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APPROVED - Update on drugs!
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APPROVED - Update on drugs!

So excited - today got approval for BOTH Solvaldi and Olysio to be provided to me for a 12 week treatment using just these 2 drugs!  As you might recall from my previous posts that my Hep Dr. believes that this combo will be the perfect cocktail for SUCCESS!  Tomorrow marks exactly 1 year since I stopped the last treatment at 24 weeks of Riba, Victrelis and Pegasus.  HORRIBLE side effects, blood transfusions and detectable AGAIN at the post 12 week mark.  It actually took me 6 - 7 months to shed all the side effects and feel normal again.  That was my 2nd attempt to SVR and at 61 years old I am really praying this treatment is indeed the final solution.
I will be the 3rd patient he has doing this same program with many more trying to get approvals from their insurance companies.
I should start within a week and will post updates weekly on how I feel and the journey.
Keep the faith and blessings will often happen!  
Happy Grammy today for sure!!!
Tags: drugs, solvaldi, olysio, Hepatitus C, HepC & Tx, side effects
56 Comments Post a Comment
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Hoping you have the best luck Keep praying God bless you and don't give up.

bbj
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WhooHoo!!! So excited for you! Our doctors have the same mindset so hopefully I'll be just a few weeks behind you!
Can't remember...did you test for Q80K? I have....don't have my results back yet but thinking I will ask to do even if I'm positive.
Key for me is that he said I could re-treat when the 'miracle' one pill is approved.
I'm over the moon excited for you....keep us updated!
Blessings!
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No Q80K test - trying it no matter what those results would have been.... however, my Dr. said that doing the 2 drugs without any others does not require that test.  Just doing what I am told by those wiser then me.  Thanks for the congrats!  Good luck to you also!
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Congrats to you and your doctor. I agree there's no reason to have the test when one has to treat anyway........ Best to you. The odds are on your side.
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    wow!!!!  that is exciting to get approval of the two together.  really happy to hear your news.  you have a good dr.  getting approval of sovaldi for geno 1 tx experienced is tough.  
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Congratulations and SVR to you!
What insurance company do you have?

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Congratulations on your approval and hope treatment goes well for you.

I saw your earlier post a couple ?
days ago  "we lost our insurance coverage so the doctor is filing for the drug companies to provide them free of charge"
http://www.medhelp.org/posts/Hepatitis-C/Anyone-know-if-Insurance-will-pay-for-these-new-drugs/show/2058000#post_9814038

So your Doctor got the drug companies to provide them free of charge within a few days.  Wow

The 12 week treatment estimated cost of both drugs full price is $150,000 (Solvaldi $84,000  Olysio $66,000)

To All  If anyone becomes aware of any insurance companies actually covering this OFF label use please reply with info and co pays.  .  

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Three cheers for you and your doctor!
After doing pegIFN based treatment with Victrelis your gonna love this combo as far side effects and adverse advents are concerned.

I did Sovaldi + Ribavirin and it didn't even feel like I was treating most of the time. I had to look at the undetectable graph line of my viral load to believe it sometimes.

Best of luck to all of you treating with this cocktail.

Cheers!
Hector
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congrats great news..  Is that  trial your doing or regular treatment
good luck
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I'm not doing any treatment yet  My reply was to GrammyA. Her doctor prescribed Off label (not trial)
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It's your personal decision to do it without a Q80K test.  But you should be aware that Victrelis is a linear protease inhibitor.  Since you failed treatment, you are resistant viruses to protease inhibitors.  Olysio is a protease inhibitor.  I think it's a cyclic protease inhibitor rather than linear.  Will that make a difference for you?  I'm not sure.

However, your doctor is misinformed that the test isn't necessary.  The test should've been offered and you could decline but the test is necessary because you failed a 1st generation protease inhibitor.

I know all about resistant viruses.  I failed incivek based therapy and finally got cured with Sofosbuvir (Sovaldi) and Ledipasvir.  Neither one are protease inhibitors.  

Good luck
HC

...
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I meant to congrat  grammy haven't been around for a while
Hung here during my treatment in 07

health is a funny thing most people don't realize they have it till they start losing it

warmest regards
Rangle
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My mistake  - my last treatment was with INCIVEK.... NOT Victrelis...... fog brain due to old age.
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Congratulations on getting approved for treatment! Hopefully this will be your ticket to SVR.

Sounds like your doctor knows what he is doing. I know you are Genotype 1b so I doubt you have to worry about the Q80K polymorphism. It is very rare in Genotype 1b.


OLYSIO (simeprevir)  -  Resistant Variant Q80K polymorphism

"Q80K polymorphism: QUEST-1 and QUEST-2 studies"
"In  the simeprevir QUEST-1 and QUEST-2 studies, researchers reported in QUEST-1 patients with HCV genotype1a had almost 20% less SVR than HCV genotype 1b. Noted, at baseline the mutation Q80K was found in approximately 1/3 of genotype 1a patients. On the contrary, in QUEST-2 this mutation was infrequent and did not impact significantly the SVR rate".

"48 percent of U.S. patients with a HCV genotype 1a  had the Q80K polymorphism at baseline"
"Johnson & Johnson went on to perform an analysis pooling all subjects from the C205, C206, C208, C216, and HPC3007 trials, and found 48 percent of U.S. patients with a HCV genotype 1a  had the Q80K polymorphism at baseline, compared to only 19 percent of patients in Europe. The mutation is almost nonexistent in those with a genotype 1b infection."

http://hepatitiscnewdrugresearch.com/olysiosimeprevir-resistant-variant-q80k.html

Best of luck.
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Pooh - you and so many others are a wealth of knowledge.... thank you for always sharing with us less educated ones. Yes, I am 1b with cirrhosis.
Grammy
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This statement by hepcat.........

"But you should be aware that Victrelis is a linear protease inhibitor.  Since you failed treatment, you are resistant viruses to protease inhibitors.  Olysio is a protease inhibitor....

May be a little too definitive with saying ""you are resistant",,however there is a test (sited below)to find out  as this is still a relatively unknow factor for those that failed with a protease type drug...iresgardless of the Q80 mutation.

Given that there will one of the NS5a inhibitors on the market within the next little while,and that in combination with "sovaldi" you know definitively you "do not have any resistance  to  ..(if indeed there may be  a resistance to the protease now )..personally I would ask my physician to consider running  the test  I site below  before proceeding ... JM thoughts......

Best of luck to you..
Will


HCV GenoSure NS3/4A analyzes the genetic sequence for the non-structural proteins NS3 and NS4A of HCV genotypes 1a and 1b that encode for an enzyme essential to viral replication. The assay detects mutations in NS3 and NS4A and specifically identifies those associated with boceprevir and telaprevir resistance.

Recommendations recently developed by the HCV Drug Resistance Advisory Group emphasize the value of resistance testing at treatment baseline and failure in support of the development and clinical evaluation of new drug candidates. In HIV, the routine use of resistance testing to guide antiviral drug treatment is established in clinical practice. In response to the recent and future availability of DAA agents, some experts anticipate that drug resistance testing will provide similar value to the clinical management of HCV infection.

http://hepatitiscnewdrugs.blogspot.com/search/label/protease%20inhibitor-%20%28NS3%2F4A%29%20Drug%20Resistance%20Test




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I noticed you did Inci and not Vic  however this is still the same class of drug...

Best ..
Will
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The updated Genosure test is for all know resistant variants, Q80K included.  Grammy has resistant variants.  The only unanswered question is which ones.
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HC  & Grammy

I would tend to agree with that and that is why I suggested the OP chat with her physician about possibly having the  the 'Genosure" test prior to proceeding with another protease and further discussion about  Sovaldi in combination a Ns5a drug (hopfully aprroved soon),,however there is also the urgency of chirrosis (cirrhosis)  present.

However given the  uncertaintly of known time for variants to return to "wild type virus"  my comment to you about  being possibly..... "too definitive " a statement

Grammy..... best of luck with this....

Will

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Hi all
I am Geno 1A null responder w/cirrhosis meld 7 last treatment was with pegintron and ribavirin. The Dr did not want me to try 3 drug combo as probably would not work and could cause me to decompensate.Basically too much risk for too little chance of success.

In regards to the discussion about Q80K is that something I should ask my Dr about on my next check next month?

I am hoping to get on Sofosbuvir/Ledipasvir combo if/when approved but have been thinking about the off label use Sovaldi-Olysio if I can get my drug coverage to buy off on it but am concerned about the implications of the Q80K.

Dont want to blow a good opportunity for cure by being pre mature treating, but don't want to risk decompensation while waiting for the new combo either.

AND GOOD LUCK to GrammyA!!!
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Who is paying for these drugs?  I am playing the game with BCBS right now and they don't want to pay for one drug much less both
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I too would like to know if the two drugs will be covered for "off-label" use together.
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I need to maybe back track that response I gave you sense I see your a geno type 1a... Yes you should check with your Doctor when you see him. Wishing you the best

"Q80K polymorphism: QUEST-1 and QUEST-2 studies"
"In  the simeprevir QUEST-1 and QUEST-2 studies, researchers reported in QUEST-1 patients with HCV genotype1a had almost 20% less SVR than HCV genotype 1b. Noted, at baseline the mutation Q80K was found in approximately 1/3 of genotype 1a patients. On the contrary, in QUEST-2 this mutation was infrequent and did not impact significantly the SVR rate".

"48 percent of U.S. patients with a HCV genotype 1a  had the Q80K polymorphism at baseline"
"Johnson & Johnson went on to perform an analysis pooling all subjects from the C205, C206, C208, C216, and HPC3007 trials, and found 48 percent of U.S. patients with a HCV genotype 1a  had the Q80K polymorphism at baseline, compared to only 19 percent of patients in Europe. The mutation is almost nonexistent in those with a genotype 1b infection."

http://hepatitiscnewdrugresearch.com/olysiosimeprevir-resistant-variant-q80k.html
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To answer the money question - here is what I know.  My drugs will be free and provided by the drug companies direct because I qualified with no insurance and only SS Disability income.  However, my doctor has 2 on this off label combo and they both were covered by Aetna Insurance.  He has others struggling with various insurance companies that are saying NO!  BCBS is the worse when it comes to a fast yes.  Once the drugs are added to the formularies for each insurance company they will be available.  Some companied LOCK down the formulary lists on an annual basis and will not add new drugs until the next year.  Others can be convinced by the doctors that it is needed immediately and perhaps get a special acceptance.  
Also, YES this is Off Label...... 2 pills per day only.... Sovaldi and Olysio.
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I read that Lab Corp has the Enhanced HCV GenoSure NS3/4 which includes testing for the Q80K in addition testing for resistance mutations to victrelis and incivik . However, when I checked Quest DX., it appears that their HCV Geno Sure does not include testing for the Q80K polymorphism, just the other two categories.
Also, was wondering if insurance covered the test, and if not what is the cost of it?
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Good morning. Quest is testing Q80K for me. Had lab draw last Thursday, hep nurse called for results and found out it takes 5 days to complete. I should find out tomorrow or Monday but again testing is being done by Quest Labs. Hope that helps!
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Just went to quest dx and I see what you're referring to...curious now to see my results and if it is specific to Q80K. I'll definitely check and let you know.
Have a great day!
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COOL!!! congratulations and keep us posted, indeed a Happy Grammy Day.wishing you all the luck in the world love Jules x
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I am really happy for you, that the drugs will be free and provided by both drug companies direct after reading this.

Gilead (sofosbuvir) and Janssen (simeprevir)
The Phase 2 trial  (had really good results)
So far, there have only been Phase 1 and Phase 2 studies.
There have not been any collaborative Phase 3 studies that could lead to FDA approval. This is due to the pharmaceutical companies deciding to concentrate on their in-house drug pipelines

http://www.hcvadvocate.org/hepatitis/factsheets_pdf/Off_label.pdf
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Thanks for your response, Pamela.  When you find out if the Q80K test is included in the Quest HCV GenoSure NS3/4 test, please let us know.  Also, did your insurance cover the test? Did you need pre-authorization?
Thx so much. ....
Maddie
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Both Sovaldi and Olysio arrived this morning.  Went to get my benchmark labs done so I can begin taking them tonight...... let the 12 weeks begin!
To answer many of your questions on the process to get these drugs..... first my Doctor had to write the prescriptions for each, and I went in to his office to fill out all the paperwork for each PLUS I had to provide a copy of my 2012 tax return and proof of current income.  He then sent the documents to each company with an explanation of treatment letter that stated I could NOT be given Interferon ever again and my best resolve was to do this Off Label treatment.  They made a decision within 3 days and the drugs arrived 2 days later.  The Olysio was sent to my Walgreens and the Sovaldi came to my house to be signed for by me.  I will be starting them tonight with my dinner as one of them is to be taken with food.  They can be taken together also and it is just the 2 pills daily for the 12 weeks.  The have a huge list of drugs that they cannot be taken with and those are provided on their individual websites also.
I hope this helps anyone needing these drugs that are not insured.
I will post again in a week to tell everyone how it is going.
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I wish you the BEST on your new combination treatment!
I too was approved for both simeprevir and sofosbuvir, and I was told they will ship to arrive Tuesday, along with ribavirin.  My doctor wants me to do this triple combination, as I have previously failed 3 (or 4  --  can you believe I lost count?) interferon-based treatments. I'm really fortunate my insurance company approved all this pretty quickly, with minimal copay.

Lets compare notes here after a few weeks.

Mark
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Hi, All.

Can anyone in this forum give a clear explanation (emphasis on the word "clear") of the various new meds in relation to viral escape variants and genotype?

I am gt1b, Tx-naive, F2/F3, 70 years old and will soon have to decide what meds to take. I don't want to make a mistake and choose the wrong ones.

Thanks.

Mike
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Great news for you too Mark!  I am so fortunate to not have to take the Riba or Interferon....  I had every extreme side effect from both of them so no more for me please.  I will be looking forward to us keeping tabs with each other as we work through this together.
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Grammy I am so excited to hear your wonderful news!!
I wish you all the best on your new tx.
D
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Not sure exactly what you refer to when you say viral escape variants.  If you mean mutations then I can tell you that Olysio has a low resistance to the Q80K polymorphism (mutation) which is naturally occuring in many  people  with GT1a.  In other words, it is there in many GT1 individuals prior to treatment, it does not develop due to treatment.  When it is present, it can decrease chances of svr with Olysio. Since you are GT1b, it is almost certain you do not possess this polymorphism.   When Sovaldi is added along with Olyisio, in those possessing the Q80K polymorphism, the svr chances may be around 80% according to my hepatologist.  This is higher than if it is given with Inf/Riba and possessing Q80K.  Since you are GT1b, and most likely without the Q80K mutation, your chances of svr are higher.  Sovaldi has high resistance to mutations.  Also, does not show any cross resistance problems to date.
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Just went to recheck Quest website and the test called Hep C Viral RNA NS3 Genotype (test code 90924) looks like it does test for Q80K polymorphism.  
http://education.questdiagnostics.com/faq/FAQ132
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Sorry, the above link not working.  Just search for Quest diagnostics test #90924, then click on "related education" tab for freq. asked questions, click on name of test on that page and you are brought to a list of questions.  Question 4 addresses Q80K.
Hope you all have a great day!
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475555_tn?1303617674
Thanks for the info, miss maddie. (Is maddie short for Madeleine or for mad?)

I take "escape variants" to mean any mutated viral sub-species that escapes from drug action.

Coupla questions for you:

- Is Q80K the only mutation that's keeping people from achieving SVR?

- What about the DAAs from Abbott and BMS vis-a-vis mutations?

- As I understand it, the IL28B mutation only affects the outcome of Interferon-based  Tx. Is that right?

Thanks for your help with this.

Mike
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Mike

- Q80K affects treatment with Olysio (Simeprevier) a second generation protease inhibitor...not all DAAs.

- Haven't researched DAAs from Abbott and BMS as thoroughly since they are still in trials and can't be taken right now unless in a trial.

- Some data suggests that IL28B genotype may represent an 'easy-to-cure' characteristic for certain IFN-free regimens

"The INFORM-1 study was the first study to demonstrate that IFN-free therapy could have a potent antiviral effect. Patients were treated with a combination of mericitabine (NI) and the danoprevir (PI) for 14 days, before follow-on PR therapy to 48 weeks. Analysis of the on-treatment viral kinetics in 15 patients during the 2 weeks of oral therapy revealed a significant difference in phase-II viral kinetics according to IL28B genotype suggesting that IL28B genotype influences the rate of clearance of infected hepatocytes during IFN-free therapy. This might be consistent with the association between IL28B genotype and spontaneous clearance of HCV"

(Source...Chu TW, Kulkarni R, Gane EJ et al. Effect of IL28B genotype on early viral kinetics during interferon-free treatment of patients with chronic hepatitis C. Gastroenterology 2012; 142: 790–795.)

Another Study...
SOUND-C2 evaluated the combination of BI 201335 (PI), BI 207127 (NNI) ± RBV (Fig. 1a). Interim results demonstrated a clear difference in SVR12 according to IL28B genotype in HCV-1a patients (Fig. 1b,c). The low SVR rates observed in HCV-1a non-C/C patients resulted from virological breakthrough in most patients, suggesting that IL28B genotype influenced the emergence of RAVs.

Source:
Zeuzem S, Soriano V, Asselah T et al. SVR4 and SVR12 with an interferon-free regimen of BI 201335 AND BI 207127, +/− ribavirin, in treatment-naïve patients with chronic genotype-1 HCV infection: interim results of SOUND-C2. J Hepatol 2012;56:Abstract 101.



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Hepcat I have hep c geno type 1 end stage liver disease cirrhosis and liver cancer and battleing two tumors .on two transplant lists.doc wants to start me on this cocktail of solvaldi and olysio but insurance denied me saying a proper prior authorization is required before they will ok it .this is new for docs as well .my meld score is a 25. I want to live I work each day with the love of my life.she would die without me .do you have any suggestions I may use to help my docs .thankyou much
          Frank 1953
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Hello GrammyA need all the help right now have liver cancer ,two tumors on liver r cancerous and trying to get the solvaldi and olysio .had no success with inter fur on and Pegasus  combo I don't know much about all of this and I want to live I'm on  two transplant lists and I'm scared to death thanks for anything
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Avatar_f_tn
May I suggest you send a message to HectorSF? I think he can offer you some very good advice. His case, similar to yours,  is nothing short of a miracle.

I wish you the very best.  Hang in there.

Nan
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Been taking Solvaldi 400mg once a day and Ribasphere 400mg twice a day for six days now to rid type 2 B hep C and very little side affects.  The worst is no sleep or sleeplessness and a minor very minor headache in the back of my head.  I never get headaches so I know it must be from the meds.  The doctor said that the studies shown say this regime shows it actually only takes 4 days to kill most if not all the virus.  But the regime still calls for 12 weeks.  How are you handling these meds and what have you heard?
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You may be comparing apples and oranges when talking about QUEST 1&2 and Sovaldi/Olysio when talking about Q80K polymorphism. QUEST 1&2 were Olysio (simeprevier) and peg/riba.

COSMOS is a more appropriate comparison since it was sofosbuvir (Sovaldi) and simeprevir (Olysio). Below is what Ira Jacobsen said at last year's AASLD about the COSMOS results regarding Q80K:

"When looked at by HCV GT1 subtype, the results show that patients with the Q80K polymorphism did not fare as well. In cohort 1, 89% of patients with that polymorphism achieved an SVR12, compared with 100% of those with GT1a or 1b without Q80K. In cohort 2, 91% of those with the polymorphism achieved an SVR4, compared with 100% of the patients with GT1a or 1b who did not have Q80K. "

http://www.internalmedicinenews.com/index.php?id=2049&type=98&tx_ttnews[tt_news]=223225&cHash=da03e20e36

Granted, COSMOS didn't have a huge number of patients (80 in Cohort 1 and 87 in Cohort 2). Nevertheless, 89% and 91% SVR for those with the polymorphism are pretty darn good numbers. Good enough for me and my gastro, I'm 1a and planning to start Sovaldi/Olysio around the end of February (my gastro doesn't see the point of doing the polymorphism test).

smaug
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Those numbers you are providing are the same reason my doctor did not see the need to Q80K test me .... and now I just finished my 3rd week.  This treatment is so easy and my 2 week labs showed that all my levels were better then EVER before and that they were 100% normal range.  In a week they will do labs again and also check the viral load.  I am totally convinced this will be my LAST treatment!

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You go, Grammy! Looking forward to hearing about your SVR.

Keep us posted on how things go.

smaug
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Have been on Olysio and Solvaldi the last 2 weeks. The only side effect has been a slight headache here and there but that's it!  Now Silverscript provided me my first 30 days and I just got word from them they denied coverage. My doctors are working on appeal but can you belive it? 1/3 done and they deny it. I'm a caretaker for my wife who has had 2 strokes and interferon is not an option. Funny thing money has top priority over life.
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Hi ,
I hope you will explain your situation to the drug companies, they have provided assisstence  to me.

Keep fighting for the Meds and you will prevail!
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Having same problem on appeal then got notice they rejected our appeal, now it goes to a personal hearing with a Court Judge to determine for the go ahead on the meds. Not really sure why they are not granting those that have been non responders to the other drugs interferon etc etc. I have to assume they will pay for another liver but will not approve the drug that cures the Hep C. Got  to turn this one over to God to handle for I am powerless, and praying my wife will have the perfect hearing and get approved. Good luck on your outcome ChevyS10.
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anyone that is on Sovaldi is lucky in my book - in the US charging $1000.00 a day and calling it a miracle drug.  
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My name is Dan I'm a Viet Nam era veteran where and when I contracted the Hep C virus. My Doctor had me wait years for Sokvodi/Olysio because I suffer from depression Interferon was not an option. The VA currantly does not offer the treatment.

Can someone explain what off label is and are the insurance companies more likely to approve it.
Thanks
Dan
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Hi Dan
Welcome to the forum.

Sovaldi is manufactured by Gilead pharmaceuticals and the "on label use" is per the prescribing information of Sovaldi with Ribavirin and interferon injections.

Olysio is manufactured by Janssen Research & Development the "on label use" per the prescribing information is again with Ribavirin and interferon injections.

The off label use means not using per the prescribing information. In this case it is using Sovaldi with Olysio with or without ribivirin. There was a clinical drug trial named Cosmos where the 2 medicines were used together with very good results. For that reason the American Association for the study of liver disease recommends this off label combination of medications for patients with specific genotypes. It is all very individualized depending on your genotype, weather you have treated previously with what medications with what result, and how much liver damage you have.

Are you seeing a liver specialist i.e. a hepatologist or at least a gastroenterologist? Have you treated previously? Do you have cirrhosis? Do you know what genotype of hep c you have. The answers will help to know what treatment might be recommended for you by your doctor. Also your doctors office hopefully will help you find a way to get your meds covered and the manufactures of the meds also offer assistance in getting you the medicines you need.

Good luck to you
From one vet to another 8 years Army
Lynn
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The feeling of being virus FREE is indescribable!  I am almost 62 - and now because of those miracle drugs Olysio/Solvaldi I have great energy and stamina.  We are in the process of remodeling a home - top to bottom.....and I am doing tons of the physical work, painting, scraping, tiling, building....and so on.  Doing all this without pain, brain fog, fatigue and issues.  I cannot tell you all how different I feel !!!!  I still have stage 4 cirrhosis and I am hoping this ole liver will start healing a bit as my body gets stronger.... then I die from something else.  I will live a good health life without alcohol and vitamins and better eating habits.  But I promise I am not giving up junk food!!
Love to all and continue to kill your Dragons!!!
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Right on Grammy.    I recently was cleared and feel great.  We only need our fellow warriors to join our rank, and then the dragon will finally put in his place.  Happy to hear the update, and enjoy your newly deserved home.
Stay well.     ...Kim
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So glad to hear you feel so much better! I am 60 and will be starting solvaldi and olysio soon. I hope I feel better as well. Doc said I could wait on new meds but I am so tired of feeling weak and all the other crap that goes with the hep that I am not waiting on anything else, I can do 12 weeks, I know. Good luck to you and thks for posting that! Awesome.
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CA