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.

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Alan Franciscus


HCV Advocate

Saturday, January 31, 2015

Delhi HC sets aside order on Gilead’s Sovaldi patent

New Delhi: In a setback to generic drug makers, the Delhi high court on Friday set aside an order of the Deputy Controller of Patents and Designs rejecting a patent to US drug maker Gilead Pharmasset Llc for the hepatitis C drug Sovaldi.

The medicine costs $1,000 a pill and cures hepatitis C in 90% of cases when given for a 12-week course. India’s patent office had questioned the therapeutic efficacy under which the patent was claimed by Gilead and rejected its application using the controversial Section 3(d) of the Patents Act, which prevents evergreening of patents and provides that no new form of an existing substance shall be patented unless the new form is much more effective than the old one.

The Indian patent office, while rejecting the patent application, had maintained that minor changes in the molecule did not improve its efficacy. With the patent set aside, domestic generic drug manufacturers could make the same drug for as low as $1 a pill. “It was expected that the appeal would succeed because the process of reasoning in the controller’s order was really shoddy, without commenting on the merits of the conclusion,” said Shamnad Basheer, former professor at National University of Juridical Sciences, Kolkata, and founder of intellectual property blog SpicyIP.

Read more at: http://www.livemint.com/Politics/1l6EyoCRGd45A6oT0qpsBO/Delhi-high-court-sets-aside-order-on-Gileads-Sovaldi-patent.html?utm_source=copy

Friday, January 30, 2015

"At the Crossroads: The Rise of Hepatitis C and the Fight to Stop It"

Hepatitis C infects an estimated five million Americans, though most of them don’t know it. But deaths from hepatitis C are on the rise in baby boomers.

And throughout New England, new infections are creeping up among a younger generation.

Less than a year ago, their only options for treatment were complicated regimens of injections that didn’t always lead to a cure. But brand new drugs could change everything. That is, if the cost doesn’t break us.


AbbVie Announces Top-line Results from Phase 3 Study of All-Oral Treatment for Hepatitis C in Japan

Jan 30, 2015

- 95 percent SVR12 rate achieved in Japanese patients new to therapy with genotype 1b chronic hepatitis C virus infection without cirrhosis and with a high viral load
- Regulatory filing in Japan planned for the first quarter of 2015

NORTH CHICAGO, Ill., Jan. 30, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) released top-line Phase 3 results for its investigational, all-oral, ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection in Japan. The primary endpoint of the GIFT-I study was achieved, demonstrating a 95 percent (n=106/112) sustained virologic response rate at 12 weeks post treatment (SVR12) in the sub-group of previously untreated, non-cirrhotic adult GT1b Japanese patients who were eligible for therapy with interferon (IFN) and had a high viral load.

"AbbVie is committed to advancing HCV care with the goal of evaluating our treatment in a broad range of patients around the world," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "The GIFT-I results are encouraging and support moving forward with our Japan development program, with a local regulatory submission anticipated in the first quarter of 2015."

In Japan, up to two million people are currently living with hepatitis C.1 Genotype 1b is the most common sub-genotype, affecting nearly half of the people infected with HCV.2

In the GIFT-I study, the primary efficacy population comprised a sub-group of treatment-naive GT1b chronic HCV infected patient population. This sub-group consisted of treatment-naive patients without cirrhosis who were eligible for therapy with IFN with or without RBV, had a high viral load (> 100,000 IU/mL) and received at least one dose of the double-blind active study drug. The primary endpoint was assessed at 12 weeks post treatment (SVR12).

In patients without cirrhosis, the most commonly reported adverse events in the treatment arm were nasopharyngitis (16.7 percent OBV/PTV/r vs. 13.2 percent placebo), headache (8.8 percent OBV/PTV/r vs. 9.4 percent placebo), and oedema peripheral (5.1 percent OBV/PTV/r vs. 0 percent placebo). Two patients without cirrhosis (0.9 percent) discontinued treatment due to adverse events.
Within the primary efficacy patient population, there were no on-treatment virologic failures and 2.8 percent of patients (n=3/109) experienced relapse.

AbbVie will disclose detailed GIFT-I study results at future scientific congresses and in publications.

About GIFT-I Study GIFT-I (M13-004) is a Phase 3, multi-center study designed to evaluate the efficacy and safety of 12 weeks of treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in adult Japanese patients (n=363) with chronic genotype 1b hepatitis C virus infection. Patients included those without cirrhosis and with compensated cirrhosis who were new to therapy (treatment-naive) or had failed previous treatment with interferon with or without ribavirin (treatment-experienced). The study consists of two sub-studies. Sub-study one included patients without cirrhosis randomized to OBV/PTV/r or placebo. Sub-study two included patients with compensated cirrhosis, who received open-label treatment with OBV/PTV/r.

Additional information about AbbVie's GIFT-I study can be found on www.clinicaltrials.gov.

About AbbVie's Investigational Two Direct-Acting Antiviral HCV TreatmentFor the treatment of genotype 1b chronic hepatitis C virus (HCV) infection in Japan, AbbVie's investigational two direct-acting antiviral treatment consists of the fixed-dosed combination of paritaprevir/ritonavir (150/100 mg) with ombitasvir (25 mg), dosed once daily.
AbbVie's chronic HCV treatment combines two direct-acting antivirals, each with a distinct mechanism of action that targets and inhibits specific HCV proteins of the viral replication process.

About AbbVie's HCV Clinical Development Program in Japan AbbVie's HCV clinical development program in Japan will focus on our investigational, two direct-acting antiviral treatment and is designed with the goal of achieving high sustained virologic response rates in chronic HCV infected patients, including additional genotypes and patients with compensated cirrhosis.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

Ombitasvir/paritaprevir/ritonavir is an investigational product and its safety and efficacy have not been established in Japan.

About AbbVieAbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking StatementsSome statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2013 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Kohnodai Hospital. National Center for Global Health and Medicine [cited 20 February 2013]. Available from: http://www.ncgm.go.jp/center/forpatient_hcv.html
2 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10: 553-562. http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html. Accessed December 2014


For further information: Media: Judy Low, +65 9880 2604, judy.low@abbvie.com; Jackie Finley, +1 (847) 937-3998, jaquelin.finley@abbvie.com; Investor Relations: Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com

Local Hepatitis C cases hit all-time high

A dangerous viral infection saw a dramatic spike in cases in Ross County during 2014, according to year-end numbers from the Ross County Health District.

Hepatitis C cases in the county jumped from 153 in 2013 to 234 last year – an increase of 53 percent and an all-time high locally.

“This is easily the highest number of cases ever reported to us,” said Kathy Wakefield, director of Public Health Nursing at the Ross County Health District. “It’s very concerning, especially considering how big of an increase it was in just one year.”


Hot on the trail of the hepatitis-liver cancer connection

Using whole genomic sequencing, scientists from RIKEN in Japan have for the first time demonstrated the profound effect that chronic hepatitis infection and inflammation can have on the genetic mutations found in tumors of the liver, potentially paving the way to a better understanding of the mechanisms through which these chronic infections can lead to cancer. Primary liver cancer is the third leading cause of cancer death worldwide, and recent studies have shown that particularly in Asia, infection with either hepatitis B or C is often associated with such cancers.

For the study, which was published in Nature Communications, the group performed whole genomic sequencing on 30 individual tumors classified as liver cancer displaying a biliary phenotype. This type of cancer originates in the liver, but is different from hepatocellular carcinoma, the dominant form of primary liver cancer, and is generally more aggressive, with poorer prognosis. They compared the data with 60 of the more-common hepatocellular carcinoma tumors. To study gene expression, they then examined RNA sequencing data from 25 of the biliary-phenotype cancers and 44 hepatocellular cancers.


Thursday, January 29, 2015

Expensive Hepatitis C Cure ─ Georgia Decides Who Gets It, Who Doesn't

There’s a new drug on the market that’s up to 99 percent effective at curing hepatitis C, an often deadly liver virus. The drug is known as “V-pak.”

Some Georgians will get it.

But thousands of HIV-positive Georgians, who also have hepatitis C, won't.

The reason? Cost.

Read more and listen to the podcast here....

Harvard Pilgrim negotiates discount on pricey hepatitis drug

Harvard Pilgrim Health Care has become the first regional health insurer to negotiate a discount on a costly new hepatitis C drug regimen that cures more than 90 percent of people with the virus but inflicts steep financial losses on payers.

Under a one-year contract with Gilead Sciences Inc., maker of the two-drug Harvoni treatment for the liver-ravaging disease, Wellesley-based Harvard Pilgrim expects to save about $10 million on reimbursements to doctors who treat hepatitis C patients. The insurer didn’t disclose how much it will pay for the drug after a rebate from Gilead.

Harvard Pilgrim followed the lead of national pharmacy benefit managers such as CVS/Caremark and Express Scripts, which buy prescription drugs in bulk. Taking advantage of a rival hepatitis C drug combination from AbbVie Inc., those companies recently bargained with both drug makers to secure rebates.

Read more....

$1,000 Pills and the Future of Global Medicine

"In spite of these undoubtedly expensive costs, such an outrageous and unaffordable cost of treatment in the midst of a growing epidemic should not be allowed."

Hepatitis C, a liver-damaging virus, is best known as a “shadow epidemic” suspected of causing precipitous rise in rates of liver cancer, a disease increasing faster than any other cancer in the United States. The disease affects more than four million Americans and is disproportionately found among society’s marginalized populations, including prison inmates and injection drug users. An estimated 130 to 150 million people are infected worldwide.

Though these statistics and stories are worthy of alarm, costs of treating this epidemic are far from urgent. In April 2014, the World Health Organization approved two new oral drugs that fight hepatitis C, but their costs are far from affordable. Gilead Science’s 12-week course of the hepatitis C drug Solvadi costs $84,000, which translates to $1,000 per pill. Johnson & Johnson’s drug Olysio, often prescribed with Solvadi, costs $66,360 for the 12-week regimen.

Pharmaceutical companies oftentimes justify these high costs by simply pointing to the length of time and amount of money that is invested in the research and development process. According to the Pharmaceutical Research Manufacturers of America, research and development for just one medicine takes 10 to 15 years and more than $1 billion.


Wednesday, January 28, 2015

UnitedHealth Said to Pick Gilead’s Harvoni as Hepatitis C Drug

(Bloomberg) -- UnitedHealth Group Inc., the biggest U.S. health insurer by sales, picked Gilead Sciences Inc.’s Harvoni as its preferred hepatitis C treatment, according to a person familiar with the matter.

The decision applies to UnitedHealth’s fully insured commercial customers, as well as to Medicaid and Medicare members. The Minnetonka, Minnesota-based insurer has about 45 million U.S. health-plan customers, though not all follow the company’s drug picks.


Quest Diagnostics and CDC Expand Public Health Collaboration to Improve Hepatitis Diagnosis and Treatment

Multi-year fee-based contract for Quest's test data and analytics expertise aims to reveal insights from national testing trends to promote guideline-based care and better outcomes for 4.4 million Americans with viral hepatitis

MADISON, N.J. and ATLANTA, Jan. 28, 2015 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today announced that it will collaborate with the Centers for Disease Control and Prevention (CDC) to identify trends in screening, diagnosis and treatment for four strains of viral hepatitis in the United States, based on insights revealed by analysis of Quest's national testing database. Under terms of the multi-year contract, Quest Diagnostics will provide CDC researchers with analytics expertise and access to the company's national Quest Diagnostics Health Trends™ database of de-identified clinical testing hepatitis data. The agreement is the first fee-based contract for hepatitis-related research awarded by CDC to a diagnostic information services provider.

The goal of the collaboration is to generate diagnostic-based insights that will improve the ability of public health authorities to develop and monitor medical guidelines designed to reduce disease prevalence and enhance outcomes through earlier diagnosis and treatment of hepatitis.

"The innovative collaboration with Quest Diagnostics will allow us to use data analytics to better monitor the implementation of CDC's testing guidelines and progress toward reducing deaths from hepatitis," said John W. Ward, MD, director of CDC's Division of Viral Hepatitis. "Increased testing is critical to ensure that those who are infected with hepatitis receive life-saving care and treatment."

"Our partnership with CDC reflects the growing value of data analytics in health care to improve decision making, both for population health and in a clinical setting," said Rick L. Pesano, MD, PhD, vice president, research and development, and medical director, infectious diseases, for Quest Diagnostics. "Transforming data into insights to measure and predict behaviors and outcomes will be increasingly important as the nation's healthcare system moves to fill gaps in guideline-based care."

Quest Diagnostics is a leader in hepatitis diagnostic information services with services that include genotyping, risk stratifying and viral load testing to aid diagnosis, treatment and monitoring. Medical and bioinformatics experts from Quest Diagnostics and CDC's Division of Viral Hepatitis will analyze de-identified test results from the Quest Diagnostics Health Trends™ national database for hepatitis A, B, C and E viral infection in American adults age 18 years and over. Analysis will include results of screening and confirmatory diagnostic tests as well as treatment-guiding genotyping and viral load tests by gender, age group, geography and type of physician. The teams will jointly develop study designs and protocols based on Quest's proprietary data-mining techniques to identify patterns in prevalence and clinical management of patients.

The new agreement supplants a non-fee-based agreement formed by CDC and Quest Diagnostics in July 2013.  Under that prior agreement, the organizations jointly analyzed de-identified hepatitis C testing data in the Quest Diagnostics Health Trends database for individuals born between 1945 and 1965. In 2012, CDC issued recommendations for one-time lab screening for hepatitis C for these "Baby Boomers," who are five times more likely than other adults to be infected with hepatitis C. Untreated, chronic hepatitis can cause liver cancer and death.

A primary objective of the expanded agreement is to identify and monitor trends in hepatitis B and C viral infection in pregnant women and to characterize these patients by demographics and type of physician. About 40% of untreated newborns infected with hepatitis B in utero will develop chronic hepatitis, and one in four of these will die from liver disease. CDC guidelines call for pregnant women to be screened with a lab test for hepatitis B, but only recommend hepatitis C screening when other risks are present. In recent years, CDC's Division of Viral Hepatitis has partnered with Quest Diagnostics and others to add pregnancy status to hepatitis B lab test orders to improve surveillance of infected mothers.

"The right screening and medical interventions can prevent the tragedy of lifelong hepatitis-related liver disease in children born to infected mothers," said Dr. Pesano. "We're proud to work with CDC to assess trends in hepatitis B screening in pregnant women in order to identify gaps in screening and treatment, because it will yield insights that will help health professionals take actions to save people's lives."

Quest Diagnostics maintains the largest private clinical database of diagnostic testing information in the United States, Quest Diagnostics Health Trends, based on more than 20 billion de-identified test results. The company's scientists, in collaboration with top health institutions, analyze and publish studies based on this data in peer reviewed publications and as a public service in order to identify trends in disease and wellness.

In a 2010 report, the Institute of Medicine underscored a lack of awareness among the public and medical providers about the health dangers of hepatitis. The IOM also called upon public and private organizations to partner to increase data collection on infection, treatment and outcomes of hepatitis B and C, and to educate at-risk populations, healthcare providers and the general public about hepatitis to promote vaccination and prevention strategies and encourage screening and testing.

About Quest Diagnostics Quest Diagnostics is the world's leading provider of diagnostic information services needed to make better healthcare decisions. The company offers the broadest access to diagnostic information services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff.  Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care.  Additional information is available at QuestDiagnostics.com.  Follow us at Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.

Quest, Quest Diagnostics, the associated logo, and all associated Quest Diagnostics marks are the registered trademarks of Quest Diagnostics. All third party marks — ®' and ™' — are the property of their respective owners.

Quest Diagnostics Contacts:Wendy Bost, Quest Diagnostics (Media): 973-520-2800
Dan Haemmerle, Quest Diagnostics (Investors): 973-520-2900

CDC Contact: CDC Media Line: 404-639-8895

Logo - http://photos.prnewswire.com/prnh/20130717/NY48934LOGO

SOURCE Quest Diagnostics: http://newsroom.questdiagnostics.com/2015-01-28-Quest-Diagnostics-and-CDC-Expand-Public-Health-Collaboration-to-Improve-Hepatitis-Diagnosis-and-Treatment

Can Regulus Therapeutics Double Again on Next Hep-C Drug Trial Update?

BOSTON (TheStreet) -- Let's interrupt the non-stop (and frankly, repetitive) chatter about hepatitis C drug price wars and turn our attention again to Regulus Therapeutics and its experimental, injectable microRNA therapy RG-101.

New trial data from a group of hepatitis C patients treated with a higher dose of RG-101 are expected in early February, according to Regulus. The company's stock price doubled last October when the first slug of RG-101 data were announced, so it's a good time to review what we know about the drug and attempt to determine what the updated results might reveal.

RG-101 uses small (micro) snippets of RNA to disrupt the replication of the hepatitis C virus and lead to its elimination from the liver. Regulus views RG-101 as a potentially new way to treat hepatitis C with a single or even a few simple and easily tolerated injections. It's a controversial idea because the best hepatitis C therapy today are already considered to be incredibly convenient. Gilead Sciences'  Harvoni requires patients to take a single, daily pill for eight or 12 weeks. No injections are needed. Abbvie's   Viekira Pak is just as effective but with a few more pills. [RA Capital portfolio manager Peter Kolchinsky owns Regulus and wrote about the bull thesis for RG-101 earlier this month].


UK: Risk of blood-borne viruses from sharps injuries continues, report claims

Healthcare workers continue to be at risk of exposure to blood-borne viruses through occupational sharps injuries, with reported cases increasing, Public Health England (PHE) has warned in a damning report.

This is despite awareness of the risk of sharps injuries, safe practices being much more widespread, and the fact safety-engineered devices to prevent such injuries are now widely available, it has added.

In its latest report on exposures to a blood-borne virus (BBV), PHE said cases reported had increased among healthcare workers from 373 in 2004 to 496 in 2013.

The updated Eye of the Needle report, which was first published in 2012, found that, over this 10-year period, approximately 30% of exposures involved a source patient infected with HIV; 54% involved hepatitis C (HCV) and 9% hepatitis B (HBV).


UK: St Neots man calls for justice from contaminated blood inquiry after losing three family members

Tony Farrugia, 43, of Howitt’s Gardens, Eynesbury, is pushing for the scope of the Penrose Inquiry – a public inquiry into HIV and Hepatitis C infections acquired from NHS treatment with blood and blood products in Scotland – to bring justice to patients and their families. He said that it would still be relevant to his cause in England, as the blood was given to patients prior to the Scottish NHS being separated from England.

Mr Farrugia lost his father Barry and uncles Victor and David – who were all haemophiliacs – as a result of the treatment they were given with contaminated blood. The hereditary condition, which prevents blood from clotting, meant that they required the protein Factor VIII to be administered during medical treatment.

Unbeknown to the public, the NHS had sourced paid-for blood donations which were distributed by American suppliers and taken from communities with an increased risk of having potentially deadly infections, such as prison inmates.


Médecins slams Gilead for licencing new hepatitis drug in India

The well-known international humanitarian organisation Médecins Sans Frontières has strongly criticised the decision by US-based Gilead Sciences to expand its existing voluntary licence agreement with eight Indian generic drug-makers for sofosbuvir and ledipasvir to include its investigational compound GS-5816, saying it will restrict access to the drugs for people across the developing world.

''Gilead's anti-diversion programme not only potentially jeopardises patient confidentiality and privacy, but could also exclude many patients that may lack the citizenship and identification papers that Gilead requires them to have in order to get access to treatment.

''Gilead's programme introduces coercion and policing upon medical providers and may result in treatment interruptions for patients, leading to treatment resistance and failure.  As far as is known to MSF, such a programme, motivated solely by commercial interests, is unprecedented,'' MSF said.

- See more at: http://www.domain-b.com/industry/pharma/20150128_hepatitis.html#sthash.REnGdQcH.dpuf

New treatments available in Alaska for Hepatitis C

ANCHORAGE –Hepatitis C is a disease that health officials say kills more Alaskans than HIV and AIDS, but according to state health officials, most of the people who have the virus don’t know it.

State Hepatitis prevention coordinator Ginger Provo says more than 16,000 Alaskans have been infected with the Hepatitis C virus since the state started keeping records in the mid 1990s. But Provo believes the real numbers are much higher. She said up to 75 percent of people who have the disease have not been diagnosed because many of them aren’t experiencing symptoms.

The one bright spot for the disease lies in its treatment. New drugs have been released recently that work better, faster and with fewer side effects than previous treatments, Provo says.


Tuesday, January 27, 2015

Missouri to save $4.2 million by switching hepatitis C drug

JEFFERSON CITY, Mo. (AP) — State officials say Missouri’s Medicaid program will save an estimated $4.2 million in fiscal year 2016 by using a newer, cheaper drug to treat hepatitis C.

The state joined a group of 25 other states to receive rebates on Viekira from drug maker AbbVie. The state in most cases will provide that drug instead of Gilead Science’s Sovaldi in an agreement announced Monday.

The expensive treatment with Sovaldi, about $84,000 for a normal course, was cited as one driver of increased Medicaid costs for the state in 2015 by the state budget director.


Quest in broad deal with CDC for hepatitis analysis

(Reuters) - Laboratory testing company Quest Diagnostics Inc said on Tuesday it had signed a $520,000 agreement with the Centers for Disease Control and Prevention to identify trends in screening, diagnosis and treatment of four strains of viral hepatitis.

Quest will provide the U.S. public health agency with analytics and access to Quest's national database of clinical testing hepatitis data, which includes information from more than 20 billion test results.

The agreement expands on Quest's previous efforts with the CDC on hepatitis C testing data for Baby Boomers, or individuals born between 1945 and 1965, one of the groups most exposed to the virus.

Read more....

Low Sodium Levels Increases Liver Transplant Survival Benefit in the Sickest Patients

Researchers report that low levels of sodium in the blood, known as hyponatremia, increase the risk of dying for patients on the liver transplant waiting list. The study published in Liver Transplantation, a journal of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, showed an increase in survival benefit for patients with hyponatremia and a Model for End Stage Liver Disease (MELD) score of 12 or more.

The MELD score measures the risk of death on waiting list. It is calculated using patient’s serum bilirubin, creatinine, and prothrombin time and is used by national organ allocation policy to determine the priority for a patient on the transplant waitlist. Patients who are most sick, with a high MELD score, are at the top of the waitlist. Previous research links low serum sodium, in combination with the MELD score, to increased waitlist mortality, prompting Organ and Procurement Transplant Network (OPTN) directors to approve a new policy that gives additional MELD score points (1 to 13 based on serum sodium value) to patients with hyponatremia.

Dr. Pratima Sharma, with University of Michigan Health System in Ann Arbor and lead study author notes, “While the OPTN serum sodium allocation formula may reduce deaths on the waitlist by enhancing access to donor organs, it is not clear if candidates with hyponatremia gain any survival benefit over patients with normal sodium levels. Our study examines if patients with low serum sodium prior to liver transplant have a greater survival benefit than patients without low serum sodium, all other things being equal.”

Using data from the Scientific Registry of Transplant Recipients, researchers identified 69,213 candidates, 18 years of age or older, who were on the waiting list for liver transplant between January 2005 and December 2012. Liver transplant recipients were matched to waitlist candidates with the same MELD score and located in the same donation service area.

Findings indicate that the liver transplant survival benefit increased significantly with decreased serum sodium levels when MELD scores were 12 or more. The survival benefit was not affected by low sodium values for candidates with MELD of 11 or less. Dr. Sharma concludes, “Our results suggest that adjustment based on serum sodium for the purpose of the liver allocation process should be considered for those candidates with low sodium levels and a MELD score of at least 12. Health care providers should also alert liver transplant patients on the waiting list that low sodium levels could increase their mortality risk on the waitlist and may affect the expected survival benefit following liver transplantation."

This research was supported by the National Institutes of Health (NIH, grants DK-088946 and 5R01 DK-70869) along with a research award from the American College of Gastroenterology. 


Access the full study on the Wiley Press Room here. (To access PDFs and embargoed stories you must be logged in to the Press Room before clicking the link. Request a login here.) Full citation: “Serum Sodium and the Survival Benefit of Liver Transplantation.” Pratima Sharma, Douglas E Schaubel, Nathan P Goodrich and Robert M Merion. Liver Transplantation; (DOI: 10.1002/lt.24063).

URL: http://doi.wiley.com/10.1022/lt.24063

Author Contact: Media wishing to speak with Dr. Sharma may contact Mary F. Masson at University of Michgan at mfmasson@med.umich.edu.

Monday, January 26, 2015

Fish Intake Tied to Liver Cancer Risk

The role of nutrition in liver cancer risk has been underrepresented in research, particularly compared to risk factors such as chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). Yet, some studies have indicated that n-3 polyunsaturated fatty acid (n-3 PUFA) may inhibit the promotion and progression stages of carcinogenesis. Fish is a source rich in n-3 PUFA, making it an ideal factor for analysis.

A new study in PLOS ONE reviewed published studies on the role of total fish intake and risk of primary liver cancer in case-control and cohort studies. Ten studies were analyzed, with all but one study hospital-based. A statistically significant inverse association between total fish intake and risk of liver cancer was observed; in comparing high vs. low intake, response models indicated that this risk was reduced by 18% and 6% per one serving/week increase, respectively. Although the exact mechanism of action is unknown, it is proposed that n-3 PUFA may inhibit cancer development via molecular biosynthesis, gene transcription and expression, and signal transduction or through its anti-inflammatory effect.

Even with these findings, residual or unknown confounding factors cannot be completely ruled out and not all studies controlled for risk factors such as HBV/HCV status. While this study supports a possible relationship between fish intake and liver cancer prevention, future well-designed studies are needed.


Source: http://www.empr.com/fish-intake-tied-to-liver-cancer-risk/article/394500/

Vitale & Codey Take Action to Provide Hepatitis C Screening to All Baby Boomers

Senate Health Committee Advances Legislation to Require Hospitals and Health Care Providers to Offer Testing to Certain High-Risk Patients

TRENTON – A bill sponsored by Senators Joseph F. Vitale and Richard J. Codey that would put New Jersey in line with CDC recommendations to test baby boomers for Hepatitis C was advanced today by the Senate Health, Human Services and Senior Citizens Committee.

“I have seen firsthand the effects that Hepatitis C can have on an individual and their family,” said Senator Vitale, D-Middlesex, Chairman of the Senate Health Committee. “If a patient is screened and made aware of the disease earlier, they can have a real shot at treatment, often so successful as to remove any trace of the disease.  Real lives can be saved with this legislation.”

The issue is close to Senator Vitale’s heart as his father passed away from complications due to Hepatitis C, a disease that he contracted through a tainted blood transfusion. The Senator notes that through this legislation, individuals will be diagnosed earlier, allowing for effective treatment to avoid liver damage, cirrhosis and even cancer.

EnvisionRx and Gilead Sciences Sign Exclusive Agreement to Help in the Fight Against Hepatitis C

TWINSBURG, Ohio, Jan 26, 2015 (BUSINESS WIRE) -- EnvisionRx®, a national, full-service pharmacy benefit management (PBM) company, today announced a partnership with Gilead Sciences Inc., a pioneer in the treatment of the Hepatitis C virus (HCV), to provide availability to HCV infection treatments Sovaldi® and Harvoni™ for EnvisionRx patients on an exclusive basis.

“EnvisionRx is committed to helping patients attain the most effective drugs at affordable prices, and we are proud to be able to offer our patients Sovaldi® and Harvoni™, the market leaders in the treatment of HCV, ” said Dawn Sherman, President of EnvisionRx. “The safety and efficacy profile of Gilead’s HCV products, coupled with the most competitive pricing in the drug class, have solidified EnvisionRx’s choice to place Gilead’s HCV products in an exclusive and preferred formulary position. We believe our comprehensive HCV approach will enable our patients to receive the best available care.”

Consistent with PBM industry practice, exceptions for other hepatitis C drugs will be allowed in some cases. Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), is the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Sovaldi™ (sofosbuvir) 400 mg tablets, is a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.


Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent

–Sofosbuvir/GS-5816 Single Tablet Regimen May Provide Important New Option for Patients in Developing Countries –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 26, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C. The expanded agreements will allow Gilead’s India-based partners to manufacture GS-5816 and the single tablet regimen of sofosbuvir/GS-5816, once approved, for distribution in 91 developing countries, which together account for 54 percent of the total worldwide population of individuals infected with the hepatitis C virus (HCV).

If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first pan-genotypic, all-oral single tablet regimen for HCV. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available.

“Today’s announcement marks an important milestone in Gilead’s effort to make effective hepatitis C treatment accessible to as many patients, in as many places, as quickly as possible,” said Gregg H. Alton, Executive Vice President, Corporate and Medical Affairs, Gilead Sciences. “Developing countries are home to a diverse mix of hepatitis C genotypes, and the development of a medicine that has the potential to cure any patient, regardless of genotype, could help accelerate access to treatment.”

Professor Abhijit Chowdhury, Head of Hepatology, Institute of Post Graduate Medical Education and Research, Kolkata, commented: “Pan-genotypic hepatitis C treatments have the potential to radically change the treatment landscape in developing countries, removing the need for patients to undergo burdensome laboratory tests. Even if testing facilities are available, their cost is a barrier to treatment access, so a regimen that can be used for any genotype is going to be a real attribute in tackling this disease on a global level.”

The amended agreements expand on Gilead’s existing generic licensing partnerships for hepatitis C, announced in September 2014, under which partners may produce sofosbuvir and the single tablet regimen of ledipasvir/sofosbuvir. Eight Indian-based generic manufacturers now hold licenses to manufacture Gilead’s HCV medicines – Biocon Ltd., Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd.

Sofosbuvir recently received regulatory approval in India (January 2015), and regulatory submissions have been completed in additional countries, including Pakistan, Thailand, Brazil, Uganda, South Africa and Nigeria.

About GS-5816
The single tablet regimen of sofosbuvir/GS-5816 is an investigational agent and its safety and efficacy have not been established. Phase 3 studies evaluating the combination of GS-5816 and sofosbuvir are currently underway, with data anticipated in the second half of 2015.

Gilead’s Approach to Treatment Access in Developing Countries
Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic means. In developing countries, Gilead’s treatment access strategies include tiered pricing, voluntary generic licensing (often in advance of U.S./EU regulatory approval), negotiation with national governments, regional business partnerships, product registration, medical education and partnerships with non-profit organizations. This approach has been successfully applied to Gilead’s humanitarian program in HIV over the past 10 years, where seven million patients are now receiving Gilead-based HIV medicines in developing countries.

For more information on Gilead Sciences, please visit the company’s website at www.Gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

- See more at: http://gilead.com/news/press-releases/2015/1/gilead-expands-hepatitis-c-generic-licensing-agreements-to-include-investigational-pangenotypic-agent#sthash.XNY7QWgP.dpuf

Saturday, January 24, 2015

Hepatitis C: What Therapy this Week?

“We really have entered this new era of direct acting antivirals, and as of this fall, we’ve finally laid to rest Interferon in the grave that we’ve all been wanting to put it in, for more than 2 decades,” opened Jacqueline G. O’Leary, MD, MPH, AGAF during her presentation at the 2015 AGA Clinical Congress of Gastroenterology & Hepatology.

According to O’Leary, sofosbuvir certainly changed everything – a truly pangenotypic polymerase inhibitor (NSSB) prescribed as 400 mg daily, never modified with no significant food effect reported. It had recently been co-formulated with ledipasvir, the first in class NSSA inhibitor, once daily dose, and also with no existing food effect.

Switching gears, O’Leary discussed the other FDA approved all oral regiment of paritapevir with ombitasvir and dasabuvir, for their genotype 1 patients. “This is a trick from HIV that allows lower dosing in medication, a dramatic increase in half-life, which adds an additional protection. This is binding against the thumb blood site, which definitely gets two thumbs up, because it allows you to give the finger to hepatitis C.”

- See more at: http://www.hcplive.com/conferences/aga-2015/Hepatitis-C-What-Therapy-this-Week#sthash.XnTiU8TC.dpuf

Genotype 1: VIEKIRA PAK Therapy

Be sure to check out our new HCSP fact sheet on Genotype 1: VIEKIRA PAK Therapy

Germany: German insurers win discounts on Gilead's Sovaldi

Jan 24 (Reuters) - U.S. biotechnology company Gilead has conceded its first discounts in Germany on its key hepatitis C drugs Sovaldi and Harvoni, German business weekly WirtschaftsWoche reported.

The head of Gilead's German operations told the magazine that discounts from the list price of 60,000 euros ($67,242) per treatment had been negotiated with four of Germany's statutory health insurers but declined to give the size of the discounts.

"Thirty-five percent of people with statutory health insurance are already profiting from the discount agreements," Carsten Nowotsch said in an interview to be published on Monday, adding that more such contracts could follow.


India: Docs get training in liver transplant in Delhi

JAIPUR: There is a ray of hope for the patients who need liver transplant. A team of 14 doctors and 15 nurses from SMS Medical College has returned from Delhi after being trained in liver transplant operation at a private hospital.

According to sources, till now there is no facility for liver transplant in the state. The patients have to go to other states like Delhi and Tamil Nadu for such operations. The Sawai Man Singh Hospital is taking it on a priority basis to introduce the facility as soon as possible in the hospital.

Dr Ashok Jhajharia, who was one of the members of team, said, "It was fruitful 15-day training of liver transplant in Delhi. It will help in introducing the facility of liver transplant in the state."


Friday, January 23, 2015

Native AIDS Survivor, Activist Runs Marathon: ‘We CAN Run Marathons too’

On January 18, 2015, I completed my first full marathon in Phoenix. It wasn’t easy because statistics told me Natives have the shortest life span after HIV infection.

Back in 2002 when I was diagnosed with HIV and Hepatitis C in Phoenix, my health was at a border between HIV and AIDS. I was immediately taken to a Native AIDS support group. To this day, I am the only one from that group who is still alive.

Born and raised on the San Carlos Apache Reservation in Arizona, I never thought a tribal would get AIDS. Education was extremely limited about the virus. Rumors were rampant when the virus was discovered, and I remember looking for red or purple spots on my body thinking it was Kaposi’s Sarcoma, a disease AIDS patients got in the early days.

Read more at http://indiancountrytodaymedianetwork.com/2015/01/23/native-aids-survivor-activist-runs-marathon-we-can-run-marathons-too-158837

NIH Announces Funding for New Technologies for Viral Hepatitis

The National Institutes of Health (NIH) has issued a funding opportunity announcement (FOA) to encourage small businesses to address viral hepatitis research opportunities delineated in the Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis (Action Plan) [PDF 2MB]. The announcement of a Small Business Innovation Research (SBIR) grant entitled New Technologies for Viral Hepatitis SBIR (R43/R44) is supported by 3 participating institutes: the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Heart, Lung, and Blood Institute (NHLBI), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

The FOA “encourages small business establishments to submit applications that address any of the specific research topics in the updated Action Plan for the Prevention, Care & Treatment of Viral Hepatitis that are assigned to the NIH and germane to the research mission of the respective NIH Institutes and Centers, in order to facilitate the development, evaluation, and validation of products that would be implemented in the public health efforts to reduce the burden of viral hepatitis in the United States.” Research objectives and strategies from the Action Plan that are relevant to this FOA include (but are not limited to) the development of: rapid screening tests, new diagnostic tests, tests for viral hepatitis-related complications, practical models of care, new and improved therapies to treat viral hepatitis or manage complications of disease or antiviral treatment, genetic-based tests for patient management or treatment selection, preventive vaccines, innovative approaches to pathogen identification and reduction in blood products.

Eligible applications include: new applications (Phase I, Fast-Track), renewals (Phase II), resubmissions (all phases), Phase IIB competing renewals, and revisions. Award amounts and durations are limited to 6 months and $150,000 for Phase I grants, and 2 years and $1,000,000 for Phase II grants. This FOA will be open for submissions beginning March 5, 2015.


Disability & Benefits: Family & Medical Leave Laws —Jacques Chambers, CLU

The federal government as well as eleven states plus the District of Columbia have enacted laws providing protection to employees who must be off work due to a medical condition of their own or that of a family member.

It is important to note that the laws do not require employers to continue any part of the worker’s salary while the employee is not working. Any income would have to come from another source, such as the employer’s sick leave and/or Short Term Disability plan, or Worker’s Compensation if it’s a job-related condition, or from state mandated disability benefits programs in California, Hawaii, New Jersey, New York, or Rhode Island.

Federal Family & Medical Leave Act (FMLA)
The federal FMLA law primarily does only two things. If you are an employee who has to take time off from work due to a serious medical condition, either your own or that of a family member, the law:
  • Protects your job while you are off work caring for either yourself or a family member with a serious medical condition so that your job will be available when you return to it;
  • Requires employers to continue your employee benefits in the same manner as it did when you were working; and,
  • Covers only the first twelve weeks of absence in a 12 month period.
  • It does NOT provide any financial benefits. That must come from other sources

Here are the main provisions of the federal FMLA:

Who is covered under the law?
Employers engaged in commerce, or an industry or activity affect­ing commerce, are covered by the law if 50 or more employees are employed in at least 20 or more calendar workweeks in the current or preceding calendar year. The right to take leave applies equally to male and female workers who are employed at or within 75 miles of the work place by an employer of 50 or more workers.
The FMLA also applies to all public agencies, state governments and political subdivisions (including the District of Columbia, U.S. territories and possessions), elementary and secondary school systems, and institutions of higher education. There are special provisions for classroom teachers so as not to disrupt the learning process of students.

Who can take advantage of the law?
An employee is eligible to take FMLA leave if:
  • The employee has been employed by the employer for at least 12 months which need not be consecutive; 
  • The employee has been employed for at least 1,250 hours of service during the 12-month period immediately preceding commencement of the leave;
  • The employee is employed at a work site where 50 or more employees are employed by the employer within 75 miles of that work site;
  • The employee is not a “key” employee;
  • The employee’s position has not been scheduled for elimination.
For what reason may an employee take time off under the law?
The FMLA requires covered employers to grant eligible employees up to 12 weeks of unpaid, job-protected leave in any 12-month period to care for family members or because of their own serious medical condition. FMLA leave may be granted for the following reasons:
  • The birth of the employee’s child and care of the infant;
  • The placement of a child with the employee for adoption or foster care;
  • The care of a spouse, child, or parent of the employee if the spouse, child, or parent has a serious health condition; or
  • The employee’s own serious health condition renders him or her unable to perform the essential functions of the job.
A non-chronic, short-term illness or injury that requires an employee to be absent from work a day or two at a time may qualify as part of the employee’s entitlement to job-protected leave under the FMLA as long as the illness or injury is a serious health condition.

What is a “serious health condition” under the law?
The law defines “serious health condition” to include any “illness, injury, impairment, or physical or mental condition that involves” either inpatient care or “continuing treatment” by a “health care provider.” The Department of Labor regulations expand this to include an illness, injury, impairment or physical or mental condition that involves: (1) inpatient care, including any period of incapacity or any subsequent treatment in connection with the inpatient care; or (2) continuing treatment from a health care provider.

What happens to employee benefits while out on FMLA?
The employer continues any existing health insurance for the duration of the leave and at the level and under the same conditions coverage was provided before commencement of the leave. Employers can ask the employee to cover his/her share of the premiums that were previously paid through payroll deduction from the paycheck. Employers are not required to continue benefits such as life and disability insurance but they cannot require employees to re-qualify for benefits when the employee returns to work.

Is the position protected?
Yes, the employee must be restored to the original or an equivalent position with equivalent benefits, pay, and all other terms and conditions of employment. The highest paid 10 percent of salaried employees may be denied job restoration to prevent substantial and grievous economic injury to the employer.

What may the employer require to grant the leave?
An employer may require certification from a health care provider to support a claim for leave. But if an employer asks one employee for proof of a serious illness, the employer must ask all employees for equivalent certification.

Does the law apply to teachers too?
There are special rules that apply to “instructional employees” that are designed to minimize disruption in the classroom while still protecting the rights of the person on disability. The special rules apply to intermittent leaves, reduced leave schedules, and the taking of leave near the end of an academic term. More detailed information can be found in the Code of Federal Regulations (29 CFR 825.600 et seq).

Other provisions of the law
  • Leave can be taken intermittently, is subject to employer approval, and does not result in a reduction in the total amount of leave to which the employee is entitled.
  • When husband and wife work for the same employer, the total amount of leave that they may take is limited to 12 weeks if they are taking leave for the birth or adoption of a child or to care for a sick parent.
  • When the need for leave is foreseeable, an employee is required to provide at least 30 days advance notice.
Does not supersede state laws
The Act does not supersede any state or local law, collective bargaining agreement, or employment benefit plan providing greater medical and family leave rights, nor does it diminish their capacity to adopt more generous family leave policies.

State Family & Medical Leave Laws
Many states have laws that apply to smaller employers or last longer than the twelve weeks of the federal law. Each state’s own law regarding family and medical leaves can vary considerably from the federal FMLA, so it is important that you check your own state’s law as well when contemplating taking time off for medical reasons.

Also, many of the state laws provide time off for employees to participate in their children’s educational activities either as part of their FMLA law or in a separate statute.
Most of the state laws offer benefits equal to or less than the federal FMLA. There are some exceptions where state law is broader:
  • CaliforniaFor maternity leave, offers 12 weeks of unpaid family leave plus 4 months of maternity leave for a total of 28 weeks per year.
  • Maine Law applies to private employers of 15 employees or more and state and local government employees with 25 employees or more, but limits leave to 10 weeks in 2 years.
  • New Jersey Only 1000 hours of service in twelve months are required to be eligible for its benefits.
  • Oregon Employers with 25 or more employees are covered, and employees are eligible after working at least 25 hours per week in the past 180 days.
  • Vermont – All employers with 10 or more employees come under the law.
  • Washington – All employers come under the law. Employees are eligible after working at least 680 hours during the past year.
Details on the state laws can be found at here:


Catch liver cancer early with regular screening

Liver cancer is one of the deadliest cancers in the world, causing more than 600,000 deaths each year. The number of Americans with liver cancer has been slowly but steadily rising for several decades with over 33,000 people expected to be diagnosed in 2014. The incidence is increasing due to the silent epidemic of hepatitis B and C, the rise in the number of people with morbid obesity and diabetes, and the persistence of alcoholic cirrhosis - all of which are risk factors for the disease.

Symptoms of liver cancer include loss of appetite, weight loss, feeling of fullness, nausea or vomiting, pain in the abdomen or near the right shoulder blade, and yellowing of the skin. Unfortunately, symptoms often do not appear until the disease is an advanced stage, which is why regular screening and surveillance are critically important for patients living with liver disease. Regular checkups in those without risk factors are also important as anyone can develop liver cancer.

"Patients often do not experience symptoms of liver cancer until it's already progressed to an advanced stage so it's important for those at risk to be screened," says Dr. Ghassan Abou-Alfa, medical oncologist at Memorial Sloan Kettering Cancer Center, chair of the Hepatobiliary Task Force of the National Cancer Institute, and a member of the American Liver Foundation's National Medical Advisory Committee.


Thursday, January 22, 2015

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

This year’s strains of influenza are particularly virulent, and unfortunately the vaccine developed this year does not provide protection against all of the strains.  The flu is a nasty virus that causes 36,000 deaths and 200,000 hospitalizations each year in the United States. The largest and deadliest flu outbreak was the Spanish flu pandemic of 1918-1919 that caused 20 to 40 million deaths.  Now we are lucky to have a healthcare system that prevents most deaths, and vaccines that provide protection against most strains of the flu. 

1. Symptoms:  Many people confuse the symptoms of flu with the cold, but the flu has definite symptoms, such as: 
  • A fever of 100 degrees or higher (but not everyone gets a fever)
  • A cough and/or sore throat
  • A runny or stuffy throat
  • Headache and/or body aches
  • Chills
  • Fatigue or feeling tired
  • Nausea (feeling sick to your stomach), vomiting, and/or diarrhea
2. People who are at risk for severe complications:
  • Children younger than 5, especially those younger than 2 years old
  • Adults 65 years and older
  • People who have medical conditions including liver disease (such as hepatitis B and C)
3. Prevention:
  • The best prevention is the flu vaccination.  It is safe and is usually effective; but this year’s flu has mutated so the vaccine is not protective against this year’s most virulent flu strain.  Even so, it is protective against 50% of the strains infecting people this year.
  • Basic hand washing can help to protect people from the cold, flu and other infections—wash the hands for at least 20 seconds with soap and water. 
  • Watch what you touch, especially other people’s items—phones, iPads, remote controls, etc.
4. The Flu:
  • If you get the flu, the best advice is to get bed rest, and monitor your temperature and drink lots of fluids.
  • There are many over-the-counter medicines that can help lessen some of the symptoms
  • Your medical provider can prescribe antiviral medications to reduce the symptoms and shorten the duration of the flu
  • Seek medical attention if you experience any of the following:
    • Difficulty breathing or shortness of breath
    • Purple or blue discoloration of the lips
    • Pain or pressure in the chest or abdomen
    • Sudden dizziness
    • Confusion
    • Severe or persistent vomiting
    • Seizures
    • Flu-like symptoms that improve but then return with fever and worse cough
5. The Bottom Line:
  • There is still time to get the flu vaccine, but if you don’t get vaccinated, be prepared to take precautions to protect yourself against getting the flu. 

Egypt: Mothers infecting children with hepatitis C in Egypt

Up to 5,000 Egyptian children a year could be infected by hepatitis C through their mothers.

A new study suggests that between 3,000 and 5,000 Egyptian children could be infected with hepatitis C virus (HCV) annually through mother-to-child transmission1.

This vertical transmission, which is still not fully understood, is believed to occur during pregnancy, child birth or during the postpartum period, most probably from cracked nipples.

The scientists from the Weill Cornell Medical College in Qatar (WCMC-Q) and the London School of Hygiene & Tropical Medicine in the UK focused on Egypt, which has the highest incidence of HCV worldwide, with an estimated 14.7% of the population carrying the virus and up to 100,000 new infections occurring each year, according to WHO.


Australia: Aboriginal Hepatitis C rising, prompting calls for improved services

As rates of the disease decrease among Australians overall, Hepatitis C is three times higher and rising in Indigenous populations.

Mainstream medical services are failing Aboriginal communities, where the rate of Hepatitis C is rising, a peak Aboriginal health body has told a federal Senate inquiry.

A public hearing in Sydney on Thursday heard submissions from stakeholders, including the National Aboriginal Community Controlled Health Organisation (Naccho), which called for improved access and funding of medical services for Aboriginal and Torres Strait Islander people.

As rates of the disease decrease among Australians overall, Hepatitis C is three times higher and rising in Indigenous populations, according to a 2013 study by the Kirby Institute. The worsening problem is mainly due to higher rates of unsafe drug injecting and possibly higher rates of incarceration, where the prevalence of intravenous drug use is much higher among Indigenous prisoners, according to multiple studies.


High number of Hepatitis C cases in Mesa County

GRAND JUNCTION, Colo. It's called the "hidden epidemic" and is more aggressive and infectious than HIV. Hepatitis C starts as a liver infection and can turn into a chronic disease.

According to The Western Colorado Aids Project, Mesa County is one of the highest counties with Hepatitis C cases in Colorado and it's on the rise. WestCAP Director Jeff Basinger estimates that 3,000 to 5,000 people in Mesa County currently have the disease.

"We have a positivity rate that ranges from 25 to 50 percent of all people we test,” said Basinger.


Longmont Woman Cured Of Hepatitis C, Credits New Drugs

DENVER (CBS4)- A woman from Longmont has been cured of Hepatitis C during her participation in a clinical trial testing an expensive new drug.

Kim Bossley is thanking the drug Sovaldi for changing her life.

It was 2005 when Bossley learned she had Hep C. Both Kim and her mother were infected during Kim’s birth through a blood transfusion. Kim’s mother died when the disease destroyed her liver.


Wednesday, January 21, 2015

Hepatitis C Outbreak ~ Lutheran Social Services ~ State of the Union Reaction

Wednesday, January 21 – A Hepatitis C outbreak in Minot has hit a number of elderly residents of a nursing home. Here to discuss Hep C and the problem of public outbreaks is Tracy Miller, state epidemiologist with the Department of Health. ~~~ We share an excerpt from this week’s Prairie Pulse television show as host John Harris visits with Jessica Thomasson, the new CEO for Lutheran Social Services of North Dakota.

Listen to the Podcast here...

Merck Will No Longer Sell its Victrelis Hepatitis C Drug in the U.S.

Rival hepatitis C drugs from Merck and Vertex Pharmaceuticals VRTX +0.21% made a big splash when they debuted in 2011, marking an advance in treatment of the liver disease and a lucrative new market segment. But now the Class of 2011 has almost sunk to the bottom, made obsolete by a newer wave of drugs, a sign of how rapidly the hepatitis C market is changing.

Merck this week notified the FDA that it will stop selling its Victrelis medicine in the U.S. by the end of this year, although the drug will remain available in other countries. The move comes three months after Vertex Pharmaceuticals discontinued U.S. sales of its own Incivek hepatitis C drug.

Both drugs are known as protease inhibitors and when they became available in 2011, they were quickly incorporated into treatment. Victrelis and Incivek each boosted cure rates and shortened treatment durations for many patients when added to the prior standard treatment.


Snapshots —Alan Franciscus, Editor-in-Chief

Abstract: Low Risk of Liver Decompensation among Human Immunodeficiency Virus/Hepatitis C Virus-Coinfected Patients with Mild Fibrosis in the Short-Term.
  Authors: J Macias et al.  Hepatology. 2014 Dec 24. doi: 10.1002/hep.27674. [Epub ahead of print]

Results and Conclusions: The authors of this study wanted to find out which HIV/HCV patients can safely wait, or wait in the short term for treatment.  This study was conducted during the time that pegylated interferon was part of the treatment regime.  A total of 1729 patients were evaluated (683 patients by liver biopsy; 1046 by liver stiffness measurement) and followed over time. The authors concluded that patients who did not have advanced fibrosis were at “very low risk” of decompensated cirrhosis, at least in the short term.  In this population, a careful watchful waiting is appropriate—in the author’s opinion.

Editorial Comments: I find this study interesting and valuable.  But I think it is a dangerous game to play.  This is a population of patients who typically have faster disease progression—faster than people who are monoinfected.  It may be safe if people are followed very carefully.  But wouldn’t it be easier and safer to treat now and not take the chance of putting people at undue risk?

Abstract: Hepatitis C Virus (HCV) Antibody Dynamics Following Acute HCV Infection and Reinfection among HIV-Infected Men Who Have Sex with Men.
  Authors:  J. Vanhommerig et al. Clin Infect Dis. 2014 Dec 15;59(12):1678-85. doi: 10.1093/cid/ciu695. Epub 2014 Sep 3.

Results and Conclusions: This study identified 63 HIV/HCV coinfected patients who had tested positive for HCV antibodies and HCV RNA (viral load).  The patients were followed for 4 years.  Five of the patients spontaneously cleared HCV and 31 of 43 patients were treated and cured.  In 36 (5 spontaneously cleared; 31 cured) the antibody titers (the measurements) declined.  In 8 of the 31 patients the HCV antibody titers disappeared. 

Eighteen of the patients were re-infected with a dif­ferent strain than the initial one and devel­oped a surge in both antibodies and HCV RNA.  The researchers believed that one patient was re-infected three separate times after the first successful treatment. 

Editorial Comments:  I couldn’t find the entire journal article to find out what type of counseling efforts were offered to the study participants.  This study, however, should remind us we need to educate people about prevention measures.  But what was interesting is that 8 people had undetectable antibody titers in this small study.  On a personal note, I did a demonstration of an HCV antibody test.  I was cured of hepatitis C more than 10 years ago.  The results showed very low reactive results.  I wonder if my antibody titers will become undetectable after time.  This study made me wonder how many ‘Baby Boomers’ became infected many years ago, naturally cleared the virus, and when tested recently had antibody titers too low to register.


Is the Promised Hepatitis C Drug War Finally Here?

Trial involving experimental medications shows six-week cure rate.

A small clinical trial has shown a combination of oral medicines can rid the body of the disease in as few as six weeks, which marks a big advancement in the treatment of hepatitis C.

The drugs included a combination of sofosbuvir and ledipasvir and one of two experimental drugs by Gilead Sciences, GS-9669 and GS-9451.

One obstacle to shorter treatments is cost. Harvoni (ledipasvir-sofosbuvir), the most recently approved rapid cure medication, costs around $95,000. The high price tag for this daily pill taken for 12 weeks poses challenges to public health insurers such as state Medicaid programs. Debates are raging surrounding who should have access to the medications and when.


Tuesday, January 20, 2015

Georgia: STOP C: Presidential couple joins fight against Hepatitis C

Georgia’s President and the first lady have joined the country's new campaign to intensify the fight against Hepatitis C.

President Giorgi Margvelashvili and his pregnant partner Maka Chichua, posted a picture on the President’s official Facebook page that showed themselves posing with their hands outstretched, showing off words written on their palms that said: "STOP C”.

Georgia declared 2015 as the year of fighting against Hepatitis C.

Read more....

TAC, SECTION27 and MSF Applaud India’s Rejection of Patent on New Hepatitis C Medicine

JOHANNESBURG, Tuesday 20th January: The Treatment Action Campaign (TAC), Doctors Without Borders (MSF) and SECTION27 applaud India’s decision to reject a patent application on sofosbuvir, an important new treatment for Hepatitis C. Last Wednesday’s decision paves the way for increased access to more affordable sofosbuvir in India and other countries who choose to implement legal flexibilities available under international law to increase access to the drug. However, existing patents on sofosbuvir in South Africa could block access to the cheaper generic versions that will become available due to the ruling.  The government should therefore urgently finalise the national intellectual property policy to allow South Africa to better protect access to medicines.

Rejection of the patent in India will allow generic manufacturers that have not already signed restrictive licensing agreements with Gilead to produce sofosbuvir at much lower prices than currently available. Research conducted by Dr Andrew Hill at the University of Liverpool, for example, suggests that sofosbuvir can be profitably produced for as little as $102 (R1,182) per 12 week course.

However, patent protection in South Africa prevents open competition, and could block generic versions of sofosbuvir and other new HCV drugs from reaching the domestic market. The same sofosbuvir patent rejected in India was granted in South Africa, and will only expire in 2025. South Africa has also granted multiple ‘secondary’ patents on sofosbuvir, with the latest patent only expiring in 2034. If reforms proposed in South Africa’s draft intellectual property policy are implemented, the number of such secondary patents granted will be dramatically reduced.


AASLD 2014: Ledipasvir and Sofosbuvir in African Americans —Alan Franciscus, Editor-in-Chief

This is the last of the AASLD 2014 conference coverage (I promise!), but there was one more study I thought was important to discuss.
The Safety and Efficacy of Ledipasvir and Sofosbuvir in African Americans:  A Retrospective Analysis of Phase 3 Data – L Jeffers et al.

The information from the Phase 3 studies of ledipasvir plus sofosbuvir, and of ledipasvir, sofosbuvir plus ribavirin, was compiled, and the information about the African American patients was extracted.  The treatment durations in these studies were 8, 12 or 24 weeks.  The patient characteristics of the African American were generally older, higher Body Mass Index, more likely to have IL28B non-CC (a variation that is less likely to respond to treatment) and lower ALT (liver enzyme levels).

The combined results from all of the phase 3 studies showed the overall cure rates among African Americans to be similar to the non-Blacks in the study groups.   The authors did note that “Although high SVR rates were observed, the limited number of black patients with cirrhosis precludes definitive conclusions in this subpopulation.”  In other words it would be hard to draw conclusions regarding effectiveness of the drugs when comparing African Americans and the other groups because there were so few African Americans in the study who had cirrhosis.
Comments: When interferon-based therapy was the standard of care to treat hepatitis C, African Americans had much lower cure rates compared to most other races.  Now that the standard of care is interferon-free therapies, African American cure rates are the same as the cure rates seen in other races.  Many old ‘facts’ die hard; so let’s put this one to rest and get the message out that that African Americans respond just as well to interferon-free therapies as other populations. 
This was a presentation that was posted to NATAP courtesy of Jules Levin.


After decades with hepatitis C, liver transplant gives man life back

Michael Trevino likely contracted hepatitis C during his military service in Vietnam. It was cured, but doctors told his wife, Ileana, just after his successful transplant that his old liver still had become cancerous.

The way J. Michael Trevino sees it, his life was saved twice.


Monday, January 19, 2015

UK: Apology is wanted by patients who are contaminated by tainted blood

IT WAS a transfusion that was supposed to help Sally Vickers deal with a blood condition, but she says it has given her a death sentence.

Those are the stern words from the 53-year-old who was pumped full of contaminated blood more than 30 years ago.

As a result she contracted hepatitis C – a condition that affects the liver – and has resulted in her giving up work, feeling tired and knowing it could one day kill her because the condition she was born with stops her getting treatment for the virus.


Are Anesthesiologists Finally Recognizing the Importance of Infection Control?

New York—When it comes to the delivery of anesthesia care, infection control matters—and infectious disease professionals think it is high time their counterparts in anesthesiology recognize that.

They should be pleased then that the issue was the topic of discussion during a session entitled “Infection Control Issues Impacting Anesthesia Practice: What’s the Evidence?” held here at the New York State Society of Anesthesiologists’ (NYSSA) 68th Annual PostGraduate Assembly (PGA) in Anesthesiology. The speakers emphasized the importance of infection control practices in the delivery of anesthesia by citing numerous examples. For instance, they noted that during anesthesia care Loftus RW et al (Anesth Analg. 2014 Jun 16. [Epub ahead of print]; PMID: 24937346) found a within- and between-case Enterococcus faecalis transmission rate of 11% to 23%; furthermore, several hepatitis B and C and other infectious outbreaks in health care settings over the past 15 years have been attributed to mishandling of medications, fluids, syringes, needles and cannulae by anesthesia professionals. However, the speakers also emphasized that some published infection control recommendations, including a provision of US Pharmacopeia (USP) Chapter <797>, for example, present unique challenges to anesthesia professionals.


Canada: Vancouver man denied access to lifesaving new Hepatitis C drugs

A resident of Vancouver’s Downtown Eastside is speaking out about the cost of treatments for Hepatitis C. Brody Williams says the only effective options left cost close to $100,000.

Brody Williams has battled the disease for years, undergoing numerous treatments. He’s one of 200,000 Canadians struggling with the virus.

But Williams isn’t getting the drugs. They come with a price tag of $75,000 – $100,000 for a course, and neither the federal Ministry of Indian Affairs, nor B.C.’s medical system will pay because he’s had four different drug treatment protocols already.


Canada: Cape Breton medical officer calls for more hepatitis C screening

About 5,000 Nova Scotians have contracted the infection. In 2013, Cape Breton recorded the second-highest rate of hepatitis C in the province — or about 24 per cent of all hepatitis C cases. 

SYDNEY — Cape Breton’s medical officer of health is encouraging the screening of patients for hepatitis C as a result of staggering rates of the disease.

Dr. Monika Dutt recently offered the advice to close to 60 doctors taking part in a family medicine gathering in Sydney.

“We have rates that are about double what we’re seeing in the rest of the province,” Dutt said in an interview with The Chronicle Herald on Sunday. “It’s something that been increasing over quite a few years now.”


Genotype 2: Prevalence, Cure and Viral Diaspora —Alan Franciscus, Editor-in-Chief

In the past genotype 2 and 3 information has been lumped together.  More recent information has emerged that there are clear differences between these 2 genotypes with respect to prevalence, disease progression and treatment cure rates. Interestingly, there is also substantial data about how genotype 2 migrated from Africa to other parts of the world via the slave trade in the 16th,17th, and 18th centuries. 

There are 7 HCV genotypes identified numbered 1 through 7.  The most common genotypes worldwide include:
  • Genotype 1 (46.2%)
  • Genotype 3 (30.1%)
  • Genotype 2 (9.1%)
  • Genotype 4 (8.3%)
  • Genotype 6 (5.4%)
  • Genotype 5 (.8%)
So far, there has only been 1 person identified with genotype 7.  Thirteen to 15% of people with hepatitis C in the United States are infected with genotype 2.   

As noted above, 9.1% of the population worldwide has gentoype 1.  This translates to about 16.5 million people infected with HCV genotype 2 globally.  Areas that have a prevalence of 10% or greater include:
  • Central Latin America— 19.3%
  • East Asia—15.3%
  • High-income Asia Pacific—24.5%
  • High-income North America—12.0%
  • Southeast Asia—18.2%
  • Western Europe—10.8%
  • West Sub-Saharan Africa—23.0%
The most common genotype 2 subtypes include 2a, 2b, 2c, but there have been 15 other subtypes identified. 

Technology is amazing!  Science can analyze the genetic make-up of hepatitis C virus to estimate the origin, date it and track the viral migration.  Previous studies were able to deduce that genotype 2 originated in West Africa at least 500 years ago. 

In the current study “Phytogeography and molecular epidemiology of hepatitis C virus genotype 2 in Africa,” by P.V. Markov et al., the authors wanted to understand where genotype 2 originated.  The study group looked at all the known subtypes of genotype 2, then concentrated on the geographical area of Guinea-Gambia, which had been theorized as the origin of genotype 2.  Using a process called the molecular clock the authors confirmed that Guinea-Gambia was indeed the source of genotype 2.  Genotype 2 then spread from West Africa to Central Africa. 

Blood-to-blood contact transmits hepatitis C.  This being the case, it is likely that the spread of hepatitis C through Africa occurred over hundreds of years.  So what made hepatitis C increase in such large numbers and spread throughout all of West Africa and Central Africa faster?  It is most likely that hepatitis C was spread throughout Africa by European campaigns to treat endemic diseases in Africa with injectable medications.  Trypanosomiasis (sleeping sickness), syphilis, yaws, malaria, and leprosy were (and some still are) rampant in Africa.  Treating these and other diseases was well-intentioned but, unfortunately, the needles were reused or not properly cleaned.  Millions of unsafe injections were given in Africa before the advent of disposal needles, which contributed to the spread of hepatitis C in Africa.

With regard to how genotype 2 was spread beyond Africa that question has also been answered based on the same genetic technology.  The introduction of genotype 2 into America—particularly in Central and South America—was the result of the transatlantic slave trade from West Africa.  This is called viral migration. 

This is the same way that yellow fever (in the same viral family as the hepatitis C virus—flavivirus family) and other diseases common in Africa were introduced into the Americas by the same transatlantic slave trade.  Similarly, European diseases such as smallpox, measles, tuberculosis, and influenza were introduced into the Americas by the Europeans.

Genotype 2 is also common in Europe not only because of the slave trade, but also due to immigration. France is believed to have contributed to the migration of genotype 2 from their West African colonies to other colonies in Morocco, Quebec, and Vietnam (French Indochina).  It appears that genotype 2i in France was introduced by West African conscripts trained and stationed in southern France during World War I—but this needs to be confirmed by larger studies. 

Genotype 2 did not only migrate from Africa to the Americas and Europe, it also migrated from South America to Asia.  This occurred by way of the slave trade from Java, Indonesia to Surinam (South America) and then back to Indonesia in the 20th century.  

Disease Progression
Genotype 2 does not increase the risk for HCV disease progression.  This is in stark contrast to genotype 3, which has been found to increase the risk for steatosis (fatty liver) and HCV disease progression, including higher rates of fibrosis and steatosis. 

The American Association for the Study of Liver Diseases (AASLD) and the Infectious Disease Society of American (IDSA) recommend that genotype 2 should be treated with the combination of Sovaldi (sofosbuvir a pill taken once-a-day) plus ribavirin (a pill taken twice dai­ly—dosage based on a person’s body weight). The duration of treatment with Sovaldi is 12 weeks. 
The cure rates are:
  • Treatment naïve:  97% (no cirrhosis 97%; cirrhosis 100%)
  • Treatment experienced:  (no cirrhosis 91%; cirrhosis 88%)
AASLD/IDSA also recommend that previous non-responders to therapy can include peginterferon in the 12 weeks of therapy.  Patients who were previous non-responders with cirrhosis may benefit by extending treatment duration to 16 weeks.

There is such a high cure rate for genotype 2 that there is very little research looking at new therapies to treat HCV genotype 2.  However, due to the high cost of current treatments, newer inexpensive therapies would be a welcome addition to the treatment landscape of genotype 2, especially in resource-poor countries.