Pricey drugs overwhelm Medicare safeguard

Pricey drugs overwhelm Medicare safeguard
July 25, 2016 by Ricardo Alonso-Zaldivar

A safeguard for Medicare beneficiaries has become a way for drugmakers to get paid billions of dollars for pricey medications at taxpayer expense, government numbers show.

The cost of Medicare's "catastrophic" prescription coverage jumped by 85 percent in three years, from $27.7 billion in 2013 to $51.3 billion in 2015, according to the program's number-crunching Office of the Actuary.

Out of some 2,750 drugs covered by Medicare's Part D benefit, two pills for hepatitis C infection—Harvoni and Sovaldi—accounted for nearly $7.5 billion in catastrophic drug costs in 2015.

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CHMP Grants Positive Opinion for 12 weeks of Viekirax for Geno 4 with compensated cirrhosis

CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) for Patients with Genotype 4 Chronic Hepatitis C with Compensated Cirrhosis (Child-Pugh A)

- The CHMP opinion represents a positive advance toward approval of the 12-week regimen of VIEKIRAX with ribavirin for genotype 4 (GT4) chronic hepatitis C virus (HCV) infected adult patients with or without compensated cirrhosis

AbbVie's EMA label expansion application supported by 97 percent SVR(12) rate (n=57/59) in a dedicated Phase 3 AGATE-I study of patients with GT4 HCV with compensated cirrhosis(1)

- In Europe, where nine million people are infected with HCV,(2) GT4 is becoming increasingly prevalent in several countries including Italy, France, Greece and Spain(3)   

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NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the use of 12 weeks of VIEKIRAX^® (ombitasvir/paritaprevir/ritonavir tablets) with ribavirin (RBV) in genotype 4 (GT4) chronic hepatitis C virus (HCV) infected adult patients with compensated cirrhosis (Child-Pugh A). VIEKIRAX with RBV is currently approved in the European Union for GT4 patients with compensated cirrhosis for 24 weeks.

"Through optimizing the use of VIEKIRAX, AbbVie strives to meet the needs of patients and physicians, including a shortened treatment duration," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone is progress toward an approval that would allow us to provide the opportunity for a cure with just 12 weeks of our regimen to genotype 4 patients with or without compensated cirrhosis in Europe."  

Chronic HCV affects more than 160 million people worldwide,⁴ with 34 million people living with GT4 HCV infection.³ In Europe, where nine million people are infected with HCV,² GT4 is becoming increasingly prevalent in several countries including Italy, France, Greece and Spain, where prevalence rates from 10 to 24 percent have been reported.³

The CHMP positive opinion is supported by data from a dedicated Phase 3 AGATE-I study of GT4 HCV infected patients with compensated cirrhosis. The randomized, open-label study evaluated the safety and efficacy of VIEKIRAX and RBV for 12 and 16 weeks. Results from the study showed that with 12 weeks of treatment with VIEKIRAX and RBV, 97 percent (n=57/59) of patients achieved sustained virologic response at 12 weeks post-treatment (SVR₁₂ ).¹

"Until recently people living with genotype 4 chronic hepatitis C had limited treatment options," said Tarik Asselah, M.D., lead study author and professor at Université Paris Diderot. "If approved, this 12-week treatment would mark another step forward in the cure for GT4 patients, allowing difficult-to-cure patients with compensated cirrhosis to be treated in half the time with VIEKIRAX, representing a significant benefit for both them and their physicians."

Results from the AGATE-I study also showed that patients treated with 16 weeks of VIEKIRAX and RBV achieved 98 percent (n=60/61) SVR₁₂ rates. The most commonly reported adverse events (≥20 percent) in the 12-week arm were asthenia, fatigue and headache (18 percent, 17 percent and 23 percent respectively); and for the 16 week arm were fatigue, asthenia, headache, anemia, nausea, and pruritus (33 percent, 32 percent, 23 percent, 23 percent and 20 percent respectively).¹ One patient in the 12-week group experienced virologic breakthrough and one discontinued prematurely after the first day of treatment. One patient missed the post-treatment week 12 visit in the 16-week group.¹ The full study results were published online in The Lancet in June 2016.

About VIEKIRAX^® VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection. VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily.

Currently, in GT4 HCV infected patients VIEKIRAX with RBV is taken for 12 weeks, except in patients with compensated cirrhosis (Child-Pugh A), who should take it for 24 weeks.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C 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 chronic hepatitis C.

Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.

Weekend Reading: Coffee can play a role in reducing risks of cancer and diabetes

Coffee can play a role in reducing risks of cancer and diabetes

Good day folks, in this issue of "Weekend Reading" we point you to a podcast over at ABC Radio on the many health benefits of drinking coffee, hosted by Dr. Kruszelnicki.
Topics covered in the two part program include the effect of caffeine on; liver cancer, type II diabetes, prostate cancer, oral cancer, and heart disease.

But what about the side effects of drinking coffee, good or bad?

There is a body of evidence that some of the side effects of coffee may actually be good for you, and they appear to have nothing to do with caffeine. But Dr Karl Kruszelnicki's grind is the observational studies that make up the 'statistics' behind the health benefits.

Listen to the podcast or read the transcript;

Coffee is now good for us—or is it?
Part One - Listen here
July 12 2016
Yes, it is a drug, and so we should remember the words of Paracelsus, 'all drugs are poisons, what matters is the dose.' Based on the fact that coffee has been used widely for over a millennium, we would expect its bad side-effects would be fairly minimal—so long as we don't take too much.
Read the transcript

Part Two - Listen here
July 19,2016
Coffee can play a role in reducing risks of cancer and diabetes
It seems that beside caffeine, there are other natural chemicals in coffee that can help with medical conditions. With regard to liver cancer, two chemicals, kahweol and cafestrol, have direct cancer protection and anti-inflammatory properties. They seem to 'upregulate biochemical pathways in the liver that protect the body from toxins, including aflatoxin and other carcinogenic compounds'.
Read the transcript

Cheers!

Behind the Headlines - Alcohol 'a direct cause of seven types of cancer'

Behind The Headlines: Analysis by Bazian edited by NHS Choices

What is Behind the Headlines?
Each day the NHS Choices team selects health stories that are making headlines. These, along with the scientific articles behind the stories, are sent to Bazian, a leading provider of evidence-based healthcare information. Bazian's clinicians and scientists analyse the research and produce impartial evidence-based assessments, which are edited and published by NHS Choices.

Alcohol 'a direct cause of seven types of cancer'
Friday July 22 2016
Several studies looking at whether alcohol causes cancer were looked at during the research

Alcohol can increase your cancer risk
"Even one glass of wine a day raises the risk of cancer: Alarming study reveals booze is linked to at least seven forms of the disease," reports the Mail Online.

The news comes from a review that aimed to summarise data from a range of previous studies to evaluate the strength of evidence that alcohol causes cancer.

The main finding was that existing evidence supports the link between alcohol consumption and cancer at seven sites, including the throat, gullet, liver, colon, rectum and female breast.

The links were said to be strongest for heavy drinking, but this study suggested that even low or moderate drinking may contribute to a significant proportion of cancer cases because of how common this level of drinking is. The study also suggests there's no evidence of a "safe" level of drinking with respect to cancer.

However, it's important to be aware that this review doesn't state how the author identified and assessed the research they've drawn upon. We don't know whether all relevant research has been considered and the conclusions must be considered largely the opinion of this single author.

Nevertheless, the main finding of the link between alcohol and these seven cancers is already well recognised.  Recently updated government recommendations state there's no safe level of alcohol consumption, and men and women are advised not to regularly drink more than 14 units a week. This review further supports this advice.

Where did the story come from?
The study was published in the peer-reviewed scientific journal Addiction. It is available on an open-access basis and is free to read online.

The study was published in the peer-reviewed scientific journal Addiction. It is available on an open-access basis and is free to read online.

Generally the media coverage of this topic was accurate, although the tone of the reporting tended to suggest this was a new discovery, when the link between alcohol and certain types of cancer is well established.

What kind of research was this?
This was a review which aimed to summarise data from published biological and epidemiological research, and meta-analyses that have pooled data, to evaluate the strength of evidence that alcohol causes cancer.

Alcoholic drinks have been considered potentially carcinogenic (cancer causing) for a while, but there are still concerns about the validity of some observational studies finding links with cancer, and uncertainty about precisely how alcohol causes cancer.

A systematic review is the best way of gathering and summarising the available research around a particular topic area. But in this case the exact methods are not described in the paper and it's not possible to say whether they were systematic.

There's a possibility that some relevant research may have been missed and that this review is giving an incomplete picture of the issue

What did the research involve?
The author of this review reports drawing upon biological and epidemiological research as well as meta-analyses conducted in the last 10 years by a number of institutions, including the World Cancer Research Fund and American Institute for Cancer Research, the International Agency for Research on Cancer and the Global Burden of Disease Alcohol Group.

The majority of epidemiological research seemed to come from cohort and observational studies.
The research was reviewed and summarised in a narrative format which explored the evidence that alcohol causes cancer, while contrasting this with the notion that alcohol consumption may offer some form of protection from cardiovascular disease.

No methods are provided and the author does not describe how they identified the research, as you would expect from a systematic review.  For example, they do not give the literature databases searched, the search dates, search terms, study inclusion or exclusion criteria, or descriptions of how studies were quality assessed.  

What were the basic results?
There were several findings from this study, the main one being that existing evidence supports the link between alcohol consumption and cancer at seven sites: oropharynx (mouth and throat), larynx (voice box), oesophagus (gullet), liver, colon (bowel), rectum and female breast.

The strength of the association differed by the site of the cancer. It was strongest for the mouth, throat and oesophagus, with the review suggesting that someone who drinks more than 50g of alcohol a day is four to seven times more likely to develop these types of cancer compared to someone who doesn't drink. As the author says, the interaction of smoking with alcohol is also believed to contribute to the risk of these cancers.

The link was comparatively weaker for colorectal, liver and breast cancer. The review suggests someone who drinks more than 50g of alcohol a day is 1.5 times more likely to develop these types of cancer compared to someone who doesn't drink.

For all of these associations there was a dose-response relationship, where increased consumption was linked with an increase in cancer risk. This applied to all types of alcoholic drinks. The highest risks were associated with heavier drinking. There was also some suggestion that the level of risk goes down over time when alcohol consumption stops.

Recent large studies have found uncertain evidence whether low to moderate consumption has a significant effect on total cancer risk. But given that this level of consumption is common in the general population, the author considers that it could still contribute to a significant number of cases.

Furthermore, they say there is no clear threshold of what constitutes a harmful level of alcohol consumption, and therefore no safe level of drinking with respect to cancer.

The author also suggests that confounding factors may be responsible for the protective effect between alcohol consumption and cardiovascular disease that has been found in previous studies. For example, this may be due to the potential bias caused by misclassification of former drinkers as abstainers.

The research went on to report that alcohol is estimated to be responsible for approximately half a million deaths from cancer in 2012 and 5.8% of cancer deaths worldwide, deeming it to be a significant public health burden.

How did the researchers interpret the results?
The author concluded: "There is strong evidence that alcohol causes cancer at seven sites, and probably others. The measured associations exhibit gradients of effect that are biologically plausible, and there is some evidence of reversibility of risk in laryngeal, pharyngeal and liver cancers when consumption ceases."

"The highest risks are associated with the heaviest drinking, but a considerable burden is experienced by drinkers with low to moderate consumption, due to the distribution of drinking in the population."

Conclusion
This narrative review aimed to summarise data from published biological and epidemiological research to discuss the strength of evidence that alcohol causes cancer.

The author gives their main finding as a link between alcohol consumption and cancer at seven sites, and also that the highest risks seem to be associated with heavier drinking. However, they state there's no "safe" drinking threshold and that low to moderate consumption still contributes to a significant number of cancer cases.

The biggest limitation of this review is that it doesn't appear to be systematic. The author provided no methods for how they identified and appraised the research they drew on. Despite referencing a number of large studies and reviews, this study and its conclusions have to be considered largely the opinion of the author following their appraisal of the evidence.

We don't know whether the review has considered all research relevant to the topic and is able to reliably quantify the risks of cancer – overall or at specific sites – associated with alcohol consumption.

An additional limitation to keep in mind is that this data mainly appeared to be from observational studies. These cannot prove cause and effect. The individual studies will likely have varied considerably in the additional health and lifestyle factors they took account of when looking at the links with alcohol. For example, smoking, diet and physical activity are all factors likely to be associated both with level of alcohol consumption and cancer risk.

As the author notes in particular, confounding factors may be responsible for the observed protective effect between alcohol consumption and cardiovascular disease.

Another limitation is that alcohol consumption is likely to be self-reported in the studies analysed, which may be inaccurate and lead to misclassification. For example, a potential bias that the author notes is classifying former drinkers as abstainers.

The author does consider the limitations of these observational findings, saying: "The limitations of cohort studies mean that the true effects may be somewhat weaker or stronger than estimated currently, but are unlikely to be qualitatively different."

But despite the methodological limitations of this review, it does support current understanding around this topic. Cancer Research UK also reports that alcohol can increase risk of these seven cancers and that there is no "safe" alcohol limit.

While we can't give a safe limit to drink when it comes to cancer, people are advised to follow current alcohol recommendations, which are to drink no more than 14 units per week and to spread your drinking over three days or more if you drink as much as 14 units a week.

Analysis by Bazian
Edited by NHS Choices

Links to the headlines
Even one glass of wine a day raises the risk of cancer: Alarming study reveals booze is linked to at least seven forms of the disease. Mail Online, July 22 2016
Alcohol is a direct cause of seven ​​forms of cancer, finds study. The Guardian, July 22 2016
Alcohol linked to at least seven types of cancer, study says, while 'health benefits are irrelevant'. The Telegraph, July 22 2016
Alcohol raises risk of seven different cancers, experts warn – even just one glass. Daily Mirror, July 22 2016
Alcohol causes seven types of cancer – and probably others, study finds. The Independent, July 22 2016

Links to the science
Connor J. Alcohol consumption as a cause of cancer. Addiction. Published online July 21 2016

Shared Drug Snorting Straws May Transmit Hepatitis C Virus

CDC
According to Morbidity and Mortality Weekly Report (MMWR) Kentucky had the highest incidence of acute hepatitis C infections from 2011 through 2014 with the rate of infants born to women diagnosed with hepatitis C increasing 124 percent.

Shared Drug Snorting Straws May Transmit Hepatitis C Virus
Sharing snorting straws for noninjection drug use may be a source for hepatitis C virus transmission, according to research published in the August issue of Obstetrics & Gynecology.
Last Updated: July 22, 2016.

Here is the report : Sharing of snorting straws and hepatitis C virus infection in pregnant women

FRIDAY, July 22, 2016 (HealthDay News) -- Sharing snorting straws for noninjection drug use may be a source for hepatitis C virus (HCV) transmission, according to research published in the August issue of Obstetrics & Gynecology.

Noelle Fernandez, M.D., from University of Tennessee Medical Center in Knoxville, and colleagues anonymously surveyed 189 HCV-infected pregnant women seen at an obstetric high-risk clinic. The survey assessed modes of potential HCV transmission, including intravenous drug use, blood transfusion, organ transplant, sexual contact, tattoos, and snorting drugs with a straw.

The researchers found that 72 percent of the respondents admitted to intravenous drug use, of whom nearly two-thirds (65 percent) reported sharing needles. The majority of women (94 percent) admitted snorting drugs, nearly all of whom (92 percent) reported sharing straws. Fifteen percent of patients reported snorting drugs and sharing straws but denied any other risk factor except sexual contact. Fifty-four straws were confiscated by law enforcement authorities and nearly one-quarter of the straws (24 percent) tested positive for the presence of human blood.

"Sharing snorting utensils (straws) in noninjection drug use may be an additional risk factor for HCV and other virus transmission," the authors write.
Source - HealthDay News

Full Text (subscription or payment may be required)

Knoxville News Sentinel
Study: Snorting straws spread hepatitis C
By Kristi L. Nelson of the Knoxville News Sentinel

Hepatitis C, the most common chronic bloodborne infection in the United States, can be transmitted by sharing straws when snorting drugs, says a newly published study out of Knoxville.

Public health officials have long known intravenous drug users are at high risk for the hepatitis C virus, spread through blood. But new research found it can be spread by sharing utensils used to snort drug powder such as cocaine or, more common in this area, crushed prescription painkillers, said Dr. Craig Towers, lead physician on a study published in the August 2016 issue of the medical journal "Obstetrics and Gynecology."

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(MMWR) Increased Hepatitis C Detection in Women of Childbearing Age and Potential Risk for Vertical Transmission

CDC
According to Morbidity and Mortality Weekly Report (MMWR) Kentucky had the highest incidence of acute hepatitis C infections from 2011 through 2014 with the rate of infants born to women diagnosed with hepatitis C increasing 124 percent.

Also see;
Shared Drug Snorting Straws May Transmit Hepatitis C Virus
FRIDAY, July 22, 2016 (HealthDay News) -- Sharing snorting straws for noninjection drug use may be a source for hepatitis C virus (HCV) transmission, according to research published in the August issue of Obstetrics & Gynecology.

Here is the report;  Sharing of snorting straws and hepatitis C virus infection in pregnant women

MedPage Today
Vertical HCV Transmission on the Rise
by Molly Walker
Staff Writer, MedPage Today
Mother-to-child transmission of hepatitis C virus (HCV) infection is increasing nationally, though the problem is particularly prevalent in Kentucky, CDC researchers reported.

Morbidity and Mortality Weekly Report (MMWR)
Increased Hepatitis C Virus (HCV) Detection in Women of Childbearing Age and Potential Risk for Vertical Transmission — United States and Kentucky, 2011–2014

Weekly / July 22, 2016 / 65(28);705–710

Discussion Only

Read Full Report on the CDC website

The national increases in HCV detection among women of childbearing age, HCV testing among infants, and the proportion of infants born to HCV-infected mothers suggest increased risk for mother-to-child transmission of HCV. This risk might be higher in certain areas of the United States, as illustrated by the findings in this report for Kentucky, which might be related to increasing illicit injection drug use (5). KDPH surveillance data for pregnant women are also consistent with demographic patterns of HCV incidence overall in Kentucky and nationally (6).

Many opportunities to improve identification and monitoring of HCV infection among women of childbearing age and infants exist. CDC recommends HCV testing for persons with a history of injection drug use and others at risk, including persons infected with HIV and persons with recognized exposures (e.g., health care workers after needle sticks or mucosal exposure to HCV-positive blood) (1,7). It is important that providers assess women of childbearing age, particularly pregnant women, for HCV risk and test accordingly. CDC also recommends HCV testing of children born to HCV-infected women (1,7). Several organizations have published guidelines on HCV testing of children,** but harmonization is needed to ensure that all women who are pregnant or planning pregnancy and all infants born to HCV-infected women are appropriately tested and linked to care if they are infected.

The potential for mother-to-child transmission of HCV has prompted some jurisdictions to consider changes in HCV case identification strategies and reporting policies. For example, the Philadelphia Department of Public Health recently demonstrated improved identification of infants born to HCV-infected mothers by cross-matching maternal information (including mother’s name and date of birth) on birth certificates to women in HCV surveillance registries (9). In 2015, Kentucky mandated reporting of all HCV-infected pregnant women and children through age 60 months, as well as all infants born to all HCV-infected women.^†† Development of national reporting criteria to include a case definition for perinatal HCV infection could standardize reporting across states.

Reporting pregnancy status as part of HCV laboratory-based surveillance would also facilitate case identification. Improved surveillance can inform HCV screening and testing recommendations for pregnant women. Furthermore, there is an opportunity to detect HCV infection through routine HCV testing of infants identified as having perinatal exposure to illicit drugs, or neonatal abstinence syndrome, and their mothers; this could enhance HCV case identification as suggested by the large proportion of HCV antibody-positive pregnant women in Kentucky who report injecting illicit drugs.

The findings in this report are subject to at least four limitations.
First, incomplete information on pregnancy status on case report forms used for surveillance in Kentucky and maternal HCV infection status on birth certificates might underestimate rates of infants born to HCV-infected mothers. Second, identifying cases of HCV-infected persons, including pregnant women, relies on completeness of reporting; therefore, the data from KDPH are likely underestimates. Third, laboratory data were limited to a single commercial laboratory and thus might not represent the United States and Kentucky populations.

Finally, HCV-infected mothers cannot be linked to their children using laboratory data, and information on children’s age in the laboratory data are limited, making it difficult to determine whether children are appropriately tested and have current infection; thus, HCV detection rates among children aged ≤2 years were not included in this report.

These findings underscore the importance of providing primary prevention services (7) and following current recommendations to identify persons at risk for HCV infection and test accordingly; doing so among pregnant women would improve early identification of HCV-infected infants and linkage of the mother and infant to care and treatment. Furthermore, identifying HCV-infected women of childbearing age before pregnancy, with linkage to care, treatment, and cure, would avoid HCV infection during pregnancy and prevent mother-to-child transmission. Expanding current and developing new public health policies to increase HCV detection among women of childbearing age (especially pregnant women) and infants should be considered; however, additional data are needed to better assess HCV prevalence among pregnant women and their infants and investigate options for perinatal prevention, care, and treatment.

Summary

What is already known about this topic?

Illicit injection drug use is a risk factor for hepatitis C virus (HCV) infection; recent increases in injection drug use and increases in incidence of HCV infection among young persons have been observed in the United States.

What is added by this report?
During 2011–2014, increased rates of HCV detection (antibody or RNA positivity) among women of childbearing age and HCV testing (antibody or RNA) among children aged ≤2 years were observed both nationally and for Kentucky (22% and 14%, nationally; >200% and 151%, Kentucky). During the same period, birth certificate data showed the proportion of infants born to HCV-infected mothers increased 68% nationally and 124% in Kentucky.

What are the implications for public health practice?
Increased HCV testing of pregnant women, harmonized testing guidelines for children born to HCV-infected women, and adoption of a standardized perinatal HCV case definition might improve early identification of infants born to HCV-infected women and subsequent linkage of the mother and infant to care and treatment to prevent HCV-related sequelae.

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New Poll - 64 Percent of Global Doctors Believe New Hepatitis C Drugs Are Worth the Cost

New Poll Finds 64 Percent of Global Doctors Believe New Hepatitis C Drugs Are Worth the Cost

July 21, 2016 01:46 PM Eastern Daylight Time

NEW YORK--(BUSINESS WIRE)--In advance of World Hepatitis Day on July 28, 2016, SERMO – the leading global social network exclusively for physicians – released new poll data that queried physicians on the costs of new hepatitis C cures.

Nearly two-thirds of doctors polled (64 percent) believe new hepatitis C drugs are worth their costs, compared with current alternatives. 2032 physicians from the U.S., Great Britain, Australia, Canada, South Africa, Norway, the Netherlands, Denmark, Sweden, Greece, Poland, Finland, Hungary, Italy, France, Argentina, Spain, Mexico, Venezuela, Colombia, Chile and Germany participated in the poll.
  
Hepatitis C is a viral infection that affects the liver and can range in severity from a mild illness to a serious, chronic disease. According to the World Health Organization (WHO), between 130 and 150 million people are currently infected with hepatitis C worldwide.
  
New medications, including Harvoni and Sovaldi – offered by Gilead Sciences – AbbVie's Viekira Pak, and Merck’s Zepatier have cure rates of approximately 95 percent, but they can cost upwards of $64,000 in the U.S., according to a WHO report. The U.S. Food and Drug Administration (FDA) recently approved the first drug to treat all forms of hepatitis C, Gilead Science’s Epclusa. In the U.S., Epclusa’s list price is $74,760 for a 12 week treatment—priced below the company’s other breakthrough hepatitis C drugs. The costs of these new drugs have drawn heavy criticism as the debate over drug pricing continues, especially as some of these drugs are offered at a much lower price in certain areas, seeing as much as a 99 percent discount in some countries.
  
Despite the WHO’s call for a reduction in drug prices, the majority of physicians polled believe the price of these drugs is justified. One U.S. radiologist said, “If you tell the drug companies TODAY, that their discovery can't be sold for more than $900, they will stop working on a cure tomorrow.”

According to one U.S. neurologist, “MS meds cost $50-60K per YEAR and are not curative. Lifetime cost can easily reach a million plus dollars. Consider the lifetime cost of treatment for a Hepatitis patient, with complications and hospitalizations. You could easily argue the medication is cost-effective, based on that comparison.” Another U.S. neurologist agreed, saying, “Everyone wants cheap cures. Newsflash: they don't exist in 99.999% of cases. This is one where I just have a hard time criticizing the drug company. In comparison to many other drugs already on the market, such as cancer drugs and MS drugs, and the value it brings as a CURE for a disease, I don't think it’s terribly priced.”
  
A U.S. family practitioner cited one of his patients as a success story, writing, “I think they are worth it but do wish they were cheaper. I am treating a 63 year old patient with Hep C genotype 2b now and he had to get his meds paid for by a foundation […] This can help him live a longer, healthier life.” A U.S. psychiatrist agreed, saying, “I am liver transplant psych and see the wonderful results of these new drugs every day! Luckily, the days of interferon are mostly behind us!”
  
Still, some physicians are wary of the impact pharmaceutical pricing is having on the practice of medicine. An Italian plastic and reconstructive surgeon felt accessibility was still a major issue, commenting, “I agree with the WHO guidelines: pharmaceutical companies must reduce the cost of drugs to ensure that all patients can be treated and not just those who are very ill.” One Canadian general practitioner agreed, noting, “Pharma is greedy. They should reduce the price because this will increase the number of patients who can afford the drug.”
  
Some doctors approached the question of value from a comparative standpoint. A U.S. ophthalmologist considered the global context, remarking, “I have read that one of the drug companies made a deal with the government of Egypt to sell a course of treatment for $900, while charging $90,000 to Americans. We are being ripped off.” A rheumatologist based in the United States looked at the price of health care more broadly when considering the price, remarking, “Drug and outrageous hospital charges are destroying our profession and forcing insurance costs skyward. Meanwhile, docs get paid less and private practice is going away… Think about this. 90,000 for a Hep C cure? What should a cardiologist get, based on value, if he saves a heart attack victim’s life? It is OK for pharma to get value, but not us?”
  
For more information on the methodology of SERMO polls, please visit http://www.sermo.com/polls.

About SERMO
SERMO is the leading social network for physicians – the world’s largest virtual doctors’ lounge where doctors talk real world medicine. SERMO’s mission is to revolutionize real world medicine by providing physicians a safe, private and trusted platform for free and open dialogue on an unprecedented global scale. SERMO has close to 600,000 fully verified and licensed members and is now available for doctors in 30 countries: the U.S., the U.K., Australia, Canada, Ireland, Mexico, South Africa, Spain, Italy, Argentina, the Netherlands, Denmark, Sweden, Norway, New Zealand, France, Finland, Colombia, Venezuela, Chile, Ecuador, Guatemala, Peru, Israel, Austria, Switzerland, Greece, Hungary, Poland and Germany. SERMO is also the world’s largest health care professional polling company with 1.8 million HCPs in both the social network and a digital research network, spanning 80 countries. SERMO conducts 700,000 surveys a year.
  
        

July Updates “We need to act now to stop people from dying needlessly from hepatitis”

Hi folks, grab a snack, kick back and read this week's collection of HCV news and research. We start with World Hepatitis Day and WHO's key message about viral hepatitis including their updated "Patent Status" on treatments for Hepatitis C.  We finish up with news, a few newsletters, and finally wonderful articles written by our favorite bloggers. 

World Hepatitis Alliance

On 28 July World Hepatitis Day (WHD) brings the world together to raise awareness of the huge burden of viral hepatitis and to influence real change in disease prevention and access to testing, treatment and care.

We have created World Hepatitis Day toolkits to help you plan for World Hepatitis Day. Learn how to reach more people with your campaign, get tips on running your own World Hepatitis Day event, and find out about the World Hepatitis 2016 campaign.

Ahead of World Hepatitis Day

“We need to act now to stop people from dying needlessly from hepatitis,” said Dr Gottfried Hirnschall, WHO's Director of the HIV/AIDS Department and Global Hepatitis Programme. “This requires a rapid acceleration of access to services and medicines for all people in need.”

WHO encourages countries to act now to reduce deaths from viral hepatitis

20 July 2016 | GENEVA - Ahead of World Hepatitis Day, 28 July 2016, WHO is urging countries to take rapid action to improve knowledge about the disease, and to increase access to testing and treatment services. Today, only 1 in 20 people with viral hepatitis know they have it. And just 1 in 100 with the disease is being treated.

"The world has ignored hepatitis at its peril,” said Dr Margaret Chan, WHO Director-General. “It is time to mobilize a global response to hepatitis on the scale similar to that generated to fight other communicable diseases like HIV/AIDS and tuberculosis.“

Around the world 400 million people are infected with hepatitis B and C, more than 10 times the number of people living with HIV. An estimated 1.45 million people died of the disease in 2013 – up from less than a million in 1990.

In May 2016, at the World Health Assembly, 194 governments adopted the first ever Global Health Sector Strategy on viral hepatitis and agreed to the first-ever global targets. The strategy includes a target to treat 8 million persons for hepatitis B or C by 2020. The longer term aim is to reduce new viral hepatitis infections by 90% and to reduce the number of deaths due to viral hepatitis by 65% by 2030 from 2016 figures.

The strategy is ambitious, but the tools to achieve the targets are already in hand. An effective vaccine and treatment for hepatitis B exists. There is no vaccine for hepatitis C but there has been dramatic progress on treatment for the disease in the past few years. The introduction of oral medicines, called direct-acting antivirals, has made it possible to potentially cure more than 90% of patients within 2-3 months. But in many countries, current policies, regulations and medicine prices put the cure out of most people’s reach. 

“We need to act now to stop people from dying needlessly from hepatitis,” said Dr Gottfried Hirnschall, WHO's Director of the HIV/AIDS Department and Global Hepatitis Programme. “This requires a rapid acceleration of access to services and medicines for all people in need.”

Improving treatment
Some countries, however, are finding ways to get services to the people who need them. These efforts are made easier by the declining price of hepatitis C medicines. Prices are now dropping, particularly in countries that have access to generic drugs. In 2015, a preliminary analysis estimated that 300 000 people living in low- and middle-income countries had received hepatitis C treatment based on the new direct-acting antivirals.

In Egypt – a lower–middle-income country with one of the world’s highest prevalence rates of hepatitis C, 200 000 people were treated during the past 12 months, and the price of hepatitis C treatment for each person dropped from US$900 in 2014 to less than US$200 in 2016. Other countries have stepped up efforts against hepatitis C. Brazil and Pakistan are already expanding treatment coverage rapidly, and Georgia has announced a plan to eliminate the disease.

Preventing hepatitis
Hepatitis B and C infections are transmitted through contaminated blood as well as through contaminated needles and syringes in healthcare setting and among people who inject drugs.

The viruses can also be transmitted through unsafe sex and from an infected mother to her newborn child.

As of 2014, 184 countries vaccinate infants against hepatitis B as part of their vaccination schedules and 82% of children in these states received the hepatitis B vaccine. This is a major increase compared with 31 countries in 1992, the year that the World Health Assembly passed a resolution to recommend global vaccination against hepatitis B.

In addition, implementing blood safety strategies, including quality-assured screening of all donated blood and blood components used for transfusion, can help prevent transmission of hepatitis B and C. Safe injection practices, eliminating unnecessary and unsafe injections, can be effective strategies to protect against transmission. Harm reduction services for people who inject drugs are critical to reduce hepatitis in this population. Safer sex practices, including minimizing the number of partners and using barrier protective measures (condoms), also protect against transmission.

On World Hepatitis Day 2016, WHO, World Hepatitis Alliance, and the Government of Brazil announce the organization of the Second World Hepatitis Summit to take place in Sao Paulo, Brazil on 29-31 March 2017.

World Hepatitis Summit

For more information
World Hepatitis Day 2016: Know hepatitis - Act now
Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection
Manual for the development and assessment of national viral hepatitis plans

Patent Status

WHO updates patent information on treatments for Hepatitis C
New medicines on the market have given hope to the millions of people who suffer from Hepatitis C, a liver disease that kills approximately 700,000 people annually.

In 2016, the World Health Assembly, WHO's policy-making body, endorsed the Global health sector strategy on viral hepatitis 2016-2021 that requests WHO to “advocate for comprehensive strategies to reduce prices of viral hepatitis vaccines, medicines, diagnostics and other commodities”.

WHO works closely with Member States to assess and promote policy options for increasing access to these medicines, which remain unaffordable to many of those who need them and put an enormous financial strain even on the health systems of high-income countries.

Knowledge of the patent status of new medicines is important for governments who are trying to make those medicines available to their populations. To that end, WHO has carried out an analysis of the patent situation for seven of the new treatments, including sofosbuvir, ledipasvir and daclatasvir, all of which have been included in the WHO List of Essential Medicines in 2015.

The reports provide clarity on whether the medicines are patent protected or not in individual countries. Reports are available on the WHO website here.

WORLD HEPATITIS DAY
          
Updates From Around The Web

Yesterday The Treatment Action Group (TAG) published their 2016 Pipeline Report; HIV and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development, along with a 2016 Hepatitis C Update. In April TAG updated their Hepatitis C fact sheets in both English and Spanish with information for patients covering; adherence, screening, and treatment.

Newsletters

In case you missed it HCV Advocate's July Newsletter is out, as well as their newly launched; HCV Medications Blog with easy to find information; listed clearly by HCV genotype. ​Easy to navigate, easy to read. 

This month in the GI & Hepatology Newsletter, Amy Karon reports on SVR in persons with cirrhosis. The article titled; Early hepatitis C SVRs tied to better outcomes, found that SVR in this patient population is associated with lower rates of liver cancer and death, Karon writes;

Among patients with hepatitis C virus infection who were in compensated cirrhosis, sustained viral response was associated with significantly lower rates of liver decompensation, hepatocellular carcinoma, and liver-related death, even in the presence of clinically meaningful portal hypertension.

If you suffer with Functional Dyspepsia (FD) check out the article; Mirtazapine improved functional dyspepsia, mental distress, also found in the July issue of GI & Hepatology Newsletter.

In short Functional Dyspepsia (FD) is a medical term which simply means - bad digestion, symptoms vary but are frequently described as a full or bloated feeling after eating. A study in BMC Gastroenterology published this March investigated the prevalence of functional dyspepsia (FD) among patients with hepatitis C, the study found that; FD is more prevalent in patients with chronic hepatitis C. Obese chronic HCV and those with higher fibrosis scores are more likely to have FD, here is the link.

In The News

New Poll - 64 Percent of Global Doctors Believe New Hepatitis C Drugs Are Worth the Cost
In advance of World Hepatitis Day on July 28, 2016, SERMO – the leading global social network exclusively for physicians – released new poll data that queried physicians on the costs of new hepatitis C cures.

TheBody.com
Hepatitis C Treatment Epclusa Approved in Canada -- Key Information
On July 11, 2016, Health Canada licensed the sale and use of a new fixed-dose combination of two anti-hepatitis C virus (HCV) drugs sold under the brand ...

New @ Healio

NAFLD most common cause of cirrhosis in multiethnic cohort
According to recent findings published in Hepatology, nonalcoholic fatty liver disease was the most common cause of cirrhosis in a cohort comprising whites, blacks, Latinos, Japanese Americans and Native Hawaiians.

Researchers develop index to better identify individuals with hepatic steatosis
Researchers developed a new score called the Framingham steatosis index that more accurately identified patients with hepatic steatosis, according to recent findings…

Patients with NASH-HCC less likely to receive liver transplant
Patients with nonalcoholic steatohepatitis and hepatocellular carcinoma are less likely to receive a liver transplant compared with patients with hepatitis C virus and…

New @ NATAP

Disparities in Absolute Denial of Modern Hepatitis C Therapy by Type of Insurance

"In conclusion, most Medicare and commercial insurance beneficiaries have access to DAA-based treatment for chronic HCV infection, but nearly half of the Medicaid beneficiaries within Delaware, Maryland, New Jersey, and Pennsylvania were denied access. Notably, nearly one quarter of Medicaid recipients with cirrhosis experienced treatment denial. Medicaid patients from these states also experienced a longer time to prescription fill than those with Medicare or commercial insurance. These data show that the restrictive preapproval policies for DAA therapies among Medicaid beneficiaries have led to an important disparity in access to HCV therapy that must be addressed...

Last but not least here are a few updates from your favorite bloggers;

Blog Updates

HEPATITISC.NET

Getting My Mojo Working
By Daryl Luster - July 19, 2016
I don’t normally write pieces on ways to pick you up, but I decided what the heck I would give it a stab. I don’t have a list so much, or any...

Managing Side Effects of Direct-Acting Antivirals
By Jenelle Marie Davis - July 18, 2016
I have just been diagnosed with hepatitis C, now what? After a hepatitis C diagnosis, your doctor will likely provide you with a secondary test. The first test checked for exposure to...

Dosage of Meds with Hep C Treatment
Karen Hoyt - July 17, 2016
If your doctor has talked to you about treatment recently, you’re getting close to being free from hepatitis C. One thing you should consider is the timing of meds with hep C...



Cirrhosis is a Pain in the Neck
Karen Hoyt

I’ve been walking around like Gomer Pyle for a long time. It’s gotten worse since the transplant. You know, because of the big tummy scar and all…. So, the one thing that I was determined to work on in Sedona was neck and shoulder pain.

Hep C Treatment Recovery; Whom Shall I Fear

By Connie M. Welch

As I look back on my own Hep C treatment recovery I thought I would share a snippet from my Hep C Treatment & Recovery journal

Hepatitis C and Nonalcoholic Fatty Liver Disease
Lucinda K. Porter, RN
Hepatitis C appears to increase the risk of NAFLD. However, before blaming hepatitis C for fatty liver disease, keep in mind that the prevalence of hepatitis C in the U.S. is less than 2 percent, whereas the prevalence of NAFLD is 30 percent. This makes it hard for hepatitis C is the sole link to NAFLD. An exception is in genotype 3, where there is clearly a higher risk for NAFLD.

Hepatitis C Treatment, Drug Interactions, and Liver Injury
Lucinda K. Porter, RN
Nearly 60 percent of patients were at risk for a drug-drug interaction from one of their medications interacting with their hep C treatment.  Patients taking Viekira had the most drug-drug interactions; Sovaldi had the fewest.

Some Good News From Latvia
Greg Jefferys

I have to admit that a lot of my blog posts lately have been a bit negative. I get quite angry about the greed of Big Pharma, the corruption in government and the medical establishment, the pathetic cowardly nature of doctors in the UK and so on. So I tend to focus on these things that are a bit negative. So it is nice to be able to share some good news for a change, and this is very good news!

Walking is the Best Exercise for Liver Disease
Karen Hoyt
For most of the last decade, I couldn’t even pretend that I was an athlete. Okay, with declining liver health, I kept cycling and walking fast trying to boost my energy, but it wasn’t on an athletic level. I’ve beat the Hepatitis C Virus and liver cancer, and I’m still at it.

Links:
Main Site

Your Guide To Hepatitis

HEP In Print 

These special issues of Hep provide information and education for people living with viral hepatitis, including hepatitis C (HCV), hepatitis B (HBV) and hepatitis A (HAV).

News

Today's Headlines

HEP Exclusives

Original Articles

Join the Conversation at the Hep B United Summit; Watch the Summit On Periscope!

The annual Hep B United Summit, organized by the Hepatitis B Foundation, convenes in Washington D.C. from Wednesday, July 27 through Friday, July 29. National and local coalition partners, experts, stakeholders, and federal partners will meet to discuss how to increase hepatitis B testing and vaccination and improve access to care and treatment for individuals living with hepatitis B.

You can watch many of these important sessions LIVE on Periscope. You can also follow the conversation at the Summit on Twitter with #Hepbunite!

View all entries, here.

Until next time....

Tina