Neuropsychiatric symptoms associated with hepatitis C virus (HCV)

Infectious Disease Advisor Contributing Writer 

September 12, 2018 

HCV Neuropsychiatric Symptoms Likely Linked to Virus' Effects on Brain Function

The neuropsychiatric symptoms associated with hepatitis C virus (HCV) infection are likely caused by the body's response to the virus' effects on brain function, according to a study recently published in the Journal of Viral Hepatitis. This neuro-inflammatory and systemic response is akin to that observed in patients with autoimmune diseases of the liver.

Continue reading: https://www.infectiousdiseaseadvisor.com/hepatitis-advisor/neuropsychiatric-symptoms-in-hepatitis-c-infection/article/795019/

Reference 

Dirks M, Haag K, Pflugrad H, et al. 

Neuropsychiatric symptoms in hepatitis C patients resemble those of patients with autoimmune liver disease but are different from those in hepatitis B patients 

[published online August 18, 2018]. J Viral Hepat. doi: 10.1111/jvh.12979

Abstract 

Chronic fatigue, mood alterations and cognitive impairment are frequent accessory symptoms of HCV‐infection. Fatigue and mood alterations have also been observed in autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC), but not in hepatitis B virus (HBV)‐infection, thus indicating an autoimmune response as possible cause of HCV‐infection associated encephalopathy. Data, however, are sparse. This study aims to prove that HCV patients feature similar to those with autoimmune liver disease but contrary to HBV patients regarding neuropsychiatric symptoms.

132 non‐cirrhotic patients (HCV: 46, HBV: 22, AIH: 27, PBC: 29, AIH/PBC: 8) completed questionnaires addressing the domains mentioned above. Eighty‐eight underwent a comprehensive neuropsychological assessment. Patient groups were compared among each other and to 33 healthy controls.

Fatigue, anxiety and depression scores were significantly increased, and the SF‐36 mental score significantly decreased in all patient groups compared to controls. Fatigue was significantly more pronounced in HCV than in HBV patients. HCV patients scored significantly worse than HBV patients but not AIH and PBC patients in the SF‐36. HCV, AIH and PBC but not HBV patients did significantly worse than controls in word learning. Recognition of words was impaired in HCV, AIH and PBC patients and recognition of figures in HCV patients, exclusively (p≤0.002). HCV patients did also worse than controls and HBV patients concerning alertness and working memory (p≤ 0.001).

The neuropsychiatric profiles of HCV patients are similar to those of AIH and PBC patients but differ from those of HBV patients, suggesting an autoimmune response as a possible cause for these differences.

Hepatitis C - Generic sofosbuvir-based interferon-free direct acting antiviral agents: a real-world multicenter observational study

In The News

Monday, September 24, 2018

Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C 

-- List Price of Authorized Generics to Reflect Discounts in the System Today -- 

Generic sofosbuvir-based interferon-free direct acting antiviral agents for patients with chronic hepatitis C virus infection: a real-world multicenter observational study

Chen-Hua Liu, Yi-Jie Huang, Sien-Sing Yang, Chung-Hsin Chang, Sheng-Shun Yang, Hsin-Yun Sun, Chun-Jen Liu, Wen-Chun Liu, Tung-Hung Su, Hung-Chih Yang, Chun-Ming Hong, Tai-Chung Tseng, Pei-Jer Chen, Ding-Shinn Chen, Chien-Ching Hung & Jia-Horng Kao

Full-Text Article 

Scientific Reports volume 8, Article number: 13699 (2018)

Published: 12 September 2018 

Abstract

Real-world data regarding the effectiveness and safety of generic sofosbuvir (SOF)-based interferon-free direct acting antiviral agents (DAAs) for patients with chronic hepatitis C virus (HCV) infection remain limited. A total of 517 chronic HCV-infected patients receiving 12 or 24 weeks of SOF-based therapies were retrospectively enrolled in 4 academic centers in Taiwan. The rate of sustained virologic response at week 12 off-therapy (SVR12) and that of treatment completion were assessed. The baseline characteristics and on-treatment HCV viral kinetics to predict SVR12 were analyzed. By evaluable population (EP) analysis, the SVR12 rate was 95.4% (95% confidence interval [CI]: 93.2–96.9%). The SVR12 was achieved in 29 of 34 patients (85.3%, 95% CI: 69.6–93.6%), 130 of 139 patients (93.5%, 95% CI: 88.2–96.6%), 119 of 124 patients (96.0%, 95% CI: 90.9–98.3%) and 215 of 220 patients (97.7%, 95% CI: 94.8–99.0%) who received SOF in combination with ribavirin (RBV), ledipasvir (LDV), daclatasvir (DCV) and velpatasvir (VEL), respectively. Of 517 patients, 514 (99.4%) completed the scheduled treatment. All 15 patients with true virologic failures were relapsers. Two decompensated cirrhotic patients had on-treatment deaths which were not related to DAAs. All 7 patients who were lost to follow-up had undetectable HCV RNA level at the last visit. The SVR12 rates were comparable in terms of baseline patient characteristics and viral decline at week 4 of treatment. In conclusion, generic SOF-based regimens are well tolerated and provide high SVR12 rates in patients with chronic HCV infection.

Introduction
Hepatitis C virus (HCV) infection remains a challenging health problem in the world. It is estimated that approximately 71.1 million people, which account for 1.0% of the world’s population, are HCV carriers1. Among patients with chronic HCV infection, about 20% of them will evolve to cirrhosis over a period of 20–30 years. Once cirrhosis is established, the annual rates of developing hepatic decompensation and hepatocellular carcinoma (HCC) are 3–6% and 1–4%, respectively2,3. In addition to increasing the risks of liver-related morbidity and mortality, HCV infection is also associated with various extra-hepatic manifestations which further compromised the patients’ health outcome and quality of life4. On the other hand, the morbidity and mortality are significantly reduced once these patients achieve sustained virologic response (SVR) by anti-HCV agents5,6,7,8,9.

The use of interferon (IFN)-free direct acting antiviral agents (DAAs) has made a paradigm shift and become the standard of care for HCV infection. Sofosbuvir (SOF) is a pyrimidine nucleotide analogue that inhibits the HCV non-structural protein 5B (NS5B) ribonucleic acid (RNA)-dependent RNA polymerase, which is essential for viral replication. After intra-hepatic metabolism to active uridine triphosphate form, the GS-461203, it is incorporated to HCV RNA by NS5B polymerase and acts as the chain terminator10. Clinically, SOF is administered once-daily with pangenotypic potency, well tolerability, a high genetic barrier to drug resistance, and low rates of drug-drug interactions (DDIs). Furthermore, SOF can be used in combination with various kinds of NS3/4 A protease inhibitors (PIs), NS5A inhibitors, and/or ribavirin (RBV) to achieve high SVR rates11,12,13,14,15,16,17,18,19,20,21,22,23. Because of the excellent therapeutic profiles, treatment of HCV by SOF-based regimens is appealing to most health care providers.

Although SOF-based IFN-free DAAs are highly efficacious and well tolerated, many HCV-infected individuals have limited governmental reimbursement or private insurance support for brand-name agents24,25,26. Allowing generic SOF-based DAAs through voluntary or compulsory licensing can scale up the HCV treatment to facilitate more efficient HCV control, particularly for patients in resource-constrained countries. Regarding the effectiveness and safety of generic SOF in combination with ledipasvir (LDV), daclatasvir (DCV), and/or RBV, several reports from China, India, Egypt and Argentina indicated that the SVR rates were >90% and most patients tolerated the treatment well27,28,29,30,31. On the basis of these encouraging results, we aimed to evaluate the performance of generic SOF-based DAAs for HCV and factors potentially affecting the treatment response in a multicenter cohort in Taiwan.

Open Access

Full-Text Article Available Online:

https://www.nature.com/articles/s41598-018-32060-7

Epclusa® (Sofosbuvir/Velpatasvir) with or without ribavirin in patients with decompensated cirrhosis

Journal of Gastroenterology - September 10, 2018 

Efficacy and safety of sofosbuvir–velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial

Tetsuo Takehara Naoya Sakamoto Shuhei Nishiguchi Fusao IkedaTomohide TatsumiYoshiyuki UenoHiroshi Yatsuhashi Yasuhiro Takikawa Tatsuo Kanda Minoru Sakamoto Akihiro Tamori Eiji MitaKazuaki Chayama Gulan Zhang Shampa De-Oertel Hadas Dvory-SobolTakuma Matsuda Luisa M. Stamm Diana M. Brainard Yasuhito Tanaka Masayuki Kurosaki

Sofosbuvir –velpatasvir for 12 weeks provides a highly effective and well-tolerated therapy for Japanese patients with HCV and decompensated cirrhosis. Ribavirin did not improve efficacy but increased toxicity.

Open Access 

First Online: 10 September 2018

Full text article available online: 

https://link.springer.com/article/10.1007%2Fs00535-018-1503-x

Abstract

Background
In Japan, hepatitis C virus (HCV)-infected patients with decompensated cirrhosis currently have no treatment options. In this Phase 3 study, we evaluated sofosbuvir–velpatasvir with or without ribavirin for 12 weeks in patients with any HCV genotype and decompensated cirrhosis [Child–Pugh–Turcotte (CPT) class B or C] in Japan.

Methods
Patients were randomized 1:1 to receive sofosbuvir–velpatasvir with or without ribavirin for 12 weeks. Randomization was stratified by CPT class and genotype. Sustained virologic response 12 weeks following completion of treatment (SVR12) was the primary efficacy endpoint.

Results
Of the 102 patients enrolled, 57% were treatment naive, 78% and 20% had genotype 1 and 2 HCV infection, respectively, and 77% and 20% had CPT class B and C cirrhosis, respectively, at baseline. Overall, 61% of patients were female and the mean age was 66 years (range 41–83). SVR12 rates were 92% (47/51) in each group. Among patients who achieved SVR12, 26% had improved CPT class from baseline to posttreatment week 12. Most adverse events (AEs) were consistent with clinical sequelae of advanced liver disease or known toxicities of ribavirin. Four patients (8%) who received sofosbuvir–velpatasvir and seven (14%) who received sofosbuvir–velpatasvir plus ribavirin experienced a serious AE. The 3 deaths (bacterial sepsis, gastric varices hemorrhage, hepatocellular carcinoma) were attributed to liver disease progression.

Conclusion
Sofosbuvir–velpatasvir for 12 weeks provides a highly effective and well-tolerated therapy for Japanese patients with HCV and decompensated cirrhosis. Ribavirin did not improve efficacy but increased toxicity.

Continue reading......

Hepatitis C virus genotype 3: clinical features, current and emerging viral inhibitors, future challenges

Ann Gastroenterol. 2018 Sep-Oct;31(5):541-551. doi: 10.20524/aog.2018.0281. Epub 2018 Jun 4.

REVIEW ARTICLE
Hepatitis C virus genotype 3: clinical features, current and emerging viral inhibitors, future challenges
Vahe Shahnazariana, Daryl Ramaia,b, Madhavi Reddya, Smruti Mohantyc

Download full article: http://www.annalsgastro.gr/files/journals/1/earlyview/2018/ev-06-2018-01-AG_3988-0281.pdf
Article available online: Europe PMC (Open Access)

Abstract
Hepatitis C virus (HCV) represents a global burden on healthcare that affects over 150 million people worldwide. In the past, HCV genotype 3 was considered difficult to treat relative to other genotypes. Genotype 3 has been associated with a higher rate of complications, including fatty liver disease, fibrosis, hepatocellular carcinoma and mortality. However, with the advent of first- and second-generation direct-acting antivirals, genotype 3 can be treated effectively. Additionally, these new drugs are well tolerated by patients and have significantly fewer side effects compared to ribavirin and interferon-based regimens. However, while great strides have been made in overcoming biological barriers, our next challenge lies in overcoming economic and financial obstacles if we are to eradicate HCV genotype 3. Herein, we review the clinical features associated with HCV genotype 3, current and emerging treatment regimens, and challenges associated with treatment.

Keywords Hepatitis C, genotype 3, sustained viral response, direct acting antivirals, treatment Ann Gastroenterol 2018; 31 (4): 1-11

Continue to article online.....

Groups call for end to Gilead’s hepatitis C drug monopoly in Europe which blocks access

MSF and groups call for end to Gilead’s hepatitis C drug monopoly in Europe which blocks access 
-Pharmaceutical company Gilead has a patent monopoly on hepatitis C drug sofosbuvir in Europe
--The patent results in exorbitant prices, meaning people are unable to afford treatment 
--MSF and other organisations are urging the European Patent Office to overturn the patent in a hearing this week. 

Munich/Paris– This week in Munich, the European Patent Office is hearing a legal challenge filed by groups in 17 countries in March 2017, against an unmerited patent that allows US pharmaceutical corporation Gilead Sciences to charge exorbitant prices in Europe for the key hepatitis C drug sofosbuvir. Médecins du Monde (MdM), Médecins Sans Frontières (MSF) and Just Treatment are among the patient and treatment provider organisations that challenged the validity of a Gilead patent on sofosbuvir, on the grounds that it does not fulfill the requirements to be a patentable invention from a legal or scientific perspective. The groups urged the European Patent Office (EPO), which will hold a public hearing on 13 and 14 September, to rethink its decision that gives Gilead this monopoly.

If the patent challenge is successful, a major step will have been taken toward allowing the production and importation of affordable generic versions of sofosbuvir in Europe. Generic versions would protect health systems across Europe from financial burden due to the excessive price of this drug. The extremely high prices in Europe of newer hepatitis C medicines—called direct-acting antivirals, or DAAs—has led civil society organisations to investigate and subsequently challenge the monopoly status and legitimacy of such patents. 

Medical Activities
Hepatitis C
Worldwide, an estimated 71 million people are infected with the hepatitis C virus, double the number living with HIV. While hepatitis C can be cured, few people have access to treatment.

Governments forced to ration treatment
“I have been through an extremely agonising wait for three years to get access to sofosbuvir”, said Clare Groves, Just Treatment patient leader who was treated and cured of hepatitis C through the National Health Service (NHS) in the United Kingdom. The NHS was forced to ration supply of the medicine due to its high price. “I was repeatedly told by my doctor that I am sick, but not sick enough to qualify for the treatment under the public health programme. I don’t want other people to be denied sofosbuvir because its price is exorbitant, so I will continue to fight for their access to this cure.”

The World Health Organization estimates that 15 million people in Europe—approximately one in 50 people—are chronically infected with hepatitis C, leading to approximately 112,500 deaths per year from related liver cancer and cirrhosis. The advent of DAA drugs, which offer a safer, shorter and more effective cure compared to older treatments, has marked a major breakthrough in the treatment of the disease, with cure rates higher than 90 percent, compared to around 50 percent previously. Sofosbuvir forms the backbone of most hepatitis C combination treatments, yet access to these newer treatments remains very limited globally because of high prices, with governments and treatment providers in many countries forced to ration treatment and limit access only to people with advanced forms of the disease.

Exorbitant prices in Europe, but affordable elsewhere
Gilead charges as much as €43,000 for one person’s 12-week treatment of sofosbuvir in Europe. Meanwhile, in countries where the drug is not patented, competition among generic producers has driven the price to just €52 for the same treatment course. Studies have shown that it costs about €0.50 per daily pill to manufacture the drug. “Financial barriers in access to medicines and healthcare have become a challenge for high-income countries in Europe”, said Olivier Maguet, of MdM’s drug pricing campaign. “Because unmerited patents are the key driver for these excessive prices, it’s time to challenge these patents in Europe.”

More scrutiny of patents needed
While the high prices charged for medicines are a well-known problem in many parts of the world, the recent excessive pricing of DAAs has brought Europe’s attention for the first time on the impact that monopolies have both on health budgets and on people’s access to many other essential medicines. Legal challenges against patents on sofosbuvir and other DAAs have been filed in several countries, and key patents on sofosbuvir have already been rejected in Egypt, China and Ukraine. Decisions are pending in other countries, including Argentina, Brazil, India, Russia and Thailand.

 “Every day, MSF witnesses first-hand how monopolies on medicines restrict people’s access to life-saving medicines,” said Gaelle Krikorian, Head of Policy at MSF’s Access Campaign. “MSF was only able to start scaling up treatment for people with hepatitis C in countries like Cambodia and India once more affordable quality-assured generics became readily available.”

“It’s high time that the European Patent Office and patent offices around the world apply greater scrutiny when granting monopolies on medicines, recognising the negative impact that unmerited patents have on people’s health”, said Gaelle Krikorian. “Revoking Gilead’s patent would end the corporation’s monopoly in Europe, and allow countries to access sofosbuvir from multiple generic manufacturers at affordable prices. It would also send a strong signal to other countries to challenge unmerited patents when people’s health and survival are at stake.”
https://www.msf.org/msf-and-groups-call-end-gileads-hepatitis-c-drug-monopoly-europe-which-blocks-access

Unapproved kratom products: FDA issuing new warning letters

September 11, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

Epidemics don’t occur overnight. As we deal with the devastating crisis of opioid abuse and overdose plaguing our nation, the U.S. Food and Drug Administration must remain vigilant and aggressive against trends that threaten to reverse our progress, or substances that have the potential to cause new epidemics of abuse.

Mitragyna speciosa, known more commonly as kratom, is a plant native to Thailand, Malaysia, Indonesia and Papua New Guinea. While it is important to generate more evidence, there is evidence that certain substances found in kratom are opioids and data suggest that one or more may have a potential for abuse. And its use has been on the rise and is of concern to the FDA. We’re not alone in our concern about the opioids found in kratom – it’s already illegal or controlled in several other countries including Australia, Denmark, Germany, Malaysia and Thailand. The substance is also banned in a number of states and municipalities in the U.S.

Science and evidence matter in demonstrating medical benefit, especially when a product is being marketed to treat serious diseases like opioid use disorder (OUD). However, to date, there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid use withdrawal or other diseases in humans. Nor have there been studies on how kratom, when combined with other substances, may impact the body, its dangers, potential side effects, or interactions with other drugs. Today’s action is based on these concerns. The FDA issued warning letters to two more unscrupulous vendors, Chillin Mix Kratom and Mitra Distributing, for marketing kratom products with scientifically unsubstantiated claims including to “relieve opium withdrawals” and to “treat a myriad of ailments including but not limited to: diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, alcoholism, and opiate withdrawal.” Simply, selling these unapproved kratom products with claims that they can treat opioid withdrawal and addiction and other serious medical conditions is a violation of federal law.

Yet despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims.

Fraudulent health claims can pose serious health risks. They may keep some patients from seeking appropriate, FDA-approved therapies. Reliance on products with unsubstantiated claims may delay those who suffer from OUD from entering recovery and may put them at greater risk of overdose and death. We know that patients receiving FDA-approved medication-assisted treatment (MAT) cut their risk of death in half, according to the Substance Abuse and Mental Health Services Administration.

As U.S. Department of Health and Human Services and the others in the federal government work to reduce the number of Americans who are addicted to opioids ad other substances, the FDA will continue to promote innovation and more widespread access to FDA-approved treatments for OUD. While HHS is taking new steps to make safe and effective MAT available to those who suffer from OUD, we must also work to reduce the stigma that is sometimes associated with use of these therapies. In parallel, we cannot allow kratom products with unsubstantiated claims to prevent those with OUD from seeking treatments that have been demonstrated to be safe and effective.

At HHS and within the FDA, we have great concern for the many Americans who misuse any drugs, especially opioids. In support of the public health, we continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider. We will also continue to take action against those who put the safety of Americans at risk and who violate federal law by making unsubstantiated health claims about products that they seek to sell.

The Food and Drug Administration, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA keeps warning about the controversial supplement kratom, but companies keep deceptively selling it  
Published: Sept 11, 2018 12:42 p.m. ET
“Simply, selling these unapproved kratom products with claims that they can treat opioid withdrawal and addiction and other serious medical conditions is a violation of federal law,” the FDA said in a Tuesday statement. “Yet despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims.”

The two companies in question, Chillin Mix Kratom and Mitra Distributing, also claimed that their kratom products could treat conditions like obesity, depression, alcoholism and high blood pressure, according to the FDA. Continue reading: https://www.marketwatch.com/story/fda-keeps-warning-about-the-controversial-supplement-kratom-but-companies-keep-deceptively-selling-it-2018-09-11

Archives
Poisonings from kratom, sold as an herbal supplement, are rising. But no one knows how much 

Mari A. Schaefer Tuesday, August 21, 2018 

Kratom is an unregulated herbal product that has been linked to at least four deaths in the Philadelphia region. 

PHILADELPHIA — An unregulated herbal product that advocates say can relieve pain and help with opioid withdrawal has been linked to at least four deaths in the Philadelphia region, but with many authorities failing to track kratom poisonings, there’s no way to know if there are more deaths related to the substance.

Kratom, derived from the leaves of a Southeast Asian tree that is part of the coffee family, has gained popularity in recent years. It is sold online, in gas stations and in smoke shops, and is typically brewed as a tea, chewed, smoked or ingested in capsules.

An estimated 3 million to 5 million people use kratom, according to the American Kratom Association, a Colorado-based nonprofit founded in 2014 to promote the herbal product. It has become a billion-dollar business, according to the Botanical Education Alliance, another kratom advocacy group.

Read more: Boston Herald 

HCV Newsletters & Updates: Obesity in liver disease, Nasal spray for opioid overdose and Fast-acting flu drug

HCV Newsletters & Updates
Welcome, check out the latest news, review this months collection of newsletters, and finish off by reading a handful of well written blogs focused on living well with hep B or C.

In The News
MSF and groups call for end to Gilead’s hepatitis C drug monopoly in Europe which blocks access 
--Pharmaceutical company Gilead has a patent monopoly on hepatitis C drug sofosbuvir in Europe
--The patent results in exorbitant prices, meaning people are unable to afford treatment

--MSF and other organisations are urging the European Patent Office to overturn the patent in a hearing this week.

STAT Morning Rounds

With an award-winning newsroom, STAT gives you indispensable insights and exclusive stories on the technologies, personalities, power brokers, and political forces driving massive changes in the life science industry — and a revolution in human health.
Fast-acting flu drug shows strong potential - An experimental, fast-acting flu drug showed strong promise in two newly published trials — but it also led to some surprising and even concerning results. The drug cut the time people were sick with flu symptoms by just over a day, but didn’t make people feel better faster than Tamiflu.

Reuters

Consort, Opiant to develop nasal spray for opioid overdose treatment 

California-based Opiant earlier this year was awarded a $7.4 million grant by the U.S. National Institutes of Health’s National Institute on Drug Abuse for the development of a nasally-applied version of overdose treatment nalmefene.

Associated Press 
Doctors explore lifting barriers to living organ donation
WASHINGTON — Surgeons turned down Terra Goudge for the liver transplant that was her only shot at surviving a rare cancer. Her tumor was too advanced, they said — even though Goudge had a friend ready to donate, no matter those odds.

HepCBC 

HepCBC is a Canadian non-profit organization offering awareness with basic information about HCV and a weekly digest of news.

Read the latest issue of the highly successful Weekly Bull.

September Updates

Hepatology - Top Story From Healio 

Healio features the industry’s best news reporting, dynamic multimedia, question-and-answer columns, educational activities in a variety of formats, blogs, and peer-reviewed journals.

HCV NEXT September/October Issue - The following articles appeared in this months issue of HCV NEXT, published online over at Healio. 

7 recent reports on obesity risks in liver disease, lifestyle intervention

September 7, 2018

Physicians and researchers have noted the increase in liver disease over the last couple decades, especially nonalcoholic fatty liver disease, correlates significantly…

NATAP
NATAP is a New York State non-profit corporation with 501(c)3 Federal tax-exempt status. Our mission is to educate individuals about HIV and Hepatitis treatments and to advocate on the behalf of all people living with HIV/AIDS and HCV. Our efforts in these areas are conducted on local, national, and international levels.
Global Hepatitis Summit A Few Selected Highlights 

Reported by Jules Levin, NATAP
In June the Global Hepatitis Summit took place in Toronto. Here are 3 selected talks highlighted of particular interest to me. The first talk by Andrew Hill he says we have a bleak scenario regarding the possibility of global HCV elimination. He says in many countries new HCV infections outstrip HCV cures and new diagnoses. New diagnoses are much lower in all poorer countries compared to high income countries. Screening is too low, all of which he uses to say the outlook is bleak for global HCV elimination unless we make changes.

The 2nd talk I chose to highlight was by Maria Prims from the Netherlands where she reports high HCV infection & reinfection rates among people taking PrEP to prevent HIV infection. She highlights an increasing HCV incidence among MSM. 376 started PrEP either daily or on demand and there were 12 HCV infections: 6 new infections & 6 reinfections.

The 3rd report below is on the use of a new broader type of model in India for HCV screening & care. A more comprehensive clinic model where IDUs can under 1 roof get a variety of services for IDU and HCV care. Sunil Solomon highlights how big & diverse the HCV epidemic is India, much bigger even only among IDUs compared to the entire HCV epidemic in Western Europe. 

Read it here...…

In Case You Missed It

A long life with HIV

'A long life with HIV' is now available to read online. The booklet provides information on living well with HIV as you get older, including things you can do to look after your health, health issues and preparing for the future.

Inovio launches Ph1 study of Hep C vaccine

Sept 4, 2018

Inovio Pharmaceuticals (NSDQ:INO) and its partner, GeneOne Life Science (KSE:011000), said today that the companies have dosed the first patient in a Phase I study designed to test a preventive vaccine against hepatitis C infection. The companies plan to recruit 24 study participants to evaluate Inovio’s GLS-6150 candidate. Participants will include people who have a sustained virologic response following treatment for Hep. C, as well as healthy controls. They are slated to receive one of two doses of vaccine, administered intra-dermally and followed by electroporation with Inovio’s Cellectra device.

Risk of Liver Cancer in Patients with NAFLD 
(Reuters Health) - People with advanced cases of nonalcoholic fatty liver disease (NAFLD) may need to be monitored for liver cancer, a large U.S. study suggests.

Vosevi Beats Hepatitis C Regardless of Drug Resistance 
In a recent study of people whose previous hep C regimen failed to cure their infection, Vosevi cured almost all of them.

Will an opt-out organ transplant law save lives?

The recent decision in England to change the organ donation law from voluntary consent (opt-in) to presumed consent (opt-out) highlighted the debate around the best approach to organ donation.

Routine oral care to treat gum disease may improve cognitive function in cirrhosis patients
Routine oral care to treat gum disease may play a role in reducing inflammation and toxins in the blood and improving cognitive function in people with liver cirrhosis.

In The Journals 
Hepatitis B Virus and Risk of Non-Hodgkin Lymphoma
Journal of Viral Hepatitis

Chronic Hepatitis C Association with Diabetes Mellitus and Cardiovascular Risk in the Era of DAA Therapy.

Most likely, DAA treatment and subsequently SVR achievement decrease cardiovascular risk. This fact is another reason for early treatment of patients, including those with a lower grade of liver fibrosis. Yet, chronic hepatitis C treatment remains inaccessible not only in developing countries but also in countries with high quality of life..

Newsletters

HCV Advocate

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

In this month’s HCV Advocate newsletter, the following noteworthy articles are available to read and educate:
-SnapShots by Alan Franciscus Risk factors, mortality, and cardiovascular outcomes in patients with type 2 diabetes—A. Rawshani, et. al.
-Incidence of hepatocellular carcinoma after direct antiviral therapy for HCV in patients with cirrhosis included in surveillance programs—P. Nahom, et. al.
-Safety and efficacy of ledipasvir‐sofosbuvir with or without ribavirin for chronic hepatitis C in children ages 6‐11—K. F. Murry, et. al
Briefly……..
-Commentary: A review of the risk of hepatitis B and C transmission through biting or spitting—H. Pintilie, et. al.
-Hepatitis C virus infection in children in the era of direct-acting antivirals—M. Pawlowska, et. al

HealthWise – A Buffet of Health Information – as the title of the article implies, Lucinda discusses the various substances that may or may not be good for your health.

Hepatitis Headlines – Three interesting news stories about hepatitis C that our readers will find interesting including heart transplants, eliminating hepatitis in the U.S. and WHO and HCV treatment guidelines.

Hep C 101 – Overview of Hepatitis C by Alan Franciscus – A new series of article for people who are new to hepatitis C or for those people who want basic information.

What’s Up – We’ve updated several of the HCV Advocate Factsheets. Use the links provided in this section to get current information on several subjects that relate to Hep C, including nutrition, alcohol, co-infection, and motherhood.
Watch our patient video about treating and curing HCV. 

Do you have hepatitis C? Get support. Get answers. A free program for patients – PackHealth.

View all newsletters here....

The New York City Hepatitis C Task Force

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

Hep Free NYC Newsletter - September 2018

October - Liver Cancer Awareness Month

Review all news updates.

HCV Action
HCV Action brings together hepatitis C health professionals from across the patient pathway with the pharmaceutical industry and patient representatives to share expertise and good practice.
HCV Action e-update

World Hepatitis Alliance
We run global campaigns, convene high-level policy events, build capacity and pioneer global movements, ensuring people living with viral hepatitis guide every aspect of our work.
View Recent Newsletters 
World Hepatitis Alliance (WHA) presents hepVoice, a monthly magazine with updates on the latest projects, news from WHA members and key developments in the field of hepatitis.

GI & Hepatology News
Over 17,000 gastroenterologists and hepatologists rely on GI & Hepatology News every month to cover the world of medicine with breaking news, on-site medical meeting coverage, and expert perspectives both in print and online. 

Hot topics

Even modest alcohol use may worsen NAFLD

Amy Karon MDedge News 

Modest alcohol consumption was associated with significantly less improvement in steatosis and significantly lower odds of NASH resolution.

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Hep-Your Guide to Hepatitis
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.
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Hepatitis Victoria

Hepatitis Victoria is the peak not-for-profit community organisation working across the state for people affected by or at risk of viral hepatitis.
Latest Podcast: Karen Hoyt a HEP Hero and she is unique in being our first international recipient!
Speaking from Oklahoma in the United States, Karen talks about her diagnosis with hepatitis C and how she experienced the full gamut of conditions leading to a liver transplant.



View the Latest Newsletter, or relax and listen to a short podcasts interviewing health experts and practioners on topics related to viral hepatitis - come have a listen!

British Liver Trust
The British Liver Trust is the leading UK liver disease charity for adults – we provide information and support; increase awareness of how liver disease can be prevented and promote early diagnosis; fund and champion research and campaign for better services. 
News: Less Survivable Cancer Taskforce calls for government to double the survival rate of deadliest cancers by 2029
The combined five-year survival rate for people with either liver, brain, lung, oesophageal, pancreatic or stomach cancers stands is currently just 14%. Today, six charities …

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The National Viral Hepatitis Roundtable

The National Viral Hepatitis Roundtable (NVHR) is national coalition working together to eliminate hepatitis B and C in the United States.

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The Hepatitis C Trust
The Hepatitis C Trust is run by patients with the goal of eliminating HCV in the United Kingdom. The Trust’s mission is to reverse the rapidly increasing death toll caused by hepatitis C in the UK until no-one dies from this preventable and treatable disease and, ultimately, it is all but eradicated in this country.

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National Institutes of Health

A monthly newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services
September Newsletter
Topics
Body Odor May Be Sign of Disease
Breathe Easier
Dealing with Bad Air Quality

Health Capsule - Weight Loss Helps Knee Arthritis 

Harvard Health

A possible culprit in early heart attacks 

Lipoprotein(a) is a fatty particle in the blood that invades artery walls, causing atherosclerosis. Also known as Lp(a), the particles are similar to “bad” LDL cholesterol molecules but with an extra protein attached. High blood levels of Lp(a)—which is largely determined by genetics—may explain some unexpected, premature heart attacks. Widespread testing for Lp(a) is not recommended because both the prevalence and the definition of what constitutes a dangerously high level are not yet clear. In addition, there are no FDA-approved treatments proved to lower heart disease risk in people with high Lp(a) levels.

Inspirational Bloggers

I Help C

Karen Hoyt is devoted to offering support and accurate information to people coping with the effects of hepatitis C.

Latest blog entry: Help for Autoimmune Liver Disease: 5 T’s

I hear a lot from people seeking help for autoimmune liver disease. Trying to figure it out is hard, but most symptoms are the same as any type of liver disease. I know, we can’t lump them all into one specific area, but they are in the same region.

Lucinda K. Porter

Lucinda Porter is a nurse, speaker, advocate and patient devoted to increasing awareness about hepatitis C.
Latest blog entry: Happiness: Purging Self-Help Advice

Hep 

Hep is an award-winning print and online brand for people living with and affected by viral hepatitis.
Latest blog entry: By Connie M. Welch
Patient Experience Living With Cirrhosis With John M., Part 2 Part 2 of Connie Welch’s interview with John M, a patient with hepatitis C and cirrhosis, who was successfully treated with Harvoni.

By Greg Jefferys -How Big Pharma Corrupts Health Services 

A look at how bribing bureaucrats and buying doctors brings about bad outcomes for public health.

Check out the talented people who blog at Hep.

Hepatitis NSW 

We provide information, support, referral and advocacy for people affected by viral hepatitis in NSW. We also provide workforce development and education services both to prevent the transmission of viral hepatitis and to improve services for those affected by it.

Latest blog entry: Pharmacists key in harm reduction

Life Beyond Hepatitis C
Life Beyond Hep C is where faith, medical resources and patient support meet, helping Hep C patients and their families navigate through the entire journey of Hep C.
Latest blog entry: Relief from Itching with Hepatitis C and Cirrhosis

Canadian Liver Foundation 

We strive to improve prevention and the quality of life of those living with liver disease by advocating for better screening, access to treatment, and patient care.
Latest blog entry: Who Gives a Sliver of a Liver to a Stranger?

Hepatitis B Foundation 

The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure and improving the quality of life for those affected by hepatitis B worldwide.
Latest blog entry: - Be Your Own Advocate in the Medical Room
The hepatitis B virus (HBV) can be transmitted two ways: 1) through direct contact with blood and 2) infected body fluids. Some risks for direct blood contact are obvious, such as touching an open wound to another open wound or cleaning up someone’s blood without any protective gear. However, other methods of blood transmission are harder to catch. Common activities like sharing razors, earrings, or toothbrushes are simple, innocent actions, yet they all have the potential for blood exchange.

HepatitisC.net
At HepatitisC.net we empower patients and caregivers to take control of Hepatitis C by providing a platform to learn, educate, and connect with peers and healthcare professionals.
Latest blog entry: Ask the Advocate: What Were Your First Symptoms of Hep C?
There are several common symptoms of chronic HCV, including fatigue, joint pain, muscle aches, low-grade fever, decreased appetite..

HIV and ID Observations 

An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.
Latest blog entry: Doravirine Sets a New Standard for NNRTIs — But What Role in HIV Treatment Today?

KevinMD

Kevin Pho is a practicing physician and most known for his blog KevinMD. Thousands of authors contribute to his blog: primary care doctors, surgeons, specialist physicians, nurses, medical students, policy experts. And of course, patients, who need the medical profession to hear their voices.

Latest blog entry: How and why to treat sleep disturbance from depression

One of the aspects of depression that’s particularly difficult is the sleep disturbance which accompanies it and often continues after the traditional symptoms of depression have finally gotten better.

On The Radio

A genetic test that can predict your dementia risk

Presented by Dr Norman Swan

Genetic test predicts dementia risk. Warning over new genetic tests on Medicare Benefits Schedule. Colonoscopy standards to reduce unnecessary treatment, risk of complications. Scan your heart to save your life...

Healthy You

Statins 'may not help over-75s without diabetes'

This type of observational study is useful for comparing what happens to groups of people in different situations (in this case, people over 75 who have or haven't been prescribed statins), but it can't show cause and effect. So in this case, it can't show whether living longer or having strokes or heart attacks are a direct effect of taking or not taking statins...

Mayo Clinic Minute: Osteoporosis is soft bones

Osteoporosis is often called "soft bones." "Osteoporosis is thinning of the bone to the point where the bones can break," says Dr. Bart Clarke, a Mayo Clinic endocrinologist. https://youtu.be/fLS1tDriG3k Watch: The Mayo Clinic Minute Journalists: Broadcast-quality video pkg (1:00) is in the downloads. Read the script. Dr. Clark says common breaks from thinning bones occur in the spine, wrist, shoulder and hip. "Women, in general, past menopause — past the mid-50s — are at high risk for this because of the…

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Tina

Risk of Liver Cancer in Patients with NAFLD

Severe NAFLD Boosts Liver Cancer Risk
By Ankur Banerjee

(Reuters Health) - People with advanced cases of nonalcoholic fatty liver disease (NAFLD) may need to be monitored for liver cancer, a large U.S. study suggests.

Fatty liver disease is known to be linked with a higher risk of hepatocellular carcinoma (HCC). But it hasn't been clear whether some patients are more at risk than others.

The new study showed that when NAFLD progresses to cirrhosis, the risk for HCC is dramatically higher.

The findings suggest that people with NAFLD and cirrhosis should be monitored for HCC, the authors wrote in Gastroenterology, online August 23.

Continue reading article: https://www.reuters.com/article/us-health-liver-fat-cancer/severe-fatty-liver-disease-boosts-risk-for-liver-cancer-idUSKCN1LK2GN

Gastroenterology

Risk of Hepatocellular Cancer in Patients with Non-alcoholic Fatty Liver Disease

Risk of HCC was higher in NAFLD patients than that observed in general clinical population. Most HCC cases in NAFLD developed in patients with cirrhosis. The absolute risk of HCC was higher than the accepted thresholds for HCC surveillance for most patients with NAFLD cirrhosis.