Wednesday, February 26, 2014

FDA update to Victrelis (boceprevir) label to include a new virologic futility rule


On February 24, 2014, FDA approved an update to the Victrelis (boceprevir) label to include a new virologic futility rule.

Specifically Section 2, Dosage and Administration, Table 1 was revised to state:
If a patient has HCV-RNA results greater than or equal to 1000 IU/mL at treatment week 8, then discontinue three-medicine regimen.

This statement is also reflected in subsection 2.4
Discontinuation of Dosing Based on Treatment Futility:
Discontinuation of therapy is recommended in all patients with 1) HCV-RNA levels of greater than or equal to 1000 IU per mL at TW8 (treatment week 8); or 2) HCV-RNA levels of greater than or equal to 100 IU per mL at TW12 (treatment week 12); or 3) confirmed detectable HCV-RNA levels at TW24 (treatment week 24).

You can view the complete revised Victrelis label and Medication Guide at Drugs@FDA.

Richard Klein  Office of Special Health Issues 
Food and Drug Administration  Kimberly Struble 
Division of Antiviral Drug Products  Food and Drug Administration

Tuesday, February 25, 2014

Sofosbuvir Provides Strong Offense Against Hepatitis C

Sofosbuvir Provides Strong Offense Against Hepatitis C

Posted by: Maureen Newman

February 25, 2014

What was once a mere hope for a hepatitis C cure now appears to be a reality, thanks to a collection of clinical trials from a number of institutions, including the University of Texas Health Science Center in San Antonio. Unlike other forms of hepatitis, hepatitis C has no vaccine, which has allowed it to emerge as a common chronic viral liver disease–there are over 170 million cases of hepatitis C globally. The standard of care in the United States consists of pegylated interferon alpha and ribavirin, which have increased sustained virological response (SVR) rates from 50% to 80%. These response rates are now being further increased by the introduction of Sofosbuvir (Solvaldi, from Gilead Sciences), a nucleotide analogue inhibitor of HCV NS5B polymerase. Sofosbuvir was approved by the FDA in 2013 for the treatment of adults infected with genotypes 1 and 4 in combination with pegylated interferon alpha and ribavirin and for the treatment of adults infected with genotypes 2 and 3 in combination with ribavirin only.

“It’s a drug that has no resistance or incremental adverse effects. It is very well tolerated, very safe, very efficacious and there are no significant drug interactions with it. I think it is going to revolutionize the way we treat hepatitis in this country and around the world,” said Sammy Saab, MD, MPH, from the David Geffen School of Medicine in UCLA, at The Liver Meeting 2013. What makes sofosbuvir so revolutionary is that it is effective in treating a wide variety of patients. Four Phase III clinical trials (FISSION, POSITRON, FUSION, and NEUTRINO) found that many factors traditionally associated with poor outcomes in hepatitis C patients (including age, interleukin-28 B genotype, body mass index, and viral load) had no effect on the efficacy of sofosbuvir–only male gender and the presence of cirrhosis were predictive of a worse outcome. Yet results from LONESTAR-2 showed that sofosbuvir is highly efficacious in patients with cirrhosis: after twelve weeks of treatment, patients with HCV genotype 2 and cirrhosis had an SVR of 93%, compared to 100% of noncirrhotics, and there was no difference in outcome for patients with HCV genotype 3. According to Eric Lawitz, MD, of the Texas Liver Institute and UTHealth, “Sofosbuvir plus pegylated IFN/ribavirin for 12 weeks demonstrated high efficacy in treatment-experienced genotype 2/3 patients who have historically low response rates and limited treatment options. SVR rates were similar in patients with and without cirrhosis.”

Genotype 3 patients from LONESTAR-2 achieved an SVR of 83%, which is lower than that of the genotype 2 patients (93%/100%)–this difference may be due to a difference in response among HCV genotypes (though one genotype does not necessarily indicate a worse outcome). “The FDA did an elegant analysis of the effect of treatment duration with sofosbuvir–ribavirin in genotype 3–infected patients,” said Mark Sulkowski, MD, medical director of the Viral Hepatitis Center in the Divisions of Infectious Disease and Gastroenterology & Hepatology. “[They] presented very convincing data that a 24-week duration of sofosbuvir–ribavirin should be the standard for all genotype 3–infected patients.” The analysis looked at data from FISSION, POSITRON, FUSION, and VALENCE, and the findings prompted the FDA to approve sofosbuvir in December. A 12-week treatment was approved for genotype 2, and a 24-week treatment was approved for genotype 3. A treatment consisting of sofosbuvir, ribavirin, and interferon was approved for patients with genotypes 1 and 4.

In addition, sofosbuvir, when used in combination with ribavirin, is effective for patients who are coinfected with HIV and is less toxic than interferon-based regimens. In the PHOTON-1 trial, “The IFN-free regimen of sofosbuvir plus ribavirin resulted in high SVR 12 rates in HCV treatment-naive, HIV-infected patients with HCV genotype 1, 2 or 3 coinfection,” said Dr. Sulkowski, who presented the study. “SVR 12 rates were similar to those observed in patients with HCV mono-infection.”

To treat non-responding patients, sofosbuvir can be used in conjuction with simeprevir, rather than ribavirin, according to data from the Phase II COSMOS trial. “The findings in this interim analysis suggest that the addition of ribavirin to simeprevir plus sofosbuvir may not be needed to achieve high rates of SVR in this patient population,” said Ira Jacobson, MD, chief of the Division of Gastroenterology and Hepatology at Weill Cornell Medical College. “[Complications] were predominantly limited to the ribavirin-containing treatment arms.”

Results such as these prompt much excitement among clinicians. Said Dr. Saab, “I think sofosbuvir is the cat’s meow.”

http://bionews-tx.com/news/2014/02/25/sofosbuvir-provides-strong-offense-against-hepatitis-c/

Monday, February 24, 2014

The Rise of Sofosbuvir

ISSUE: FEBRUARY 2014 | VOLUME: 1

The Rise of Sofosbuvir

by Kate O'Rourke

Many clinicians are ecstatic about the recent approval of sofosbuvir (Sovaldi, Gilead Sciences) for
patients with hepatitis C virus (HCV) infection. At The Liver Meeting 2013, several presentations provided new insight into just how sofosbuvir will perform in clinical practice.

“I think sofosbuvir is the cat’s meow,” said Sammy Saab, MD, MPH, professor of medicine and surgery and head of outcomes research in hepatology at the David Geffen School of Medicine, University of California, Los Angeles.

“It’s a drug that has no resistance or incremental adverse effects. It is very well tolerated, very safe, very efficacious and there are no significant drug interactions with it. I think it is going to revolutionize the way we treat hepatitis in this country and around the world.”

Continue reading.............

Bristol-Myers' Hepatitis C combo Daclatasvir and Asunaprevir gets breakthrough designation


Bristol-Myers Squibb Receives U.S. FDA Breakthrough Therapy Designation for All-Oral Daclatasvir Dual Investigational Regimen for Chronic Hepatitis C


FDA grants Designation request for investigational daclatasvir (DCV) and asunaprevir (ASV) combination therapy for treatment of genotype 1b chronic hepatitis C (HCV) infection

Marks second Breakthrough Therapy Designation for a daclatasvir-based regimen; 3DAA regimen granted Designation in 2013

 Monday, February 24, 2014 8:30 am EST

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV). The designation is based on data from the company’s ongoing Phase III clinical trial program evaluating the all-oral combination regimen of DCV, an investigational NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin.

According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

“The FDA’s decision to grant Breakthrough Therapy Designation for our DCV Dual Regimen (daclatasvir and asunaprevir combination therapy) marks the second time that the FDA has granted the Designation to a daclatasvir-based regimen, further underscoring its potential to help address the high unmet needs of the HCV patient population,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “This is an important milestone for Bristol-Myers Squibb as we continue our strategic focus on the development of innovative medicines to address areas of high unmet medical need, where potential expedited review can make a critical difference for patients.”

Approximately 170 million people worldwide are infected with hepatitis C, with an estimated 2.7–3.9 million chronically infected in the U.S. Many of these people have been living with HCV for decades, putting them at heightened risk for developing serious, potentially life-threatening liver disease.

New data from Bristol-Myers Squibb’s ongoing Phase III clinical program studying the DCV Dual Regimen is anticipated to be presented at an upcoming scientific forum. Data from a separate daclatasvir and asunaprevir Phase III trial in Japanese patients with HCV genotype 1b who were either interferon-ineligible/intolerant or non-responders (null and partial) to interferon-based therapies served as the basis for a regulatory filing in Japan in October 2013.

Bloggers note 
Related on the website - AASLD 2013 - Daclatasvir and asunaprevir Phase III trial in Japanese patients 

Bristol-Myers Squibb also recently announced that the European Medicines Agency (EMA) validated the company’s marketing authorization application (MAA) for the use of daclatasvir for the treatment of adults with HCV with compensated liver disease, including genotypes 1, 2, 3, and 4. The application seeks the approval of daclatasvir for use in combination with other agents for the treatment of chronic hepatitis C and will be reviewed under an accelerated regulatory review.

About Hepatitis C

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, up to 25 percent may progress to liver cancer.

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, an investigational NS5A replication complex inhibitor that has been studied in more than 5,500 patients as a foundational agent for multiple direct-acting antiviral (DAA) based combination therapies.

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

Bloggers note
Watch Video Abstract
Dr. Gregory T. Everson discusses his manuscript "Efficacy of an Interferon- and Ribavirin-Free Regimen of Daclatasvir, Asunaprevir, and BMS-791325 in Treatment-Naive Patients With HCV Genotype 1 Infection." 

In addition, enrollment has begun for the Phase III ALLY Program, in which daclatasvir in combination with sofosbuvir, is being studied in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients and patients infected with HCV genotype 3.

 Bloggers note
Related on the blog - Its Back: Daclatasvir Plus Sofosbuvir-Three HCV Clinical Trials Sponsored By Bristol-Myers Squibb - on the website - Daclatasvir and Sofosbuvir

Other compounds in the pipeline include:
Asunaprevir (ASV) is an investigational NS3 protease inhibitor for hepatitis C which has been studied as a component of DCV-based treatment regimens
BMS-791325 is a non-nucleoside inhibitor of the NS5B polymerase, currently in Phase III development for hepatitis C as a component of DCV-based treatment regimens
Peginterferon lambda is an investigational type III interferon that has the potential to offer an alternative to peginterferon alfa in patients for whom an interferon-based regimen is required or preferred

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.



Saturday, February 22, 2014

Steven Flamm, MD, discusses the hepatitis C drug pipeline, cost of new drugs and coverage

Published on Feb 21, 2014
Steven Flamm, MD, medical director of the liver transplant program for Northwestern Medicine discusses the hepatitis C drug pipeline.

Topics include Sovaldi (sofosbuvir), interferon free regimes, pricing, possible U.S. managed care restrictions with regard to Canadian coverage.



Less than three years ago, the FDA approved two new breakthrough drugs for treating chronic hepatitis C (HCV)—Victrelis (boceprevir) and Incivek (telaprevir)—the first protease inhibitors approved for HCV. Although their introductions caught the attention of the marketplace, their successors are arriving quickly.

Late last year, the FDA approved two new HCV drugs, Solvadi (sofosbuvir), a polymerase inhibitor to treat genotypes 1 through 4, manufactured by Gilead Sciences, and Olysio (simeprevir), a protease inhibitor from Janssen Therapeutics targeting genotype 1.

Costing $1,000 a day, 400 mg of sofosbuvir is taken with either ribavirin alone, or with ribavirin and interferon, orally, once a day for 12 to 24 weeks, depending on the genotype. Simeprevir at 150 mg, also an oral, once-a-day drug, is recommended for 12 weeks in combination with ribavirin and interferon, followed by another 24 weeks of ribavirin and interferon. Its cost is $790 a day. 

The Centers for Disease Control and Prevention (CDC) estimates that 3.2 million persons are chronically infected with HCV. Approximately 75% to 85% of people infected with the HCV virus will develop chronic infection. 

Successful treatment is measured by a sustained virologic response (SVR), which signifies an undetectable viral load/serum HCV RNA (ribonucleic acid—the virus’ genetic material) after the designated period of treatment.

As with any new specialty drugs, insurers, pharmacy benefit managers and physicians must weigh the value of the new products, balancing cost, efficacy, effectiveness and ease of use. 

Managed Healthcare Executive recently convened three key thought leaders to discuss the impact of simeprevir and sofosbuvir and whether they will stand the test of time. 

Transcript has been edited for length.

Full Report: Healthcare reform and hepatitis C: A convergence of risk and opportunity
  
Mary Dorholt leads Express Script’s specialty clinical strategy and protocol development, creating clinical guidelines for patient care and physician interaction. She is also responsible for driving organizational research around specialty medications and Express Scripts’ experience. Prior to her current role, she was responsible for provision of specialty strategic guidance to employer, government and labor organizations. She holds a doctor of pharmacy degree from the University of Minnesota College of Pharmacy in Minneapolis and B.S. degrees in mathematics and biology.

Karla Thornton, MD, MPH, is a professor in the Division of Infectious Diseases at the University of New Mexico School of Medicine in Albuquerque. She also serves as the associate director of Project ECHO (Extension for Community Healthcare Outcomes). Using her clinical expertise in the treatment of hepatitis C and HIV, she facilitates teleECHO clinics through which she trains other clinicians on comprehensive care. In 2009, Dr. Thornton started an education project that trains New Mexico state prisoners to be peer educators in hepatitis C, other infectious diseases and addiction. 

John Poniatowski joined CIGNA in 1994, and currently serves as clinical program director, specialty pharmacy for CIGNA Pharmacy Management. He is responsible for establishing and executing utilization management and health management strategies related to the use of specialty pharmaceuticals. Programs focus on the integration of medication therapy with CIGNA’s medical, health and wellness programs to improve health outcomes and lower overall healthcare costs. Poniatowski received his bachelor of pharmacy degree from Northeastern University and his M.S. degree from Saint John’s University. He completed an American Society of Health-System Pharmacists’ hospital pharmacy residency at Mercy Hospital in Rockville Centre, N.Y.



MHE: Why has there been an increase in cases of hepatitis C?

Thornton: There actually is not an increase in the incidence of new infections, but what’s happening is that we’re identifying more people who are chronically infected with hepatitis C. The actual incidence of hepatitis C has decreased dramatically over the last 20-plus years. In the 1980s, incidence was about 200,000 cases per year compared to an estimated 17,000 cases in 2010. 
About a year ago, the CDC and the U.S. Preventive Services Task Force came out with guidelines to actually screen more people. They recommend that anyone born between 1945 and 1965 get a blood test for hepatitis C. The recommendation is important because we haven’t been very good at screening in the past. 

Dorholt: Sometimes there’s a perception of increasing new infections because there’s been this warehousing phenomenon going on where patients who don’t necessarily need to be treated—those who are not showing overt signs of disease or are not deteriorating—are being held back [from treatment] while physicians wait for the newer, more efficacious and perhaps easier-to-use medications to treat those patients that they know are infected. 

MHE: As for warehousing patients to wait for a newer treatment, is that a problem? 

Thornton: I don’t think I would characterize it as a problem. These folks that have the virus are not always becoming sicker, so there is time to wait for perhaps a more successful opportunity for treatment. 

Poniatowski: When Incivek and Victrelis came to market in mid-2011, they were obviously seen as improvements over the prior two drug combinations, so we saw an increase of people coming in to be treated. That continued through 2011 into late 2012, and then started tapering off by 2013 for the reason that Mary stated: It’s not always urgent to treat these folks, and clinicians knew that there were better drugs coming around the corner. 

MHE: Before the introduction of Incivek and Victrelis, what was the situation for HCV drugs? And what can sofosbuvir and simeprevir do that their predecessors cannot?  

Thornton: The prior treatment before May of 2011 was injected pegolated interferon and oral ribavirin for all genotypes. 
The success rate with that particular regimen was about 50% in genotype 1 patients, which is the predominant genotype in the United States, and higher in genotype 2 and 3 patients—up to 70%. All genotypes required interferon—that is a very difficult drug to take. It has a lot of toxicity; people can’t tolerate it. And the duration of therapy at that time for genotype 1 patients was a minimum of 48 weeks. 

Telaprevir and boceprevir increased the cure rate in genotype 1 to about 70%, compared to about 50% with interferon and ribavirin alone. They also introduced what was called response-guided therapy, meaning the duration of therapy will depend on a patient’s actual response to the medication. If someone had a good initial response to therapy, they might just need six months of therapy versus 48 weeks. The new therapies had the potential to increase the cure rate and shorten the duration. 
Simeprevir is an improvement over its immediate predecessors because it’s one pill, once a day. It has fewer side effects and drug interactions and has a very similar cure rate to that of telaprevir and boceprevir. Unfortunately, you still have to take interferon and ribavirin, and it’s a response-guided therapy just like the other ones are. Therefore, people would also have to continue on interferon with simeprevir.

Sofosbuvir is a brand new class of drugs called a polymerase inhibitor. For genotype 1, it’s given in combination with pegolated interferon and ribavirin, but it’s only for 12 weeks. It shortens the duration for using interferon, and the cure rate for 12 weeks is about 90% in patients who have not previously been treated. For the other genotypes, that particular drug is given just in combination with ribavirin. And again, there is a much higher cure rate than what we were seeing in the past with interferon-based regimens. 

Dorholt: I think it also is fair to say that the direction of new drug development in this area continues to move toward the shorter, all-oral regimen that can be used in the majority of hepatitis C patients in the United States. That really eliminates the historically used pegolated interferons and ribavirin. We’re not necessarily there for genotype 1, which is the most predominant type of hepatitis C in the United States, but these drugs are getting us much, much closer, and there is a lot in the pipeline that will help us move the needle as well.

Poniatowski: As each generation of HCV medications comes to market, they bring different advances, hopefully all driving towards the fact that the patient will be more likely to take the drug as intended, and for the full duration. The result is not just achieving better effectiveness, but fewer side effects with less likelihood of stopping the drug. 

MHE: Are sofosbuvir and simeprevir considered to be cures?

Thornton: Yes. Any drug that gets rid of the hepatitis C virus, and there’s no virus six months after therapy, is considered a cure. 

Dorholt: All of the approved agents, even the interferons and ribavirins have been cures; they just differ in the number of patients that are successfully cured. For patients who achieve SVR, the incidence of them actually relapsing is very low at 1% to 2%. For the older two drugs, the SVR is around 40%, while it is in the range of 80% to even 90% with the new medications. 

MHE: Since simeprevir requires interferon, won’t the problem with side effects and longer treatment times with that drug still exist? 

Thornton: That’s true, because with simeprevir as a response-guided therapy, somebody could still end up getting an entire year of interferon therapy. Recently, guidelines for treatment of chronic hepatitis C from the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) came out, and they do not recommend simeprevir as first line therapy for genotype 1 because of the risk of having to prescribe that much interferon.  However, when simpeprevir is used in combination with sofosbuvir, it’s only 12 weeks of interferon, and there is a very high cure rate.

Poniatowski: There is at least one interferon-free regimen in genotype 1 that is FDA-approved for the population that’s considered interferon-ineligible. 

Thornton: FDA labeling says that for interferon intolerant, or unwilling individuals, the second-line therapy would be a combination of sofosbuvir and ribavirin for 24 weeks. You don’t get as good of a cure rate, but it is an option for people who really need therapy and can’t wait for newer therapies, nor can they take interferon. 

**Hi folks, as mentioned, the AASLD/IDSA launched an up-to-date guidance for the treatment of hepatitis C. The new guidelines will have a complex algorithm for practitioners around the country to follow and see whats the right treatment, for the right patients, for the right about of time. Information includes both newly FDA approved drugs sofosbuvir and simeprevir, as well as off-label use for specific HCV combinations. Click here to begin reading.....

MHE: Let’s discuss the new guidelines and their implications.

Thornton: The guidelines are the result of a joint effort by the two associations (AASLD and IDSA), and this is the first time this has ever happened. It is exciting for us in the field to have guidelines that are going to be kept up-to-date and are user-friendly. In the past, they were always behind if a new drug came out. At least in my practice, they reflect exactly what we’re doing. 

Poniatowski: I was impressed and surprised by the timing because practice-based guidelines don’t typically react that quickly to changes in the marketplace. I was struck by the fact that the earlier two new improved drugs are not recommended. The other thing that’s interesting is that the guidelines recommend a combination of simeprevir and sofosbuvir, which is not yet approved by the FDA. It’s precedent setting so that when the next drugs arrive, we can expect guidelines to be just as timely. 

Thornton: The combination has been shown—at least in Phase II clinical trials—to be extremely effective for even people who are the most difficult to treat, who have cirrhosis and have previously failed therapy. In the clinical practice, we are desperately trying to get that combination for the patients who are interferon-ineligible.

Dorholt: This is kind of groundbreaking in terms of how quickly they have encompassed the new drugs into the guidelines and even incorporated some things that are not necessarily FDA approved, that are a little bit off-label but have evidence. 

MHE: Is the FDA working on approval of the combination of simeprevir and sofosbuvir? 

Poniatowski: It’s a tough question about which to speculate because it really comes down to the pharmaceutical manufacturers’ strategies—two different companies deciding whether or not they want to actually pursue that type of label and indication. Not only has the combination been incorporated into the guidelines, but there also are ongoing studies, so you know the requirement for FDA approval is certainly not a necessity for practitioners to use the drugs in such a way. The lack of approval is not the only consideration for payers in determining whether it would be appropriate to cover that combination. 

The coverage question at Cigna is based on the evidence in terms of published studies, and we really consider the specific characteristics of each patient case and hold periodic conversations between our medical director and the physician.

Thornton: The many different permutations and combinations of drugs and durations of therapy for hepatitis C must come into play when decisions are being made about what types of therapy to recommend and which courses of therapy are most appropriate.


MHE: How are patients going to be able to afford these new drugs? 

Dorholt: At Accredo, we never want to see cost be a barrier to patients who need a medication. If patients express any level of concern about costs or payment while we’re working with them, we connect them to our reimbursement specialists, who can find appropriate financial assistance, including a patient assistance program or resources available from a foundation. 
We also work with our payer clients to help them make cost share choices to manage costs, while also not deterring patient access because costs are so excessive. From our research and understanding of patient behavior, we know that there’s a tipping point where that can occur, and so benefits also have to be created using that perspective.

Poniatowski: Due to our holistic approach to patients, Cigna Specialty Pharmacy Services also informs customers about programs and resources available to them, including financial assistance programs for the costly specialty medications. 

MHE: Is there a way for physicians to determine who is going to benefit most from these new drugs?

Dorholt: Because of the complexity of the drugs and the nuances of patients, I think there are many elements that play into the individual selection process. Efficacy, for example, is a major factor. You also have to think about the viral genotypes and their subsets because that will influence which drug you pick and which is more successful. 
Other things that need to be considered are: previous treatment history and the response to that treatment, because there is some cross resistance between some of these products; the severity of the disease and whether the patient already has cirrhosis; a patient’s other diseases that might influence drug choices; whether medications for those other conditions have an effect; and if a patient has HIV. 
In addition, you have to look at patient dynamics: What is that patient’s ability to handle a really complicated regimen with complicated side effects? 

Poniatowski: A combination of what a person’s disease looks like, what drugs are on the market and their pros and cons, and what is on the horizon is necessary in making that decision about treating now or waiting.

MHE: What kinds of disease management programs prove to be most effective in targeting non-adherence and eliminating the virus?  

Poniatowski: At Cigna, we approach disease management programs by looking at patients holistically, not just paying attention to their hep C because they may have comorbid conditions. Instead, we consider their care across the whole spectrum of their disease. 

Cigna Specialty Pharmacy Services creates teams of pharmacists, certified pharmacist technicians, registered nurses and call center personnel whose training focuses on a particular chronic condition such as hepatitis C. They continually monitor adherence, side effects and drug interactions and reach out to the treating doctor when adjustments are needed.

Dorholt: Any effective program in our portfolio has to include a multifaceted approach to support the patient, including direct education, clinical outreach, ongoing adherence messaging and reminders, and technology-based tools to create a sense of community or patient connection. 

Express Script’s specialty unit, Accredo, offers patients with hepatitis C one-on-one counseling by pharmacists with expertise specifically in managing hepatitis C. Nurses and pharmacists make follow up calls to these patients depending on their specific situations. 

Thornton: Our most important offering is Project ECHO, providing 24 service centers of excellence around the state of New Mexico that treat hepatitis C. 

Hepatitis C treatment is actually embedded in patients’ primary care settings, which offer a team-based approach. Along with a clinician, there is always a community health worker, a medical assistant or someone with similar capabilities. The key is having very close follow-up with providers and the hepatitis C team in clinics where patients are treated. When we studied the effectiveness of treatment through the project, we had really phenomenal responses and adherence rates because people were being treated within their own home base and in their own primary care setting. 

Article Source 



Smile Saturday- Jimmy and JT

Smile Saturday- Jimmy and JT




Jimmy & Justin perform the fifth installment of the "History of Rap." Song list below.

LL Cool J -- I'm Bad

Run DMC -- Beats to the Rhyme

Crazy Calls - Wait for the Beep

Beastie Boys -- Fight For Your Right

Tone Loc -- Wild Thing

DJ Jazzy Jeff & the Fresh Prince - Fresh Prince Theme

Salt N' Pepa -- Whatta Man

Positive K -- I Got A Man

The Notorious B.I.G. - Big Poppa

Dr. Dre feat. Snoop Dogg - Dre Day

Warren G feat. Nate Dogg - Regulate

N.W.A. -- Straight Outta Compton

Ini Kamoze - Hot Stepper

Outkast - So Fresh, So Clean

Busta Rhymes feat. P. Diddy & Pharrell -- Pass the Courvoisier, Part II

Kris Kross - Jump

Skee-Lo -- I Wish

Jay Z - 99 Problems

Ludacris -- Move Bitch (Get Out the Way)

Drake -- Started From the Bottom

Kendrick Lamar -- Swimming Pools (Drank)

Kanye West feat. T-Pain -- Good Life

Run DMC -- Walk This Way

Subscribe NOW to The Tonight Show Starring Jimmy Fallon: http://bit.ly/1nwT1aN

Friday, February 21, 2014

Gilead's Ledipasvir and Sofosbuvir:European Medicines Agency advises on compassionate use of new combination therapy for chronic hepatitis C

Related Feb 10 - Gilead Files for U.S. Approval:Ledipasvir/Sofosbuvir Fixed-Dose Combo For Genotype 1 Hepatitis C

21/02/2014
European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C

Combination of ledipasvir and sofosbuvir to be used in patients in urgent need of therapy to prevent progression of liver disease

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given an opinion on the use of a fixed-dose combination of ledipasvir and sofosbuvir in the treatment of chronic (long-term) hepatitis C virus (HCV) infection in a compassionate-use programme.

Compassionate-use programmes are set up at the level of individual Member States. They are intended to give patients with a life-threatening, long-lasting or seriously disabling disease with no available treatment options access to treatments that are still under development and that have not yet received a marketing authorisation.

In this specific case, Sweden requested an opinion from the CHMP on the conditions under which early access through compassionate use could be given to a combination of ledipasvir and sofosbuvir, with or without ribavirin, for adult patients with genotype 1 HCV infection and advanced liver disease, who are at a high risk of their liver being no longer able to function normally (decompensation) or death within 12 months if left untreated.

In clinical trials, the combination of ledipasvir and sofosbuvir, with or without ribavirin, used for 12 or 24 weeks, has shown high efficacy in treating patients with genotype 1 virus, including patients with compensated cirrhosis (scarring of the liver but normal liver function) and patients who have previously failed treatment with the protease inhibitors telaprevir or boceprevir (other treatments for hepatitis C). Many of these patients have very advanced liver disease and are in urgent need of effective therapy in order to halt the progression of liver injury.

This is the third opinion provided by the CHMP since October 2013 on compassionate use of medicines in development for the treatment of hepatitis C.

The aim of the CHMP assessment and opinion on a compassionate-use programme for new medicinal products is to ensure a common approach, whenever possible, regarding the criteria and conditions of their use prior to their authorisation under Member States' legislation. The opinion provides recommendations to the EU Member States that are considering setting up such a programme, and its implementation is not mandatory. In addition to describing which patients may benefit from the medicine, it explains how to use it and gives information on safety.

The assessment report and conditions of use of the combination of ledipasvir and sofosbuvir with or without ribavirin in this setting will be published shortly on the Agency's website.

Notes
  • The fixed-dose combination of ledipasvir and sofosbuvir is being developed by Gilead Sciences.
  • Sofosbuvir, which is part of this compassionate-use opinion, was granted a marketing authorisation valid throughout the European Union on 16 January 2014. For more information, see Sovaldi.

PDF European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C

Researchers Look to Reduce Hep C Infections with 'Staying Safe' Intervention for Injecting Drug Users

Researchers Look to Reduce Hep C Infections with 'Staying Safe' Intervention for Injecting Drug Users

Despite a number of social/behavioral intervention and educational programs, the spread of hepatitis C (HCV) in people who inject drugs (PWIDs) remains a chronic problem. Now, researchers affiliated with New York University’s Center for Drug Use and HIV Research (CDUHR) are focusing on intervention strategies that highlight the lesser-known dangers of HCV transmission through the sharing of other injection equipment such as cookers, filters, drug-dilution water and water containers.

Their article, “The Staying Safe Intervention: Training People Who Inject Drugs in Strategies to Avoid Injection-Related HCV and HIV Infection,” published in AIDS Education and Prevention (Vol. 26:2, April 15, 2014), explores the feasibility and efficacy of their “Staying Safe Intervention,” a strengths-based social/behavioral intervention conducted with small groups of PWID, designed to facilitate long-term prevention of HIV and HCV.

“The Staying Safe Intervention seeks to reduce injection risk by intervening upstream in the causal chain of risk behaviors by modeling, training in, and motivating the use of strategies and practices of long-term risk-avoidance,” says Dr. Pedro Mateu-Gelabert, the study’s Principal Investigator, at the NYC-based National Development Research Institutes.

Mateu-Gelabert and his NDRI-CDUHR team evaluated 68 street-recruited injectors from the Lower East Side of Manhattan; the objective was to reduce participants’ injection risk behaviors, empower and motivate behavioral change, and teach tactics to help reduce drug intake. The current program was built upon findings of their 2005 study, “Staying Safe,” which looked at the behaviors and strategies of individuals who had injected drugs for long periods of time (8-15 years) but had not contracted HIV or HCV.

“The Staying Safe Intervention does not focus exclusively on the moment of injection,” explains Mateu-Gelabert, “but on the upstream determinants of risk behavior, such as stigma, risk networks, social support and income, while encouraging injectors to plan ahead in order to better manage the drug-related risk contexts they are likely to face.”

The social/behavioral intervention showed substantial improvement in motivation and planning to avoid injection-related risks, increased use of stigma management strategies, and decreases in drug withdrawal episodes (known to reduce safe injection practices) and number of weekly injections. The research team also noted that participants in the study have been spreading the word on safer drug use within their communities.

The Centers for Disease Control and Prevention (CDC) estimates that not only do nine percent of new HIV infections originate from drug use, but 18 percent of PWID are HIV positive and up to 70-77 percent of PWIDs have HCV.

“Given the substantial reductions observed among Staying Safe participants in key injection-related risk behaviors associated with HCV transmission, the Staying Safe Intervention may have the potential to contribute to sufficient additional risk reduction to help address the seemingly intractable rates of HCV transmission among PWID,” says Mateu-Gelabert.

Currently, Mateu-Gelabert’s team is researching HCV and HIV risk associated with nonmedical prescription opioid use. Future research will evaluate the effectiveness of the Staying Safe Intervention in preventing HIV and hepatitis C infection among young prescription opioid users who have transitioned to heroin injection.

The project described was supported by Award Numbers R21DA026328, R01DA019383, R01DA031597, and R01DA035146 from the National Institute on Drug Abuse.

Source: New York University College of Nursing

http://www.infectioncontroltoday.com/news/2014/02/researchers-look-to-reduce-hep-c-infections-with-staying-safe-intervention-for-injecting-drug-users.aspx

Thursday, February 20, 2014

Lessening liver damage - Possible improved treatment for acetaminophen poisoning


Lessening liver damage

Scientists believe they’ve found improved treatment for acetaminophen poisoning

February 19, 2014

By Joseph Caputo, Harvard Correspondent

B. D. Colen/Harvard Staff

The human liver can safely process up to 4 grams (8 pills) of acetaminophen, best known as Tylenol, over 24 hours. Surpassing that amount risks poisoning or killing liver cells.

Harvard stem cell scientists studying the effect of nitric oxide on liver growth and regeneration appear to have serendipitously discovered a markedly improved treatment for liver damage caused by acetaminophen toxicity, the root of half of the hospital visits involving acute liver failure in the United States.

The human liver can safely process up to 4 grams (8 pills) of acetaminophen, best known as Tylenol, over 24 hours. Surpassing that amount risks poisoning or killing liver cells. Accidental acetaminophen overdoses commonly occur when people who feel sick but don’t know the dangers posed by the over-the-counter pain and fever reducer exceed the safe dosage. Such poisoning kills hundreds of people each year.

Writing in the journal Cell Reports, the researchers described how nitric oxide, which is commonly used to relax cardiac blood vessels in patients with heart disease, enhances liver growth and regeneration, independent of its effect on blood vessels. Using zebrafish and mice, the research team also showed how manipulating these pathways with drugs could improve treatment of toxic liver injury caused by acetaminophen overdose.

The only federally approved treatment for acetaminophen toxicity, N-acetylcysteine (NAC), is most effective if a patient seeks medical help within 8 to 12 hours of overdose. Unfortunately, most overdose-specific symptoms, such as confusion and intestinal bleeding, don’t occur until the liver injury is critical.

“We tried to model that in our studies where we gave fish Tylenol first, waited 18 hours, and gave them a new nitric oxide-based drug combined with the clinically approved drug,” said study co-senior author Wolfram Goessling of the Harvard Stem Cell Institute. “These drugs worked together to improve liver injury even when out of the previously established therapeutic window, and so we think there’s significant potential for clinical application.”

Goessling and his research associates happened upon the nitric oxide-liver injury connection while investigating the signaling pathways that are important for liver development. Goessling’s lab, which he shares with study co-senior author Trista North, screened thousands of known drugs on zebrafish embryos to see which produced a bigger or smaller liver. The compounds with the most dramatic effect were a family of drugs that affect nitric oxide and nitric oxide signaling.

Andrew Cox, a postdoctoral fellow in Goessling’s lab, conducted a series of experiments to show that nitric oxide enhanced liver formation during organ development in zebrafish and that blocking nitric oxide led to smaller, less-developed livers. Further investigation found that nitric oxide worked through different pathways in the liver than it did in the blood vessels, where its ability to regulate blood flow has been well established.

“During these experiments, we found a recently recognized pathway, called protein nitrosylation, where the activity of proteins gets changed by nitric oxide,” Goessling said. “We think that’s the basic principle behind how it works in liver development.”

The members of Goessling and North’s lab found it was possible to enhance liver growth and regeneration by disrupting the nitrosylation pathway so that nitric oxide could better change proteins in the liver. They found a nitrosylation enhancer currently used in clinical trials for other purposes and began testing it in clinical models of illnesses such as Tylenol overdose, where it proved successful.

“This potential drug doesn’t only work in fish,” Goessling said. “We did use mouse models to show that this might have relevance to human disease.”

If the nitrosylation drug for liver toxicity reaches clinical trials, it would join a handful of other drugs developed from zebrafish research that originated from Harvard Stem Cell Institute labs.

Last year, a compound discovered by North and Goessling while they were working as postdoctoral fellows in the lab of Leonard Zon was found to expand cord blood during hematopoietic stem cell transplants in a Phase 1b clinical trial. Another drug for melanoma, also discovered in the Zon lab, reached the federal Food and Drug Administration approval process in 2011.

The research was funded by a Harvard Stem Cell Institute junior faculty grant, a Public Health Service grant, the Pew Charitable Trusts, and an American Liver Foundation Postdoctoral Research Fellowship award

Flu Hitting Younger Adults Hard: More deaths than usual among younger and middle-aged adults

THURSDAY Feb. 20, 2014, 2014 -- (HealthDay News)

The flu is hitting younger and middle-aged adults unusually hard this season, but getting vaccinated reduces the need for a doctor's care, U.S. health officials said Thursday.

People aged 18 to 64 represent 61 percent of all flu hospitalizations this flu season, according to the U.S. Centers for Disease Control and Prevention. This age group accounted for only about 35 percent of flu-related hospitalizations the last three seasons, officials said at a CDC news conference.

"We think one of the reasons flu is hitting younger adults hard is that such a low proportion get a flu shot, even those with underlying conditions like asthma, COPD, and diabetes," said CDC Director Dr. Tom Frieden at the news conference.

"The bottom line is, influenza can make anyone very sick, very fast and it can kill. Vaccination every season is the single most important thing you can do to protect yourself," he added.

More deaths than usual have occurred among younger and middle-aged adults this season, too. People 25 to 64 years old have accounted for about 60 percent of flu deaths -- triple the rate for that age group three seasons ago, the CDC said.

Flu activity will likely keep up for several more weeks, especially in places where flu surfaced later in the season, the CDC officials noted. Southern states, especially Alabama, Louisiana, Mississippi and Texas, saw an early spike in flu activity this season. During January, flu activity decreased in the Southeast and South Central states but picked up in the West and Northeast, health officials said.

The currently circulating H1N1 virus, which is striking younger adults, emerged in 2009 and triggered a pandemic. H1N1 viruses have continued to circulate since the 2009 pandemic, but this is the first season since then that they have predominated in the United States, according to the CDC officials.

While flu hospitalizations are still highest among the elderly, adults aged 50 to 64 now have the second-highest hospitalization rate followed by children up to 4 years old. During the 2009 pandemic, people 50 to 64 years also had the second-highest hospitalization rate, the CDC said.

"Younger people may feel that influenza is not a threat to them, but this season underscores that flu can be a serious disease for anyone," said Frieden.

He stressed the value of vaccination. The current flu vaccine has cut the risk of needing medical care for flu-related problems by about 60 percent across all ages, he said, noting that's "encouraging."

However, by November, only one-third of 18- to 64-year-olds had been vaccinated. "That's why we're seeing more hospitalizations and deaths" in that age group, he noted.

Frieden said it's important to remember that some people who get vaccinated may still get sick. "People at high risk of complications should seek treatment if they get a flu-like illness. Their doctors may prescribe antiviral drugs if it looks like they have influenza," he explained.

Dr. Len Horovitz, an internist and pulmonary specialist at Lenox Hill Hospital in New York City, said six of his patients in the last three weeks -- mostly young adults -- who were vaccinated still had symptoms and tested positive for influenza after a nasal swab test.

He urged people who think they have the flu to see their doctors sooner rather than later if flu symptoms arise. "It's important to see a physician if it's in the first 24 to 48 hours because you can treat with [the antiviral drug] Tamiflu, even in people who have been vaccinated," said Horovitz.

People at high risk for flu complications include pregnant women, people with asthma, diabetes or heart disease, the morbidly obese and people older than 65 or younger than 5 years, but especially those younger than 2 years.

The CDC recommends that everyone 6 months and older get an annual flu vaccine. "This season vaccinated people were substantially better off than people who did not get vaccinated," Frieden said.

Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases, stressed it's not too late to get a flu shot.

"I want to remind you that the season is not over and things could change," she said at the press conference.

Horovitz said to prevent flu infection, practice good hand washing and avoid touching your face. Also, avoid kissing on the face when someone is sick, and steer clear of people who are coughing.

"If you're walking behind someone coughing who has flu, even outdoors, droplets are more sustained in cold air than warm air, so cover your face," Horovitz added.

Sourc - HealthDay

More information
For more on this year's flu, follow @CDCFlu on Twitter, or visit the U.S. Centers for Disease Control and Prevention.

CDC -Editorial Note

Update: Influenza Activity — United States, September 29, 2013-February 8, 2014

Influenza activity in the United States began to increase in mid-November and remained elevated and widespread as of February 8, 2014. During September 29, 2013-February 8, 2014, pH1N1 accounted for the majority of circulating influenza viruses, but influenza A (H3N2) and influenza B viruses also were identified. This season, influenza activity first increased in the southern states. By the end of December 2013, high influenza activity was seen throughout the United States. During the first 4 weeks of 2014, influenza activity decreased in the southeast and south central areas of the United States but began increasing in the west and northeast areas. Elevated influenza activity in parts of the United States is expected for several more weeks.

Surveillance data from previous influenza seasons have shown that the epidemiology of influenza is related to the circulating subtype, which can vary by season. This is the first season that pH1N1 has been the predominant influenza virus circulating in the United States since this subtype emerged in 2009. Although illness was seen in all age groups during the 2009 pandemic, persons aged 50-64 years had the highest influenza-associated death rate and second highest influenza-associated hospitalization rate among all age groups (2).

Preliminary surveillance data for the 2013-14 influenza season suggest that although overall disease prevalence is lower than during the 2009 pandemic, persons aged 18-64 years are again at relatively high risk for severe illness from influenza this season.

As of February 8, 2014, persons aged 18-64 years represented 4,077 (61%) of influenza-associated hospitalizations reported by FluSurv-NET. In contrast, during the past three seasons in which H3N2 or B influenza viruses predominated, persons aged 18-64 years accounted for only 35% (2012-13), 40% (2011-12), and 43% (2010-11) of all influenza-associated hospitalizations reported by

FluSurv-NET (Figure 4). For the 2013-14 season, cumulative influenza-associated hospitalization rates for persons aged 18-49 years (16.8 per 100,000) and 50-64 years (38.7 per 100,000) in FluSurv-NET have already surpassed the end-of-season rates from three of the previous four seasons (3).



During the three previous influenza seasons, the total number of P&I deaths reported through the 122 Cities Mortality Reporting System ranged from 37,444 to 41,708, of which <1% to 2% were deaths for which influenza was listed on the death certificate as an underlying or contributing cause of death. Although the age distribution of pneumonia deaths this season is similar to previous seasons, the age distribution of influenza deaths has changed. The number of influenza deaths during the current season (through February 8, 2014) among persons aged 25-64 years (352) exceeds the 138 deaths reported for that age group for the entire 2012-13 influenza surveillance season (September 30, 2012-September 28, 2013). This age group has accounted for approximately 62% of all influenza-associated deaths already this season, compared with 47% in 2010-11, 30% in 2011-12, and 18% in 2012-13 (Figure 4).

The more severe impact of pH1N1 on adults aged 18-64 years seen this season and during the pandemic is thought to result from at least two factors. First, persons in this age group likely lack the cross-protective immunity to pH1N1 seen in adults aged ≥65 years, which was likely acquired from past infection with antigenically related viruses (4). Second, preliminary vaccination coverage estimates for this season indicate that by early November 2013, adults aged 18-64 years had been vaccinated against influenza at a rate substantially lower (33.9%; 95% confidence interval [CI] = 31.9%-35.9%) than those aged 6 months-17 years (41.1%; 95% CI = 38.8%-43.4%) and ≥65 years (61.8%; 95% CI = 57.9%-65.7%) (5). In previous years, adults aged 18-64 years also have been less likely to receive influenza vaccine, compared with persons in other age groups (5). Although some persons infected with pH1N1 during the 2009 pandemic might retain some residual immunity, this protection has likely declined over time. Furthermore, seroprevalence studies showed that only a minority (approximately 35% of all ages combined) were seropositive for pH1N1 after the 2009 pandemic, with even smaller percentages (26%) among those aged 25-64 years (6).

Surveillance data available from the 2013-14 season are a reminder that, although some age groups are at increased risk of influenza complications every year (e.g., adults aged ≥65 years), influenza can cause severe illness in persons of any age, even in adults aged 18-64 years. Vaccination is the primary means to prevent influenza and its complications and is recommended annually for all persons aged ≥6 months. Data from the current and two previous influenza seasons suggest that vaccination reduced the risk for medical visits associated with influenza by 47%-61% (7,8). Health-care providers should continue to recommend and offer influenza vaccine for the remainder of the season to all unvaccinated persons aged ≥6 months.

Early and aggressive treatment of influenza with neuraminidase inhibitor antiviral drugs should be used when indicated, and data from this season show that pH1N1 remains susceptible to these agents. Currently circulating influenza A virus strains have shown resistance to amantadine and rimantadine, also known as adamantanes; therefore, adamantanes are not recommended for antiviral treatment or chemoprophylaxis of currently circulating influenza A virus strains (9).

Antiviral treatment is recommended as early as possible (ideally within 48 hours of illness onset) for patients with severe illness (e.g., patients hospitalized with influenza) or patients at high risk for serious influenza complications, including children aged <2 years, adults aged ≥65 years, and persons with certain underlying medical conditions (10).††† If treatment can be initiated within 48 hours of illness onset, antiviral medications also may be considered for outpatients with suspected or confirmed influenza who are not known to be at increased risk for developing severe illness (10).

Influenza surveillance reports for the United States are posted online weekly and are available at http://www.cdc.gov/flu/weekly. Additional information regarding influenza viruses, influenza surveillance, influenza vaccine, influenza antiviral medications, and novel influenza A infections in humans is available at http://www.cdc.gov/flu.

February Hepatitis C Newsletter Updates: Baby Boomers, New Drugs and Monthly Pubmed Review

February Newsletters Updated

Good day folks, is anyone having a difficult time coping with this crazy weather?

Here in my part of the world the snow continues to pile up, in addition I have a lovely collection of icicles hanging from every inch of my roof.

While standing in front of my home, snapping a few pictures of these amazing ice sculptures, I encountered a drive-by, of sorts.

Slowly, an old truck pulled over to where I was standing, inside a red faced kid nodded my way. I nodded back, he apparently wanted a better look at my lovely glistening icicles. With a cell phone in one ear, music in the background, he opened his mouth and proceeded to spoil my day.

The Conversation Went Like This

Infant In The Truck - I see you have an icicle problem. 

Woman Admiring Her Icicles - Aren't they awesome! Problem? What problem, unless you hate icicles, I smiled. 

Child From Inside The Truck - All I see is an ice dam lady, and a potential for major water damage.

Woman Confused - Huh?

Teenager In The Cute Truck - Lady, if you don't get that snow off your roof, when it melts it won't have anywhere to go but inside your home.

Women Shaking - Huh?

Young Man Sitting Proudly In His New Truck- The water is going to end up running down your walls. THE walls inside your home!

Woman - Who said?

Wise Adorable Little Man - ?

Woman - Just a moment, sir.
(Woman feverishly runs inside potentially damaged home, grabs laptop, finds problem - handyman may come in handy)

Woman - Thank you so much for bringing this to my attention, could you remove the snow today? 

Charming Hero - Yep, sure can, it will cost ya two hundred bucks lady.

Me - Will you take a check?

There you have it, a risk for a serious problem - I had no idea existed. What a perfect  prelude to a more serious problem, a health problem affecting over 3 million Americans. The same scenario is applied here, over 75% of people infected with hepatitis C - have no idea they are infected! Consider this your drive-by;
If you are a baby boomer, you are at risk for hepatitis C. Of the more than 3 million Americans who have hepatitis C, more than 75% were born between 1945 and 1965.
Hepatitis C – the “silent epidemic”
Finding those infected with the disease is actually an enormous problem. It can take decades for symptoms to appear. During that time, people often have no idea they are infected. In fact, 75 percent of people who are infected with the virus do not know that they have it.
The longer the virus goes undetected, the greater a person’s risk of developing serious liver disease, including cirrhosis and liver cancer.

To learn more check out the American Liver Foundation's February newsletter, for additional HCV newsletters published this month, click here.


February Newsletters Updated




HEPATITIS C BABY BOOMERS
If you are a baby boomer, you are at risk for hepatitis C. Of the more than 3 million Americans who have hepatitis C, more than 75% were born between 1945 and 1965.
READ MORE
CORE PROGRAMS
Our core programs are tailored for people of all ages, whether they are living with or at risk for liver disease. The American Liver Foundation® (ALF) implements a variety of education programs about liver health and wellness and ways to prevent, treat and live with liver disease.
READ MORE 

Viral Hepatitis Treatment Choices Initiative
Focusing on hepatitis A, hepatitis B and hepatitis C, this program is offered to hospitals, detox centers, prisons and community-based organizations that provide services for addiction and substance abuse. It covers information about the liver, disease risk factors, prevention, coping with the challenges of living with a hepatitis virus and advances in treatment. ALF provides resources and educational materials to help individuals understand how they can go about seeking the treatments they need.

We have many more programs, including those on the local level through ALF’s 16 division offices located throughout the country. For more information about our national and regional programs, call us at 1-800-GO-LIVER (1-800-465-4837).
  
HE WEBINAR  
On January 23, 2014, more than 300 people tuned in to the American Liver Foundation's webinar on hepatic encephalopathy (HE); the first of a four-part webinar series ALF will be presenting on a variety of liver disease topics.
READ MORE
   
 LIVER LIFE CHALLENGE: DISNEY RUN
Thirty people from around the country ran nearly 754 miles collectively and raised $106,944 to support the American Liver Foundation®. The ALF Liver Life Challenge®, part of the annual Walt Disney World® Marathon Weekend, took place January 8-12th in Orlando, Florida. Proceeds benefit ALF's national and regional programs.
READ MORE

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Other Updates:

Source - Gastroenterology & Endoscopy News

ISSUE: FEBRUARY 2014 | VOLUME: 65:2

The combination of daclatasvir plus asunaprevir, both manufactured by Bristol-Myers Squibb (BMS), looks poised to gain approval in Japan for treating patients with hepatitis C virus genotype 1b infection. Experts speculate that BMS will seek approval in the United States for this drug combination at a later date, but with the addition of a third drug, BMS-791325, and for an overall genotype 1 indication. 
Over the next five years, a whirlwind of new direct-acting antiviral agents for hepatitis C are expected to get the green light from the FDA. The recent approval of simeprevir and sofosbuvir–containing regimens is only the tip of the iceberg.





GI & Hepatology News
GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors.

February Issue 

COMMENTARY – The price and cost of hepatitis C treatment
Chronic hepatitis C virus infection is a major cause of liver disease, affecting 180 million
people globally.
 
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Enjoy the rest of your day!
Tina