Possible 8-Week Cure for Patients with Hepatitis C
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The Editors at Hepatitis Central
February 15, 2017
Learn more about a new, investigational Hepatitis C drug that has been granted priority review by the FDA. It is meant to help patients without cirrhosis who are new to treatment.
Investigational Hepatitis C Drug Granted Priority Review
By Jennifer Barrett
The FDA has accepted AbbVie’s New Drug Application (NDA) for and granted priority review to its investigational, pan-genotype regimen of glecaprevir/pibrentasvir (G/P). The treatment is being evaluated for its ability to treat all major genotypes (GT1-6) of chronic hepatitis C virus (HCV).
The NDA is based on data from 8 studies which evaluated more than 2300 patients in 27 countries across all major HCV genotypes and special populations.
Continue reading this entire article:
http://www.pharmacytimes.com/product-news/investigational-hepatitis-c-drug-granted-priority-review
42 Comments
Eight-week cures are already possible in some cases with existing drugs. I was cured in eight weeks with Harvoni as I was treatment naive, and despite having had hep c genotype one for decades I was not cirrhotic. In fact, I had no detectable virus after four weeks.
I too was cured after 30 some odd years with genotype1. Harvoni did the trick . Although there were no side affects while taking the drug, since then , coincidentally , strange things are happening in my body. My feet and ankles have gone numb and I get recurring , painful cramps in feet and legs.. I swear they cannot tell what is causing it but I KNOW it has to be related to the treatment and I am paying dearly in the aftermath
Sorry to hear that. I have seborrhoeic dermatitis on my neck under my hair and it is very hard to cope with. I know some people with hep c who also had it were pleased to find it vanished once cured. However, in my case I now have skin issues all over my body too. Places like my navel, my ears and one side of my scrotum itch and get sore, and my chest and legs itch too.
My hospital just noted this as a possible side effect but aren’t convinced it’s related to treatment because they say they usually only see skin problems on those who have Ribavarin in addition to Harvoni. The only suggestion was to see my GP, but as there’s no cure for seborrhoeic dermatitis and I’ve tried everything and seen my doc already. . .
All I can say is: it’s better than having hep c. Your issues seem worse and I hope you can get help.
I have seen a very close friend and family member almost die due to this. Living overseas, I have seen others avail themselves of much better and cheaper options than the US manufacturers. They license other companies to make the drugs and sell them for as little as $750 Per 12 week treatment, up to $1500 for Epclusa generic. They are not fake – just licensed for overseas sales – save yourselves.
Hear that.
I want all to be forewarned that unless you have a specific Geno type lab test to determine your specific Hep-C, an 8 week Harvoni treatment may be a waste of time and money. I took Harvoni for 8 weeks, 6 months after treatment my hep-c viral load was back to the same viral load before treatment. I am now taking epclusa with ribavarin for 3 month treatment, more expensive than Harvoni. so far not so good with mid treatment blood test. I am a geno type 1
Sorry to hear that Stephen Harvoni was GIFT from GOD to me after a HORRIFIC experience with Infon/riba. In early 2000 My TX was 48 weeks by week 16 I thought I was going to DIE from the HORRIBLE side effects it caused!!! My V/L did drop but I couldn’t take the mental & physical TORMENT That I was experiencing!! Took Havoni for 12 week in 2015 Buy week 4 my V/L dropped from 18 mil to 3 hundred points and was ND after 8 weeks with virtually NO Side effects!! I am OFFICIALLY SVR!!!! Good Luck!!
Glad to hear!
Sorry to hear I also am type1
I’m so sorry for your status. I’m 1 and waiting on to be approved to take Epclusa. I have always avoided ALL meds and now here I am ;/
i also relapsed after 8 weeks of harvoni….
Am sorry to hear of Stephen and you relapsing after Harvoni. I’ve been told that my hospital hasn’t seen anyone have hep c come back after they’ve been clear for 24 weeks, if it’s going to happen it’s usually sooner.
I wonder How much they are gona sale this one, they making dtuck but you can not efford it,
Probably unaffordable
If Hep C was required to be tested in the annual panel of blood tests we take NONE of us would have Cirrhosis right now from blood transfusions!! However doctors and the government make money for us all to be suffering from Uncurable Cirrhosis instead of curable hep c before it gets to this point. I’m a raw vegan that has never drank or did drugs yet here I am too. NOT that ANYONE with any lifestyle choice should be living with something that could have been avoided if hep c were mandatory in blood panel test.
I had blood transfusion 1983!!!! Was NOT told by any doctor I had hep c until JAN 2017, with added Cirrhosis!!!
Now charging me for all kinds of test and meds!! Hmmm where were all these test the last 33 years!! I have five surgeries and a child in the last 33 years!!! Pulled all my labs and radiology records and see now that docs have known for years and NOT One has to me!! Hmmm epidemic ??? Yeah government and medical murder of Americans!!!! Doctors don’t make money on healthy people!!
Anyone interested in joining me in making hep c testing mandatory or in the blood panels they make you take at annual physical?? They are sure ready to test you for diabetes, heart disease etc —ALLLL things they can make you take RX for!!
Hang in there I had hepatitis C for 28 years I had to finally quit my job and get rid of everything and claim indigent in order to get the drug company to help me out with the treatment. My buddy has cirrhosis of the liver and had hepatitis C and get treatment and is cured from hepatitis C and his liver is doing fine at the moment no problems so hang in there there’s light at the end of the tunnel
The hepatitis C virus was discovered in 1989. Prior to that, it was associated with blood transfusions, but was called non-A, non-B hepatitis because the virus could not be identified. It is now known that there are several genetic types (genotypes) of the hepatitis C virus.
There was no test at that time of your transfusion in 1983. Nor did anyone know of the grand significance of the disease at that time.
I don’t think there should be mandatory blood panels at physicals. Mandatory blood tests are a clear violation of constitutional rights. Also, I would suggest making sure you have all your life insurance policies in place first if you are going to mandate that hep c blood panels are a requisite to annual physicals.
Right on, I got so sick of the implication of IV drug use, I searched for years, until I found the time & place, I got “Non-A Non-B” in the 70’s, it was a hospital, one run by my faith, no less, I chose them over a nearby inner-city Hosp. out of fear of something like this. Well, it was only because I went acute, shortly afterwards, not years later, that I was able to run out a timeline. And find the source.
You’re fed up. I’m Pissed Off, these cures are, at first, funded by tax dollars, while the scientists get Govt paychecks & then, when it’s good they get millions selling the patent to Pharma, yeah a double dip.
Then Pharma spends less than $5 a pill manufacturing it and charges US a full $ 1,000.00, that’s so wrong, it’s like being played for a sucker. paying Tax $ to the NHS, again when the ‘discoverer’ sells it, for millions. Then we get held hostage for cures that cost a few cents, to make, but a Thousand Bucks to take.
And, oh yeah, their PR Dept. is telling the world,
“It’s their fault, they mainline dope.”
Just to insure we won’t get a lot of sympathy trying to prices lower, where they should be.
What a Rip-off, if a Union did anything like that, they’d be charged, imprisoned, fined out of business. I say, they’re criminals.
I agree Champ!
I want the government criminally responsible! They add 20 tests I your annual panel. Why wouldn’t they add Hep C since such a issue! And that could NOT cause terminal Liver issues IF you were made aware sooner than 33 years later!!
But as I said doctors and government and pharmaceutical companies do NOT make money getting you well the quick and easier route.
Prayers with you. I’m so mad too!
Michele Adams, you are so correct. Because HCV was considered an “epidemic”, drug companies were not required to perform the same tests required by the FDA. Therefore they were able to release their drugs immediately! And now that Trump has taken away the pharmaceutical regulations that were there to protect us, who knows what meds will be recommended!
I’m type 1a with very mild fibrosis of 1. Abbvie supplied the 12 wk course of Viekira Pak XR & Ribavirin at no cost because my insurance (express scripts) denied my claim twice. I finished in Dec ’16. I have NO idea what the long term effects will be simply because long term trials were never done. Look it up. But I do know the long term effects of Ribavirin and pegulated interferon and those side effects still haunt me.
Thank you so much for sharing your story Robin Newlon, and also, the little known fact that ‘epidemic’ drugs are not under the same stringent regulations as other drugs that are required by the FDA. I can tell you Robin, that I was not aware of that fact, and it makes me even more concerned than before. Thank you! As always, one must do as much research as possible before embarking on new drugs. After learning as much as possible, weighing in on risks vs benefits, only then (and even then, with the utmost hesitation) can we at the least make an educated decision on what is best for us. I have a friend whose ‘brain’ is literally fried from the drug Ribaviron that was prescribed along with the Interferon. This friend swears to this day, it was more the Ribaviron that cooked his brain, way more than the affects of the nasty interferon. However, of course his doctors would not even acknowledge his experience. – (interferon in their opinion (Dr’s), the nastier of the two). In disgust, my friend told his Dr’s – “You take the damn drug”! “Then you tell me!”. These drugs are very hard on the human body. Very. I do wish you the best.
I’m on Epclusa and week 2 was almost gone and week 8 all gone. Lots of added wrinkles to face and hair breaks off by the handful. But if all clear I don’t care. HOWEVER, I am nervous now about what you say about brain damage bc I do NOT trust pharmacy or doctors. I am a raw vegan and had to take the Epclusa to get rid of the hep c. But I have refused all their other meds including anesthesia when they removed a tumor. Just don’t trust doctors or pharmaceutical companies at all. Your story makes me REALLY nervous for a come back of virus and for long term side effects. Sorry you have had issues :/ (contracted from blood transfusion when ruptured liver/spleen in car accident 1983. JUST told this year there was an issue!
I wish you the best with your treatment, during and after. Hep C affects all our organs. Hepatic encephalopathy is a result of liver disease. When your liver isn’t functioning properly, the toxins that your liver usually removes from your body are instead allowed to build up in your blood, and can eventually reach your brain. Unfortunately too the very medicine that can cure obviously has side effects, and it is too early of course to know what they are with Epclusa. However, here is a study on ribaviron and interferon and the effects on the brain: A Persistent Dementia-like Condition Following Treatment of Hepatitis C With Pegylated Interferon and Ribavirin https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3394469/
As always, it will be a personal decision for each and everyone of us, whereby we have to determine if the benefits outweigh the risks. Unfortunately, there is always a cost, financial and physical, when it comes to pharmaceuticals, our bodies and our livelihoods/way of life. My best to you.
Fed up jus wanted to kno with your 8weeks of treament with epclusa were you cured.?
Why don’t you guys try the generic versions ?? Its far more cheaper than that originators. i know some name of generic drug having a very good output.
Hi everyone, please take note that ALL pharma companies base their success “cure” rates (95% to 100%) on being SVR negative at 12 weeks post treatment!! That means NOTHING!! Interferon achieved that, and then a few weeks later it was back! and with side effects to last a very long time, Pharma companies do not tell you how many people have died during or after treatment, or how many have committed suicide during treatment (I wonder why) So when you hear next about a “new” miracle drug with a success rate of 95% based on being SVR negative at 12 weeks post treatment consider it useless!! Only when they come up with a drug that will keep you SVR negative for YEARS and with minor to no side affects, only then think about entering a treatment program. All of these new “miracle” drugs have NOT been tested long enough, only recently a new study revealed that some of these new drugs that “eradicate” Hep C, actually also accelerate liver cancer!! Now, if you don’t understand the medical language, or what certain things mean, or you just feel completely lost, talk to someone who knows, you can call help lines to start with, have a good and trusted doctor, like a family doctor, perhaps a friend that has been through it, or if you want you can email me on davidvarshavsky@gmail.com and I’ll try to help you as much as I can.
I endorse the above view. It is nothing but fleecing the hapless patents
I was involved in a clinical trial, I had zero virus detected at two weeks! It has been over a year and I am still negative! The only side effects I had were headache and fatigue! Liver ultrasound negative. My fibro score was 3-4.
I need to find a clinical trial in my area. Just not sure where to start. Any info is welcomed, I have been referenced to Harvoni. Just no health insurance and I’m resourced out.
Try and sign up for ACA aka Obama care. I’m on passport. My doctor contacted the drug company. They send it a coupon.
You have to pay for the insurance based on income, but the Harmonic cost a fortune without coupon.
if you still need sovosbufir (sovaldi) by gilend I will give you an interesting offer price of $ 5000 / bottle is the postage to your place
if you still need sovosbufir (sovaldi) by gilend I will give you an interesting offer price of $ 5000 / bottle is the postage to your place
Has anyone tried Harvoni? How long does treatment last? What are the side effects?
This information might be helpful http://www.hepatitiscentral.com/harvoni-ledipasvir-and-sofosbuvir/what-is/
I was on Harvoni. Medicaid covered 100% of the costs ($1120 per pill for 90 days). I am now clear with no detectable viral load for almost two years now. It was weird because I never drank and I didn’t do drugs. Close as anyone can figure, it came from a herniated disc operation that got horribly infected in 2004. These posts here are the 1st I’ve read/heard of about the hep C flaring up and coming back.
I also took Harvoni for nine weeks (Gilead gave me an extra week while we petitioned my extended health for another four week regimen. They refused). I also relapsed and to make matters worse a small tumour which proved to be cancerous was discovered on my liver (studies have ascertained that 40-50% of people suffering from chronic hep c will probably develop cancer) . I had that removed and it’s been almost two years that I have been cancer free. There are new regimens undergoing clinical trial that will be helpful for people such as myself and others that have commented on this forum; unfortunately they still may be a year out from being on market. I was just turned down for a clinical trial because of my cancer issue. They require one to be cancer free for five years.
It’s hard not to become despondent but there is hope on the horizon as the trial results seem to be positive.
I am sorry for your ca do but HepC patients have 1-4 % of liver cancer…ya know almost the same as everyone else – not 40-50% manyo lies have been delivered to us over the years. I have been made more sick by treatments then the Hep C. I am glad you are CA free. I would never recommend any Hep C meds by Gilead. Harvoni is a terrible med with nightmare long lasting side effects.
Did you get rid of the Hep c ?????
Hep c leads to cirrossis! Cirrossis leads to masses, aka tumor, aka cancer! I don’t drug nor drink. I know this as of Sept 2017. They will cut off 1/2 of my liver, it’s a 10 hr operation. This is called a resection. This buys me 5 yrs instead of doing nothing & dying a painful death in 6 months. They say a liver transplant is in my future… I am glad that I still have time to do the above!
Dont give up! Sounds like my problems… but my Drs are really fighting hard for me & I am greatful. Don’t give up…
name Amir wahid shah. Village Diwana baba Buner Kpk
Number 03409102133
Easy for …..someone to say, and not sure of your circumstances but the choice is live or die in many cases? i know…