twenty-two days

[bluemetal]

Has anyone discontinued tx on sovalldi-olysio before completing the 84 days? Im a Gt 1a  F-4 cirrhotic. Had no prior tx until now. Started the S-O combo on 7/16/14. Terminated tx 8/6/14, twenty-two days later due to rare but serious side effect. Not from the drug combo per se but probably due to some other unrecognized medical condition. (Currently being looked into). Blood work is due 8/11/14 to detrmine whether the 22 days had any impact on the virus. Must now place entire hope on isolating cause for terminating tx and wait for that miracle drug coming in Oct.

[Idyllic]

Sorry treatment did not work out for you.
I gather a PCR is included in the labs you had done. It'll be interesting to see if you were UND. Hope you are recovering from the complication you experienced.

[bluemetal]

This will be a lengthy post to get a point across. As Mike (mike716) stated in his 7/13/14 post, Lindas failure on S-O tx "is a wake-up call for all of us" and particularly for the med personell who are acting like S-O is a cure and not giving their patients the proper testing aqnd survelliance. In my case, I started tx 7/16 and terminated on 8/6 (22 days) due to severe side effect not listed in the warning sheet. It continued to increase until the pain in upper back, shoulder and neck carried to the right arm, hand and fingertips with inflammation. This was level 10 PAIN. I called it in and the hepatologist agreed--terminate tx. Now,nearly a week later the right hand and fingers remain partially inflamed and numb-like feeling. Permanant nerve damage? Some other organ injured by the Olysio? The drug still in the system? The list of possibilities is extensive and therefore moot. The fact is, as Mike also coined correctly, the science lab and pharmecuetical giants that created Olysio (Sovaldi is innocent) created the "stock-boosting media hype" to proliferate a highly-charged atmosphere of optimism and hope. A good thing for many but realism would have been the better approach. This false optimism was based upon clinical trials which, albeit showed some promising results, involved subjects who were selected based upon exclusion-inclusion criteria that ensured, as Kim (Livelife777) put it in a 7/16 post, "the cream of the crop". Lindas (hepcandme) 7/9 post says it all concerning thenumber of relapsers and failed tx on this combo. She suffered 84 grueling days only to learn one month after the tx ended that the virus did not clear. Worse, and I pray Im wrong, will likely increase in strength before leveling off. Our only REAL hope as Gt1a's lies in Gileads miracle pill due out this fall, and lets hope its not another media hype to boost market stocks.

[candyce1953]

I am very very sorry you had extreme side effects and had to go off treatment

I just did 12 weeks Sovaldi and olysio and am cured after having hep c 43 years, I was not hand picked was not in a clinical trial, was just off label cause I am interferon intelligible because of auto immune diseases

All my side effects were actually from Sovaldi, extreme fatigue
I stayed out of the sun since I did it during this winter and had no side effects to olysio

I think it is different for everyone and our under lying medical conditions
I had hypothyroid, primary billary ciroshis, reuhmatold arthritis ,1B and 2/3 fibrosis

Cured SVR 12 weeks after ending treatment

Was grateful - and very happy I did it!!

[QWC]

Thank You for speaking "the truth", as I am so tired of being lied to and others playing down their side effects.  I am so sorry you had to deal with that --it sounds so painful--glad you stopped when you did.  I am new to this site, but have been diagnosed since 2008, although I believe I caught the dreaded virus in 2002  through accidentally pricking myself while helping my boyfriend cap his Enbrel needles.  He went on the horrible interferon in 2009 and almost died and did not get cured.  We are also "waiting" for them to iron out the wrinkles because I witnessed first-hand how the Hepatologist and everyone lied to him about his failed treatment.  Another thing is that I noticed you said you are GT 1a--I just found out after 6 years (only being told I was GT1), that I am not only the hardest to cure 1a, but ALSO GT 2 as well.  So I believe you are so right --that we can only wait and pray for them to start curing the 1a's.  After I alarmingly just discovered last week that I am 1a and 2, I got so freaked out, that I started to go to sites like NIH  (National Institute of Health), and actually read an article there written by a scientist stating that they have realized that the new treatment out right now really only cures the 1b's, and they have , of course, pushed the 1a treatment to the back burner, because of its difficulty.  Praying and waiting.  It is so frustrating.

[hepcandme]

What a great post. I have been concerned about this very thing:

"Worse, and I pray I'm wrong, will likely increase in strength before leveling off."

I must say that I don't feel any worse since ending treatment (not better either) but we are going to do another set of labs in early September so I will dutifully report back whether I am getting worse re: liver function

I still am confused about how viral load affects things because my doc and others have stated that these viral loads go up and down and no one seems to understand why nor they seem overly concerned about it?

If I could start treatment again tomorrow, I would do so in a heartbeat. It's frustrating and hope-draining to have to wait until October 10th to have the FDA approve the new regimen and then whatever time it takes to get it to patients

I do think that some had very few side effects on the S/O treatment. Perhaps because some had gone through such Brutal treatments in the past. Or because of the different ways we process drugs or any number of factors that make everyone's situation unique

Everyone is different and we are the lab rats. Still, what better time to be fighting this disease? Oh, I guess that would be After they've perfected the cure!

Hang in there! I'm right with you Q and Blue

[nan535]

My husband is GT 1a. He completed treatment (sovaldi/ribavirin 24 weeks)  two weeks ago. To say he had a difficult treatment is putting it mildly. He is post transplant with mild decompensated cirrhosis again. He suffers from episodes of HE which were greatly exacerbated while on treatment. The only thing that prevented him from stopping treatment were the weekly lab reports which showed improvements in almost every relevant number. Treatment gave his liver a break from the relentless attack of the virus (made stronger due to the immunosuppressant drugs he is taking).  
   I'm sorry to hear you had to stop treatment. Everyone is different and has his/her set of medical circumstances which definitely impacts on how what reacts to treatment with these new powerful drugs. As my husband said to me "he feels like a guinea pig".  The alternative, however, was worse. He probably would have suffered liver failure by now.
   We don't know if he will reach SVR or not. Frankly, I am not looking forward to his Week 4 post treatment results. The thought that this monster virus may be back again is just too hard to take after such a difficult treatment. In this case, I definitely think not knowing is better.
    I would not worry too much about not completing treatment. There are several treatments in the pipeline that will be available soon. With the experience doctors are now gaining with these new treatments, hopefully the right one will be found for you.

Nan

[candyce1953]

I just cured after 43 years on Sovaldi olysio, started May 8, SVR last week 24 weeks ago (12 of treatment) I was 1 b though

(I have read 1a cirrhotic have cured on 24 weeks of Sovaldi Oylsio )
Or

Gilead Sovaldi and Bristol Meyers Daclastasir  
That is the one with highest percentage cure

Read the EASL CONFERENCE treatment suggestion
Good luck
Xoxo

[bluemetal]

Finally, a touch of Realism. The bottom line: hope for the best but expect the worse. Ive got another medical appointment in 1 hour so Ill get back online later. In fact theyve lined up so many appointments for me that Im starting to feel like a lab rat. At least my med team is concerned (or perhaps 'curious' as all scientists) My recent blood test results should be back by friday. Ill post then. In the meantime I suggest everyone research as much as possible Gileads forthcoming miracle cure.. that single once-a-day pill that alledgidly has a 100% cure rate in all genotypes. Balance hope with despair and keep it REAL.

[bluemetal]

Two hours ago, following my zillionth medical visit, I was in my time machine (purple Pontiac Sunfire 2.2 liter) doing 60mph on a two-lane blacktop along a rural trafficless back mountain road listening to Alice-In-Chains singing a rock blues ballad called Would...    "Know me broken by my master, Teach thee on child of love hereafter. Into the flood again, same old trip it was back then. So I made a big mistake, try to see it my way...Am I wrong? Have I run too far to get home? If I would, could you?"... Its a song directed toward people who pass judgements. Also the soundtrack to the movie Singles. Its relevance to this post: ours is a stigmatized disease associated with drugs, sex, uncleanliness even though many of us contracted it through blood transfusion or accidentally. Ive moved well beyond the judgemental persecution stage and am free. Whether Im cured or not is of little consequnce, Ive accepted it either way and as such have liscense to live life to the fullest NOW. Like flying around curves on rural back roads at death-defying speeds. I feel somuch better after my hiway fix.        On a more boring note: my labs on the HCV RNA viral load after that 22-day S+O trip will be ready friday. Ill post for those interested.

[candyce1953]

http://files.easl.eu/easl-recommendations-on-treatment-of-hepatitis-C.pdf

EASL conference re treatment and treatment recommendations all new nn inter we've rom treatments

[Dee1956]

I am really sorry to hear about your experience.  It is awful to have a side effect was not reported during the trials.  I  am really sorry.

I did Incivek when it was first approved, I had problems that my doctor was not aware of since the drug had not been out very long.

Take Care
Dee

[bluemetal]

Yes, the Phase 3 ION-2 study. Funded by Gilead Sciences, completed Feb 2014. 440 subjects. It was than expanded across 53 locations throughout the U.S involving more than 10,000 patients to cover a diverse population, some receiving the S/L combo, others getting S/L/R . The clinical directors decided that among the 200 cirrhotic patients in the first arm treated 12 weeks, only 4% relapsed, therefore, the tx duration was set at 12 weeks. The Phase 2 ELECTRON trial however, led to the SYNERGY study which proved that adding a third direct-acting antiviral, either GS-9669 or GS 9145 (Gileads secret ingredient witheld from competitors) maintained a cure rate of 95-100% after 6 weeks of tx. THIS will be the tri-contents of Gileads forthcoming miracle drug in autumn. 1 pill a day for 42 -84 days (depending on individual case). All genotypes, cirrhotics included. If its not a fairy tale to boost stock than we are about to become part of medical history. The only fly in our imaginary soup is price. This drug is coming with a price tag that will literally break the proverbial back of that medicare-toting camel unless good old uncle Sam prevails in the ongoing hearing where Gileads CEO's and president are, this very moment, on a sort of trial themselves to answere for their outragous pricing.  Finally, in the words of one ofmy favorite Dickens characters..."God bless us everyone".

[penn1023]

Incivek is going off market. Vertex is discontinuing it due to better therapies.People on it now can finish but that's it.

[candyce1953]

Sounds good !!!

[QWC]

Thank You for your kind wishes and Congratulations on your treatment success!  Not sure what you were saying about , "read the something conference"?  I'll google or Bing it .  Keep us posted on your good stats.

[bluemetal]

Lab results today. Platelet ct.  151  standard range 140-400. WBC, RBC, HGB,HCT, MCV, MCH,MCHC,RDW- all normal. AST-29 standard range 10-50. ALT-25 standard range 10-50.  Must have HCV RNA Quantitive done seperately. I thought it was included in this test but not till end of Aug. That test will determine how much of the virus was destroyed. Not that it matters because unlike hoping4cure, about half of Gt1a F-4's fail to clear or relapse on this S-O combo.  Previous HCV RNA Quantitive test results are as follows: 10/22/13- HCV RNA iu/ml- 105256 with log 5.02.  5/22/14- 177042 with log of 5.25. The latter was flagged as H (high) and came with a warning in red letters for some reason. For those unfamilar with the above abbreviations theyre all related to plasma such as WBC (white blood count) etc. Anyway, except for unrelentless pain (luckily tolerable today) I feel good. Must be the cool weather up on this mountain and the fact that I finally got some sleep after another 21 hour insomnia run.                

[Idyllic]

Must have HCV RNA Quantitive done seperately. I thought it was included in this test but not till end of Aug.
_____________

Wow double sorry things worked out like this. It is difficult to know what to ask for with these labs. Like I said in my earlier post it would have been interesting to see what a PCR yielded right when you quit the meds. Just to know if by some fluke the meds you did manage to take knocked the virus down in any meaningful way.

If you terminated treatment on 06 Aug and have a PCR at the end of Aug (say the 31st or so) that is close to 25 days EOT or since your last day on meds.

I hope you feel better the more time lapses.

[QWC]

I like your post, hepcandme.  Yes, I keep dreaming of that "perfect" world when everything is ironed out and each individual has special 'specific' meds that are perfectly adjusted to the individual's unique type of the virus.  Then, some days, when I'm feeling really negative about that "perfect" world where doctors also actually gave a damn ---  I think maybe we'll all get hit with an asteroid and we won't have to worry about viral loads, genotypes, hormones, hair loss (one of my biggest fears).  But miracles do happen sometimes, so I will keep praying and waiting---I will not go on the poisonous interferon after I saw what it did to my boyfriend, I don't even want ribaviron.  So waiting....Q  

[QWC]

My best advice to you blue, is to wait --- please don't rush into another treatment until they have stuff for us 1a's figured out--it might seem like forever, but I say this because I have a cousin who was on treatment 3 times (got it through a blood transfusion), and he asked his doc, "if I keep going on treatment and relapsing, won't it make the virus stronger?"  His doc unfortunately said, "Yes".  Be patient and take good care of ourselves by eating lots of fruits and vegss, I even take a lot of carefully researched herbs that are good for the liver.  And I try, (but it is so hard) to lay off the sugar.  I notice my liver hurts when I eat sugar.  Thinking of you, Q

[bluemetal]

Cirrhosis is a catch-22 of supreme evil design. We are becomming a colony of vampires, damned in whatever we try, and damned if we dont try. A catch-22 by definition: a situation in which a desired solution to a problem is impossible to attain because of inherently illogical rules or conditions in the problem itself.  Ex:a cirrhotic liver cannot properly or adequately absorb and process vitamins A, D, K, with D being thee most difficult. Yet D is required for life and any attempt to attain the required dose leadfs to dire consequences (i.e. portal hypertension, etc) We learn this the hard way when stepping into direct sunlight (deadly to vampires). UV radiation carries mega doses of D and will even penetrate regular clothing. A few minutes in the summer sun can cause symptoms ranging from very rapid heartbeat (portal hyper) to anemic-like weakness, sunburn, etc. Many cirrhotics reverse sleep patterns, not out of morbid fear of the sun but simply because of physiological changes induced by the damaged liver. We become creatures of the night. The only solution to this unsolvable problem , while wearing full bright white hooded cloaks and sunglasses, is to clear the virus or prepare for transplant. On a more enlightening note--this just hit the news for those who havent heard: Aug 15, 2014, Achillion Pharmaceuticals (www.achillion.com). Phase 2 Proxy study. Sovaldi/ACH-3102 combo. 100% SVR4 with 8 weeks tx.  Gt1a with HCV RNA baseline vof 7.22 log. No on-tx viral breakthrough or post-tx relapse 12 weeks SVR. At last it looks like they found the "achilles heel" of this virusl Achillion is now on par with Gilead. By years end the war of all viral warswill be in full rage with the cure at our doorstep. Theres hope yet fellow vamps!

[Sarah1949]

I'm glad to hear this because I was just approved for Sovaldi but denied for Olysio pending a Q80K test, and so was thinking if I can't get the Olysio should I go with the Ribavirin. And now, I definitely think I'll refuse the Riba and wait for October 10. Unless, I get the Olysio.

My mother also had a terrible time with Interferon back in the 90's and her experience was enough to make me swear I'd never do Interferon.

[dontworry_behappy1]

Welcome to the forum.  

[QWC]

Thank You, Bluemetal.  It seems like there is finally some good news.  Do you now if there is any comparison with this new news to that other treatment that won't be approved for a couple months (forgive my spelling---I think it is called something like Daviduclir--some D word?? that is also supposed to work for the 1a's?)
Did I tell you I also found out I have GT 2 as well as 1a and think my treatment might need to be more complicated...I cannot even Find ANYONE in both communities I am in who has this "very rare" Multiple Genotypes case--I've been searching and really cannot find any info on it.  ...Q

[QWC]

Yeah--I won't let them put anything with Ribaviron or interferon near me--I know it would either kill me or turn me suicidal--after I saw what it did to him,  (at least 5-6 years ago), I would even summarize that it is more poisonous than the chemo and radiation I traumatically had to watch kill my Mom in the 90's.  Q