Anyone have very high viral load but no symptoms and low other markers?

[New York Girl]

Has anyone else had the situation of extremely high viral loads (11 million+) but low LFT's and other markers (fibrosis 1, no cirrhosis)? I've most likely had this in my system for almost 40 years, with no symptoms that I am aware of, but the high viral load is a bit scary. I'm still trying to get approved for Harvoni, and wonder how urgent treatment is at this point. Maybe in a year or two approval will get easier?

[dragonslayer]

New York,

Viral load doesnt correlate well with liver health... You can have a very low viral load and be cirrhotic, and have a high viral load and have little or no liver damage, like yourself. 

More important in judging the immediacy of treatment need would be your fibrosis/inflammation scoring determined by biopsy or fibroscan.   Your doctor would be the best judge of this for you.

[Bituman]

Has anyone else had the situation of extremely high viral loads (11 million+) but low LFT's and other markers (fibrosis 1, no cirrhosis)? I've most likely had this in my system for almost 40 years, with no symptoms that I am aware of, but the high viral load is a bit scary. I'm still trying to get approved for Harvoni, and wonder how urgent treatment is at this point. Maybe in a year or two approval will get easier?

Check out my signature.  Very similar history to yours.  To my knowledge, I never had any symptoms from HCV.  LFT's on high end of normal range.  Since diagnosed in 2007, my doctor recommended I wait for more effective and tolerable treatment.  Along came Harvoni, he recommended I get treated. 

What Dragonslayer says is pretty spot on.  I assume since you are pursuing treatment that your doctor has recommended it. 

Good luck!

Bob

[New York Girl]

Thank you both so much! Yes, my doctor has prescribed Harvoni, but Express Scripts has denied Harvoni, will only provide Viekera Pack as first line treatment, Harvoni only if VP fails. I am determined NOT to take ribavirin for a variety of individual reasons - I went through a horrible chemo treatment 7 years ago, involving many blood transfusions for lowered red blood counts, as well as more side effects than I can list here. I was determined to be a slow metabolizer, and riba stays in the system in normal people for 6+ months. For me it could be double that, and the dosing is complicated and potentially dangerous. Since I can't afford to stop working, I am really pretty scared of the riba side effects and want to avoid it if there is any way. I'm getting a second opinion to see if this doctor can make a stronger case for me, or if he thinks it would make sense to wait and try again if I can't get it approved now. This whole think is making my nuts!

[Bituman]

Thank you both so much! Yes, my doctor has prescribed Harvoni, but Express Scripts has denied Harvoni, will only provide Viekera Pack as first line treatment, Harvoni only if VP fails. I am determined NOT to take ribavirin for a variety of individual reasons - I went through a horrible chemo treatment 7 years ago, involving many blood transfusions for lowered red blood counts, as well as more side effects than I can list here. I was determined to be a slow metabolizer, and riba stays in the system in normal people for 6+ months. For me it could be double that, and the dosing is complicated and potentially dangerous. Since I can't afford to stop working, I am really pretty scared of the riba side effects and want to avoid it if there is any way. I'm getting a second opinion to see if this doctor can make a stronger case for me, or if he thinks it would make sense to wait and try again if I can't get it approved now. This whole think is making my nuts!

When I started considering treatment, I had already decided that I preferred Harvoni but would accept Viekera Pack if that was my only choice.  I made this decision for exactly the same reason as you.  But now that I've watched all these threads, it seems like the riba that is part of Viekera Pack is somewhat tolerable.  Lots of others on here can comment on that, especially Lynn.  Like you I have a history of really nasty chemotherapy: two solid years of puking, rashes, no hair, mouth sores, etc.   That experience did weigh heavily on my mind when considering treatment.  It remains to be seen whether I was lucky to get treated with Harvoni rather than Viekera Pack. Anyway, I think it's a good idea that you are getting a second opinion.  But if it turns out that your only option is Viekera Pack then that's not such a bad option compared to what you've already been thru, and it's a very effective treatment.  I used to train for and run marathons.  Once, somebody gave me a shirt that said, "think running a marathon is tough, try chemotherapy."  So...think Viekera Pack is tough...try chemotherapy..." 

Congrats on beating cancer!  you will beat HCV too, and it will very likely be an easier fight.  Good luck. 

Bob

[New York Girl]

Bob, thanks for sharing that. It sounds like you went through something much like I did, and I'm so glad you are OK now. I love the marathon and chemo quote! Did the doctors think your chemo reaction was "typical"? And how was the Harvoni for you? Did you have many side effects? I was in and out of the hospital with my chemo, even after they decided I wasn't able to clear the drugs as quickly as I "should" have been, and ended up bedridden for almost 3 months. I just can't afford, either financially or psychologically, to risk that again. But I am not hopeful about my appeal either, since the first doctor I saw wrote a pretty weak letter. Hoping the new one (who I can't see till August) will do better!

[Bituman]

Yep, my chemo side effects were then considered normal.  First three months were real bad, but then it became increasingly tolerable as the months went by.  By the end of 24 months, I was sick for only a few days after chemo.  All this time I was a full time student at a major university, in a challenging curriculum.  That's why I wasn't particularly worried about side effects from Harvoni or Viekera.  I had already endured much worse and I was anxious to be rid of HCV.  As it turned out, I had no side effects from Harvoni, which is the case for most (although not all) people.  Moral of all this is that you would probably breeze thru treatment.  First, most people have minimal or manageable side effects.  Second, even if you have some issues, your previous experience has hardened you to discomfort.  I bet you would smack down any side effects with no problems working.  The question you have to answer is, "am I more afraid of treatment or the long term consequences of HCV?"  For me it wasn't even close. 

Really hopeful that your new doc is more skilled than the other one in gaining insurance approval.  Keep us posted on how it's going. 

Bob

[New York Girl]

Bob, your story does give me hope! The question: "are you more afraid of treatment or of long-term consequences of HepC" is actually not so easy for me to answer, since the chemo literally almost killed me (which is why they stopped it short of completion) and the HCV has had no symptoms to date. I realize no symptoms doesn't mean no danger, but it's still hard to weigh. I am willing to risk the symptoms of Harvoni, which sound quite manageable, but maybe not those of ribavirin. Anyhow, the new doc is head of liver disease and liver transplant at a major NY hospital, so hopefully he will have more experience and info than my first one (who has never treated anyone with Viekera Pack). Also, I'm a lot older than you (I'm 65) so, not to be morbid about it, I have fewer years ahead to worry about! I probably won't know anything for a few months, but will definitely post when I do. Thank you again, and to everyone else here, for sharing their stories!

[rainbowray]

Hi New York Girl,

Viekera Pack is suppose to be successful with 1A Genotype if that is you.
If you ar 1B it is almost a 100% cure rate. If you do not have cirrohsis, then
why are you concerned about Ribavirin, it is not in Viekera Pack or needed.
If I had the option at the time when I recieved treatment, with my 1B, I would have danced to get Viekera Pack.
I did sovaldi/ribavirin over a year ago, I tested now with no viraload, so all is ok with the hepc, but I would never had agreed to Ribavirin if I knew what I know about it now. I agree, don't take Ribivirin, not needed for you at all.

What I am not in agreement in is waiting, even for Harvoni because Viekera Pack is a good option.   Hep C can cause other issues beside liver problems, when it decides to progress, it can happen quickly. I had hepc over forty years and felt I contained it with a good life style, (food and herbs) but I developed Cryoglobunemia from the hepc in my body so long. Now I have to deal with that.
My opinion is don't wait too long.

[New York Girl]

Wow. That's scary. I do have 1a, but was told by my doctor that he wouldn't prescribe Viekera Pack without ribavirin, because the cure rate without it is so much lower (90% vs 97%). That was my first suggestion, because of my unwillingness to take ribavirin, but it seemed a non-starter with him. I may do it anyway, if I am unable to get Harvoni, since my insurance states that it will cover Harvoni if V-Pack fails (doesn't say anything about the addition of ribavirin in the policy, I just noticed!). I thought that the riba was included in the pack, but if it isn't, that might be the solution, even though it could potentially mean double treatments. So incredibly stupid of the insurance company!!

[rainbowray]

Well, I made a mistatement somewhat.

http://blogs.hepmag.com/lucindakporter/2014/12/abbvies_viekira_pak.html

For 1B no ribavirin if no cirohsis, and 100% cure rate.
For 1A it is suppose to be about 3-5% better with ribavirin for 12 weeks, no cirohsis.

So I made a mistatement, even though the treatment I took for 24 weeks only had about 85%-90% chance. I succeded.  So Viekira pak without ribavirin has a better % than what I took, for 1A.

If you have doubts, wait if Harvoni can be approved.   If I knew what I was up against and in your situation, I may have gotten the Viekira Pak with ribavirin, and take the Ribavirin till I was at undetected, and then stop it.   I'm not saying you should do it, but I won't take ribavirin for anything now. It really is very harsh.

[KimInTheForest]

Everybody's experience with these drugs - including ribavirin - is really very different. I don't think anyone considering treatment should be scared off of 12 weeks with ribavirin, if that treatment is what is available to them right now and is giving them an excellent chance of being cured of Hepatitis C. I am on Week 7 of 12 of Harvoni+Ribavirin, and honestly the ribavirin has so far been a non-issue. Yes, my hemoglobin is now below normal. But except for being short of breath if I climb a hill, I feel fine, am getting lots of work done every day, have great mental clarity since starting treatment, have had no mood issues or emotional/psychological stuff. Most of the time I wouldn't even know I am on drugs. The biggest persistent side effect I have had from the ribavirin has been a dry cough, which I can control with Ricola lozenges.

My cough will go away after end of treatment, and my hemoglobin will rebound. In some people that takes a few weeks, in others just a few days. There are a number of us on these forums right now who are on Ribavirin and are not having any real problem with it, certainly nothing that would make us skip this chance to be cured. Some of us are taking it with harvoni, some with sovaldi, some with ViekiraPak.

You have a great chance to be cured with 12 weeks of ViekiraPak and Ribavirin, New York Girl. That should be seriously considered. Just because some people are having a rough go with ribavirin does not mean you will.

best to all,
kim

[New York Girl]

Kim, that's very reassuring to hear, and I'm so glad you have been having such an easy time of it. If I hadn't been told I lack one of the enzymes that metabolizes all of these drugs, I wouldn't have blinked an eye about the ribavirin. I think my situation is unique; only 1% of the population has this abnormality, and they don't (maybe even can't) test for it. It was only discovered during chemo, when one of the drugs I got (5FU) was causing life-threatening complications which virtually no one else on that treatment had experienced. So it might be fine, or it might be a nightmare; it might be a nightmare even with just Harvoni or just Viekera (Viekera contains 3 drugs, so that increases the chances it will be a problem; Harvoni has just two) but adding yet another with demonstrably greater toxicity scares me. But I really do want to get treated before I have real liver damage (F1-2 now). So I've decided I will risk taking Harvoni, and possibly Viekera, but not ribavirin. And since Viekera is less effective without the ribavirin, I'm pushing hard for Harvoni. We'll see if the insurance company will budge. They are enough to drive anyone to drink :-)

[elizabethfaraone]

Hi, New York Girl, I'm an ex-New Yorker.  I think Ribavirin is a dangerous drug.  Viekira Pak for genotype 1b is safer because it is administered without Ribavirin.  To get Harvoni, you and your doctor have to jump through a few hoops.  Your doctor goes back and forth with the insurance company until there is a final refusal while you submit an application to Gilead Support Path:  http://www.mysupportpath.com/

I completed treatment with Harvoni in February 2015 and I got the medicine for free through Gilead Support Path.  I'm still recovering and trying to build my strength.  I think I've had the virus since 1987.  I strongly advocated for myself, following the research, refusing Interferon/Ribavirin treatment, and when Harvoni was approved by the FDA, I had the hard task of finding a doctor who would prescribe it and advocate for me.  I was able to find one immediately and that was lucky, because a lot of doctors in NJ are lousy.  There are better doctors in NYC.

[New York Girl]

Wow, did you use a NYC doctor? If so, who? The doctor I saw came highly recommended, and he did say he preferred Harvoni for me, but his appeal letter was lukewarm at best. He's never used ribavirin with these new drugs, only with interferon, so he kind of downplayed the sides. I'm thinking of asking my cancer doctor to write me a letter saying ribavirin is contraindicated based on my experience in chemo - not sure he will do that, but worth a try. Also, my appointment in August with the head of the liver disease and transplant unit at a major NYC hospital might yield results. Unfortunately I am over the income limit for support path help; I did call, but all they would offer is a coupon for a reduced price on the first month. The cost of the full treatment would still be around $70,000! What a nightmare!

[elizabethfaraone]

I live in New Jersey and found a doctor close to me.  His name is Devjit Nayar.  http://gacj.net/  You might want to consult with him and ask him if he's willing to strongly advocate for you.  He seems honest and intelligent.

I'm sorry that you would be required to pay out of pocket.  Did you see this blog:  http://hepatitisctreatment.homestead.com/

You MUST ask your oncologist to write a letter stating that Ribavirin is contraindicated for you.

In the meantime, stay detached and focused.  This process of getting appropriate medicine is heartbreaking, I know.

Also, the truth is that we're not going to know the safety of these medicines for years to come, as we compile our stories as time goes by.

Wow, did you use a NYC doctor? If so, who? The doctor I saw came highly recommended, and he did say he preferred Harvoni for me, but his appeal letter was lukewarm at best. He's never used ribavirin with these new drugs, only with interferon, so he kind of downplayed the sides. I'm thinking of asking my cancer doctor to write me a letter saying ribavirin is contraindicated based on my experience in chemo - not sure he will do that, but worth a try. Also, my appointment in August with the head of the liver disease and transplant unit at a major NYC hospital might yield results. Unfortunately I am over the income limit for support path help; I did call, but all they would offer is a coupon for a reduced price on the first month. The cost of the full treatment would still be around $70,000! What a nightmare!

[TXLastTime]

I also got approved through Gilead Support Path for Sovaldi. My local state health plan denied me two times and this was my last option.

Taking a $1,000 pill for free is a good feeling and am thankful for Gilead for helping me get rid of my Hep C Genotype 3. The Ribavirin is being covered under my state health plan.

So far into my 5 days of treatment and no serious side effects except first day had a headache and itching. The itching comes and goes. Also, a problem with Insomnia but taking sleeping pills for that problem.

 

[BDK]

Hi NYC,
I am very leery about ribavirin, as you are.  My reason is because of taking it with interferon, in 1999, to treat the hep C, and developing pulmonary sarcoidosis, and having to stop treatment half way thru.  The sarcoidosis has never returned.  the doctor wasn't sure if it was just the interferon or the riba as will that caused it.  So, in Nov 2014, my doc prescribed Harvoni.  Anthem denied it, I appealed it, Anthem denied it again, and I appealed that.  They denied it again.  I requested an independent medical review, which was granted.  For the review, I submitted lots of past paperwork from 1999 showing that I coudn't take riba because of the question of sarcoidosis, therefore my only treatment was Harvoni.  Today, I heard the results of the appeal - in which they overturned Anthem's denial and I am approved!  It was clear in the reviewer's summary, that one of the reason's the denial was overturned is because I cannot take riba and can only take Harvoni.

So, if you have already had 2 denials, and have appealed those and both appeals were also denied, then request an external medical review. The denial letter should tell you how to do this.  It varies with if you have an HMO or not.  You have 4 to 6 months to do it from when you got your last denial letter (depending on your insurance.)

Good luck!  Barbara

[New York Girl]

Wow, Barbara, thank you - and CONGRATULATIONS! Yours is a great reminder that perseverance does pay off, and I am so glad you kept at it. The insurance companies are banking (literally) on the fact that we will just give up and go away, and the more that we don't do that, the more they will see that their restrictive policies are not going to work. Right now my husband has appealed to his employer (who are ultimately the ones who will be covering the cost, and who are the ones who OK'd the deal with Abbie) to see if they can get Express Scripts to pay it by intervening directly on his/my behalf. If that doesn't work, I will try what you did. So far my initial doctor has not answered my emails or calls at all, in response to the letter I wrote with new medical information in it. I have a second opinion scheduled for the beginning of next month, with a new doctor, who may be more responsive. Let me and us all know how your Harvoni treatment goes, and GOOD LUCK!

[elizabethfaraone]

Continue to try to get the medicine.  If all else fails, there are alternative ways to get the medicine.  Fortunately, you're not in a huge rush, although I believe everyone should be treated ASAP.

Manufacturers of Generic Hepatitis C Medications

by Greg Jefferys

Mylan, who manufacture Sovaldi and the generic version Myhep, was founded in the USA in 1961 specifically to manufacture generic drugs. Its Indian branch manufactures for the US and European markets as well as India and Asia. It is FDA approved and Gilead licensed.

Cipla who manufacture Hepcvir under licence from Gilead also manufacture in an FDA approved factory.

My information, from several reliable sources in India, is that GILEAD has licensed Mylan to manufacture Harvoni in India and Mylan has applied for approval from the relevant Indian Authorities. I have been advised that this approval should be granted within the next six months. So some time before Christmas 2015.

So we have this situation where Sofosbuvir is being manufactured under licence from Gilead in factories inspected and approved by the US FDA and yet doctors are saying: "Oh no we can not prescribe generic Sofosbuvir out of India because we can not trust the quality."

When the reality is that up to half of the drugs that doctors prescribe every day are probably manufactured in India.

So what is really going on here?

We have a situation where hundreds of thousands of people are suffering and dying from a disease for which there is a cheap and effective cure but their doctors are not prepared to write a prescription for the medication that will cure them because the medication comes from a country that manufactures about 40% of the world's prescription medicines.

So don't wait around for doctors, bureaucrats and health department functionaries to decided your fate, take personal control of your health and start treatment now, it is not difficult and not expensive. You can either fly to India and get the medication yourself or you can have it couriered to your door. It depends on the Customs laws in your country. Some people might need to go to India and do the treatment there. You can live comfortably in India for less than $200 per week.

[BDK]

Thanks NYG, and by the way, I did the appeals and the request for external review on my own - just used copies of records that I had previously requested.  Didn't involve my doctor at all.  My insurance plan is an EPO, meaning it is funded thru my employer but administered thru Anthem, hence I requested an  external review directly from Anthem.  (In CA, if I had an HMO, it would be to a different agency.)  And I also copied the president of my business (it's huge) on what was going on.  He deferred my letter to he VP for HR, who also told m that because the insurance is an EPO, that if my independent review resulted in a denial, I had a another step to go, and could appeal to the business person who ran the plan.  I never got that far so am not sure of the details, but it sounds like your husband's plan might be similar.

Good luck, and please do keep us informed.

[New York Girl]

Thanks, BDK, and I will!

[Scoutdoy]

Hey New York girl ....my viral count is 13.9 million....whew, that is a load, but all my markers are normal and I have no liver damage so far. I was stunned when my doctor got me approved for Harvoni.  I will tell you this though, be your own advocate and be persistent.  My doctor has a special team just for getting people approved and for appeals. I truly believe the initial request by your doctor requesting harvoni is critical. Honestly, if my doctors office didn't reply to phone message or e-mails about your concerns I would be Leary about their sincerity in the effort of trying to get this drug for you the first request. My doctor  included every symptom I have ever experienced along with additional information on why I needed this drug. I got approved within 2 weeks. Good luck to you and stay positive. Not to be crude but put your bitch hat on if they don't put the first request in as essential for you. It's your life this is affecting, not theirs. I start my treatment with Harvoni next week! Good Luck.

Scout

[elizabethfaraone]

This doctor might be able to help you get the medicine.  http://www.vitals.com/doctors/Dr_Douglas_Meyer.html

Has anyone else had the situation of extremely high viral loads (11 million+) but low LFT's and other markers (fibrosis 1, no cirrhosis)? I've most likely had this in my system for almost 40 years, with no symptoms that I am aware of, but the high viral load is a bit scary. I'm still trying to get approved for Harvoni, and wonder how urgent treatment is at this point. Maybe in a year or two approval will get easier?

[New York Girl]

Thanks to both of you, and congratulations! I finally got my doctor to advocate for me - he had a peer-to-peer talk with the insurance last week, but I haven't heard any results yet. Keep your fingers crossed! We have also advocated with the HR person in charge of the medical insurance at my husband's job (through which I am covered), and am hoping he will help as well. But yes, Scout, my bitch hat is securely in place, and I will not give up on this one!

[Scoutdoy]

Good for you...I know New York well, spent half of my life there. Father lived there, mother lived in Midwest.  I just read that Caremark made some kind of deal or agreement with pharmaceutical company for Harvoni.  Didn't get to read the hole article but sounds like insurance is starting to move in the right direction. Hope so anyway

Scout

[New York Girl]

VICTORY IS MINE! I just got the word that my husband's employer has intervened and issued a waiver to force Express Scripts to cover my Harvoni! This was a very long (took 6 months) battle, but very well worth the fight. Thanks to all for your encouragement and advice. Once I actually start the drug, I will post on progress.

[KimInTheForest]

Congrats on getting your Harvoni covered New York Girl!

kim

[elizabethfaraone]

Great news that you got the medicine.  Thanks for sharing how you did it.  Another option for those who are unaware that their employers can pressure the insurance company.  After all, they do have leverage.

[New York Girl]

Yes indeed. In fact, with many large companies, it's the company that actually pays the costs. The insurance company and drug plan simply administer it. So if the employer says "pay" they do. If you can find someone sympathetic, and unwilling to tell you no to your face, you have to get sicker before we will consider treating you, it's well worth a try. We were very lucky, and I wish everyone the same luck!

[Scoutdoy]

That's fantastic!!! I too work for an extremely large company that is self insured and has Bcbs just administer our plan. Good luck. On a bright side I have experienced no real side effects so far with Harvoni that I can think of except one very very strange thing. My pupils have a blue ring on them. I am almost 50 and my eyes have always been solid green. It's kind of creepy....but my kids think they look super cool! LOL

[elizabethfaraone]

is the light blue circle around your iris or pupil?

[Lynn K]

Interesting article

http://www.allaboutvision.com/conditions/eye-color.htm

Changes in Eye Color

The iris is a muscle that expands and contracts to control pupil size. The pupil enlarges in dimmer lighting and grows smaller in brighter lighting. The pupil also shrinks when you focus on near objects, such as a book you are reading.

When the pupil size changes, the pigments in the iris compress or spread apart, changing the eye color a bit.

Certain emotions can change both the pupil size and the iris color. That's why some people say their eyes change colors when they're angry or loving.

Eye color also can change with age. This happens in 10 to 15 percent of the Caucasian population (people who generally have lighter eye colors).

For instance, my once very brown eyes are now hazel, a combination of brown and green. However, some hazel eyes actually get darker with age.

Note that if your adult eye color changes pretty dramatically, or if one eye changes from brown to green or blue to brown (called heterochromia), it's important to see your eye doctor. Eye color changes can be a warning sign of certain diseases, such as Fuch's heterochromic iridocyclitis, Horner's syndrome or pigmentary glaucoma.

[Scoutdoy]

Thank you for the information Lynn. It's kind of weird though, going my whole life with green eyes and in the last 3 days both eyes have a very distinct blue ring around them.  If it was only one eye I would be concerned more than I am.  I also have not had to wear my glasses the last several days which has been nice.

[elizabethfaraone]

Get tested for elevated blood lipids.  The ring can be an indication of that.