Determined to try and keep pace with rival hepatitis C
treatments in the pipeline by Boehringer Ingelheim and a rash of other
pharmaceutical giants, Vertex ($VRTX) today unveiled a
slate of somewhat positive interim midstage results for an all-oral combo
regimen that includes its game-changing drug Incivek along with the
experimental VX-222--its non-nucleoside polymerase inhibitor--and ribavirin.
Cutting Edge Interferon Free Hepatitis C Treatments |
The previous standard goal for new hepatitis C drugs is the
sustained elimination of all signs of the virus by week 12, allowing patients
to stop treatment. In my clinical trial, I was normal and clear by week 4 and
this allowed me to stop the brutal treatment after six months.
Researchers and drug developers are aiming for the fastest cure rates
possible.
Vertex noted that 11 of 46 treatment naïve patients with the
genotype 1a and 1b virus met the criteria of having "undetectable
hepatitis C virus at weeks two and eight of treatment and were therefore
eligible to stop all treatment at 12 weeks. " Data showed that viral loads
were below the "lower limit of quantification" for 83% of the
patients at week 12.
Based on the data, Vertex says it will push ahead with a
Phase IIb study of the interferon-free combo, anticipating that investigators
can nail late-stage data for an NDA to the FDA as early as late 2014--keeping
on an ambitious development schedule. "Our ultimate goal is to
develop well-tolerated, interferon-free treatment regimens with high viral cure
rates and short treatment durations for people with hepatitis C," said
Vertex CSO Peter Mueller.
It is so essential for people to know about this and get
tested for the virus. Over two million Americans have Hepatitis C and do not
know it. Their livers are ticking time bombs that are so easy to defuse given
the new medical developments. But in the general population, particularly in
America, nobody knows what the hell is going on. The awareness level is close
to zero and a major Act Up-like campaign that proved so effective in combating
HIV is desperately needed.
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