Treatment Decision

[Ginabros]

Hi everyone!

I have had both Hep B and C for over 30 years. I am on the antiviral, called Entecavir, to keep my Hep B viral load undetectable. Due to my being co-infected with both viruses I have been hesitant to try any of the new Hep C treatments. However, when I finally decided to give Harvoni a try this warning came out: https://www.fda.gov/Drugs/DrugSafety/ucm522932.htm. I called Gilead but I have been unsuccessful in finding out of whether the population of people who had their Hep B virus reactivated fall within the “was fully cured and seroconverted” group or my category : “still have the Hep B virus but antiviral med keeps it dormant”. I am scared to gamble with my health and make my condition worse. My doctor says let’s try, but it is not his health that is on the line.  I couldn’t find any message board/forum for Hep B and C co-infected people or any studies on successful treatment outcomes so I would like to ask you for your opinion on the above dilemma I have.. What's your take on it?

And a few more questions..

Do you know how I can get in touch with someone from Gilead who can give me the additional info I need and not just read out loud what the label says?

My Hep C gynotype is 1. Is Harvoni the most effective and proven treatment on the market right now? What tests (HCV RNA, scans etc.) would be helpful in telling if I am a good candidate for it?

I read that some people who responded to Harvoni and SVR, physically  feel ever worse after the treatment. Is it common?

Thank you so much for taking your time to read this and provide your opinion!

[Lynn K]

There is also another new medicine called Epclusa from Giliead with an even higher likelihood of cure at 98% for genotype 1a unfortunately it has the same box warning. Although Harvoni is one of the best it is not the only treatment available.

Here is a link about Harvoni which includes contact information.

http://www.harvoni.com

Here is a link to the Harvoni prescribing information sheet.

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

And the box warning information about Hep B from the above document

"WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HARVONI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1)]."

Yeah you are definitely in a catch 22 situation you don't want to awaken the virus but it is not a good thing to be infected with both hep b and hep c it would be great to eliminate one of them. I hope you are seeing a hepatologist as your situation is a bit more complicated that most. I do note the warning references those with hep b who are NOT receiving anti hep b medicines and you are.

As far as sides there have been sadly a few here who experienced difficult symptoms which they attribute to their treatment but as far as I am aware there has not been a link established between their symptoms and their treatment.

Fortunately, the majority of people had little to no side effects on treatment with either Harvoni or Epclusa mostly just a few mild headaches or some tiredness while some experiences an increase in energy. The headaches are best addressed by ensuring you are drinking adequate fluids the old 8 glasses a day we are all recommended to drink any way or maybe just a bit more.

I wouldn't really dwell on the remote possibility of troublesome side effects I would be more thinking about the hep b concern. There are also other medicines that can treat hep c so I am really thinking you should see a hepatologist or at least a gastroenterolgist experienced in treating both hep b and hep c they will be best able to answer the question which treatment will be most safe and effective for you.

Good luck

[elias]

Hi Ginabros:

I dont know enough bout HBV/HCV co-infection to directly address your concern.

But the following  CME Internet Symposium discussion does address this based on the most recent information from the annual AASLD Liver Meeting. It's a fairly long podcast, over 40 minutes. The discussion of HCV treatment reactivating HBV infection is in the latter part of the symposium. Its discussed by Nezam Afdal , one of the nation's top medical specialists in the field of HCV treatment:

http://hosted.medipix.com/aasld2016/

Hope it helps you put this in perspective.

=======================

I agree with Lynn here bout Epclusa being more effective even for GT 1.

The best summary of Gilead's research on this is in the following New England J. of Medicine article. Astral I Phase 3 study:

http://www.nejm.org/doi/full/10.1056/NEJMoa1512610#t=article

Treatment outcomes and side-effects described in detail

[Gaj]

Hi Ginabros,

Please be aware that this issue of HBV reactivation or "flare" has only occurred in a very small percentage of HBV infected patients who have treated for HCV, it is only a risk in those who have not fully sero-converted. What often happens with dual infection is that the HCV virus tends to outcompete and suppress HBV. Once HCV treatment occurs the removal of the HCV virus can provide the HBV with the opportunity to become dominant and start replicating at increased levels again which causes the normal risks associated with active HBV.

The main points from Gilead's warning are:

HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy.

See the underlined section in Gilead's above advice. You are currently taking Entecavir which would considerably reduce the risk of reactivation occurring both during and after treatment.

Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated

From what you say you have a HBV viral load which is why you are prescribed Entecavir which can be used with most of the current HCV medications including Harvoni and Epclusa. As you have a co-infection it is very important that you discuss the most appropriate treatment (which should include a HBV suppressor such as Entecavir) with a specialist who has experience with both HIV and HBV and that you both ensure that appropriate monitoring of your HBV occurs during and after HCV treatment.

Best wishes for a successful treatment.

[I fightis thetitis]

Hey Ginabros,

What are your recent labs like?
If you post them in your signature line that will help you if we hear from some hepc/b alum who have gone through this already.
What is the current with your liver?

Best of luck!

Greg
 

[Ginabros]

Hi everyone!

Thank you so very much for your responses!
I have decided that I need a little more information about the condition of my liver at the moment , before I can make the treat or no treat decision. For the last few years the doc was only checking my HBV markers  and twice a year had me do ultrasound. He said that if I am not on treatment for HCV no need to draw blood for this since we already know I have the virus. My ALT has been between 50 and 70, sometimes slight elevated AST. HBV viral load is undetectable since I am on entecavir but i am not cured and still have the virus.  The last HCV viral load I did was a few years ago and it was pretty high. I am genotype 1 (don't remember the letter). I will post this data in the signature line soon.
So, I talked to my doc and the plan is to do labs for HCV and fibroscan. Then I will try to make the wise decision..... Having both viruses makes it more complicated and scary.
If you hear from anyone coinfected like me, I would really appreciate you letting me know so I can get in touch with that person. Or vise versa..

Again, thank you for your support!