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Treatment ? Clinical Trail?
Hi, i have very little knowledge of Hep B and apologize ahead of the time for stupid questions.
Background: found out i'm hep b carrier at age 16, when my brother was tested positive, the whole family went for testing, and i was the unlucky one, my mom for some reason was tested negative, but my dr. believe it was from my mom, that my mom's result was false negative. She never re-test. I'm female and 35 years old now. My previous dr. (2003-2012) always says that since my liver function is normal, no medication is recommended even though my viral count was high. then i moved an have a new dr since 2012, he however believes that i should take tenofovir because my viral count is high, but he said it's my choice and i could take time to think about it. so when i finally decided to take this medicine, he said there's now a new trial on going, and it might cure hep b, and i'm a perfect candidate for it. So it's the Gilead's trial of " Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment"
I'm scare of the side effects, and read that there was death on a previous hep C trail.
I have no medical knowledge and wanted to know if there's any danger in clinical trial. what are the pros and cons? If i don't do it, and this trial is successful, how soon will the medication be available?
my test result as of july 2014,
HEPATITIS BS AG - Reactive
HEPATITIS Bs Ab QUAL - Non-reactive
ALT-23
AST-22
ALPHA FETOPROTEIN - 2.9
FERRITIN - 10
HEPATITIS BE AB - Negative
HBV DNA QUANT. PCR - 122,189,878 iu/ml
HEPATITIS BE AG - Positive
i read many posts by the community, and it seems like i need to get HBsAg quantitative number, which i didn't see from my result, just email my dr to get that.
thank you all.
Background: found out i'm hep b carrier at age 16, when my brother was tested positive, the whole family went for testing, and i was the unlucky one, my mom for some reason was tested negative, but my dr. believe it was from my mom, that my mom's result was false negative. She never re-test. I'm female and 35 years old now. My previous dr. (2003-2012) always says that since my liver function is normal, no medication is recommended even though my viral count was high. then i moved an have a new dr since 2012, he however believes that i should take tenofovir because my viral count is high, but he said it's my choice and i could take time to think about it. so when i finally decided to take this medicine, he said there's now a new trial on going, and it might cure hep b, and i'm a perfect candidate for it. So it's the Gilead's trial of " Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment"
I'm scare of the side effects, and read that there was death on a previous hep C trail.
I have no medical knowledge and wanted to know if there's any danger in clinical trial. what are the pros and cons? If i don't do it, and this trial is successful, how soon will the medication be available?
my test result as of july 2014,
HEPATITIS BS AG - Reactive
HEPATITIS Bs Ab QUAL - Non-reactive
ALT-23
AST-22
ALPHA FETOPROTEIN - 2.9
FERRITIN - 10
HEPATITIS BE AB - Negative
HBV DNA QUANT. PCR - 122,189,878 iu/ml
HEPATITIS BE AG - Positive
i read many posts by the community, and it seems like i need to get HBsAg quantitative number, which i didn't see from my result, just email my dr to get that.
thank you all.
Best Answer
Hi Rach! I buy through e-bay or amazon Solgar Vit D 10.000. I can'drink coffee without milk for sure. I eat everything, except sugar. Since I know for hep b , I put honey instead of sugar, sleep a lot. Since two years I am reading everyday about tenofovir. It is the only potent and effective drug with no resistance, and everyone taking it is feeling fine. No side effects, mostly could occur to people with coinfection with hiv. Just listen your doctor, he is a warrior, he won his battle trying antiviral with interferon, he also put himself on clinical trial. He is a scientist.
Yes, regarding the baseline testing.
I will need to do a screening blood test and baseline testing first and then the clinical trial dr. will let me know if my condition seems okay for the trial, based on what they know of course.
I will need to do a screening blood test and baseline testing first and then the clinical trial dr. will let me know if my condition seems okay for the trial, based on what they know of course.
Stef,
my dr. told me this for HBsAg
Component Value Range & Units Status
HBV DNA QUANT. PCR 72291944 (A) Not Detected IU/ml Final
what does it mean?
my dr. told me this for HBsAg
Component Value Range & Units Status
HBV DNA QUANT. PCR 72291944 (A) Not Detected IU/ml Final
what does it mean?
lactic acidosis has been seen rarely only on decompensated cirrhosis, so it is best they check lactate levels at start but not an issue
while for kidneys and bone density it is known the problem is already present baseline, you can be relatively sure by checking:
creatinine clearance by 24hr urine collection and urine/blood phosphate levels
moc, not sure if same in english, choose the new one with no radiation exposure to see how bones are
while for kidneys and bone density it is known the problem is already present baseline, you can be relatively sure by checking:
creatinine clearance by 24hr urine collection and urine/blood phosphate levels
moc, not sure if same in english, choose the new one with no radiation exposure to see how bones are
Thank you Stephen,
i think i read about the lactic acidosis with TDF that scared me. There were also kidney issue that you mentioned and some bone density issue too.
Again, it's hard to tell because the effects are different for people with different health condition.
But thanks again for your input.
i think i read about the lactic acidosis with TDF that scared me. There were also kidney issue that you mentioned and some bone density issue too.
Again, it's hard to tell because the effects are different for people with different health condition.
But thanks again for your input.
thank you Stef.
i was asking my dr for the quant and haven't heard. I only see the qualitative, which is 'REACTIVE', i wonder if they didn't test for the quantitative. It's NYC, pretty famous hepatitis specialist, I would image he wanted to see the quantitative part of my HbSAg.
here's the genotype result done two years ago.
HBV SURFACE ANTIGEN MUTATIONS Not Detected
HEPATITIS B GENOTYPE Type B
HBV RT POLYMERASE MUTATIONS Not Detected
As far as side effects, it's hard to tell if it's very safe. they all disclose the most common side effects, and some uncommon (more serious) side effects. Below is what was provided.
GS-4774 was well tolerated with no serious side effects. The most common side effects were injection site reactions. These reactions included pain, soreness, redness, and swelling on the part of the body you received the injection. It is likely that you will have some swelling at the site of the injections; you may also have soreness and thickening of the skin. If these reactions occur, they may be treated with aspirin or aspirin like drugs and they may completely go away but it is possible that skin thickening might not completely go away. The treatment with GS-4774 may result in increased liver inflammation that can be severe with resulting jaundice (yellowing of the eyes and skin) and will be measured with a blood test. If this occurs, you may be required to discontinue the study and be given medication to treat the inflammation.
Tenofovir DF (TDF, Viread®) SIDE EFFECTS
Common potential side effects identified in HIV patients who received at least one dose of Tenofovir DF 300 mg during clinical trials or expanded access program, include:
• gastrointestinal side effects including o diarrhea
o nausea
o vomiting
o flatulence (intestinal gas)
• dizziness
Those side effects were often mild or moderate in severity, and did not lead to
discontinuation of Tenofovir DF.
i was asking my dr for the quant and haven't heard. I only see the qualitative, which is 'REACTIVE', i wonder if they didn't test for the quantitative. It's NYC, pretty famous hepatitis specialist, I would image he wanted to see the quantitative part of my HbSAg.
here's the genotype result done two years ago.
HBV SURFACE ANTIGEN MUTATIONS Not Detected
HEPATITIS B GENOTYPE Type B
HBV RT POLYMERASE MUTATIONS Not Detected
As far as side effects, it's hard to tell if it's very safe. they all disclose the most common side effects, and some uncommon (more serious) side effects. Below is what was provided.
GS-4774 was well tolerated with no serious side effects. The most common side effects were injection site reactions. These reactions included pain, soreness, redness, and swelling on the part of the body you received the injection. It is likely that you will have some swelling at the site of the injections; you may also have soreness and thickening of the skin. If these reactions occur, they may be treated with aspirin or aspirin like drugs and they may completely go away but it is possible that skin thickening might not completely go away. The treatment with GS-4774 may result in increased liver inflammation that can be severe with resulting jaundice (yellowing of the eyes and skin) and will be measured with a blood test. If this occurs, you may be required to discontinue the study and be given medication to treat the inflammation.
Tenofovir DF (TDF, Viread®) SIDE EFFECTS
Common potential side effects identified in HIV patients who received at least one dose of Tenofovir DF 300 mg during clinical trials or expanded access program, include:
• gastrointestinal side effects including o diarrhea
o nausea
o vomiting
o flatulence (intestinal gas)
• dizziness
Those side effects were often mild or moderate in severity, and did not lead to
discontinuation of Tenofovir DF.
check your hbsag quant in iu/ml (architect or elecsys machines can do this) and your genotype so we may know if you can easily clear on sequential treatment without making trial with unknown sides effect of new drugs
gs-4774
check if you can be informed about all sides effects and dangers of this or this plus tdf.if this is very safe i would go for the trial
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