Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.

For more information on how to use this blog, the HCV drug pipeline, and for more information on HCV clinical trials
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Alan Franciscus

Editor-in-Chief

HCV Advocate



Monday, October 5, 2015

Patients have mixed feelings about hepatitis drugs

By Vickie Aldous
Mail Tribune

Posted Oct. 4, 2015 at 12:01 AM

Patients who have coped for years with hepatitis C have had mixed reactions to new drugs that can cure the disease, from elation about the treatment to shock about the price.

One Southern Oregon woman who asked not to be named said she went through a six-month course of older medication, but suffered side effects such as internal bleeding that required her to be hospitalized and given blood transfusions. The grueling treatment cleared her body of the virus, but three months later, the virus reemerged.

In March 2014, she started a three-month course of Sovaldi, a new medication which produced no side effects and wiped the virus from her body. The virus has not returned.

Read more....

NYU Researchers Find Development of Serious Liver Damage in Mid- to Late-adulthood Among People Who Inject Drugs with Untreated Chronic Hepatitis C Infection

October 5, 2015
N-56 2015-16

Few people who inject drugs are engaged in needed care for chronic HCV infection; Early engagement in treatment needs to be a policy priority for these individuals

The Hepatitis C virus (HCV) infection is a chronic blood-borne viral infection that affects an estimated 160 million people, or 2-3% of the population world-wide. Alarmingly, chronic HCV infection accounts for one-quarter of the cases of cirrhosis and hepatocellular carcinoma (HCC). If HCV is left untreated, chronic liver disease will occur in 60–70% of the cases, cirrhosis in 5–20% of the cases, and 1–5% will die from decompensated cirrhosis or HCC.

In most high-income countries, such as the United States, where drug injection is the primary route of HCV transmission, the disease is concentrated among people who inject drugs (PWID). While it is estimated that 50–80% of PWID are chronically infected, fewer than 5% of PWID have received treatment.

In a new study, “Hepatitis C virus (HCV) disease progression in people who inject drugs (PWID): A systematic review and meta-analysis,” published in the International Journal of Drug Policy, a team of researchers from New York University’s Center for Drug Use and HIV Research (CDUHR) assessed existing data on the natural history of HCV among PWID. A total of twenty-one studies examined over 8500 PWID, who contributed nearly 120,000 person-years at risk, for the study of four major HCV-related outcomes included in the synthesis.

Read more....

Sunday, October 4, 2015

"All Natural" Alternatives for Erectile Dysfunction: A Risky Proposition

Since everything is processed by the liver, I thought it was important to post this warning...Alan

Men, beware! Products falsely marketed as “dietary supplements” or “foods” that promise to enhance your sexual performance or increase sexual stimulation might contain hidden drug ingredients or other undisclosed ingredients — and can endanger your health.

Thus far, FDA lab tests have found that nearly 300 of these products contain undisclosed drug ingredients. These can include the same active ingredients found in prescription drugs that are FDA-approved for the treatment of erectile dysfunction (ED), such as Viagra, Cialis and Levitra. Not only do these products contain undisclosed drug ingredients, but they also sometimes may include combinations of undisclosed ingredients or excessively high doses, both potentially dangerous situations.

Even a cautious consumer can’t tell that these products are, in fact, tainted with undisclosed drug ingredients, because their labels do not list the potentially hazardous ingredients, says M. Daniel Dos Santos, Pharm.D., Ph.D., of FDA’s Division of Dietary Supplement Programs. Consumers may be misled to believe these products are safe because their labeling often suggests they are “all-natural” or “herbal” alternatives to FDA-approved prescription drugs for the treatment of ED.

Read more....

Friday, October 2, 2015

Regulus to Present Updated Data Supporting RG-101 as Novel microRNA Therapeutic for the Treatment of HCV at The Liver Meeting® 2015 (AASLD)

-Phase I Clinical Data will be Featured in Viral Hepatitis Plenary Session-

LA JOLLA, Calif., Oct. 2, 2015 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that two abstracts related to RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 ("miR-122") for the treatment of chronic Hepatitis C Virus (HCV) infection, were accepted for presentation at The Liver Meeting®, the 66th Annual Meeting of the American Association for the Study of Liver Disease (AASLD), to be held November 13-17, 2015 in San Francisco, CA.

Viral Hepatitis Plenary Session, November 17, 2015, 8:45am - 9:00am: A Single Dose of RG-101, a GalNAc-Conjugated Oligonucleotide Targeting miR-122, Results in Undetectable HCV RNA Levels in Chronic Hepatitis C Patients at Week 28 of Follow-up

Investigators will present extended follow-up data from the Phase I clinical study of RG-101 demonstrating that a single subcutaneous administration of either 2 mg/kg or 4 mg/kg of RG-101 as monotherapy resulted in HCV RNA levels below the limit of quantification in 6/22 patients with various HCV genotypes at week 28 of follow-up.

Poster Presentation, November 17, 2015, 8:00am - 12:00pm: Treatment with the Anti-miRNA122 Oligonucleotide RG-101 Results in a Decrease in IP-10 but Does Not Affect the Levels of Other Cytokines in Patients with Chronic Hepatitis C

Investigators will present data examining immunological changes observed in the plasma of patients who received a subcutaneous administration of RG-101 in the completed Phase I study.
Results demonstrated that HCV patients had significantly higher IP-10 levels at baseline compared to healthy controls. In HCV patients who received a subcutaneous administration of RG-101, a significant decline was observed in IP-10 serum concentrations compared to baseline, and RG-101 did not trigger a systemic immune activation

Read more....

Thursday, October 1, 2015

AbbVie Demonstrates Commitment to Hepatitis C Patients with New Data on VIEKIRA PAK™ and Ongoing Clinical Development Program at The Liver Meeting® 2015

Note:  There are some interesting studies of AbbVie drugs being presented that will feature new combination of drugs that will offer shorter treatment durations and more treatment options for people with genotypes 1, 2 and 3.  

- New data to be presented on VIEKIRA PAK in genotype 1 hepatitis C patients with chronic kidney disease and on AbbVie's investigational HCV pipeline medicines, ABT-493 and ABT-530

NORTH CHICAGO, Ill., Oct. 1, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research-based biopharmaceutical company, today announced that 34 abstracts from its chronic hepatitis C clinical development program have been accepted for presentation at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco from November 13-17, further demonstrating AbbVie's strong leadership and ongoing commitment to patients with chronic hepatitis C virus (HCV) infection.

Presentations will highlight new data from Phase 3b studies of AbbVie's FDA-approved VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets), taken with or without ribavirin (RBV), for adults with genotype 1 (GT1) chronic HCV infection, including studies of GT1 patients with chronic kidney disease and genotype 1b (GT1b) patients with compensated cirrhosis. Additionally, new clinical studies will be presented on AbbVie's HCV pipeline medicines, ABT-493 and ABT-530, focused on investigating pan-genotypic, ribavirin-free, once-daily treatment options that may allow for shorter treatment durations of as little as eight weeks.

"We are pleased to present new data from studies of the VIEKIRA PAK regimen in HCV patients, including those with chronic kidney disease and GT1b compensated cirrhosis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These data, as well as our findings from our investigational compounds, further demonstrate AbbVie's firm commitment to supporting the care of patients with chronic HCV infection."

Select AbbVie clinical presentations include:

RUBY-I: Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir +/- Ribavirin in Non-Cirrhotic HCV Genotype 1-infected Patients With Severe Renal Impairment or End-Stage Renal Disease; Pockros, P, et al.; Poster #1039; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)RUBY-I is an ongoing open-label study evaluating 3D+/-RBV in patients with stage four or five chronic kidney disease and GT1 infection.

TURQUOISE-III: 12-Week Ribavirin-Free Regimen of Ombitasvir/Paritaprevir/r and Dasabuvir for Patients with HCV Genotype 1b and Cirrhosis; Poordad, F, et al.; Poster #1051; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)Hepatitis C virus infected patients have historically been more difficult to treat when they have cirrhosis. This poster reports on the safety and efficacy of the 3D regimen without RBV in patients with HCV GT1b infection and compensated cirrhosis. VIEKIRA PAK is not recommended for patients with decompensated liver disease.

Efficacy, Change in MELD Score, and Safety by Baseline MELD Score in Patients With Compensated Cirrhosis Receiving Ombitasvir/Paritaprevir/r and Dasabuvir Plus Ribavirin in Phase 3 TURQUOISE-II Trial; Jacobson, I, et al.; Poster #1106; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)Model for end-stage liver disease (MELD) scores assess liver disease severity. In this analysis, the efficacy and safety of 3D+RBV and changes in MELD score by baseline MELD score is evaluated.

Preliminary Safety and Efficacy Results in TOPAZ-II: A Phase 3b Study Evaluating Long-Term Clinical Outcomes in HCV Genotype 1-infected Patients Receiving Ombitasvir/Paritaprevir/r and Dasabuvir +/-Ribavirin; Reau, N, et al.; Poster #1065; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)TOPAZ-I (ex-U.S.) and TOPAZ-II (U.S.) are evaluating the impact of SVR12 on the progression of liver disease through five years post-treatment in a broad population of HCV GT1-infected patients receiving 3D+/-RBV. This interim analysis reports on-treatment safety and efficacy of 3D+/-RBV among patients in the TOPAZ-II study.

Long-Term Efficacy of Ombitasvir/Paritaprevir/r and Dasabuvir With or Without Ribavirin in HCV GT1-Infected Patients With or Without Cirrhosis; Zeuzem, S, et al.; Poster #1086; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)In this analysis, the efficacy through post-treatment week 48 of the 3D regimen in HCV GT1-infected patients with or without cirrhosis is examined.

SVR4 Results in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or Pegylated Interferon/Ribavirin Null Responders with the Combination of the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 (SURVEYOR-1); Poordad, F, et al.; Oral presentation #41; Sunday, November 15, 2015, 4:00 p.m. – 4:15 p.m. PT; Parallel Session 5, Hep C Clinical TrialsIn this Phase 2 study, treatment with ABT-493 and ABT-530 for 12 weeks is evaluated in HCV GT1-infected subjects without cirrhosis. Efficacy and safety results are reported.

SVR4 Rates with the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 2 Infection (SURVEYOR-2); Wyles, D, et al.; Oral presentation #250; Tuesday, November 17, 2015; 12:00 p.m. – 12:15 p.m. PT; General Session, Parallel 37: Hepatitis C: Pre-approval Clinical Studies IIThis presentation evaluates the efficacy and safety of ABT-493 and ABT-530 with or without RBV in non-cirrhotic GT2-infected treatment-naïve and pegylated interferon/RBV treatment-experienced subjects.

SVR4 Rates with the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 3 Infection (SURVEYOR-2); Kwo, P, et al.; Oral presentation #248; Tuesday, November 17, 2015, 11:30 a.m.– 11:45 a.m. PT; General Session, Parallel 37: Hepatitis C: Pre-approval Clinical Studies IIThis presentation evaluates the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in non-cirrhotic GT3-infected treatment-naïve and pegylated interferon/RBV treatment-experienced subjects.

Select Health Economics and Outcomes Research (HEOR) abstracts include:

Lifetime Risks of Liver Morbidity and Mortality in Patients with Chronic Genotype 1 Hepatitis C Virus and HIV Coinfection Treated with 3D±R (Ombitasvir/ Paritaprevir/ Ritonavir, Dasabuvir ± Ribavirin) vs other Standards of Care in the U.S.; Saab, S, et al.; Poster #1087; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m.

Hepatitis C: Therapeutics (Approved Agents).  This study evaluates the lifetime risks of liver morbidity and mortality in patients with GT1 HCV and HIV coinfection treated with 3D±R for 12 or 24 weeks compared to other standards of care in the U.S.PT

The Healthcare Cost Burden of HCV-infected Baby Boomers in the U.S.; Brookmeyer R, et al.; Poster #1068; Sunday, November 15, 2015,  8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)This study quantifies healthcare costs for 50-64 year-old "baby boomers" with HCV by diagnosis and insurance status.

The full AASLD 2015 scientific program can be found at www.aasld.org.

HCV Advocate Eblast: October 1, 2015

Check out what we have in store for you in the October 2015 Newsletter -

HCV Drugs by Alan Franciscus, Editor-in-Chief

Read about Achillion’s latest clinical trial results from their PROXY study, information about insurance denials, how far we have come in treating the most difficult to treat patients, but how far we still have to go to cure everyone with hepatitis C, drug-drug interactions and re-treatment issues.

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HealthWise by Lucinda K. Porter, RN

In this month’s column, Lucinda answers some important post-treatment questions from people living with hepatitis C.

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What The Heck Are RAVs? by Alan Franciscus, Editor-in-Chief

If you have been treated before with a direct-acting antiviral medication, but not cured, this brief overview is an important topic to understand.

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SnapShots by Alan Franciscus, Editor-in-Chief

Three studies that look at treating people with advanced liver disease and re-treatment  of people who had been previously treated with direct-acting antiviral medications but did not achieve a cure.

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What's New? by Alan Franciscus, Editor-in-Chief

We have merged our HBV Website to our HCV Website – find out more…. Don’t forget to check out our newly re-designed Facebook and Twitter accounts!  Just go to Facebook and Twitter and type in 'HCV Advocate'.  Follow us and learn all the latest information about hepatitis C and about what we are doing.


To read the newsletter click here

The Five: Coffee —Alan Franciscus, Editor-in-Chief

In celebration of National Coffee Day.....but remember adding a bunch of sugar and cream most likely eliminates the benefits! Alan

For some people that morning cup of Joe is the perfect way to start the day.   Surprisingly, there are many published studies that show that caffeinated coffee can improve the health of the liver and provide other health benefits.  There are some caveats to these health claims that I will discuss at the end of this article.  First let’s talk about the good news—the possible health benefits:

1. Liver Fibrosis / HCV Disease Progression:  
In a review of 177 patients—121 patients with HCV who drank about 2 ¼ cups of coffee a day were found to have reduced levels of liver fibrosis.  The results were only found in those who drank caffeinated coffee.

In another review, 766 participants in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial found more good news.  Those who had hepatitis C-related bridging fibrosis or cirrhosis on a liver biopsy and who failed to achieve a cure after being treated with pegylated interferon and ribavirin therapy also yielded some surprising results.  Those with advanced liver disease who regularly consumed coffee were found to have lower rates of HCV disease progression.

2. Liver Cancer: 
A small study found that people who drank one to three cups of coffee a day had a 29% lower risk of developing liver cancer compared to those who drank 6 cups or less a week.

Another study which reviewed 16 different studies involving over 3,200 patients found that drinking more than 3 cups of coffee a day might cut the risk of liver cancer by up to 50%.

3. Other Conditions:  
There are many studies that show a link between the reduction or prevention of certain types of cancers and drinking caffeinated coffee (skin, breast, colon, prostate, uterine, oral).  There are also studies that show that caffeinated coffee can lower the risk of diabetes and death.

4. The Downside: 
Now, I am going to burst the bubble!  Coffee, specifically caffeine, is a drug (a stimulant).  Moreover, with any drug you can have withdrawal: It can take more than eight weeks to withdraw entirely from caffeine—although, caffeine withdrawal is usually just an annoying headache and some light fatigue.
Drinking or consuming caffeine can raise blood pressure, lead to heart arrhythmia (irregular heartbeats), can cause cramps, diarrhea and other gastrointestinal health issues.  If you drink it too close to bedtime, it can cause insomnia.  Too much caffeine can cause depression, anxiety and other types of nervous behaviors.    Although rare there have been serious health consequences from people drinking energy drinks and shots.

Examples of the typical amount of caffeine:*

  • Coffee – 100 mg per cup
  • Tea – 14 mg to 60 mg per cup
  • Chocolate – 45 mg in 1.5 oz bar
  • Most colas (unless they are labeled “caffeine-free”) – 45 mg in 12 oz. drink
  • Candies, energy drinks, snacks, gum – 40-100 mg per serving

*http://www.nlm.nih.gov/medlineplus/ ency/article/002445.htm

There are many other side effects of caffeine, but I will stop here.  However, for most people caffeine in moderation is safe and well-tolerated!

5. Final Thoughts:  
What does all of this mean?   It is hard to draw concrete conclusions from these studies because you cannot measure what people drink, how it is made and what chemicals are in the coffee.  However, there must be something in caffeinated coffee that is contributing to all of these positive outcomes.  There are over 1,000 natural chemicals in coffee, and some of these chemicals may be contributing to the caffeine and providing these benefits.  Scientists are studying the various chemicals, and we may soon have more concrete information that may lead the way to more potent medications to treat many conditions.  In the meantime, it could not hurt to have a cup of Joe—that is if your health allows it.