New Gilead Trial listed for Genotype 1s & 4s

[sunru]

One of the locations listed is San Francisco. Does anyone know when they will be recruiting in Northern California?

Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
This study is currently recruiting participants.
Verified September 2013 by Gilead Sciences
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01938430
First received: September 5, 2013
Last updated: NA
Last verified: September 2013

[sunru]

(\__/)
(='.'=)
(")_(")  Lynn, so happy to hear the news that you heard back from them. You will be approved at least for Arm 1 after what you've been through. My thoughts and prayers be with you.

I forwarded the email that was on NCT0198430 listing just asking about when study will open in SF but no response. I'll have to re-send asking a different question.

[Shyrlgame]

Crossing everything and sending positive vibes.
Best wishes

[flyinlynn]

I am also geno type 1A and a null responder. I was diagnosed with cirrhosis in January 2008 and Hep C in November 1989.

Guessing I caught the bug in 1977 or 1978 in my wayward youth

[flyinlynn]

Just got an email from the center in Seattle. I am on the list to be considered

" we have added you on the list but as you know we are going down the list and screening each patient and depending on availability; we will call you." He added to call him on Friday if I don't hear back before then.

Fingers eyes and anything else that can be are crossed

[sunru]

Do you know with Sofosbuvir/Ledipasvir and other antiviral combo, if one does not have a 1.5 drop in viral load at 4 weeks, can one develop a resistance to the DAAs?  Or would it be possible to try again  with a similar DAA combo later?

[sunru]

I hear ya!  I'm in the same boat, trying not to decompensate. Searching everywhere to get tx immediately that I might be able to tolerate. The sofosbuvir protocol tx in December has to be taken with Inf/rbv so that's not an option. Getting in to a study is a risk I feel strongly to take rather than waiting.  It's better than risking having gall bladder surgery with cirrhosis.  I'd rather try to lower the viral load or better yet attain SVR if at all possible with geno 1a.

[flyinlynn]

They are also having this trial here in Seattle at UW Harborview . The web page says not recruiting but I contacted them and they are reviewing records to find candidates currently.

I have sent them my records and am hoping I can get in. I am a Child A but have had banding for esophageal varicies and am taking spiroactone for edema and small amount of ascities. I also have platelete count 85 enlarged spleen and have had my gall bladder out in 06.  

The Dr's won't treat me with current therapies because I am a previous null responder from Intron A to peg interferon/ riba. So likelihood of success in my case with Telaprevir not so much and possibility of serious complications too great. Too well to be sick but too sick to be well.

I hope to find out next week if they will let me participate. That or hope for quick approval of the new therapy so I can get prescribed before I become fully decompensated.

Best to everyone on this rocky path we find ourselves on

Lynn

[jerialice]

darn i got excited there for a minute!! but off to see the wizard in the next few weeks so hopeful they will have a TX for us
"SOCx2 relapsing geno-1b" types. my liver disease is minimal so i wait.
hoping it will not blow up in the meantime.

meanwhile best of all things to you guys getting on board this train!!!!

[HectorSF]

Yes, let hope that that this treatment can prevent the damage done by hepatitis C recurrence post transplant that leads to poor post transplant survival in hepatitis C infected patients.

Congratulations on curing your hep C!

Hector

[gerard11]

As one who has completed a Gilead trial (SVR12 as of 9-12-13) that was for post transplant patients, with Hepititas C, a cirrhotic liver, and a non responder to current FDA approved thearpy, I am jumping for joy that others will have a chance to clear their virus!!!!
I am so delighted that others will have the same chance that I had to get their lives back and to feel better!!!!! Wonderful!!!!!! To all who are treating, Peace.

[HectorSF]

Strike this part of the sentence.
"or those who have had transplants and now have hep C again."

This trial is for patients who currently can not treat their hepatitis C with current treatments because their liver disease is too advanced or those who have had transplants and now have hep C again.

It should read...
"This trial is for patients who currently can not treat their hepatitis C with current treatments because their liver disease is too advanced."

Hector

[HectorSF]

I do not know when requiting for this trial will start but I do know where and who will be conducting the trial here in San Francisco. The trial will be located at my transplant center, UCSF. It will be lead by my hepatologist who leads all of the hepatitis clinical trials at UCSF.

"Official Title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have ADVANCED LIVER DISEASE or are POST_LIVER TRANSPLANT"

There are 7 treatment groups. Some are pre-transplant (groups 1-2) the others are post transplant (groups 3-7).

For those on the wait-list that are infected with chronic hep C, if this treatment were to work they could avoid treating their hep C after their transplant. All of these pre-transplant patients will need liver transplants whether they cure their hep C or not, as their liver disease has already progressed to far to ever be reversed.

Also this trial is for patients who have already had liver transplants and whos hep C has recurred in their donor liver causing fibrosis and cirrhosis. Current post transplant treatments have very low rates of success and the side effects makes treatment very difficult to complete when one is on immunosuppressants without transfusions, Procrit, Neupogen, and other interventions.

NOTE: This trial, as the title says, is NOT for most patients infected with hepatitis C genotype 1 & 4. It is not for patients with CPT class A compensated cirrhosis. Those patients can still treat their cirrhosis with other treatments. This trial is for patients who currently can not treat their hepatitis C with current treatments because their liver disease is too advanced or those who have had transplants and now have hep C again.

It is only for patients with CPT (Child-Pugh score) class B (moderate hepatic impairment) and class C (severe hepatic impairment) cirrhosis. DECOMPENSATED cirrhosis and End-stage Liver Disease (ESLD). Meaning that these patients will already be on transplant waiting lists and many are frequently hospitalized for bleeding varices, HE comas, repeated paracentesis and other possible life-threatening complications due to liver failure.

The other participants in this trial are post-liver transplant patients with various degrees of fibrosis and cirrhosis. Groups 3-7.

Hope this helps.

Cheers!
Hector

[still_above_dirt]

Yes, this regimen is a good combo. These are the same study drugs that ION1, ION2, and ION3 participants are/were taking. ION2 accepted prior-treatment and protease-inhibitor-experienced candidates, as well as a small number of cirrhotics. There's a thread about ION "X" treatment statuses in this forum (it's my thread) and everybody that has posted interim results there has reported RVR or EVR during treatment and have strong suspicion to believe that they are SVR4 or SVR12 (as we are blinded as to our EOT+4 and EOT+12 statuses and can only base our beliefs on whether we got disinvited from the study or not -- and no one, to my knowledge, has gotten a "sux2BU" letter from the trial sponsor). Nobody, to my knowledge, has quite made it to getting their "report card" for the EOT+24 "final exam" just yet.

I have had two VL tests conducted independently of the ION2 trial and, as a 3X-prior-tx and PI-exp'd pre-cirrhotic guy, have attained SVR18 so far (I think I'm the only person reporting there that's gotten an independent VL test done). No one in that thread has reported viral breakthrough or relapse.

Now, ION3's phase 2 predecessor LONESTAR, had reported in a Gilead press release a while back that one of its nineteen tx-exp'd folks, a cirrhotic, had, regrettably, relapsed and as I recall that individual was on a 12wk regimen (too lazy to doublecheck my facts there -- sorry).

The only thing I would change if I were in charge of this this study is declaring success based on LLoD, not LLoQ. I think that the VL test that Gilead uses has a LLoD of 7.1 IU/ml and LLoQ of 25 IU/ml. Let's face it, trial participants don't want to be non-quantifiable but detectable, they want to be undetectable.

Nevertheless, it is indeed excellent news that the scope of these investigational drugs is being expanded to include the "with advanced liver disease or post-liver transplant" crowd. Truly excellent.

[sunru]

I just found out about this new study this afternoon. There's a spot on the page where you can email the contact person, so I asked the same question in an email asking when it will open up in SF.

Yes, there are a large number studies opening across the nation, but some of them are open now and Calif. is listing "not yet recruiting" for SD, LA & SF.

I will have to check the web about this combo, as I recall it is a good one.

Thanks for your reply.

[Bill200]

Sorry I don't know but glad to see it.  Doesn't it tell the centers on the clinicaltrials.org page?  I would think you could call, they might even have a contact on the web page.

IMO, this combo is the cure based on the trial results I've seen.  The Sofo does very good on its on but this combo is hitting near 100% isn't it?

Good luck.

-David