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Author Topic: Sovaldi a little dissapointed.  (Read 5147 times)

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Offline 4wandering

  • Newbie
  • Posts: 2
Sovaldi a little dissapointed.
« on: May 12, 2015, 03:35:11 pm »
I've had three rounds of various versions of Peg and riba that have initially beat back the virus only to have it reappear months later.

The last time at the docs office he sold me on the efficacy of treatment with Sovaldi and riba for 24 weeks. He told me 95% cure rate so I opted in. The insurance company stepped up to the plate and paid for everything except a $5 copay. What a blessing.

So in doing further research I come upon Gilead's statistics on cure rates.

Apparently someone with genotype 3 that has treatment experience and is already cirrhotic and or has fibrosis (don't know the difference) has only a 60% cure rate.

Very depressing news, and right from Gilead's website.

Am I missing something here or is this a play to enrich both Gilead and the Dr. At 60% I don't know that I would have opted in.

Thoughts??


Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,516
  • Get tested, get treated, get cured, fight Hep c!
Re: Sovaldi a little dissapointed.
« Reply #1 on: May 12, 2015, 04:00:20 pm »
For someone in your position it is the best game in town and 60% is better than no chance without treatment.

Back in the day I treats with interferon based 3 times and was a null responder every time my odds of a cure started at about 35% and went done from there every time. Last time my odds were 14% and they would not let me treat because I had cirrhosis. I even got a second opinion because I was desperate to be cured but they said no because I was too sick

You have cirrhosis you need to try
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline 4wandering

  • Newbie
  • Posts: 2
Re: Sovaldi a little dissapointed.
« Reply #2 on: May 12, 2015, 04:12:19 pm »
Lyn,

I get it and am grateful that I am in a position to be able to get something that might help.

I am a little upset with my Dr. for playing up the results.


Offline apache

  • Member
  • Posts: 52
Re: Sovaldi a little dissapointed.
« Reply #3 on: May 12, 2015, 06:24:45 pm »
Quote
I am a little upset with my Dr. for playing up the results.

It's been my experience that a lot of Dr's don't really know the statistics as well as many of those who are in this discussion forum.

The best source of info, as you have pointed out, is Gilead's trials.
For reference, the "short" version of those results (the 30 or so page detailed product insert) are here:

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

And the official full-length 200+ page version (with lots of interesting details) is here:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000MedR.pdf 

For example, the 200+ page version has (on page 75, table 32) a detailed breakdown of relapse rates (8 vs 12 wks) for fine granularity splits of viral load.

And on page 76 (Table 33) it breaks it down by race, sex, age, weight, Genotype, IL28B

And pages 81,82 (Fig 2 & 3) have a week-by-week graph of % of patients who achieve HCV RNA < LLOQ (ie, achieve undetectable status).    These last two graphs are the source of the "most people clear by Week 4" statement.  YMMV.

Good luck!

Offline dragonslayer

  • Member
  • Posts: 873
Re: Sovaldi a little dissapointed.
« Reply #4 on: May 12, 2015, 06:46:09 pm »
>>And pages 81,82 (Fig 2 & 3) have a week-by-week graph of % of patients who achieve HCV RNA < LLOQ (ie, achieve undetectable status).<<

Hi Apache.. I dont want to lead the dialog askew, but this statement begs the question, 'what is really meant by undetectable?'

The above section of the filing doesnt mention 'undetectable' at all.   It mentions HCV RNA < LLOQ, which for the trials, was a value less than 25.. 

Now, consider, that with many if not all of the tests,  the result can be < LLOQ Detected, or, < LLOQ Undetected....  For the Gilead trials, all we really know, so far as I can tell, is that success or svr was measured by viral quantification of < LLOQ(25).  Since I havent seen it written anywhere, it seems Gilead hasnt made this distinction.... Are we to assume that some results were < 25 Detected, and some were < 25 Undetected, and both were deemed SVR for these results tables?   The only assumption I can make is that, at 12 wks post treatment, being NOT considered SVR when results are < 25 Detected would be a bit of a logical impossibility... For the virus not to replicate beyond 25 IU/mL at 12 wks post treatment would for all intents  and purposes, mean the virus is impotent, and the patient is cured.

Sorry for getting off on a tangent,  but I think its important, because it does occasionally come up.

update:  I just found this Gilead definition of 'relapse' on page 59 of the filing doc:

"Relapse:
– HCV RNA ≥LLOQ during the post-treatment period having achieved HCV
RNA <LLOQ at the last observed on-treatment HCV RNA measurement,
confirmed with consecutive values or last available post-treatment
measurement"

Notice they dont define it in terms of going from HCV RNA < LLOQ Undetected to HCV RNA < LLOQ Detected!
« Last Edit: May 12, 2015, 06:59:04 pm by dragonslayer »
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

 


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