I was offered a clinical trial. Should I take it?

[luckyman316]

Hey guys, wanted to give you all some more info. Went for my follow-up today and I was offered a "clinical trial" for Hepatitis B, since they suspect it's going chronic at this point. The clinical trial was basically a combination of Viread (Tenofovir TDF) and Son of Viread (Tenofovir TAF). The study they are doing is basically to measure bone density over time and the impact on kidneys.

I was also presented with 2 other options, Baraclude, once a day, and straight up Viread, once a day. My question to you guys is... who here has had experience with any of this. Were there obvious side effects you experienced?

Oh yeah, I found out the virus is "active" in me and also that I'm Genotype D. My cancer markers were not a concern and no Hep C, A or HIV were found in me either.

Curious on what advice you guys can give me? For reference sakes, I am going to put my lab results in another post in this thread.

[Jatashankar]

I also contracted this infection via needles of ******* dentist

[luckyman316]

Stef, besides what you mentioned above.. can you add any advice for me during this trial? Stuff like the best exercises to do to stay active and keep strong (or get stronger), etc. Curious on some opinions.

[luckyman316]

Looks like the trial has the Fibroscan being done. Should be interesting.

[luckyman316]

So after discussing with family and friends, they have all urged me to do this clinical trial. We also concluded last night that I contracted this through a dirty dentist needle. It was only logical explaination... but that's beside the point right now.

I asked the doctor more questions and he gave me the answers I wanted to hear (and the truthful answers too). One of the main things I was concerned about is some sort of issue I was having involving some inner ear disorder and brain fog and the hep b. He said there have actually been some talks about it and it's possible the virus may be causing it.... if it goes away when treated then I'll know for sure that was the cause....That being said, since this came about when I first got Hep B, I'm certain it's the cause.

I'm still worried about side affects, especially with the potential bone density loss... I don't want to wither away and look skinny. I'm fairly healthy and active and want to remain that way (play sports, work out at gym, get to work every day, etc.). But I need to chance this. Anyone on here have an experience they can share with Viread (Tenovofir)?

Does anyone know how far along they are from a "cure drug"? I heard 3-5 years? In the meantime, I'm just going to keep praying to God for a miracle that my body clears and is cured of this before any of this starts.

[calebz]

Those trials are a good thing, you get all the lab done for free and on a single visit.Saves time and nerves really. Just consider the risks of phase 3 with the new drug.

[studyforhope]

fibroscan is available in the USA now, quant hbsag is not. Any doctor can order a fibroscan and you can even initiate this yourself.

[luckyman316]

Thanks! I've been thinking about this all day and have been leaning more and more towards this trial, and def want to start it sooner than later at this point. Is fibroscan and quant hbsag test available in the USA? I figured a doctor from the Hep B org would order this.. right?

[studyforhope]

you have 100 million copies, high ALT, e Ag neg and basal core promotor and precore mutations. Not treating would be a big mistake. It would also be naive to hope that you can just clear this. You have been offered the most side effect free potent replication suppression therapy that we can see realistically available at this time and in the near future.
Get a fibroscan and quant hbsag if you can.

[luckyman316]

BTW you're giving me some promising hope.. so thank you!

I wish I never got this. Until this day, I don't know how I got it (Not from parents, 100% certain and not from sex or drugs, 100%.. suspect dirty dentist needle) but at this point, I just want to clear it.

[luckyman316]

Thanks, appreciate all the advice on here. This is actually a Phase III trial now. I'm just generally concerned about the side effects. I'm very active and want to remain that way... but I guess it's better than having issues later on if I have this still.

[luckyman316]

I am 36, going to be 37.

[studyforhope]

If you have the choice, I would take the tenofovir alafenamide arm. It offers the power of tenofovir at a ten times reduced dose. Whatever the remaining side effects of tenofovir due to inhibition of the mitochondrial gamma polymerase are, they are likely to be dramatically reduced. This might well be an important step forward in HBV treatment. The results of a phase II trial on HBV patients have been presented at the AASLD 2013, it looks quite promising.

[The_PS]

You have precore/core promoter mutation, Hbe - , but high viral load. If I were you, I will give a try. How old are you then?

[Rome70]

With your dna you should not be reluctant to take drugs. The fact that you have no sympthoms is nothing new, hbvers have no symptoms until cihrosis develops.
The only option that you have is NUC for 3-5 years and then add on of interferon.
So this trial is a good option it is the drug that you need and it is free and under good supervision.

[luckyman316]

Thank you Stef, for your replies. I'm still reluctant to take any drugs. Believe it or not, I have no symptoms of Hep B other than the blood work showing Hep B. But I know I probably should take something, until they find a cure (unless I cure it through the drugs). I'm just worried about the symptoms or side effects of the drugs, if any, because I'm fairly active and want to remain so.

[stef2011]

that trial is useless for you and even for us, we already know tenofovir has no kidneys/bone problems for hbvers (only hiv infected have problems but most of them are drug users so anything can be with a almost dead body like that, hiv is an angel compared to what drugs can do)

none of the options offered to you are a cure for hbv but since tenofovir is the most potent you better go with it (you also have very high hbvdna so tdf is better), to get cured you need pegintf add on in 3-5 years

you miss hbsag quantity, we need that before saying tenofovir is the best option and even needed as a baseline to know improvment

[luckyman316]

For numbers and lab sakes:
CBC Results:
WBC - 7.0
RBC - 4,79
Hemoglobin - 14.8
Hematocrit - 45.1
MCV - 94
MCH - 30.9
MCHC - 32.8
RDW - 13.8
Platelets - 254
Neutrophils - 56
Lymphs - 32
Monoctyes - 9
Eos - 3
Basos - 0
Neutrophils (absolute) - 3.9
Lymphs (Absolute) - 2.3
Monocytes (Absolute) - 0.6
Eos (Absolute) - 0.2
Baso (Absolute) - 0.0
Immature Granulocytes - 0
Immature Grans (Abs) - 0

Comp. Metabolic Panel
Glucose - 83
BUN - 20
Creatinine, Serum - 1.16
eGFR If NonAfrican Am - 81
eGFR if African Am - 93
BUN/Creatinine Ratio - 17
Sodium, Serum - 142
Pottasium, Serum - 4.1
Chloride, Serum - 103
Carbon Dioxide, Total - 24
Calcium, Serum - 9.6
Protein, Total Serum - 6.6
Albumin, Serum - 4.3
Globulin, Total - 2.3
A/G Ratio - 1.9
Bilirubin, Total - 0.5
Alkaline Phosphatase, S - 71
AST (SGOT) - 61
ALT (SGPT) - 115

Urinanalysis Gross Exam
Specific Gravity 1.027
pH - 6.0
Urine-Color - Yellow
Appearance - Clear
WBC Esterase - Negative
Protein - Negative
Glucose - Negative
Ketones - Negative
Occult Blood - Negative
Bilirubin - Negative
Urobilinongen, Semi-Qn - 0.2
Nitrite , Urine - Negative

HBV Real-Time PCR, Quant
HBV IU/mL - 18,907,000
log10 HBV IU/mL - 7.277
HBV Copies/mL - 110,040,000
log10 HBV Copies/mL 8.042

Panel 083824
HIV 1/0/2 Abs-Index Value <1.00
HIV 1/0/2 Abs, Qual - Non Reactive

HBV Genotype/PreCore
HBV Genotype - HBV Genotype D detected
HBV PreCore Mutation - Basal Core promoter mutation at 1764 was detected. HBV PreCore Mutation 28 was detected.

Prothrombin Time (PT)
INR - 1.1

AFP, Tumor Marker (serial)
AFP, Serum, Tumor Marker - 1.7

TSH - 1.770

PTT, Activated
aPTT - 26

Hep B Surface Ab
Hep B Surface Ab, Qual - Non-Reactive

Mitochondrial (m2) Antibody - 2.8

Vitamin D, 25-Hydroxy - 59.6

HCV Ab w/Rflx to Verification
HCV Ab - 0.1

Phosphorous, Serum - 4.0

Antinuclear Antibodies Direct
ANA Direct - Negative

Ferritin, Serum - 258

HBsAg Screen - Positive Abnormal

Hep Be Ag - Negative
Hep Be Ab - Positive Abnormal
Thyroid Peroxidase (TPO) Ab - 8
Hep B Core Ab, Tot - Positive Abnormal
Hep A Ab, Total - Negative

So yes, happy my vitamin D levels went up. Still feel I could use 20 more points on there. Also need Hep A vaccine. The rest is good, except for the Hep B portion which I need to clear.