Study results promising for hepatitis C patients awaiting or completing liver transplant

Study results promising for hepatitis C patients awaiting or completing liver transplant

AN ANTONIO (April 30 2015) -- A number of new, highly effective oral treatments for various types of hepatitis C have been approved in the past few years. However, two groups who have not benefitted from the new treatments are patients with hepatitis C who have advanced liver disease and patients who have received a liver transplant but the advanced liver disease has returned because of hepatitis C.

"The problem for these patients is that unless the hepatitis C is cured, the virus continues circulating in their blood infecting the new liver, usually within a few months of transplant. One-third of them have cirrhosis again within five years," explained Fred Poordad, M.D., clinical professor of medicine and chief of hepatology at The University of Texas Health Science Center at San Antonio.

"This puts these patients back at high risk of dying from chronic hepatitis C or liver disease," said Dr. Poordad, principal investigator of the ALLY-1 study, who presented the results April 25 at The International Liver CongressTM of the European Association for the Study of the Liver (EASL) in Vienna, Austria.

The Phase III clinical trial evaluated a 12-week course of daclatasvir - the new drug being evaluated - combined with sofosbuvir and ribavirin for patients with chronic hepatitis C. Patients accepted into the trial either had a liver transplant with returning hepatitis C or had hepatitis C with advanced cirrhosis (scarring of the liver).

Study results showed an overall cure rate of 94 percent for patients with a liver transplant and returning hepatitis C, and 83 percent for patients with advanced cirrhosis.

The study's primary endpoints also were reached, with 95 percent of post-transplant genotype 1 patients and 82 percent of genotype 1 patients with advanced cirrhosis being cured 12 weeks after treatment. Patients with other genotypes of the disease were enrolled as well, with benefits seen in all groups.

Genotypes are subgroups or strains of a disease, such as hepatitis C. There are many subtypes of hepatitis C based on the geographic regions where the strain is most prevalent. Over time, each strain evolved differently so that treatments are based on the genotype of the disease. For example, genotype 1 is the type of hepatitis C most common in the United States and is the most difficult to treat.

The study regimen was well tolerated and showed few serious side effects. "Transplant patients take a variety of medications to prevent organ rejection that can complicate the treatment of hepatitis C. In ALLY-1, we saw no drug-to-drug interactions between transplant and hepatitis C therapies and no need to make close adjustments to patients' transplant-related drugs while they received the hepatitis C regimen," Dr. Poordad said.

The ALLY-1 study was conducted at five major transplant centers in San Antonio and Houston, Texas; Miami, Fla.; Ann Arbor, Mich., and Seattle, Wash.

Hepatitis C is a liver disease found worldwide that is spread though contact with blood or semen, such as shared drug injection needles, inadequate sterilization of medical equipment, unscreened blood and blood products, accidental needle sticks in the health profession, and sexual intercourse with a person who has hepatitis C. The disease also can be passed from mothers to their children through the birthing process.

According to the U.S. Centers for Disease Control and Prevention, 3.2 million people in the U.S. have chronic hepatitis C, and 70 to 80 percent do not have symptoms. Nonetheless, it is a serious disease that can lead to long-term health problems such as liver damage, liver failure, liver cancer and death. It is often discovered later, after significant liver damage has occurred.

In the U.S., people born between 1945 and 1965 have the highest risk of hepatitis C due to higher drug use. People in this age group are urged to have a one-time blood test for hepatitis C to detect the virus and begin receiving treatment, if necessary, before significant liver damage occurs. There is no vaccine to prevent hepatitis C.

Daclatasvir, a drug developed by Bristol-Myers Squibb, was approved in Europe in 2014 for use with other medications for genotypes 1 through 4 for the treatment of chronic hepatitis C in adults. It is also approved in Japan as well as many countries in Central and South America, the Middle East and Asia Pacific. Daclatasvir regimens also have been included in the EASL's recommendations for the treatment of hepatitis C in Europe.

The U.S. Food and Drug Administration is reviewing daclatasvir for possible approval in the United States.

###

For current news from the UT Health Science Center San Antonio, please visit our news release website, like us on Facebook or follow us on Twitter.

The University of Texas Health Science Center at San Antonio, one of the country's leading health sciences universities, ranks in the top 13 percent of academic institutions receiving National Institutes of Health (NIH) funding. The university's schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have produced more than 29,000 graduates. The $787.7 million operating budget supports eight campuses in San Antonio, Laredo, Harlingen and Edinburg. For more information on the many ways "We make lives better®," visit http://www.uthscsa.edu.

Bristol hep C drug helps cure 97 pct of HIV coinfected patients-study

Bristol hep C drug helps cure 97 pct of HIV coinfected patients-study

BY BILL BERKROT

Fri Feb 27, 2015 1:45am IST
Feb 26 (Reuters) - Ninety-seven percent of hepatitis C patients also infected with HIV were cured of the liver-destroying virus after 12 weeks of treatment with Bristol-Myers Squibb's daclatasvir and Gilead Sciences' Sovaldi, according to data from a study presented on Thursday.

The results could help put Bristol's hepatitis C program back on track in the United States, following a setback last year.

In the Ally-2 study, including new patients and those not helped by prior treatment, 149 of 153 were deemed cured of hepatitis C regardless of what other anti-viral regimens they were on for HIV, the virus that causes AIDS.

"The results of Ally-2 signaled that nearly all HIV-HCV coinfected patients in the study could be cured of hepatitis C with a 12-week regimen on daclatasvir and sofosbuvir," Dr. David Wyles, the study's lead investigator, said in a statement, using the chemical name for Sovaldi.

There were no reported serious side effects related to the hepatitis drugs, and patients did not require any alteration of HIV medications over potential drug-drug interactions.

"This is a paramount consideration for clinicians treating this patient population," added Wyles, who presented the data at the Conference on Retroviruses and Opportunistic Infections (CROI) meeting in Seattle.

About 300,000 Americans with HIV also suffer from hepatitis C, according to the Centers for Disease Control and Prevention, making them prone to more rapid progression to liver damage.

Daclatasvir is approved in Europe, Brazil and Japan as part of combination therapy, but has fallen behind rivals in the world's most lucrative market. In November, the U.S. Food and Drug Administration declined to approve daclatasvir in combination with other antiviral drugs.

The company had sought FDA permission to market daclatasvir in combination with another Bristol drug, asunaprevir. But Bristol abandoned its U.S. marketing application for asunaprevir due to potential competition from more potent drugs, leaving the FDA without data to gauge the effectiveness of daclatasvir as part of a combination regimen.

The FDA asked for new data on daclatasvir with other drugs, which the Ally results could help satisfy.

Sovaldi is part of Gilead's market-leading hepatitis C franchise and half of its own one-pill-per-day combination treatment Harvoni.

All 26 patients in the Ally-2 study with the less common genotypes 2, 3 and 4 of the virus were cured by the combination. A shorter eight-week regimen tested among 50 patients led to a 75 percent cure rate. (Reporting by Bill Berkrot; Editing by James Dalgleish)

Reuters

AASLD- BMS Daclatasvir+sofosbuvir achieves SVR12 in 90% of treatment-naïve/ 86% of treatment-experienced geno 3 patients

Daclatasvir+sofosbuvir regimen achieves SVR12 in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 patients

ALLY-3 is the first Phase 3 study of an all-oral, ribavirin-free treatment regimen for genotype 3 HCV patients with a 12-week treatment duration

Genotype 3 is the second most common genotype worldwide and has emerged as one of the most difficult to treat

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY) today announced late-breaking data from the landmark ALLY Trial investigating a ribavirin-free 12-week regimen of daclatasvir (DCV) in combination with sofosbuvir (SOF) in genotype 3 hepatitis C (HCV) patients, a patient population that has emerged as one of the most difficult to treat. The results of the study, which showed sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced patients, will be presented at The Liver Meeting® 2014, the Annual Meeting of The American Association for the Study of Liver Diseases (AASLD), in Boston, MA, November 7 – 11.

“Both treatment naïve and treatment experienced patients in the ALLY-3 study achieved high SVR rates. These results are encouraging given that patients with genotype 3 have emerged as among the hardest to treat,” said David R. Nelson, M.D., Professor of Medicine, Molecular Genetics and Microbiology Director, UF Clinical and Translational Science Institute, and Assistant Vice President of Research for the University of Florida. “Genotype 3 is associated with a more rapid progression of disease and remains a challenge to the efficacy of even newer regimens. The ALLY-3 results demonstrate the possibility of bringing a cure to genotype 3 patients in an all-oral, 12-week regimen.”

These results build upon the existing body of data on the daclatasvir and sofosbuvir combination. Data from an open-label, randomized study of daclatasvir with sofosbuvir in genotypes 1, 2, and 3 demonstrated that the 24-week regimen of daclatasvir and sofosbuvir (± ribavirin) achieved SVR12 in 89% of patients with genotype 3. The ALLY study presented at The Liver Meeting investigates the regimen for 12 weeks, halving the previous treatment duration. Other ongoing ALLY studies examine diverse HCV populations across all genotypes: cirrhotic and post-liver transplant patients, as well as treatment-naïve and treatment-experienced patients who are co-infected with HIV.

“HCV is a complex disease, and the treatment community needs multiple options to address the remaining unmet medical needs,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “Daclatasvir has shown pan-genotypic activity in bench research, a factor which is becoming increasingly important as we learn more about the complexity of HCV. Further, daclatasvir’s potential to be combined with many other agents, including sofosbuvir, is significant in continuing to develop additional treatment options that may help patients of all genotypes achieve cure.”

In the ALLY-3 study, the daclatasvir and sofosbuvir combination regimen was well tolerated, with no deaths, treatment-related serious adverse events, or discontinuations due to adverse events. The most frequent side effects (≥5%) were headache (19.7%), fatigue (19.1%), nausea (11.8%), diarrhea (8.6%), insomnia (5.9%), abdominal pain and arthralgia (both 5.3%). Additionally, there were 17 (11.2%) treatment failures, with 16 relapses post-treatment and 1 rebound at the end of treatment. There were no viral breakthroughs in this ribavirin-free regimen.

About ALLY-3: Study Design

This Phase 3 open-label clinical trial enrolled 152 genotype 3 HCV patients; 101 treatment-naïve patients and 51 treatment-experienced patients in 2 cohorts each received daclatasvir 60 mg and sofosbuvir 400 mg once daily for 12 weeks, with 24 weeks of follow-up. The primary endpoint was SVR12 rates, defined as HCV RNA < LLOQ target detected or not detected at follow-up week 12 in treatment-naïve and treatment-experienced patients.

The full abstract for the presentation is available at The Liver Meeting website.

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Approximately 170 million people worldwide are infected with hepatitis C, with an estimated 2.7–3.9 million chronically infected in the United States. 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, up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of those, up to 20 percent may progress to liver cancer.

About Genotype 3

Genotype 3 is estimated to affect 54.3 million people and is the second most common worldwide behind genotype 1 (83.4 million). It is now potentially the most difficult-to-treat genotype, and the more aggressive nature of genotype 3 lies in the damage it causes to the liver, as it is associated with progressive disease, increased rates of steatosis and a disproportionately increased risk of hepatocellular carcinoma.

About Bristol-Myers Squibb’s HCV Portfolio

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

Daklinza (daclatasvir) was recently approved in the EU for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. Daklinza is also approved in Japan in combination with Sunvepra (asunaprevir), a NS3/4A protease inhibitor. The Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis.

In 2013, Bristol-Myers Squibb’s investigational all-oral DCV-TRIO regimen (daclatasvir/asunaprevir/beclabuvir) received Breakthrough Therapy Designation in the U.S., which helped to expedite the start of the ongoing Phase 3 UNITY program. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. In addition to UNITY 1 and 2, both the UNITY-3 study among Japanese treatment-naïve and -experienced genotype 1 patients and UNITY-4, which studies the DCV-TRIO regimen without ribavirin in cirrhotic and non-cirrhotic patients in Korea, Russia and Taiwan, are currently ongoing. The DCV-TRIO regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.

About Bristol-Myers Squibb

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

Bristol-Myers Squibb Forward Looking Statement

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

Daclatasvir plus Sofosbuvir for HCV infection: An oral combination therapy with high antiviral efficacy

Accepted Manuscript

Journal of Hepatology (2014)

Daclatasvir plus Sofosbuvir for HCV infection: An oral combination therapy with high antiviral efficacy

Tarik Asselah

DOI: http://dx.doi.org/10.1016/j.jhep.2014.04.042

Publication stage: In Press Accepted Manuscript

Abstract 

Download PDF

This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

COMMENTARY ON:
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.

Sulkowski MS, Gardiner DF, Rodriguez-Tor res M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestro sa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rot olo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM; AI444040 Study Group. N Engl J Med. 201 4 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218.

Copyright © (2014) Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society. http://www.ncbi.nlm.nih.gov/pubmed/24428467

Abstract:
BACKGROUND: All-oral combination therapy is desirable for patients with chronic hepatitis C virus (HCV) infection. We evaluated daclatasvir (an HCV NS5A replication complex inhibitor) plus sofosbuvir (a nucleotide analogue HCV NS5B polymerase inhibitor) in patients infected with HCV genotype 1, 2, or 3.

METHODS: In this open-label study, we initially randomly assigned 44 previously untreated patients with HCV genotype 1 infection and 44 patients infected with HCV genotype 2 or 3 to daclatasvir at a dose of 60 mg orally once daily plus sofosbuvir at a dose of 400 mg orally once daily, with or without ribavirin, for 24 weeks.

The study was expanded to include 123 additional patients with genotype 1 infection who were randomly assigned to daclatasvir plus sofosbuvir, with or without ribavirin, for 12 weeks (82 previously untreated patients) or 24 weeks (41 patients who had previous virologic failure with telaprevir or boceprevir plus peginterferon alfa-ribavirin).

The primary end point was a sustained virologic response (an HCV RNA level of <25 IU per milliliter) at week 12 after the end of therapy.

RESULTS: Overall, 211 patients received treatment. Among patients with genotype 1 infection, 98% of 126 previously untreated patients and 98% of 41 patients who did not have a sustained virologic response with HCV protease inhibitors had a sustained virologic response at week 12 after the e nd of therapy. A total of 92% of 26 patients with genotype 2 infection and 89% of 18 patients with genotype 3 infection had a sustained virologic response at wee k 12. High rates of sustained virologic response at week 12 were observed among patients with HCV subtypes 1a and 1b (98% and 100%, respectively) and those with CC and non-CC IL28B genotypes (93% and 98%, respectively), as well as a mong patients who received ribavirin and those who did not (94% and 98%, respectively). The most common adverse events were fatigue, headache, and nausea.

CONCLUSIONS: Once-daily oral daclatasvir plus sofosbuvir was associated with high rates of sustained virologic response among pa tients infected with HCV genotype 1, 2, or 3, including patients with no res ponse to prior therapy with telaprevir or boceprevir.

(Funded by Bristol-Myers Squibb and Pharmasset (Gilead); A1444040 ClinicalTrials.gov number, NCT01359644.).

Introduction 
There have been major advancements in these last years with large numbers of trials with various direct-acting antivirals (DAAs) oral regimen showing increased SVR rates, favorable tolerability, and shortened treatment duration [1-5]. These DAAs target multiple viral sites: NS3/4a protease inhibitors, NS5B polymerase inhibitors, and NS5A inhibitors. HCV regimens in Phase II or III, or already approved in 2014 are listed in Table 1.

This paper will comment on the recently published phase IIb trial with daclatasvir plus sofosbuvirfor HCV Infection, reporting spectacular results [3].

Daclatasvir
Daclatasvir is a first-in-class HCV NS5A replication complex inhibitor [6]. Daclatasvir is active at picomolar concentrations in vitro in HCV replicons expressing a broad range of HCV genotypes and acts in an additive to s ynergistic fashion with interferon (IFN) and other DAAs. The resistance profile of daclatasvir reveals inhibitor sensitivity maps to the N terminus of domain 1 of N S5A. NS5A inhibitors could block hyperphosphorylation of NS5A, which is believed to play an essential role in the viral replication cycle.

Sofosbuvir
Sofosbuvir is a nucleotide analogue HCV NS5B polyme rase inhibitor [7]. Polymerase inhibitors interfere with viral replication by binding to the NS5B RNA-dependent RNA polymerase. Nucleoside inhibitors (NI) mimic the natural substrates of the polymerase and are incorporated into the RNA chain causing direct chain termination. NI require conversion to an active tri phosphate form. As the active site of NS5B is highly conserved, NI have generally a pan-genotypic efficacy. However, single amino acid substitutions in every position o f the active site may result in loss of function of NI, but resistance to NI is typicall y very low as HCV has reduced fitness.

Daclatasvir plus Sofosbuvir study design and result s In this open-label study, 44 HCV genotype 1 (G1) na ïve patients and 44 HCV-G2 or G3 patients were initially randomly assigned to dac latasvir (60 mg QD) plus sofosbuvir (400 mg QD), with or without ribavirin ( RBV), for 24 weeks [3] .

The study was expanded to include 123 additional HCV-G1 patients who were randomly assigned to daclatasvir plus sofosbuvir, with or without RBV, for 12 weeks (82 naïve patients) or 24 weeks (41 with previous failure wit h telaprevir or boceprevir plus PEG-IFN–RBV)(Fig. 1A).

Patients with cirrhosis were excluded. Overall, 211 patients received treatment. Among HCV -G1 infected patients, 98% of 126 naïve patients and 98% of 41 patients who failed with protease inhibitors had an SVR at week 12 after the end of therapy (SVR12)(Fig. 1B).

A total of 92% of 26 patients with HCV-G2 and 89% of 18 patients with HCV-G3 had a SVR12.

All patients had an HCV RNA level of less than 25 IU/ml by week 4. We have to be cautious regarding the results report ed for HCV genotype 3, the SVR rate was of 89% after 24 weeks of daclatasvir plus sofosbuvir. This SVR appears to be similar to SVR obtained with sofosbuvir plus ribavirin given during 24 weeks in genotype 3 non-cirrhotic patients [8].

A highly efficient regimen, even in “difficult to cure” patients Daclatasvir plus sofosbuvir was associated with high rates of SVR among patients with characteristics that were previously known to be associated with a poor response [9]. Impressively, this regimen was highly efficient in “difficult to cure” patients. All patients in whom prior failure with protease inhibitors had an SVR.

Among these patients, 71% had virologic breakthrough or non-response, 80 were infected with subtype 1a, 98% had a non-CC IFNL3 genotype (previously IL28B ). Virologic breakthrough and relapse were rare and we re not observed in any of the 193 patients infected with HCV genotype 1 or 2, des pite pre-existing daclatasvir- resistant variants in 27 patients. Of the 5 patient s infected with HCV-G1 or G2 without SVR12 after treatment, 3 had missing data at week 12 but had a SVR24 (including 1 who returned after the database lock) and 2 were lost to follow-up.

Among the 18 patients with HCV-G3 infection, virologic relapse occurred in 1 of 5 patients with a pre-existing daclatasvir resistant variant, and in a second patient, who did not have pre-existing daclatasvir-resistant variants, an HCV RNA level below 25 IU/ml was detected at weeks 8 and 10. Because of low virus levels during treatment and an SVR12, the role of viral variants could not be assessed.

Sofosbuvir-resistant variants were not detected in any of the patients. Ribavirin does not appear to be useful for this DAA s combination In this study, response rates were similar among patients treated with or without Ribavirin (RBV).

These findings may reflect the antiviral potency and high resistance barrier of the daclatasvir–sofosbuvir combination a nd suggest that RBV is not required with every oral DAA regimen. Of course, RBV is associated with anemia, and is teratogenic, and therefore RBV-sparing regimen are desirable. However, we cannot exclude, that in cost-effectiveness strategies, RBV may have a role.

Take home messages and perspectives

Finally, once-daily, oral treatment with daclatasvir plus sofosbuvir was associated with high SVR rates in HCV-G1, 2 or 3 naïve patients and in HCV-G1 patients with previous failure to protease inhibitors.

The development of resistance appears uncommon with daclatasvir plus sofosbuvir. Also, in the same issue of the NEJM, a phase IIb study with a 12-week DAAs combinations of ombitasvir (previously ABT-450/r, protease inhibitor), dasabuvir (previously ABT-267, NS5A inhibitor), ABT-333 (non- nucleoside polymerase inhibitor), and RBV were associated with high rates of SVR among HCV-G1 naïve patients and among patients with failure to prior PEG-IFN-RBV therapy [3].

This ombitasvir based oral regimen has shown excellent results in phase III [10-12]. The fixed dose combination of sofosbuvir and ledipasvir (NS5A inhibitor) has also demonstrated excellent results in phase III [13-15] .

Furthermore, the Cosmos study - evaluating simeprevir (protease inhibitor) plus sofosbuvir with or without RBV in GT1-naive subject s and prior null-responders - reported also impressive results [16-17].

It is a Phase 2a, randomized, open-label study that evaluated 2 cohorts of patients. Cohort 1 (n = 80) randomized prior null- responders with Metavir scores F0-F2 and cohort 2 ( n = 87) evaluated prior null- responder and naïve G1 individuals with F3-F4 scores.

Data from cohort 1 demonstrated that 93% and 96% of patients with Metavir F0-F2 scores treated with simeprevir and sofosbuvir with or without ribavirin, respectively, for 12 weeks achieved SVR12. In cohort 2, 93% of participants assigned to simeprevir/sofosbuvir either alone or with ribavirin for 12 weeks achieved SVR12; among t hose treated for 24 weeks, SVR12 rates were 93% and 100%, respectively. In genotype 1a patients with the Q80K polymorphism at baseline, 89% and 83% achieved SVR after 12 weeks of treatment with and without ribavirin, respectively.

The most common adverse events in both treatment arms were fatigue, headache, nausea, and insomnia. Two patients discontinued treatment due to adverse events.

We have to recall that several of these phase 2 studies have limitations: mainly the small number of patients limits an exact evaluation of efficacy and the possibility to detect adverse events. Also, patients with cirrhosis are excluded, and they might be less likely than those without cirrhosis to have a response, and also at higher risk of side effects.

Again, HCV-G4 patients are neglected, and we have to recall that they represent around 40 million worldwide, and account for the majority of new infection, with no access to therapy, or in the best cases peg -IFN plus RBV for 48 weeks with above 40% of SVR [18].

In conclusion, these fantastic data from different published trials encourage us to remain very optimistic. We do hope that the majority of HCV infected patients will become “easy-to-cure” and there will be more facilities to access to treatment.

Conflict of interest
Tarik Asselah is a speaker and investigator for BMS , Boehringer-Ingelheim, Janssen, Gilead, Roche, and MSD.

Download PDF 

View Slides and Data @ NATAP

Sofosbuvir and Daclatasvir Combination Therapy in a Liver Transplant Recipient With Severe Recurrent Cholestatic Hepatitis C - (11/25/13)
 
EASL/2012: Potent Viral Suppression With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) and GS-7977 (Nucleotide NS5B Inhibitor), +/- Ribavirin, in Treatment-Naive Patients With Chronic HCV GT1, 2, or 3 (100% SVR gt1, 91% gt2) - (04/19/12)
 
EASL: Sustained Virologic Response With Daclatasvir Plus Sofosbuvir ± Ribavirin (RBV) in Chronic HCV Genotype (GT) 1-Infected Patients Who Previously Failed Telaprevir (TVR) or Boceprevir (BOC) - (04/27/13)

ONGOING PHASE 3 STUDIES of daclatasvir+sofosbuvir:
Phase III HIV/HCV Co-Infection Daclatasvir (DCV)+ Sofosbuvir (SOF).......in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6)

 Phase III Daclatasvir + Sofosbuvir in Cirrhotic Subjects and Subjects Post-liver Transplant.......
A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Genotype 1-6 Chronic Hepatitis C Infection Subjects With Cirrhosis Who May Require Future Liver Transplant and Subjects Post-Liver Transplant......This trial is open to patients with cirrhosis due to chronic HCV, and to patients who have already received a liver transplant for chronic HCV. All subjects will be treated with Daclatasvir and Sofosbuvir for 12 weeks. Under certain conditions, the treatment duration may be extended for cirrhotic subjects. The study will test how well this combination of investigational drugs works to treat chronic HCV.

Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV

Gastroenterologists Would Prescribe Sovaldi/Daclatasvir plus Ribavirin to 60 Percent of Genotype-3 Patients

Gastroenterologists Would Prescribe Sovaldi plus Daclatasvir plus Ribavirin to 60 Percent of Their Genotype-3 Patients, According to Findings from Decision Resources Group

BURLINGTON, Mass., April 1, 2014 /PRNewswire/ -- Decision Resources Group finds that surveyed gastroenterologists in the United States and Europe agree that the percentage of hepatitis C virus (HCV) genotype-3 infected patients with cirrhosis of the liver achieving a sustained virologic response (SVR) is one of the attributes that most influences their prescribing decisions. Clinical data and interviewed experts indicate that interferon-free regimens containing Gilead's Sovaldi (sofosbuvir) and Bristol-Myers Squibb's NS5A inhibitor daclatasvir have convenience and efficacy advantages over currently available regimens for HCV genotype-3 infections. However, competition from other NS5A inhibitors, such as Gilead's GS-5816, may constrain uptake of daclatasvir.

Other key findings from the DecisionBase report entitled Hepatitis C Virus Genotype 3: What Untapped Opportunities Remain for Treatment of Genotype-3 Infections:

Payer receptivity to new HCV genotype-3 therapies: Almost half of surveyed U.S. managed care organization pharmacy directors would not reimburse a new HCV genotype-3 therapy offering a 6-week duration if priced at $100,000 per course, with a notable share citing price and insufficient clinical benefit as the reasons. This suggests that, assuming comparable efficacy, payers are unwilling to accept a premium for a shorter course of therapy.

The importance of cost in treatment decisions for HCV genotype-3 infections: Conjoint analysis of drug attributes influencing prescribing behavior revealed that surveyed gastroenterologists perceive the cost of treatment as important as SVR rate in treatment decisions for HCV genotype-3 infected patients. This suggests that the cost of sofosbuvir plus ribavirin is a key barrier to prescribing and that physicians and payers will favor a lower-cost alternative with comparable efficacy and safety.

Estimated prescribing of the sofosbuvir and daclatasvir combination: Surveyed U.S. gastroenterologists indicated that they would prescribe sofosbuvir and daclatasvir plus ribavirin to 60 percent of their HCV genotype-3 patients.

Comments from Decision Resources Group Analyst Seamus Levine-Wilkinson, Ph.D.:
"Gilead's interim phase two data for their pangenotypic interferon- and ribavirin-free combination of Sovaldi and the NS5A inhibitor GS-5816 indicates that up to 100 percent of genotype-3 infected patients achieved SVR4. If these impressive results are confirmed in planned phase three studies, likely including evaluation of a coformulated sofosbuvir and GS-5816 one-pill, once-daily regimen, then this combination will provide a highly effective, safe, pangenotypic, and convenient single-tablet regimen for HCV infections. In other words, this could be one pill to rule them all."

"Cost of HCV therapies is a serious concern among both payers and physicians. Given the high price for a 24-week course of Sovaldi, the new standard of care for HCV genotype-3 infections, it is likely that payers and physicians will be very skeptical of any new HCV genotype-3 therapy priced at a premium to Sovaldi. Conversely, a drug developer that is able to offer a lower-cost interferon- and ribavirin-free regimen for HCV genotype-3 that achieves high SVR rates, will be very well positioned to compete in this market segment."

About Decision Resources Group
Decision Resources Group offers best-in-class, high-value information and insights on critical issues within the healthcare industry. Clients rely on this analysis and data to make informed decisions. Find out more at www.DecisionResourcesGroup.com.

EASL - Bristol-Myers to Present Data for Daclatasvir in Multiple Investigational All-oral Combinations

Bristol-Myers Squibb to Present Data for Daclatasvir in Multiple Investigational All-oral Combinations across Hepatitis C Genotypes at The International Liver CongressTM

Daclatasvir data demonstrates potential to address high unmet needs, including cirrhotic and treatment-experienced patients, and those with genotypes 1, 2, 3 and 4

Breadth of viral hepatitis data underscores Company's commitment to advancing research of liver diseases

Dateline:

"The wealth of data we are sharing at the International Liver Congress continue the positive momentum for daclatasvir after the Marketing Authorization Application was validated for Accelerated Regulatory Review by the European Medicines Agency, highlighting the important potential role for daclatasvir-based regimens in Europe."

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 12 abstracts have been accepted for presentation at The International Liver CongressTM, the 49th annual meeting of the European Association for the Study of the Liver (EASL), in London, April 9 - 13.

Key presentations include:

Two sets of pivotal results from a global, Phase III study (HALLMARK DUAL) investigating the efficacy and safety of an all-oral, interferon- and ribavirin-free regimen of daclatasvir and asunaprevir, including data in cirrhotic and non-cirrhotic patients with HCV genotype 1b infection, will be presented as late-breakers.

Virologic response results from analyses investigating daclatasvir in combination with sofosbuvir across genotypes 1, 2 and 3.

Virologic response and safety data for the investigational all-oral 3DAA regimen (daclatasvir/asunaprevir/BMS-791325) in genotype 4 patients, as well as bioequivalence data for the daclatasvir 3DAA regimen, which is being studied as a fixed-dose-combination treatment with twice daily dosing.

"These results are encouraging and show the potential of daclatasvir across multiple treatment regimens, with the goal of helping patients achieve cure regardless of genotype, stage of disease or response to previous therapies," said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb.

"The wealth of data we are sharing at the International Liver Congress continue the positive momentum for daclatasvir after the Marketing Authorization Application was validated for Accelerated Regulatory Review by the European Medicines Agency, highlighting the important potential role for daclatasvir-based regimens in Europe."

Bristol-Myers Squibb is studying a broad portfolio of compounds in hopes of providing flexible treatment options to address the diverse unmet medical needs of a global HCV patient population. These investigational compounds include daclatasvir, an investigational NS5A replication complex inhibitor that has shown high antiviral potency and pan-genotypic activity across HCV genotypes in vitro; asunaprevir, an investigational NS3 protease inhibitor; BMS-791325, an investigational non-nucleoside inhibitor of the NS5B polymerase; and peginterferon lambda-1a (Lambda), an investigational type III interferon that has the potential to offer an alternative to alfa-interferon.

The complete list of Bristol-Myers Squibb data presentations is below. Abstracts can be accessed on the ILC/EASL website at http://www.ilc-congress.eu.
          
Title  Date/Time   
Hepatitis C: Direct-Acting Antiviral Data   

Oral Presentation (late-breaker) : All-oral dual therapy with daclatasvir and asunaprevir in patients with HCV genotype 1b infection: Phase 3 study results
April 12, 15:30 - 17:30   

Poster (late-breaker) : Efficacy and safety of daclatasvir in combination with asunaprevir (DCV+ASV) in cirrhotic and non-cirrhotic patients with HCV genotype 1b: Results of the HALLMARK DUAL study
April 10, 09:00 - April 12, 18:00   

Oral Presentation : Effect of baseline NS5A polymorphisms on virologic response to the all-oral combination of daclatasvir + sofosbuvir ± ribavirin in patients with chronic HCV infection
April 11, 16:00 - 18:00   

Poster : Effect of ribavirin on the safety profile of daclatasvir + sofosbuvir for patients with chronic HCV infection
April 12, 09:00 - 18:00   

Poster : All-oral therapy with daclatasvir in combination with asunaprevir and BMS-791325 for treatment-naive patients with chronic HCV genotype 4 infection
April 12, 09:00 - 18:00   

Poster : Daclatasvir, asunaprevir, and BMS-791325 in a fixed-dose combination: A phase 1 bioavailability study in healthy volunteers
April 12, 09:00 - 18:00   

Hepatitis B: Peginterferon Lambda-1a Data  

Poster : Peginterferon Lambda-1a pharmacokinetics in subjects with impaired renal function
April 12, 09:00 - 18:00   

Oral : Peginterferon Lambda for the treatment of chronic hepatitis B (CHB): A phase 2b comparison with peginterferon alfa in patients with HBeAg-positive disease
April 12, 15:30 - 17:30   

Hepatitis C: Global Health Economics and Outcomes Research (GHEOR)  

Oral Presentation : External validation of the risk-prediction model for hepatocellular carcinoma (HCC) from the REVEAL-HCV study using data from the U.S. Veterans Affairs (VA) health system
April 10, 16:00 - 18:00   

Poster : The impact of fibrosis on the risk of long-term morbidity and mortality in chronic hepatitis C patients treated in the veterans administration health care system
April 11, 09:00 - 18:00   

Poster : Early virologic responses and adverse events from the comparative assessment of effectiveness of antiviral therapies in hepatitis C study (CMPASS)
April 12, 09:00 - 18:00   

Poster : Determining the comparative effectiveness of emerging treatment regimens for hepatitis C virus (HCV) infection from single arm phase III trials
April 12, 09:00 - 18:00

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, up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of those, up to 25 percent may progress to liver cancer. In the European Union (EU) an estimated 9 million people are living with hepatitis C, and an estimated 170 million people worldwide are infected with the virus.

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 (DCV), an investigational NS5A replication complex inhibitor that has been studied in more than 5,500 patients as part of multiple direct-acting antiviral (DAA) based combination therapies. DCV has shown a low drug-drug interaction profile, supporting its potential use in multiple treatment regimens and in people with co-morbidities.

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

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

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

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.

An Update: Treat Hepatitis C Now Or Wait?

Hepatitis C: Treat Now Or Wait?

Only twenty more days until spring folks! The family is so over winter, we're all hoping March comes in like a lamb and stays! How about you?

To usher in March, we have a collection of slides which offer SVR rates on both FDA approved and investigational HCV agents, including interferon-free regimens in late stage clinical trials. A few other  topics touch on off-label use by combining two newly approved drugs, terminology used to determine treatment response and links to relevant information.

The slide-set is best viewed in full screen mode, please click here to begin.

Information is extracted from news articles, peer-reviewed journals, as well as liver meetings/conferences, and research manuscripts.

HCV Antivirals Race to Market - Gilead, AbbVie, Janssen, Boehringer Ingelheim and Bristol-Myers Squibb

 Just In
March 2014
Hepatitis C: Treat Now Or Wait?
To usher in March, we have a collection of slides which offer SVR rates on both FDA approved and investigational HCV agents, including interferon-free regimens in late stage clinical trials. A few other  topics touch on off-label use by combining two newly approved drugs, terminology used to determine treatment response and links to relevant information.
The slide-set is best viewed in full screen mode, please click here to begin. 

Related-
Bristol-Myers Daclatasvir Hepatitis C Treatment to Get Faster Review by the European Medicines Agency

Daclatasvir and Sofosbuvir: New drug combo cures toughest cases of hepatitis C, hints to future injection-free therapies

AbbVie Amazing All-oral Regimen: 100--96 percent cure rates mostly in 12weeks even in patients w-cirrhosis 

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

ISSUE: FEBRUARY 2014 | VOLUME: 65:2 

Source - Gastroenterology & Endoscopy News

by Kate O'Rourke

Boston—Over the next five years, a whirlwind of new direct-acting antiviral agents (DAAs) for hepatitis C are expected to get the green light from the FDA. The recent approval of simeprevir (Olysio, Janssen) and sofosbuvir (Sovaldi, Gilead)–containing regimens is only the tip of the iceberg.

“There are multiple, oral, interferon [IFN]-free DAA regimens in late-stage clinical trials with high SVR [sustained virologic response] rates,” said Mark Sulkowski, MD, medical director of the Viral Hepatitis Center in the Divisions of Infectious Diseases and Gastroenterology & Hepatology and professor of medicine at the Johns Hopkins School of Medicine, in Baltimore.

These include the Gilead-based regimen of sofosbuvir plus ledipasvir, with or without GS-9669; AbbVie’s ABT450/r plus ABT267 and ABT333; Boehringer Ingelheim’s faldaprevir plus deleobuvir, with or without PPI-668; Janssen’s simeprevir and samatasvir plus TMC647055/r; and Merck’s MK-8742 plus MK-5172. At press time, Bristol-Myers Squibb was in the process of submitting a regulatory filing for either daclatasvir plus asunaprevir, or this combination plus BMS 791325..............
Continue reading.........

February 2014 Hepatitis Newsletters: Mixing And Matching HCV Drugs

February 2014 

Hepatitis Newsletters

It's almost Valentine's Day folks, will you be purchasing any flowers and candy for that someone special next week? Retailers hope so, the holiday is a billion dollar business, this year consumers will spend close to $1.66 billion on candy, according to an article over at Huffington post.  

The Ten Dollar Liver
Just in time for Valentine's Day, a chocolate liver, waiting to quiver, is available on Craigslist.  Apparently, the owner went a bit crazy and ordered too many chocolate organs, the site now aspires to sell all fifteen liver looking Valentine treats over the next week. One wonders if all fifteen "Valentine Livers" aren't sold, could they, would they, will they be re-purposed for Easter?

Speaking of chocolate livers, did you see the article published in the January 2014 issue of Journal of Hepatology? Researchers suggest drinking more coffee and eating more chocolate - just may be associated with lower levels of liver enzymes in persons living with HIV and hepatitis C.

“Our results provide the first evidence that daily chocolate intake and, more generally, polyphenol rich food intake, may contribute to decreased AST [aspartate aminotransferase] and ALT [alanine aminotransferase] levels and potentially improve liver function in HIV-HCV coinfected patients,” the researchers wrote.  “They also suggest that polyphenols contained in coffee, but also in cocoa, can be involved in the causal process, which leads to reduced inflammation.”

Read a short summary published December 2013 online at Healio, or the full article in the Journal of Hepatology.   

February newsletter Updates
Added February 20, 2014

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

  Check Us Out On Twitter and Facebook

    

Other Updates:

Source - Gastroenterology & Endoscopy News

ISSUE: FEBRUARY 2014 | VOLUME: 65:2

 
IFN/RBV-Free Combo for HCV

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. 

+ read more  

HCV Antivirals Race to Market

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.

+ read more 

New Acetaminophen Warnings Build on Previous FDA Actions

Following the FDA’s recent announcement that it is asking physicians and other health care professionals to stop prescribing combination drugs that include more than 325 mg of the analgesic and fever reducer acetaminophen, medical professionals, journalists, patients and members of the general population alike took to the Web to weigh in on the ruling.

+ read more 

Hepatitis Newsletters

Take your time and browse through this month's informative HCV Newsletters, filled with liver health, research and current news for people treating and living with the hepatitis C virus.

HCV Advocate

The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education

HCV Advocate Newsletter

February 2014

In This Issue:

HCV Drug Development News

Alan Franciscus, Editor-in-Chief 

This month's column features the latest information about drugs in development to treat hepatitis C, including impressive results from two articles from the New England Journal of Medicine—AbbVie's interferon-free study and the controversial Gilead and BMS study. Included are pieces about the latest combination trials, and a very interesting drug that may be a one-shot cure—although it is just entering into studies with humans. 

HEALTHWISE: Acetaminophen: Safe or Harmful?

Lucinda K. Porter, RN 

There are two sides to every drug and this applies to acetaminophen, in many ways a wonder drug! 

HCV and Hispanics – Prevalence

Alan Franciscus, Editor-in-Chief 

Finally a study that breaks down the prevalence of HCV in the United States by country of origin instead of lumping everyone under one label—Hispanics.

DISABILITY & BENEFITS: Presumptive SSI

Jacques Chambers, CLU  

When it comes to disability it is very important to know exactly where you stand especially prior to applying for disability benefits. Jacques outlines the information about presumptive disability programs. 

Snapshots 

Lucinda K. Porter, R

In this month's column, Lucinda reviews studies on the prevalence of HCV, a study on the impact of treatment with sofosbuvir/ribavirin on quality of life, as well as an eye-opening study on the manufacturing costs of sofosbuvir, simeprevir, daclatasvir and faldaprevir.

 

HBV Journal Review

Christine Kukka
In this month's column Chris reviews the following studies that will help you understand the complexities of hepatitis B, including:

Tests for Antigens and Drug-Resistant Virus Emerge as Valuable Diagnostic Tools
Experts Issue a Report Card on Side Effects from Antivirals
Experts Weigh in on Why They Prefer Either Antivirals or Interferon
Doctors Explain Which Medical Guidelines They Follow, Or Ignore
Truvada Effective in Lowering Viral Load in Young Adults with High Viral Load
Hepatitis B Causes Most Liver Cancer Deaths in China
Smoking Shortens Survival after Liver Cancer Surgery

Connect With HCV Advocate

HepCBC Hepatitis C Education and Prevention Society

HepCBC’s MONTHLY NEWSLETTER

February Newsletter (PDF)

The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001. The monthly newsletter contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.

Important

Read and Sign the HCV MANIFESTO! 
Show your support for the rights of HCV+ people to live free of discrimination and to access appropriate healthcare.

In This Issue

Gilead Canada's "Momentum" program being set up to enable access to sofosbuvir

In Memorium: Keith Jewell

Mixing and matching HCV drugs from different pharmaceutical companies

Percuro Clinic:Neighbours helping neighbours

Update on "Dale" - patient from rural BC awaiting liver transplant
Preparing for Marathon

Guided Autobiography and Body Mapping Project

Conferences, Medication Assistance, Compensation

HCV Support Groups in Canada

AND MORE!!

Download February Newsletter Here

Stay Connected



 

NYC Hep C Task Force
The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community.

NYC Viral Hepatitis Monthly E-Newsletter
February 2014 NYC Hep ABC Newsletter

In This Issue

Webinar
Hepatitis C: Policy, Action, and What it Means for Communities of Color.
February 13 (3 PM ET)
Presenters: Colleen Flanigan, NYS DOH; Oscar Mairena, NASTAD & Tracie M. Gardner, Legal Action Center.

Improving Health Care of Drug Users
Training (CASAC). February 21st (1-4 pm). Harm Reduction Coalition Training Institute.

Effective Leadership
Training. March 7th.10th. Harm Reduction Coalition Training Institute.
NYS Hep C & Harm Reduction Legislative Advocacy Day.
March 12th, Albany. Get Involved.

International Conference on Viral Hepatitis (ICVH)
(CME). NYC. March 17-18.
NY Hep C ‘Baby Boomer’ Testing Law is in effect!
NYS Hepatitis C Testing Law. 2171 requires healthcare providers to offer hep C test to baby boomers. Requires full diagnostic testing for those who screen anti-body positive and either follow-up health care or referral to a health care provider who can provide follow-up health care.

See new Frequently Asked Questions document from NYS Department of Health.

And more.......

Click here to start reading....

Subscribe to this Newsletter

Join Us






Hepatitis Foundation International (HFI)

The Hepatitis Foundation International is dedicated to liver health and the prevention of liver related diseases. We inform and educate by making available reliable and up-to-date facts. We want you to make well-informed decisions for yourself and your loved ones' health and well-being. We are proud to present this website as your personal Internet gateway to hepatitis information and liver care.

OUR STORIES

The Hepatitis Foundation International is proud to offer this series of very special stories about the people involved in the fight against hepatitis and other liver-related diseases.

You will learn about the courageous lives of people personally affected by the ravages of hepatitis.

You will find uplifting stories of how people engage in the daily fight to bring widespread awareness to the importance of liver health...

Begin Reading Here.....

Hepatitis Foundation International 

Blog 

The Liver Lady Speaks...

Feb. 7, 2014 — 

What You Don’t Know CAN Hurt You   

What we don’t know, costs American's billions of dollars and thousands of lives each year.

Billions are being spent caring for chronic liver related diseases that are preventable.  Ignorance about the important role the liver plays in converting the food we eat into hundreds of life sustaining body functions is causing untold suffering and an enormous burden to our national health care system. 

Who is responsible for this lack of basic knowledge?  

Information about the liver has been absent from school curricula for decades. Ignorance is a major contributor to the unintentional development of liver related illnesses later in life. Preventable chronic diseases that depend on healthful selection of foods include: diabetes, obesity, fatty liver, high cholesterol, atherosclerosis, strokes and cardiovascular disease.

We have all heard messages promoting diets that include the basic food groups, vegetables, leaner cuts of meat in smaller portions, and fewer sugary drinks for decades.  Most people are aware that fatty foods can add inches to their waist lines.  What they don’t know is that fatty liver disease is caused by an accumulation of excess fats in liver cells, the chemical converters in their liver.  Fats cause cells to swell up and die.  Dead liver cells are called cirrhosis.  Add a few glasses of wine a day.  Breathe in pollutants and possible exposure to the hepatitis viruses through tattoos or body piercings. Add exposure to hepatitis through unprotected sex, more dead liver cells…more cirrhosis.

However, information to enable everyone to make healthful informed decisions about their own health is missing.  Sadly, individuals unknowingly continue laying the groundwork for future chronic debilitating diseases.

Someone you love could end up with too few healthy liver cells causing the liver to shut down. When your liver shuts down, so do you. Tragically, this can happen without warning of trouble as the liver is a non complaining organ.

How can we expect individuals to make healthful food and lifestyle choices when they are totally unaware of the impact bad choices can have on their future health? We cannot change what we don’t know.

Chubby babies, overweight children and obese adolescents should set off an alarm that liver health education must begin on day one of our lives.  We have made sure our astronauts have a healthy diet while circling the earth.  We need to put as much emphasis on helping children to know why and how to protect their precious liver.  By making healthy food and lifestyle choices as children, many debilitating liver related chronic illnesses could be prevented.

Let’s fill the gap.  Surveys show that individuals who learn about the liver are motivated to avoid liver damaging behaviors. Liver health education is most effective when it begins in pre K and continues through high school.  Where else can we reach a large captive audience when they are receptive to learning?

An investment in prevention through liver health and wellness education can begin saving lives and healthcare dollars today.

For additional information or if you have questions, contact info@hepatitisfoundation.org .

Stay Updated







Caring Ambassadors Hepatitis C

The Caring Ambassadors Hepatitis C Program (CAP-Hepatitis C) is a national non-profit organization devoted exclusively to meeting the needs of the hepatitis C community.

The Caring Ambassadors Program mission is to help improve the lives of those affected by long-term diseases through advocacy, information, and support.

Monthly Pubmed Review of the most relevant research on hepatitis C.
View All Monthly Literature Reviews At  CAP Hepatitis C Literature Review 

Powered by Issuu

Publish for Free

Hepatitis C news, is an online community for those living with hepatitis C. Join us for news, views and features about hep C, read the real-life experiences of our guest bloggers, and learn about living well with the condition.

New In February @ Hepatitis C News

Hep C and Liver Transplants
February 5th, 2014 For patients with advanced hepatitis C-related liver disease, liver transplants can offer a second chance of recovery for people whose condition has significantly deteriorated.

News Video

Published on Jan 27, 2014

Another monthly dose of all things hep C! This time around we take a look at new legislation in New York that legalizes the use of marijuana for chronic hep C, the growing craze of tattoo parties and the realities of sex and dating with the virus.




Check out
Hepatitis C News YouTube Channel

Stay connected






Canadian Liver Foundation

News Updates

Canadian Liver Foundation’s Newsroom

New tools to help patients with "silent stalker" hepatitis C - February 3, 2014

 

Safety warning for hep B patients taking Arzerra - February 2, 2014

 

Hepatitis C investigation at Brantford General Hospital - January 17, 2014

 

Most With Hepatitis C May Soon Find Hope in New Treatments - January 16, 2014

 

Is your liver too fat? - January 15, 2014 

Newsletter

Livewell is our e-newsletter exclusively for friends and donors of the Canadian Liver Foundation. Each issue highlights liver health issues, exciting research projects, upcoming events and includes profiles of our outstanding volunteers and donors.

The Livewell newsletter is distributed 4x per year. Please click here to fill in the form and we will be happy to add you to our subscriber list!

CLF updates you and interacts with you on all things liver

Stay Updated







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.

January Issue - Please Check Back

Stay connected



Bloggers Corner

Hepatitis C News -Bloggers
Hear from our community of bloggers
Our growing team of contributors from around the world who share their experiences of hep C is a really valuable part of our online community.

Hepatitis C and Exercise
 By Connie M. Welch 

January 31, 2014 8:38 PM

Hepatitis C and Exercise, What are the recommendations? Dr. Joseph Galati M.D. a Hepatologist from Houston, Texas shares valuable information on how we can improve our health and take care of our liver through proper exercise.

Dark chocolate benefits for the liver 
Chocolate has been known uplift the spirit – but what great news that it’s good for our liver too! Dark chocolate, in particular, contains rich antioxidants that help cleanse the liver and control blood pressure, which is important for people suffering liver cirrhosis

Opening Doors to the Latest Hepatitis C Drugs 
 Lucinda K. Porter, RN
2014-02-02

Recommendations for "Testing, Managing, and Treating Hepatitis C" carry huge weight, as many medical providers use this expert advice in their own practices. The Recommendations offer all-oral interferon-free alternatives for all genotypes except genotype 5 and 6 hepatitis C patients.

Of Interest

Genotype: Hepatitis C Treatment
News and research is offered on this page with a focus on treatment options for HCV genotypes 1-6 , including FDA approved drugs, and investigational agents currently in clinical trials. Information is extracted from news articles, peer-reviewed journals, as well as liver meetings/conferences, research manuscripts and interactive learning activities

Hepatitis C Guidelines: The Right Treatment, For the Right Person, For The Right Amount Of Time
Dr Michael Charlton, medical director of Intermountain Medical Center's Transplant Program  talks about the new national guidelines issued this week to manage and treat the hepatitis C virus The new guidelines will have a complex algorithm for practitioners around the country to follow and see whats the right right treatment, for the right patients, for the right about of time.

The Mediterranean Diet For Liver Disease 
There are few things about which I am obsessive, one is bedbugs, the other is dieting.
Clinical research has demonstrated adhering to a diet plan with foods named in the Mediterranean diet may help preserve memory as we age, reduced both liver fat and inflammation, help protect against liver cancer, may have potential benefits for people chronically infected with hepatitis, reduce the risk for diabetes, heart attack and stroke  

Healthy Liver - Healthy Digestion
Did you know in the absence of severe liver damage - no diet for people living with hepatitis C is recommended. However, eating the right foods, careful weight management including exercise can improve overall liver health and aid in digestion. This section of the website offers a quick glance at the above topics with a focus on digestion and a somewhat familiar disorder called Functional Dyspepsia (FD). The medical term simply means - bad digestion, the symptoms vary but are frequently described as a full or bloated feeling after eating. An article provided below about managing FD from Harvard Health offers insight into the uncomfortable disorder which apparently has no clear identifiable cause, or cure.

Health Sites Worth The Click




A monthly newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services

In This Issue

February Features

 

Stop the Spread of Superbugs
Antibiotics can destroy many types of bacteria that can make us sick. Sadly, our overuse of antibiotics is helping to create new drug-resistant “superbugs” that are difficult to defeat.  
 Read more about drug-resistant bacteria.




Gripped by Gout Avoiding the Ache and Agony
Sudden, painful swelling at the base of the big toe is often the first warning sign of gout. It can affect other joints as well. The good news is, most types of gout are treatable, especially if caught early.   
Read more about gout.

Find Us On Facebook







ACP Internist provides news and information for internists about the practice of medicine and reports on the policies, products and activities of ACP

Current Issue - February 2014

Patient Communication  
Look for reasons if patients refuse advice

By Terri D’Arrigo

Refusal can be frustrating for physicians, who likely see their medical advice as contributing toward healing and improving quality of life. But patients reserve the right to make informed decisions about their care, even if these decisions run counter to what’s been recommended.
More


Dermatology
Psoriasis symptoms can be tough to address

By Charlotte Huff

A recent survey showed that many psoriasis patients are not satisfied with their care, reporting inadequate relief from such symptoms as itching and scaling. Learn more about clues to diagnosis and suggestions on treating and managing symptoms of both mild and more severe disease.
More

Home stool test will detect most colorectal cancers
Fecal immunochemical tests (FITs) have high accuracy, high specificity and moderately high sensitivity and can detect about 4 out of 5 colorectal cancers, according to an evidence review.

Washington Perspective
Why 2014 may be a make-or-break year for health reform

By Robert B. Doherty

2014 is shaping up to be a critically important year in determining whether the country moves forward or backward on expanding health insurance to 30 million uninsured persons and providing better consumer protections for many millions more.
More

Follow ACP On Twitter



Stay safe and healthy, see you soon.

Tina