Should I extend treatment on Harvoni !!

[pacman1372]

Dear all , a very good day to everyone and i hope that you all are well .

Call it paranoia , or insurance , or anxiety , i cant find the right word for it !!

So here is my question .

I am 43 , geno 1A , treatment experienced as in : 8 years ago , did 24 weeks of riba and inf and was taken off due to horrid side effects , had cleared at week 12 but virus bounced back within a month of getting off the tx .

I Started Generic harvoni 10 weeks ago and had a viral load of 4.2 mil at Sot , fibroscan score was 5.2 , was Negative for the virus at week 4 and am on week 10 now with 2 more weeks to go .

Being in India , harvoni is freely available here now and i was wondering if i should go another 4 -6 weeks , ie : do 16 -18 weeks instead of the 12 .

I understand and have read the recommended duration chart by Gilead and see that i fit the category of 12 weeks , its just that i want to be 100% sure that i get this virus done and over with , once and for all .

I also know that God forbid i relapse this time due to some reason , i would have to do 24 weeks next time , probably with riba involved ..

Just wanted to know the views of others and if you guys would do 16 or 18 weeks if you could get the meds for cheap and freely available to yourselves .

I hope that i will get some responses .

Wishing you all well

God bless and warm regards  

[darbara]

As you are treatment experienced and with a low Fibroscan score, this 12 weeks should be good BUT AS YOU HAVE BEEN TREATED BEFORE that is where the risk lies. We can never be sure till 24 weeks have gone by. I would suggest take another 4 weeks more and after 12 check you viral load, fibro and LFT. Dont stop after 12, you can stop once you get your SVR12 results or just complete the course of 16 weeks.

[darbara]

The cure rates are always better with treatment naive as far as Harvoni goes be it  Cirrhosis or not.
Treatment experienced brings on a resistance in the body thats the risk.
In Europe is 12 wks + riba for treatment experienced OR 24 weeks only Harvoni OR 12 weeks treatment naive.

[pacman1372]

Thanks Darbara , going to speak to my Doc tmrw and see what he has to say .

[darbara]

Harvoni dosing information

Usual Adult Dose for Chronic Hepatitis C:

1 tablet orally once a day

Duration of Therapy:
-Therapy-naive patients without cirrhosis: 12 weeks; 8 weeks can be considered if pretreatment HCV RNA less than 6 million international units/mL
-Therapy-naive patients with cirrhosis: 12 weeks
-Therapy-experienced patients without cirrhosis: 12 weeks
-Therapy-experienced patients with cirrhosis: 24 weeks

Comments:
-Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.
-Therapy-experienced patients are those patients who have failed treatment with either peginterferon alfa/ribavirin or peginterferon alfa/ribavirin/HCV protease inhibitor.

Use: For the treatment of chronic hepatitis C genotype 1 infection

[dointime]

Hello pacman,
If you really want to be 100% sure then you have to do 24 weeks.  I say that because the trials that have been done were either for 12 or 24 weeks, nothing in between.  For non-cirrhotics those trials show 100% success for 24 weeks.  If you want to do less than that, ie. 16 or 18 weeks  then you might boost your chances by a few percent above the 95% obtained in the trials, but really you are asking how long is a piece of string.

dointime  

[pacman1372]

Hello , and thank you for your input , i highly value and appreciate it .
best wishes always .

[darbara]

Being in India you could recommend to us what brand of generic Harvoni is best.

[pacman1372]

Lol mate , I was going to ask you if my doc gives approval to go a few more weeks ..

[darbara]

Ledifos or Mylans Myhep- Lvir or Hepicat LP

[darbara]

Somehow dont like Dr Reddys may its Mr Reddys name. Lol

[darbara]

You need to take 24 continuous weeks of treatment to achieve the best results.

If you take 12 weeks your success rate will be ~ 85% ie 15% fail rate (1:6) 1 chance in 6 of relapse

If you take 24 weeks your success rate will be ~ 95% ie 5% fail rate (1:20) 1 chance in 20 of relapse

1:20 is much better odds than 1:6

We assess treatment success in the weeks following FINISHING treatment

SVR4 = Undetectable (UND) 4 weeks after treatment stops and means 96% chance permanent cure
SVR12 = Undetectable (UND) 12 weeks after treatment stops and means 99% chance permanent cure
SVR24 = Undetectable (UND) 24 weeks after treatment stops and means 99.8% chance permanent cure

[pacman1372]

The Svr info above is VERY informative , thanks a ton for sharing Darbara ...

[pacman1372]

darbara my friend do u have a link to the the svr info above !! if so , please put here or message me , thank so much in advance

[darbara]

done

[darbara]

So in short only after 4 weeks of stopping treatment can you know your chances and then after 12 and then after 24 weeks AFTER STOPPING TREATMENT not on treatment.
So to know if you have achieved SVR you need to stop treatment and check after 4, 12 and 24 weeks.

I hope I did not spoil the party. Lol

[flyinlynn]

SVR is for weeks off treatment. On treatment results mean little the only testing the matters is the post treatment results. SVR4 (that is 4 weeks after treatment has ended and you continue to be not detected) correlates at 98.5%  with SVR12 meaning if you make SVR4 odds are good you will make it to SVR12 which is considered by most as cured although some prefer to see SVR24 before declaring you cured.

[darbara]

Here are all the Indian brands I know
Hepcinat-LP
Myhep- Lvir
HEPCVIR-L
Ledviclear
Ledifos

[pacman1372]

Thanks a ton my friend :)

[Dil310]

Myhep Lvir and Hepcinat -Lp are both from reputed companies and therefore trustworthy . I m going to start with Myhep Lvir from Mylan .  Here in my city in India, more hepatologists  r recommending Myhrp Lvir .

[darbara]

Yes more commission from Mylan ? Whats wrong with Ledifos or Lediclear. I think all is the same

[darbara]

But good luck and get well soon.

[darbara]

May 20, 2015

Harvoni Boasts Near-Perfect Hep C Cure Rates in Cirrhotics
Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir), with or without ribavirin, cures 92 to 100 percent of people with genotype 1 of hepatitis C virus (HCV) and cirrhosis, MedPage Today reports. Researchers conducted a pooled analysis of data from Phase II and III trials LONESTAR, ELECTRON, ELECTRON-2, 337-0113, ION-1, ION-2 and SIRIUS. They presented their findings at the Digestive Disease Week annual meeting in Washington, DC.

Ninety-one percent of the participants had cirrhosis. About two-thirds had failed a previous treatment attempt, and of that group two-thirds had taken a protease inhibitor-inclusive regimen.

Ninety-two percent of those who took Harvoni for 12 weeks achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), while those who took the tablet for 24 weeks had a 98 percent cure rate. Those who took Harvoni and ribavirin for a respective 12 weeks and 24 weeks had a 96 percent and 100 percent cure rate.

Among the treatment-experienced participants who took 12 weeks of just Harvoni, 90 percent were cured. If they took ribavirin and doubled the treatment time, this cure rate increased to 96 percent.

[pacman1372]

Thanks again Darbara , Spoke to my Doc this morning and he feels that 12 weeks is enough for me , hope that i am one of the 90% that achieves svr in 12 weeks .
best wishes always .  

[darbara]

you will

[darbara]

What is good today is that is is short and long time cures out there, 2 years back it was a different ball game. New trials and medicines are coming yearly. HAPPY NEW YEAR !!

[Dil310]

Thanx dear Darbara for the info . I m geno 1a, treatment naive, Fibro score 4.9. , VL abt 7 lacs. Liver is perfect. Though I was expecting to take only Harvoni (generic), My doc has also added riba to it to further enhance the success rate percentage . He also advised to take it empty stomach.  From the info shared by u above it is clear that riba adds to success %.  Now i feel satisfied & ready to start . Thanx & wish u a very gud health.

[darbara]

Does your Doc doubt generic Harvoni that hes added Ribavarin ?

[dointime]

Dil310 - I never heard of such bad advice on how to take riba.  Riba should be taken in the middle of a meal containing some fat, ie. eat half, take pills, eat other half.  Meal should not have too much fibre in it because fibre hinders absorbtion, but needs to have fat which helps absorbtion.

dointime

[darbara]

I dont think you need riba but your doctor knows your condition better. A better cure in your case would mean 24 weeks Harvoni. Do read up on the side effects of Riba.
I am genotye 1a, F4, V/L 1 Million, treatment naive and my doc did not mention/consider riba just 12 weeks Gilead harvoni. But he will check after 4-6 weeks and if need be add ribavarin or extend Harvoni treatment to 24 weeks.

[Dil310]

Dear dointime , thanx for the info ..  I have not started yet .  Now I will surely raise concern with my Doc or if need be I will take the advice of another Hepatologist. Wish u a great health.

[Dil310]

Dear Darbara, thanx for ur views, now I m gonna consult another Hepatologist before starting .
Best regards

[darbara]

Welcome. I just feel as it is we are sick with HepC why pound the body with more medicine than needed. I really feel you dont need riba BECAUSE
1. You are treatment naive
2. Your fibrosis is low
3. You are healthy otherwise
4. your viral load is less than 6 million
5. You have correct genotype 1 a for Harvoni only.
6. Ribavarin has its own side effects like anemia etc. etc.

In pacman1372 case he could have added ribavarin if he wanted to but as he is treatment experienced, he did not probably because of the side effects. He will clear the virus  get the SVR as he has low fibro and low viral load. Wish him the best in 2016.

My case is very similar to yours:
Geno: 1a
V/ L less than 1 million
Fibro F3/F4
Treatment naive.

I am taking 12 weeks Harvoni ONLY.
If it dont work then we see ATLEAST today we have medicines for cure so I was bothered with relapse BUT not now.

Happy Holidays and may 2016 fix us all !!

[pacman1372]

Dil310 , hello, I agree with Darbara and dointime and their views 100% .
you should only be on harvoni , you dont need riba , and believe me riba has quite a few side effects , i could just not handle them and the inf when i took them .
best wishes and am sure u will beat the virus .

[pacman1372]

Thank you Darbara for your advice and good wishes  mate .
wish you and everyone else here a healthy , happy , peaceful and VIRUS FREE 2016 .

God bless and best wishes always .

[darbara]

Thanks m8. All the best. Waiting for your SVR news !

[pacman1372]

10 more days to go for tx to end :)
Have planned the following for blood tests ...

VL testing schedule planned is at 4 weeks and 12 weeks, and then EOT+4 and EOT+12.

[pacman1372]

& Eot + 24

[darbara]

ok keep in touch

[Dil310]

Hello dear Darbara & Pacman, thanx a lot for ur valuable suggestions . After consulting the other Hepatologist as well as keeping in view ur experience , I m going to start with Harvoni alone .  If need arises in future , Riba can be added.  No doubt, riba has its own side effects . Hope I fall in the 92% category.  .. Warm regards..  

[jassudabbu]

Now a days No gastroenterologist is prescribing Ribavirin with Sofosbuvir or Ladipasvir.
If the need arise,Daclatasvir is available in Indian Market.

[darbara]

Good luck I am sure you will do well. I think its the right step.

[pacman1372]

Good day to everyone and hope all are doing well .
One more question that came to mind today and i wanted to get your views here .

What is the use of of a vl test at week 12 !!
well let me re-phrase that for my current situation .

I am thinking the following , a week 12 vl test is probably to see if there has been a viral breakthrough while on tx , i am thinking of getting my vl test done one week earlier , ie beginning of week  12 , i would certainly finish my entire tx , BUT incase and god forbid there is a breakthrough i would have about 4-5 days to get a prescription from a Doc and get meds to continue for another 12 weeks maybe with riba if need be ...

Am i thinking right !!

If i get my vl done one day after eating my last tab of week 12 and see that there has been a vl breakthrough for some god forsaken reason i would be in a mess and it would take me a few days to get things sorted out in regard to getting more meds .

this way i could be prepared if i need to continue , as in there would not be a break in my tx .

i would certainly be getting a 4 week post eot also .

your views on the same would be appreciated .

thanking you in advance

Best wishes and god bless .

[darbara]

You have a 95 to 97 % chance to clear the virus so why panic. The medicine has worked for you till now.
Just do the V/L test EOT and then 12 weeks after EOT
How were your sides on this twinvir treatment ?? Are you feeling better ?

[darbara]

Here is a copy and of wait Lynn K wrote:

Yes on treatment testing means nothing relative to being cured.

However continued not detected 12 weeks post treatment (SVR12) is considered by the majority of the medical profession as evidence of viral eradication and thus cured. Some doctors prefer to hold to the old standard of SVR 24 but none the less as the virus if present multiplies at such a high rate if any viable virus were remaining below detectable levels (LLOQ) at EOT they will quickly replicate and be detectable. This is why the majority of relapse occur by week 4 post and that SVR4 correlates at 98.5% with SVR 12 and SVR12 is 99.8 % likely cured.

We had a couple of people here who were weakly detected at EOT but when tested at 4 and 12 weeks post they were not detected we are guessing they may of had some either virus pieces that were detected or some not viable dying virus that could not reproduce. But for whatever the reason they are now called cured by their doctors.