Thursday, March 29, 2012

Vertex, Boehringer Ingelheim, Other Pharmaceutical Giants Racing To Get Interferon-Free Hepatitis C Treatment Through Clinical Trials And To The Marketplace

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.

 Science and health researchers have the Hepatitis C virus on the ropes. It is our job to deliver the knockout punch!

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