Hope for GT 2 and 3?

[Maxlaw]

As I'm sure most of you know, the newest drugs (Harvoni and Viekira Pak) are for GT1...and GTs 2 and 3 still must take Sovaldi and Ribavirin, for either 12 or 24 weeks.  GT1 has now become "easier" to cure than GTs 2 or 3, but there is some focus on GTs 2 and 3 in clinical trials.

I am currently participating in a trial for AbbVie's next generation NS3/4A inhibitor (ABT-493) and NS5A inhibitor (ABT-530) (these two drugs are the next generation of the NS3/4A protease inhibitor Paritaprevir and the NS5A inhibitor Ombitasvir which are in Viekira Pak).  These two drugs have been shown to have very strong potentency across all genotypes in vitro, and also have been shown to have a very high barrier to resistance in vitro, especially against GT 3a.  When combined, one has been shown to have a synergistic effect on the other.

I and some of the others that I've had a chance to speak to who are in the same trial were all undetected at 4 weeks (I am starting week 7 of 12 weeks).  My personal VL went from 311K to <25 in one week and was UND at 2 weeks!  But, importantly, none of us (I'm only referring only to the 4-5 people I have had conversations with) have had ANY side effects on these drugs.  Of course, we all know that the important milestone is 12 weeks after EOT, but everyone is very hopeful for a cure.  I can only hope that these drugs prove to be a good option for GTs 2 and 3 in the near future!

This particular trial is a Phase IIb trial and the estimated primary completion date is September 2015.  My understanding is that it is AbbVie's intention to combine these two drugs into one composition for Phase III trials starting late this year/early next year.

Anyway, I just wanted to relay what I think is very positive information (at least in my experience) for GTs 2 and 3.

Best wishes to all my fellow warriors!

--Max

[petra]

Thanks for that. I will be looking for your updates. I just finished 12 weeks of sovaldi and ribavirin 11 days ago. Now the waiting begins but I would rather wait knowing that there is possibly backup.
Cheers, Petra

[CE]

I agree, Petra. Us 2's and 3's need more alternatives in case one don't work. Right now, if Sovadi and riba don't work, we have nothing. Best of luck in your trial, Maxlaw! I hope it works for you and gives us all hope. And Petra, good luck to you, I hope you get SVR and don't need an alternative! Please, both of you keep us posted of your status! Best wishes!       Chris

[Maxlaw]

Yes, Petra, I sure hope you get SVR and don't need an alternative!!  But I agree that it might ease the anxiety knowing that there is another treatment coming along for GT 2 and 3 that might be even better than Sovaldi/RBV.

There is also another next-generation NS5A inhibitor from Gilead called GS-5816, which is currently in Phase III trials and is pan-genotypic.  It is given with Sovaldi with or without RBV. It was also tested on harder to treat patients (those with cirrhosis and those previously treated), and the cure rates were high from the Phase II trials.  So, something else to look forward to if we need it.

I am truly blessed to be able to receive the AbbVie treatment in a trial, and boy don't I know it from reading all the posts from everyone about the battles they have had to fight to get their insurance to approve treatment!  It's just crazy to me that the insurance companies don't want to get people cured and save themselves having to pay out more money in the long run when people get sicker.  My insurance company's PBM is Express Scripts, who was leading the fight against the price of Sovaldi, and now Harvoni, and in fact ES signed an agreement with AbbVie to supply their drugs over Gilead's drugs for GT1.  They most likely wouldn't have approved my treatment anyway, because I didn't meet their "sick enough" guidelines, based on my labs and liver biopsy.

Anyway, I'll sure keep everyone posted about this treatment so they will have the information for future decisions.

--Max 

[CE]

I always thought the idea was "preventative", not "sick enough"! How sad that they want people near death before giving them something to improve their life. Sometimes it's just too late.