Hello everyone, here is a look back at this weeks research and headlines.
HCV treatment in elderly patients
Lucinda Porter RN
The age that hepatitis C was acquired may have an impact on prognosis. A number of studies have reported that individuals who are infected with hep C at older ages tend to have a worse prognosis than those who acquire hep C while young. People over age 40 more likely to develop HCV-related liver cancer. Age can also have a negative impact on liver transplantation survival; older liver transplant recipients have a significantly lower survival rate than younger patients...
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July 27
Battling hepatitis C in the elderly
Plenty of studies have been done globally for younger adults, but seniors have different risk factors and comorbidities, notes an article in Clinical Gastroenterology and Hepatology journal. “Although the safety and efficacy of hepatitis C therapies have been extensively studied in patients between ages of 18 and 65, patients who are over 65 still remain an understudied and difficult to treat population,” the authors write...
July 17
Treatment of Chronic Hepatitis C in the Aged – Does It Impact Life Expectancy? A Decision Analysis
Since currently complications of HCV mostly affect members of the elderly population, they are in urgent need of effective HCV treatment. The approach we suggest for the treatment of patients over 70 with chronic HCV is illustrated in Fig 3. For those patients who have no major co-morbidities, more than moderate fibrosis, and a life expectancy greater than one year, there is a possibility of offering treatment. This needs to be presented to the patient and discussed before a final decision...
Download Full Text Article Battling hepatitis C in the elderly
Plenty of studies have been done globally for younger adults, but seniors have different risk factors and comorbidities, notes an article in Clinical Gastroenterology and Hepatology journal. “Although the safety and efficacy of hepatitis C therapies have been extensively studied in patients between ages of 18 and 65, patients who are over 65 still remain an understudied and difficult to treat population,” the authors write...
July 17
Treatment of Chronic Hepatitis C in the Aged – Does It Impact Life Expectancy? A Decision Analysis
Since currently complications of HCV mostly affect members of the elderly population, they are in urgent need of effective HCV treatment. The approach we suggest for the treatment of patients over 70 with chronic HCV is illustrated in Fig 3. For those patients who have no major co-morbidities, more than moderate fibrosis, and a life expectancy greater than one year, there is a possibility of offering treatment. This needs to be presented to the patient and discussed before a final decision...
*Commentary on this article is available in the August issue of HCV Advocate.
Fibrosis
Aug 12
A study in women coinfected with hepatitis C and HIV found that use of marijuana was not associated with progression to advanced liver fibrosis...
Aug 12
CNN
Marijuana will remain a Schedule l controlled substance, which declares it has "no currently accepted medical use and a high potential for abuse," the Drug Enforcement Administration said Thursday. This keeps the drug in the same category as heroin, LSD and Ecstasy...
Why the US decision to expand marijuana supply for research matters
Aug 12
CNN
Marijuana will remain a Schedule l controlled substance, which declares it has "no currently accepted medical use and a high potential for abuse," the Drug Enforcement Administration said Thursday. This keeps the drug in the same category as heroin, LSD and Ecstasy...
Why the US decision to expand marijuana supply for research matters
Aug 12
Policy change could accelerate development of treatments derived from the drug.
Study finds clues to fibrosis progression in chronic HCV infection
Aug 11
Fibrosis progression in hepatitis C virus–infected individuals is not linear, is associated with alanine aminotransferase–related flares, and varies according to stage, with those who are least fibrotic tending to have the highest progression, according to a study...
Facebook
Non-Profit Organization · Iron City, Tennessee
A annual festival to raise money , promote awareness of natural healing plants and support legalization of them. This event is held @ Sycamore campground .
Liver Cancer
As a terminator of hepatitis C virus (HCV) infection, sofosbuvir-based direct-acting antiviral agent (DAA) regimens have achieved great success in the eradication of HCV in patients with hepatitis C and related end stage liver diseases[[1], [2]]. Recently, we read with interest the studies by Reig et al.[3 and Kozbial et al.[4 on the surprisingly high incidence of hepatocellular carcinoma (HCC) recurrence and occurrence in patients with advanced liver diseases during interferon-free therapy and after sustained virologic response (SVR), respectively. Notably, the time interval between the initiation of DAAs (or SVR) and tumour occurrence is very short. These studies promote the current awareness and understanding of the risk for hepatocarcinogenesis in the era of DAAs. However, similar episodes have not frequently been observed in Chinese patients until now...
Related
Alcohol Intake Increases Risk for HCC in Patients With HCV-Related Cirrhosis
July
Alcohol consumption — including light-to-moderate — was associated with an increased risk for hepatocellular carcinoma among patients with hepatitis C virus infection-related cirrhosis, according to published findings.
Liver Transplant
National proposal aims for fairer liver transplant distribution
August 11, 2016 by Sean D. Hamill, Pittsburgh Post-Gazette
The organization that oversees the nation's transplant system said Wednesday that it believes a new proposal would greatly reduce geographic disparities that make getting a liver transplant harder in some areas of the country and easier in others...
Related
Alcohol Intake Increases Risk for HCC in Patients With HCV-Related Cirrhosis
July
Alcohol consumption — including light-to-moderate — was associated with an increased risk for hepatocellular carcinoma among patients with hepatitis C virus infection-related cirrhosis, according to published findings.
Liver Transplant
National proposal aims for fairer liver transplant distribution
August 11, 2016 by Sean D. Hamill, Pittsburgh Post-Gazette
The organization that oversees the nation's transplant system said Wednesday that it believes a new proposal would greatly reduce geographic disparities that make getting a liver transplant harder in some areas of the country and easier in others...
Aug 13
Hospitals across the United States are throwing away less-than-perfect organs and denying the sickest people lifesaving transplants out of fear that poor surgical outcomes will result in a federal crackdown..
Healthy You
Video
Is There a Special Diet for Liver Disease Patients?
Aug 10
by Dr. Joe Galati
Probably the most common question I am asked, is regarding a special diet to follow if you have liver problems. Here is an updated answer to these questions...
Aflatoxin Alert: Moldy Nuts and Corn Increases Your Liver Cancer Risk 60-Times If You Have Hepatitis B
August 10
One of the biggest health threats to people living with chronic hepatitis B is a toxic, nearly invisible mold called aflatoxin found in corn, peanuts, peanut butter, almonds, Brazil nuts, walnuts and pistachios. People with hepatitis B who eat food with high levels of aflatoxins face a liver cancer risk that is 60-times above average. In addition to nuts and grains like quinoa, aflatoxin can be found in figs, milk and cheese, soybeans, dried spices and cottonseed. It is less common in rice, as long as rice is hulled, which removes aflatoxin mold.....Is There a Special Diet for Liver Disease Patients?
Aug 10
by Dr. Joe Galati
Probably the most common question I am asked, is regarding a special diet to follow if you have liver problems. Here is an updated answer to these questions...
Aflatoxin Alert: Moldy Nuts and Corn Increases Your Liver Cancer Risk 60-Times If You Have Hepatitis B
August 10
Summertime Foods to Help Hepatitis C
July 28
By Karen Hoyt
When it’s summertime and the weather is high, you need to eat good food to stay strong with hepatitis C. Since the garden goods are easy to find, use this time to...
Herbal and Dietary Supplements
Aug 8
Many patients with liver disease use complementary and alternative medicines (CAMs) despite some being potentially hepatotoxic, often don’t tell their healthcare providers.
These were the findings of researchers at Duke University School of Medicine who analysed data from the 2012 [US] National Health Interview Survey. Of 647 adults with liver disease, 41% reported using CAMs in the prior year, compared with 33% of adults without liver disease. The most common modality was herbs and supplements (23%), and 3% of respondents reported consumption of a potentially hepatotoxic substance in the previous 30 days. Only a small proportion of CAM therapies were used specifically for liver disease, with milk thistle being the most common. Among respondents with liver disease, CAMs were used more commonly for anxiety or depression, fatigue, and substance use. The majority believed that these therapies improved health. Nearly one-third of therapies were not reported to healthcare providers, mostly because they don’t ask...
Reference - Complementary and alternative medicine use in United States adults with liver disease. Henson JB, Brown CL, Chow SC et al. J Clin Gastroenterol. 2016 Jul 29. [Epub ahead of print]
Reference - Complementary and alternative medicine use in United States adults with liver disease. Henson JB, Brown CL, Chow SC et al. J Clin Gastroenterol. 2016 Jul 29. [Epub ahead of print]
Aug 12
The U.S. Food and Drug Administration issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers...
Related
15 Supplement Ingredients to Always Avoid
July
With the help of an expert panel of independent doctors and dietary-supplement researchers, Consumer Reports identified 15 supplement ingredients that are potentially harmful. The risks include organ damage, cancer, and cardiac arrest. The severity of these threats often depends on such factors as pre-existing medical conditions as well as the quantity of the ingredient taken and the length of time a person has been exposed to the substance....
Liver injury due to herbal and dietary supplements: A review of individual ingredients
Authors Elizabeth Zheng, Victor Navarro
Authors Elizabeth Zheng, Victor Navarro
First Published: 27 April 2016 Vol: 7, Pages: 80–83 DOI: 10.1002/cld.541
Often, it is difficult to identify the culprit ingredient that is responsible for liver damage among a multitude of different components within a particular supplement. However, some ingredients have been associated with hepatotoxicity. We aim to review those ingredients that have been implicated in liver injury and, in doing so, give the practitioner a rationale to implicate a supplement containing them as a cause for injury...
Abstract
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Research - Hepatitis C Therapy
Elbasvir-grazoprevir
August
NEJM Journal Watch
Elbasvir–Grazoprevir Is Effective in HCV-Infected Patients Who Abuse Drugs
Atif Zaman, MD, MPH reviewing Dore GJ et al. Ann Intern Med 2016 Aug 8.
Ongoing illicit drug use did not reduce adherence to the HCV regimen nor efficacy...
Sofosbuvir, velpatasvir, and GS-9857
July
NEJM Journal Watch
HCV Therapy of Genotype 3: Is It Still a Challenge?
Published on 07/22/2016
By Ramakrishna Behara and Nancy Reau
Hepatitis C genotype 3 accounts for 30 percent of all infections secondary to hepatitis C and is the second most common genotype worldwide, behind genotype 1. Estimates report that in the U.S., it accounts for 8 to 13 percent of infections. Historically, genotype 3 has been uniquely challenging to manage in large part due to lower response to therapy combined with high rates of steatosis, fibrosis progression and a disproportionately high rate of hepatocellular carcinoma. With the launch of the first wave of interferon-free treatment, many of the direct-acting antivirals (DAA) had higher overall sustained virologic response (SVR) to genotype 3 but did not compare to the SVR rate for treatments approved for genotype 1. Thus, recent drug development has focused on pan-genotypic agents to equalize efficacy across all genotypes...
Weekend Video
A cure at what cost? More states easing restrictions on Hepatitis C treatments
Published on Aug 12, 2016
Have a safe and healthy weekend.
Tina
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Research - Hepatitis C Therapy
Elbasvir-grazoprevir
August
New, highly curative hepatitis C therapy is both safe and effective as a treatment option for people who inject drugs receiving opioid substitution therapy according to the results of a world-first clinical trial led by professor Gregory Dore at the Kirby Institute at UNSW Australia and published today in the Annals of Internal Medicine...
NEJM Journal Watch
Elbasvir–Grazoprevir Is Effective in HCV-Infected Patients Who Abuse Drugs
Atif Zaman, MD, MPH reviewing Dore GJ et al. Ann Intern Med 2016 Aug 8.
Ongoing illicit drug use did not reduce adherence to the HCV regimen nor efficacy...
Sofosbuvir, velpatasvir, and GS-9857
July
NEJM Journal Watch
A Regimen for HCV-Infected Patients Who Fail Direct-Acting Antiviral Therapy
Atif Zaman, MD, MPH reviewing Lawitz E et al. Gastroenterology 2016 Jul 30. Gane E et al. Gastroenterology 2016 Jul 30.
Combination fixed-dose sofosbuvir-velpatasvir plus GS-9857 was highly effective in phase II studies.
Although infrequently, direct-acting antiviral agents (DAAs) fail in treating chronic hepatitis C virus (HCV) infection and treatment-induced resistance can develop. Treatment options are limited for this population.
In companion phase II, industry-funded studies, researchers evaluated the safety and efficacy of daily triple therapy with sofosbuvir (an NS5B inhibitor; 400 mg), velpatasvir (a second-generation NS5A inhibitor with a high barrier to resistance; 100 mg), and GS-9857 (an investigational, next-generation NS3/4A protease inhibitor; 100 mg) in treatment-naive and treatment-experienced (i.e., previously failed DAAs) patients with HCV genotypes 1–6 infections.
In one open-label trial involving 197 HCV genotype 1 patients, all treatment-naive patients without cirrhosis who received 8 weeks of triple therapy achieved sustained virologic response at 12 weeks posttreatment (SVR12). Among treatment-naive patients with cirrhosis, treated for 8 weeks, SVR12 rates were 81% with added weight-based ribavirin and 94% without ribavirin. A small cohort without cirrhosis receiving 6 weeks of therapy achieved an SVR12 of 71%. Treatment-experienced patients with or without cirrhosis received 12 weeks of triple therapy, and all achieved SVR12.
Another open-label trial involved 128 patients with different HCV genotypes (58% genotype 3, 26% genotype 2). Among treatment-naive patients without cirrhosis, who received 6 weeks of triple therapy, SVR12 was 88%; among those with cirrhosis, treated for 8 weeks, SVR12 was 93%. Among treatment-experienced patients with or without cirrhosis, who received therapy for 12 weeks, SVR12 was 100% with cirrhosis and 97% without.
In both studies, the most common adverse effects were headache, fatigue, nausea, and diarrhea. Discontinuation rates due to adverse events were ≤2%.
Comment
This triple-DAA regimen was highly effective across HCV genotypes when given for 8 weeks in treatment-naive patients and 12 weeks in treatment-experienced patients with and without cirrhosis. A 6-week regimen was less effective, and adding ribavirin added no benefit. If subsequent phase III trials produce similar results, we might soon have a simple and effective 8–12-week regimen that is pangenotypic and ribavirin-free.
Note to readers: At the time NEJM Journal Watch reviewed these papers, their publisher noted that they were not in final form and that subsequent changes might be made.
Editor Disclosures at Time of Publication
Disclosures for Atif Zaman, MD, MPH at time of publication Nothing to disclose
Citation(s):
Lawitz E et al. Efficacy of sofosbuvir, velpatasvir, and GS-9857 in patients with genotype 1 hepatitis C virus infection in an open-label, phase 2 trial. Gastroenterology 2016 Jul 30; [e-pub]. (http://dx.doi.org/10.1053/j.gastro.2016.07.039)
Atif Zaman, MD, MPH reviewing Lawitz E et al. Gastroenterology 2016 Jul 30. Gane E et al. Gastroenterology 2016 Jul 30.
Combination fixed-dose sofosbuvir-velpatasvir plus GS-9857 was highly effective in phase II studies.
Although infrequently, direct-acting antiviral agents (DAAs) fail in treating chronic hepatitis C virus (HCV) infection and treatment-induced resistance can develop. Treatment options are limited for this population.
In companion phase II, industry-funded studies, researchers evaluated the safety and efficacy of daily triple therapy with sofosbuvir (an NS5B inhibitor; 400 mg), velpatasvir (a second-generation NS5A inhibitor with a high barrier to resistance; 100 mg), and GS-9857 (an investigational, next-generation NS3/4A protease inhibitor; 100 mg) in treatment-naive and treatment-experienced (i.e., previously failed DAAs) patients with HCV genotypes 1–6 infections.
In one open-label trial involving 197 HCV genotype 1 patients, all treatment-naive patients without cirrhosis who received 8 weeks of triple therapy achieved sustained virologic response at 12 weeks posttreatment (SVR12). Among treatment-naive patients with cirrhosis, treated for 8 weeks, SVR12 rates were 81% with added weight-based ribavirin and 94% without ribavirin. A small cohort without cirrhosis receiving 6 weeks of therapy achieved an SVR12 of 71%. Treatment-experienced patients with or without cirrhosis received 12 weeks of triple therapy, and all achieved SVR12.
Another open-label trial involved 128 patients with different HCV genotypes (58% genotype 3, 26% genotype 2). Among treatment-naive patients without cirrhosis, who received 6 weeks of triple therapy, SVR12 was 88%; among those with cirrhosis, treated for 8 weeks, SVR12 was 93%. Among treatment-experienced patients with or without cirrhosis, who received therapy for 12 weeks, SVR12 was 100% with cirrhosis and 97% without.
In both studies, the most common adverse effects were headache, fatigue, nausea, and diarrhea. Discontinuation rates due to adverse events were ≤2%.
Comment
This triple-DAA regimen was highly effective across HCV genotypes when given for 8 weeks in treatment-naive patients and 12 weeks in treatment-experienced patients with and without cirrhosis. A 6-week regimen was less effective, and adding ribavirin added no benefit. If subsequent phase III trials produce similar results, we might soon have a simple and effective 8–12-week regimen that is pangenotypic and ribavirin-free.
Note to readers: At the time NEJM Journal Watch reviewed these papers, their publisher noted that they were not in final form and that subsequent changes might be made.
Editor Disclosures at Time of Publication
Disclosures for Atif Zaman, MD, MPH at time of publication Nothing to disclose
Citation(s):
Lawitz E et al. Efficacy of sofosbuvir, velpatasvir, and GS-9857 in patients with genotype 1 hepatitis C virus infection in an open-label, phase 2 trial. Gastroenterology 2016 Jul 30; [e-pub]. (http://dx.doi.org/10.1053/j.gastro.2016.07.039)
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Gane E et al. Efficacy of sofosbuvir, velpatasvir, and GS-9857 in patients with HCV genotype 2, 3, 4, or 6 infections in an open-label, phase 2 trial. Gastroenterology 2016 Jul 30; [e-pub]. (http://dx.doi.org/10.1053/j.gastro.2016.07.038)
Gane E et al. Efficacy of sofosbuvir, velpatasvir, and GS-9857 in patients with HCV genotype 2, 3, 4, or 6 infections in an open-label, phase 2 trial. Gastroenterology 2016 Jul 30; [e-pub]. (http://dx.doi.org/10.1053/j.gastro.2016.07.038)
Full Text PDF Download
GS-9857 in Patients With Chronic Hepatitis C Virus Genotype 1–4 Infection
A Randomized, Double-blind, Dose-ranging Phase 1 Study
In summary, administration of multiple doses of GS-9857 was well tolerated and resulted in a robust decline of HCV RNA levels in patients with genotype 1–4 HCV infection. Notably, the potent antiviral activity of GS-9857 was preserved in the presence of commonly observed NS3 mutations associated with resistance to protease inhibitors. GS-9857 demonstrated linear PK when administered at doses ranging from 50 to 300 mg under fasting conditions. The median half-life of GS-9857 ranged from 29 to 42 h, conducive to once-daily dosing. Lastly, GS-9857 has demonstrated additive antiviral activity when evaluated in vitro in combination with sofosbuvir or velpatasvir.[5] Together, these data support the further development of once-daily GS-9857 in combination with other DAAs for the treatment of patients with chronic HCV infection....
Hepatitis outlook: July 2016
In Case You Missed It
GS-9857 in Patients With Chronic Hepatitis C Virus Genotype 1–4 Infection
A Randomized, Double-blind, Dose-ranging Phase 1 Study
In summary, administration of multiple doses of GS-9857 was well tolerated and resulted in a robust decline of HCV RNA levels in patients with genotype 1–4 HCV infection. Notably, the potent antiviral activity of GS-9857 was preserved in the presence of commonly observed NS3 mutations associated with resistance to protease inhibitors. GS-9857 demonstrated linear PK when administered at doses ranging from 50 to 300 mg under fasting conditions. The median half-life of GS-9857 ranged from 29 to 42 h, conducive to once-daily dosing. Lastly, GS-9857 has demonstrated additive antiviral activity when evaluated in vitro in combination with sofosbuvir or velpatasvir.[5] Together, these data support the further development of once-daily GS-9857 in combination with other DAAs for the treatment of patients with chronic HCV infection....
Hepatitis outlook: July 2016
If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.
In Case You Missed It
Published on 07/22/2016
By Ramakrishna Behara and Nancy Reau
Hepatitis C genotype 3 accounts for 30 percent of all infections secondary to hepatitis C and is the second most common genotype worldwide, behind genotype 1. Estimates report that in the U.S., it accounts for 8 to 13 percent of infections. Historically, genotype 3 has been uniquely challenging to manage in large part due to lower response to therapy combined with high rates of steatosis, fibrosis progression and a disproportionately high rate of hepatocellular carcinoma. With the launch of the first wave of interferon-free treatment, many of the direct-acting antivirals (DAA) had higher overall sustained virologic response (SVR) to genotype 3 but did not compare to the SVR rate for treatments approved for genotype 1. Thus, recent drug development has focused on pan-genotypic agents to equalize efficacy across all genotypes...
Weekend Video
A cure at what cost? More states easing restrictions on Hepatitis C treatments
Published on Aug 12, 2016
The new Hepatitis C drugs have come with a big catch: the price tag. It's difficult to know the exact cost — public and private payers negotiate private agreements with drug companies — but one of the main drugs, Sofosbuvir (the brand name is Sovaldi), has been listed at $1,000 a pill before discounts. It's taken once a day for up to three months, often in combination with other drugs, making the cost of a cure upwards of $100,000.
Have a safe and healthy weekend.
Tina
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