...
here.
Stay tuned ....


The
FDA
… aka Food & Drug Administration is the agency that gives drug companies
the go ahead - or not - to sell medications in the U.S.
Ideally, the drugs have to pass a series of studies, aka Phases. FDA.gov's site describes them like so:
Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects
Phase II: The study drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III: The study drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Straightup, the best deal for us is the Phase IV trial, aka "marketing study" that will determine what kind of language a Pharma can use to sell its drug. Our best bet because the drug's already proven safe.
There's also "Pre-clinical," which is pretty much lab stuff; messing with gunk in petri dishes; animal testing ... like with hep C, chimpanzees are used, because dogs can't catch it; preclinical proves the general concept.
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