Harvoni and Levothyroxine

[yestothis]

Hi everyone.
I am new to the forum. Have had C for about 35 years, had a short trial of Intron A shots 3 times a week in 1996. I went off that soon since  I didn't get good results.

Fast forward to now, I am on the road to Harvoni. My hubby just went through it well enough and it cleared , so now it's my turn when all the labs & tests are done.

What I am wondering is.

Will I have to wait a number of hours between taking  my thyroid med [Levo], and the Harvoni pill?

does anyone know about this? I will be talking to the pharmacy soon, but am on the road so am wondering.

thanks all

[Lynn K]

This is a link to the Harvoni prescribing information sheet section 7 covers drug interactions.

http://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

I assume you advised your prescribing physician of all medications you take including any OTC meds. If there was any special instructions they should have discussed that with you at least I hope they would have.

One thing to be aware of is if you take antacids or acid reducing mrdicines like Tums, Prilosec Nexium, Zantac, Pepsid etc there are very specific instructions on how to take Harvoni with these classes of medicines.

Good luck on treatment

[Lynn K]

I also found this

https://www.drugs.com/drug-interactions/harvoni-with-synthroid-3567-16903-1463-869.html

[yestothis]

Hi Lynn, so good to see your reply so quick.
Yes, I listed every single thing in my life that I take or do [botox even ].
I knew about the tums needing a 4 hour space in both directions from the pill, other than tums I have no other drugs that would interact.

I will have my interview with the specialist pharmacy as soon as the harvoni is ok'd. I was hoping someone on the forum had some experience with the Levo also.

I'm lucky that I saw my hubby through his treatment and do know a lot from that. I am both nervous and excited. He had it since before we met, so a long time also. We are imagining that his is cleared for good and will know that in about 2.5 months when they do the test again.

 I consider myself a pioneer in the treatments since I was on the shots way back when, and now look forward to reaping the fruit of that "experiment" as all these new cures are coming forth. I have taken good care of myself after finding out I had chronic non.A/non.B .
 I got it in 1980 and was so sick I had to go to the hospital-i was still sick when they sent me home but all I remember hearing is i'll be better in 3 months.
 I thought it went away then found out a few years later in a routine lab with elevated enzymes that it was chronic so I changed my lifestyle completely by 1986. In 1996 they even found a name for it Hep C ; and now is the time for me to go with harvoni.
I have always had good labs, even though the biopsy in 96' already showed liver damage I just kept imagining the best.
I think I have moderate liver damage now and am looking forward to clearing this virus.

I read your story and I love that you found your svr. You are a great inspiration.

[Lynn K]

Yeah hi to a fellow pioneer and as we say dragon warrior!

As you probably read I was diagnosed with hep c in 1990 but was probably infected in 1978. I too treated with interferon. My first treatment was with interferon Alpha monotherapy three shots a week of interferon for 6 months with no other medicine because that was the only treatment at that time. They didn’t even have a viral load test back then but my liver enzymes never decreased so they knew I was still infected.

Later I tried the improved interferon pegalated interferon aka pegintron brand name Pegasys only 1 shot a week this time along with ribavirin. My viral load actually increased on treatment so I was a null responder. Later still I treated with pegintron ribavirin and a trial drug with again no decrease in the virus.

By that time I was diagnosed with cirrhosis so when the next new med came along incivek with interferon and ribavirin my doctor would not let me take it because the risks were too great and the odds of it working for me was about 18% because on my prior treatment history and having cirrhosis. That was 2008.

So with no treatment available and diagnosed with cirrhosis my future was fairly grim.

Finally the new generation drugs were approved beginning in 2013. I treated with Sovaldi and Olysio and was ecstatic to see my viral load go to not detected and my liver enzymes in normal range for the first time in decades! Sadly 12 weeks after I completed treatment my virus was back to pretreatment levels and I had relapsed. Naturally, I was devastated by this news. That was Sept 2014. In oct 2014 harvoni was approved and I started treatment in November. I was treated for 24 weeks of Harvoni and after discussing with my doctor we decided to add ribavirin in hopes of increasing my odds of success so I took ribavirin for 15 weeks of my 24 with Harvoni.

Thankfully my treatment worked this time and I am now cured after 3 rounds of interferon based treatment and 2 treatments with the new DAA’s.

It has been a long and winding road...

Has your doctor suggested a Fibroscan test to determine your current liver damage? My fibrosis score was progressive with each subsequent liver biopsy. My first liver biopsy in 1993 was F1. My doctor had me have a liver biopsy every 5 years. My next in 1998 was F2, 2003 was F3 and finally in 2008 F4 cirrhosis. I know this would be frightening to face but if that is the case you really need to know. If you have less than F2 after treatment you won’t need additional follow up but if F3 or F4 we remain at increased risk for liver cancer (HCC) and will need to be followed. Our risk of HCC or further progression of liver disease is greatly reduced with cure and some have even seen improvements if their fibrosis scores in later Fibroscan results post treatment.

My treatment with harvoni was easy. It got tougher when we added ribavirin because I developed anemia but I made it through.

Best of luck on treatment.  I really don’t think your Levo will be an issue

[yestothis]

hi Lynn, wow . what a long road you had.

I said "no" to more treatments after the shots 3x a week, I was so sick.

so... yes, one fibrosure said f3 from my family doc. Now the specialist is doing it all again with fibroscan and also ultrasound. About a dozen specialized blood tests.

I'll do labs next Tuesday or Wednesday. Then the ultrasound on the 23rd.

I am configuring my life around me to prepare for the treatment so I won't have too much to do during that time. I am hoping to start mid February for 8 weeks as was suggested.

I love that we now have good options to move this virus out of our body 

[Lynn K]

Not sure 8 weeks is a good idea in your situation per the prescribing information sheet
http://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

On page 4

HARVONI for 8 weeks can be considered in treatment-naïve genotype 1 patients without cirrhosis who have pretreatment HCV RNA less than 6 million IU/mL

In other words 8 weeks is an alternative treatment other than the standard 12 listed in table 1

This should only be considered for treatment naïve with low viral load without cirrhosis. You don’t qualify based on your prior treatment plus being at least F3 near cirrhosis. Really it it were me I would want the 12 weeks to avoid the risk of relapse.

Do you know your viral load?

Also, if you are diagnosed as F4 per table 1 you should be treated for 24 weeks with an option for 12 weeks Harvoni with 12 weeks ribavirin.

“HARVONI + ribavirin for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin [see Clinical Studies (14.2)]. See footnote § for ribavirin dosage ‡ recommendations.”

This is why it is so important to know the status of your liver fibrosis before treating.

I really hate to be the bearer of bad news. I just want to make sure these issues are being considered.

[yestothis]

hi Lynn, yes. my vl has been around the 6 for a long time. also I am a low f3 by that scan. And I was only on the shots for about 6 weeks since there were no good results.

a friend at work did well on 8 weeks also even with a long history of the hcv.  I think my blood tests have been so good all these years that might make a difference.

i'll know at the 30 day blood work how the vl is doing. i'm confident that 8 weeks is good for me.

[Lynn K]

On treatment testing means little it really only is to confirm treatment adherence.

On Sovaldi and Olysio I was not detected at 4 weeks on treatment and at EOT but 12 weeks later when tested again for SVR I had relapsed. The only test that is meaningful is the 12 week post treatment test.

With having prior treatment and a viral load of 6 million you really don’t qualify for 8 weeks. Back when Harvoni was new the few relapsed we had here primarily were those treated for 8 weeks. Nearly 100% of patients are not detected on treatment. Just a rare few have any level of virus on treatment.

It may have worked for your friend but was she treatment naïve, without liver damage and a viral load below 6 million?

My liver enzyme tests were always just very slightly elevated and occasionally in normal range. Liver enzyme tests do not correlate to extent of liver damage or severity of infection. People can have high liver enzymes with no liver damage or like me have totally normal liver enzymes and extensive liver damage. Elevated liver enzymes only show something is irritating your liver how much damage has occurred.

Per the prescribing information sheet page 34  table 12

SVR rates for treatment naïve 8 weeks versus 12 weeks

Genotype 1a    8 weeks treatment 93% (159/171)  12 weeks 96% (165/172)

Page 35

Table 11 Study ION-3: Relapse Rates by Baseline Viral Load after 8 and
12 Weeks of Treatment in Treatment-Naïve Non-Cirrhotic Subjects with Genotype 1 HCV

HCV RNA ≥6 million IU/mL     8 weeks 10% (9/92)    12 weeks 1% (1/85)

Page 37

Table 14 Study ION-2: SVR12 after 12 and 24 Weeks of Treatment in Subjects with Genotype 1 HCV with or without Cirrhosis Who Failed Prior Therapy

 SVR12      12 weeks 94% (102/109)   24 weeks 99% (108/109)

 Relapse     12 weeks 6% (7/108)        24 weeks 0/109


Anyway of course this is between you and your doctor but I can’t help but try to encourage you to treat at least for 12 weeks. You certainly want to win this fight and not risk treatment failure.

From the AASLD American Association for the Study of Liver Diseases

Treatment recommendations for those without cirrhosis who failed prior treatment with interferon ribavirin

https://www.hcvguidelines.org/treatment-experienced/gt1a/p-r/without-cirrhosis

Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg)     12 weeks

And for post successful treatment follow up recommendations

https://www.hcvguidelines.org/evaluate/monitoring

For patients who do not have advanced fibrosis (ie, those with Metavir stage F0, F1, or F2), recommended follow-up is the same as if they were never infected with HCV.

Surveillance for hepatocellular carcinoma with twice-yearly ultrasound examination is recommended for patients with advanced fibrosis (ie, Metavir stage F3 or F4) who achieve SVR.

[Lynn K]

I am sure you understand my concern is based on my own prior treatment experiences.

I really want to wish you the best results and cure of hep c and worry that 8 weeks for you may not be enough. If you should relapse you risk becoming resistant and needing additional treatment while being even harder to cure.

[yestothis]

I am sure you understand my concern is based on my own prior treatment experiences.

I really want to wish you the best results and cure of hep c and worry that 8 weeks for you may not be enough. If you should relapse you risk becoming resistant and needing additional treatment while being even harder to cure.

Hi Lynn, I sure do understand what you are saying. My hubby had to do 12 weeks with the same doctor, so I really trust their judgment .

I too think everyone needs to be aware of what's going on when the seek treatment.

It sounds like you really had a brutal series of treatments and I am so glad you are feeling good and that you finally saw your C cleared.

ok, I will check back again once I am approved and got all my tests done.

[Lynn K]

Ok I’ll quit beating you up

Just wanted you to think about it

For most people treatment was really easy. For myself after everything I had been through it almost was too easy I felt guilty like you should have to suffer to be cured. Until we added the riba at week 9 it was a walk in the park maybe a couple of mild headaches and whether that was the treatment or just a headache I would have had anyway I don’t know. I did not change my routine worked every day even went on a trip.

Best of luck to you in your fight with the dragon