Cocrystal Announces Positive Interim Data from an Ongoing Phase 1 Study with CC-31244 for the Treatment of Chronic Hepatitis C Infection
November 07, 2016
ATLANTA, GA and BOTHELL, WA -- (Marketwired) -- 11/07/16 -- Cocrystal Pharma, Inc. (OTCQB: COCP), announced positive data from a randomized, double-blind Phase Ia/Ib study of CC-31244, a pan-genotypic, potent NS5B non-nucleoside inhibitor (NNI), for the treatment of chronic hepatitis C virus (HCV) infection.
The study is designed to evaluate CC-31244's safety/tolerability and pharmacokinetics, including food effect and antiviral activity. The study includes two groups: Group A (single ascending doses, and multiple doses in healthy volunteers), and Group B (multiple doses in HCV infected individuals).
The study has dosed a total of 42 healthy volunteers with single (20, 50, 100, 200 and 400 mg) and multiple doses of CC-31244 at 200 and 400 mg for 7 days. Five HCV GT1 infected patients were dosed, four with 400 mg of CC-31244 once daily for 7 days and one with placebo.
Data from the once daily 400 mg dosing arm demonstrate that CC-31244 had a substantial and durable antiviral effect with an average HCV RNA viral load decline from baseline of 3 log orders by 48 hours after dosing. The average viral load at 6 days post last dose remained on average 1.9 log orders below baseline. In addition, no viral breakthrough was observed during the treatment period. No serious adverse event was reported.
"To date, CC-31244 appears to be safe and well tolerated in both healthy and HCV-infected subjects. This study is ongoing with additional cohorts and Cocrystal anticipates reporting the complete dataset by the first quarter of 2017," said Gary L. Wilcox, Ph.D., Interim Chief Executive Officer of the Company. "The human pharmacokinetic and safety data were consistent with the drug's preclinical profile."
"Our initial clinical data are particularly encouraging. Our preclinical data indicate that the drug accumulates significantly in the liver. These data support the notion that CC-31244 is a potential best-in-class NNI which could be used as an important component in an all oral, ultra-short HCV combination therapy," added Sam Lee, Ph.D., President and co-inventor of this drug.
About CC-31244
CC-31244 is an investigational, oral, potent, pan-genotypic NNI with high barrier to drug resistance designed and developed using the Company's proprietary structure-based drug discovery technology. The molecule interacts with the NS5B RNA polymerase of all major HCV genotypes
About Hepatitis C
Hepatitis C is a viral infection of the liver that according to The World Health Organization in 2013 affects over 150 million people worldwide of whom only about 1% have been cured to date. The annual number of deaths due to Hepatitis C is estimated at 350,000 globally or nearly 1,000 per day. Most patients develop chronic infections, which can lead to fibrosis (scarring), cirrhosis, liver failure, and liver cancer. The worldwide market for hepatitis C antiviral drugs was $12 billion in 2015.
About Cocrystal Pharma
Cocrystal is a pharmaceutical company seeking to discover and develop novel antiviral therapeutics as treatments for serious and/or chronic viral diseases. Cocrystal employs unique structure based technologies and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. These technologies, including our nucleoside chemistry expertise, are designed to efficiently deliver small molecule therapeutics that are safe, effective and convenient to administer. The company has identified promising, preclinical stage antiviral compounds for unmet medical needs including hepatitis, influenza and norovirus infections. Cocrystal has previously received strategic investments from Teva Pharmaceuticals, OPKO Health, Brace Pharmaceutical, LLC, and The Frost Group. For further information about Cocrystal, please refer to www.cocrystalpharma.com.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Cocrystal, they are forward-looking statements reflecting the current beliefs and expectations of management including statements regarding development plans for treatments related to Hepatitis C. Forward-looking statements in this release include any implication that our future clinical results will be comparable to our initial data, and involve substantial risks and uncertainties that could cause our clinical development programs, performance or future results to differ significantly from what is expressed or implied by the forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see filings Cocrystal has made with the Securities and Exchange Commission.
Contact:
Tricia Truehart
ttruehart@troutgroup.com
Source: Cocrystal Pharma, Inc.
Released November 7, 2016
Tuesday, November 8, 2016
Healthy Holiday Foods and Fun Make Smart Choices as You Celebrate the Season
Healthy Holiday Foods and Fun Make Smart Choices as You Celebrate the Season
Source - NIH News in Health, Nov 2016
Source - NIH News in Health, Nov 2016
Mashed potatoes and gravy, Grandma’s apple pie, and other holiday favorites can be a joyous part of any celebration. But to feel your best, you know you need to eat in moderation and stay active. How can you avoid temptation when delicious foods and calories abound?
“From Halloween through New Year’s, there’s always a decision to make about food,” says Dr. Marci Gluck, an NIH psychologist who studies obesity and eating behaviors. Tasty treats tend to appear more often at work and festive gatherings, and to come as gifts. They may also tempt you when grocery shopping. “As the holidays approach, it’s important to think ahead and make a plan,” Gluck says.
Consider your health goals for the holiday season, whether it’s avoiding overeating, staying active, connecting with others, reducing stress, or preventing weight gain. You can plan to make time for buying healthy groceries, cooking at home, scheduling regular physical activity, and setting aside a little quiet time for yourself.
Gluck suggests you start by adopting a flexible mindset. “Many people have an attitude of all or nothing: either I’m on a diet or I’m not on a diet,” she says. This “either-or” thinking can lead to negative self-talk, or being hard on yourself for small indulgences, overeating, or weight gain.
“Most people just throw their plan out the window when they think they’ve slipped up, and they ‘fall off the wagon,’” Gluck says. “Celebrations don’t have to derail your lifestyle. You’ll have plenty of opportunities to follow your plan and eat healthy.”
Look for opportunities to make healthy choices and feel good about them. “Small choices really can make big changes,” Gluck says. “Each moment that you put something in your mouth or choose to exercise adds up over time. That can be true for weight loss or weight gain.”
Around the holidays, we often find ourselves with too many food options, for too many days in a row. It can be challenging to decide what to eat and when to say no.
“Eat what you love—in moderation,” suggests Jody Engel, a nutritionist and registered dietitian at NIH. Consider choosing items that are unique to the season, instead of eating foods you can have any time of the year.
When you feel the urge to splurge in unhealthy ways, Engel recommends trying something else first, like drinking a glass of water, eating a piece of fruit, or climbing a few flights of stairs. You might even consider walking around your house or office for 5 minutes or more. Such diversions might be enough to help you resist unhealthy temptations.
You could also try eating mindfully, Engel suggests. Slow down to really taste and enjoy your food. Eating more slowly also allows your body time to signal your brain when you’re full, which takes about 20 minutes. If you eat too much too quickly, it’s easy to gobble up as much as twice what your body needs before your brain even gets the message.
Dr. Susanne Votruba, an NIH obesity and nutrition researcher, says it’s a good idea to identify and avoid any “trigger foods”—foods that may spur you to binge or eat more than usual. Overeating can bring feelings of bloating, reflux, indigestion, and nausea.
“Some people can eat less healthy foods in moderation and be fine, or have ‘cheat days’ where they allow themselves to eat whatever they want for a day and stay on track for the rest of the week,” Votruba says. “Others may have to avoid certain ‘trigger foods’ completely, or they’ll spiral into unhealthy eating patterns for the rest of the week or abandon their plan altogether. Everyone is different.”
Because of these differences, Votruba says, it’s important not to force food on other people. “Even if you don’t have an issue with food, be aware of other people around you, and respect their choices,” she says.
What if you do fall to temptation? “Every day is a new day when it comes to eating,” Votruba says. “If you overeat one day, work to get back on track the next meal or next day.”
While food is a big part of the holidays, remember that there are other paths to staying healthy. “Don’t make the holidays be just about food,” Votruba suggests. “The key is not only what you eat, but how much you’re moving. Even little bits of extra exercise can be very helpful for everyone over the holidays.”
Plan ahead for how you’ll add physical activity to days that might otherwise involve a lot of sitting. Get the whole family involved, Engel suggests. “You have to make an effort to incorporate exercise into days of big eating,” she says. “Otherwise the day will come and go.”
Sign up to walk or run a community race. Enjoy catching up with family or friends on a walk or jog instead of on the couch. In between meals, take a family hike at a nearby park, stroll around your neighborhood, or play a game of flag football.
The emotions of winter celebrations come into this picture, too. “Joy, sadness, and stress are associated with overeating during the holidays,” Gluck says. “People who are emotional eaters may be particularly vulnerable to temptations around the holidays.”
If holiday stress causes you to derail your healthy plans, consider ways to reduce stress and manage emotions. These might include talking to a trusted friend, meditation, physical activity, or just getting outside.
“If you know you have a difficult time during holidays, plan outings once or twice a week with people who make you feel happy,” says Gluck. “If it’s in your best interest, also feel okay about declining invitations without feeling guilty.”
Support your family and friends, too. Encourage them to eat healthy during celebrations and throughout the year. If you’re serving dinner, consider baking, broiling, or grilling food instead of frying. Replace sour cream with Greek yogurt, and mashed potatoes with mashed cauliflower. Make take-home containers available ahead of time, so guests don’t feel they have to eat everything in one sitting.
See the Wise Choices box for more healthy eating tips. And happy, healthy holidays to all—from NIH News in Health.
For more consumer health news and information, visit Health.nih.gov.
Watch - An Introduction to Access to Generic Hepatitis C Medicines
Following the success of the first two webinars in the Knowledge for Change series covering access to diagnostics and medicines, we were pleased to deliver the next in the series, ‘An Introduction to Accessing Generic Hepatitis C Medicines’ on 1 November. The webinar explored the generics landscape for hepatitis C with discussions on legalities, quality and performance of generics medicines as well as providing examples of how people across the globe are accessing them.
Chair: Raquel Peck, CEO, World Hepatitis Alliance
Panellists:
- Andrew Hill, Senior Visiting Research Fellow, Department of Pharmacology, University of Liverpool
- Giten Khwairakpam, Project Manager for Community and Policy, TREAT Asia
- Erika Duenas, Advocacy Officer, Medicines Patent Pool
Chair: Raquel Peck, CEO, World Hepatitis Alliance
Panellists:
- Andrew Hill, Senior Visiting Research Fellow, Department of Pharmacology, University of Liverpool
- Giten Khwairakpam, Project Manager for Community and Policy, TREAT Asia
- Erika Duenas, Advocacy Officer, Medicines Patent Pool
Sunday, November 6, 2016
HCV Reading: AASLD Key Abstracts Reviewed By Pacific Hepatitis C Network
HCV Weekend Reading: Week In Review
Hello everyone, here is a look back at last weeks publications, headlines, and hot topics including today's news with updates as the day progresses.
Hello everyone, here is a look back at last weeks publications, headlines, and hot topics including today's news with updates as the day progresses.
What's New
This month Pacific Hepatitis C Network (PHCN) just started a news in review newsletter. Don't miss a two part blog post summarizing key HCV abstracts that will be presented at next weeks American Association for the Study of Liver Diseases 67th annual meeting. Next read through Hep C Tip News, with information about the latest drugs to treat hepatitis C. Finally stay updated by joining Pacific Hepatitis C Network's mailing list.Related:
AASLD 2016 Updates On This Blog
AASLD 2016 Conference Updates
Digest Of News
In addition review important HCV headlines in the latest edition of The Weekly Bull online over at HepCBC.
Health Review - A User's Guide to the Common Cold
Johns Hopkins Fall/Winter 2016 Health Review is out, with expert advice on how to survive the flu and cold season; A User's Guide to the Common Cold. Another article of interest; Understanding Inflammation about chronic inflammation and its effects on the body is featured in the Spring/Summer 2016 issue.
In Case You Missed It
The November index of HCV newsletters was recently updated to include three new publications, begin here.
Hot Topic - In Today's News
The November index of HCV newsletters was recently updated to include three new publications, begin here.
Hot Topic - In Today's News
Nov 6
Buyers clubs for cheaper drugs help fight hepatitis and HIV
A Indian-made course of treatment for the liver-destroying disease hepatitis C, meanwhile, can be had for around 1,000 pounds against a list price for branded drugs of around 35,000.Gilead is also a leading producer of patented hepatitis C drugs, along with Merck and AbbVie.
Published Nov 2
Watch - An Introduction to Access to Generic Hepatitis C Medicines
Following the success of the first two webinars in the Knowledge for Change series covering access to diagnostics and medicines, we were pleased to deliver the next in the series, ‘An Introduction to Accessing Generic Hepatitis C Medicines’ on 1 November. The webinar explored the generics landscape for hepatitis C with discussions on legalities, quality and performance of generics medicines as well as providing examples of how people across the globe are accessing them.
Todays' News
Nov 7Buyers clubs for cheaper drugs help fight hepatitis and HIV
A Indian-made course of treatment for the liver-destroying disease hepatitis C, meanwhile, can be had for around 1,000 pounds against a list price for branded drugs of around 35,000.Gilead is also a leading producer of patented hepatitis C drugs, along with Merck and AbbVie.
Published Nov 2
Watch - An Introduction to Access to Generic Hepatitis C Medicines
Following the success of the first two webinars in the Knowledge for Change series covering access to diagnostics and medicines, we were pleased to deliver the next in the series, ‘An Introduction to Accessing Generic Hepatitis C Medicines’ on 1 November. The webinar explored the generics landscape for hepatitis C with discussions on legalities, quality and performance of generics medicines as well as providing examples of how people across the globe are accessing them.
Todays' News
Bayer applies for Regorafenib authorization to treat liver cancer
German drugmaker Bayer on Monday said it submitted an application to have its cancer drug Regorafenib approved for the second-line treatment of liver cancer patients following successful clinical trials.
Nov 6
Lawmakers Hear From Organ Harvesting Investigators
In 2006 international human rights lawyer David Matas and former Crown attorney and cabinet minister David Kilgour first released an initial investigative report into allegations of live organ harvesting in China; Kilgour-Matas Report. Read their latest report, released in June, at a House of Commons hearing on Nov. 3, along with other articles on recent advocacy efforts and government solutions.
Cairns leads regional Queensland in roll out of new hepatitis C drug
“In Australia there’s about 250,000 people with hepatitis C and we think, since the medication has become available on March 1, we’ve treated nearly 40,000 people Australia-wide.”
NM aims to control hepatitis C costs
Albuquerque Journal
Last year, the New Mexico Medicaid program spent $36.5 million for hepatitis
Recent News and Research
Nov 7
All Genotypes
Concise review: Interferon-free treatment of hepatitis C virus-associated cirrhosis and liver graft infection
Chronic hepatitis C is a major reason for development of cirrhosis and a leading cause for liver transplantation. The development of direct-acting antiviral agents (DAA) offered new therapeutic options for patients with advanced cirrhosis and liver graft recipients. This review gives a high topical summary of most current therapeutic options of DAA-based antiviral therapy in patients with hepatitis C virus associated cirrhosis before and after liver transplantation.
Nov 4
Shorter Hep C Regimens Hot Topic at the Liver Meeting
Medscape-40 minutes ago
BOSTON — Shortening the length of curative regimens for hepatitis C treatment will be one of the hot topics here at The Liver Meeting 2016. One study likely to ...
Reported by Jules Levin
IDWeek Oct 26-30
New Orleans 2016
Sofosbuvir/Velpatasvir Plus Voxilaprevir for 6, 8, or 12 Weeks in Genotype 1-6 HCV-infected Patients: An Integrated Analysis of Safety and Efficacy from Two Phase 2 Studies
Safe and effective sofosbuvir-based therapy in patients with mental health disease on hepatitis C virus treatment
The prevalence of mental health disease (MHD) among patients with chronic hepatitis C virus (HCV) can be high. However, patients with MHD may be marginalized with respect to HCV therapy and MHD is one of the most frequently cited reason for exclusion from HCV therapy. HCV therapy has evolved from interferon-based to directly acting antiviral (DAA)-based therapy with excellent tolerability and efficacy. Our study found that baseline MHD did not impact efficacy nor treatment adherence to sofosbuvir-based therapy. Furthermore, we found that Becks Depression Inventory scores improved with sofosbuvir-based therapy, suggesting that HCV treatment with the newer DAA therapies may have additional mental health benefits.
Alcohol use disorder and its impact on chronic hepatitis C virus and human immunodeficiency virus infections
Alcohol use disorder (AUD) and hepatitis C virus (HCV) infection frequently co-occur. AUD is associated with greater exposure to HCV infection, increased HCV infection persistence, and more extensive liver damage due to interactions between AUD and HCV on immune responses, cytotoxicity, and oxidative stress. Although AUD and HCV infection are associated with increased morbidity and mortality, HCV antiviral therapy is less commonly prescribed in individuals with both conditions. AUD is also common in human immunodeficiency virus (HIV) infection, which negatively impacts proper HIV care and adherence to antiretroviral therapy, and liver disease...
Prevention of Progression to Cirrhosis in Hepatitis C With Fibrosis
Are direct-acting anti-virals cost-effective treatment for patients with HCV infection with liver fibrosis who are at high risk of progression to cirrhosis?
Evidence shows value of treating all stages of chronic HCV
Evidence from 38 studies, involving 73,861 patients, showed a significant mortality benefit of achieving SVR in patients with all stages of fibrosis. Long-term studies with follow-ups of five to 12 years suggested that, particularly among non-cirrhotic patients, there was a significant decrease in mortality in SVR versus non-SVR groups.
Healio
MRE, MRI-PDFF best other techniques for detection of fibrosis, steatosis
Recent findings show magnetic resonance elastography was more accurate for detecting liver fibrosis vs. transient elastography, and MRI-based proton density fat fraction was more accurate than controlled attenuation parameter for detecting steatosis, in patients with biopsy-proven nonalcoholic fatty liver disease.
Biopsy Not Needed to Track Impact of Direct-Acting Antivirals
Noninvasive technology can accurately measure liver stiffness and track progress in liver disease cure.
News In Review
The Pacific Hepatitis C Network
The Pacific Hepatitis C Network
The Pacific Hepatitis C Network’s mission is to strengthen the capacity of individuals and organizations throughout British Columbia to prevent HCV infections and improve the health and treatment outcomes of people with HCV.
One of its projects is the Hepatitis C Treatment Information Project your web-based hepatitis C treatment information toolkit for entering into that world and building your understanding about hep C treatment.
One of its projects is the Hepatitis C Treatment Information Project your web-based hepatitis C treatment information toolkit for entering into that world and building your understanding about hep C treatment.
The Pacific Hepatitis C Network‘s News in Review Newsletter
November 5, 2016 Welcome to the Pacific Hepatitis C Network (PHCN)‘s very first hepatitis C news in review newsletter. This is where we review all of the major issues and events around hepatitis C and hep C treatments. It is an email that includes links to all of our recent blog posts—including the blog post about the big news surrounding the hep C treatment Epclusa (generic name: sofosbuvir/velpatasvir).
EPCLUSA RECOMMENDED BY CADTH
Epclusa (generic name: sofosbuvir/velpatasvir), developed by Gilead Sciences Canada, Inc., just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation. Click here to read more about their recommendation sent to the provinces and territories to help them decide on whether or not to cover the treatment and how to cover it.
HEPATITIS C ADVOCACY HIGHLIGHTS
In October, Daryl Luster wrote two blog posts for the Pacific Hepatitis C Network. Daryl is a hep C advocate who is PHCN’s president, a member of the Executive Steering Committee for Action Hepatitis Canada (AHC), a counselor for the Help-4-Hep helpline, and the administrator of multiple peer support groups. In 2010, Daryl was cured of hep C while participating in a clinical trial. The two blog posts he wrote were:
• DAAs: Long Term Effects
• AHC BC Regional Meeting: October 18-19
HEP C ABSTRACT HIGHLIGHTS TO BE PRESENTED AT THE LIVER MEETING 2016
The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, will be held in a week. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, will be hosting the meeting and, as always, the meeting promises to be exciting.
To celebrate the meeting and all of the amazing discoveries that will be presented, the Hepatitis C Treatment Information Project wrote the following blog posts summarizing and highlighting some of what will be presented about hep C treatments:
• The Liver Meeting 2016 Hep C Abstract Highlights (Part1)
• The Liver Meeting 2016 Hep C Abstract Highlights (Part2)
• Live Stream Sessions from The Liver Meeting 2016
THE BASICS SERIES
The Basics Series by the Hepatitis C Treatment Information Project is a series of blog posts about the very basics about hep C and hep C treatments. So far, the series has five issues, entitled the following:
Hepatitis C Genotypes: The Basics
Pan-Genotypic Hepatitis C Treatments: The Basics
To treat or to wait? That may be the question with hep C treatment.
Treatments Covered by BC PharmaCare for Hep C Genotypes 1a/1b
Treatments Covered by BC PharmaCare for Hep C Genotypes 2-6
For more information about the topics in this newsletter, please click on the links, visit PHCN’s Hepatitis C Treatment Information Project, or email us.
HepCBC
HepCBC is a non-profit organization run by and for people infected and affected by hepatitis C. Our mission is to provide education, prevention and support to those living with HCV.
Weekly Bull
Friday, November-4-16
News in Brief
Pan-Genotypic Hep C Drug Epclusa™ Recommended for PharmaCare Coverage by CADTH
November 4, 2016
Epclusa™, a Direct-Acting-Antiviral combo for ALL GENOTYPES of Chronic Hepatitis C, received approval from CADTH on October 28, 2016. This combo of (generics) sofosbuvir and velpatasvir, from Gilead Sciences, was recommended by CADTH’s Canadian Drug Expert Committtee (CDEC) for reimbursement by provincial and territorial PharmaCares.
BC Ministry of Health’s Refusal to Reimburse Critical Drug “Zaxine™” for Hepatic Encephalopathy
November 4, 2016
BC Ministry of Health sent a puzzling reply to HepCBC’s request for reimbursement of hepatic encephalopathy drug rifaximin (Zaxine™). BC is the only province/territory which does not cover it; many of BC’s End Stage Liver Disease (ESLD) patients are suffering from preventable brain damage because of this. This drug has been shown to be of great benefit to patients suffering from ESLD, either in combination with lactulose, or instead of lactulose in cases where lactulose does not work. Nevertheless, BC is still refusing to cover it.
Who sets the maximum price allowed for patent medicines in Canada, including hep C treatments?
November 4, 2016
The “Patented Medicine Prices Review Board” (PMPRB) does! PMPRB asked patient groups for feedback on proposed changes to PMPRB’s mandate. In our submission, HepCBC asked for maximum pricing to reflect “prevalence” of a disease (how many people have it), because the more treatments you can sell, the more you can lower your price and still make the same or better profit. We advocated for pricing which is more in line with European rather than American prices. We also advocated for an “Equitable Profit Margin”. We said it is not so important to patients if Research and Development is done in Canada as long as clinical trials are conducted here. Read HepCBC’s full (8 page) submission:
These researchers think they have a solution to the global crisis in drug prices
November 4, 2016
Jerome Zeldis remembers exactly how he felt when he heard about the $84,000 price tag on a powerful new hepatitis C treatment three years ago. “I was somewhere between annoyed and outraged,” recalled Zeldis, the former chief medical officer of the biotech juggernaut Celgene. So he has started Trek Therapeutics as a public benefit corporation – a relatively new type of corporate structure that places public welfare on equal footing with profit.
DAA Combination Treatment Fast and Effective for Hepatitis C
November 3, 2016
Sofosbuvir, velpatasvir, and voxilaprevir for 8 weeks does the trick across all genotypes, treatment experienced, DAA relapse or cirrhosis! Two phase 2 studies of combination direct-acting antiviral agent (DAA) treatments were published recently in Gastroenterology. They were accompanied by an editorial simply titled “Hepatitis C Therapy: Game Over!”
What Are the Out of Pocket Costs for Harvoni, Viekira Pak and Epclusa under Medicare Part D?
November 3, 2016
We often get asked this question by American visitors to our site, and we hope this page will help provide the answers you need. Not all drugs are covered by Medicaid but there are “coupons” that you can use. The information is from GoodRX. This is for the USA only.
Vietnam vets urged to receive hepatitis C testing
November 2, 2016
American Legion Post 1619 is working on a statewide awareness campaign and urging all Vietnam-era veterans to get tested for hepatitis C. Two free clinics are scheduled for Nov. 4 and 5 in Morrisonville. MORRISONVILLE NY — The boot camp ritual was robotic in its precision. Soldiers lined up for their vaccination shots. Needles were outdated, “jet guns” were in, and soldiers received high pressure blasts of an 18-drug cocktail before being shipped off.
Acute hepatitis after heavy energy drink use ‘a warning to the consumer,’ liver specialist says
November 1, 2016
Construction worker relied on 4 to 5 bottles a day to get through his shift A construction worker who consumed an excessive amount of energy drinks developed a rare case of acute hepatitis, say doctors who want patients to know about the potential risks to the liver from such over-consumption.
HCV reinfection common in MSM with HIV
November 1, 2016
In a retrospective study, researchers found that hepatitis C virus reinfection is common among HIV-positive men who have sex with men after successful treatment and spontaneous clearance. “A subsequent high incidence of HCV reinfection has been reported regionally in men who both clear the infection spontaneously or who respond to treatment.
Recurrent viremia infrequent in hepatitis C
November 1, 2016
The prevalence of recurrent viremia was low among patients with hepatitis C who achieved sustained virologic response, data from a recently published study demonstrate. Among those patients who did experience late recurrent viremia, most had HCV reinfection. (HCV reinfection common in MSM with HIV).
Two genes linked to increase in immunity to hepatitis C after childbirth, study shows
October 31, 2016
Alternative forms of two genes are associated with a boost in immunity to hepatitis C after childbirth, a study led by a Nationwide Children’s Hospital physician-researcher shows. At three months postpartum, the number of viruses circulating in the blood declined sharply in most women who carried particular versions of IFNL3 and HLA-DPB1 genes. Mothers lacking these gene variants experienced little change in viral levels after delivery.
Tampa Bay woman with Hepatitis C reduces co-pay for treatments with coupon
October 31, 2016
PASADENA, FL (WFLA) — The FDA has approved several new cures for people fighting chronic diseases, but the problem is, many people can’t afford the drugs and insurance companies will cover only the sickest patients. That includes a drug now on the market for people with Hepatitis C called Harvoni — a pill that patients take for 8 to 12 weeks. Wendy Latorre, of Pasadena, says when she heard about the drugs she was extremely hopeful. “And then she found out the cost!
Dating after Hepatitis C: Hope on the horizon for the 1 in 30 boomers estimated to be infected
October 30, 2016
Baby boomers are 6 times more likely to be infected than other adults. We need to talk about testing and treatment. Recently I went on a first date — a stroll in a city park — that went rather well. We had so much in common, from a love of reading to a history of youthful troublemaking. If I wasn’t convinced already he was someone I could relate to, my new friend shared that he’d been cured of Hepatitis C. I could hardly believe it.
Why all those discarded needles are signs of progress for HIV, Hep C in Southern Interior
October 29, 2016
THOMPSON-OKANAGAN – Nearly 400 new Hepatitis C cases and as many as 15 HIV cases were recorded by Interior Health last year, and most were caused by injection drug use. The numbers may seem surprisingly high, but are average compared to recent years, according to senior medical health officer Dr. Trevor Corneil, who says they’ve actually been on an overall downward trend over the past 15 years with the advent of harm reduction strategies.
Generic hepatitis C drugs purchased online achieve high cure rates
October 28, 2016
Use of generic versions of direct-acting antivirals resulted in very high cure rates for people who obtained the products through three buyers’ clubs, indicating that the generic products are effective, according to three presentations at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow) this week. People who purchased the drugs were cured of hepatitis C at a cost of around $700-$900 in South-East Asia and Eastern Europe.
Friday, November-4-16
News in Brief
Pan-Genotypic Hep C Drug Epclusa™ Recommended for PharmaCare Coverage by CADTH
November 4, 2016
Epclusa™, a Direct-Acting-Antiviral combo for ALL GENOTYPES of Chronic Hepatitis C, received approval from CADTH on October 28, 2016. This combo of (generics) sofosbuvir and velpatasvir, from Gilead Sciences, was recommended by CADTH’s Canadian Drug Expert Committtee (CDEC) for reimbursement by provincial and territorial PharmaCares.
BC Ministry of Health’s Refusal to Reimburse Critical Drug “Zaxine™” for Hepatic Encephalopathy
November 4, 2016
BC Ministry of Health sent a puzzling reply to HepCBC’s request for reimbursement of hepatic encephalopathy drug rifaximin (Zaxine™). BC is the only province/territory which does not cover it; many of BC’s End Stage Liver Disease (ESLD) patients are suffering from preventable brain damage because of this. This drug has been shown to be of great benefit to patients suffering from ESLD, either in combination with lactulose, or instead of lactulose in cases where lactulose does not work. Nevertheless, BC is still refusing to cover it.
Who sets the maximum price allowed for patent medicines in Canada, including hep C treatments?
November 4, 2016
The “Patented Medicine Prices Review Board” (PMPRB) does! PMPRB asked patient groups for feedback on proposed changes to PMPRB’s mandate. In our submission, HepCBC asked for maximum pricing to reflect “prevalence” of a disease (how many people have it), because the more treatments you can sell, the more you can lower your price and still make the same or better profit. We advocated for pricing which is more in line with European rather than American prices. We also advocated for an “Equitable Profit Margin”. We said it is not so important to patients if Research and Development is done in Canada as long as clinical trials are conducted here. Read HepCBC’s full (8 page) submission:
These researchers think they have a solution to the global crisis in drug prices
November 4, 2016
Jerome Zeldis remembers exactly how he felt when he heard about the $84,000 price tag on a powerful new hepatitis C treatment three years ago. “I was somewhere between annoyed and outraged,” recalled Zeldis, the former chief medical officer of the biotech juggernaut Celgene. So he has started Trek Therapeutics as a public benefit corporation – a relatively new type of corporate structure that places public welfare on equal footing with profit.
DAA Combination Treatment Fast and Effective for Hepatitis C
November 3, 2016
Sofosbuvir, velpatasvir, and voxilaprevir for 8 weeks does the trick across all genotypes, treatment experienced, DAA relapse or cirrhosis! Two phase 2 studies of combination direct-acting antiviral agent (DAA) treatments were published recently in Gastroenterology. They were accompanied by an editorial simply titled “Hepatitis C Therapy: Game Over!”
What Are the Out of Pocket Costs for Harvoni, Viekira Pak and Epclusa under Medicare Part D?
November 3, 2016
We often get asked this question by American visitors to our site, and we hope this page will help provide the answers you need. Not all drugs are covered by Medicaid but there are “coupons” that you can use. The information is from GoodRX. This is for the USA only.
Vietnam vets urged to receive hepatitis C testing
November 2, 2016
American Legion Post 1619 is working on a statewide awareness campaign and urging all Vietnam-era veterans to get tested for hepatitis C. Two free clinics are scheduled for Nov. 4 and 5 in Morrisonville. MORRISONVILLE NY — The boot camp ritual was robotic in its precision. Soldiers lined up for their vaccination shots. Needles were outdated, “jet guns” were in, and soldiers received high pressure blasts of an 18-drug cocktail before being shipped off.
Acute hepatitis after heavy energy drink use ‘a warning to the consumer,’ liver specialist says
November 1, 2016
Construction worker relied on 4 to 5 bottles a day to get through his shift A construction worker who consumed an excessive amount of energy drinks developed a rare case of acute hepatitis, say doctors who want patients to know about the potential risks to the liver from such over-consumption.
HCV reinfection common in MSM with HIV
November 1, 2016
In a retrospective study, researchers found that hepatitis C virus reinfection is common among HIV-positive men who have sex with men after successful treatment and spontaneous clearance. “A subsequent high incidence of HCV reinfection has been reported regionally in men who both clear the infection spontaneously or who respond to treatment.
Recurrent viremia infrequent in hepatitis C
November 1, 2016
The prevalence of recurrent viremia was low among patients with hepatitis C who achieved sustained virologic response, data from a recently published study demonstrate. Among those patients who did experience late recurrent viremia, most had HCV reinfection. (HCV reinfection common in MSM with HIV).
Two genes linked to increase in immunity to hepatitis C after childbirth, study shows
October 31, 2016
Alternative forms of two genes are associated with a boost in immunity to hepatitis C after childbirth, a study led by a Nationwide Children’s Hospital physician-researcher shows. At three months postpartum, the number of viruses circulating in the blood declined sharply in most women who carried particular versions of IFNL3 and HLA-DPB1 genes. Mothers lacking these gene variants experienced little change in viral levels after delivery.
Tampa Bay woman with Hepatitis C reduces co-pay for treatments with coupon
October 31, 2016
PASADENA, FL (WFLA) — The FDA has approved several new cures for people fighting chronic diseases, but the problem is, many people can’t afford the drugs and insurance companies will cover only the sickest patients. That includes a drug now on the market for people with Hepatitis C called Harvoni — a pill that patients take for 8 to 12 weeks. Wendy Latorre, of Pasadena, says when she heard about the drugs she was extremely hopeful. “And then she found out the cost!
Dating after Hepatitis C: Hope on the horizon for the 1 in 30 boomers estimated to be infected
October 30, 2016
Baby boomers are 6 times more likely to be infected than other adults. We need to talk about testing and treatment. Recently I went on a first date — a stroll in a city park — that went rather well. We had so much in common, from a love of reading to a history of youthful troublemaking. If I wasn’t convinced already he was someone I could relate to, my new friend shared that he’d been cured of Hepatitis C. I could hardly believe it.
Why all those discarded needles are signs of progress for HIV, Hep C in Southern Interior
October 29, 2016
THOMPSON-OKANAGAN – Nearly 400 new Hepatitis C cases and as many as 15 HIV cases were recorded by Interior Health last year, and most were caused by injection drug use. The numbers may seem surprisingly high, but are average compared to recent years, according to senior medical health officer Dr. Trevor Corneil, who says they’ve actually been on an overall downward trend over the past 15 years with the advent of harm reduction strategies.
Generic hepatitis C drugs purchased online achieve high cure rates
October 28, 2016
Use of generic versions of direct-acting antivirals resulted in very high cure rates for people who obtained the products through three buyers’ clubs, indicating that the generic products are effective, according to three presentations at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow) this week. People who purchased the drugs were cured of hepatitis C at a cost of around $700-$900 in South-East Asia and Eastern Europe.
I have a little news of my own, I just found out my son is getting married! Enjoy the rest of your weekend folks.
Tina
Buyers clubs for cheaper drugs help fight hepatitis and HIV
Buyers clubs for cheaper drugs help fight hepatitis and HIV
Frustrated by the high price of antiviral drugs, thousands of patients from London to Moscow to Sydney are turning to a new wave of online "buyers clubs" to get cheap generic medicines to cure hepatitis C and protect against HIV infection.
While regulators warn that buying drugs online is risky, scientific data presented at a recent medical conference suggest that treatment arranged through buyers club can be just as effective as through conventional channels.
Continue reading....
Frustrated by the high price of antiviral drugs, thousands of patients from London to Moscow to Sydney are turning to a new wave of online "buyers clubs" to get cheap generic medicines to cure hepatitis C and protect against HIV infection.
While regulators warn that buying drugs online is risky, scientific data presented at a recent medical conference suggest that treatment arranged through buyers club can be just as effective as through conventional channels.
Continue reading....
Saturday, November 5, 2016
Lawmakers Hear From Organ Harvesting Investigators
In "2006" international human rights lawyer David Matas and attorney David Kilgour released their initial investigative report into allegations of live organ harvesting in China, the primary organ source was Falun Gong practitioners. Provided further down this post is their latest report, presented at a House of Commons hearing on Nov 3, 2016.
Here is a little background on the plight of Falun Gong practitioners in China;
Chinese Spiritual Practice
Falun Gong, is a Chinese spiritual practice for mind and body is centered on the belief of Truthfulness, Compassion, and Forbearance. The spiritual practice began in China in 1992 and was soon banned by the Chinese government in 1999, what followed were allegations of the arrest and execution of tens of thousands of followers by Chinese authorities.
Brief history of the plight of persecution of Falun Gong practitioners in China
On 20 July 1999, the Communist Party leadership initiated a nationwide crackdown and multifaceted propaganda campaign intended to eradicate the practice. It blocked Internet access to websites that mention Falun Gong, and in October 1999 it declared Falun Gong a "heretical organization" that threatened social stability. Falun Gong practitioners in China are reportedly subject to a wide range of human rights abuses: hundreds of thousands are estimated to have been imprisoned extrajudicially, and practitioners in detention are subject to forced labor, psychiatric abuse, torture, and other coercive methods of thought reform at the hands of Chinese authorities. As of 2009, human rights groups estimated that at least 2,000 Falun Gong practitioners had died as a result of abuse in custody. Some observers put the number much higher, and report that tens of thousands may have been killed to supply China's organ transplant industry.
Source - Wikipedia
Former Chinese Hospital Worker’s Account of Organ Harvesting
In an article published last month from China Uncensored, an employee who worked at the Tianjin First Central Hospital in the mid-2000s also known as the Orient Organ Transplant Center because it was located in China and had an extremely large amount of organ transplant patients, provided a statement to New Tang Dynasty Television about the experience;
I’m currently living in mainland China. Once, I worked at the organ transplant center in Tianjin First Central Hospital. What I’ve learned could perhaps serve as a rare warning to those who persist in persecuting Falun Gong. It’s also a cautionary tale for my fellow countrymen with a conscience.
Many of the foreign transplant patients came to China looking for a liver or kidney. The bulk of these foreigners were South Koreans, while the rest came from Japan or Taiwan.
At the time, I wasn’t aware that the organs these foreigners had spent large sums of money to purchase came from Falun Gong practitioners. Many of us were too naive, and didn’t imagine that those blinded by money had in fact been brainwashed by the Chinese Communist Party.
Read a translation of the complete statement, here.
Nov 4
Canadian Lawmakers Hear From Organ Harvesting Investigators
 |
Matas and Kilgour provided a briefing
on organ transplantation abuse in China
|
Human rights subcommittee urged to help stop organ pillaging from prisoners of conscience in China
OTTAWA—Two investigators who have spent 10 years researching evidence of forced organ harvesting from prisoners of conscience in China told Parliament’s human rights subcommittee that the practice of killing for profit-driven transplants continues unabated in China today.
International human rights lawyer David Matas and former Crown attorney and cabinet minister David Kilgour presented the findings of their latest report, released in June, at a House of Commons hearing on Nov. 3.
Based on an analysis of over 700 organ transplantation centres in China, the report indicated that Chinese hospitals have performed an estimated 60,000 to 100,000 organ transplants a year since the year 2000, and that most of the organs were sourced from innocents—Uyghurs, Tibetans, House Christians, with Falun Gong practitioners being the primary source....
Continue reading...
International human rights lawyer David Matas and former Crown attorney and cabinet minister David Kilgour presented the findings of their latest report, released in June, at a House of Commons hearing on Nov. 3.
Based on an analysis of over 700 organ transplantation centres in China, the report indicated that Chinese hospitals have performed an estimated 60,000 to 100,000 organ transplants a year since the year 2000, and that most of the organs were sourced from innocents—Uyghurs, Tibetans, House Christians, with Falun Gong practitioners being the primary source....
Continue reading...
Nov 2
Six Ways to Stop Organ Harvesting in China
A forum in Germany proposes a series of concrete responses to abuses in China
Friday, November 4, 2016
AASLD - Shorter Hep C Regimens Hot Topic at the Liver Meeting 2016
The Liver Meeting 2016: American Association for the Study of Liver Diseases (AASLD)
Medscape Medical News, November 4, 2016
Shorter Hep C Regimens Hot Topic at the Liver Meeting
Medscape-40 minutes ago
BOSTON — Shortening the length of curative regimens for hepatitis C treatment will be one of the hot topics here at The Liver Meeting 2016.
One study likely to garner significant interest examines an investigational conjugated drug (RG-101) that, used in combination with oral direct-acting antivirals, can produce high rates of sustained responses after just 4 weeks of therapy in patients with genotypes 1 and 4 hepatitis C.
Continue Reading....
Young Adults' Problem Drinking May Have Lasting Health Effects
Young Adults' Problem Drinking May Have Lasting Health Effects
PISCATAWAY, NJ – Young adults with symptoms of alcohol dependence may see health effects late in life—even decades after conquering their problem drinking, according to a study in the November 2016 issue of the Journal of Studies on Alcohol and Drugs.
Researchers found that, of 664 U.S. male veterans, those who had symptoms of alcohol dependence for at least five years in young adulthood generally had poorer physical and mental health by the time they were in their 60s.
And that was true even if they'd gotten control over their drinking problems by the age of 30.
The findings are surprising, said lead researcher Randy Haber, Ph.D., of the Palo Alto Veterans Affairs Health Care System, in Menlo Park, Calif.
It's clear that people's lives improve when alcohol dependence goes into remission, Haber pointed out, but it is not clear whether there are hidden consequences that remain after heavy drinking has ceased. For instance, evidence shows that both brain and body are affected by excessive drinking, but we don’t know how long these effects last.
The new findings suggest that years of alcohol dependence during young adulthood result in silent but "permanent" injuries that, in later life, appear to result in serious health problems, according to Haber.
The findings are based on men taking part in a larger study of Vietnam-era veterans. Haber's team focused on 368 men who did not report any symptoms of alcohol dependence at any point in adulthood, 221 who had at least three symptoms of dependence in young adulthood and middle-age and 75 who had symptoms in early adulthood but not after the age of 30.
Overall, the study found that men who had alcohol dependence symptoms for at least five years in early adulthood scored lower on standard measures of both physical and mental health once they'd reached their 60s.
For example, those with alcohol dependence in young adulthood had, on average, three medical conditions in later life whereas those without this history reported two. In addition, their scores on a depression scale were about twice as high.
Most important, these effects were seen even among men who'd been free of dependence symptoms for several decades.
The reasons are unclear. But, Haber said, other studies have shown that chronic drinking may injure parts of the brain involved in emotional regulation, self-control and decision making. It's possible, he noted, that years of alcohol exposure in early adulthood could have lasting effects on those brain areas.
Still, Haber stressed that this study is reporting "averages" and not what any one person is destined for.
He said that people who not only quit problem drinking but also turn their lifestyle around—eating well, not smoking and just generally "taking care of themselves"—will likely see health benefits that last into late life.
Plus, he said, there is a "whole body of literature" showing that when people with alcohol dependence go into recovery, their lives improve in almost every area.
"If you have entered (alcohol dependence) recovery, keep going," Haber said. "Live your life to its fullest."
Haber, J. R., Harris-Olenak, B., Burroughs, T., & Jacob, T. (November 2016). Residual effects: Young adult diagnostic drinking predicts late-life health outcomes. Journal of Studies on Alcohol and Drugs, 77(6), 859–867. doi:10.15288/jsad.2016.77.859
To arrange an interview with Randy Haber, Ph.D., please contact Michael Hill-Jackson at the VA Office of Public Affairs at 650-444-7380 or michael.hill-jackson@va.gov.
The Journal of Studies on Alcohol and Drugs (www.jsad.com) is published by the Center of Alcohol Studies at Rutgers, The State University of New Jersey. It is the oldest substance-related journal published in the United States.
To learn about education and training opportunities for addiction counselors and others at the Rutgers Center of Alcohol Studies, please visit AlcoholStudiesEd.rutgers.edu.
PISCATAWAY, NJ – Young adults with symptoms of alcohol dependence may see health effects late in life—even decades after conquering their problem drinking, according to a study in the November 2016 issue of the Journal of Studies on Alcohol and Drugs.
Researchers found that, of 664 U.S. male veterans, those who had symptoms of alcohol dependence for at least five years in young adulthood generally had poorer physical and mental health by the time they were in their 60s.
And that was true even if they'd gotten control over their drinking problems by the age of 30.
The findings are surprising, said lead researcher Randy Haber, Ph.D., of the Palo Alto Veterans Affairs Health Care System, in Menlo Park, Calif.
It's clear that people's lives improve when alcohol dependence goes into remission, Haber pointed out, but it is not clear whether there are hidden consequences that remain after heavy drinking has ceased. For instance, evidence shows that both brain and body are affected by excessive drinking, but we don’t know how long these effects last.
The new findings suggest that years of alcohol dependence during young adulthood result in silent but "permanent" injuries that, in later life, appear to result in serious health problems, according to Haber.
The findings are based on men taking part in a larger study of Vietnam-era veterans. Haber's team focused on 368 men who did not report any symptoms of alcohol dependence at any point in adulthood, 221 who had at least three symptoms of dependence in young adulthood and middle-age and 75 who had symptoms in early adulthood but not after the age of 30.
Overall, the study found that men who had alcohol dependence symptoms for at least five years in early adulthood scored lower on standard measures of both physical and mental health once they'd reached their 60s.
For example, those with alcohol dependence in young adulthood had, on average, three medical conditions in later life whereas those without this history reported two. In addition, their scores on a depression scale were about twice as high.
Most important, these effects were seen even among men who'd been free of dependence symptoms for several decades.
The reasons are unclear. But, Haber said, other studies have shown that chronic drinking may injure parts of the brain involved in emotional regulation, self-control and decision making. It's possible, he noted, that years of alcohol exposure in early adulthood could have lasting effects on those brain areas.
Still, Haber stressed that this study is reporting "averages" and not what any one person is destined for.
He said that people who not only quit problem drinking but also turn their lifestyle around—eating well, not smoking and just generally "taking care of themselves"—will likely see health benefits that last into late life.
Plus, he said, there is a "whole body of literature" showing that when people with alcohol dependence go into recovery, their lives improve in almost every area.
"If you have entered (alcohol dependence) recovery, keep going," Haber said. "Live your life to its fullest."
Haber, J. R., Harris-Olenak, B., Burroughs, T., & Jacob, T. (November 2016). Residual effects: Young adult diagnostic drinking predicts late-life health outcomes. Journal of Studies on Alcohol and Drugs, 77(6), 859–867. doi:10.15288/jsad.2016.77.859
To arrange an interview with Randy Haber, Ph.D., please contact Michael Hill-Jackson at the VA Office of Public Affairs at 650-444-7380 or michael.hill-jackson@va.gov.
The Journal of Studies on Alcohol and Drugs (www.jsad.com) is published by the Center of Alcohol Studies at Rutgers, The State University of New Jersey. It is the oldest substance-related journal published in the United States.
To learn about education and training opportunities for addiction counselors and others at the Rutgers Center of Alcohol Studies, please visit AlcoholStudiesEd.rutgers.edu.
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