Gilead Submits TAF NDA For Hepatitis B
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.
Hepatitis B :: Gilead's Hep B Drug As Effective As Viread But Safer
There is a link about tenofovir alafenamide (TAF).
View 7 RepliesOraquick (2nd Generation) OR Third / Fourth Generation Tests?
I am female, I had one exposure exactly 30 days ago, (4 weeks) unprotected vaginal intercourse with a man of unknown status. I took an Oraquick in-home HIV test on day 23 then again on day 30 and both come out negative. The symptoms I have had are excessive urination and a rash on upper arm. So of course I started freaking out. I plan on taking more on week 6, 9, and 13. You can say I'm obsessive. Any who, how accurate are the Oraquick oral swab HIV test at 4 weeks post exposure. I hear many people say its nearly 90 to 95 percent accurate by this time, however are they referring to a third and fourth generation HIV test, because as you know Oraquick is only a SECOND generation, so does these statistics refer to the Oraquick test or not? When will antibodies be detected at the earliest for an Oraquick HIV test? Has anyone tested neg on an Oraquick oral swab HIV test at three and four weeks then later tested positive on a blood test or any other test?
View 3 RepliesHepatitis C :: Harvoni Day 6 - Still A Long Way To Go
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 .
View 6 RepliesHepatitis C :: Cured By Harvoni
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!
View 6 RepliesHepatitis C :: What To Eat / Food While On Harvoni?
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.
View 1 RepliesHepatitis C :: Harvoni With Carafate For Pancreatitis?
I have chronic pancreatitis and they put me on carafate and I have hep c since 2000, cirrhosis since 2007, no prior hep c treatment was wondering about Harvoni and carafate?
View 2 RepliesHepatitis C :: Medicare Covers Harvoni?
Will Medicare cover for me? I can't afford the regular super high cost. Any programs for discounts here in the SF Bay Area?
View 1 RepliesHepatitis C :: $5 Copay For Generic Harvoni And How To Get It?
I have been written a prescription for Harvoni or generic. I've found generic at Gandhi Medicos for $1140 US.
I am in US and I'm wondering if anyone has any dealings with this Co. also.
Hepatitis C :: Naturopathy Vs. Harvoni - Experiences?
I'd like to relate our experience with Hep C treatment. My husband got Hep C back before it even had a letter, in the 1970s, and he is now 62. He has never been much of a drinker, which is very fortunate. He has always had a ridiculous amount of energy, and an active occupation. He kept an eye on his liver (don't take that literally!), and the diagnosis never much affected him. But after a divorce about 10 years ago, he began to consume more alcohol than before, and his liver enzymes crept up, and his biopsy in 2009 said he had Stage 4 cirrhosis. Yet function was still fine, and still he did not feel affected by the disease. The doc said, the numbers say it's time for interferon.
The side effects and prognosis for cure were not encouraging, and I contacted naturopaths I know to get a recommendation for someone for him to see. They recommended a doctor at John Bastyr Naturopathic College in WA State, and we went to see her. She specializes in traditional Chinese medicine for cancer, HIV and liver diseases. She prescribed an herbal combination, and some other supplements. And ZERO alcohol. She was the first doctor who actually said NONE. Other doctors would pussyfoot around and say, don't drink a lot, but no one said, don't have any at all. Not even one beer on Friday. Not drinking was not a problem for him, as he had already mostly stopped having any once he got the Stage 4 pronouncement.
The treatment regimen she started him on made him feel worse, so he went back, and she put him on a different formula, something called Livercel, made by Nutricology. It contains a proprietary blend of Patrinia extract, Phellodendron amurense extract, Yi-Chen wormwood extract and Schisandra extract. He also was taking milk thistle and a few other things. This herbal combo reversed the numbers, brought his liver function (alt and ast) down to high normal, whereas they had been going way up.
He kept to this regimen and was going along fine, back to not feeling impacted by the virus, though of course he knew it was still there. However, at his checkup last June, his numbers were starting to go up again, and now that there was a real cure available, his naturopath said, ok, now the new drugs have been proven effective and have minimal side effects, so time to give that a try, if you can afford it. Which of course, hardly anybody can. So then we started on that journey.
Meanwhile, what my husband hadn't mentioned to me was that because he was feeling so unaffected by the disease, he had started being not so diligent about taking the Livercel. Taking it once a day instead of twice, or skipping a day, etc. Once he got the higher numbers in June, he started taking them religiously, never skipping. And you know what? HIS NUMBERS WENT DOWN AGAIN. The RNA quantitation was 15,774,971 in June, and on the 11th January, it had gone down to 6,646,637. Down about 60%. This shows to me that the Livercel was having effect. So look into that while you are waiting for the new medicines to be available at a reasonable price.
Meanwhile, although his allopathic doctor's request for Harvoni was initially denied by the health care insurance company, they approved it when she resubmitted it. And they signed him up for the Harvoni's patient co-pay subsidy. He has been on it for a week, and so far no side effects at all. I asked him if he felt anything at all yet, and he said, "I think they must have given me the placebo.
Hepatitis C :: A Great First Week On Harvoni
Well first week went by and doing great. haven't had any side effects to speak of, 11 more weeks and hopefully i'll be cured
View 4 RepliesHepatitis C :: Harvoni 4 Weeks Results
Started 24 week treatment with Harvoni 1/20/15 Genotype 1-a Stage 4 Cirrhosis with Compensated liver
Ast 123 then, 45 now
Alt 165 then, 165 now
Viral load then: 2,600,000 now less than 15
Hep C still detected but I thought this was great for the 1st 4 week prognosis since I am on pill for 24 weeks.
How is everyone else doing?
Hepatitis C :: High BP, Low Pulse On Harvoni
That's what I am experiencing along with shortness of breath, fatigue and aching. These are mild problems compared to the interferon based tx so I figured I'd just go with the flow. What has me more concerned is my low pulse which is consistently under 60 at rest and barely over 60 with exercise and I am breathing heavily most of the time. I had not heard of any relationship between Harvoni and high bp until I found this: ...
View 17 RepliesHepatitis C :: When To Start Second Round Of Harvoni?
EOT 17 after 8 weeks of treatment on Harvoni. SVR test scheduled for June 17th. I just had a blood test done at another doctor and am awaiting results. If it shows virus has come back and is growing, how long before I can effectively take a second round of Harvoni treatment?
View 24 RepliesHepatitis C :: Ribavirin/Sovaldi? Can't Take Harvoni
I'm a Gt3 and while I'm excited to be on treatment, I also feel slighted almost that I can't take Harvoni. I'm always searching for results from others with the same as me but I don't see much. I have 8 more weeks to go from a 24 week treatment of Ribavirin and Sovaldi.
View 15 RepliesCirrhosis Of The Liver And Hepatitis C Cured By Harvoni
I haven't been in here for awhile, My husband took harvoni and is free of hep c, He has been on the transplant list for 4 years, He had the tips procedure done in 2011 because of a bleed out that almost killed him, He has had liver cancer, They probed the cancer and it is gone, He is on lactulose because of H E , Also he vomits every third day and no one knows why, So we had a meeting with the transplant doctor yesterday, and because his hep c is gone and his meld score is only 16, They took him off the list, I asked what would happen if he got worse or whatever, And they said we would have to start over again, So now we have decided, no matter what we have been sitting too long , it's time to enjoy life and start traveling, Whatever happens ,, happens,,, Had to vent Thanks
View 1 RepliesHepatitis C :: Harvoni A Cheap Option Than Interferons?
I ended up with hep C in 1971, but my doctor could never find what was wrong with me until the test for hep C came out in 1991. After testing positive I had a biopsy and had over 50% liver damage, so they put me on Interferon for 6 mo and I was negative for 13 mo then back again for another 6 mo treatment which put me negative for another 13 months. Then I insisted on a 12 month run and I have been negative for 14 years, but just found out today that it's back.
Problem is I can no longer afford insurance under Obama care, so I can't afford a long expensive treatment. I haven't heard about Harvoni, so is this a less expensive option? My interferon treatment was around $2000 a month and I can't afford that. I am disabled so I can't get insurance through work and I am going on two years with SS Disability jacking me around. I have a lot of pain in my side where the biopsy was done 17 years ago, so I suspect my liver is in bad shape, so would Harvoni be an option? Being I am almost 60 now I am only seeing the option to live with it until I am 66 and can get Medicare and hope I last that long and that medicare lasts that long. I don't see the 650 a month on Obama care as ever being an option due to my wife having a job as a bartender. A bartenders salary means we are wealthy according to Obamacare and there is no subsidy.
Hepatitis :: Which Insurance Company Covers Harvoni?
Which insurance company covers the hep c drug Harvoni?
View 1 RepliesHepatitis C :: Wonderful Harvoni TX - Achieved SVR / Cured
Received my 6 month end of Harvoni treatment.
Achieved SVR/Cured
So happy!!! Harvoni is such a wonderful drug. I thank God for it. It was amazing, I never felt so good while I was on it. It made me feel great. I did 12 weeks of treatment and my viral load was 5.8 mi. Type 1A