History is being made - Ledipasvir & Sofobuvir - Harvoni

History is being made with the new FDA Approved Hepatitus C - Genotype 1 treatment: Ledipasir-Sofosbuvir, otherwise known as Harvoni. The new antiviral drug is a single pill, once daily dose that has up to a 99% cure rate!

Duration of treatment varies due to the amount of liver damage and past treatment experience.
Treatment naïve with or without cirrhosis 12 weeks
Treatment experienced** without cirrhosis 12 weeks
Treatment experienced** with cirrhosis 24 weeks

*Consider treatment duration of 8weeks in treatment-naïve patients without cirrhosis who have a pretreatment HCV RNA less than 6 million IU/mL
**Treatment-experienced patients who have failed treatment with either (a) peginterferon alfa plus ribavirin or (b) HCV protease inhibitor plus peginterferon alfa plus ribavirin
Source: Harvoni Prescribing Information. Gilead Sciences

There are some side effects, but none of them appear to be serious: Fatigue, Headache, Nausea, Diarrhea, & Insomnia.
Source: Harvoni Prescribing Information. Gilead Sciences

You can read the full article here: Ledipasvir-Sofobuvir (Harvoni)

This is a major breakthrough for the many people that are infected with Hepatitus C - Genotype 1, which happens to be the hardest hepatitus to cure.

Cures rates are as follows:
Among the 440 patients who underwent randomization and were treated, 20% had cirrhosis and 79% had HCV genotype 1a infection. The rates of sustained virology response were high, 94% in all treatment groups:
12 weeks of ledipasvir–sofosbuvir = 96%
12 weeks of ledipasvir–sofosbuvir and ribavirin = 99%
24 weeks of ledipasvir–sofosbuvir = 99%
24 weeks of ledipasvir–sofosbuvir and ribavirin = 99%
Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection

I hope and pray that this is the antiviral medication that will cure my Hepatitus C, type 1a. I will be starting treatment in a couple of weeks!

The Fight to Help Us Become Virus Free...The Drug Companies!

This is a very promising article about a new Hep C treatment plan in the pill form...

Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza® (daclatasvir) and Sunvepra® (asunaprevir) Dual Regimen

Offers new treatment option for genotype 1 HCV patients in Japan who are interferon-ineligible/intolerant, or did not previously respond to treatment

Japanese HCV patients in urgent need of care now have opportunity for cure, including older patients and those with compensated cirrhosis

Monday, July 7, 2014 7:00 am EDT
"This milestone underscores the company’s commitment to delivering innovative medicines to patients with the highest unmet needs, and we believe Daklinza-based regimens will play a significant role in the evolution of HCV treatment for patients in Japan, and globally."
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza® (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra® (asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. The Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis.

“Japan has a unique hepatitis C patient population, many of whom are older and have been unable to take, or respond to, traditional therapies, so we have a real sense of urgency to treat these patients now,” said a lead study investigator Kazuaki Chayama of Hiroshima University in Japan. “The approval of the Daklinza+Sunvepra Dual Regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV patients.”

Of the 1.2 million people living with HCV in Japan, approximately 70% have genotype 1b. Further, a significant number of patients with HCV in Japan are over the age of 65, leading to more disease-related complications and a decreased likelihood of tolerating interferon-based therapies, the historical standard of care for treating HCV.

“The approval of Daklinza+Sunvepra in Japan reflects our strategic focus on developing a treatment option that meets the needs of the Japanese HCV patient population,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “This milestone underscores the company’s commitment to delivering innovative medicines to patients with the highest unmet needs, and we believe Daklinza-based regimens will play a significant role in the evolution of HCV treatment for patients in Japan, and globally.”

The Daklinza+Sunvepra Dual Regimen

The indications for Daklinza and Sunvepra in Japan are for the improvement of viraemia in either of the following patients with chronic hepatitis C genotype 1, or chronic hepatitis C genotype 1 with compensated cirrhosis: (1) patients who are ineligible or intolerant to interferon-based therapy, and (2) patients who have failed to respond to interferon-based therapy.

The approval is supported by results from a Phase III study demonstrating that the 24-week regimen of Daklinza and Sunvepra achieved overall SVR24 (sustained virologic response 24 weeks after the end of treatment; a functional cure) among 84.7% of Japanese HCV patients with genotype 1b. Among patients 65 years of age or older who were either interferon-ineligible or intolerant, 91.9% achieved SVR24. Further, patients with compensated cirrhosis present at baseline had overall SVR24 rates of 90.9%.

The regimen used in the Phase III study resulted in low rates of discontinuation (5%) due to adverse events (AEs). In addition, the rate of serious adverse events (SAEs) was low (5.9%) and few SAEs were experienced by more than one patient. Nasopharyngitis was the most common AE in the study (30.2%).

Results from the HALLMARK-Dual study, the Phase III multinational clinical trial investigating the Daklinza+Sunvepra Dual Regimen among genotype 1b HCV patients, demonstrated similar results to the Japan registration study and support filings in countries that have a high prevalence of genotype 1b, such as Korea and Taiwan.

About Bristol-Myers Squibb’s HCV Portfolio

Bristol-Myers Squibb’s research efforts are focused on advancing late-stage compounds to deliver the most value to patients with hepatitis C. At the core of our pipeline is daclatasvir, a potent pan-genotypic NS5A complex inhibitor (in vitro), which continues to be investigated in multiple treatment regimens and in people with co-morbidities, and is undergoing regulatory review in the U.S. and Europe.

Daclatasvir is being studied in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase III ALLY Program.

In 2014, the U.S. Food and Drug Administration (FDA) granted Bristol-Myers Squibb’s investigational Daclatasvir+Asunaprevir Dual Regimen Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV infection.

In 2013, Bristol-Myers Squibb’s investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation in the U.S., which helped to expedite the start of the ongoing Phase III UNITY Program. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. The daclatasvir 3DAA regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.

About Hepatitis C

Globally, there are 150 million people infected with HCV, with genotype 1 being the most prevalent. Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Up to 90 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, 20 percent of people with chronic hepatitis C will develop cirrhosis and, of those, about 5 to 7 percent of patients may ultimately die of the consequences of infection.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that daclatasvir or asunaprevir or any other compounds mentioned in this release will receive regulatory approval in other countries or that they will become commercially successful products. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.



Contact:

Bristol-Myers Squibb
Media:
Carrie Fernandez, 609-252-4831
cell: 215-859-2605
carrie.fernandez@bms.com
or
Investors:
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
or
Ryan Asay, 609-252-5020
ryan.asay@bms.com

All we have to do is hang in there until this treatment is approved in the United States...October maybe! Hang!!

Walter Trout with a New Liver

Honey, Liver, & Sleep

The amazing benefits of Honey! With one of the side effects of Hepatitis C treatment being sleeplessness, according to this website, you can change this side effect with just 1-2 tablespoons of honey before bedtime!
Wow!! I don't know about you, but I'm going to try this remedy!
You can read all about it at: http://www.benefits-of-honey.com/honey-diet.html

Another Baby Boomer Effected with a Bad Liver - Walter Trout

This wonderful man and musician is waiting for a liver transplant with his wife (Marie) and many fans.

Marie Trout

My cell phone rang at 6AM this morning. A quick look confirmed it was from the hospital. I felt a careful sense of optimism as I grabbed for the phone and expected to hear: “We have a liver for Walter!” But my phone froze. I couldn’t pick up the call. The phone was unresponsive. So after a few fumbling and tired attempts to answer it, I realized I had missed the call. And then the voicemail came in: “This is Doctor K.J. We are having some trouble waking Walter up; he is unresponsive, so we thought we would let you know.”

No new liver call this time. The confused and tired state of mind that Walter had been in yesterday had worsened. Now he was unconscious.

I spent the day at his bedside without making contact with him. He is deep in a place and I couldn’t reach him. Today was the first day for tears for me in a long time. Seeing him there, but without being able to sense him, was painful.

The doctors are not too worried about it. They say that this is par for the course, and the good news is that Walter is now first on the list. They assured me that the encephalopathy will reverse once a new liver goes in. They tried various other approaches to see if we could get Walter conscious – but they were unsuccessful. His vital signs remain good; he moves and has good muscle strength. His brain has not been deprived of oxygen at any point. They did a CT scan to make sure that all looked good upstairs – and it did. One very experienced and trusted doctor said that he had seen patient reverse completely after months in this state once the liver transplant took place.

Because Walter is not conscious, I decided that I don’t want to leave him here without anyone to be his advocate this weekend. Since he cannot speak for himself, I cannot leave him alone. So I called our travel agent and cancelled my flight to go see our middle son play his final show at the High School music program. That hurt too.

I called both of our sons who I am now not going to see tomorrow, and had a good talk with them. They understood. I know they were disappointed too. This disease is making it impossible to plan anything. In February I had a trip planned to go see our oldest son in Denmark and be with my mom for her birthday. Had to cancel. We had to cancel the tour I had booked for Walter and the band for 2014. The ripple effects of this disease touch so many more people than just Walter and I. Our sons, my mom, the band, our crew, fans, friends, promoters, agents, record label, publicists, you reading this right now…

I feel the pain, the disappointment, and the sorrow. There is no way of sugarcoating that. I feel for the people who are affected by this. Most of all I feel for Walter who is struggling to stay alive in a body that is polluted.

And such is life sometimes, without any easy solutions; without any quick fixes. Life can be complex, full of riddles, full of heart ache, pain and incomprehensible twists and turns. Things don’t always go the way we want.

And then just writing all of this, I also know that because things are difficult now, they won’t always be. While Walter is unresponsive right now, he won’t always be. Because I feel sad now, I won’t always be. Because our kids are disappointed now, they won’t always be. This too shall pass.

I deliberately avoid the “what if” scenarios that could be constructed by an anxious mind. I go by what the most likely outcome of all of this is going to be: A new liver for Walter. It is not in the sadness, the disappointment, and the sorrow that I would lose my fighter spirit. However, I know that if I allowed my mind to go on unsolicited trips into worry-land, I would quickly drain every last bit of hope and strength out of my being. So every time I feel my mind wanting to spin its worst-case scenarios – I stop it. I only deal with the known – and leave the unknowns to the universe.

Who knows what happens next? I continue to do all I can. And I will deal with it as it comes. I remain at Walter’s side to help him in every way I can. I tell my sons that I love them… so very much. I stay on top of business decisions as needed. I send thankful thoughts of gratitude to all of you who care to read these words. I continue my walk whether it rains, pours or shines. One step at a time! Boldly and with determination!

Walk Your Walk & Talk Your Talk...Don't give up!

Hepatitis C Treatment News

Reversing Fatty Liver Disease

A very interesting video on Reversing Fatty Liver Disease with Dr. Sandra Cabot & Nutritionist Margaret Jasunska. They speak about the role that hormones play in telling ones brain whether you are hungry or not and about good saturated fat, insulin, and carbohydrates in people with Fatty Liver Disease. It is very important to mention that if you diet or take supplements:
Do It In Moderation! You can cause more very serious problems if you overdo any diet!