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.
Hi, as Stephen mentioned, tenofovir is potent antiviral with no known sides. However for gs-4774, you should ask for previously seen side effects.
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 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.
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
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.
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.
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
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?
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.
Hi rach. I live in NY as well. Could you tell me who is your dr?, or send me sms inbox. Meanwhile,they don't do Hbsag test here, if you have chance to go outside usa do it. If you choose to go on trial, I will be curious if they test people for hbsag before going in, or it is a game of healthinsurance, or what's the problem? such a cheap test
Well, they are not providing the vaccines after the trial. I read Gilead is obnoxious with putting a high price tag on their medicines. Ugh...
Yap, you are right, Gilead is more for profit than for patients.
Sent you a mdm Mer971.
By the way, i'm starting to religiously taking Vit D3, what brand and dosage is good? would you guys suggest any?
Thanks.
And on that note, any diet/food is particular helpful? thinking about Vit D, i'm not a milk drinker, never was, should i really start drinking milk for the sake of my liver? any other tips is appreciated.
I understand there's a lot of great threads here, feel free to link it here for me to read if it's already discussed elsewhere.
it's funny you mentioned coffee. when i first see my dr. i asked him if i should keep my coffee to one cup, he said coffee is good, 2 or 3 cups are fine. drink it away. LOL. i do use creme in my coffee. I only have alcohol on occasion, or events i go to, so there's no issue there.
On vit d, you take two gels a day for 20,000 iu, right?
oh.. i didn't realized it's 10,000. i was only taking 2,000 iu before.
am i way off here?
rach, taking 10,000iu daily is pretty essential for us. I did this last year and feel MUCH MUCH better. At a point, I even upped it to 20,000iu to get my levels above 100. The lab cutoff is 100 but if you read what Stef posts, we could go as high as 150 and be safe.
Coffee is fine.. it's been actually said to be beneficial for your liver. Of course, there are downsides to it too. I used to drink 3/4 cups a day and ended up with bad teeth because of it lol
You need to stay away from alcohol as much as you can. My doctor gave me the whole "2-3 beers a week or 1-2 glasses of wine are fine" but I know better. It doesn't hurt anyone to tell people "I can't drink right now, doctor's orders". Also, it's been said to stay away from dairy...
Yes mandatory off all dairies even those in processed foods and restriction of nuts.water 2.5l of water with calcium less than 10mg/l.this will make vitd25oh very safe at 150ng/ml and is also healthy in general, dairies are contaminated from the rubbish food animals are fed and all the drugs given to them
re alcohol, my dr also told me one glass a day is perfectly fine. hmm... definitely do learn a ton on this board. Thanks again.
honestly had no idea about off all dairies. why is that? is there an article i should read?
Also nuts? doctors never mention about this. what's the rational behind it?
what about organic dairy?
so 2.5L of water with 25mg of calcium? i don't think it's possible to get calcium supplement in such a small dose 25mg? i normally see 500mg in supplements here.
I'm sure i'm missing something here ;) doesn't really make sense.
Rach what steff is saying is that if in your test calcium is under 25ng/ml is better to drink every day 2.5 ml of water. So if you don't know your levels of calcium better do it
What article, there are but the thing is so obvious
full of useless calcium, full of rubbish fed the animal (the animals must eat grass in the wild, nature never built them to eat cereals of rubbish in the food they have today).the milk is so full of antibiotics, steroids and drugs in genereral that many countries among the less corrupt report what they found in it, even italy which is very corrupt made public what is found in milk
and end of story milk has cancer causing agents, breast jn particular, and humans and mammals in beneral were never meant to eat milk all life.all mammals just eat as born and then stop