GS-9674 Phase 3 Study

General Clinical Trials
1

Hi Everyone,

I am curious to see if anyone else on this site was participating in the GS-9674 Phase 3 study. I was enrolled in the study, and I began taking the medication on 11/29/19.

Unfortunately, one of the side effects is itching…go figure. I have been lucky in that I haven’t had much itching with my PSC, but since starting GS-9674 I have definitely been noticing moderate pruritus. Thankfully, it is more of a nuisance, and while moderate, it hasn’t been severe.

The RN that administers the medication to me indicated that on the positive side, it very likely means I am receiving the medication vs. the placebo, since pruritus is a known side effect of the medication.

Anyway, I was just curious to see if others were participating in the study.

GS-9674 100mg
GS-9674 100mg2080×1560 1.25 MB

2

Hi,
I started taking GS-9674 on 1/8/2020. My LFTs have been elevated since 2008 and I have had significant itching since 2014. After starting GS-9674 (2/3 chance of getting the med), we believe I am getting the med because the itching is off the chart, dizziness, headaches, abdominal distention and discomfort. I am taking Claritin, Pepcid, Prilosec,Singulair, Cholestyramine,Atarax and Xolair injections and I take Ambien to help me sleep (doesn’t overide the itching). My entire body itches, especially at night. Heat and pressure make it much worse. I have torn the skin off of the bottoms of me feet and all of the hair is now missing from my lower legs (and I had pretty nice looking guy legs, lol). I am into the second week of the drug, I know this is not a cure but hopeful it will stop some of the itching. If anyone knows of something that I am not taking that will help with itching or sleep, let me know and I’ll discuss it with my trial coordinator. I am only sleeping maybe 3 hours a night due to the itching. I take a sleepy time tea as well. I am a healthcare professional who works in Healthcare IT, I need more sleep.

I haven’t told to many people I have this, I don’t want them to feel burdened but I would like to have someone to talk to who has similar symptoms.

3

Hi,

I am sorry that you are experiencing so much itching. What dose are you taking?

They originally had me on 100mg, but bumped me down to 30mg when I started having a lot of itching and nausea, which really weren’t much of a problem before I started taking the medication.

After lowering the dose to 30mg, 95% of the itching and nausea went away. At my next visit this Wednesday, we are going to bump the dose up to 60mg, and see how well I tolerate that dose. You may want to consider discussing a temporary dose reduction with your medical support staff.

Are you currently taking Ursodiol? I have been taking that for a couple of years now, and I will say it improved quality of life for me, including reduced itching. The drug is supposed to thin the bile acids, allowing the bile to more easily flow around the strictured bile ducts. It made a big difference for me.

Others have suggested Rifampin for the itching. I don’t have experience with this, as my itching never got that bad. The site’s moderator, Mark (fcmmark), I believe, used this medication, and can probably provide some insight. I would definitely reach out to Mark. He is very helpful, and always willing to offer advice.

I tried Cholestyramine in the beginning, but did not find to to be very helpful for me.

Hope that helps. Please feel free to message me at any time. It would be nice to get someone else’s feedback regarding their GS-9674 experiences.

Steve

4

Hi Steve,

Thanks for the quick response, makes me feel a little less alone.

Little about me:

  • 52 year old male
  • Gay with husband and six children
  • Live in Roanoke Virginia, work for Carilion Clinic
  • Participating in the Trial at University of VA, I am one of two people
  • I have a radiology background but work in IT
  • I have three auto immune diseases: 1)Crohns, 2)Dermatographia 3) PSC

I am taking the 100 mg dose, it has heightened my itching. The itching before was already a 9 out of 10. I am hopeful that this drug kicks in. One of my providers offered a pheresis to clean my blood.

Questions for you, if too personal, I totally understand.
Age?
When diagnosed?
Would you get liver transplant?
How long have you been in the trial?

GS-9674, even though this a double blind study, the clinical trail coordinator, principle investigator doctor and I believe I am getting the drug because of the symptoms. I am dizzy, stomach and bowel upset, headaches and severe itching.

That’s my story. Thoughts?
L

5

Hi,

I am currently 44. I was diagnosed in November of 2016, and I am considered early stage. When they did the liver biopsy for the study, I was categorized as an F1, on a scale of F0 to F4. MRCP shows some stricturing, but not too bad at this point.

Since I have started taking Urso, my liver enzymes are all normal. Prior to starting Urso, ALP would creep up to the 250s at times, and ALT and AST in the 150s.

Everyone’s PSC is different. I haven’t had too much itching. My big symptom seems to be right upper quadrant pain.

I absolutely would get a transplant in a heartbeat when the time comes when I need one. I just pray one will be available when I need it :slight_smile:

I started the GS study on 11/29/19, so almost 2 months now. They did have to lower my dose temporarily from 100 mg to 30mg due to itching, which I did not have much of before starting the drug. Unfortunately, itching seems to be a major side effect of the drug, and similar drugs like ocaliva. So, I am not sure how much relief you will get from the itching, and it’s possible that GS will aggravate the itching, and not decrease it.

Steve

6

I have recently started the phase 3 trial. I feel like I may be on placebo as I am having no side effects at all! Curious to talk with others going through the same thing.

7

Hi Joanie,

Not everyone has adverse side effects, so it is possible you are receiving medication. I know that they are pushing for an open label at the end of the study, while they await FDA approval. If that happens, then I believe everyone in the study would be eligible for the actual medication - even those on the placebo.

I look forward to hearing more about your experience.

Steve

8

Well, after lowering my dose to 30mg, and then upping to 60mg for 30 days, I am now back on 100mg. We’ll see how it goes.

9

I have been in this study for about 6 months and my AST, ALKA PHOSPHATE are trending back to the the normal ranges which is nice sign but when I first got in the study my Fibroscan was like 6.7 then after the bloodwork continued to improve had a fibroscan today and it was 10.5 so it kind of threw me for a loop.
The itching has been present but comes and goes I have had pain in my stomach but I think its from UC nothing to terrible.

1 Like
10

Hi there. Glad to hear the study is going well for you. To be honest, I wouldn’t read too much into the fibroscan scores. I can’t remember my exact numbers, but my first fibroscan, a year before starting the study, had a higher score. Then, my first study scan showed a much lower score, and then my third scan showed a higher score. Long story short, my fibroscan numbers have bounced all over the place, and in my opinion, aren’t that reliable.

I would pay much more attention to the liver biopsies, MRCPs (MRIs), and blood chemistry. The fact that your AST and ALP are trending back to normal ranges is definitely a good sign. I have been in the study for almost a year now. I too get right upper quadrant pain (RUQ) pain from time to time, which seems to become aggravated with activity, such as exercising or strenuous lifting. Not sure why.

How did your first liver biopsy go? I was in extreme discomfort for about 2 1/2 weeks, to the point that I had to take painkillers just to go to sleep. I am definitely not looking forward to the biopsy at the end of the study.

It’s good to hear from others in the study. Please feel free to reach out if you have any questions or just want to compare notes, and check in from time to time.

Best of luck,

Steve

1 Like
11

Hey Steve,

I had Liver Biopsy 15 years ago and it took 3 days to recover and it was brutal. The last one before the study I barely felt it ,but I was scared going into it so don’t know what to expect on the one at the end of the study. It may be unpredictable when it comes to the puncture how severe the pain will be.I had a ERCP done last year and I had to go to the emergency later that night. It was worse pain I have ever felt. They hit me with Dilaudid and it finally subsided so I guess when they are inside the body around the organs the pain is unpredictable like everything else associated with this disease.
Do you lift weights or do any strength training ?
I hope all is well with your study and we can continue to hold on and at least there is hope with all these new drugs coming through the pipeline on potential breakthroughs . I will keep you posted. I have a colonoscopy Monday to check out the UC.

Patrick

1 Like
12

Hi Patrick,

Yes, I lift weights and do strength training. Most of the time, it doesn’t bother me, but every now and then I get RUQ pain, and have to rest for a few days until it subsides.

Funny that we were just talking about Fibroscan scores, since I just had one today. So, my scores look something like this, from oldest to most recent: 8.7, 5.3, 11.2(???), and today 4.7. So…they have been all over the map, and not too reliable. My Liver Biopsy was an F1, so not too bad there.

1 Like
13

Hi there

This is my first post on this forum.

I too am on the GS-9674 Phase 3 trial based in Vancouver BC CANADA (I live in Victoria though). I started last year in February 2020, and have passed the one year mark.

I was convinced that I was on the placebo, but the research coordinator thought otherwise as my LFT numbers were normalized to a degree… at least for the first few months. They started progressively going up since about last August. Overall, my number were substantially reduced after being put on 750mg ursodial, about 1/2 year after initial diagnosis. I was diagnosed in March/April 2017 when I was 47. I am female and don’t have IBD and am vegan. This latter bit definitely helped my situation especially my colonscopies. I became plant based for ethical reasons but the health benefits are definitely prominent (plant based limiting processed foods).

Anyway, the past couple of weeks I started feeling worse (nature of the disease as you all know) – this time it was more than RUQ pain, but was accompanied by slight nausea. At the end of two weeks, I felt it time to use my blood req to check my levels. As suspected, things were a little out of whack.

First time with my ALP numbers being this high…not tragic, but in the mid-400s and my eosophils are high and RDW low. I don’t want to take antibiotics unnecessarily so my gastro/hep and I agreed that I would gauge through tests along with fever/chills.

The pruritis increased but was unbearable last night and my skin is raw. It is so frustrating as it happened on the weekend and my gastro isn’t around, and neither is the research coordinator. I went through an NP and the gastro on call won’t give me anything because he doesn’t want me to be kicked out of the trial but I know that bile acid sequestrants won’t do that - I was even offered this by the research gastro/hep and research coordinator. So frustrating because I couldn’t speak and answer the GOC questions directly. Now I have to have 2 more sleepless days and nights with less skin until I can speak with my specialist.

Anyone else been offered a sequestrant to deal with the pruritis from the trial? I know mine isn’t drug-related but rather just the course of the disease.

Fortunately until now, the pruritis was over less than an hour each time and localized. Now it is all over.

I know most mention bottom of feet and hands but I itch in the groin, scalp, mid-section, back, buttocks, legs and arms… basically everywhere including my neck. Anyone else have it all over?

I do get temporary relief from a lukewarm bath but it doesn’t last long.

Thanks for listening and hopefully for responding to some of my questions!

14

Hey Birdy,

Yes! The itching is horrible. Not everyone experiences it but I do. Questran helps. I have completed the study and was seeing good results from the open label drug but then my biopsy came back as a F4 which is outside the guidelines for the study.

I am interested in hearing more of your story.

15

Thank you Lonivision

That post was about a year ago. It was a flare and since then, I have only had a few minor short bouts that weren’t debilitating.

I am now taking the study drug for sure and will be for two years. This began following the completion of the blinded study which ended for me in January. They said it isblooking quite promising as a treatment for halting or slowing progression of PSC. We shall see in a few years when results are available

Unfortunately, research protocols don’t permit Questran, only Cholestrymine which hasn’t been effective

Hope you are well.

1 Like
16

I think his message was for me :blush: