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Hepatitis C Main Forums => Hepatitis C and HIV Coinfection => Topic started by: Oneupsf on October 20, 2014, 08:07:51 pm

Title: Started Harvoni
Post by: Oneupsf on October 20, 2014, 08:07:51 pm
Hello Everyone!

I'm new here and wanted to share some of my good news.

I'm co-infected HIV/HepC.  HIV for 28 years and HepC unknown, but it's believed the infections may have happened at the same time.  I learned of the HepC in 2009 with a blip on the liver lab radar screen, elevated AST/ALT.  Infections may be the result of a needle stick injury in 1982 out of the course of my profession.

Started TX W/ Peg/Riba in 2010 and stopped after 12 weeks, severe side effects and response was insufficient to continue.

Type 1a, viral load 9 million as of 9/10/2014.  Liver bx in May 2012 0 scores for fibrosis and 1+ mild portal inflammation in some portal triads.  HIV undetectable with Truvada and Tivicay.  TCells = 629.

The good news.  I started Harvoni on October 16th.  I'm disabled with a Medicare Advantage Plan (HMO).  I was shocked I got this medication so fast!  I went to see a new ID doctor who has never treated a Hep C patient.  The doctor disclosed her lack of experience and asked if I was okay with that.  I said, let's do this.  I waited for Harvoni, did my homework and printed out 30 plus pages of drug info for the doctor.

I requested a hand written RX for Harvoni and the doctor complied.  I took the RX to a local pharmacy.  They enter the RX in their system and my insurance approved it in 30 minutes.  I had to wait one day for the pharmacy to get Harvoni from their supplier.

I started Harvoni on October 16th.  The side effects are ever so slight, a mild headache when I wake up in the AM and only for an hour or two.  I'm a little restless with sleep.  I take Harvoni at 10:00pm to sleep through side effects.

Call it psychosomatic but, I feel some positive benefits after 5 days. Doctor thinks it's too soon as well.  My legs don't feel so heavy and I swear my head is a bit clearer. 

I'll keep everyone posted as to my progress.  Not sure if I will go 12 weeks or 24 weeks.  Viral load was high at baseline and the co-infection.

We are still trying to figure out when to do labs to track effectiveness.  Were thinking the first ones at 14 days.  Does anyone know what's recommended?
Title: Re: Started Harvoni
Post by: lporterrn on October 21, 2014, 12:12:11 am
Hi One,
Your experience exactly mirrored mine (except I was monoinfected) - I felt better quite quickly, except that I was on ribavirin too, so in about 4 weeks, I tanked because of the anemia, which you won't have t deal with. BTW, one 500 mg acetaminophen in the morning took care of the headache.
Here are some guidelines: http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have (http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have) 
I am very excited for you - who is your insurer? I am surprised you got this approved, and so quickly!
Title: Re: Started Harvoni
Post by: Oneupsf on October 21, 2014, 12:49:36 am
Hi Lucinda,

Thanks!  I'm insured through United HealthCare.  I have a friend that shared my situation and his doctor went off label and treated with Solvadi and Olsyio.  He had United HealthCare as well.  He said his doctor entered the RX electronically to the pharmacy at his visit.  He said by the time he went downstairs to the pharmacy, no longer than 30 minutes, the prescriptions were ready for him.  I believe it may have something to do with the co-infection and prior TX failure as to why it's approved so quickly.  His treatment was a success!

I'm so happy your treatment was a success, YEA and congratulations! Oh, how I remember Ribavirin and how awful it was.

Thanks for the link and info on lab testing recommendations! I'll forward it on to my doctor.

I knew I was feeling better and not crazy.  My doctor has never treated anyone for Hep C so maybe that's why she thought it was too soon. I think its like a lot of viruses, as the load decreases you naturally begin to feel better.

I'm keeping my fingers crossed that this works for me and I'm on the road to recovery. 

I truly believe everyone suffering with this disease should be able to access these medications without having to battle insurance carriers for coverage.  Life is tough enough with this Dragon breathing down your neck.  Maybe a petition at Change.org or something like that is in line.  I feel I have to do something to help people out.

Thanks again!
Title: Re: Started Harvoni - Update
Post by: Oneupsf on October 22, 2014, 10:37:25 pm
Too good to be true!

United Healthcare sent me a letter stating that they covered the first 28 days of Harvoni because, I was in my first 90 days of being new to the plan and required by Medicare to cover it.

They state Harvoni is not on their 2014 drug list and only provided it to me as a "temporary" 28 day supply.  They state for them to cover it for the remaining course of treatment my doctor will have to get a; "Formulary exception from the plan."

This is crazy!  I believe stopping anti-vitals mid-course can lead to virus resistance.

It appears the doctor has an awful lot of work to do to get them to cover the remaining course of therapy.  I'll have to stop if she can't medically justify me continuing on because, I can't afford the medication.

Wish us luck!
Title: Re: Started Harvoni
Post by: Bucky on October 23, 2014, 10:30:59 am
"I believe stopping anti-vitals mid-course can lead to virus resistance."

 Well it is know that stopping HIV antivirals will lead to VR so I would say the same would be true for these meds. This is a tricky time of year concerning insurance coverage. I believe that you should have approval for 12 weeks before you start.
Title: Re: Started Harvoni
Post by: Oneupsf on October 23, 2014, 10:39:57 am
I agree!  I was blindsided by this.  I thought when I picked up the first fill the next two would go through the same. 

I should not have started the medication until I had all three bottles in hand.  It would have been worth waiting two months for the peace of mind.  The stress of all of this is unbelievable. 
Title: Re: Started Harvoni
Post by: lporterrn on October 23, 2014, 11:17:50 am
Call My Support Path and talk to them about this:  1-855-7-MYPATH (1-855-769-7284)
Title: Re: Started Harvoni
Post by: Oneupsf on October 23, 2014, 11:23:34 am

They are working on it.  They really are a great group and very professional.  But, they have policies and no emergency supply until the insurance denies it once again and we go to the next level appeal.

It's gonna be close, and if I run out, so be it!
Title: Re: Started Harvoni
Post by: Oneupsf on October 23, 2014, 09:17:32 pm
Here is a letter that I wrote and faxed at 3:00am regarding United Healthcare's denial of my refill for HARVONI. 

Having HIV/Hep C for 25 plus years has taught me one thing, insurance companies are as much your enemy as the viruses themselves.

HARVONI also messes with your sleep patterns.  Not complaining, it's a cakewalk compared PEG/RIBA.

Wait and see how they respond.....

October 23, 2014

Part D Appeals and Grievance Department
MS: CA124-0197
PO Box 6106
Cypress CA 90630-9948

Re:              XXXXXXXXXXXX
GRP #:      XXXXXX

Dear Appeals and Grievance Department,

I’m in receipt of your letter dated 10/17/2014 pertaining to; “Drug Not Covered,
Harvoni, TAB 90-400mg.”

I’m appealing this denial on the grounds that it is unjustified and jeopardizes my health and wellbeing.

I started taking the Harvoni on October 16, 2014.  This is a medication that once started, should not be discontinued due to the risk of the Hepatitis C virus becoming mutated and resistant to the compounds, ledipasvir and sofosbuvir.

The denial of coverage would force me to stop taking the medication and therefore putting me at risk of developing a virus that is resistant to these classes of medications.  Developing a resistance would prevent me from future treatments with these classes of medications should the need arise.  This could put my life at risk!

Harvoni was FDA approved on October 10, 2014 for the treatment of Hepatitis C infection.  My physician prescribed a 12 week course of treatment as recommended and approved by the drug manufacture and the F.D.A.

I had the prescription filled on October 15, 2014.  When the prescription was submitted to United Healthcare on October 15, 2014, it was approved without further documentation requirements. 

I’m perplexed and want to know why it was authorized for the first fill of the medication without it being on your drug list?  I also want an explanation as to why you now require a prior authorization?

Your practices are very risky and I would have never started the medication until all of the requirements had been satisfied.  United Healthcare never outlined any requirements for this medication until after it was filled and I began using it.

I also would like for you to provide me with a emergency plan to continue this medication until your, after the fact, documentation requirements are met.

In the meantime, I will be contacting a Patient Rights Advocate Attorney to see what my legal rights are should I suffer any type of injury from the actions of United Healthcare.

Title: Re: Started Harvoni
Post by: lporterrn on October 24, 2014, 11:44:07 am
This is like a suspense novel, except it is real, and happening to you. Please keep us posted - I am on the edge here waiting with you.

Nice letter, btw - it could be a model for others to use.

One other point - I kept my mouth shut about this because you were approved for Harvoni, but technically the FDA did not approve a co-infection indication for Harvoni. I don't know why, since the clinical evidence supports one.
Title: Re: Started Harvoni
Post by: willie g on October 24, 2014, 01:31:09 pm
WOW oneupst,  so sorry to hear all that, I had or have not ever heard of that drug. when I read your Dr. had not treated anyone for hep c an instant red flag went up. my family care Dr. was going to try and do the same but I being a rare specimen on different meds I requested a referral to a gastro, hep c professional .I am really glad I did.but on my 3rd visit I asked how everybody else was doing on s/o treatment? he said "your the first to be on these drugs" we both had a laugh but I did walk out of there scratching my head. then s/o took off thru whole nation and other country's so I was relieved cause I could follow others progress. at one point united care messed up on a shipment and i was out for two days,, they were really sorry and I could tell they were sincere. I have suggested to folks to call 5 days before they run out to check on things and get a tracking number. that worked real well for me. I was not approved as fast as you or others [which also seemed weird when you stated that] 30 minutes? heck no it was more than 30 days and I have good insurance. the pharmacy part is real important as well as a good Dr. in this field,, they don't always work hand in hand. not because they don't care but this world and demands are sky rocketing as well as costs for these drugs so I felt and feel you should treat the drs. andpharmacies as one entity. a lot of times folks on the other end of the phone say ,''OK, oh yes no problem, everything is fine don't worry but I have also found that person can just be a receptionist and not direct care[don't get me wrong there are some great receptionists out there] but when we are dealing with our lives we are our own best advocates. as I have stated before we are given the boats and the oars but we have to do the rowing. any time I talked with someone I would get their name their title etc.[in a nice way] and write down the day and time I talked with them. in the beginning it was a crap shoot and I was scared about all the technical stuff but once I took the bull by the horns I felt much better. sorry for rambling on and I hope I helped you or others.  PS I am 2 weeks or so off of treatment of s/o and at half way point I was undetectable which made me look up and say thanks when I left office and after 12 weeks of treatment I am doing well' they said my blood was better than better.so I'm a happy camper. the Dr. did say though after being questioned about how much my liver had been damaged and would it heal, he said by my blood work I have a good functional liver  but if I wanted I could have a test[probably biopsy] to determine that and it would cost 79 to 300 dollars. I wish I had done that in beginning but he wanted me and so did I to get started right away. I told him I still have tenderness and pain once in awhile.he said well Willie your liver was quite enlarged but not so much now and he stated your a big guy so taking pressure off that area by losing some weight will help but trust me once again if It persists I will have the test. at this time I am too busy enjoying my results lol  6 months from now I go back for final update and well go from there. I AM PRAYING FOR YOU right now and things will work out,, just follow thru as you are doing and please keep us all posted and thankyou very much.  ''just'' Willie g  and to all out there s/o saved my life so any negative you hear out there make sure you don't get drawn into it unless of course you personally are or think these or any other meds are hurting you,, this stuff is scary enough and people are people and some people can be peopless lol  catch my drift . speaking of wacko[did I say that lol] I was up in old forge after I took my last dose[needed to zoom away] and in this shop they had this crooked stick with a nut glued on top of it [12 inches long] with a piece of rawhide on bottom to hang or whatever.it was coated real nice and as I looked at it I thought''what the hell is this''? there was something printed on it so I put my readers on and then I laughed my ass off, ''what did it say you may ask? it said, NUT SCRATCHER,  oh boy,, did I buy it? well what do you think? I have had it on my belt everysince I bought it and I don't have to say anything when people ask ''what is that''?  I just turn it over and let them read it.lol  enough said [of course I told my grandchildren its a back scratcher and of course the youngins wanted to scratch their backs as my sweet daughter walked away once again SHAKING HER HEAD.
Title: Re: Started Harvoni
Post by: Bucky on October 24, 2014, 02:38:46 pm
The whole Harvoni thing exploded on here while you were off on your crotchless panty run.
Title: Re: Started Harvoni
Post by: willie g on October 24, 2014, 02:57:53 pm
BUCKY YOU SLY DOG,, you got me,,,  ha ha  ill have order forms soon,some in camo   ''just'' willie g
Title: Re: Started Harvoni
Post by: Oneupsf on October 24, 2014, 07:53:28 pm
Lucinda, Bucky, Willie g,

Thanks so much for your kind words and support, they are truly appreciated!

I received an automated phone call from the pharmaceutical review company that United HealthCare contracts with.  The message was; "Your medication has been approved".

After all of these years of dealing with numerous H.I.V. meds and the insurance companies, I will not jump for joy until I swallow that last pill.  I've become a bitter old pill myself, and so untrusting.

Lucinda, your right about it not receiving FDA approval for patients co-infected with HIV.  I intentionally did not mention my HIV in the letter for that reason.  As I said to my doctor when she brought this up, "We are not treating my HIV with Harvoni".

I know my co-infection needs to be taken into account in the grand scheme of things but, I could be co infected with many other unknown viruses at this point in time.  I may have been co-infected with HCV in the mid 80's when diagnosed with HIV, and one of my Gastro doctors believes that to be the case .  We launched a war against my HIV with 45 pills a day in 1996 and chances are I was co-infected with HCV then.

I realize my rationale is way out there.  These are very intelligent viruses and they infect without FDA approval.

I personally think this whole FDA co-infection approval issue just muddies the waters and another opportunity for insurance companies to deny coverage for expensive treatment options. 

I will let everyone know as to my progress in obtaining the next refill.

So far, the treatment has been easy.  The headaches have eased significantly and generally I'm feeling pretty darn good.  The difficult issue is with sleep.  My sleep pattern is all messed up.

A fabulous weekend to you all!
Title: Re: Started Harvoni
Post by: lporterrn on October 24, 2014, 09:45:17 pm
I like your thinking!!!! And hope we will be celebrating soon.
Title: Re: Started Harvoni
Post by: Oneupsf on October 28, 2014, 01:10:49 am
Good News, Good News, Good News!

First.  I received a letter from the insurance company regarding my appeal.  They have approved Harvoni for the 12 week course of treatment.  YEA!

Second.  In two weeks time my ALT went from 42 down to 20.  And, my AST went from 30 down to 17. Bilirubin nudge up slightly from 0.8 to 0.9.  YEA, YEA!

Viral load results should be available in about 5 days.  Fingers crossed!
Title: Re: Started Harvoni
Post by: willie g on October 28, 2014, 01:40:41 am
HEY BUCKY,i think your buddy is real cool, getting ready for the season?  take care my friend. hope your health is doing well ''just'' willie g
Title: Re: Started Harvoni
Post by: lporterrn on October 28, 2014, 04:59:41 pm
Hooray Oneupsf!
Title: Re: Started Harvoni - Update
Post by: Oneupsf on October 29, 2014, 02:07:03 pm

After being on Harvoni for 11 days the viral load went from 9,196,402 on 10/16/2014 to the results below.  I'm sure by today it is most likely undetectable.

Huge Success!

HCV RNA RT-PCR, QT       72
Title: Re: Started Harvoni - Update
Post by: Bucky on October 29, 2014, 03:11:49 pm

After being on Harvoni for 11 days the viral load went from 9,196,402 on 10/16/2014 to the results below.  I'm sure by today it is most likely undetectable.

Huge Success!

HCV RNA RT-PCR, QT       72

Title: Re: Started Harvoni
Post by: Oneupsf on October 29, 2014, 04:12:43 pm
Thanks, Bucky!

Finally, I can deliver good news to my two sons and grandchildren. The old fart may be around longer than you think.  They may have been planning and plotting their inheritance.  You can't kill bad weed I alway's say, the reason I'm still here.

I will keep positive wishes and crossed finger for you as you approach December 8th.  It's going to be a early Christmas gift for you!

How have you been feeling?

Title: Re: Started Harvoni
Post by: Bucky on October 29, 2014, 04:43:00 pm
See below
Title: Re: Started Harvoni
Post by: Bucky on October 29, 2014, 04:45:33 pm

I feel better everyday!  I dug up an old stump in my side yard this morning and I am sure that I will be sore tomorrow.

Thanks for the good wishes and I hope to get the best Christmas present ever. Being virus free would be  even better than getting my first bicycle.
Title: Re: Started Harvoni
Post by: kylejacobs on November 11, 2014, 10:34:19 am

Wow Bucky!  That's amazing!  I started Harvoni on October 31.  My baseline viral load the day I started taking the medicine was 224994.  I had to have some follow-up test done one week later.  I am hoping that my viral load came down as quickly as yours.

Consider following my blog where I discuss my experiences while taking Harvoni.  http://blogs.hepmag.com/kylejacobs/
Title: Re: Started Harvoni - Update
Post by: emmett on December 24, 2014, 06:38:12 am
Congrats and best of luck for a new and healthier life.
Title: Re: Started Harvoni
Post by: george on January 09, 2015, 11:36:18 pm
This website needs to update, like to 2015
Title: Re: Started Harvoni
Post by: anniemybaby on January 22, 2015, 06:12:16 pm
I'm on day 4 of harvoni and the inside of mouth is very sore tongue hurts I'm wandering if I need to call my dr
Title: Re: Started Harvoni
Post by: anniemybaby on January 22, 2015, 08:11:41 pm
Can I take milk thistle while on harvoni
Title: Re: Started Harvoni
Post by: Lynn K on January 23, 2015, 03:49:01 am
I do not believe milk thistle is contraindicated with Harvoni however I personally am not taking anything now even vitamins to avoid messing with my treatment. But St John's Wort is on the list not to take with Harvoni. Treatment is short wait till you are done is my suggestion.

A couple of people have said something about moth sores if you are concerned ask your doctor.
Title: Re: Started Harvoni
Post by: anniemybaby on January 23, 2015, 08:43:13 am
Thank Lynn n yes I called my doctor he's gonna call in a prescription mouth rinse
Title: Re: Started Harvoni
Post by: anniemybaby on January 26, 2015, 04:50:19 pm
I go for my first blood work Thursday feeling nervous