BREAKTHROUGH DISCOVERY IN NUTRITIONAL IMMUNOLOGY: Diindolylmethane (DIM) is a powerful natural immune booster

BREAKTHROUGH DISCOVERY IN NUTRITIONAL IMMUNOLOGY:

Diindolylmethane (DIM) is a powerful natural immune booster

At the University of California at Berkeley, the Chairman of the Nutritional Sciences Department and the Director of the National Institutes of Health Cancer Research Program were studying the biological properties of Diindolylmethane (DIM), a naturally occurring compound found in Brassica vegetables (broccoli, cauliflower, cabbage, kale, brussels sprouts), when they made a remarkable discovery: DIM is a potent activator of the immune response system. They patented their discovery and ActivaMune was launched as a first-in-class nutritional supplement to enhance the immune system and help raise funds for their ongoing nature-based biomedical research.ActivaMune's unique and patented formula combines multiple nutrients for maximum effectiveness: Diindolylmethane (DIM), Sulforaphane, Selenium, Lycopene, Lutein, Zeaxanthin, Calcium and Vitamins C, D3 & E.

Intense endurance sports, stress from work or school, environmental pollution, lack of sleep, and the aging process all take a toll on the immune system. Revive your immune system today with an all natural patented formula exclusively licensed from the University of California at Berkeley. Endurance sports athletes are advised to take the product before and after their workouts.

ActivaMune provides phytonutrients equivalent to approximately five pounds of fresh organic uncooked broccoli, tomatoes and spinach per day in addition to important vitamins and minerals. Most broccoli extract supplements on the market today do not have the active ingredients in ActivaMune as their manufacturing process (heat or freeze drying) destroys the enzyme necessary for the production of the key phytonutrients present in this supplement.

The Co-Founders and Scientific Advisory Board members of our company are internationally renowned scientists in the fields of nutrition, oncology and immunology:

Dr. Leonard Bjeldanes, Ph.D. Professor and Former Chairman, Nutritional Sciences Department, UC Berkeley. Dr. Bjeldanes is the most cited scientist worldwide in the field of Diindolylmethane research.

Dr. Gary Firestone, Ph.D. Director, National Institutes of Health Cancer Research Program, UC Berkeley. Dr. Firestone and Dr. Bjeldanes at UC Berkeley have together published more scientific papers on DIM than any other scientific team worldwide.

Dr. Christopher Benz, M.D. Professor of Medicine in Oncology, UCSF, founder of the first laboratory at UCSF dedicated to breast cancer research, Program Director, Cancer and Developmental Therapeutics Program, Buck Institute for Research on Aging.

Dr. Warner Greene, M.D., Ph.D. Professor of Medicine in Immunology, UCSF, Director, UCSF Gladstone Institute of Virology and Immunology, Board Member, United States Institute of Medicine, National Academy of Sciences.

Dr. Giuseppe Del Priore, M.D., M.P.H. Professor of Medicine and Director of Gynecologic Oncology at the Indiana University School of Medicine. Dr. Del Priore led the first human clinical study of DIM as a naturally occuring treatment for Cervical Dysplasia caused by the HPV virus.

Proceeds from ActivaMune support biomedical research.

Thank you for your support.

Source.

ActivaMune is a nutritional supplement. The statements made on this website have not been evaluated by the US Food and Drug administration. The product featured is not intended to diagnose, treat, cure or prevent any disease. For medical advice please contact a licensed healthcare professional.

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Introducing ActivaMune with Patented Technology from UC Berkeley Diindolylmethane (DIM) Immune, Breast, Prostate, Colon & Skin Lycopene Selenium  Immune, Breast, Prostate & Vision Health Cardiovascular, Breast & Prostate Health Lutein Immune, Vision & Prostate Health Zeaxanthin Vision Health Vitamins C, D3, E and Calcium

Introducing ActivaMune with Patented Technology from UC Berkeley Diindolylmethane (DIM) Immune, Breast, Prostate, Colon & Skin HealthLycopene Selenium  Immune, Breast, Prostate & Vision Health Cardiovascular, Breast & Prostate Health Lutein Immune, Vision & Prostate Health Zeaxanthin Vision Health Vitamins C, D3, E and Calcium

Gastroenterology. 2011 Mar;140(3):818-29. doi: 10.1053/j.gastro.2010.12.027. Epub 2010 Dec 16.

Early menopause is associated with lack of response to antiviral therapy in women with chronic hepatitis C.

Villa E, Karampatou A, Cammà C, Di Leo A, Luongo M, Ferrari A, Petta S, Losi L, Taliani G, Trande P, Lei B, Graziosi A, Bernabucci V, Critelli R, Pazienza P,Rendina M, Antonelli A, Francavilla A.

Source

Department of Gastroenterology, University of Modena and Reggio Emilia, Modena, Italy. erica.villa@unimore.it

Abstract

BACKGROUND & AIMS:

Chronic hepatitis C (CHC) and liver fibrosis progress more rapidly in men and menopausal women than in women of reproductive age. We investigated the associations among menopause, sustained virologic response (SVR), and liver damage in patients with CHC.

METHODS:

We performed a prospective study of 1000 consecutive, treatment-naïve patients 18 years of age and older with compensated liver disease from CHC. Liver biopsy samples were analyzed (for fibrosis, inflammation, and steatosis) before patients received standard antiviral therapy. From women (n = 442), we collected data on the presence, type, and timing of menopause; associated hormone and metabolic features; serum levels of interleukin-6; and hepatic tumor necrosis factor (TNF)-α.

RESULTS:

Postmenopausal women achieved SVRs less frequently than women of reproductive age (46.0% vs 67.5%; P < .0001) but as frequently as men (51.1%; P = .283). By multivariate regression analysis, independent significant predictors for women to not achieve an SVR were early menopause (odds ratio [OR], 8.055; 95% confidence interval [CI], 1.834-25.350), levels of γ-glutamyl transpeptidase (OR, 2.165; 95% CI, 1.364-3.436), infection with hepatitis C virus genotype 1 or 4 (OR, 3.861; 95% CI, 2.433-6.134), and cholesterol levels (OR, 0.985; 95% CI, 0.971-0.998). Early menopause was the only independent factor that predicted lack of an SVR among women with genotype 1 hepatitis C virus infection (OR, 3.933; 95% CI, 1.274-12.142). Baseline levels of liver inflammation, fibrosis, steatosis, serum interleukin-6 (P = .04), and hepatic TNF-α (P = .007) were significantly higher among postmenopausal women than women of reproductive age.

CONCLUSIONS:

Among women with CHC, early menopause was associated with a low likelihood of SVR, probably because of inflammatory factors that change at menopause.

Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

US National Library of MedicineNational Institutes of Health

Comment in

• Hormones: a potential explanation for differences in response rates to therapy for chronic hepatitis C infection. [Gastroenterology. 2011]

 Source PMID:

 

21167831

 

[PubMed - indexed for MEDLINE]

Panel recommends FDA approve sofosbuvir for hepatitis C

• October 25, 2013

The FDA’s Antiviral Drugs Advisory Committee today recommended approval of sofosbuvir, a first-in-class, once-daily oral nucleotide inhibitor from Gilead Sciences, for treatment of chronic hepatitis C virus genotypes 1, 2, 3 and 4.

The panel voted unanimously and enthusiastically in support of approving sofosbuvir in combination with ribavirin for treatment of HCV GT 2 and 3 in adult patients.

“This is a game-changer,” committee member Marc G. Ghany, MD, MHSc, staff physician with the liver diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases, said.

The panel also voted 15-0 but offered more reservations in support of approving sofosbuvir in combination with pegylated interferon and ribavirin (PR) for treatment of HCV GT 1 and 4 in treatment-naive patients.

“I was hesitant to give approval for a one-arm study,” committee member Dean Follmann, PhD, chief, biostatistics research branch, National Institute of Allergy and Infectious Diseases, said. “The 90% success rate is what really made me comfortable with this.”

The votes followed a discussion on a series of phase 3 studies of a sofosbuvir-based regimen, generally of 12 to 16 weeks, that demonstrated similar or superior effectiveness to current treatment options at primary endpoint of sustained virologic response (SVR) at 12 weeks.

The committee also discussed, but did not vote, on whether evidence supported sofosbuvir in combination with PR for treatment of chronic hepatitis C in patients with GT 1 infection who are nonresponders to a prior course of PR.

Studies did not directly analyze this patient population, but the FDA presented extrapolated data that suggested about 75% of treatment-experienced patients might respond positively to the therapy.

Several committee members expressed concern over the lack of real data, while others suggested it was a risk worth taking.

Thomas P. Giordano, MD, MPH, associate professor of medicine at Baylor College of Medicine, questioned whether voicing approval was appropriate.

“Clinicians are going to do what they have to do to take care of their patients, but the agency’s responsibility is at a different level,” he said.

On the discussion of whether evidence supported use of sofosbuvir in combination with ribavirin in hepatocellular carcinoma patients meeting Milan criteria awaiting liver transplantation, panel Chairman Yoshihiko Murata, MD, PhD, division of infectious diseases, University of Rochester School of Medicine and Dentistry, said there was a consensus among the panel on the need to treat this population.

“It’s work in progress, but it’s work that has to be done,” Donald J. Alcendor, PhD, associate professor, department of microbiology  and immunology at Meharry Medical College, said.Source http://www.healio.com/infectious-disease/hepatitis-resource-center-2013/panel-recommends-fda-approve-sofosbuvir-for-hepatitis-c

Medscape Medical News FDA Panel Recommends Approval of Simeprevir for Hepatitis C

An advisory committee to the US Food and Drug Administration (FDA) unanimously recommended simeprevir (Janssen) for the treatment of chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, combined with peginterferon alfa and ribavirin in adults with compensated liver disease (including cirrhosis) who are treatment naïve or who have failed previous interferon therapy with or without ribavirin.

Simeprevir is an HCV protease inhibitor, and if approved it will be the third HCV protease inhibitor approved in the US. Boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex Pharmaceuticals, Inc) were approved in 2011, according to background information provided by the FDA. The proposed dose is 150 mg once daily, in combination with peginterferon alfa and ribavirin.

"We clearly need better drugs, and the evidence is strong that this is a better drug than we have," voting member Curt H. Hagedorn, MD, Chief, Medicine Service, at Central Arkansas Veterans Healthcare Service, in Little Rock, Arkansas, noted.

The vote follows a discussion of data from 3 phase 3 randomized, double-blind, placebo controlled clinical trials (C208, C216, and HPC3007) in patients with chronic HCV GT1. Patients in the treatment groups (N = 781) were given simeprevir 150 mg daily for 12 weeks plus peginterferon and ribavirin (PR) for 12 weeks, followed by PR only for either 12 or 36 weeks based on the individual's virologic response to therapy. Patients in the control groups (N = 397) were given placebo for 12 weeks combined with PR for 48 weeks.

Those in trials C208 and C216 were treatment-naïve, and those in HPC3007 had received 24 weeks or more of a pegylated interferon-based treatment and had relapsed within 1 year after the last medication dose. Efficacy data from C208 and C216 were pooled because the studies were nearly identical in design.

Efficacy

The trials' primary endpoint was sustained virologic response 12 weeks after the anticipated end of treatment (SVR12), which was defined as an undetectable HCV RNA at treatment end and HCV RNA < 25 IU/mL 12 weeks after the anticipated end of treatment.

The pooled results from C208 and C216 showed an SVR12 rate of 80% in the treatment group and 50% in the control group. For the relapsed patients in HPC3007, the SVR12 rate was 79% in the treatment group and 36% in the control group.

Secondary endpoints for all 3 trials included SVR24 and SVR 72. Both endpoints correlated well with the primary endpoint of SVR12, but data were incomplete at the week 60 data cut-off.

SVR rates were lower in patients with a high baseline viral load, advanced disease on liver histology (bridging fibrosis and cirrhosis), older age, African American ethnicity, and absence of the IL28B CC genetic polymorphism.

The presence of the Q80K HCV GT1a polymorphism (commonly found in GT1a patients in the US) at baseline had a substantial impact on the efficacy of simeprevir. In the pooled trials, the differences in SVR12 rates in GT1a patients with the Q80K polymorphism were not statistically significant between the treatment (58%) and control (55%) groups. In HPC3007, the SVR12 rates for those with the Q80K polymorphism were 47% in the treatment group and 30% in the control group.

In those without the Q80K polymorphism, the SVR12 rates were 84% in the treatment groups vs 43% in the control group for the 2 pooled trials, and 78% in the treatment group vs 24% in the control group for the relapser trial. The committee recommends screening all patients with GT1a infection for the Q80K viral polymorphisms before initiating simeprevir (combined with pegylated interferon and ribavirin) and considering alternative treatment options for those with this polymorphism.

SVR12 rates were significantly higher in the simeprevir arm compared with the placebo arm in all other subgroup analyses.

Mean simeprevir area under the concentration-time curve 24-h postdose (AUC_24h) values were 2.4 and 5.2-fold higher, respectively, in HCV-uninfected subjects with moderate or severe hepatic dysfunction compared with healthy controls. Mean simeprevir AUC_24h values were also approximately 3.4-fold higher in HCV infected patients of East Asian ancestry compared with the pooled phase 3 population, which was about 91% Caucasian. For this reason, the committee would like to see additional studies in patients of East Asian origin.

Safety

A total of 4 deaths occurred in the treatment groups, and they were judged to be unrelated to treatment.

In the pooled analysis, 2% of those in the simeprevir group had serious adverse events, versus 3% of those in the control group during the initial 12 weeks. A total of 3 patients (0.4%) in the simeprevir group had significant adverse events, which were determined to be related to simeprevir by the study investigator; 1 patient experienced major depression and 2 patients experienced photosensitivity reactions.

Other common adverse events were rash (218 [28%] treatment groups; 79 [20%] control groups), influenza like illness (203 [26%] treatment groups; 84 [21%] control groups), pruritis (168 [22%] treatment groups; 58 [15%] control groups), and nausea (173 [22%] treatment groups; 70 [18%] control groups).

"I think this is a great opportunity at treating more HCV infected patients," said voting member Amanda H. Corbett, PharmD, BCPS, FCCP, a clinical associate professor at the University of North Carolina at Chapel Hill's Eshelman School of Pharmacy.

"Efficacy was clearly demonstrated and the safety profile is clearly favorable," explained voting member Thomas P. Giordano, MD, MPH, an associate professor of medicine at Baylor College of Medicine, medical director of HIV services at Harris Health System, and a research scientist at HSR&D Center of Excellence, Michael E. DeBakey VA Medical Center, in Houston, Texas.

Several committee members remarked on the need for postmarketing studies in racial and ethnic minorities, patients coinfected with HIV, and other underrepresented populations. A number of members suggested that the FDA should be more proactive with the pharmaceutical industry at the beginning of the clinical trial process to ensure a more diverse study population that more accurately represents the clinical population being studied.

The committee members have disclosed no relevant financial relationships.

US Food and Drug Administration (FDA)-Antiviral Drugs Advisory Committee Meeting.    Source http://www.medscape.com/viewarticle/813197

Bristol-Myers Squibb Launches Initiative to Support Search for Cure in Chronic Viral Diseases

 

  

PARIS, October 16, 2013 /PRNewswire/ --

Partnering for Cure to kick off with debate on HIV cure at European AIDS conference

Bristol-Myers Squibb (BMS) announced today at the 14^th European AIDS Conference (EACS) in Brussels the launch ofPartnering for Cure, a scientific initiative to support education and research and to transform clinical outcomes for patients with chronic viral diseases, namely HIV, hepatitis B (HBV) and hepatitis C (HCV).  The initiative, which confirms BMS' commitment in virology, is rooted in the company's legacy in virology and ongoing research in HIV and viral hepatitis.

The Partnering for Cure initiative is led by an expert panel of clinical and research experts from across Europe, includingGermany, France, Switzerland, Sweden, Belgium, Italy, Spain and the UK. Composed of three core components - education, scientific exchange and scientific research - the programme will focus on reviewing current treatment paradigms, providing a forum for discussion on the evolution of treatment towards cure and facilitating research seeking novel cure pathways in chronic viral diseases.

Following a first meeting in six sites on September 16, today's Partnering for Cure satellite symposium at EACS will put HIV cure 'on trial', with faculty members arguing for and against the case that cure is possible. Audience members will be given the opportunity to vote on the evidence presented.

"We need this programme: a programme to cure HIV, HBV and HCV," said Christine Katlama, Partnering for Cure Faculty Chair, from the Hôpital Pitié-Salpêtrière in Paris. "We have so many patients across the world and we need a cure. The answer is in the lab, the answer is also in the clinical field and there is a lot to do. We need to move forward and work together andPartnering for Cure is a fantastic opportunity to do just that."

Chronic viral infections make a substantial contribution to the burden of chronic diseases and premature mortality worldwide.  In December 2012, the Global Burden of Disease Study reported 1,465,000 deaths caused by HIV/AIDS and 1,445,000 deaths caused by viral hepatitis in 2010.^[i] Infections with hepatitis B and C viruses also cause an estimated 57% of cases of liver cirrhosis and 78% of cases of primary liver cancer annually.^[ii] Whilst important advanceshave been made over the last decade, particularly in HIV, significant unmet needs and the opportunity for cure remains.      

Bristol-Myers Squibb has been actively involved in virology research and development since the 1980s, initially focusing on HIV but more recently on HBV and HCV. "This is an important and ambitious programme that reflects our genuine engagement in virology," said George Hanna, Vice President, HIV Development, Bristol-Myers Squibb. "It is a way to showcase the BMS commitment to cure in chronic viral infections and to advance investigational compounds - with novel mechanisms of action - that aim to address unmet clinical needs in HIV, HBV and HCV. Along with our ongoing research in virology, we remain steadfast in our pursuit of partnership platforms with policy, advocacy and healthcare professional stakeholders."

As part of the Partnering for Cure programme, Bristol-Myers Squibb will also support three independent research projects focused on improving current understandings of HIV, HBV and HCV and creating novel treatment and cure strategies. Research applications will be accepted via the website, http://www.bms.com/israpplications until October 31, 2013 and will be subject to blind evaluation by the Partnering for Cure faculty.  

To view the multi-media press release, including comments from Partnering for Cure faculty members and BMS, please click the link below.  

http://www.epresspack.net/mmr/news/2520

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.

Bristol-Myers Squibb Virology Support Programmes

Like Partnering for Cure, Bristol-Myers Squibb supports a number of scientific and educational programmes within the virology community around the world that encompass disease education, disease awareness and sharing of best practices. These include SHE® (Strong, HIV positive, Empowered Women/Strong, HIV positive Women Educational Programme), a comprehensive and innovative programme for women living with HIV and their healthcare providers and PATH B® (Patients and professionals acting together for hepatitis B), a joint initiative between hepatitis patient groups and hepatologists to provide comprehensive information and support for patients with chronic hepatitis B.

References

i. Global Burden of Disease Study 2010, The Lancet, Volume 380, No9859, Dec 15, 2012, p2053-2260  

ii. WHO and WHA, Global Policy Report on the Prevention and Control of Viral Hepatitis, 2013, http://global-report.worldhepatitisalliance.org/en/home.html

SOURCE Bristol-Myers Squibb (BMS)

AGA DHRP Now Open to Report on Hepatitis C and IBD Data

October 17, 2013

The , made possible by support from Santarus, Inc. and Bristol-Myers Squibb, is now open to report on 2013 hepatitis C and IBD data. The DHRP was developed by AGA to make it easy for clinicians to demonstrate quality in patient care, achieve recognition, qualify for payor incentives, avoid CMS penalties and earn ABIM maintenance of certification (MOC) points.

DHRP participants who meet thresholds for quality can receive recognition through the Health Care Incentives Improvement Institute, Inc. (HCI3) Bridges to Excellence (BTE) program for Hepatitis C Care Recognition and BTE IBD Care Recognition. BTE recognition enables health-care providers to report quality performance to multiple payors through a single program, and gain rewards such as recognition and incentive payments. Applicants who achieve recognition receive a certificate and the right to advertise as a BTE-recognized provider. BTE recognition lasts for one year. BTE Hepatitis C Care Recognition was designed in collaboration with IDSA and AASLD.

Participants can also use the DHRP to collect and report quality measures data for the CMS Physician Quality Reporting System (PQRS) in order to avoid penalties. Starting in 2013, Medicare Part B providers will be penalized for non-participation in the CMS’ PQRS. 

Data that is collected as part of DHRP can also be used to meet quality measurement requirements for ABIM’s Practice Improvement Modules (PIMs). The program allows you to easily capture the pre- and post-intervention data necessary to complete your PIM for either HCV or IBD, all using the same data, measures and process through BTE and PQRS.

Eligible applicants include individual MDs, DOs, nurse practitioners and physician assistants who have treated at least 25 hepatitis C or IBD patients within the previous year. Eligible PQRS applicants must report on at least 11 unique Medicare Part B FFS patients billed to CMS.

AGA members pay only $300 per disease state. Non-AGA members are welcome to participate for a fee of $550. IDSA and AASLD members can participate in DHRP for hepatitis C for $300 as well.                                                                         source AGA 

FDA reviews 2 promising new drugs for hepatitis C

October 22, 2013 1:24 pm  •  By MATTHEW PERRONE

(0) Comments

Doctors may soon have two new drug options for patients with hepatitis C, just as the liver-destroying virus becomes a major public health concern for millions of baby boomers.

The Food and Drug Administration holds a public meeting this week to review two experimental medications from Johnson & Johnson and Gilead Sciences. The new drugs, if approved, could offer a quicker, more effective approach to eliminating hepatitis C, a blood-borne disease blamed for 15,000 deaths in the U.S. this year.

In a review posted online Tuesday, the FDA reported that J&J's drug simeprevir has a slightly higher cure rate than currently available treatments, though it also caused rashes and sunburn in some patients.

On Thursday the FDA will ask a panel of outside experts whether the drug should carry warnings about rashes and sunburn on its label. The agency is not required to follow the panel's advice, though it often does.

The meeting comes at a time when federal health officials are urging baby boomers to get tested for the virus, which can go unnoticed for decades before causing symptoms.

Between 3 million and 4 million Americans are infected with hepatitis C, and people born between 1945 and 1965 are five times more likely to have it than people of other age groups, according to the Centers for Disease Control and Prevention.

Many baby boomers contracted the virus by sharing needles or having sex with an infected person in their youth. The disease was also spread by blood transfusions before 1992, when blood banks began testing for the virus.

"If something is not done soon, all these people who were infected in the 60s and 70s are going to start experiencing the long-term consequences of liver disease," said Gaston Picchio, head of hepatitis drug development for J&J's Janssen Therapeutics unit.

Most people with hepatitis C do not even know they have the virus until after liver damage has occurred, causing abdominal pain, fatigue, itching and dark urine.

For most of the last 20 years, the standard treatment involved a grueling one-year regimen of pills and injections that caused flu-like symptoms and cured less than half of patients. Many patients failed to complete the full treatment cycle. Others delayed starting treatment at all in the hopes that more effective treatments would come along.

Two drugs approved in 2011 kicked off a new effort to treat the disease. Research shows that adding the two new drugs _ Vertex Pharmaceuticals' Incivek and Merck & Co.'s Victrelis _ to the older drug cocktail can boost cure rates to between 65 and 75 percent.

And the drugs the FDA is reviewing this week have the potential to push cure rates even higher.

J&J's simeprevir cured 80 percent of patients who had not previously been treated for the disease, according to the FDA's review. Additionally, the vast majority of patients were able to cut their treatment time in half to 24 weeks, compared with the usual 52 weeks. The New Brunswick, N.J., company is seeking approval to combine the daily pill with the older treatment regimen for patients with the most common form of the virus. J&J developed the drug with Swedish drugmaker Medivir.

On Friday, the same FDA panel will review another hepatitis C drug from Gilead Sciences Inc. that some analysts say will become the first-choice for treating the disease. The pill, known as sofosbuvir, has been shown to cure up to 90 percent of patients after just 12 weeks of therapy, according to one company study. Additionally, analysts believe the drug will eventually be used without interferon, the injectable medication used in the current drug cocktail that causes nausea, diarrhea and other unpleasant side effects.

Gilead is racing against other drugmakers to develop the first all-pill approach to treating hepatitis C, long viewed as the holy grail by drugmakers. Similar efforts are underway from Abbott Laboratories, Bristol-Myers Squibb Co., Vertex Pharmaceuticals and others.

Pharmaceutical industry consulting firm Decision Resources estimates the market for hepatitis C drugs will grow to more than $23 billion by 2018. Sales of the drugs are expected to decline to $17.5 billion by 2021 as more patients are cured of the virus.                                                                                            Source The Journal Times

FDA Reviews 2 Promising New Drugs for Hepatitis C

Hepatitis C

WASHINGTON October 22, 2013 (AP)

By MATTHEW PERRONE AP Health Writer

Doctors may soon have two new drug options for patients with hepatitis C, just as the liver-destroying virus becomes a major public health concern for millions of baby boomers.

The Food and Drug Administration holds a public meeting this week to review two experimental medications from Johnson & Johnson and Gilead Sciences. The new drugs, if approved, could offer a quicker, more effective approach to eliminating hepatitis C, a blood-borne disease blamed for 15,000 deaths in the U.S. this year.

In a review posted online Tuesday, the FDA reported that J&J's drug simeprevir has a slightly higher cure rate than currently available treatments, though it also caused rashes and sunburn in some patients.

On Thursday the FDA will ask a panel of outside experts whether the drug should carry warnings about rashes and sunburn on its label. The agency is not required to follow the panel's advice, though it often does.

The meeting comes at a time when federal health officials are urging baby boomers to get tested for the virus, which can go unnoticed for decades before causing symptoms.

Between 3 million and 4 million Americans are infected with hepatitis C, and people born between 1945 and 1965 are five times more likely to have it than people of other age groups, according to the Centers for Disease Control and Prevention.

Many baby boomers contracted the virus by sharing needles or having sex with an infected person in their youth. The disease was also spread by blood transfusions before 1992, when blood banks began testing for the virus.

"If something is not done soon, all these people who were infected in the 60s and 70s are going to start experiencing the long-term consequences of liver disease," said Gaston Picchio, head of hepatitis drug development for J&J's Janssen Therapeutics unit.

Most people with hepatitis C do not even know they have the virus until after liver damage has occurred, causing abdominal pain, fatigue, itching and dark urine.

For most of the last 20 years, the standard treatment involved a grueling one-year regimen of pills and injections that caused flu-like symptoms and cured less than half of patients. Many patients failed to complete the full treatment cycle. Others delayed starting treatment at all in the hopes that more effective treatments would come along.

Two drugs approved in 2011 kicked off a new effort to treat the disease. Research shows that adding the two new drugs — Vertex Pharmaceuticals' Incivek and Merck & Co.'s Victrelis — to the older drug cocktail can boost cure rates to between 65 and 75 percent.

And the drugs the FDA is reviewing this week have the potential to push cure rates even higher.

J&J's simeprevir cured 80 percent of patients who had not previously been treated for the disease, according to the FDA's review. Additionally, the vast majority of patients were able to cut their treatment time in half to 24 weeks, compared with the usual 52 weeks. The New Brunswick, N.J., company is seeking approval to combine the daily pill with the older treatment regimen for patients with the most common form of the virus. J&J developed the drug with Swedish drugmaker Medivir.    

On Friday, the same FDA panel will review another hepatitis C drug from Gilead Sciences Inc. that some analysts say will become the first-choice for treating the disease. The pill, known as sofosbuvir, has been shown to cure up to 90 percent of patients after just 12 weeks of therapy, according to one company study. Additionally, analysts believe the drug will eventually be used without interferon, the injectable medication used in the current drug cocktail that causes nausea, diarrhea and other unpleasant side effects.

Gilead is racing against other drugmakers to develop the first all-pill approach to treating hepatitis C, long viewed as the holy grail by drugmakers. Similar efforts are underway from Abbott Laboratories, Bristol-Myers Squibb Co., Vertex Pharmaceuticals and others.

Pharmaceutical industry consulting firm Decision Resources estimates the market for hepatitis C drugs will grow to more than $23 billion by 2018. Sales of the drugs are expected to decline to $17.5 billion by 2021 as more patients are cured of the virus.

Source                                                                                                                                                     ABC News

Hepatitis A

Viral hepatitis; Infectious hepatitis

Last reviewed: October 16, 2011.

Hepatitis A is inflammation (irritation and swelling) of the liver from the hepatitis A virus.

Causes, incidence, and risk factors

The hepatitis A virus is found mostly in the stools and blood of an infected person about 15 - 45 days before symptoms occur and during the first week of illness.

You can catch hepatitis A if:

• You eat or drink food or water that has been contaminated by stools (feces) containing the hepatitis A virus (fruits, vegetables, shellfish, ice, and water are common sources of the hepatitis A virus)
• You come in contact with the stool or blood of a person who currently has the disease
• A person with hepatitis A does not wash his or her hands properly after going to the bathroom and touches other objects or food
• You participate in sexual practices that involve oral-anal contact

About 3,600 cases of hepatitis A are reported each year. Because not everyone has symptoms with hepatitis A infection, many more people are infected than are diagnosed or reported.

Risk factors include:

• International travel, especially to Asia or South or Central America
• IV drug use
• Living in a nursing home or rehabilitation center
• Working in a health care, food, or sewage industry

Other common hepatitis virus infections include hepatitis B and hepatitis C. Hepatitis A is the least serious and mildest of these diseases. The other hepatitis infections may become chronic illnesses, but hepatitis A does not become chronic.

Symptoms

Symptoms will usually show up 2 - 6 weeks after being exposed to the hepatitis A virus. They are usually mild, but may last for up to several months, especially in adults.

Symptoms include:

• Dark urine
• Fatigue
• Itching
• Loss of appetite
• Low-grade fever
• Nausea and vomiting
• Pale or clay-colored stools
• Yellow skin (jaundice)

Signs and tests

The doctor will perform a physical examination and may discover that you have an enlarged and tender liver.

Blood tests may show:

• Raised IgM and IgG antibodies to hepatitis A (IgM is usually positive before IgG)
• Elevated liver enzymes (liver function tests), especially transaminase enzyme levels

Treatment

There is no specific treatment for hepatitis A. Rest is recommended when the symptoms are most severe. People with acute hepatitis should avoid alcohol and any substances that are toxic to the liver, including acetaminophen (Tylenol).

Fatty foods may cause vomiting, because substances from the liver are needed to digest fats. Fatty foods are best avoided during the acute phase.

Expectations (prognosis)

The virus does not remain in the body after the infection has gone away.

Over 85% of people with hepatitis A recover within 3 months. Nearly all patients get better within 6 months.

There is a low risk of death, usually among the elderly and persons with chronic liver disease.

Complications

There are usually no complications. One in a thousand cases becomes fulminant hepatitis, which can be life threatening.

Calling your health care provider

Call for an appointment with your health care provider if you have symptoms of hepatitis.

Prevention

The following tips can help reduce your risk of spreading or catching the virus:

• Always wash your hands thoroughly after using the restroom and when you come in contact with an infected person's blood, stools, or other bodily fluid.
• Avoid unclean food and water.

The virus may spread more rapidly through day care centers and other places where people are in close contact. Thorough hand washing before and after each diaper change, before serving food, and after using the restroom may help prevent such outbreaks.

If you have recently been exposed to hepatitis A and have not had hepatitis A before or have not received the hepatitis A vaccine series, ask your doctor or nurse about receiving either immune globulin or the hepatitis A vaccine. Common reasons why you may need to receive one or both of these include:

• You live with someone who has hepatitis A
• You recently had sexual contact with someone who has hepatitis A
• You recently shared illegal drugs, either injected or noninjected, with someone who has hepatitis A
• You have had close personal contact over a period of time with someone who has hepatitis A
• You have eaten in a restaurant where food or food handlers were found to be infected or contaminated with hepatitis A

Vaccines that protect against hepatitis A infection are available. The vaccine begins to protect 4 weeks after receiving the first dose. The 6- to 12-month booster is required for long-term protection.

Travelers should take the following precautions:

• Avoid dairy products.
• Avoid raw or undercooked meat and fish.
• Beware of sliced fruit that may have been washed in contaminated water. Travelers should peel all fresh fruits and vegetables themselves.
• Do not buy food from street vendors.
• Get vaccinated against hepatitis A (and possibly hepatitis B) if traveling to countries where outbreaks of the disease occur.
• Use only carbonated bottled water for brushing teeth and drinking. (Remember that ice cubes can carry infection.)
• If no water is available, boiling water is the best method for eliminating hepatitis A. Bringing the water to a full boil for at least 1 minute generally makes it safe to drink.
• Heated food should be hot to the touch and eaten right away.

References

1. Advisory Committee for Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). Recommended immunization schedules for children, adolescents, and adults -- United States, 2010 (accessed November 9, 2010).
2. Advisory Committee for Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC) Update: Prevention of hepatitis A after exposure to hepatitis A virus and in international travelers. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2007;56:1080-1084. [PubMed]
3. Hoofnagle JH. Acute viral hepatitis. In: Goldman L, Ausiello D, eds. Cecil Medicine. 23rd ed. Philadelphia, Pa: Saunders Elsevier;2007:chap 151.
4. Sjogren MH, Cheatham JG. Hepatitis A. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver Disease. 9th ed. Philadelphia, Pa: Saunders Elsevier; 2010:chap 77.
5. Victor JC, Monto AS, Surdina TY, Suleimenova SZ, Vaughan G, Nainan OV, Favorov MO, Margolis HS, Bell BP. Hepatitis A vaccine versus immune globulin for postexposure prophylaxis. N Engl J Med. 2007;357:1685-1694. [PubMed]

Review Date: 10/16/2011.

Reviewed by: David Zieve, MD, MHA, Medical Director, A.D.A.M., Inc. and George F. Longstreth, MD, Department of Gastroenterology, Kaiser Permanente Medical Care Program, San Diego, California.

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Copyright © 2013, A.D.A.M., Inc.

What is the difference between Hepatitis A, B and C?

Question: Can you explain the difference between Hepatitis A, B and C (and other letters)? If I get a vaccination for hepatitis, which am I protected from?

Answer: “Hepatitis” means inflammation of the liver. It can have many causes, including viruses, medications and alcohol. Most commonly, however, we think of the viruses, called A, B and C.

Hepatitis A causes an acute hepatitis that almost always gets better on its own. It is easily spread from person to person, in food and water, and can infect many people at once. Hepatitis B can be both acute (short-term illness) and chronic (ongoing illness), and is spread through blood or other body fluids in various ways. Hepatitis C is almost always chronic and spreads only by blood. Hepatitis A and B can be prevented by vaccination, but not Hepatitis C. There are now many good medications available to treat chronic Hepatitis B and C.

The symptoms of acute hepatitis include yellowing of the skin and eyes, nausea, fever and fatigue. Chronic hepatitis may have no symptoms, and can last many years and lead to cirrhosis of the liver, which means the liver becomes heavily scarred and less functional. Cirrhosis can sometimes lead to cancer of the liver or liver failure, both of which may require a liver transplant.

Prevention is very important. Other than vaccination, people should be very careful about hygiene (such as hand-washing after using the restroom) to prevent Hepatitis A. Hepatitis B and C can be transmitted by sex or sharing needles, razors, or toothbrushes with someone who has the disease. In the U.S., there are about 4 million people with Hepatitis C, and 2 million with Hepatitis B. All three forms of viral hepatitis are very common around the world.

 Source                                                                                                                                                                                                       Richard Manch, MD, is the medical director of the Banner Good Samaritan Liver Disease Center in Phoenix, Ariz.