HealingWell
Search Close Search
☰

My Hep B Clinical Trial Log

Support Forums
>
Hepatitis
✚ New Topic ✚ Reply
12 3 4 5 6
❬ ❬ Previous Thread
Posted 4/11/2014 1:04 PM (GMT 0)
So, today I started my "screening" for the Clinical Trial Meds for Hep B (essentially, Tenofovir TAF or TDF, depending which I get)

So things:

-Drew lots of blood, but I seemed to be ok with this
-All vitals were ok.. Blood pressure was 110/76, Heart Pulse was at 76 and then 74 with the EKG, Weight was 197lbs (Apparently I've gained 10lbs since a few months ago, which I'm happy about!), Physical Exam went ok.
-Was told during the clinical trial, I cannot take Milk Thistle. Was also asked to reduce my Vitamin D supplements since I'm back in normal range.
-Had my first of 2 Hepatitis A Vaccine -- a little sore in the spot but ok so far
-Will be coming in for bone density scan in 2 weeks, if all blood/lab works are normal
-4 weeks time, will start meds if needed and if I qualify and will need to be on clinical trial for 2 years to start and take meds every day


I'll post the numbers that came back on blood tests for clinical trial when I get them.
Posted 4/11/2014 2:49 PM (GMT 0)
Really cool!! It will be interesting to follow your progress.. Best of luck..... Barry
Posted 4/11/2014 3:00 PM (GMT 0)
LM, do you know the criteria for this trial?

I think I found the documentation here : clinicaltrials.gov/ct2/show/NCT01940471

If this IS the trial, note that it is a double blind study, which means some will get the drugs and neither the docsor patients know who is getting the drugs and who is getting the placebo. And it is long...did you know that?


I ask becasue Mike was all set up for a Giliad trial in January and then at the last moment, on the day we went to pick up the pills, they told us that they couldn't let him start because he didn't meet one of the criteria for the "arm" of the study they were doing...he was to be in the POST TRANSPLANT, genotype 1a, with high Hep C Viral load post TP, WITH cirrhosis. They assumed he HAD cirrhosis because of his liver biopsy and his bloods, but when they did the Fibroscan a the last moment, it came out Stage 3 Fibrosis, NO cirrhosis...so we were so very disappointed. If we had better understood the trial documentation, we would have known better that all that testing is to make sure you meet all the criteria they are measuring.

In his case, it was a late study, so not double blind...everyone knew everything...docs and patients.

about the same time, he got prescribed the medication from his Hep for a regular Hep C treatment (Olysio and Sovaldi) and it was covered by his insurance, so he is doing that now...Sovaldi and Olysio.

I hope all is well for your starting right away and for responding positively to the meds.

ML
Posted 4/11/2014 3:29 PM (GMT 0)

MamaLama said...
LM, do you know the criteria for this trial?

I think I found the documentation here : clinicaltrials.gov/ct2/show/NCT01940471

If this IS the trial, note that it is a double blind study, which means some will get the drugs and neither the docsor patients know who is getting the drugs and who is getting the placebo. And it is long...did you know that?


I ask becasue Mike was all set up for a Giliad trial in January and then at the last moment, on the day we went to pick up the pills, they told us that they couldn't let him start because he didn't meet one of the criteria for the "arm" of the study they were doing...he was to be in the POST TRANSPLANT, genotype 1a, with high Hep C Viral load post TP, WITH cirrhosis. They assumed he HAD cirrhosis because of his liver biopsy and his bloods, but when they did the Fibroscan a the last moment, it came out Stage 3 Fibrosis, NO cirrhosis...so we were so very disappointed. If we had better understood the trial documentation, we would have known better that all that testing is to make sure you meet all the criteria they are measuring.

In his case, it was a late study, so not double blind...everyone knew everything...docs and patients.

about the same time, he got prescribed the medication from his Hep for a regular Hep C treatment (Olysio and Sovaldi) and it was covered by his insurance, so he is doing that now...Sovaldi and Olysio.

I hope all is well for your starting right away and for responding positively to the meds.

ML

Thanks, yes it is a double blind study but this one works differently. You either get:

A.) Tenofovir TDF 300mg and a 25mg TAF Placebo pill (1 out of 3 chance of getting this one)

or

B.) Tenofovir TAF 25mg and a 300mg Placebo Pill (2 out of 3 chance of getting this one)

(Placebo pill is just a sugar pill, so either way I am being treated)

The study is 2 years, and I can opt out of it at *ANY* time. Being that there is no cure for Hep B, I'll be getting the drugs and treatment for free and after the 2 year study, everyone goes to open label in the last phase where we all pretty much get TAF for the continuation.

The only down side I am looking at, is getting my blood drawn every 4 weeks. I initially thought this was going to be done every quarter but it's not. It's every month. That sort of concerns me. I'll know if I qualify for it in 2 weeks time and then it will be another 2 weeks that I have to come in for the pills

The good news is.. that if I have to go out of the country, I can take these with me even though it's not FDA approved
Posted 4/11/2014 3:46 PM (GMT 0)
LM

This sounds like a no brainer...and it is likely it will work. It seems like it is relying on the same mechinism as the AIDs antivirals work and seems a likely winner. This research has been going on for a long long time and it seems like this wave of treatments coming to market are going to put a dent in viral Hepatitis worldwide...if only there is enough money and committment to get meds to everyone.

Look how long it has taken to get polio under control...and my sister was in trials for that as a child...in the 50s. The kids stood on line around the block hoping to get in those trials. My mother was desperate for us to be innoculated.

Keep us posted, this is new for us and a lot of folks will be interested to hear how it is going for you.

ML
Posted 4/11/2014 5:22 PM (GMT 0)
Thanks! Yeah, I was excited when he says that the meds work and suppress the virus REALLY quick. I was especially happy to hear that it's more than likely I would have little to no side effects from these meds. Of course, it is not a cure, but he said they are VERY close to one (ARC-520 I believe is in Phase II) and it's possible that the med may be approved by the time this trial is done.

I'll keep you guys posted on everything and anything that happens with this.
Posted 4/27/2014 4:17 PM (GMT 0)
Going in for baseline visit tomorrow, which includes the bone density scan. After the scan, they are dispensing the meds to me and I *think* I start taking it tomorrow to start Day 1 treatment. I'm nervous because of potential side effects, but I'm trying to not even think of that in hopes I have absolutely NONE. But I'm excited for it too because I get a feeling most of my symptoms will go away once I got undetectable. I asked doctor if there is anything I need to avoid eating or drinking and he said "Eat as your normally do and drink whatever you want. If you want a glass of beer or wine then that is fine 2-3 times a week" (FYI, I hardly drink so avoiding alcohol is not an issue for me).

FYI, here is a list of my current symptoms (none seem to be Hep B related but I've read their is some correlation between liver disease and these symptoms):

1.) Ringing in the ears, tinnitus. Gets worst from time to time for no reason at all. Did not have this prior to Hep B, even after loud concerts. Read that liver issues can cause this and inner ear problems hmmm

2.) Weakness and shakiness - First I thought it was Parkinsons but I'm not having the other Parkinson's symptoms. Doctors called it anxiety. Tried giving me Xanax. It helped the 3 times I took it but then said "I can't live on Xanax, maybe the Hep B is causing this. I didn't have this prior to Hep B"

3.) Loss of muscle in legs - They have slowly came back with exercise and sports, but this is where my main weakness is, in my legs.. and my legs used to be really strong. I'd be able to leg press 250lbs-300lbs and I struggle now with 170lbs

4.) Joint pain.. it's there. I've ready this has been a symptom of Hep B. Not sure if this will ever go away but I'll continue a workout routine in hopes it helps. I tried chiropractic relief. While helpful, it didn't cure the joint pain. I'm stopping as I felt it wasn't the route I needed to take.

5.) Brain fog.. Hep B doctor has acknowledged this could be a side of Hep B. He said if it goes away while treated, then it's definitely the Hep B. The brain fog has sort of caused some weird panic attacks as well, so I suspect this will go away.

Anyway, that's that. I'll post more numbers from my last results when I get them tomorrow and update on anything going on.

Post Edited (luckyman316) : 4/27/2014 10:32:39 AM (GMT-6)

Posted 4/27/2014 5:02 PM (GMT 0)
LM, thoughts with you. We are definitely in a new era after years and years of waiting for drugs to help those with liver disease. Remind me where you are...I can't recall and US doc ever allowing beer or wine with liver disease. Good think you are not a drinking man....cause allowing one or two around here would be ten in a month. Better for us to just say no. ML
Posted 4/28/2014 4:03 PM (GMT 0)
I'm actually in the United States. NJ to be exact.

Just got back from my first clinical trial day, and the first day on meds. So far, no side effects (It's only been a few hours though) but I'm happy nothing immediate.

The first day took a bit because I needed a bone density scan on top of blood work and physical. The wait for the scan took a while but I don't need another one now for 6 months.

That being said, for numbers sake, I'm just going focus on the liver and Hep B numbers that were given to me prior to taking meds.

HBsAg - Positive
HBe Ab - Positive
HBe Ag - Negative
HBV DNA IU/mL - 22,300,000 (Increased from 18 million a month ago)
AST- 99
ALT - 219

I asked about the major increase in liver fuctions and they said that the numbers are different than the prior labs because it's a different lab.

Anyway, will update more on my next numbers I get (from blood drawn today) in 4 weeks.
Posted 4/28/2014 4:30 PM (GMT 0)
this is interesting lucky. hope your #s turn around soon.
barry
Posted 5/12/2014 5:55 PM (GMT 0)
Wanted to share my latest lab, this was last lab pre-medication...

FIBROTEST
Fibr. Score - 0.16
Fibr. Stage - F0, No or minimal Fibrosis
ALT - 179
AST - 82

HBV DNA IU/mL - 18,400,000
HBVLog10 - 7.26
HBsAg - Positive
HBe AB - Positive
HBe Ag - Negative
25- Hydroxy Vitamin D - 76.6 ng/mL

Somehow, my liver enzymes reduced as did my viral load.... without being on meds. Go figure! I'll share more after next blood test to see how much as reduced.
Posted 5/30/2014 5:26 PM (GMT 0)
So, I have not posted on this log because I felt there was nothing significant to share at the moment. I do have some results back, but not my viral load. So in the meantime, I wanted to talk about my experience with the medications and anything I noticed with them...

At first, I thought I was getting cold spells 2 days into the medication. I was concerned with lactic acidosis so I asked my doctor and he said it never happens with Hep B patients on these meds. He said it was just a warning put on the label. Turns out, it was just the air conditioning being raised in the building I work in :)

I did have some nausea the first few days while taking these meds. At first, I was taking it with lunch and wasn't feeling right during the day. So I decided to take this before bed. Bad idea, as I had food in me but wasn't digesting right. So, I now take this at 8-9pm when I usually eat my late dinners. That made a huge difference.

I also had some diarrhea the first week on this. My stools, got a little lighter while on these meds. Nothing of concern though. I've had brief "dizzy" spells of 5 seconds or so, again nothing to be concerned with. Also, skin itching.. which I attribute to the Hep B.

Those were the worst side effects I had. Now, onto the good:

-My strength feels as if it's returning while on these meds. Not 100% but about 70% there

-My brain fog, while still there, is slowly lifting. Some days good, some days bad

-The good weight I had lost when this all started and went active, is coming back.

-Sleeping patterns are pretty good and my appetite is back to normal.

-Tinnitus (ringing) in my ears also reduces. I noticed if there was anything I did that affected my liver -- such as taking motrin or not eating the best foods, it would increase.

These are the upsides. I'm also sober -- alcohol free since I started the meds. I've had many offers for many drinks too, and I've turned them all down. No real pressure to drink from friends or other people, thank God! I'll share all results when I get the viral load results back.

Post Edited (luckyman316) : 5/30/2014 11:34:03 AM (GMT-6)

Posted 5/30/2014 9:15 PM (GMT 0)
hey lucky, good to hear from you. you have the right attitude for success. glad that your health is improving. definitly, let us know the results your 4 week labs, and v/l.
keep the faith!
barry
Posted 6/6/2014 1:51 PM (GMT 0)
Hey Guys, wanted to share my one month result on this clinical trial. I'm only going to share the numbers that are relevant. Keep in mind, they did not do all the tests this time around (such as Fibroscan, HBsAg, Vitamin D, etc.). Those tests are done on certain schedule for the clinical trial. But here is the great news:

Total Bili: 0.2 mg/dL

Dir Bili: < 0.1 mg/dL

Ind Bili: < 0.2 mg/dL

ALT (SGPT): 88 U/L

AST (SGOT): 48 U/L

HBV DNA IU/mL - 40,200

Yes, a HUGE drop! shocked

Still not undetectable. I think the goal is below 48 IU/mL for the clinical trial. Hoping that happens within 6 months and my body naturally seroconverts...

Posted 6/6/2014 8:53 PM (GMT 0)
Wow, your viral load is really really down already! Hoping for the best...same as at my house.

Mama Lama
Posted 6/8/2014 1:04 AM (GMT 0)
fantastic lucky, what a relief!!! great respose!
Posted 6/8/2014 1:43 AM (GMT 0)
Sounds good! Most of us here don't know a lot about Hep B, so our advice is fairly minimal. We are interested in hearing from Hep B folks. Then we are able to help others.
Posted 6/20/2014 8:45 PM (GMT 0)
Wanted to share more in regards to my week 8 blood drawing. Unfortunately, I did not see the doctor or the person who was coordinating the study as both were on vacation. So they had a backup coordinator do my 8 week follow up. I could just tell she did not want to be there, so I tried to lighten her mood. They had to draw blood and do urine sample and of course, I couldn't push enough urine out due to me having to go soooo bad a half hour before my appointment that I just could not hold it in.

Nothing much has changed with side effects from meds. Just a few headaches here and there. If anything, I've been feeling stronger week by week. Probably the Vitamin D helping :)

Chit chatting with the coordinator, I told the coordinator that my friends wanted me to go with them on a wine tour and I had to explain to them that I quit drinking but can still go and see how it's made. After that, she told me "well, the doctor did clear you to have a drink on occasion but it's really up to you . But here's a trick, if you don't want to consume then just taste it and spit it out.." I kind of chuckled at this and went on my way. Yeah, no drinking for me thank you!
Posted 6/29/2014 1:47 PM (GMT 0)
I just wanted to share more with 2 months on this. Of course, still not considered "undetectable". Even when I'm undetectable, I'm still not cured. Was hoping viral load would go down more but such as is...

HBV DNA IU/mL - 7,650
HBV LOG 10 - 3.88
Total Bili -- 0.8 mg/dL
Dir Bili -- 0.2 mg/dL
ALT (SGPT) - 69
AST (SGOT) - 43

This is all I can share for this month, all other tests are irrelevant towards liver and Hep B. Next visit should show more results.
Posted 7/17/2014 4:28 PM (GMT 0)
Wanted to share a little more.

Had my monthly follow-up today and was supposed to see regular doctor. Unfortunately, he came in later than my appointment so I did not see him but saw my usual sudy doctor today.

Study doctor went over all my blood results and said besides the Hep B and being overweight by 20lbs, I was healthy as a horse :) He also told me that my viral load keeps reducing drastically. Since this is week 12, he suspects I'll go undetectable either this blood draw or next and see the number 0 next to my viral load (Let's hope!)

Overall, I've been feeling much much better. I have good days and bad days but I'd say I'm 75-80% better than where I was when this first started. I told the study doctor this and he said "Yeah, that's the virus for you!"

I'll share results in 2 weeks when I get them! I believe this blood draw is the one where they check to see if I seroconverted or not. Wouldn't that be something, huh?

Post Edited (luckyman316) : 7/17/2014 11:29:31 AM (GMT-6)

Posted 7/17/2014 5:02 PM (GMT 0)
Lucky,
That would be something!! I wish you luck. Knowing your are healthy as a horse...good news, as well. Great attitude you have. Big Hugs
Posted 7/18/2014 1:15 AM (GMT 0)
I don't know what you are converting.. but this is such wonderful news!! WTG!!! keep on keepin on!! beat this thing!!

Sandia
Posted 7/18/2014 2:00 PM (GMT 0)
Sandia,
Essentially I'm reducing my Viral Load for Hepatitis B and improving my liver functions by taking an anti-viral medication. Unfortunately, reducing a viral load does not "cure me" of Hepatitis B, even if it goes undetectable. It doesn't work the same as Hep C. While it might clear out of my bloodstream, it still lives inside of my liver and it also intergrates with Human DNA whereas Hepatitis C does not. So that difference enables Anti-viral medications which are now available, to cure Hep C. Hope this helps understand a bit.
Posted 7/28/2014 3:57 PM (GMT 0)
Wanted to give you guys my latest numbers:

HBV DNA IU/mL - 1,440
HBV LOG 10 - 3.16
Total Bili -- 0.6 mg/dL
Dir Bili -- 0.1mg/dL
ALT (SGPT) - 60 (Still high)
AST (SGOT) - 36 (now in normal range)
HBsAg - Positive (Still)
HBe Ab - Positive
HBe Ag - Negative

Was hoping I'd knock down to undetectable on the viral load, but such as is.. I did not. Almost there! Also, the HBsAG *is* measured in quantitive but in lab only. In the states, it's not available commercially. They watch it in the labe and if seroconversion, they decide what to do from there based on numbers.
Posted 7/28/2014 9:23 PM (GMT 0)
lucky,

I am very happy to see your clinical trial posts for the Hep B folks that visit here. Thanks so much for continuing. I am happy to see your VL drop, and hope you do get this knocked down to undetectable. My best, and Big Hugs
✚ New Topic ✚ Reply
123456