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New Options without Ribavirin and Interferon Coming Soon

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First, an update on my lab results. I now have reached SVR12 as of November 6th and hope the others on this trial will be doing the same. My last labs showed that everything was in normal levels.

The best solution for all hepatitis C genotypes is going to be the combination of the just approved Sovaldi (sofosbuvir) & daclatasvir (prescribed off-label once daclatasvir gets FDA approval); or Gilead's two drugs Sovaldi and GS-5816. Either of these would work in all genotypes without the need for ribavirin or interferon. With these drugs there would not even be a need for genotype testing... same drugs regardless of genotype.

Let's all continue to pray that these drug companies will soon realize they can make billions by working together. Otherwise their 'demographics' (i.e. people with HCV) are dying off at the rate of 1000 each and every day. At any rate, we must all continue to do what we can to make sure patients, doctors, and the FDA are aware of the success of these drug combinations, and there is no need to subject people to the brutal side effects of interferon or ribavirin, which can be long-lasting and even permanent. So please keep spreading this message in any way you can think of and I will continue to do the same.

Also, if anyone has any other ideas or suggestions on how to facilitate this, please let me know. I still find it hard to believe this is not worthy of national news coverage since we are dealing with a worldwide epidemic!

2 Comments

Great news Margaret. I know that this has been a real battle for you and now it seems that you are on the other side and can start living a somewhat "normal" life, disease free. HalleluYah! I don't know if you remember but I told you a while back that something good was going to happen and it has and it is happening fairly quickly, not quickly enough for some though. I have an appointment with the Texas Liver Institute tomorrow and hopefully I'll be able to get into a study. With all of the advances being made the end of studies seems to be coming to an end. Hopefully the price for these pills will drop to where the regular people can afford the cure. May
God's Blessings fill you to overflowing. So that you may say along with David, that your cup overflows.
Tuck

You are an angel Margaret! Your information and help over the last year have been inspirational to many and may have saved lives by raising awareness of the Pharm. Cartel mentality that sadly has run rip shod over our FDA causing trials curing up to 99% of all hep C genotypes to be halted for BUINESs reasons.
I am so happy you received treatment even if it meant swallowing one's pride and succumbing to the co. Largely to blame for the lack of a two pill 12 week 99% cure. Instead folks like me face RIbavirin who could not get into trials. Luckily I have insurance but 2 weeks in on RIbavirin and Sovaldii my RBC and HCT /hemoglobin show signs of potential anemia that frankly are same as I showed on the toxic duo of interferon/RIbavirin.

Now, I am having to jump ahead as can not wait for 5816 or Daclatasvir and also I am now hearing that "off label" (really not off label but not phase 3 FDA approved) prescribing was first getting approvals but - surprise- Now denials of co-administration of Sovaldi and (FDA-approved but not in combo I assume in spite of studies in EU) the other approved antiviral for Hep-C Telepravir ( think that is correct as its type 1 combo I focused less on it) are being denied as the cure rates are not above 90% but smell a rat in Ledepesvir (GS-5885).

Excuse me but ny genotype 3A cure rate on Sovaldii/Ribavirin for 24 (toxic) weeks is between 63% and 90% depending whose study one believes.
So how did I get approved? Luck? Patriotism for American mfg? Lol! - Or. Not possible our fully funded by Big Pharmaceutical cos. - FDA - is _not_ getting wheels greased by lobbyists from less wealthy pharmaceutical makers?
Hard to get how a 99% cure in phase 2 of Sovaldii/Daclatasvir (Bristol Myers Squibb)
So, common sense would indicate that just as EU is reviewing compassionate access to precisely this combination that the USA is not doing a thing as people are dying for a cure(as you and I nearly have) So- I fear that what you suggest of Sovaldii and Daclatasvir could be denied "off label" approval w/o risk of legal repercussions to insurers given that the two expensive meds that work better than any phase 3 combo trial to date across GTs 1-6 is STILL clearly ino guarantee of getting out to those in dire need- given the greed we see in pricing at $1000/day for one's primary medication leaves little money for a second agent. My guess is we in USA will see Sovaldi/GS-5816 a lot sooner than we see Daclatasvir/Sovaldi since phase 3 never occurred. Shame on the F:DA the AMA and every liver Medical Doctor who did not put out a statement as the one brave Medical Doctor from Baltimore did!

Finally, noticed 4 days in that prescribing info failed to list Sovaldi is lowered in therapeutic dosing if used with common fatigue med Modafanil(Provigil) and assume Nuvigil as it's an isomer of Modafanil (same molecule mirror image).
Also they incorrectly cite that Raltegravir (Isentress)- an HIV med, can be safely co administered however list daily dose as 400 mg daily while any Medical Doctor knows the dose of Raltegravir us 400 mg twice daily!
The absolute lackadaisical attitude of the marketing arm and patient info packets is appalling and Inhave already informed Sovaldi makers yet not one thing changed and patient info indicates no problems taking modafanil with Sovaldi- one needs to find the Sovaldi "Monograph" for this buried info and thank god I stumbled upon it( well Dug deep actually as co admin is a big deal for nany of us been screwed before by lack of diligence by pharma. Cos.
Regards,
Brian-
P.S. Hope this reaches hep mag folks as they sent off the VP of sales in POZ mag with a special article( like a VP of sales is a relevant event to patients?) Seems even our advocacy journals are bowing to the donations of big money? Hope not !

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This page contains a single entry by Margaret Dudley published on December 9, 2013 10:13 AM.

Good News for World Hepatitis Day was the previous entry in this blog.

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