That's a question I have wondered about myself. I am sure there are different opinions and I don't know if any are in stone. I was waiting to see if anyone else expressed an opinion before I replied but figured I would go ahead. I am Genotype 1a. no cirrhosis like you and was prescribed Sovaldi and Olysio only for 12 weeks. I told my doctor I did not want to take Ribavirin or anything else with these two others. He said okay but didn't think I would be approved. Surprising to the doctor and myself I was approved. The doctor said the main treatment drug is Sovaldi and the Olysio is prescribed with it due to the drug maker not wanting Sovaldi to ever be prescribed alone. I think it is possible that with all three the possibility of SVR is more likely, not sure. I hope someone else has an idea here.
My thought is because that is what the American Association for the Study of Liver Disease Recommendations for Testing, Managing,
and Treating Hepatitis C recommends for the treatment of Genotype 1 treatment naive non-cirrotics who are eligible for interferon.
based on the NEUTRINO clinical trial results
Also that is per the prescribing information on label usage on the Sovaldi prescribing insert the little paper that shouild accompany the prescription.
again this is based on the NEUTRINO clinical trial results as well.
The Sovaldi Olysio with or without Ribavirin is the recommended treatment for interferon ineligible patients like for example me because I have cirrhosis and also have failed interferon based treatment 3 times as a null responder. Of course the Solvaldi Olysio is off label as they are not intended to be used together but the COSMOS trial showed good efficacy for these types of patients. Of course being off label can make it more challenging to get this prescribed although many here have been successful getting this combination as we have seen.
So that's my 2 cents
When I talked one on one with the sovaldi rep she said a simple explanation is:
HCV blood cells are in a strand....kind of like a strand of twisted pearls.
They are connected. The sovaldi comes in and "snips" the connection.
This makes the HCV cells start to separate from the cell strand. Now think of the Riba as fighter pilots. They come in...target the HCV cell...and destroy it.
In the process they can also destroy good blood cells because they really can't differ between good and bad. That is why you have to get weekly blood tests to check your blood platelets.
You will go UND (undetectable) during treatment hopefully leading to a status of SVR.
So I vision the sovaldi and O as the seperator and the riba as the destroyer.
Have to separate the HCV cells to make them vulnerable.
Have you treated before? If treatment naïve be thankful you're not taking interferon. I'm also GT1a and on Sovaldi / Olysio + Riba. This is day 25 and approved for 24 weeks. However, I'm cirrhotic and treated twice before. Was a null responder with 48 weeks of SOC and relapsed two months post 48 weeks of SOC+Victrelis.
Did you test for Q80K? We didn't test as some of the later studies indicated that polymorphism associated with 1a's, if present, should not preclude the prescribing of Olysio. Not knowing if I had Polymorphism is the main reason for adding Ribavirin. My GI doc felt I'd remain healthy enough to wait for sol/led next year and was not as excited as I was to begin this course. I thought that with a 9 year history of cirrhosis, why wait.
The three drugs all interrupt the ability of the virus to replicate itself but in distinct ways. Sovaldi is a polymerase inhibitor, Olysio a protease inhibitor (somewhat similar to the last class of PI's) and Riba is thought to deplete nucleotides thus blocking replication and maturation of viral cells.
If you've never taken Ribavirin before keep an eye on your Hemoglobin (hgb) as hemolytic anemia is a common side effect. So far at 25 days my hgb has fallen off rather slowly and a little higher than at the same point of previous attempts. Expecting it to stabilize in the 11's which is doable.
Been watching your awesome progress Lynn as we have similar stats.
Best wishes LandL,
I am 3 weeks in with Sov/Olysio, 1a with cirrhosis, tx naive. I was not prescribed Rib as I already have low WBC, RBC, and platelets. My hepatologist wanted to reduce risk for me. This is a legitimate case I have learned that has been accepted by a number of insurers in approving the off-label combination that excludes Rib.
I am now wondering why you and I are doing different treatments I am only taking Sovaldi and Olysio no riba and only 12 weeks. Although I am happy about the non riba and 12 weeks now I am worried about the possibility of relapse post treatment.
Ok read a little further I see you did Victrelis I never did that one because I already had cirrhosis by then that is my guess why the 24 weeks for you vs 12 weeks for me.
I have known I have hep c since 1990 and been a 3 time null responder. I also slowly progressed over the years and was diagnosed with cirrhosis in 2008. I did not have the Q80K check. I am holding I have treated enough I guess I will know in 12 weeks
there are different combos/mixes of these three drugs......it all depends on the state of your liver and several other tests they take.
Interferon is a beast...it affected all my muscles, caused me rashes, and hair loss, and aged me 20 years in 2 years.
I am now on sovaldi/riba...so far have done well on it...1st mo. lots of energy...2nd month did too much...wasn't hydrating enough or resting,,..,platelets dropped,,., almost needed a transfusion...but doctor changed the dosage on the riba,,,, dizziness & nausea have gone......platelets normal now,,, resting more and not overdoing my activities. Everyone is different....my age is also a factor.... but got my fingers crossed as I want this HCV gone before I have my transplant.
Have had HCV since mid 90's....null responder to every single other drug protocol they put me on.....was on 5....but interferon or pegainferon was included in them and they just didn't work.
I'm cheering you on Heart. This time, you're going to be cured!
Thanks for all the replies! Love it. I am tx naive and am waiting on the polymorph results. Am getting more and more reluctant to take the riba..
Just wanted to say hang in there and do whatever you need to do to get through this treatment successfully. It will make such a huge difference to have a liver transplant knowing you don't have to worry about recurrent Hep C. The virus in a new liver transplant recipient is much stronger and damages the liver much faster due to the immunosuppressant drugs you will be taking.
I know you feel that those prior treatments didn't work and yes, they didn't in terms of eradicating the virus in your body. But as I read many of the posts of the null responders like yourself and compare it to what happened to my husband (end stage liver disease with a MELD score as high as 33 at one point)) I have come to the conclusion that those treatments helped slow the progression of the disease even in the null responders and that hopefully now this will help the new treatment to be successful. (Hope that made sense).
I am praying for all of you null responders in particular because I know what disappointment you all have experienced (some over and over) after committing yourselves to treatment and coming out of it unsuccessfully.
I wish you the best as you move forward in treatment.
Your doctor knows your overall medical condition better than anyone else and is thinking you'd benefit with the addition of Ribavirin. Are you treating for 12 or 24 weeks? I've treated a total of 96 weeks with Riba before this 3rd try. If the side effects are similar this time my thinking is that it is only for 24 weeks. You can handle this if it means to rid yourself of HCV forever.
Lynn I think your treatment course was the right one and believe you'll be SVR at your 12 week. From what I've seen there is little difference in SVR from the two arms.
We discovered HCV in 1992 on reenlistment physical. No follow-up and retired in 1994. Had a major variceal hemorrhage 2005. Dx'd cirrhosis during that admission based on clinical findings.
Treated 48 weeks 2006 w/SOC, null responder.
Treated 48 weeks 2011 w/SOC+Vic, took boatloads of Neupogen & Procrit to avoid dose reduction. relapse 2 months post.
I've had the same GI doc since before the first treatment attempt. He actually was hesitant to begin this sol/oly + riba so early in the game and believed I'd remain healthy enough to wait and treat with sol/led when it hits the market next year. I thought the odds were worth the chance if Tricare insurance would approve. I asked him for the 24 weeks only because of my old mind set thinking that cirrhotic's must treat longer-not based on the results of this new class of drugs.
My doctor also wasn't too hip on adding Riba and let me decide (of course some studies show better results by not adding it). I think that the real star in both of our cases is the Sovaldi, not the secondary drugs.
He also offered to test for Q80k and I didn't really want to know if I was poly or not. I think I've seen that approximately 48% of 1a's are poly. Regardless of previous PI attempts. If that's true, then 52% don't have it, maybe we're two of them.
I asked for 1200 mg Riba thinking, rightly or wrongly, that more is better.
Was not overly optimistic about getting approval thru Tricare on the first try based on off label use and exorbitant cost to taxpayers. My appointment with him where we discussed this was on a Thursday morning. On the following Monday the specialty pharmacy called saying they're overnighting the meds.
IMHO everything that's happened with our treatment course so far is for a reason, as will be the outcome. I'm excited Lynn and will be watching for you and others here to reach SVR this time.
"Curious what the Ribavirin addresses........"
"Hepatitis C virus (HCV or sometimes HVC) is a small (55–65 nm in size), enveloped, positive-sense single-stranded RNA virus ."
"RNA viruses have genomes composed of RNA that encodes a number of proteins. The viral genome is replicated by some of those proteins, while other proteins protect the genome as the virus particle moves to a new host cell."
"..... when ribavirin is incorporated into RNA, as a base analog of either adenine or guanine, it pairs equally well with either uracil or cytosine, inducing mutations in RNA-dependent replication in RNA viruses. Such hypermutation can be lethal to RNA viruses."
Thanks Nan...hopefully you are right....I started all of this out in '96 with a hepatologist coming in to the exam room with tears streaming down his face to tell me I had the virus so severe and load count so high they approximated that I had 30 days left to get my affairs in order. Then gave me a VCR tape about HCV....when I watched it all the people on it who had HCV died in their sleep. Frightening tape,
Mentally I was in shock with him crying and all but at the same time silently screaming ********. I quietly got up, handed him a tissue, and told him to get off his *** and find me a hepatologist who was proactive. I had a lot of living to do.
He got me S. Chris Pappas who asked me..."are you lucky?"...I said most of the time...then he asked "do you gamble?"" Yes, He said "well if you feel like taking a chance...think I have a few things for you"...he was my doctor for 3 years until he left and went into fulltime HCV and liver research. He turned me over to Paul Kwo and have been with him every since.
Everyone should take a chance on treatment. If you've got a great hepatologist who is devoted to HCV and liver research and treatment. Be proactive.....it's your life.
Interferon related drugs might work for some but for like I had awful side effects and the side effects aged me so quickly. However until 2 years ago I worked 70-80 hours a week...as a EMT, took paramedic courses, plus bartending when I had a few free hours, The I went into call center management as a manager at nights and managed anywhere from 100-200 people, Everyone I worked for knew I when on was on treatment and were find with a day here and there off, I believe focusing on work helped me because I didn't sit there worrying away all day about myself.
However 18 years later I still have the HCV...went from a liver like a babies to needing a transplant....am stage 4 decomposed liver, On pre-transplant list....starting year 2 of waiting. ...Have a MELD of 13-14..but doctors want to do asap due to my age. 67 & I have absolutely no health problems except the HCV and liver. Plus with a decomposed liver, the worse it gets the more it taxes other organs,
Drives me nuts when I read posts and people do not seem to know that livers have 2 stages....composed and decompose...and that each stage has 4 levels and each level has 3 stages, Composed livers can rejuvenate,,,,,,, Decomposed livers can not unless in the every early stages but mostly not because one has to wait for MELD to be of a certain number and usually they use available livers for the very ill. Out of approximately 17,000 patients on a pre-transplant list this year, 3 - 4 thousand will receive a new liver. Any one on a liver pre-transplant list knows there are many requirements you must match to receive the new liver.
Normally it usually takes several plus years for one to move from composed to decomposed, But it will eventually happen. That's why it is important to treat the HCV as soon as you can, adjust your diet, smallest trace of sodium, no sugar, no alcohol, no smoking, no red meats, get away from processed foods...they are high in salts, sugar. If anything is no fat it is high in salt and sugar. Limit your fats to only the good ones. No carbonation or caffeine...increase water...more vegetables and fruit...can have chicken and fish.... I miss bacon...so sad.
If this drug doesn't work then at the end of December or in January there is a new drug going to be available. So they are starting to really work on curing this beast. I was on 1200 riba had to go to 1000,,,,,was getting so nauseous and dizzy I was walking into walls and thing. low platelets. They are mostly stabilized now.
When I first got this I read and read and researched everything....and at that time it meant books not computers. Everyone is so much luckier now because they have the internet and we can have websites like this.
Read, research, watch all these posts, have found info in all of them even when the title of the post doesn't seem to fit my need,,,, I have a good hepatologist who specializes in HCV....my first hepatologist who gave me 30 days to live was not...
and remember that each of us are individuals and while we might be at the same stage, type, etc.....our own bodies will react differently to the same drug or to the same disease. Listen to your instincts, I like how people post website info...it is nice... Years ago when I wasn't as ill I could have done that. Now all I can do is tell you what is going on with one individual, me.
For everyone on treatment remember at the same instant we took our first breath we were guaranteed our last breath....its what you do in between
those two breaths that makes all the difference.
Good Luck to Everyone.
Wow...that last post (2 hrs ago) was a powerful witness to 'keep on keeping on'. I agree with what you said - but could not have expressed it nearly so well. I am treating now (begin, finally, on Tues June 17th) so that maybe I will not progress to Cirrhosis. I am hopeful, from things I have read here, that if I become SVR, the F3 will also improve - the liver is the only organ that can regenerate itself. Is that great or what?
HITK: Hang in there. Sounds like you will lick this dragon. Love your spirit.
Prayers and blessings.
I finished the SOV/OLY12 week treatment back in mid May. I am a 1a with cirrhosis, my platelets have remained constant at 45. I was treated with the triple therapy which included Incivek back in 2011 and made it 6 months until I couldn't take it anymore. Relapsed after two months. I was a little reluctant to try another protease inhibitor because of the problems associated with the first generation, being hospitalized from the drug and the doctors not knowing what to do if the rash had kept advancing. Oyslio is so much safer plus a low dose, one pill a day as apposed to being saturated with nine pills a day, three every eight hours. Regarding the Sovaldi/Oyslio treatment, I was so sure the virus had returned after completing the 12 week treatment that I went ahead and had myself tested at day 20 EOT. I just wanted to get the bad news over with and not wait another 10 days plus 4 to get the results back. I got the results back yesterday and to my surprise, I am still undetected. From what I’ve read online most that do relapse are within the first 30 days with these new meds. Someone posted online that after 30 days the chance of relapse is only 2% which I hope turns out to true. If treated previously with a protease inhibitor there might be some resistance to Oyslio. The Sovaldi/Ledipasvir Electron group's cure rate was 100% for people that were prior null responders with Sovaldi and ribivarin. Those 100% numbers included those treated with compensated and decompensated cirrhosis as long as ribivarin is added to the mix. So retreating with Sovaldi doesn’t seem to be an issue as it would be with Oyslio. Those with cirrhosis actually only had a 65% cure with the Sovaldi/Ledipasivir treatment without ribivrin in the Electron group. I asked my doctor to add the ribivarin to my treatment and even extend it out beyond the 12 weeks but he declined to do so. I was approved for 24 weeks if needed. It seems like a lot of doctors are adding even low doses of ribivarin to the Sovaldi/Oyslio treatment as an insurance policy when treating those with advanced liver disease. I read online that one doc was even only adding 300mg a day. When Sovaldi was first tested as a mono treatment 100% of people on the trial cleared the virus. When the treatment was stopped 100% relapsed. When ribivarin was added later in the following trial the cured number of people went through the roof. So it makes perfect sense that ribivarin would be added to help boost the immune system especially for those that are older, been treated before and are advanced. I felt during treatment that the Oyslio did stress the liver somewhat because bilirubin and ALP numbers went up along with some weight gain around my stomach. After 48 hours of stopping the treatment I developed pretty bad muscle and joint pain which comes in waves even weeks after treatment. What helps most is hitting the gym and staying totally away from anything that is inflammatory such as sugar, caffeine, dairy products etc. something that people with liver damage should be doing anyway. My doc might have only wanted me to do the 12 weeks because not many have been treated with this combo and if it failed to just have me retreated in October with the Sov/Led ribivarin treatment even if I can only tolerate the ribivarin for part of the treatment. There were many more people treated and much more hard data available from trials conducted using that combo. Best to eat right, exercise, drink plenty of water and get plenty of rest while on any of these treatments. I got a bad sunburn in 15 minutes when I was out in direct sunlight. Watch out for weight gain around your mid section which is what happened in my case and if you do make sure you let your doc know about it. Definitely felt a little bloated during the second and third months. The specialist up at Duke said he wanted me to get real skinny, no fat around the mid section so I'm now trying to get that to be a reality. I hope this helps someone, not many posts from people that have completed the treatment so far.
“Perfect Results for Sovaldi/Ledipasvir, But Only With Ribavirin”
“Among genotype 1-infected patients who had failed prior treatment with SOF plus RBV, 100 percent (19/19) achieved SVR12 following 12 weeks of LDV/SOF plus RBV. Additionally, 65 percent (n=13/20) of genotype 1-infected patients with decompensated or Child-Turcotte-Pugh Class B cirrhosis receiving 12 weeks of LDV/SOF without RBV achieved SVR12. LDV/SOF with and without RBV was well-tolerated, including among patients with more advanced liver disease.”
- See more at: http://www.lifebeyondhepatitisc.com/2014/04/hep-c-treatment-combo-sovaldi-olysio-hep-c-patient-tammy-part-1/#sthash.KANUlsMV.dpuf
Interesting Hoping for Cure....are your platelets still in the 40's? Mine went down to 9 but came back up to 10...hanging in there in the lower teens. He was going to do sovaldi/Oyslio /riba but liver in too bad of shape. So he removed the Oyslio. I am genotype 1. He didn't do the Oyslio because I was Child Pugh cirrhosis. So your next to last paragraph probably fits me.
The sovaldi not causing any bad effects...but the riba....it lowers your platelets....has increased my fatigue....haven't noticed any sun problems...did with interferon though....took years to get over it...my skin would sunburn even though fully covered up. Until we lowered the riba I was having tightness of chest, along with the dizziness.
You are so correct. Exercise is good....if you aren't dizzy...too much sleeping slows down your blood flow which a bad liver has to work overtime to move to your other organs...so it is best to eat right, exercise, drink plenty of water and get plenty of rest while on any of these treatments
Hope you are doing okay.
Thanks for this very informative post. Great news on your post 20 day undetected. Will you test again before the post 12 week test?. I'm also a 1a cirrhotic
I'm on day 27 of Sol/Oly +Riba and was interested in seeing how Olysio spiked your Bili. Mine was elevated (3.9) at my 2 week labs and I just blamed the Riba for RBC hemolysis and the liver converting that to bilirubin. Looks like Oly may have a hand in it since you didn't take the Riba. Has your Bili / enzyme's returned to pre-tx levels?
Did you notice any physical changes prior to your first UND that led you to believe you'd become UND? For as long as I can remember I've had rather excessive oily scalp and skin. During the last treatment with SOC+Vic my skin secretions changed and became what I'd consider normal. This occurred several weeks before I'd gotten the first undetected PCR. Skin remained normal throughout the remainder of tx and was UND at EOT. However, several weeks before my relapse PCR my skin had become oily again and I'd just knew that I had relapsed.
Scheduled for the 4 week lab/PCR in two days. If this oily skin theorem is worth anything I noticed a change beginning on day 18.
Encouraging information with Sol/Led + Riba for cirrhotic's in the Electron studies. Hopefully, you and the rest of us here won't need to go that route.
Best wishes on your SVR,
I completed 12 weeks of Sol/Oly (SIM/SOF) + ribavirin on April 7. I've been undetectable since week 4 of treatment, including a test at 4 weeks after treatment completion.
I did have some lab abnormalities during early treatment, including a rise in my bilirubin up to 6.3 (from 1.4), as well as an increase in my creatinine to 1.7 (from 1.2). I did have to decrease the riba dose from 1000 daily to 600 daily because of increasing anemia.
The bilirubin remained somewhat elevated in the 3+ range throughout treatment, and has returned to normal now that I've completed. Creatinine was treated with better hydration.
Bilirubin elevation is occasionally seen with Olysio, but elevation to 6-7 is unusual. My doctor believes it is due to underlying defect in my liver's metabolism called Gilbert's syndrome, an otherwise asymptomatic problem.
My 12 week EOT blood test for SVR will be about July 7 - keeping my fingers crossed.
"I started all of this out in '96 with a hepatologist coming in to the exam room with tears streaming down his face to tell me I had the virus so severe and load count so high they approximated that I had 30 days left to get my affairs in order. Then gave me a VCR tape about HCV....when I watched it all the people on it who had HCV died in their sleep. Frightening tape,
Mentally I was in shock with him crying and all but at the same time silently screaming ********. I quietly got up, handed him a tissue, and told him to get off his *** and find me a hepatologist who was proactive. I had a lot of living to do."
I reposted your initial paragraphs because it is a powerful testimony on how no one should ever let anyone else (including doctors) take their hope away. Saying I am shocked at what this doctor did to you is a huge understatement. Thank God that you had the strength, belief and yes, hope that you would beat this thing and not let his own ineptitude make you believe that your life was over. Here you are 17 years later still fighting the incredible fight.
I'd be curious if you ever let him know how wrong he was. I hope he did not do that to anyone else who are not as strong as you are. I believe my husband is alive today and also fighting the good fight because he too had the strength, belief and hope that he would beat this thing.
Know that you will continue to be in my thoughts and prayers and that soon this will all be behind you.
Excellent news on your post PCR, you've got to be excited! If I'm not mistaken this first month is the most predictive for SVR. It really is great to see these results from the current generation of treatment drugs.
I remember your post back when your bilirubin went to 6.3. I had to look up GS but that would explain a lot of the elevated bili. I believe you are also 1a right? What stage is your liver?
I'm cirrhotic and over the past couple years, even during the latter days of SOC+Vic in 2012, the bilirubin has been WNL. Six months ago it bumped to 1.6 and baseline this time before starting S/O+R was 2.2.
The two week draw showed 3.9 which is little lower than the same time when treating with SOC back in 2006. It may settle down in a bit.
Best wishes on your SVR on 7/7.
My bilirubin went from .9 to 1.1 at two weeks. At end of treatment it was up to 1.3. My ALP went from 111 to 131 during that time and my kidney functions were a little elevated. My platelets stayed the same during the entire treatment at 44 and 45. I had a light rash on my arms during treatment but no other changes. Forcing myself to drink a lot more and take note if I feel like I need more water at anytime of the day. That seems to help with the muscle and joint pain.
My blood pressure is always normal but when I went in for the viral load test the last time it was way up there I guess from stressing whether I had relapsed or not. I'm going to be retested at day 34 by my gastro doc. including the liver panels. I read a post a few days ago where one person was the only one to relapse out of the 45 other patients that were treated by the same doctor with this combo which I believe was just the two drugs without ribivarin.
It's early yet but the number of people that are not relapsing at 30 days is looking like a good indicator towards a cure as was the case with the COMOS trial at 4 and 12 weeks EOT.
One more thing that I forgot to mention that is huge for cirrhotics is to pass everything you take in every 24 hours. That's what I've been focusing on as well as diet and hydration over the last three days and it's working. Everyday I feel a little bit better.
Just my taking a little milk of magnesia for a couple of days gets you started and also adding a little benefiber in water helps. Believe it or not you should have three stools a day. Benefiber dissolves clear in water and has no taste.
Just makes sense that it takes a huge load off your liver and would also help bring down inflammation in your body. I bought Dr Wes Jones book and it was a real help. I got nowhere with the gastro doc in my area regarding constipation, they just said take more Metamucil or that constipation is part of the liver disease. Not true. Here's a video to check out.
Great posts everyone. L and L just wanted to add, I took the Ribavirin for 12 weeks, and it really wasn't that bad. Had anticipated the worst and was somewhat surprised. Don't get me wrong, would have been happier without it but with SVR in mind very manageable. Seems as tho I may be one of the 1st groups to treat (other then the controlled group) with the new meds. Am geno 2, Sovaldi/Ribavirin, 12 weeks, early cirrhosis, never treated. Started meds Jan 15, ended April 7th. 110 lbs, Riba 1200. Hmg only went down to 10.4. 30 days post EOT, UND. Get my 3 month post blood draw in 2 weeks. June 28th. Get the results within a day. Know additional 3 months would be more secure, but wanted to let all know that will post the results as soon as they are forthcoming. Have felt as tho my virus has been cleared up until lately. All the aches and pains are back and hopeful not a bad sign. With anticipation, will post once I know. Should a relapse occur, optomistic that the prize is within reach. Wishing everyone positive results, and a world devoid of this horrendous virus. Kim
Really agree with your thoughts on regularity and inflammation. Also, so important for cirrhosis related HE. Watched the utube video and the MDs recomendations make perfect sense. As I as browsing, came across the People's Pharmacy. They always give easy to follow advice as well. Just thought I would throw out a simple tip they shared. Sugarless gum! Same effect and readily available. Kim