How to find out the right combination of Hep C medication

[Rene Martin]

My name is Rene Martin, Dutch, male, 58 y/o

Since 5 years I am living in Thailand on a retirement visa. I have no health insurance.

I do not drink alcohol, do not smoke tobacco and have always been fit and healthy.

Around 4 weeks ago I suffered from an acute pancreatitis and was in hospital for 2 days. Last week I had a laparoscopic cholecystectomy.

Blood tests revealed that I have Hep C genotype 1A, most likely already for some 3-4 decades.

There is no evidence of cirrhosis on the CT scans or Ultrasound, but I have not done a Fibro scan yet. I have never had any symptoms related to the Hep C.

How do I find out which medication is best suited for me, and what is the best way to obtain those medication (from India?)

Thanks in advance for any advice!

[Lynn K]

Your doctor should know the best meds for you and what is available in Thailand. Harvoni is one option as is Viekira Pak but you would have to take Viekira Pak along with Ribavirin.

Good luck
Lynn

[Rene Martin]

Hello Lynn

Thank you for your reaction. The problem is that the local liver doctor is not very cooperative and all he said that Sofosbuvir will be available in Thailand next year.

I am therefor looking to buy the medication in India.

[jakas]

If you look around you can get the meds in Thailand from GOOD people who import it there and at cost. Search google for Giten Khwairakpam he lives in Bangkok. Shiba Phurai is another.
If you plan to travel to India you can buy your meds from there or check how you can import them to Thailand. It wont be difficult.
Cost is 900 to 1200 USD. for 12 weeks. I was gonna go the generic route but got approved for Harvoni so I did not need to travel thus I know all these details of cost and suppliers. Been studying a lot 
For your genotype 1a Harvoni or its generics IMHO should be the drug for you.
You can check a site fixhepC for many options also.

[Rene Martin]

Dear Jakas,

Thanks a lot for the information! I have contacted Giten already. If possible I want to avoid traveling to India and I am already negotiating with a facilitator who wrote:

"Harvoni shipped to you with Doctors prescription will range between $1150 to $1300 based on if you need a Doctor to monitor your test results over email."

Buying in Thailand would of course be even better, so thanks again for the contact!

[beto]

It still amazes me the difference in costs depending where you get the meds. 

[jakas]

Right there mine costs $ 50000 for 12 weeks, thats Europe.

[Lynn K]

My 24 weeks would have cost me $189,000 in the US (like I have that kind of money).

I have no idea what my insurance company paid but all I had to pay was $30 with the Harvoni copay coupon.

[KimInTheForest]

How do I find out which medication is best suited for me, and what is the best way to obtain those medication (from India?)

Hi Rene. Re: your 1st question - which drugs are best suited for you... I always consult this chart:
http://www.hepmag.com/articles/2512_18756.shtml

As you can see, it gives several options for Geno 1a, treatment naive, no cirrhosis.

As far as the India connection goes for buying generic versions of the drugs, Greg Jeffreys, who went that route himself, has been doing an awesome job of blogging about it and helping other people get the generic drugs from India:
http://blogs.hepmag.com/gregjefferys/

Good luck!
kim

[Rene Martin]

Dear Kim,

Thank you for your help. I am already in contact with Greg and some of his contacts in India.  There are several charts that show the different combinations for Hep C 1A:

http://www.hepatitisc.uw.edu/go/treatment-infection/treatment-genotype-1/core-concept/all

but being treatment naive and most likely without cirrhosis does limit the options and I have yet to consult a specialist.  I will continue researching before deciding what to do next.

[Gaj]

Hi Rene,

1A plus naive and no cirrhosis is probably a good thing as far as hep c goes. The "limited" options available include the optimum two from a results perspective. These being either Ledipasvir/Sofosbuvir(aka Harvoni) or Daclatasvir/Sofosbuvir for 12 weeks depending on cost/availability.
If your fibroscan shows mid/high levels such as F2 or F3 you may consider treating with these for something like 16 or 20 weeks in consultation with your specialist if funds permit. (12 or 24 weeks as the only options tend to be driven by insurer/manufacturer wishes for simplicity/profit and the limiting constraints during clinica trials as much as anything) Most Indian suppliers can supply in multiples of 4 weeks should you require.

[Rene Martin]

Dear Gaj,

Thank you very much for your valuable advice, really appreciate it.  I don't mind paying extra for a few weeks more medication if that increases the change of a 100% cure.  Harvoni seems to be the best option for me. Will have to wait with deciding until I have a result from a Fibroscan.

[Rene Martin]

Does anyone know how to interpret this:

TEST         SPECIMEN       METHOD   RESULT      UNIT           REFERENCE RANGE
-------------------------------------------------------------------------------
HCV PCR    Serum or         PCR             -           IU/ml            Detect range
Viral load   EDTA plasma                                                       15-100x10^6
Taqman

HCV Viral    Serum or         PCR         1247797     IU/ml             15-100x10^6
load          EDTA plasma
Taqman

HCV log 10   Serum or       PCR     H      6.10                           <1.63
equivalence  EDTA plasma

Comment: Linear range of HCV-RNA Viral Load (version 2.0) = 15 - 100x10^6 IU/ml

I am asking after reading this:

"Note: with genotype 1, a treatment duration of 8 weeks can be considered in treatment-naive patients without cirrhosis who have a baseline HCV RNA level less than 6 million IU/mL."

http://www.hepatitisc.uw.edu/page/treatment/drugs/ledipasvir-sofosbuvir

[Lynn K]

You have a viral load of 1,247,797 IU/mL or on the logarithmic scale 6.10 log 10 . Spoken as log base 10 which is a related but different scale scientists use to analyze numbers. Things like virus or bacteria colonies also used in describing earthquake force.

The 6 million they are referencing is related to your test result 1,247,797 so your viral load is just a bit over 1 million.

[Rene Martin]

Dear Lynn,

Thank you for your fast response. I presume a relatively low Viral load is good news, and might mean that my chances of being 100% cured are good and I might even need only 8 weeks of Harvoni.

[Lynn K]

There have been a few more relapses that we have seen here in the forum with those who were on 8 weeks but it does have a very high success level for treatment naive with viral load less than 6 million that is why it is available as an alternate treatment.

See page 27 table 8 of the Harvoni prescribing information sheet

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

 Lists SVR12 results from the ION clinical trial for those treated for 8 weeks as 93%

[Rene Martin]

Very valuable information, thanks again!  Does this mean it's better to be safe than sorry and go for the full 12 weeks, especially because it seems there are no side effects and it's just a matter of paying a bit more for the extra 4 weeks of medication?

I guess table 8 gives the answer:

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

[Lynn K]

Remember that I have failed 4 prior treatments before succeeding I would want the 12 weeks but on the other hand if you don't need 12 weeks to be cured it is always best to take the lowest effective dose of any medicine.

A very large determining factor for many is their insurance will only allow them 8 weeks of treatment.

Like I say I am not a doctor but to me my feeling is if you are tolerating the meds and can get 12 weeks I would do that.

The clinical trial result was 96% for treatment naive, low viral load, without cirrhosis and 93% for the 8 week group.

If you have the option and your doctor agrees the choice is yours

Best of luck to you
Lynn

[Gaj]

Agree with Lynn on this. You need to find a specialist who has your best interests at heart to advise you. Please ensure he is aware you are self funding and need his advice of the best options for your ongoing health without funding restrains, then you can apply those later if necessary.

One comment on the 8 weeks that some insurance policies limit people to:

As with all insurance, to some extent they are trading the odds for best cost effectivity so it is cheaper for them (and your premiums) to provide 8 week treatment at a cost saving of 33% over 12 weeks treatment. The additional failure rate is only 96 - 93 = 3% so best $ practice dictates that those additional 3% who fail could be retreated for longer or with new drugs in the future and there are still considerable savings over treating everyone for the 12 weeks.
That works really well when there are sufficient patients to cover the odds but where the individual is providing the funding, not so well if you do need to retreat.

[Rene Martin]

Lynn and Gaj, thanks a lot for your input.

Considering that the difference is only a few hundred dollars and the side effects seems to be negligible, I reckon it's best to do 12 weeks Harvoni.

Am negotiating with several suppliers in Indian and in Thailand. It clearly is worth to shop around...