Saturday, February 25, 2017

Hepatitis C - Big Pharma Quietly Enlists Leading Professors to Justify $1,000-Per-Day Drugs

Big Pharma Quietly Enlists Leading Professors to Justify $1,000-Per-Day Drugs
by Annie Waldman
ProPublica, Feb. 23, 2017, 8 a.m.

This story was co-published with Consumer Reports.

Over the last three years, pharmaceutical companies have mounted a public relations blitz to tout new cures for the hepatitis C virus and persuade insurers, including government programs such as Medicare and Medicaid, to cover the costs. That isn’t an easy sell, because the price of the treatments ranges from $40,000 to $94,000 — or, because the treatments take three months, as much as $1,000 per day.

To persuade payers and the public, the industry has deployed a potent new ally, a company whose marquee figures are leading economists and health care experts at the nation’s top universities. The company, Precision Health Economics, consults for three leading makers of new hepatitis C treatments: Gilead, Bristol-Myers Squibb, and AbbVie. When AbbVie funded a special issue of the American Journal of Managed Care on hepatitis C research, current or former associates of Precision Health Economics wrote half of the issue. A Stanford professor who had previously consulted for the firm served as guest editor-in-chief.

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Jet guns should be a recognized risk factor for hepatitis C

Jet guns should be a recognized risk factor for hepatitis C
By PAUL HARASIM
LAS VEGAS REVIEW-JOURNAL
When I watch the federal government’s current public service messages on TV urging baby boomers to get tested for hepatitis C, I can’t stop thinking about how my arm, and those of many men next to me, bled as we received jet gun vaccinations during our earliest days in the military.

Powerful air pressure from the jet gun forced a tiny stream of medication through our skin without a needle. Because the shot hurt, many of us flinched. Our skin broke, and as we started bleeding, the blood blew back on the jet gun.

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2017 - Management of extrahepatic manifestations of chronic hepatitis C virus infection

On This Blog;

Article in Press
To appear in: Journal of Hepatology
Received Date: 10 November 2016
Revised Date: 5 February 2017
Accepted Date: 6 February 2017

Evidence-based recommendations on the management of extrahepatic manifestations of chronic hepatitis C virus infection
Manuel Ramos-Casals, Anna Linda Zignego, Clodoveo Ferri, Pilar Brito-Zerón, Soledad Retamozo, Milvia Casato, Peter Lamprecht, Alessandra Mangia, David Saadoun, Athanasios G Tzioufas, Zobair M Younossi, Patrice Cacoub

Full Text
Download Accepted Manuscript
DOI: http://dx.doi.org/10.1016/j.jhep.2017.02.010

Lay Summary
  • The current therapeutic armamentarium against HCV has been recently expanded with an explosion of new molecules (DAAs) with high virological efficacy
  • The objective of this international consensus is to provide therapeutic recommendations for HCV patients with extrahepatic manifestations (EHM).
  • The use of non-antiviral therapeutic approaches should be evaluated according to the type of EHM and severity of the clinical presentation
  • B cell depletion with rituximab is the established biologic approach to cryoglobulinaemic vasculitis (CV) employed to date.
  • The efficacy of therapies in EHM patients should be evaluated not only according to the virological response, but also according to the full impact of the other clinical and immunological responses achieved.
  • Clinical experience of the use of the new DAAs in EHM remains very limited, with less than 100 cases reported in the last 2 years (overwhelmingly in CV patients)



Friday, February 24, 2017

The Liver Loving Diet - A Must Read For People With HCV Or Liver Disease

The Liver Loving Diet

My admiration runs deep for a small group of bloggers who spend hours in front of a computer helping those suffering with HCV. What they accomplish is astounding, why do they do it?

So that no one with this disease ever feels alone.

HCV is a progressive liver disease that can be cured, although cirrhosis is usually irreversible and can potentially lead to life threating complications.

Karen Hoyt understands this only to well, she is devoted to offering support and accurate information to people coping with the effects of liver disease. Karen writes from a patients' perspective about living with and treating hepatitis C, cirrhosis, liver cancer and liver failure on her blog, "Your Best Friends Guide To Hepatitis C."

This compassionate author, HCV advocate, and survivor, once again is doing what she does best, keeping us informed and full of hope. Karen has recently announced her new book, "The Liver Loving Diet" is available to enjoy, a book that will help you learn to eat well during all phases of liver disease. For the cost of a few cups of liver friendly coffee - this book can be yours.

Purchase is now available through PayPal, click here to learn more.

From Karen

Low Sodium, Healthy Protein Plan
After my diagnosis with Hepatitis C and liver failure, I got busy putting together a low sodium, healthy protein plan for eating.

Here at Your Best Friends Guide, you all have blown me away with requests for an easy menu plan. I love the emails pouring in from you all sitting in hospitals, grocery stores, and at home. You’ve begged for recipes. Well, it’s taken some time (2 years), but I heard you and here it is!

Drumroll please….

The Liver Loving Diet Book is a big picture peek at liver disease that helps you understand how valuable it is to eat well during treatments, cures, setbacks, cancer, and transplant. My diet played a huge role in keeping me alive and active. Now I’m handing all that power to you in one tidy package – tied up with love and priced at $4.99. I worked extra hard to give you a simple book with over 300 pages of personal stories and recipes.

Visit Karen on Facebook or follow her on Twitter

Thursday, February 23, 2017

Hepatitis C virus infection and risk of thyroid cancer: A systematic review and meta-analysis

Systematic review

Hepatitis C virus infection and risk of thyroid cancer: A systematic review and meta-analysis
Peng Wanga, 1, Zhaohai Jingb, 1, Changjiang Liua, Meihua Xua, Pei Wanga, Xiao Wanga,
Yulei Yina, Ying Cuia, Dunlin Renc, Xiaopang Raoa, ,

Received 8 August 2016, Accepted 21 January 2017, Available online 20 February 2017
http://dx.doi.org/10.1016/j.ajg.2017.01.003

Abstract
Purpose
Several epidemiological studies investigated the relationship between hepatitis C virus (HCV) infection and risk of thyroid cancer, but the results were not consistent. A systematic review and meta-analysis was conducted to assess the impact of HCV infection on thyroid cancer risk.

Methods
The literature was searched up to March 15, 2016 for case-control or cohort studies on the association between HCV infection and thyroid cancer risk. The summary relative risks (RR) and 95% confidence intervals (CI) were calculated.

Results
Five studies (two case-control studies and three cohort studies) were included in the meta-analysis, with a total of 751,551 participants and 367 cases of thyroid cancer. Meta-analysis of those 5 studies found that there was no statistically significant association between HCV infection and thyroid cancer risk (summary RR = 2.09, 95%CI 0.78–5.64, p = 0.145; I2 = 81.2%). However, HCV infection was significantly associated with increased risk of thyroid cancer (summary RR = 2.86, 95%CI 1.63–5.03, p = 0.003; I2 = 24.9%) after adjusting the heterogeneity.

Conclusion
There is a possible association between HCV infection and increased risk of thyroid cancer, and more cohort studies are needed to validate the possible association.

Abbreviations
RR, relative risk;
CI, confidence interval;
NOS, Newcastle Ottawa scale;
HCV, hepatitis C virus

With hep C franchises languishing, Merck’s MK-3682 goes from blockbuster to bomb

With hep C franchises languishing, Merck’s MK-3682 goes from blockbuster to bomb
by John Carroll

A little less than three years after acquiring the hepatitis C drug MK-3682 (uprifosbuvir) in its $3.85 billion buyout of Idenix, Merck’s prospects in the field have cooled dramatically, and its once great hopes for the drug have been reduced to nearly nothing.

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Of Interest
MK-3682 + grazoprevir + elbasvir or MK-3682 + grazoprevir + MK-8408 There are two triplet therapies and at least one doublet regimen in development by Merck (Kenilworth, NJ) that include MK-3682 (a novel NS5b nucleotide polymerase inhibitor) with or without grazoprevir and with either elbasvir or MK-8408 (a novel NS5A inhibitor). MK-3682 was tested in 300 mg and 450 mg doses in the CREST 1 (for genotypes 1 and 2) and CREST 2 (for genotype 3) studies. The CREST 1 study showed mITT SVR24 of 91–100% for genotypes 1 (n = 93 with 46 GT1a and 47 GT1b) with either elbasvir or MK-8408 at both doses for MK-3682. However, only the MK-3682 (450 mg)/grazoprevir/MK-8408 regimen showed efficacy >90% in genotype 2 patients (n = 61). For genotype 3 patients, both the 300 mg and 450 mg doses of MK-3682 showed SVR24 rates >90% (n = 86).....

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Egypt Targets Spain, Belgium, Italy, Netherlands and the UK hepatitis C patients for medical tourism

Egypt targets hepatitis C patients for medical tourism

In mid 2016, Prime Pharma, a private Egyptian pharmaceutical company, launched Tour n’ Cure to revive therapeutic tourism in Egypt. The first target is hepatitis C patients from around the world. Countries targeted are Spain, Belgium, Italy, Netherlands and the UK.

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Chronic Hepatitis C Virus Infection and the Risk for Diabetes

Chronic Hepatitis C Virus Infection and the Risk for Diabetes
Does chronic hepatitis C infection increase diabetes risk?
February 23, 2017

Abstract
Background

The association between hepatitis C virus (HCV) infection and the occurrence of type II diabetes remains controversial. Prospective studies are needed to assess its causal temporality.

Methods
A cohort of 21 559 adults enrolled from seven townships in Taiwan during 1991–1992 and followed till the end of 2010. Incident diabetes over a study time period from 2000 to 2010 was ascertained through computerized linkage with the National Health Insurance database and the National Death Certification profiles. Cox's proportional hazards models were used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs). Antibodies against HCV (anti-HCV) were tested for all participants, and serum HCV RNA levels were measured for anti-HCV seropositives.

Results
During 180 244 person-years of follow-up, there were 1917 incident diabetes cases recorded. The cumulative risk for diabetes was 10.9% for anti-HCV seronegatives and 16.7% for anti-HCV seropositives respectively. The HR for diabetes of anti-HCV seropositivity was 1.53 (95% CI: 1.29–1.81) compared with anti-HCV seronegatives after adjustment for risk predictors. The adjusted HRs were 1.63 (1.31–2.02) for anti-HCV seropositives with positive HCV RNA compared to anti-HCV seronegatives (P<.001).

Conclusion
Chronic HCV infection was associated with an increased risk for diabetes after adjustment for other risk predictors.

Discussion Only
Medscape - Full Text Article
Liver International
In this study, our data suggested that HCV infection brought significant increasing risk for the occurrence of diabetes after controlling several risk factors. Whereas the findings from NHANES were inconsistent, and their most recent report did not demonstrate an association of HCV infection with diabetes or with insulin resistance. NHANES is a large survey that consists of interviews, health examinations and laboratory data collected from a stratified, multistage probability cluster sample to obtain a nationally representative sample of the noninstitutionalized civilian US population. The first investigation using the NHANES data that evaluated the relationship between HCV infection and diabetes used the survey collected in the cycles of 1988–1994.[12] The investigators found that among individuals who were 40 years of age or older, those with HCV infection had an increased likelihood of having diabetes with the odds ratio of 3.8 (95% CI: 1.8–7.8) after controlling risk factors.[12] However, during the later study cycles (1999–2004 and 2005–2008), a statistically significant association was not found.[10] In the NHANES survey, the prevalence of obesity, insulin resistance and diabetes increased steadily over the same time period.[25] Thus, it is possible that estimates of the relationship between HCV infection and diabetes became attenuated in the presence of this epidemic of obesity and increased numbers of metabolic factors in recent decades. More recently, investigators using NHANES data have found that chronic hepatitis C patients, defined as anti-HCV seropositives with positive HCV RNA levels, had a two-fold risk for insulin resistance or diabetes,[9] suggesting that serum HCV RNA testing which enables the differentiation of past HCV infection with spontaneous clearance of HCV RNA (undetectable HCV RNA) and chronic HCV infection (detectable HCV RNA) might be important.

Finally, the most recent report from NHANES, using data from the 1999 through 2010 surveys failed to find an association between HCV infection and diabetes.[11] However, they did find a positive relationship between insulin resistance and elevated liver enzymes.[11] The elevated serum liver enzyme levels may be as result of either HCV infection or other conditions such as metabolic syndrome or steatohepatitis. It is difficult to disentangle the association of these factors and diabetes by cross-sectional study design in which participants were tested for their serum levels of liver enzymes and diabetes at the same time. Compared with the participants in NHANES, the participants in our study had lower educational levels, lower BMI and a lower percentage of cigarette smoking and alcohol drinking habits than the participants in NHANES. In other words, our study population seemed to have relatively fewer metabolic risk factors for diabetes. The major risk factor for HCV infection was illicit drug use in NHANES, whereas iatrogenic factors were the main transmission route for HCV infection in our population.[17,26] Thus, differences in the findings from our study from those in the NHANES study might be caused by differences in the characteristics of the study populations as well as in the study design.

Comparing to anti-HCV seronegatives, the adjusted HR was 1.39 for anti-HCV seropositives with seronegative HCV RNA, and 1.63 for anti-HCV seropositives with seropositive HCV RNA respectively. It showed a trend effect on the risk of diabetes for patients who had replication of HCV. Whereas, among anti-HCV seropositives, the risk of diabetes was only increased slightly when comparing to HCV RNA seronegatives and RNA seropositives, suggesting that the lipid profiles may be altered once individuals infected by HCV. However, the mechanisms still need to be further evaluated. Our study suggested that HCV infection has a major public health impact, not only for hepatic diseases but also for extrahepatic diseases.

Our cohort is recognized as a natural history cohort because most of the participants did not have the experience of antiviral treatment as a result of its high cost and adverse effects. Until October 2003, only patients with abnormal ALT levels (>82 U/L) and moderate fibrosis proven by liver biopsy could be reimbursed for treatment by the National Health Insurance. However, there are still huge gaps of self-awareness, referral and linking to care.[27] Although it is an important clue to compare the patients with or without antiviral treatment for further clarification of the associations between HCV infection and diabetes in the future.

In addition, we identified diabetes cases through a computerized data linkage with the National Health Insurance database, which provided coverage for 96% of the total population for Taiwan (23 million) in 2000, 98% in 2005 and 99.6% in 2009.[22] A limitation of our study is that we enrolled the participants and collected the questionnaires and blood samples during 1991–1992, whereas the index date for the linkage with the National Health Insurance database for the study described in this study was January 1, 2000 when the claims data were released. Life style and biochemical markers in the REVEAL-HCV enrolees might have changed over the period 1991–1992 to 2000. In particular, there might have been new infection with HCV during the 10 years of follow-up. However, establishing the incidence of HCV is very difficult because most infections are initially asymptomatic. In Taiwan the incidence of transfusion-associated hepatitis decreased as a result of the effectiveness of a series of donor screening intervention.[28] Also the presence of such cases would result in an underestimate of the effects of HCV on the incidence of diabetes. In this study, we defined the patients with diabetes with the stringent criteria: patients with at least one hospital admission code with diabetes diagnosis or with three or more outpatient visits code for diabetes,[21,22] which made the findings conservatively.

During the long-term follow-up, BMI may change when individuals change their life style, it is important to consider the follow-up changes on anthropometrical parameters. In our study, the anti-HCV seropositives were asked and invited for regular health examinations every 6–12 months. We obtained BMI data during their follow-up, and it showed similar results in the four models of multivariate analyses. The stratification analysis showed that chronic HCV infection may increase the risk for diabetes by comparing anti-HCV seronegatives. The changes in BMI during follow-up of each person were highly correlated (r=.84, P<.0001), and the correlation was even higher after grouping by <23 and ≥23 (r=.98, P<.0001). Another limitation of our study is that we did not measure blood glucose in our study. Thus, data of blood glucose are not available. However, serum level of triglycerides is highly correlated with blood glucose. We included triglyceride levels as an alternative marker for glucose levels in the analyses.

In a previous study, anti-HCV seropositives had increased mortality from diabetes (106.1 per 100 000 person-years) than anti-HCV seronegatives (60.8 per 100 000 person-years).[5] These results are consistent with the results from a database study of deaths in patients with diagnosed chronic hepatitis C infection which showed a 1.77 times increased risk of death from diabetes compared to the general population in the USA.[29] Although the evidence from these two studies of mortality provided an indication of a relationship between HCV and diabetes, it could not determine whether the infection increased the risk for the incidence of diabetes or worsened the prognosis for those with diabetes. The current longitudinal study has estimated the incidence of diabetes in those with and without anti-HCV seropositivity. Although data on steatosis in our study were lacking, we stratified by surrogate measures for steatosis including BMI, ALT and triglycerides.

In conclusion, our data suggested that HCV infection has increased risk for the occurrence of diabetes after controlling other risk factors. Chronic hepatitis C patients may benefit from antiviral treatment to decrease their risks for diabetes. More affordable prices of the effective drugs are required to increase the accessibility for the patients in need.
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