Harvoni+Riba clinical trial for Geno 3 in Canada

[KimInTheForest]

This is the clinical trial I am currently participating in, and it appears to still be open to new participants in some locations in Canada, if this interests anyone:

https://clinicaltrials.gov/ct2/show/NCT02413593

It involves 12 weeks of Harvoni+Ribavirin for treatment-naive, Genotype 3 people with HCV (i.e., you cannot have tried any previous HCV treatment). Also cannot have cirrhosis for this trial.

If you scroll down the list of locations at various cities in Canada, you will see that some are listed as "not yet recruiting". Those might still have spots available, if you live near any of those cities. Ask your doctor to refer you, if you are interested. I think the ones that say "recruiting" may actually be full now and in progress. That is certainly true for my location, which is listed here as "recruiting".

Wellness to all,
Kim

[Debula]

Thank you for bringing that our attention.  My husband is genotype 3 but the doctor offered him Sovaldi + Riba.  They decided to wait because of the Riba side effects until the new drug (can't think of the name at the moment) gets approved hopefully this summer
Hope you beat it with Harvoni + Riba
Good luck

[KimInTheForest]

Thanks Debula!

With your Geno 3 husband, you may want to double-check the approval schedule for the non-riba treatment he is waiting for because, as you probably know, things get approved for Geno 1 first, and it can be a much longer wait for Geno 3. Where I am in Canada, I still would not be eligible for 24 weeks of Sovaldi+Riba, even though it has been approved now for Geno 3 people in my province - but only for treatment-experienced Geno 3 people, not treatment-naive Geno 3s because of costs, I guess. They want us to try the much cheaper bad old toxic drugs (INF/Riba) before giving us less toxic but more expensive Sovaldi+Riba.

Also, this particular Harvoni trial is just 12 weeks (which has had excellent results for Geno 3s elsewhere - 90% or better). And while I was not crazy about taking Ribavirin, I figured 12 weeks will be doable. And so far I have had minimal sides. Am into Week 4 of 12.

Good luck to you and your husband.

kim

[Debula]

Thank you!
I think the drug I am talking about is made specifically for genotype 3
But thanks for the info.  I suspect even if approved here in the US it will be hard to get insurance to pay for it just like Harvoni for a lot of people.

"Bristol-Myers Squibb Announces Acceptance of New Drug Application for Investigational Daclatasvir for FDA Review for the Treatment of Hepatitis C Genotype 3"

It is nice to follow your posts and see that you are doing well even while on Riba

[KimInTheForest]

It is nice to follow your posts and see that you are doing well even while on Riba

I am expecting the Riba-anemia thing to kick in at some point and hit me with tiredness and fatigue. Maybe around the halfway mark?

kim

[Debula]

I am expecting the Riba-anemia thing to kick in at some point and hit me with tiredness and fatigue. Maybe around the halfway mark?

kim

Or hopefully not at all

[RightHere]

Hey Kim,

Hope all is well. I've been looking into likelihood of developing anemia (something to do while we wait to see if my partner gets into the Harvoni+RBV 12 week trial).

From what I can see there have been two studies that looked at this treatment combination in genotype 3 (one that included treatment-naive GT3 (n=26) participants and another study by the same study centers that included treated-experienced GT3 (n=50). See reports and abstracts related to the Electron-2 study, Edward Gane et al. out of New Zealand. (Links to news reports on these pasted below).

On anemia: I found a reference to the 26 person cohort of treatment-naive and side effects and it looks like only, ". . . 3 people (12%) taking ribavirin developed moderate anemia (hemoglobin <10 g/dL)." and in the study with the larger group of 50 treatment-experienced, only 2 people (4%) experienced hemoglobin levels <10 g/dL. So it seems you may not have a high likelihood of experiencing clinical anemia if I'm understanding this correctly. It made me feel a bit better knowing this.

Question for you if you don't mind. It sounds like your blood tests are being processed by central study lab in the US and I was wondering how quickly are you getting the results back from them and your local study center? So far there's been lots of the waiting game and I'm curious what it will be like during the trial (knock on wood). cheers RH

http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4621-easl-2014-sofosbuvirledipasvir-is-safe-and-effective-for-relapsers-and-hard-to-treat-patients

http://www.newevidence.com/virology/entries/High_efficacy_12_week_ledipasvir_sofosbuvir/

[KimInTheForest]

Thanks for that anemia info, RightHere. That is reassuring! I am nearly at end of Week 4 (of 12) and still feeling quite good and normal - not excessively tired, and no other significant sides.

As for the processing times on labs… For the most part, when I have blood drawn one week, my results are available when I visit the following week. This wasn't true on my Day 1 Viral Load, though. I still don't know what that was. It got held up for some reason. And I noticed someone posted something about that on another thread, saying that the lab technician in US told him (or his Dr.) that the reagent used to do the quant. PCR is in short supply, so PCR tests were backlogged.

After my visit/check-up this coming Tues, I won't go back for 4 weeks. So I guess I will ask if I can get my lab results sooner by phone or email because I don't want to wait 4 weeks to find out.

It's been a very easy ride so far.

best to you,
kim

[RightHere]

Thanks Kim.
I'm with you on asking for results by phone; four weeks would definitely be a long time to wait. Very glad to hear it continues to go well for you.
cheers RH