Gilead Submits TAF NDA For Hepatitis B
Jan 13, 2016
Gilead Sciences (NASDAQ:GILD) files its New Drug Application (NDA) with the FDA seeking clearance of tenofovir alafenamide (TAF) 25 mg for the treatment of adults with chronic HBV infection. The company is transitioning its product line to TAF from TDF (tenofovir disoproxil fumarate) because it is just as effective at a dose less that one tenth that of TDF and is less stressful on the bones and kidneys.
The company intends to file its TAF Marketing Authorization Application (MAA) in Europe this quarter.
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Has anyone heard of a new drug in the works from Gilead, which is supposed to cure hep c in geno 1a patients with cirrhosis, having pre-treatment and null responders.
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There is a link about tenofovir alafenamide (TAF).
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my father is 66 years old, it has been found out through blood test (ANTI HCV) his cutoff value is 1.00 and patient value is 12.51. which further reveals reactive hepatitis. what do you suggest for him?
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Do you get flu like symptoms with HEP C?
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I in a relationship with a girl and it all started as arrange marriage and now it has turned into love last week i did my Hep B(HbsAg) test (Its Chronic) and i came positive there after i did my Liver Function Test and everything is very good in liver as per doctor , I'm currently going through AntiGen E and AntiBody To Antigen Test and reports would be coming today but now the real problem has come from her parents which is quite obvious as they don't want risk their daughter life by getting married to a Hep B patient.
Myself and her even visited Doctors together and consulted about the disease and they said its all fine to get married once she takes Vaccines of 6 Months (3 doses) and i should keep checking my liver every year just to keep a watch and i should eat healthy and stay fit apart from that there are no medicines for it to cure.
Now she is going to take her parents to the doctor to let all their doubts cleared by doctor itself same doctor whom we visited she understands(She is physiotherapist) the things but does not want to go ahead if there a health risk involved here which is rationally correct as well.
Are there people here who went ahead with ahead marriage despite knowing partner is Hep B positive ?
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I was wondering if anyone here has coinfection and what are you doing about it?
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I want to ask, after how many moths/years will I die, after getting the infection, if no treatment is started. And also after how many moths/years will I develop liver cancer, if no treatment is started.
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I am a fresh graduate and I was looking for a job then found one, I was hired and before I could start they wanted to get my medical result first. They told me I won't be able to get the job anymore since my result in HBsAg was reactive. In the medical it says "3516.26 S/CO; The Cut-Off value reported for this assay cannot be correlated to an end-point titer; rechecked and verified." Is my Hep B chronic? And can I still get a job even though I am now a carrier of this disease? I am really depressed now it's like I've wasted 4 years of studying
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After 1month of viread, my alt increased from 200 to 373.
Before:
Hbv DNA 170 million
As I said my Sgpt 200
Hbeag reactive
After 1 month
Hbv DNA 133,000
Hbeag reactive
Sgpt 373
My alt increasing is this normal?after 2 more months what will be next happen to my sgpt.please share with ur tdf experienced.
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I have been diagnosed with Hep B. I was admitted to hospital with exceptional readings (ALT >4,000, bilirubin 180, all pho 162, gamma get 417, AST >2,500). I've been given various drips and the numbers are coming down. ALT has now halved. In addition to the drips I was also put on Viread.
My physician was concerned how my immune system was attacking the liver and between all treatments, in three days the readings are coming down. My jaundice is going and my urine now looking paler (almost normal).
Given the symptoms indicate a severe acute response to infection, does this suggest my body will put up a good fight to rid itself of the virus. Also, is there a risk Viread could actually lead to my body not developing the antibodies? I've read the following study, which suggests Viread can be highly effective in treating severe acute Hep B and also assist (or at least not inhibit) the development of antibodies.
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I'm on day 6 with Harvoni and still a long way to go, was wondering on how some of you are doing on the same treatment .
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I don't post a lot on here but wanted to share with everyone the miracles that exist now for treating Hep C. I saw my doctor on Friday and she let me know that my 12 week post treatment labs after 24 weeks of Harvoni came back with a negative viral load and that I am now cured (12 Week SVR). This was my 3rd treatment and thanks to God, it worked. There is hope for all of us. I have had Hep C for 30+ years and am a Genotype 1A, with a Fibrosis level of 3+. As a 3+, I still have an increased risk for HCC, so I will continue to get lab work done every 6 months, ultrasounds every 6 months and a CT scan every 18 months. I encourage everyone to keep on treatment - we are at a place where so many of us now have a chance for a cure!
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I was wondering what people are eating, if anything, when they are taking their Harvoni? I know that it is prescribed with or without food but I saw a comment on another forum that said that Harvoni works better in an acidic environment. However, I have not come across that information anywhere else. Just wondering as I want to make sure that I am doing all that I can so that treatment works this time after failing 3 times.
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How does one take the Sovaldi? On its own at a different time of day or together with the first dose of Ibavyr?
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someone wrote on other forum that Sovaldi killed her mother. She is suing the doctor and it's kind of scary reading about it. Have there been many deaths associated with Sovaldi?
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Has anyone on treatment with any Sovaldi combo experienced ascites?
I have been on Sovaldi and Olysio for 8 weeks now and have noticed quite a bit of fluid just at the top of my ribs, making me look maybe 3 months pregnant. I don't want to say anything to the doctor because I don't want to stop my tx. I know everyone says drink a lot of water, but I am thinking perhaps I have been drinking too much water and the kidneys are suffering with processing it. Also, my breathing is more heavy than it was just a week ago if I go walking. I do new labs in a week so will be able to see if anything is awry, but mostly I'm curious as to whether anyone else has experienced this.
Perhaps it is not even ascites and I've just been eating too much.
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I am a 27 old man ,hbv carrier .i want to know if there is any study about the relation between ggt and smoking.my ggt after a 2 month of quiting smoking was 22.and when i resmoke a 2 pack per day four 2 month it become 26.i read that ggt is better under 20 u/l.
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If the organ receiver is vaccinated, then is it possible to transplant from hbv sufferer's body?
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My new girlfriend, who I like very much, was very open with me about the fact that she had a blood transfusion as a baby for several surgeries she had to have, which left her HCV positive. She and I were about to move into the sexual part of our relationship, so we both got tested for STDs to show each other we had a clean bill of health. Well as it turns out, her bloodwork showed she was HCV positive again...this is after achieving SVR (not sure for how long she had achieved this yet). She told me and was very upset, so I obviously just gave her a hug and held her. No other way to respond she was so upset. I'm curious, does anyone on here have any experience with this? Possibility for false positives or possibility for her to need to seek additional treatment? I hope you can forgive any questions that may seem ignorant. I am mostly focused on her health, but naturally I'm also concerned about the implications for our future relationship (I understand it is very low risk to pass it to me through sex, but still, I'm human, and I'm just carefully looking at this situation). If anyone can shed some light on her situation, I'd love to hear it. She's a great woman and I'd like to get any info for her that could help.
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For those that recall, I've been on the clinical trial for TDF vs. TAF. It's a double blinded study which means I do not which drug I was on. I tried asking my doctor today about this and he just smirked a little at me and said "we don't know" but I suspect he does know and opted not to tell me as per agreement/contract. However, this does not change the fact that going forward, I will now be treated with TAF for the remainder of the trial which last 9 months.
Anyway, I decided to mention to him that this new formula was going through FDA approval and he was well aware. I asked him how long would it take for it to be approved and he said about 9 months. He's very confident that it will go through without any hesitation.
Naturally, I asked him a series of questions, such as what happens if my insurance does not approve the new formula or if the FDA approves it before the trial ends or it does not get approved at all. Here were some of the answers I was given:
-If FDA Approves it before the trial ends, I will finish the trial as they want to collect as much data as they can.
-If FDA does no approve, the trial will be extended
-It's possible my insurance may not cover the new formula, especially if it ends up being significantly higher in price than the old formula. If that is the case, they can look at getting me onto the old formula or if it came down to it, switching me to entecavir.
-Price wise, they'd look at getting me a copay card to offset any of the pricing down the line. Asked about this and was told "could be a couple of hundred a month but we'll do our best to make it cheaper".
-I also asked about clinical trials down the line with them, which they said they don't have anything at the moment but I should look into the trials that are being aimed for the cure.
Overall, not only am I concerned about switching to TAF now (in case I have any reactions or symptoms come back) but what concerns me the most is the fact that they are even thinking about switching me from Tenofovir to entecavir. To me, this does not even make any since since Tenofovir works a LOT better.
Now, I did get a result back of my Ultrasound. Unfortunately, I have a cyst on my kidney that seems to be growing but my last blood test seems to be fine with kidney function. I also have a polyp on my gallblader (gallbladder) which I have had for years now. More importantly, my liver: No abnormalities, perfectly normal.
On that note, I'll share my results going forward.. including the results from the blood being drawn today prior to TAF (which I should have in 2 weeks). For prior results, please see my old posts.
Please note, I am no doctor, I am a patient.... I know I get many questions via PM as if they are directed towards a doctor, but I can only answer so much based on my experience. Also, I have no way of getting TAF other than through this trial and do not know of any other way. Please feel free to ask anything you'd like. I'll answer my best and will give some feedback of the meds and how they are working for me down the line.
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