Hep C Discussion Forum

angelseven · Senior Member

RE: 8 weeks of Harvoni

BobK · Member

Hi AngelSeven,

I too was concerned with what you are saying about length of treatment. I was on Sovaldi/Olysio on a 12 weeks protocol. I had researched and found that relapse at 24 weeks was very slightly lower (maybe 2-3%), so I pushed my doctor to get me on the 24 weeks. The doctor agreed, but my insurance company would not budge. So I contacted Gilead and they got me the meds for free! They were awesome and helped the whole way through the process. I guess when Gilead is making 3 billion per quarter since the release of their new medicines, it doesn't hurt to give back a little. :) Most companies have these types of assistance programs.

Good Luck.

Harvoninme · Senior Member

My DR was kind enough to call me back to discuss this even though she is on vacation. She is, as always, on top of things. My low viral load (320k) was one of the main factors in their decision. Also, we are taking about a few percentage points difference. I still have over a 90% chance to reach SVR forever.

We all have to work this out for ourselves. I'm at peace with it. I do support those who choose to pursue a longer TX and encourage everyone to discuss it with their DR.

TazKat · Senior Member

I will say I dpn't know much about the harvoni. I cleared being stage 4 on the solvadi. keep ur chin up & advocate advocate advocate for urself..

Taz

Miss B · Senior Member

Angelseven,

I also don't think you are over reacting. I think it's good to be prepared.

It might be a good idea to email your doctors & let them know that you read this update to the guidelines & ask for an opinion of the update & get confirmation that they will cover re-treatment if necessary & have that all on the record if you should ever need it.

It seems to me that the AASLD is not fully endorsing the Post-Hoc Analysis of the ION-3 Trial to re-calculate the improved/lower relapse rates for the 8 week protocol.

This analysis was not controlled and thus substantially limits the generalizability of this approach to clinical practice.

http://www.hcvguidelines.org/node/71

B161 · Member

Hi Angelseven, I don't think you are over reacting, if I was you I would PUSH for the 12 week protocall. I do think Gilead can help out, despite all the chaos in the media about the cost of Harvoni-go for it. Why not tell your doc you want the best possible outcome!!!

Matt Chris · Guru

Hey Gals

I share your concern on the eight week duration, if your doctor agrees and see's something important in the new guildline from AASLD that makes a case, I would ask him to submit a addendum letter of necessity to your insurance provider.

Your biggest problem will be the time crunch, maybe emailing your doctor the new info. and asking him to immediately address this concern. The reason is the insurance companies can move slow on both the request and if you have an appeal, so tell your doctor to mark it request URGENT!

You also most likely will have to do the leg work on the new guidelines and accompanying supporting data, some doctors won't be in the loop. Include your references in the email.

The best thing is most of you have lower starting viral loads, but if you are handling the meds well why not go another 4 weeks could make the difference. Its obvious that your doctors thought you were good candidates for the 8 weeks, asking them again will provide you a least so comfort and reassurance.

matt

Harvoninme · Senior Member

Interesting update, thanks for sharing that. I'll mention this to my Tx Team. Chances are they've already read this and may even be discussing it as I type.

We're talking a few percentage points- the cure rate might be 93% instead 97%. I'm lucky in that I had a very low VL (<400k) so I believe my chances of clearing are pretty good on 8 weeks. 3 months ago I was willing to do triple with a much lower cure rate and a lot more side effects. I think I'm still going to choose to be grateful for a short TX with a fabulous cure rate. We can't know how these rates will hold up in 5 years. If it comes back, I'll treat again with whatever is the next great miracle drug. Keeping hope alive here. :)

Miss B wrote:
The AASLD published revised guidelines on 12/19. There's a clarification about the 8 week protocol that seems to advise careful consideration of the 8 week protocol. It's under the Genotype 1a box, but under the 1b box it says that info applies to both 1a & 1b: There is no measurable difference demonstrated to date in treatment response to ledipasvir/sofosbuvir for HCV genotype 1 subtypes, thus the supporting evidence remains the same as for HCV genotype 1ainfected patients
http://www.hcvguidelines.org/node/71
However, relapse rates were higher in the 8-week arms (20 of 431) regardless of RBV use compared with the 12-week arm (3 of 216). Post hoc analyses of the 2 RBV-free arms assessed baseline predictors of relapse and identified lower relapse rates in patients receiving 8 weeks of ledipasvir/sofosbuvir who had baseline HCV RNA levels below 6 million IU/mL (2%; 2 of 123), and was the same for patients with similar baseline HCV RNA levels who received 12 weeks (2%; 2 of 131). This analysis was not controlled and thus substantially limits the generalizability of this approach to clinical practice. Shortening treatment to less than 12 weeks should be done with caution and performed at the discretion of the practitioner.

Miss B · Senior Member

The AASLD published revised guidelines on 12/19. There's a clarification about the 8 week protocol that seems to advise careful consideration of the 8 week protocol. It's under the Genotype 1a box, but under the 1b box it says that info applies to both 1a & 1b: There is no measurable difference demonstrated to date in treatment response to ledipasvir/sofosbuvir for HCV genotype 1 subtypes, thus the supporting evidence remains the same as for HCV genotype 1ainfected patients

http://www.hcvguidelines.org/node/71

However, relapse rates were higher in the 8-week arms (20 of 431) regardless of RBV use compared with the 12-week arm (3 of 216). Post hoc analyses of the 2 RBV-free arms assessed baseline predictors of relapse and identified lower relapse rates in patients receiving 8 weeks of ledipasvir/sofosbuvir who had baseline HCV RNA levels below 6 million IU/mL (2%; 2 of 123), and was the same for patients with similar baseline HCV RNA levels who received 12 weeks (2%; 2 of 131). This analysis was not controlled and thus substantially limits the generalizability of this approach to clinical practice. Shortening treatment to less than 12 weeks should be done with caution and performed at the discretion of the practitioner.

Harvoninme · Senior Member

If someone fits the profile for 8 weeks, there is no evidence (as far as I know) that an extra month is necessary. Amazingly, the cure rate was 1% higher for the 8 week group over the 12 week group, as I recall.

If someone has more information on this, I'd love to read it.

If you think you don't belong in the group, that's a different story. I was a little concerned about that as they were making my treatment decisions based on a 4 year old biopsy (and current blood tests). Based on my blood tests, VL load and history, I fit the criteria. I'm choosing to be grateful I only have to endure 8 weeks of these strong drugs.

I'm keepin' the faith that 8 weeks is enough.

fourlocos · Senior Member

I am in the same 8 week plan with similar worries.

angelseven · Senior Member

My viral load was 1.8 million... on week two virus was barely detected... waiting for week 4 results... all blood tests normal.. at two weeks alt and ast in normal range.. first time in 18 years... so I am a little worried about only doing 8 weeks, that is all my insurance will pay for.. I could push it and get the doctor to write another request for 12 weeks, if I am denied again it is possible Gilead might pay... so my question is " am I overreacting"

Thanks so much, connie

-- Edited by angelseven on Monday 22nd of December 2014 12:17:05 AM

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