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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.
I am surprised to hear about the "deadly" side effect associated with Tenofovir. TDF has been in use for HBV for 8 years, and much longer for HIV. So the side effects of TDF are well known, the most common being kidney issue. However, many studies have reassured that the drop in kidney function is limited in patients without any known prior kidney problems. You should satisfy yourself on this by talking to your doctor.
I think you have asked the most important question already( medical bill in case an injury or sickness was developed due to the trial), you may also like to ask:
1. the schedule required during the trial such as frequency of testings;
2. long term free supply of TDF, after the trial;
3. follow up period.
I think you have asked the most important question already( medical bill in case an injury or sickness was developed due to the trial), you may also like to ask:
1. the schedule required during the trial such as frequency of testings;
2. long term free supply of TDF, after the trial;
3. follow up period.
Thank you so much!.
I did have a fibroscan two years ago, the score was 5 or 6, lowest level, so the dr said it's all good. He hasn't ordered another one for me yet. I've been doing ultrasound once a year and everyone of these had great result.
I'm still deciding whether i should do this trial. some of the reported side affects from Tenofovir were deadly.
never thought about even asking if Gilead would offer the vaccine free if it's proven to be effective....
would you be so kind and advise on some good questions to ask?
I've asked if they will take care of medical bill in case an injury or sickness was developed due to the trial.
I did have a fibroscan two years ago, the score was 5 or 6, lowest level, so the dr said it's all good. He hasn't ordered another one for me yet. I've been doing ultrasound once a year and everyone of these had great result.
I'm still deciding whether i should do this trial. some of the reported side affects from Tenofovir were deadly.
never thought about even asking if Gilead would offer the vaccine free if it's proven to be effective....
would you be so kind and advise on some good questions to ask?
I've asked if they will take care of medical bill in case an injury or sickness was developed due to the trial.
Hi, as Stephen mentioned, tenofovir is potent antiviral with no known sides. However for gs-4774, you should ask for previously seen side effects.
I am not a doctor, theses are just my opinions.
HBV is a chronic disease and can go through many different phases during its natural course. It seems you are in the first phase, the immune tolerance phase, during which the virus is highly replicative (hence the high viral load in your blood), but the body's immune system is not attacking the infection (hence your ALT is normal). Since the liver is not damaged in this phase, many doctors prefer not to treat. However, some doctors will reconsider when the patient is older and there is very potent drug, such as Tenofovir, that can treat the condition now. Personally, I will do a Fibroscan to ascertain the state of the liver, to determine whether treatment is necessary.
GS4774 is a therapeutic vaccine and it has completed a Phase 1 clinical trial in healthy cohort and reported to be safe. Yours is the second of a phase 2 studies in patients with Hepatitis B (the first one requires patients to be already on antiviral treatment). So on the safety aspect, I believe it is safe, of course, you should seek information from your doctor and Gilead. The vaccine is heat inactivated yeast engineered to express several HBV viral proteins.
http://www.globeimmune.com/infectious-disease/gs-4774/
The only downside to participating in your trial is that you cannot be guaranteed to the in the arm that also receives the vaccine, but you will definitely receive Tendofovir. There are benefits to be in a clinical trial as you will be monitored frequently, also you may be offered the vaccine free if it is proven to be effective. You should ask your doctor and Gilead all these questions.
All the best and do keep us informed if you decide to proceed.
HBV is a chronic disease and can go through many different phases during its natural course. It seems you are in the first phase, the immune tolerance phase, during which the virus is highly replicative (hence the high viral load in your blood), but the body's immune system is not attacking the infection (hence your ALT is normal). Since the liver is not damaged in this phase, many doctors prefer not to treat. However, some doctors will reconsider when the patient is older and there is very potent drug, such as Tenofovir, that can treat the condition now. Personally, I will do a Fibroscan to ascertain the state of the liver, to determine whether treatment is necessary.
GS4774 is a therapeutic vaccine and it has completed a Phase 1 clinical trial in healthy cohort and reported to be safe. Yours is the second of a phase 2 studies in patients with Hepatitis B (the first one requires patients to be already on antiviral treatment). So on the safety aspect, I believe it is safe, of course, you should seek information from your doctor and Gilead. The vaccine is heat inactivated yeast engineered to express several HBV viral proteins.
http://www.globeimmune.com/infectious-disease/gs-4774/
The only downside to participating in your trial is that you cannot be guaranteed to the in the arm that also receives the vaccine, but you will definitely receive Tendofovir. There are benefits to be in a clinical trial as you will be monitored frequently, also you may be offered the vaccine free if it is proven to be effective. You should ask your doctor and Gilead all these questions.
All the best and do keep us informed if you decide to proceed.
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