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Author Topic: After tx (POST) 4wk or 12 wk SVR results (Harvoni only) - CHECK IN HERE PLEASE!  (Read 757539 times)

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Offline charly8

  • Member
  • Posts: 113
Now that a lot of people are coming off treatment, we need a tally of peoples status.

NOTE: Please post only if you have results from post EOT tests SVR 4wk thru SVR 12wk after EOT. 

Please list only SVR4 or SVR 12 status.  No results on tx or at EOT because most are undetected then anyways.

Please list the following: (copy and paste into your post as I have done below to keep this thread clean)
1. 4wk - 12 wk EOT VL status
2. Treatment duration
3. tx naive or experienced
4. Genotype (1a or 1b)
5. F1-F4 fibrosis status (date)
6. Initial VL (date)

Current Status
So far we have 15 people that hit at least the SVR4 mark.  3 of 15 have relapsed.  (20%)

Breakdown by treatments
8 weeks of tx - 2 of 3 have relapsed
12 weeks of tx- 1 of 12 have relapsed

Note:  We currently have a 20% relapse rate.  This is with very limited data and certainly not scientific.   Even still this does not seem to correspond to the 95% SVR rate that Gilead has boasted in their studies.  Lets hope we get some more SVR'S
« Last Edit: April 29, 2015, 07:18:09 pm by charly8 »
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline chaser

  • Member
  • Posts: 17
  • We are all damaged in our own exquisite way, no?
Re: 4wk EOT or 12 wk EOT results (Harvoni) - CHECK IN HERE PLEASE!
« Reply #1 on: April 29, 2015, 12:17:57 pm »
8 weeks of Harvoni. Undetected at 4 and 8 weeks. Treatment naive. Genotype 1a. No fibrosis. Initial viral load 3.5 million. I am now waiting 3 months for first post treatment blood work. So far, so good. Good luck to all.   

Offline charly8

  • Member
  • Posts: 113
Re: 4wk EOT or 12 wk EOT results (Harvoni) - CHECK IN HERE PLEASE!
« Reply #2 on: April 29, 2015, 12:25:45 pm »
I am going to start with what people have posted on this board already.

Paleface
1. 12 wk post EOT VL status - Undetected
2. Treatment duration - 12 weeks
3. tx naive or experienced - TX experienced
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - F1-F2
6. Initial VL (date) - 5.7 mil

JillLynn
1. 12 wk post EOT VL status - Undetected
2. Treatment duration - 12 wks
3. tx naive or experienced - Tx experienced
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - F2
6. Initial VL (date) - 1.5 mil

Lukey
1. 6 wk psot EOT VL status - Detected VL of 782,040 (Relapse)
2. Treatment duration - 8 wks
3. tx naive or experienced - Tx naive
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - Unknown
6. Initial VL (date) - 5.7 mil

PaulG
1. 12 wk post EOT VL status - Detected (Relapse)
2. Treatment duration - 8 wks
3. tx naive or experienced - Tx naive
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - Unknown (F3 12 years ago)
6. Initial VL (date) - 2.5 mil

Dragonslayer
1. 11 wk post EOT VL status - Undetected
2. Treatment duration - 8 wks
3. tx naive or experienced - Tx naive
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - F0-F1 (2013)
6. Initial VL (date) - 2.4 mil

Mm
1. 4 wk Post EOT VL status - Undetected
2. Treatment duration - 12 wks
3. tx naive or experienced - Tx experienced
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - F2-F3
6. Initial VL (date) - 6 mil

Nicole_1234
1. 6 wk Post EOT VL status - Undetected
2. Treatment duration - 12 wks
3. tx naive or experienced - Tx experienced
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - unknown
6. Initial VL (date) - 0.65 mil

Mikee
1. 8 wk Post EOT VL status - Undetected
2. Treatment duration - 12 wks
3. tx naive or experienced - unknown
4. Genotype (1a or 1b) - unknown
5. F1-F4 fibrosis status (date) - unknown
6. Initial VL (date) - unknown

Kate0b1
1. 4 wk Post EOT VL status - Undetected
2. Treatment duration - 12 wks
3. tx naive or experienced - tx experienced
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - unknown
6. Initial VL (date) - unknown

Katie
1. 8 wk Post EOT VL status - Undetected
2. Treatment duration - 12 wks
3. tx naive or experienced - tx naive
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - no cirrhosis
6. Initial VL (date) - 2.6 mil

Islandgirl
1. 4 wk Post EOT VL status - Undetected
2. Treatment duration - 12 wks
3. tx naive or experienced - tx naive
4. Genotype (1a or 1b) - 1b
5. F1-F4 fibrosis status (date) - unknown
6. Initial VL (date) - unknown

JoeK9999
1. 12 wk Post EOT VL status - Undetected
2. Treatment duration - 12 wks
3. tx naive or experienced - tx naive
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - F0-F1 (2012)
6. Initial VL (date) - 3.8 mil

Long_Haul
1. 4 wk Post EOT VL status - Undetected
2. Treatment duration - 12 wks
3. tx naive or experienced - tx experienced
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - F4 (2000)
6. Initial VL (date) - NA

terih
1. 3 wk Post EOT VL status - Detected 414,111 - (Relapse)
2. Treatment duration - 12 wks
3. tx naive or experienced - tx naive
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - F2-F3 (11/2014)
6. Initial VL (date) - 2.56 mil (11/2014)

marv777
1. 12 wk Post EOT VL status - Undetected
2. Treatment duration - 12 wks
3. tx naive or experienced - tx experienced
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - F1
6. Initial VL (date) - 6 mil

« Last Edit: April 30, 2015, 08:52:02 am by charly8 »
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline charly8

  • Member
  • Posts: 113
Re: 4wk EOT or 12 wk EOT results (Harvoni) - CHECK IN HERE PLEASE!
« Reply #3 on: April 29, 2015, 12:27:33 pm »
8 weeks of Harvoni. Undetected at 4 and 8 weeks. Treatment naive. Genotype 1a. No fibrosis. Initial viral load 3.5 million. I am now waiting 3 months for first post treatment blood work. So far, so good. Good luck to all.   

Please only post EOT 4 week or 12 week AFTER EOT results, because most 99% of people go undetected while on treatment.

Thanks!
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline charly8

  • Member
  • Posts: 113
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline terih

  • Member
  • Posts: 74
Well this is as good a place as any to throw my hat in the ring! I've known for quite a while that I relapsed, but didn't want it to be my first post here and didn't want to be the first to post about a relapse! So here goes! Teri

1. 12 week treatment Harvoni
2. Treatment naive
3. Genotype 1a
4. Fibrosis F2-F3  Nov. 2014
5. Last pill Feb. 3rd, 3 wks. post treatment viral load 414,111
6. Initial viral load 2.56 million  Nov. 2014

I seriously doubt I got those in the proper order, sorry! I have an appointment with the Texas Liver Institute next month, I guess one of the Doctors there just spoke at the Liver Conference, so I feel like I've hit the Big Time!  ;)
I am holding out great hope for everyone here and wish every one of you the best!

64 yrs. on this fine planet!
diagnosed 1993
Stage 1 cirrhosis
Genotype 1a
12 wks. Harvoni  Relapse late Feb. 2015
Currently treating with Solvaldi/Olysio
The light at the end of the tunnel, is often not a train!

Offline Cally Balmoral

  • Member
  • Posts: 27
Now that a lot of people are coming off treatment, we need a tally of peoples status.

NOTE: Please post only if you have results from post EOT tests SVR 4wk Thur SVR 12wk after EOT. 

Please list only SVR4 or SVR 12 status.  No results on tx or at EOT because most are undetected then anyways.


1. EOT  8+ weeks
2. TX 12weeks
3. tx experienced
4. Genotype (1a or 1b)
5. none
6. undetected

 
Cally

Offline dragonslayer

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  • Posts: 873
Charly,

Awesome Job compiling this data!
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

Offline marv777

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  • Posts: 3
Hello all, just received my 12 week EOT and came back undetected and all other numbers are great. I am a two time non responder, did mono therapy in 2000 and then in 2004 did peg- intro and ribavarin and had to stop tx at 48 weeks due to side effects. Started Harvoni on Nov. 5th and finished on Jan. 28 th. Vitals, 1a, F- 1, 6 mill. viral load at start of tx. Did 12 week tx and was undetected at 4 and 12 week tests. I am now free at last of this dreaded disease.

Offline kate0b1

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  • Posts: 293
1. 4wk post EOT UND (12 week test june 5th)
2. 12 weeks
3. experienced (triple therapy)
4. Genotype 1a
6. last test was from relapse 100,000

kate

Offline Mm

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  • Posts: 10
Thank you Charly!  This is a wonderful resource. My missing information is that I was F2-F3.  I will post all the info next month as you suggested.
Mm 

Offline Katie

  • Member
  • Posts: 784
Thanks for doing this Charly.  This is really good information!  For the newbies, I do think the EOT test results would be beneficial so they can see that strong responders who test Detected can still clear.  This is something where Harvoni is different than the previous treatments and is a new finding just recently published.  My doctor wasn't even aware of it.  It sure would have helped me out when I got my EOT results as DETECTED.  It could be they will start to eliminate EOT tests altogether, but I don't think that is the case at this time.

Just my opinion and thanks again for taking the time doing this!

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline Katie

  • Member
  • Posts: 784
Double posted ???
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline apache

  • Member
  • Posts: 52
Quote
Thank you Charly!  This is a wonderful resource.

Indeed.  Very nice compilation.  Thanks!

Offline mario555

  • Member
  • Posts: 226
Charly. Thank you for doing this. It is very appreciated!
60 years old. Likely infected 1975. Geno 1a
F4  8 millions VL,  AST 140  ALT 140
Generally in good health except problems are creeping up rapidly!
2 failed attempts Inf 2000 and Inf-riba 2010
Harvoni 24 weeks
Start 11/13/2014   EOT 4/27/2015
VL2 - UND
VL4 - UND (may 25)
VL12 - UND
VK24 -  UND
Hopefully cured forever!

Offline Jjules224

  • Member
  • Posts: 10
Thanks for gathering this info-- I am self pay and took all the equity out of my house to make sure I could  get "cured"    Only on day 17 but this could change my mind on filling the prescription … 35,000 for each upcoming  month (2 and 3 )  .    :(
1970s - Contracted HCV
1985 -  Diagnosed non A nonB 
1992 -  DX Hep C (Genotype 1a)
viral load 11,000,000
Started Harvoni April 13
( turned down 3 times by insurance-  gutted the equity in my house so I am self pay)   

Happy to meet other folks going through the same journey…. tired of the shame and the disease,

Offline Katie

  • Member
  • Posts: 784
Thanks for gathering this info-- I am self pay and took all the equity out of my house to make sure I could  get "cured"    Only on day 17 but this could change my mind on filling the prescription … 35,000 for each upcoming  month (2 and 3 )  .    :(

Considering GT 1a had a very low cure rate and horrible treatment in the past, Harvoni is a major breakthrough and is working wonders.  Keep in mind, very few people are 8 -12-24 weeks post treatment so the data isn't in.

Have you called Gilead to see if they could assist you with the cost.  It seems they are helping many without insurance coverage.

Good luck to you, no matter what your decision.  We all have to do what is best for us, but please consider the alternative of severe liver disease.  Give Gilead a call!

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline Lynn K

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  • Member
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  • Get tested, get treated, get cured, fight Hep c!
Giliead has a max household income cap of $100,000.00/year. When I was having difficulty being approved by my insurance I called and asked.

Jjules please stay the course you don't want to miss this train.
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 charly8

  • Member
  • Posts: 113
I am surprised that nobody has posted results in almost a week!  I thought a lot of people came off treatmetn mid to late march.
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline Lynn K

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  • Member
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  • Get tested, get treated, get cured, fight Hep c!
I am done with my 24 weeks today I will get back to you after I get my week 4 and week 12 post treatment viral loads.

Anybody else with results to report?
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 Katie

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  • Posts: 784
There are probably quite a few just waiting for post treatment tests, and then there are those who once finished will just drop off the forum.  It might be good to post on other threads to let them know this survey is being done.  I happened upon it accidentally.  It can be difficult to find a new thread.

Congratulations Lynn!!!  We will all be waiting with you and sending good wishes for a complete cure!

Katie
« Last Edit: May 04, 2015, 07:10:46 pm by Katie »
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline mario555

  • Member
  • Posts: 226
Good luck Lynn K. We'll be riding the 12 weeks wait together I guess?
My doctor just called me and wanted to have a VL done asap. I wonder why because if I was UND after 4 weeks, why would he expect anything else than UND at EOT? I only had one VL at week 4 during the last 24 weeks. As much as I know, you don't go back up once you clear the virus? Anyway, I'll post again with my results later on..
60 years old. Likely infected 1975. Geno 1a
F4  8 millions VL,  AST 140  ALT 140
Generally in good health except problems are creeping up rapidly!
2 failed attempts Inf 2000 and Inf-riba 2010
Harvoni 24 weeks
Start 11/13/2014   EOT 4/27/2015
VL2 - UND
VL4 - UND (may 25)
VL12 - UND
VK24 -  UND
Hopefully cured forever!

Offline Lynn K

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  • Get tested, get treated, get cured, fight Hep c!
Thanks for your well wishes I guess I can officially board the waiting train.

I am going to ask about getting a 4 week test since it is said to be about 98.5% probable SVR by then. And the the wait for the big 12 week test.

Mario I wouldn't worry too much he is probably just getting data they just want to see the EOT test. I wanted to trade the EOT for a 4 week post and they said we will just do both
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 charly8

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  • Posts: 113
PAPPY
1. 12 wk post EOT VL status - Detected VL 7867179 (Relapse)
2. Treatment duration - 8 wks
3. tx naive or experienced - Unknown
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - Unknown
6. Initial VL (date) - Unkown
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline charly8

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  • Posts: 113
I cant modify my posts, but here is the current status:

Current Status
So far we have 16 people that hit at least the SVR4 mark.  4 of 16 have relapsed.  (25%)

Breakdown by treatments
8 weeks of tx - 3 of 4 have relapsed
12 weeks of tx- 1 of 12 have relapsed

Note:  We currently have a 25% relapse rate.  This is with very limited data and certainly not scientific.   Even still this does not seem to correspond to the 95% SVR rate that Gilead has boasted in their studies.  Lets hope we get some more SVR'S.  We will need the next 64 people to report Undetected to get back to 95% SVR rates.
« Last Edit: May 05, 2015, 07:44:45 am by charly8 »
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline mario555

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  • Posts: 226
These results strengthen my opinion that 8 weeks should be offered only in limited cases and not arbitrarily or following a strict set of rules. I really am sorry to hear the bad news for those 4 relapses.
Thanks to Charly8, we all appreciate the work you are doing for our benefit!
60 years old. Likely infected 1975. Geno 1a
F4  8 millions VL,  AST 140  ALT 140
Generally in good health except problems are creeping up rapidly!
2 failed attempts Inf 2000 and Inf-riba 2010
Harvoni 24 weeks
Start 11/13/2014   EOT 4/27/2015
VL2 - UND
VL4 - UND (may 25)
VL12 - UND
VK24 -  UND
Hopefully cured forever!

Offline kate0b1

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  • Posts: 293
+ 1 thanks for doing this, its good info to know going forward since we are the real test
people

kate

Offline mario555

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  • Posts: 226
After 24 weeks treatment, I still have light upper quadrant pain so I don't think it's virus related given the fact I had cleared the virus after 4 weeks! I also still have tinnitus and a kind of vertigo. One good news is that 1 week after the end of my treatment, I am starting to feel like my old self (get up and go, mood, etc). I am now watching the group to see how things are working out for everyone. Thanks again Charly for your implication. We all appreciate it (even my doctor)!
60 years old. Likely infected 1975. Geno 1a
F4  8 millions VL,  AST 140  ALT 140
Generally in good health except problems are creeping up rapidly!
2 failed attempts Inf 2000 and Inf-riba 2010
Harvoni 24 weeks
Start 11/13/2014   EOT 4/27/2015
VL2 - UND
VL4 - UND (may 25)
VL12 - UND
VK24 -  UND
Hopefully cured forever!

Offline dragonslayer

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  • Posts: 873
Cmon all you 8-weekers.  Give us some good SVR4 and later results!  We cant let this 75% 8 wk failure stat stand...   Im sure as more 8 weekers complete treatment,  those failure stats will go WAY down.. They'd better!!!!!  I hope that some national level relapse data comes out soon so we can get a true picture of whats happening with Harvoni in the real world.
« Last Edit: May 05, 2015, 01:35:33 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

Offline terih

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  • Posts: 74
Hi Charly, I just wanted to weigh in, after seeing my new Doc, who from here on out will be referred to as Dr. Awesome! He doesn't think that my treatment period was long enough, he doesn't think prior Doc made a proper assessment! I thought I had a fibroscan, I didn't, had some kind of weird ultrasound! No IL28B testing! Since I have a fatty liver and weigh more than I should, he would have done 24 wks. So there's that! Sounds more like Doctor failure to me than medication failure! I should be in their DAA failure study in August! So good news!
And yes, thank you for doing this!
« Last Edit: May 05, 2015, 07:28:30 pm by terih »
64 yrs. on this fine planet!
diagnosed 1993
Stage 1 cirrhosis
Genotype 1a
12 wks. Harvoni  Relapse late Feb. 2015
Currently treating with Solvaldi/Olysio
The light at the end of the tunnel, is often not a train!

Offline dragonslayer

  • Member
  • Posts: 873
Hi Charly, I just wanted to weigh in, after seeing my new Doc, who from here on out will be referred to as Dr. Awesome! He doesn't think that my treatment period was long enough, he doesn't think prior Doc made a proper assessment! I thought I had a fibroscan, I didn't, had some kind of weird ultrasound! No IL28B testing! Since I have a fatty liver and weigh more than I should, he would have done 24 wks. So there's that! Sounds more like Doctor failure to me than medication failure! I should be in their DAA failure study in August! So good news!
And yes, thank you for doing this!

Before I commenced treatment, I asked my doctor if we needed to factor my unfavorable IL28B status, and he told me they dont check that in conjunction with Harvoni.. Apparently, its correlation is statistically insignificant.
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

Offline Lynn K

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  • Member
  • Posts: 4,546
  • Get tested, get treated, get cured, fight Hep c!
Are you sure it wasn't a fibroscan? That would be exactly how I would describe a fibroscan as a kind of weird ultrasound. With a thumping action. Otherwise I have no idea what test that would have been.

Have you see this info?

When a short course of sofosbuvir/ledipasvir fails, some people can be cured of hepatitis C with a double treatment duration

http://www.aidsmap.com/When-a-short-course-of-sofosbuvirledipasvir-fails-some-people-can-be-cured-of-hepatitis-C-with-a-double-treatment-duration/page/2965963/


Best to 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 terih

  • Member
  • Posts: 74
@ Dragonslayer, The reason the new Doc gave for having that test done, is that it measures how strong your immune system is, the stronger your immune system, the better your chance of SVR! Maybe since I have an auto immune illness, that factored into my relapse.

@ Lynn, That is one of the Docs where I'm doing my next treatment! They are HepC warriors! I really think my new Doc wants me on a newer and better combo, hence the trial in August. I truly feel like I have managed to stumble into something very good!  :)

I have no idea what the other test I had is called, but I have a scan coming up on June 1st, so I will let you know how they compare!
« Last Edit: May 06, 2015, 10:58:55 am by terih »
64 yrs. on this fine planet!
diagnosed 1993
Stage 1 cirrhosis
Genotype 1a
12 wks. Harvoni  Relapse late Feb. 2015
Currently treating with Solvaldi/Olysio
The light at the end of the tunnel, is often not a train!

Offline debham

  • Member
  • Posts: 68
Teri,
Good luck with the new Dr. I sure hope they find a solution for you.
Deb
Diagnosed 2003
VL 300,000
Geno type 1 a
Start TX 4/01/15
VL 2.3 million
Tx Naive
12 wk Tx
Harvoni
Last Ultra Sound
No presents of fibrosis

Offline terih

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  • Posts: 74
Deb, thank you so much! I feel like I'm in good hands finally and have much faith in my soon to be had SVR!

Good luck to you also, when is your SVR date?? I'll be here cheering you on!
64 yrs. on this fine planet!
diagnosed 1993
Stage 1 cirrhosis
Genotype 1a
12 wks. Harvoni  Relapse late Feb. 2015
Currently treating with Solvaldi/Olysio
The light at the end of the tunnel, is often not a train!

Offline mario555

  • Member
  • Posts: 226
Terih. I have read extensively on the development of cures and as much as I know, Harvoni doesn't really need your immune system to work contrary to the old Interferon which boosted your immune system in order to destroy the disease through you! Harvoni is more like a little glued cap that will attach itself to the virus 'legs'. When the little legs are capped, the virus can't grab itself to new liver cells and can't reproduce.
It is sure that if your immune system is compromised, other considerations might be assessed for your specific treatment. Good luck with your future treatment, my prayers are with you!
60 years old. Likely infected 1975. Geno 1a
F4  8 millions VL,  AST 140  ALT 140
Generally in good health except problems are creeping up rapidly!
2 failed attempts Inf 2000 and Inf-riba 2010
Harvoni 24 weeks
Start 11/13/2014   EOT 4/27/2015
VL2 - UND
VL4 - UND (may 25)
VL12 - UND
VK24 -  UND
Hopefully cured forever!

Offline terih

  • Member
  • Posts: 74
Hi Mario, Thanks for the info! I'm thinking, since I do have an autoimmune disease, it might have something to do with the big R! Who knows, all I know is they took 12 vials of blood to try and figure it out. And no cookie! Adulthood, pshaw!  ;D

Thank you so much for the good wishes, and know that I'm wishing the best for you also!
64 yrs. on this fine planet!
diagnosed 1993
Stage 1 cirrhosis
Genotype 1a
12 wks. Harvoni  Relapse late Feb. 2015
Currently treating with Solvaldi/Olysio
The light at the end of the tunnel, is often not a train!

Offline Cally Balmoral

  • Member
  • Posts: 27
Hi all.....I am 8 weeks post treatment with Harvoni and still am undetected.  Yea!  Thanks all for sharing.
Cally

Offline Johnny_Wayne

  • Member
  • Posts: 47
I also relapsed 12 week post treatment.

Treated for 12 weeks on Harvoni.
I have absolutely no idea how the relapse happened.
My other info is in the signature line.
This makes what? 4 relapses out of 16 folks treated? That's 25% I think.
« Last Edit: May 08, 2015, 01:36:19 pm by Johnny_Wayne »
Diagnosed 04/2014
Started Harvoni 10/2014
Undetectable 01/2015
Relapsed 04/2015
F4 Cirrhosis (Compensated - barely)
Child Pugh Score 6-7
MELD Score 10
Started Olysio/Sovaldi/Ribavirin (24 weeks)
EOT Not Detected 11/9/2016
--------------------------------
5-10-2017
Virus undetected SVR 24 Achieved
I AM FINALLY CURED!

Offline mario555

  • Member
  • Posts: 226
Cally. I'm really happy for you! Just wish I'll be able to say the same in 6 more weeks!!!
Johnny. Sorry for you. I think there are more than 4 out of 16.  We have one of us who keeps tabs on the rate of success. He should be doing new totals soon. I would think there are at least 6 on this forum that relapsed...
60 years old. Likely infected 1975. Geno 1a
F4  8 millions VL,  AST 140  ALT 140
Generally in good health except problems are creeping up rapidly!
2 failed attempts Inf 2000 and Inf-riba 2010
Harvoni 24 weeks
Start 11/13/2014   EOT 4/27/2015
VL2 - UND
VL4 - UND (may 25)
VL12 - UND
VK24 -  UND
Hopefully cured forever!

Offline Cally Balmoral

  • Member
  • Posts: 27
Sorry to hear that Johnny_Wayne.  What is your next step?  Did or do you have any of the post tx symptoms?  I hope you can stay positive tho I know that will be hard.  Cally
Cally

Offline Katie

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  • Posts: 784
Please keep in mind, not everyone is reporting and I am sure many who have completed the treatment, have just dropped out of the forum, especially if they are undetected.  The results are disappointing so far though so please spread the word to report to this thread.
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline Cally Balmoral

  • Member
  • Posts: 27
Thanks Mario555.....Cally
Cally

Offline JoeK9999

  • Member
  • Posts: 88
Thanks for the compilation.
« Last Edit: May 08, 2015, 03:11:25 pm by JoeK9999 »
Diagnosed July 1995 - Genotype 1a
Think I have I had since the early 70's
Prior to Harvoni treatment:
VL 3.8 million AST/ALT 40/56
Mild inflammation, no fibrosis
Treatment naive
 
Started Harvoni 10/23/2014 for 12 weeks
11/20/2014  HCV RNA Qual - Detected
Last Day of Harvoni 01/15/2015
04/08/15 - 12 week post harvoni VL test - Not Detected
07/05/15 - 24 week post harvoni VL test - Not Detected
01/19/16 - 1 Year  post harvoni VL test - Not Detected
AST/ALT 22/22
CURED!!

Offline cj

  • Member
  • Posts: 24
You can add mine in ..geno type 1a, vl 2.4 mil,, f0-f1 fibrosis, harvoni 12 wk , 17 days vl 72, finished april 7th..now need Dr for side effects ..low iron, high blood preasure, severy body aches what dont ache don't work and just top it off with 15 extra pounds ...yes I'm grateful. ..waiting 12wk eot


Offline BubbaT

  • Member
  • Posts: 267
Terih. I have read extensively on the development of cures and as much as I know, Harvoni doesn't really need your immune system to work contrary to the old Interferon which boosted your immune system in order to destroy the disease through you! Harvoni is more like a little glued cap that will attach itself to the virus 'legs'. When the little legs are capped, the virus can't grab itself to new liver cells and can't reproduce.
It is sure that if your immune system is compromised, other considerations might be assessed for your specific treatment. Good luck with your future treatment, my prayers are with you!

Mario, I have a comment about the immune system, it seems reasonable to assume ...

IF the  immune system was working as designed it would rid the hepc virus or any  Virus on its own, like some people are able to do without anti viral drugs..

So, with that logic, isn't it reasonable to assume the Immune system is not working to the full extent...
Or to put it another way, Is Compromised?
Age 57 male
Infected late 70's
Diagnosed 95
1a, 2 prev biopsy 95, 2004
Ct 2007, 2015
Treatment Naive
F4 A3. Fibrosure/ CT 2-5-15. Ammonia 222
VL 2.2 mil.
Started Harvoni  3-3-15. 12weeks, finished 5-26-15
4 week VL undetected
12 week EOT undetected

Offline mario555

  • Member
  • Posts: 226
I agree that most people clear the virus on their own when first infected. The ones not clearing it are often infected massively and the immune system is overwhelmed such as in a blood transfusion. Or in my case, repeated attacks through injections.
Even if your immune system was 100 times more powerful (interferon treatment), the virus attacks are too strong to be beat!
Harvoni doesn't use your immune system, it attacks the virus directly in screwing up its capacity to reproduce. This is why 2 DAA's (direct acting agent) are better than one because it 'hits' the virus two ways. With Inf-riba, you had only 1 DAA and it was "non-specific". With Harvoni, you have Sovaldi + Ledipasvir.
New novel ways to beat the virus are coming out using 3 DAA's or other ways. A wait of 1 extra year will offer many new ways to get rid of the virus. This is why I suggest to people who are less in a hurry to wait!
60 years old. Likely infected 1975. Geno 1a
F4  8 millions VL,  AST 140  ALT 140
Generally in good health except problems are creeping up rapidly!
2 failed attempts Inf 2000 and Inf-riba 2010
Harvoni 24 weeks
Start 11/13/2014   EOT 4/27/2015
VL2 - UND
VL4 - UND (may 25)
VL12 - UND
VK24 -  UND
Hopefully cured forever!

Offline terih

  • Member
  • Posts: 74
Good morning Mario, I've thought on this a lot, what came to me is this....You know how some people have a low viral load at end of treatment, and their immune system takes care of it, maybe mine just couldn't do that! That is what makes the most sense to me about why it is important to have a good immune system with these drugs. Maybe I'm wrong, what do you think? I do have an autoimmune disease, but never thought it would factor into this treatment. Hope you are doing well!
64 yrs. on this fine planet!
diagnosed 1993
Stage 1 cirrhosis
Genotype 1a
12 wks. Harvoni  Relapse late Feb. 2015
Currently treating with Solvaldi/Olysio
The light at the end of the tunnel, is often not a train!

Offline MEG

  • Member
  • Posts: 304
@Mario---thanks so much for that excellent explanation of how Harvoni works...although I don't have a compromised immune system, per se, I was sick with cold viruses/sinusitis for the entirety of my treatment. But the Harvoni got me undetected by week 4 of 12. Waiting EOT 4 weeks VL on the 18th.

It's this waiting period--while I"m still recovering from the colds that I'm most concerned. That my immune system is too busy fighting too many viruses---unless the Harvoni indeed killed every hcv.

Teri, my understanding about the people who are very low detected at EOT have so called impotent viruses. Fragments of hcv that are unable to replicate but the machine picks them up anyway.

I'm hoping that harvoni eradicated it by EOT!
Best luck to all of us!
« Last Edit: May 09, 2015, 10:28:40 pm by MEG »
Geno 1a. IL28B+ with TT polymorphism.
Diagnosed 1993.
Liver Biopsy 1993 --inflammation.
Fibroscan 2014---no fibrosis.
ALT range---60s
AST range---80s.
Platelets: 200K range.
Viral load--2 million range.

Began Harvoni on January 23.
Finished 12 week course on April 19.

May 18---4 week EOT labs:
VL: UNDETECTED.
AST: 23
ALT: 22...........These have not been this low throughout treatment and since my 20s.

12 weeks EOT on July 15---Undetected.

Offline Bob V

  • Member
  • Posts: 231
Charly,

Awesome Job compiling this data!

I agree :)
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Bob V

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  • Posts: 231
Mario555

Excellent post.

BTW if I come back detected I'm going to wait until 3DAA's are approved before retreating.
« Last Edit: May 12, 2015, 01:43:32 pm by Bob V »
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Momof3

  • Member
  • Posts: 55
1. 4wk EOT undetected
2. 8 weeks
3. tx naive
4. Genotype 1a
5. F0-F1 fibroscan score 2.5 Jan 2015
6. Initial VL 689,594 feb 10 2015

I would also like to mention I was detected at<15 4 weeks into treatment

Numbers are looking good so far I am super happy
Hep c GT 1a from transfusion at birth 1986
Treatment naive
Stage f0-f1 fibroscan score 2.5kpa
Harvoni started 02/11/2015 8 weeks
Baseline VL 689,594 ALT 35 AST 25
2 weeks ALT 13 AST 16
4 weeks VL <15 detected ALT 12 AST 15
 UNDETECTED  at EOT April 7
4 weeks post Harvoni UNDETECTED ALT 10 AST 14
12 weeks post Harvoni UNDETECTED ALT 8 AST 15
24 weeks post Harvoni UNDETECTED ALT 13 AST 18

CURED!!!!

Offline debham

  • Member
  • Posts: 68
Good  luck with your next labs!!!!!
Diagnosed 2003
VL 300,000
Geno type 1 a
Start TX 4/01/15
VL 2.3 million
Tx Naive
12 wk Tx
Harvoni
Last Ultra Sound
No presents of fibrosis

Offline flipflops

  • Member
  • Posts: 10
I will be finishing 8 weeks on Sunday May 17, EOT labs scheduled June 1, UND at  4 weeks, will post when I know.

Offline MEG

  • Member
  • Posts: 304
@Momof3

Yay! I was just recently thinking about you. Congratulations! What a wonderful feeling it must be.....

I'm having my 4 week EOT labs next Monday. I'm beginning to get nervous. Seeing your results makes me feel better. Deep breaths.

Enjoy your life without HCV! PS: since you've had it all your life, are you experiences any changes in your body. Things that you thought were just random symptoms/problems beginning to resolve themselves?

All the best, Meg
Geno 1a. IL28B+ with TT polymorphism.
Diagnosed 1993.
Liver Biopsy 1993 --inflammation.
Fibroscan 2014---no fibrosis.
ALT range---60s
AST range---80s.
Platelets: 200K range.
Viral load--2 million range.

Began Harvoni on January 23.
Finished 12 week course on April 19.

May 18---4 week EOT labs:
VL: UNDETECTED.
AST: 23
ALT: 22...........These have not been this low throughout treatment and since my 20s.

12 weeks EOT on July 15---Undetected.

Offline Momof3

  • Member
  • Posts: 55
Meg...

Thanks for the kind words!! Fingers crossed for you aswell! I didn't really have any symptoms of hep c except for fatigue! As of now I have less of that and the kids aren't draining me as much. My hair is growing faster? It grew quickly before but now even more? Lol my hairstylist I'm sure is enjoying that! Other than that nothing different. My skin is still horrible but I get that from my fathers side of the family so bummer lol

Hope you're doing well, I can't wait to hear your results
Hep c GT 1a from transfusion at birth 1986
Treatment naive
Stage f0-f1 fibroscan score 2.5kpa
Harvoni started 02/11/2015 8 weeks
Baseline VL 689,594 ALT 35 AST 25
2 weeks ALT 13 AST 16
4 weeks VL <15 detected ALT 12 AST 15
 UNDETECTED  at EOT April 7
4 weeks post Harvoni UNDETECTED ALT 10 AST 14
12 weeks post Harvoni UNDETECTED ALT 8 AST 15
24 weeks post Harvoni UNDETECTED ALT 13 AST 18

CURED!!!!

Offline MEG

  • Member
  • Posts: 304
Momof3

How nice that you have better energy. I bet that as time goes on and your body heals you'll feel even better.

How fun that your is growing faster....my skin is not better either ;-(  LOL....

Thanks for your thoughts. Only we know how hard it is and how badly we want to be cured...Hugs, Meg
Geno 1a. IL28B+ with TT polymorphism.
Diagnosed 1993.
Liver Biopsy 1993 --inflammation.
Fibroscan 2014---no fibrosis.
ALT range---60s
AST range---80s.
Platelets: 200K range.
Viral load--2 million range.

Began Harvoni on January 23.
Finished 12 week course on April 19.

May 18---4 week EOT labs:
VL: UNDETECTED.
AST: 23
ALT: 22...........These have not been this low throughout treatment and since my 20s.

12 weeks EOT on July 15---Undetected.

Offline anniemybaby

  • Member
  • Posts: 133
Not sure of all my numbers drs never sent me results on everything
Genotype 1a
No cirrhosis
Diagnosed 2014
Started 8 wk treatment of harvoni
2,4,6,8 wk undetected
June will be my 3 Month post treatment test
I feel brand new no longer sick
Annie

Offline Bob V

  • Member
  • Posts: 231
Momof3

Congrats.
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Karen3717

  • Member
  • Posts: 28
Bob, I saw an article on BMS's triple DAA on this website today.  Looks promising.  I stumbled onto that news while reading the last post from editors.
Transfusion 1982; Multiple accidental needlesticks; healthcare worker
(+) HCV antibody 1991
Genotype 1a
2001-Pegintron/Ribavirin 48 wks. Relapse 2mo post tx
2015-VL 316,000
Fibrosure-F2
Started Harvoni 3/13/15
2 weeks:  HCV PCR <15-DETECTED
4 weeks: HCV PCR <15-DETECTED
8 weeks: HCV PCR <15-DETECTED
12 weeks:  HCV PCR: NOT DETECTED!
4 Weeks EOT: HCV PCR:  NOT DETECTED!
12 Week post TX:  HCV PCR NOT DETECTED!

Offline Bob V

  • Member
  • Posts: 231
Bob, I saw an article on BMS's triple DAA on this website today.  Looks promising.  I stumbled onto that news while reading the last post from editors.
---------
Karen
I've been following the DAA on the website too and I get Lucinda's FB feed which is excellent.

I'm trying to get some friends on treatment, glad to see there's more and more options.

Bob
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Anand

  • Member
  • Posts: 34
Anand:

4 wk and 12 wk after EOT: undetected
Treatment for 84 days or 12 wks from 11/12/14.
Treatment naïve
Genotype: 1a
F3
1.18 mil (11/12/2014)
Age: 77 yrs

Offline Bob V

  • Member
  • Posts: 231
Anand
Great news, congrats :)
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Katie

  • Member
  • Posts: 784
Congratulations Anand!  What great news for you. 

I am curious how you are feeling.  Many of us had more difficult post treatment symptoms than while on treatment or very similar.

Have a wonderful summer and hope you are feeling good.

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline debham

  • Member
  • Posts: 68
Congratulations Anand!!!!!
I'm so happy to hear about these reports of 12 week EOT Undetected. YaY!!!!!
Deb
Diagnosed 2003
VL 300,000
Geno type 1 a
Start TX 4/01/15
VL 2.3 million
Tx Naive
12 wk Tx
Harvoni
Last Ultra Sound
No presents of fibrosis

Offline Dandelion

  • Member
  • Posts: 6
1) 4wk EOT - RELAPSE - 510000 VL detected - was UND at 4wk and 12wks during Tx
2) 12wks Tx - start 1-8-15
3) Tx naive
4) 1b
5) Fibrosure F2-F4 - Dec. 2014
6) 6.5m VL - Dec. 2014
7) Blood trans 2 hosp '80
F - age 64

Hi all, Congrats on all the UND's. I re-tested 4 days after 4wk EOT VL and got 440000 VL. I've been on a strict diet and supplement protocol based on food sensitivities and nutritional needs as advised by my orthomolecular immunologist these last 24yrs. I have done meditation and yoga nearly all my life as well. Since 2wks post EOT I have felt better than I have in decades, working out daily at the gym and able to bike 3mi a day and even am able to do intensive strength training now as well. I feel better in every way. LFT's, Lipid profile, Metab. profile, Prothombin time, and ultrasound are all normal. It makes so little sense that I'm detected at this time. Any thoughts are appreciated. Keeping the faith here.
« Last Edit: May 14, 2015, 10:16:16 pm by Dandelion »

Offline Anand

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  • Posts: 34
Bob, Katie and Deb,

Thanks.  I really appreciate.  I have been away from this forum for a while for the past few months. 

Now to Katie: I have been very lucky, during and post Harvoni treatment.  They were uneventful. Since I am 77 years of age my doctor opted for the 12 week treatment instead of 8 as may have been warranted by other factors. I had a heart attack in 1987 with HEP C infused blood transfusion.  I have been running 2 miles every other day and every other day I visit Gym to work the machines to keep my blood flowing especially as I get older. I have been doing this for several years. I also do breathing exercise and Yoga and meditation. This may have helped.  During treatment I did shoulder stand so that my legs were up and moving like scissors just so the Harvoni got a good circulation in my legs. I am not saying this worked or not but I did not want leave anything to chance.  I have to go for fibroscan in February 2016 to monitor the status of my liver. Thanks for your concern and you have a wonderful summer. Will be in touch.   Anand

Offline Bob V

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  • Posts: 231
Dandelion
Sorry about your HepC lab result. Sounds like your doing all the right things health wise and have some good people working with you. Have you given any thought to re treatment?

One thing VL 6.5M and only 12wk treatment, I thought over 6m it was 24wks.
« Last Edit: May 14, 2015, 11:56:36 pm by Bob V »
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline dragonslayer

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  • Posts: 873
Dandelion
Sorry about your HepC lab result. Sounds like your doing all the right things health wise and have some good people working with you. Have you given any thought to re treatment?

One thing VL 6.5M and only 12wk treatment, I thought over 6m it was 24wks.

No, Bob... 6 mil is the cutoff for 8 wk eligibility.. Otherwise, its 12 wks.  24 wks is reserved for treatment experienced AND cirrhosis.
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

Offline Dandelion

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  • Posts: 6
Hi Bob,
Thank you for your kind words. I've thought about it and even have PAN ready to pay my deductable if I go for another round which my Dr will Rx me if I request. I'm just not sure I should given I may have variants and cure rate is less than 50% I think. Confused to say the least. Also thinking I should wait til 12wk post (late July)to decide as I may have cleared by then?
Thanks Again,
Dandy

Offline DLedin

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  • Posts: 5
Just to add to the results being posted here:

Yesterday I received word from my doctor that my 12 weeks after treatment lab results show that I am cured.

I was a genotype 1A with no previous treatment experience. My liver status was F1.

My treatment was with Harvoni for 12 weeks.

-Doug

Offline debham

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  • Posts: 68
Great to hear Doug... Congratulations on the end results. I'm still in the race for a good finish. On week 7 of Tx 5 to go.  :) ;D
Diagnosed 2003
VL 300,000
Geno type 1 a
Start TX 4/01/15
VL 2.3 million
Tx Naive
12 wk Tx
Harvoni
Last Ultra Sound
No presents of fibrosis

Offline Bob V

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  • Posts: 231
No, Bob... 6 mil is the cutoff for 8 wk eligibility.. Otherwise, its 12 wks.  24 wks is reserved for treatment experienced AND cirrhosis.
--------
Thanks Paul, I remembered that after I posted last night…I’ve been sick this week so the brain fog is back 


Hi Bob,
Thank you for your kind words. I've thought about it and even have PAN ready to pay my deductable if I go for another round which my Dr will Rx me if I request. I'm just not sure I should given I may have variants and cure rate is less than 50% I think. Confused to say the least. Also thinking I should wait til 12wk post (late July)to decide as I may have cleared by then?
Thanks Again,
Dandy
----------
Dandy
This is a tough one. I wish I had some words of wisdom but……………..
Bob


Just to add to the results being posted here:

Yesterday I received word from my doctor that my 12 weeks after treatment lab results show that I am cured.
------------

Great news Doug, congrats.

Bob
« Last Edit: May 15, 2015, 10:09:28 am by Bob V »
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Just want to say a big thank you to all posting under this topic, as I am still fighting w/ ins. to even get the Harvoni.  I joined recently and hop around to various topics, and this is the first I've seen this particular question.  Does this forum do polls anywhere, as this is basically what this is? Can the moderators help with this?
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline mario555

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  • Posts: 226
We have a poll of some kind. You are supposed to report your post treatment results in 4-8-12 weeks UND or with relapse. One of us is keeping track of our results. Until recently, stated results of 95% cures are not matching real life results. It is extremely interesting to follow!
60 years old. Likely infected 1975. Geno 1a
F4  8 millions VL,  AST 140  ALT 140
Generally in good health except problems are creeping up rapidly!
2 failed attempts Inf 2000 and Inf-riba 2010
Harvoni 24 weeks
Start 11/13/2014   EOT 4/27/2015
VL2 - UND
VL4 - UND (may 25)
VL12 - UND
VK24 -  UND
Hopefully cured forever!

Offline charly8

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  • Posts: 113
Sorry I have not updated in a while, I have been on vacation and without internet.

Anyways I wish I could modify my posts, but I cant. 

Looks like we got some results:

DLedin
1. 12 wk post EOT VL status - Undetected (SVR)
2. Treatment duration - 12 weeks
3. tx naive or experienced - TX naive
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - F1
6. Initial VL (date) - unknown

Dandelion
1. 4 wk post EOT VL status - 510000 (relapse)
2. Treatment duration - 12 weeks
3. tx naive or experienced - TX naive
4. Genotype (1a or 1b) - 1b
5. F1-F4 fibrosis status (date) - F2-F4 Fibrosure
6. Initial VL (date) - 6.5 mil

Anand
1. 12 wk post EOT VL status - Undetected (SVR)
2. Treatment duration - 12 weeks
3. tx naive or experienced - TX naive
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - F3
6. Initial VL (date) - 1.18 mil

MomoF3
1. 4wk EOT undetected
2. 8 weeks
3. tx naive
4. Genotype 1a
5. F0-F1 fibroscan score 2.5 Jan 2015
6. Initial VL 689,594 feb 10 2015

Johnny_Wayne
1. 12 wk post EOT VL status - detected (Relapse)
2. Treatment duration - 12 weeks
3. tx naive or experienced - Unknown
4. Genotype (1a or 1b) - 1a
5. F1-F4 fibrosis status (date) - F4
6. Initial VL (date) - Unknown

Cally Balmoral
1. 8 wk post EOT VL status - undetected
2. Treatment duration - 12 weeks
3. tx naive or experienced - Tx experienced
4. Genotype (1a or 1b) - Unknown
5. F1-F4 fibrosis status (date) - Unknown
6. Initial VL (date) - Unknown

Current Status
We have 22 people that hit at least the SVR4 mark.  6 of 22 have relapsed.  (27.3%)

Breakdown by treatments
8 weeks of tx - 3 of 5 have relapsed (60%)
12 weeks of tx- 3 of 17 have relapsed (18%)

Note:  We currently have a 27.3% relapse rate.  This is with very limited data and certainly not scientific.   Even still this does not seem to correspond to the 95% SVR rate that Gilead has boasted in their studies.  Lets hope we get some more SVR'S.  We will need the next 98 people to report Undetected to get back to 95% SVR rates.
« Last Edit: May 16, 2015, 11:51:06 pm by charly8 »
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline charly8

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  • Posts: 113
Oh... and I will be joining this list in about a week.  I just gave blood for my 4 week post SVR results.

Wish me luck!
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline Momof3

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  • Posts: 55
Charly8 my info is all wrong if that is myself check my signature pls :)
I did post all my stats properly on Wednesday if you would like to scroll up a bit
I think it's awesome for all this info to be all put together thank you for taking the time to do it all
« Last Edit: May 16, 2015, 09:29:39 pm by Momof3 »
Hep c GT 1a from transfusion at birth 1986
Treatment naive
Stage f0-f1 fibroscan score 2.5kpa
Harvoni started 02/11/2015 8 weeks
Baseline VL 689,594 ALT 35 AST 25
2 weeks ALT 13 AST 16
4 weeks VL <15 detected ALT 12 AST 15
 UNDETECTED  at EOT April 7
4 weeks post Harvoni UNDETECTED ALT 10 AST 14
12 weeks post Harvoni UNDETECTED ALT 8 AST 15
24 weeks post Harvoni UNDETECTED ALT 13 AST 18

CURED!!!!

Offline Dandelion

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  • Posts: 6
Good Luck Charly8!! And thank you for all your work compiling data.
Dandy

Offline Katie

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  • Posts: 784
Fingers crossed for you Charly!  Can't you just copy and past to keep the list going?  You are probably doing that but thought I'd ask.  Thanks so much for taking the time to do this.  it is very valuable and how was your trip?  Awesome, I bet!  :D

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline charly8

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  • Posts: 113
momo,

Sorry, corrected now.


Thanks Katie, I was trying to keep the same format for the posts.  I originally wanted one list in the first post that was easily compiled, but I can not edit those posts. 
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline Katie

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  • Posts: 784
Charly...NOW I understand!  HA!  I guess I'm a bit slow, and here I thought the brain fog was gone!

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline mario555

  • Member
  • Posts: 226
Charly8. The best of luck to you with your results! 2 weeks after the end of my 24 weeks treatment, my doctor asked for a VL. I should get my VL2 next week. I only expect to see if I am UND (I was after 4 weeks). I will only get another test after 12 weeks in the middle of July. I am turning 60 in July so it would be a fantastic gift for me!
As for you, congratulations for taking time to go on a holiday following your treatment. Often when vyou have had hep c for a long time, we tend to let life's little pleasures to go by us (martyr syndrome??).
60 years old. Likely infected 1975. Geno 1a
F4  8 millions VL,  AST 140  ALT 140
Generally in good health except problems are creeping up rapidly!
2 failed attempts Inf 2000 and Inf-riba 2010
Harvoni 24 weeks
Start 11/13/2014   EOT 4/27/2015
VL2 - UND
VL4 - UND (may 25)
VL12 - UND
VK24 -  UND
Hopefully cured forever!

Offline connie

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  • Posts: 13
Connie


1.   2 weeks barely detected, 4 weeks und, 8 weeks und, 10 week und, 12 weeks viral load of 6,000,  3 months after EOT viral load 1.5 million  RELAPSE
2.   8 weeks of Harvoni
3.   Tx naïve
4.   1a
5.   F-2
6.   Initial viral load date ... who knows but in 1996 about 700,000

Offline connie

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  • Posts: 13
Thanks for compiling this list... I have at lease 3 other people that have relapsed on other groups not including Dandelion :-[


Offline DeeDee

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  • Posts: 30
Good Morning/Afternoon/Evening
Sorry I haven't been on the forum but my genotype was 1B
I started Harvoni treatment 01/10/15 and completed the 8 weeks on 03/06/15
My test showed I had 15 out of 2,017,239 after treatment
Recent test:
Component Latest Ref Rng 5/15/2015
ALBUMIN 3.8 - 5.0 g/dL 4.1
AST 10 - 35 U/L 17
ALKALINE PHOSPHATASE 0 - 153 U/L 89
ALT 10 - 35 U/L 14
BILIRUBIN 0.3 - 1.3 mg/dL 0.3
BILIRUBIN, DIRECT 0 - 0.3 mg/dL <0.2
PROTEIN 6.0 - 8.3 g/dL 7.2
HCV RNA HCVXD IU/mL HCV RNA NOT DETECTED
HCV RNA COMMENTS :::::::::::::::::::::::::::::::::::::::::::::

I am happy to inform you that the hepatitis C virus is no longer detectable, which is certainly reassuring given the fact that it was still detectable at a low level when last checked.
Although this is great news, we will need to check again in about 6 weeks to be sure that the virus remains undetectable.
If the virus level is still negative at that time, 12 weeks or more after finishing treatment, this indicates that the hepatitis C has been cured.

I am doing the happy dance


Offline debham

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  • Posts: 68
@DeeDee Congratulations... Do you feel better? Do you notice any change?
Deb
Diagnosed 2003
VL 300,000
Geno type 1 a
Start TX 4/01/15
VL 2.3 million
Tx Naive
12 wk Tx
Harvoni
Last Ultra Sound
No presents of fibrosis

Offline DeeDee

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  • Posts: 30
Hi debham

Thank you...I never felt any kind of way.  I asked for the test and that's how I found out.  It never showed up in any of my physicals.  I think the 3rd thru 5th days I lost my appetite, had a rash and felt nausea but it passed.  The only thing I have notice now is that my urine is clear.
I was disappointed when my first test result came back and showed I had not cleared it but this last one made me feel a whole lot better.
There are some amazing people in this forum and that helped a lot also :)

Offline Sam1224

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  • Posts: 62
Connie


1.   2 weeks barely detected, 4 weeks und, 8 weeks und, 10 week und, 12 weeks viral load of 6,000,  3 months after EOT viral load 1.5 million  RELAPSE
2.   8 weeks of Harvoni
3.   Tx naïve
4.   1a
5.   F-2
6.   Initial viral load date ... who knows but in 1996 about 700,000

Connie
Sorry to hear that. Time to go back to Dr. and continue the battle. The cure is right around the corner for all of us if we are persistent.

Offline Katie

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  • Posts: 784
Good Morning/Afternoon/Evening
Sorry I haven't been on the forum but my genotype was 1B
I started Harvoni treatment 01/10/15 and completed the 8 weeks on 03/06/15
My test showed I had 15 out of 2,017,239 after treatment
Recent test:
Component Latest Ref Rng 5/15/2015
ALBUMIN 3.8 - 5.0 g/dL 4.1
AST 10 - 35 U/L 17
ALKALINE PHOSPHATASE 0 - 153 U/L 89
ALT 10 - 35 U/L 14
BILIRUBIN 0.3 - 1.3 mg/dL 0.3
BILIRUBIN, DIRECT 0 - 0.3 mg/dL <0.2
PROTEIN 6.0 - 8.3 g/dL 7.2
HCV RNA HCVXD IU/mL HCV RNA NOT DETECTED
HCV RNA COMMENTS :::::::::::::::::::::::::::::::::::::::::::::

I am happy to inform you that the hepatitis C virus is no longer detectable, which is certainly reassuring given the fact that it was still detectable at a low level when last checked.
Although this is great news, we will need to check again in about 6 weeks to be sure that the virus remains undetectable.
If the virus level is still negative at that time, 12 weeks or more after finishing treatment, this indicates that the hepatitis C has been cured.

I am doing the happy dance

I'm doing the Happy Dance with you DeeDee!

That is 3 for 3 on Detected at EOT but cleared by post week 8 or 12.  Are there any others out there where this has occurred?  Please let us know!

Have the best time of your life DeeDee...a great 2015 and forward we go!

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline Bob V

  • Member
  • Posts: 231
DeeDee
Congrats
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline charly8

  • Member
  • Posts: 113
Often when vyou have had hep c for a long time, we tend to let life's little pleasures to go by us (martyr syndrome??).

Thanks mario! and very true.
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline charly8

  • Member
  • Posts: 113
Just to update with the latest info for Connie & DeeDee.

Current Status
We have 24 people that hit at least the SVR4 mark.  7 of 24 have relapsed.  (29.1%)

Breakdown by treatments
8 weeks of tx - 4 of 7 have relapsed (57%)
12 weeks of tx- 3 of 17 have relapsed (18%)

Note:  We currently have a 29.1% relapse rate.  This is with very limited data and certainly not scientific.   Even still this does not seem to correspond to the 95% SVR rate that Gilead has boasted in their studies.  Lets hope we get some more SVR'S.  We will need the next 116 people to report Undetected to get back to 95% SVR rates.
« Last Edit: May 19, 2015, 03:15:17 pm by charly8 »
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline Mike

  • Member
  • Posts: 999
You cannot extrapolate from these reported results.

First, not everyone is posting results on this thread.

Second, those who fail treatment may be more inclined to report these numbers on this thread.

Third, being detected with a minimal viral load at the SVR4 mark does not mean the person will not achieve a SVR12 mark (a few viruses maybe present - but neutered and unable to replicate).

Fourth, a 57% failure rate with 8 weeks of Harvoni is clearly inaccurate, as is an overall failure rate of 29.1%. The numbers are simply specious.

Mike
Genotype 1a
Treated 2001 with PEG and RIBV
Treated in 2014 SOL+PEG+RIBV
Cured July 2014

Offline charly8

  • Member
  • Posts: 113
You cannot extrapolate from these reported results.

First, not everyone is posting results on this thread.

Second, those who fail treatment may be more inclined to report these numbers on this thread.

Third, being detected with a minimal viral load at the SVR4 mark does not mean the person will not achieve a SVR12 mark (a few viruses maybe present - but neutered and unable to replicate).

Fourth, a 57% failure rate with 8 weeks of Harvoni is clearly inaccurate, as is an overall failure rate of 29.1%. The numbers are simply specious.

Mike

Mike,

I agree with your points, and I clearly state that it is not scientific. 

I am just reporting the facts of the relapse rates "as reported" on these boards to the best of the information available.  The reader has to interpret these results for themselves.

Your point number 3 needs distinction though.   There are definitely people that remain detected at very low levels <15 u/ml that go on to SVR.  And these people are not included as relapses. (i.e.  Katie and Dragonslayer and others)

But the results when people are in the 500,000 vl range (as stated on this board) are clearly relapses.
« Last Edit: May 19, 2015, 03:53:34 pm by charly8 »
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline charly8

  • Member
  • Posts: 113
Also, I was hoping that there would be some more official real world data as to the relapse rates for Harvoni, I have searched but not found anything online.  Only the FDA phase studies and NDA filing data.

If anybody knows of said real world data please provide a link, I was hoping that there would be some EASL literature but sadly not found anything.  According to Gilead's earnings report there are approximately 70,000 USA & 20,000 EU patients coming off treatment and some more official data would be helpful for the prescribing doctors and patients.
« Last Edit: May 19, 2015, 04:10:51 pm by charly8 »
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline Mike

  • Member
  • Posts: 999
The real world numbers should closely mirror the clinical numbers, which are 90%+ cure rates.

This is because the efficacy (cure) rates have been statistically validated (confirmed) during phase I-III clinical trials. Because of this, and the research methods used,  there should be little, if any statistical variance or deviation from the clinical results and the real world results.

What needs to be studied, however, is the long-term effects of taking Harvoni and it's effectiveness on sub-populations not included in the clinical trials (which is the purpose of phase IV research).

Thus:

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II: The drug or treatment is given to a larger group of people to DETERMINE IF IT IS EFFECTIVE and to further evaluate its safety.

Phase III: The drug or treatment is given to large groups of people TO CONFIRM ITS EFFECTIVENESS, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Because of the research methods used to study the efficacy Harvoni on the populations studied, we can conclude with  a high degree of medical and statistical certainty that the clinical results will be reflected in the real world numbers.

Best wishes, Mike
Genotype 1a
Treated 2001 with PEG and RIBV
Treated in 2014 SOL+PEG+RIBV
Cured July 2014

Offline Katie

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  • Posts: 784
Hi Mike,  I agree but it is interesting to see how our fellow warriors are doing since we have communicated for so long and struggled together through our hopes and fears.

One thing I am becoming concerned about, are the issues folks are dealing with after they finish their treatments; many having symptoms which they have never experienced before.  I am lucky as I am doing fairly well, did great with Harvoni and then lost my endurance and energy afterwards with a couple days of severe vertigo.  This past week I feel improvements daily so am not concerned for myself, however some are having serious health related issues.  I would like your views on this and wonder how the follow up on long term post treatment consequences are being tracked?  I would think they would need to know what is being experienced.

As always, thanks for your input and support.

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline mario555

  • Member
  • Posts: 226
I think the main point of doing this compilation of results (thank you Charlie8) is to provide us with a bit of homemade feedback! Also as Katie states, knowing fellow warriors tribulations.
My personal opinion is that real world numbers will be lower than the study results. The reason is that during the studies, patients are 'somewhat' hand-picked, are better followed and have been tested up to 12 weeks afterwards.
In real life you get a mix of under prescribed people, lack of adherence and God forbids, you might have a relapse at week 13.
The company wants to put its best face forward and will underpublicise its negative press.
As a conclusion, this medication is great looking at the success for many of us. Unfortunately, relapses will end up being twice as advertised (my guess)
60 years old. Likely infected 1975. Geno 1a
F4  8 millions VL,  AST 140  ALT 140
Generally in good health except problems are creeping up rapidly!
2 failed attempts Inf 2000 and Inf-riba 2010
Harvoni 24 weeks
Start 11/13/2014   EOT 4/27/2015
VL2 - UND
VL4 - UND (may 25)
VL12 - UND
VK24 -  UND
Hopefully cured forever!

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Important -- I spoke with a person at Gilead Sciences today, as I wanted to ask what data was being compiled POST TREATMENT, for how long, by whom, and when such would be made available to the public.  I was told they are not required by the FDA to compile data post market ......  but they of course do want to know of any relapses or other side effects as more and more patients finish their treatment. I was told doctors, or even more often, PATIENTS, usually will contact them re: relapses or serious events, i.e., the bradycardia medication issue that came up in March.  I was also told that this person was not aware of any "specific" Phase IV studies, as referenced by Mike earlier on this post, but that trials were certainly still being conducted as could be found on the clinical trials.gov website.

SO -- the bottom line is that both patients and their doctors need to take it upon themselves to contact Gilead with any issues.  Although this "poll" Charly8 is doing isn't perfect, this forum is probably the fastest way anyone who's interested is going to get firsthand info on the issues of side effects or relapses.

I called Gilead's Forest City headquarters at 650-574-3000 and spoke to a person in the medical/clinical dept. Hope this helps!!  FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

 


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