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Author Topic: Vosevi for Gt 3 failures  (Read 13322 times)

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Offline Coach

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Vosevi for Gt 3 failures
« on: August 07, 2017, 01:27:22 PM »
I took Solvaldi/Rib and relapsed. Vosevi was recently approved by FDA. Has anyone started it or have knowledge of when it will become available??

Offline gnatcatcher

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Re: Vosevi for Gt 3 failures
« Reply #1 on: August 07, 2017, 08:27:16 PM »
Hi, Coach. Gilead is free to sell it, given that the FDA approved it on July 18: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567467.htm  The question is how quickly insurance companies will cover it. If yours isn't geared up to approve it, you might contact Gilead to see if Gilead will cover nearly all of the cost in your case. Gilead did just that for a lot of us soon after Harvoni was approved, probably to expedite building up market share.

I searched this site and didn't find anyone on Vosevi, but see this post by Gaj:
https://forums.hepmag.com/index.php?topic=5005.msg50990#msg50990

Good luck!

Gnatty
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 9.4 kPa [F2-F3]
ALT 15
AST 20
ALP 85

Offline Coach

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Re: Vosevi for Gt 3 failures
« Reply #2 on: August 08, 2017, 10:44:51 PM »
Thanks Gnatty.

Offline Coach

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Re: Vosevi for Gt 3 failures
« Reply #3 on: August 27, 2017, 04:28:55 PM »
The Vosevi was surprisingly easy to obtain. It is not yet listed as a specialty drug and I didn't need prior approval from the insurance company. Will be starting next week.

Offline gnatcatcher

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Re: Vosevi for Gt 3 failures
« Reply #4 on: August 27, 2017, 04:44:03 PM »
Amazing! Every good wish to you.

Gnatty
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 9.4 kPa [F2-F3]
ALT 15
AST 20
ALP 85

Offline Lynn K

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Re: Vosevi for Gt 3 failures
« Reply #5 on: August 28, 2017, 05:09:21 AM »
Alright Coach!

Congrats on getting treatment and good luck
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 lporterrn

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Re: Vosevi for Gt 3 failures
« Reply #6 on: August 28, 2017, 01:03:09 PM »
Hope you will be posting your experiences. I am very curious about Vosevi (and Mavyret). May you breeze your way to health and freedom.
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
http://blogs.hepmag.com/lucindakporter/

Offline Coach

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Re: Vosevi for Gt 3 failures
« Reply #7 on: August 28, 2017, 05:41:44 PM »
Thanks Lucinda, I'll keep everyone updated.

Offline Coach

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Re: Vosevi for Gt 3 failures
« Reply #8 on: September 06, 2017, 09:33:50 AM »
Started the Vosevi this past weekend. My base numbers .  HCV 329,600. HCV RT PCR 5.518 (not sure what this is) AST 33 and ALT 54. So far no sides.

Offline gnatcatcher

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Re: Vosevi for Gt 3 failures
« Reply #9 on: September 06, 2017, 01:28:35 PM »
The 5.518 is just the 329,600 stated as a logarithm (base 10) for the convenience of doctors. Glad you're doing well.

Gnatty
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 9.4 kPa [F2-F3]
ALT 15
AST 20
ALP 85

Offline Coach

  • Member
  • Posts: 64
Re: Vosevi for Gt 3 failures
« Reply #10 on: September 25, 2017, 04:33:58 PM »
Into my 4th week of Vosevi and I am feeling great .. No side effects. Soo much better then the SOl/ Ribavarin which I had previously. My first blood work came back with Less then 15 viral count , which isn't undetectable but is way down from 329000 which was my base. it was a RNA quantative test so wondering what less then 15 means. ?? Also is this the more accurate test??

Offline gnatcatcher

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Re: Vosevi for Gt 3 failures
« Reply #11 on: September 25, 2017, 05:57:57 PM »
Yes the RNA quantitative test is the best one to determine viral load. The <15 is the sensitivity of that test: if it detects 15 or more international units per ML of blood, it gives an actual number (like the 329,600 you had before treatment). Otherwise,
either
1. If it can't find any at all, the <15 sensitivity will be mentioned in the result, but it'll also say NOT DETECTED (or UNDETECTED or some such term).
or
2. If it finds some hep C, but less than 15 IU/ML, it'll show the <15 without any mention of undetected.

Either way, you are doing just fine. Your viral load is way down after three weeks or less of Vosevi. Glad you continue to feel great on treatment.
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 9.4 kPa [F2-F3]
ALT 15
AST 20
ALP 85

Offline lporterrn

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  • LucindaPorterRN
    • LucindaPorterRN
Re: Vosevi for Gt 3 failures
« Reply #12 on: September 26, 2017, 03:45:42 PM »
That is wonderful!!!!!!!! Especially the ease of it.
One thing, some labs will state a result as <15 and leave off the word nondetectable or undetected, so if that word is missing, it doesn't necessarily mean that they found something in the low range. As Gnatty said, it is good news.
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
http://blogs.hepmag.com/lucindakporter/

Offline Coach

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Re: Vosevi for Gt 3 failures
« Reply #13 on: October 02, 2017, 04:19:05 PM »
Just started my 5th week of Vosevi , feeling really well . The only thing I need to do is drink plenty of water. Also got a letter from CVS specialty saying I have to go thru them for the rest of my script. I have to get one more months worth, so hopefully this is not a problem. Going for my 4 week BW tomorrow.

Offline gnatcatcher

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Re: Vosevi for Gt 3 failures
« Reply #14 on: October 02, 2017, 05:32:43 PM »
Coach, glad you continue to feel really well. CVS specialty pharmacy supplied all three of my Harvoni bottles. The CNP supervising my treatment said to place each order as much ahead of time as CVS specialty pharmacy allowed, which worked out fine. Because it was summer, for bottles 2 and 3 I asked for (and got) ice packs, and CVS decided to use overnight shipping, so they came in plenty of time.
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 9.4 kPa [F2-F3]
ALT 15
AST 20
ALP 85

Offline Coach

  • Member
  • Posts: 64
Re: Vosevi for Gt 3 failures
« Reply #15 on: October 06, 2017, 09:49:07 AM »
Got back the BW for 4 weeks on Vosevi and I am cautiously optimistic ..(since I have been down this road before) . The Virus is now UNdetected. My AST-23, ALT-27. The only thing my Doc was a little concerned about was my Hemoglobin was 17.5 and Hematocrit 51.9 both slightly high. Not sure if this is related to meds or not. Doc said to contact my regular doc about this ?? Didn't seem worried. Still no sides, drinking plenty of water.. Feeling fortunate and lucky...

Offline gnatcatcher

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Re: Vosevi for Gt 3 failures
« Reply #16 on: October 06, 2017, 11:30:24 AM »
Yessssss! Rooting for it to stay undetected forever.

If your regular doc is like mine, he won't be concerned about "slightly high." (My hemoglobin and hematocrit have sometimes been a little high.)
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 9.4 kPa [F2-F3]
ALT 15
AST 20
ALP 85

Offline lporterrn

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  • LucindaPorterRN
    • LucindaPorterRN
Re: Vosevi for Gt 3 failures
« Reply #17 on: October 06, 2017, 01:03:28 PM »
This is news that is cause for alcohol-free celebration!!!!!!!
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
http://blogs.hepmag.com/lucindakporter/

Offline Coach

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Re: Vosevi for Gt 3 failures
« Reply #18 on: November 01, 2017, 03:46:50 PM »
 The 8 week BW is in and everything is excellent AST 20 ALT 21. Feeling a little more tired during the day and a  occasional mild headache in the afternoon, but a quick nap and an advil take care of it. Will be finishing up the meds on thanksgiving.

Offline gnatcatcher

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Re: Vosevi for Gt 3 failures
« Reply #19 on: November 01, 2017, 05:09:17 PM »
Great news, Coach -- looks like you'll have a very happy thanksgiving!
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 9.4 kPa [F2-F3]
ALT 15
AST 20
ALP 85

Offline lporterrn

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  • Posts: 1,828
  • LucindaPorterRN
    • LucindaPorterRN
Re: Vosevi for Gt 3 failures
« Reply #20 on: November 06, 2017, 12:28:57 PM »
Fantastic news, and thanks for sharing your experience. That will be one heck of a Thanksgiving celebration.
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
http://blogs.hepmag.com/lucindakporter/

Offline Lynn K

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  • Get tested, get treated, get cured, fight Hep c!
Re: Vosevi for Gt 3 failures
« Reply #21 on: November 07, 2017, 02:32:27 AM »
Great news coach

Rooting for great results for you!
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 Coach

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  • Posts: 64
Re: Vosevi for Gt 3 failures
« Reply #22 on: November 07, 2017, 08:05:54 AM »
  Thanks Everyone for all the support.

Offline Coach

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Re: Vosevi for Gt 3 failures
« Reply #23 on: November 17, 2017, 11:17:26 AM »
I am finishing up the Vosevi this week. BW will be done on 11/27 , then I  will be hoping for positive news over the next months/years / life... During my failed tx with sol/rib I continued my daily milk thistle 2000 mg and a Green Max powder. This time during Vosevi tx  I did not take either one. I read somewhere that the MT protects the liver and might also protect it from the Vosevi?? Wondering about peoples thoughts on this and also if I am cured continuing to restart  the MT. I don't think it can hurt in anyway and I do believe it has helped in the past.?????

Offline Lynn K

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Re: Vosevi for Gt 3 failures
« Reply #24 on: November 17, 2017, 01:51:20 PM »
I don’t think milk thistle effected your treatment I believe because these meds are so new and they cannot know all possible interactions or interactions and because success is so important my thinking is just not to take anything you don’t have to.

I know when I failed treatment with Sovaldi and Olysio I wondered if I did anything to contribute to that failure but eventually decided I just had tough bugs.

I do not really subscribe to the effectiveness of milk thistle. I haven’t seen any solid evidence of effectiveness. I took milk thistle but my liver disease nonetheless continued to progress. So if you want to take milk thistle that is your decision of course. I believe it is neither helpful or harmful except for he money spent buying it making your wallet a bit lighter.

Wishing you all the best on your upcoming test results and finally being cured
« Last Edit: November 17, 2017, 03:18:32 PM by Lynn K »
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 Coach

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Re: Vosevi for Gt 3 failures
« Reply #25 on: December 03, 2017, 10:09:48 AM »
  Finished up vosevi tx last week. BW results came back with excellent news undetected and all #s are where a healthy person should be.. Going back in 4 weeks to do more BW and hoping the undetected remains. Does anyone know how long the vosevi remains in the system. I feel great no longer dehydrated.

Offline Lynn K

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Re: Vosevi for Gt 3 failures
« Reply #26 on: December 03, 2017, 04:26:37 PM »
About 5 half lives is standard for most medicines. A half-life is 1/2 of one dosing period so if you take a medicine daily a half-life is 12 hours. Then 5 half lives would be 60 hours or about 2 and a half days until all of a medication is gone from your system.

If the dosing period for a medicine is more often then the 5 half-lives would be proportionally reduced as well. So if you were taking a medicine every 4 hours then the time until it is gone from your system would be just 10 hours after your last dose.

If a chemical likes to store in fat cells like THC in marijuana for example then it takes longer. But this is not the case for the DAA’s they are excreted readily through urine and feces.
« Last Edit: December 03, 2017, 04:31:43 PM by Lynn K »
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 Coach

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Re: Vosevi for Gt 3 failures
« Reply #27 on: December 03, 2017, 04:48:21 PM »
Thank You.

Offline gnatcatcher

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Re: Vosevi for Gt 3 failures
« Reply #28 on: December 03, 2017, 05:28:20 PM »
Coach, congratulations!
The specific half lives for the three medicines in Vosevi are shown here:
https://reference.medscape.com/drug/vosevi-sofosbuvir-velpatasvir-voxilaprevir-1000176#10
(The longest half life of the three is 33 hours.)
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 9.4 kPa [F2-F3]
ALT 15
AST 20
ALP 85

Offline Lynn K

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  • Get tested, get treated, get cured, fight Hep c!
Re: Vosevi for Gt 3 failures
« Reply #29 on: December 03, 2017, 06:13:59 PM »
So by my 5 half-lives rule of thumb about 3.5 days to have excreted the meds from your system.
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 Gaj

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  • Posts: 167
  • Optimist
Re: Vosevi for Gt 3 failures
« Reply #30 on: December 03, 2017, 09:52:23 PM »
Hi Coach,

Congratulations on completing your Vosevi treatment.   :)

To add a little “rough science”, the half life effect is complicated due to the drugs involved all being dosed every 24 hours and the minimum half life being 17 hours for Velpatasvir. This means there will have been some gradual build up of all three (to differing levels) over the course of tx.

Here is a rough calculation for Voxilaprevir which at 33 hrs half life is the longest and slowest to clear.

Half Life Voxilaprevir

EOT+     Level
33hr =    50%
66hr =    25%
99hr =    12.5%
132hr =   6.25%
165hr =   3.125% ~ 1 week
198hr =   1.6%
231hr =   0.8% = ~10 days

As you can see, after ~ 10 days the Voxilaprevir level will be down from EOT to less than 1%. (Sofosbuvir will be a little quicker and Velpatasvir will be down to less than 0.5% at that stage.)

So by the end of week 1 EOT the levels will be fairly low and after 2 weeks gone other than extremely small traces. This matches with my own experiences and those of other patients I have discussed this with, that being noticeable difference after one week and ‘back to normal’ after two.

Best wishes

Male - 61 years
Genotype 3a (since 1978?)
Diagnosed 2012
Treated 2013 PEG/Riba/Dac (Relapsed)
F4 - HCC#1 Resected 06/15 - #2 RFAblated 11/15
11/18/15 Commenced Generic Tx - Sof/Dac/Riba (24wks)
Pre Tx = ALT: 270  AST: 209  ALB: 31
05/05/16 = ALT: 34  AST: 32  ALB: 40  VL: Undetected (EOT)
06/16/16 = Relapsed
06/23/16 = ALT: 92  AST: 59  ALB: 40  VL: 290,770
01/12/17 3rd Tx - Zepatier + Sofosbuvir (16wks)
05/03/17 EOT und
06/22/17 SVR7 und
07/27/17 SVR12 UND!
10/26/17 SVR24 UND & Cured!!!

Offline Lynn K

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Re: Vosevi for Gt 3 failures
« Reply #31 on: December 03, 2017, 10:16:38 PM »
Yeah mine is just a tool for rough estimation. After 3.5 days you are approaching 12.5% so not a whole lot of drug left.

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 lporterrn

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Re: Vosevi for Gt 3 failures
« Reply #32 on: December 04, 2017, 03:05:15 PM »
Wonderful news Coach - thank you for sharing this with us. Waiting with you for the final results.
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
http://blogs.hepmag.com/lucindakporter/

 


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