EU Approves Drug That Is Up to 100% Effective Against Hep C
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Many Americans were prepping to celebrate Labor Day weekend while Europeans in the Hepatitis C community had something else to rejoice about. Instead of preparing for a barbeque or holiday sale, physicians, patients and researchers in Europe were ecstatic about the August 27, 2014 approval of daclatasvir, Bristol-Myers Squibb’s Hepatitis C virus NS5A inhibitor.
Hepatitis C Overview
Transmitted via blood-to-blood contact, Hepatitis C is a contagious, viral infection of the liver. Experts estimate that 150 million people are infected with chronic Hepatitis C worldwide, including about 3 to 4 million in the United States and 9 million in the European Union. According to the World Health Organization, about 20 percent of people with chronic Hepatitis C will develop cirrhosis – a severe and potentially lethal form of liver disease. Those with advanced Hepatitis C are also at risk of developing liver cancer and liver failure. Thus, effective treatments for this infection are in great demand.
For many years, treatment for Hepatitis C involved at least 48 weeks of interferon and ribavirin. This combination of drugs had an approximate success rate of 50 percent, and is associated with a long list of severe side effects. Boasting success rates up to 75 percent, the recent addition of protease inhibitors to interferon and ribavirin dramatically improved the odds of beating Hepatitis C. However, medications still in development are promising to cure an even greater percentage of Hepatitis C infections, in a shorter period of time, with fewer side effects.
Bristol-Myers Squibb’s Hepatitis C NS5A inhibitor, daclatasvir, is a top contender for the newest and best Hepatitis C drug.
About Daclatasvir
On August 27, 2014, the European Commission approved daclatasvir (Daklinza) to treat adults with chronic Hepatitis C in combination with other drugs. Made by Bristol-Myers Squibb, Daklinza blocks the action of NS5A, a protein essential for Hepatitis C replication.
In their news release, Bristol-Myers Squibb claim that oral daclatasvir in combination with oral sofosbuvir cured up to 100 percent of participants in clinical trials. This outstanding success rate even includes patients with advanced liver disease. The following treatment outline is:
- Hepatitis C genotype 1 or 4 without cirrhosis – Daclatasvir and sofosbuvir for 12 weeks. For those who did prior treatment (including a protease inhibitor), treatment may be prolonged to 24 weeks.
- Hepatitis C genotype 1 or 4 with compensated cirrhosis – Daclatasvir and sofosbuvir for 24 weeks. Treatment may be shortened to 12 weeks for treatment naïve patients with a positive prognosis (IL28B CC genotype or low baseline viral load). Ribavirin can be added for patients with advanced liver disease or previous non-responders.
- Hepatitis C genotype 3 with compensated cirrhosis and/or previous non-responders – Daclatasvir and sofosbuvir and ribavirin for 24 weeks.
- Hepatitis C genotype 4 – Daclatasvir for 24 weeks with 24 to 48 weeks of peginterferon alfa and ribavirin. If the Hepatitis C is undetectable at weeks 4 and 12, all three medications should continue for 24 weeks. If patient has undetectable Hepatitis C at only 4 or 12 weeks, daclatasvir should be discontinued at 24 weeks and peginterferon alfa and ribavirin continued for a total duration of 48 weeks.
Daclatasvir’s Study Results
Multiple studies support the use of daclatasvir for Hepatitis C. In a study of daclatasvir and sofosbuvir for genotypes 1, 2 and 3, results showed undetectable levels of Hepatitis C 12 weeks after treatment in:
- 99 percent of treatment-naïve patients with Hepatitis C genotype 1
- 100 percent of patients with Hepatitis C genotype 1 who had previously failed treatment with the protease inhibitor telaprevir or boceprevir
- 96 percent of patients with Hepatitis C genotype 2
- 89 percent of patients with Hepatitis C genotype 3
While these extremely high success rates are encouraging, the low rate of side effects is even more exciting. The daclatasvir/sofosbuvir combination had very low rates of discontinuation (less than 1 percent) due to serious adverse events. The most common adverse events were fatigue, headache and nausea.
While it is exciting that this potential cure is now available in 28 countries of the European Union, those in the U.S. still have to wait – but hopefully not for long. Applications for the daclatasvir dual regimen are currently under review by the U.S. Food and Drug Administration (FDA). The FDA granted priority review status and set a target review date of November 30, 2014 for daclatasvir.
Many people have been waiting for an interferon-free Hepatitis C drug regimen that is both effective and tolerable. It appears that Bristol-Myers Squibb may be ending that wait – at least in Europe. Hopefully, daclatasvir will continue to reveal a high safety and efficacy profile and gain approval by the FDA before year’s end so infected Americans have even more to celebrate in 2015.
Related Articles
http://news.bms.com/press-release/bristol-myers-squibb-submits-ndas-daclatasvir-and-asunaprevir-us-fda-treatment-hepatit, Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C, Retrieved August 31, 2014, Bristol-Myers Squibb, Business Wire News HQ(SM) 2014.
http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4810-european-regulators-approve-daclatasvir-for-hepatitis-c, European Regulators Approve Daclatasvir for Hepatitis C, Retrieved August 31, 2014, hivandhepatitis.com, 2014.
http://www.medscape.com/viewarticle/830520, Daclatasvir (Daklinza) for Chronic Hepatitis C Cleared in EU, Megan Brooks, Retrieved August 31, 2014, WebMD, LLC, 2014.
http://www.pharmabiz.com/NewsDetails.aspx?aid=83807&sid=1, MSF urges BMS to make daclatasvir accessible in low-and middle-income countries, Ramesh Shankar, Retrieved August 31, 2014, Saffron Media, Pvt, Ltd, 2014.
43 Comments
Add the cost of these programs is what?
Solvaldi, the cure we have NOW, is $1,000 a pill and you need to take 24 of them, but if you have Obamacare and stage three or four then they will cover it.
Big Pharma is cashing in on this isn’t it? Well, I am on Medicare, so, I just feel sorry for those who need to come up with that kinda cash. Is there any programs out there for the middle class?
Drug companies have some discount programs but its a long application process as I understand it. As far as I know you can’t get the drug at all if you are not stage 3 or 4.
I honestly do not understand the stage 3 or 4 thing, how do you know what Stage” you are in? I have had A, B,and C which in turn caused cirrhosis, is that close?
You need to see an MD and get a sonegram to see how bad your liver is.
If you have cirrhosis, you almost certainly will qualify, Roger. At least as far as the stage 3 or 4 thing. I am a 2-time liver transplant patient (in 2004). and with you having cirrhosis, I pray you are keeping track of your condition with a good gastroenterologist. The new treatments sound amazingly good to me and I am supposed to start myself this month. Best of luck to you….hope you will be cured soon too.
what about va –if it will be used??
This is basically an ad. The real 100% drug cure is Sovaldi.
Why do you say this? If you are going to make statements like this you should back it up.Do you have a vested interest in Savaldi?
All you have to do is google the name Solvaldi, its here and available now, 100% cure for almost all genotypes. If you have stage three or four then ACA will cover it. Its very strange the author never mentions it. I have no interest in Solvaldi or any other drug! Just trying to be observant!
Solvaldi and Sofusbuvir are the same drug. It explains Sofusbuvir (Solvaldi) throughout the article.
Sovaldi, interferon and Ribavirin did not work for my husband. It is not 100%.
Will the VA give the Veterans these meds or not?
I agree, the VA has put me on hold for three years now. Guess I will have to be about dead before I can receive treatment.
Do you really have to get your health care thru VA? Don’t you have other options?
I am 100% service connected disabled by the VA. I have been trying since 1999 just to find the Genotype of my Hep-C. They are about as good a nothing at all.
Wow. I am surprised to hear that you can’t even find out your genotype. If you have been disabled for at least 2 years you would be entitled to Medicare. If you are then you can sign up for a plan under medicare which will enable you to receive treatment under one of the medicare plans from a civilian Dr. If you reside in California, I could possibly help you with this. I am a licensed insurance agent specializing in helping people with Medicare plans. This is a free service that I offer. In what part of the country do you live?
If you are eligible for Medicare, and most people are if they are over 65, or disabled for at least 24 months, you can go outside of VA for care. They probably do not tell you this. If you are in CA I can help you with this. I am licensed insurance broker in CA only. My partner is in AZ . If you need assistance with these programs, call me. 562-833-2346
I still do not understand my having the antibodies for hep c. I have never been sick, my liver is normal as per ultrasound and blood numbers are excellent. Would I want treatment regardless and if this new drug is approved, with our healthcare, none of us could afford it in the United States. So, my excitement for this wonderful breakthrough is also sad b/c how would we ever afford access to it??
anti bodies does not mean you have virus. It means you were exposed it it and developed antibodies. You could have the virus but need to be tested for the antigens, not just the antibodies.
Thank you Valerie…my doctor does a viral load count. Every year and I have some type of genotype? Does that mean anything? He acts as if I have it at a very low rate. I so don’t understand. He has never discussed any treatment for me. Thanks again..
The most common genotype in US is 1 and it was hardest to cure but now they have new treatments that are much easier to take and less sides. No interferon. To see if you have damage, they would do a biopsy but they also have a non invasive blood test that works well if you are either very low damage or high damage. You should be going to a hepatologist or a gastroenterologist and they would discuss treatment options and there is no rush if little damage. Viral load is not necessarily indicative of amount of damage but means you can take your time in deciding if little damage.
Thanks again Valerie…you are a wealth of information…I hope you are feeling well. I just have one other question…you have given me more than my doc. I am curious if being positive would cause me to to not feel well at times? Like achy and just feeling low? My doc hinted once that may be why I am achy but I didn’t understand how….anyway like I said I hope you are feeling well assuming this is part of your life too. In the meantime I will see if I can find the genotype I am in since of course I don’t understand that either LOL… THANK YOU.
The most common symptom of Hep C is tired ness plus just being told one has the virus could cause depressed feelings but now that they basically seem to have a cure and one that does not appear to be treacherous as past treatments plus with a high percentage of clearance, you could rid yourself of virus. A lot of people are without symptoms unless the liver is damaged. Hope you are seeing a specialist. You can not tell how much damage by a viral count but treatment will stop damage plus the liver is rare in that it can heal itself as virus is eliminated, to some degree.
Hi Valerie, well, I guess I should ask my doc why he hasn’t recommended a gasto type doctor. My ultrasound showed normal liver but I guess that doesn’t really answer any questions either. I appreciate your taking time out to help me understand all of this. I guess I have had it for many years..it was detected about 5 years ago and doesn’t seem to be showing change. I will def. ask my doctor to refer me or ask why he hasn’t. Again, people like you are rare and again thank you. Marlene
Insist on Liver Biopsy…Insist on liver cancer screening AFP via serology and don’t let doctors ignore you or push you around. Take charge of your diagnosis and be politely insistent that protocols for Hep C are followed. Too bad if they don’t like it. Then look around and find a Gastroenterologist you really like and that not only listens but cares enough to do the right thing for your health.
I’ve had genotype 1a for 35 years. Started out with VL 4,600,00 zero liver damage per biopsy 10 years ago. All serology labs normal. I am now VL 16,000,000 but it goes up and down which has nothing to do with disease progression only concern is when you treat. Not as easy with a very high VL such as mine. I have never been tired or fatigued from it and am asymptomatic. Go figure? I also drank alcohol all of those years. Mostly beer on the weekends. I never smoked which I heard is actually detrimental to Hep C as well. I stayed at a normal weight for my short stature 5’2″ and small boned and have consistently kept my weight at about 103. I am 60 years old and was told in the very beginning that estrogen is a liver protectant and that once I am through menopause which I am it could progress much quicker. If you can find a way to treat, do it because this time is the best time to have to be dealing with this. All except the high cost. It’s truly exasperating. I wish you all the best! I have known many that have passed from this disease and I know many that have been like myself which so far asymptomatic. I have also known approximately 3 that spontaneously cleared the virus on their own but still show they have been infected and via doctors advice get checked every 5 years. The reason being if there is one virus left you can eventually become positive. My best friend was found to have the antibodies and but had cleared on her own. 15 years later, just recently she was re-tested and is still negative. YAY!
i hope these are monitored more than the posting date displayed. i have just started on savaldi and daklinza meds. i got them through the VA in a new program called patient choice which is a gov program speeding up treat to vets instead of them having to wait. problem is that i had to wait for the program to be initiated before getting treatment, and there was more damage done during this wait than previous, at least i started them anyway 2 weeks in and have noticed some energy improvement but for the most part i feel wiped out constantly, hopefully this will change. i have geno 1 and taking savaldi and daklinza., as i mentioned above is there and time period to feeling somewhat better ???
I know many have taken the Sovaldi and Daclinza and have all cleared the virus. Side effects vary from person to person. Drink lots of water.
you want a liver biopsy!
You are correct. Very few can afford it.
Does it hurt LOL? And who does it? Do I need a gastro type doctor? Am I looking for cirrhosis and cancer or extent of damage or all of the above. Seems like something I should pursue. Wouldn’t an ultrasound show some of these things or any at all? Thanks for your input..appreciated!
My liver biopsy was not painful at all….they gave me meds to “relax” me but I was out of it and was in & out of sleep till they we done. My husband experience was great but MAKE SURE THEY GIVE YOU SOMETHING TO RELAX YOU 🙂 I heard it was alot worse then it really was. The worst part was hanging in recovery for 6 hours 🙂 hope this helped.
Now the next thing do is resolve the scarring that was done after all of the years with cirrhosis hcv. Hopefully, there will some medicine available that will do this.
I believe the cure will only be released ones enough people die of it. Wasn’t that the case with HIV and what is happening to Ebola victims. We are much to long “healthy” before hell breaks loose …it all comes down to investments and the profits that could be made, I am a carrier of Hep C 1, for more than 30 years it can happen every day now. Yes I take milk-thisle and all other little things I can do to help myself but nonetheless I am chronicle and nobody is helping .. Europe is even worse and certainly the Netherlands are very retrograded.
It is great there is a cure for people with a compensated liver, I note there was no mention of decompensated liver. Have there been any trials including them?
i just did a 12 weeks treatment and clear my virus in 6 weeks…..after 4 weeks with out medication the virus came back…..this is my life for 13 yrs….i clear and relapse….but we have to keep up and try what ever we can get….good luck everyone
How can we get this treatement drug (affordability) in african country such as Egypt or Sudan?
Is it safty for pateint with hep C +di abetes type 2 ?
Do not forget Hep C type 5 & 6 please. I live in California almost 40 years. Have had Hep C type 6 more than 12 years, I m as a nurse worked an Asian mental health Hosp. in LA.. I Got kick, bite, spit in the face many time.. Lead to spinal surgery twice plus Hep C type 6.. Fail 2 X treatment with old medications . Hopefully the ins. Kaiser of CA will treat for me with new medications .
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My docs refused to follow the manufacture’s recommended duration of 24 weeks, so coming to the end of the 12-week therapy I’m going to be pretty unhappy if it didn’t work; previous non-responder with compensated cirrhosis. Darn docs just never listen!!
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