Friday, January 18, 2019

Many Popular Dietary Supplements Can Yield Dangerous Liver Results

Many Popular Dietary Supplements Can Yield Dangerous Liver Results
January 15, 2019 
A recent paper from two U-M hepatologists highlights the liver dangers associated with consuming some herbal and dietary supplements designed to build muscle or lose weight.

Athletes often use over-the-counter products to help lose weight or improve their energy and performance levels.

However, the vast majority of herbal and dietary supplements (HDS) never undergo formal efficacy or safety tests because their manufacturing, production and content are not closely regulated by the Food and Drug Administration, says Robert Fontana, M.D., University of Michigan’s medical director of liver transplantation, and Ammar Hassan, M.D., a U-M hepatology fellowship graduate, who have explored several over-the-counter HDS products linked to liver injury.

As the number of HDS products available in the United States continues to grow, more than 80,000 commercial products are available to consumers, with nearly 50 percent of adults reporting regular use of at least one kind of supplement. Many adverse effects are linked to consuming HDS products, including hepatotoxicity, or chemically induced liver damage, according to the Drug-Induced Liver Injury Network.

Fontana and Hassan explored several popular over-the-counter HDS products linked to liver injury in a recent article in Seminars in Liver Disease. Here is a rundown:

Bodybuilding supplement hepatotoxicity

The majority of bodybuilding HDS products that lead to liver injury appear to contain androgenic anabolic steroids (AAS) or are contaminated with these and other chemicals.

AAS are synthetic derivatives of testosterone. Some medical conditions require the use of AAS products, including primary male hypogonadism and hereditary angioneurotic edema, but athletes use many of these steroids without medical supervision for their performance-enhancing and muscle-building properties.

SEE ALSO: Troubling Trends in Drug-Induced Liver Damage

“The use of these products is very common among amateur and professional athletes, including many active-duty military personnel,” Fontana says. “Data suggests that 69 percent of these individuals use at least one HDS product, while 22 percent report using more than three a day.”

These products are often purchased at health food stores or online in bulk. Over the past two decades, a significant increase in the incidence of liver injury related to the illicit use of AAS has been reported.

“Bodybuilding supplements that contain AAS can lead to liver damage, including severe cholestatic hepatitis, which can take months to resolve,” Fontana says. “Additionally, various multi-ingredient nutritional supplements taken to enhance energy, increase performance and facilitate weight loss can lead to potentially severe, or even fatal, liver damage.”

Non-bodybuilding supplement hepatotoxicity

Some of the most frequently used non-bodybuilding supplements associated with hepatotoxicity include green tea extract and multi-ingredient nutritional supplements that contain both botanicals and other compounds. These products include familiar names like Hydroxycut, Oxy ELITE Pro and LipoKinetix.

Green tea extract, or GTE, is derived from unfermented leaves of the Chinese tea tree, Camellia sinensis. One of the active ingredients in GTE is epigallocatechin gallate, which is a catechin, or a compound that is abundant in teas, cocoa products and certain berries. It boasts purported weight-loss properties by stopping fat-causing lipogenic enzymes.

While the public tends to view HDS products as safer than most conventional medications because they are derived from plants and other “natural sources,” this is not always the case, Fontana says.

“Various animal studies have shown the hepatotoxic (and possibly deadly) potential of GTE,” he says. “Extreme levels of GTE will lead to elevated aminotransferase (enzymes) in mice that significantly reduce their survival rates.”

Further, the Drug-Induced Liver Injury Network reported a study in which six patients who took GTE-containing Slimquick weight-loss products suffered hepatocellular injury, while four of the six were also severely jaundiced. Additionally, three patients from this group were hospitalized, and one had to have a liver transplant.

Hydroxycut hepatotoxicity

The first reported incidents of hepatotoxicity attributed to ephedra-containing Hydroxycut involved 12 patients in the U.S. who developed severe hepatitis after consuming supplements. Of the patients, 75 percent were female, with a mean age of 38.

It took an average of just eight weeks for an individual to develop hepatocellular injury after taking Hydroxycut.

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Eight of these patients recovered from their liver damage, while three underwent liver transplantation, Fontana says. One patient died before transplantation.

At least 17 additional cases of Hydroxycut-associated liver injury have been reported with similar phenotypes of liver injury and outcomes. And in 2004, the FDA banned the sale of supplements containing ephedra.

In May 2009, the FDA published a warning about Hydroxycut-related hepatotoxicity, resulting in withdrawal of 14 Hydroxycut products from the market.

“Without regulations like standardized chemical analyses and product manufacturing guidelines, it is nearly impossible to determine the exact chemical makeups for these types of supplements,” Fontana says. “And that just adds another element of danger to consuming them.” 


Fontana has received research grants from AbbVie, Gilead Sciences and Bristol-Myers Squibb. He also provides consulting services for Alnylam Pharmaceuticals.

NHS England’s plan to eliminate Hepatitis C decisively backed by High Court

NHS England’s plan to eliminate Hepatitis C in England by 2025 is on track after all aspects of a High Court challenge by pharmaceutical company AbbVie were dismissed.
18 January 2019
The NHS’s single largest medicines procurement, a deal worth almost £1 billion over five years, was launched in April last year but contract start dates had to be delayed by six months after legal action by AbbVie.

The High Court today handed down the judgment decisively backing NHS England’s plans to eliminate Hepatitis C.

In the ruling, the judge rejected all challenges brought by AbbVie against NHS England’s smart procurement for the supply of curative, direct acting antiviral treatments and industry backed projects to find and treat people with the virus as quickly as possible.

John Stewart, director of specialised commissioning at NHS England, said: “Court cases such as this are a waste of NHS resources and taxpayers’ money, in this case resulting in an unavoidable delay in our efforts to tackle the threat of Hepatitis C, which disproportionately affects some of the most vulnerable and marginalised people in society.

“We remain committed to driving best value to help eliminate Hepatitis C in England by 2025 or sooner, and with this court case behind us we can now get on with the job.”

Hepatitis C is a cancer-causing infectious disease, spread by contact with an infected person’s blood.

In recent years, Public Health England estimated that around 160,000 people are infected with Hepatitis C in England, although around half are unaware of their infection.

The disease, which can go undetected until the liver becomes damaged, can now be successfully cured in weeks using new oral tablets.

In 2015, NHS England established 22 Operational Delivery Networks (ODNs) to support treatment and testing efforts across the country and over 32,000 patients have been treated so far with around 95% being cured of the disease. NHS England plans to eliminate Hepatitis C in England by 2025, five years earlier than World Health Organisation goals.

The Hepatitis C procurement is the latest in a series of ‘smart deals’ the NHS has delivered to drive value for the taxpayer and benefits for patients.

These include a £300 million saving after negotiating deals with five manufacturers on low cost versions of the health service’s most costly drug, adalimumab; striking the first full access deal in Europe for CAR-T therapy which can potentially cure some children and adults with blood cancers where other treatments have failed; and reaching a deal to make the life-extending lung cancer drug pembrolizumab, available for routine use on the NHS.

Thursday, January 17, 2019

After The Cure: What’s Next? Hepatitis C Post-Treatment Management

Listen to experts discuss important HCV related topics in the following easy to access webinar series provided by HepCure.

Achieved SVR, What’s Next? HCV Post-Treatment Management
This month Dr. Anthony Martinez of University at Buffalo presented; Achieved SVR, What’s Next? HCV Post-Treatment Management. 

Topics Discussed
1. Define sustained virologic response (SVR).
2. Describe how to manage cirrhotic patients post-SVR
3. Discuss at-risk populations for HCV reinfection

Begin here.....

View All Presentations

Recommended Reading 
AASLD-IDSA Hepatitis C Guidance:
Monitoring Patients Who Are Starting HCV Treatment, Are on Treatment, or Have Completed Therapy
Post-Treatment Follow-Up for Patients Who Achieved a Sustained Virologic Response
Patients who have undetectable HCV RNA in the serum, as assessed by a sensitive polymerase chain reaction (PCR) assay, ≥12 weeks after treatment completion are deemed to have achieved SVR. In these patients, HCV-related liver injury stops, although they remain at risk for non-HCV–related liver disease, such as fatty liver disease or alcoholic liver disease. Patients with cirrhosis or advanced fibrosis remain at risk for developing hepatocellular carcinoma (HCC).
Continue reading...….

May 2017 Gastroenterology
American Gastroenterological Association Institute Clinical Practice Update—Expert Review: Care of Patients Who Have Achieved a Sustained Virologic Response After Antiviral Therapy for Chronic Hepatitis C Infection
Ira M. Jacobson, Joseph K. Lim, Michael W. Fried

Full-text - Download PDF

Background and Objective
With the advent of safe and highly effective DAAs, cure of HCV infection has become more frequent. On the basis of randomized and observational studies, systematic reviews, and expert opinion, the authors of this clinical practice update present key recommendations about whether, when, and how long HCV patients who have achieved SVR should receive ongoing liver care.

Key Points
Confirm long-term virologic response at 48 weeks posttreatment. This recommendation is based on clinical trial results that have identified a late-relapse rate of ±0.5%. However, further confirmation of virologic response beyond 48 weeks posttreatment is not supported by the available evidence.

For patients with stage 3 fibrosis or liver cirrhosis, continue post-SVR surveillance for hepatocellular carcinoma (HCC) for an indefinite period of time, since research has identified no point beyond which the risk for HCC is reduced to that of patients without liver disease. For patients with earlier stages of fibrosis, no surveillance is recommended.

Continue endoscopic screening for varices in all patients with cirrhosis (whether or not they have SVR). However, in patients with SVR who are not at risk for progressive liver disease, if no varices are identified within 2 to 3 years, cessation of further surveillance may be considered.

Noninvasive methods can be used to assess progression and regression of fibrosis after SVR. However, do not alter HCC surveillance protocols in patients with baseline cirrhosis, even when regression of fibrosis is noted, since fibrosis regression assessed by noninvasive testing has not been shown to accurately indicate a reduction in HCC risk.


Naloxone - FDA clears the way to increase access and lower cost

In The News
FDA clears the way to increase access and lower cost of life-saving opioid overdose treatment drug
-Naloxone is used in emergency rooms across the U.S. to reverse a drug overdose from opioids.
-The FDA is streamlining the labeling for naloxone.
-The change clears the way for drugmakers to sell it without a prescription.

FDA Press Release
Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths
SILVER SPRING, Md., Jan. 17, 2019 /PRNewswire/ -- With the number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017, it's critical that we continue to address this tragedy from all fronts. This includes new ways to increase availability of naloxone, a drug used to treat opioid overdose.

When someone overdoses on an opioid, the person may lose consciousness and breathing may become shallow or stop. This can rapidly lead to death if there's no medical intervention.

However, if naloxone is administered quickly, it can counter the overdose effects, usually within minutes. While the person administering naloxone should also seek immediate medical attention for the patient, the bottom line is that wider availability of naloxone and quick action to administer it can save lives.

Naloxone is a critical drug to help reduce opioid overdose deaths. Prevention and treatment of opioid overdose is an urgent priority. Increased availability of naloxone for emergency treatment of overdoses is an important step. One potential way to improve access to naloxone is to make it available for over-the-counter (OTC) sale. FDA-approved versions of naloxone currently require a prescription, which may be a barrier for people who aren't under the care of a physician or may be ashamed or even fearful of admitting to issues with substance abuse. Having naloxone widely available, for example as an approved OTC product, is an important public health advance, and a need that we've been working on at the FDA.

Although FDA-approved prescription naloxone formulations have instructions for use in product labeling, they don't have the consumer-friendly Drug Facts label (DFL), which is required for OTC drug products. Before submitting a new drug application or supplement for an OTC drug product, companies must develop a DFL and conduct studies to show that consumers can understand how to use the product without the supervision of a health care professional. Some stakeholders have identified the requirement to perform these studies as a barrier to development of OTC naloxone products.

To encourage drug companies to enter the OTC market and increase access to naloxone, the FDA took an unprecedented step: we developed a model DFL with easy-to-understand pictograms on how to use the drug. We also conducted label comprehension testing to ensure the instructions were simple to follow.

This is the first time the FDA has proactively developed and tested a DFL for a drug to support development of an OTC product. We proactively designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone and make it available to patients. One of the key components for OTC availability is now in place. In short, we've crafted model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access. This action was part of our broader commitment to addressing the opioid crisis.

Today, we're announcing the results of our work, including posting two model DFLs (one for use with a nasal spray and one for use with an auto-injector) and the supporting FDA review. These efforts should jumpstart the development of OTC naloxone products to promote wider access to this medicine. The model DFL contains the information (except for individual product-specific information) that a consumer needs to administer naloxone safely and effectively.

During this period without a FY19 appropriation for the FDA, we've been focused on making sure that we continue critical aspects of our work, to the extent permitted by law. At this time, for products (such as naloxone) that are covered by a user fee program, our review of existing medical product applications and associated policy development regarding our review are funded by limited carryover user fee balances. We'll continue to update the public on how we're approaching our work during the lapse in appropriations.

Consumer comprehension of the model DFL was iteratively tested by an independent research contractor in a prespecified research design involving over 700 participants across a wide range of potential OTC naloxone users. This included people who use heroin; people who use prescription opioids; family and friends of people who use opioids; adolescents; and the general public. An FDA review team not directly involved in the conduct of the study independently reviewed the study report and determined that the comprehension results were satisfactory. Overall, the study demonstrated that the model DFL was well-understood by consumers and is acceptable for use by manufacturers in support of their OTC naloxone development programs. Using this information, naloxone manufacturers can now focus their efforts on final label comprehension testing of how well consumers understand the product-specific information that hasn't been already tested in the model DFL. I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with applications as soon as possible.

The model DFL comes in two versions. One is for use with a nasal spray and one for use with an auto-injector. But the product-specific instructions in each version are placeholders that have not been tested by the FDA for comprehension or human factors performance. Sponsors can replace these placeholders with their own product-specific information and test it if necessary. Apart from this product-specific information, the model DFL otherwise contains all the key information needed for an untrained bystander to administer naloxone. In designing the model DFL, the FDA team sought input from multiple stakeholders in the addiction care community, as well as from the FDA internal experts, to streamline the DFL to contain only the most critical information, so that it could be easily understood in an emergency. We're grateful to the hundreds of study participants who helped us see this DFL through their eyes, which enabled us to refine the DFL multiple times until we reached a final version. These research participants enabled these efforts.

This work builds on our ongoing efforts to get this life-saving drug into the hands of those who need it most. In addition to the approval of injectable naloxone for use in a health care setting and both prescription auto-injector and intranasal forms of naloxone, which facilitate use by laypersons, we also released draft guidance to advance development of generic naloxone hydrochloride nasal spray.

Additionally, we also held a two-day advisory committee meeting last month to solicit input and advice on strategies to increase the availability of naloxone products intended for use in the community. We asked our external advisors from the FDA's Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees to consider various options for increasing access to naloxone.

As part of HHS' ongoing efforts to combat the opioid crisis and expand the use of naloxone, in April 2017, the Department announced its 5-Point Strategy to Combat the Opioids Crisis. Those efforts include: better addiction prevention, treatment, and recovery services; better data; better pain management; better targeting of overdose reversing drugs; and better research. In April 2018, Surgeon General VADM Jerome Adams issued an advisory encouraging more individuals, including family, friends, and those who are personally at risk for an opioid overdose to carry naloxone. In December 2018, Adm. Brett P. Giroir, MD, Assistant Secretary for Health and the Secretary's Senior Advisor for Opioid Policy, released guidance for health care providers and patients detailing how naloxone can help save lives.

We're taking many steps to improve availability of naloxone products and we're committed to working with other federal, state and local officials; health care providers; patients; and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction.

For More Information:
FDA: Information about Naloxone

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

Media Inquiries: Sarah Peddicord, 301-796-2805, sarah.peddicord@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration

10% of patients halt statins on their own, report shows

10% of patients halt statins on their own, report shows

Side effects attributed to the drugs should be discussed with a doctor first, UW Medicine cardiologist says.

In the past decade, U.S. adults’ health has generally worsened due to poor nutrition and inactivity. Statin therapy has become the cardiologist’s go-to strategy to reduce patients’ “bad” cholesterol – that is, low-density lipoproteins (LDL). In fact, statins are so effective at reducing risk of heart attack and stroke that one in four Americans over 40 is taking these medications.

With that backdrop, the American Heart Association published a report last month that acknowledged that up to 10 percent of patients discontinue their statins on their own because they experience a side effect that they attribute to the drug.

“We know that up to half of patients who’ve had a heart attack, potentially a life-threatening event, will stop taking their medications within a year,” Yang said. “And we have found that, among patients who discontinue their guideline-directed medical therapies – blood pressure or cholesterol medications, or even aspirin – that’s associated with a significantly higher risk of having a recurrent (heart) event.”

As the pool of statin-takers has increased, Yang acknowledged, so, too, have reports of side effects. Most common are achy muscles and joints and GI distress (constipation or diarrhea). Observational studies have linked statins with higher risk of diabetes and cataracts and foggy memory. But those incidences appear to be rare, Yang said, and subsequent analyses have not consistently borne out these earlier associations.

“The main point is that there are generally no major life-threatening complications or side effects of these medications,” Yang said.

Patients who are experiencing a new symptom after starting a statin should bring it to their provider’s attention.

“A major part of my job is to educate each patient on what data is accurate, and that way we can have a good discussion about risks and benefits of medication to treat cholesterol. Allowing the patient to express their concerns and what they’ve read on the internet or elsewhere is fundamental. Unfortunately, many studies reported online are not well-designed or lack strong scientific foundation.”

Region’s 1st hepatitis C heart-transplant recipient is cured

Region’s 1st hepatitis C heart-transplant recipient is cured
Brian Donohue
UW Medicine is declaring success with the Pacific Northwest’s first heart-transplant recipient to purposely acquire the hepatitis C virus (HCV) from the donor organ and then have the disease eradicated by antiviral medication.

Kerry Hayes, 49, of Anacortes, Washington, was deemed clinically cured of hepatitis C (HCV) on Dec. 20 after a blood test detected no viral load. He had acquired HCV during a transplant July 3, 2018, at UW Medical Center in Seattle and subsequently completed an eight-week course of daily antivirals.

“I’m happy and, yeah, it’s a relief,” said Hayes. “The treatment was a piece of cake, nothing to be scared of. I haven’t had any problems – no rejection or issues with the heart at all.”

Last summer, UW Medical Center formalized a transplant protocol to increase the viability of hearts from HCV-infected donors. Typically such organs are discarded unless they are a match for transplant candidates who already have the virus.

Only a fraction of U.S. transplant centers make such use of organs. The HCV heart protocol is the only one of its kind in the Pacific Northwest, according to LifeCenter Northwest, the region’s organ-procurement agency.

Currently, 30 to 35 heart-transplant candidates are on a waiting list at UW Medical Center. Each is given a thorough explanation of the HCV protocol and, at multiple junctures, given the opportunity to accept such an organ if a match becomes available, explained Jason Smith, the cardiothoracic surgeon directing the protocol.

“We hope Mr. Hayes’ positive outcome gives confidence to other transplant candidates who might benefit by opting in to this protocol,” he said. “Patients have been very receptive to being listed for these organs because it gives them the chance to get a heart potentially much sooner than they would otherwise.”

Hayes, an oil refinery worker, had lived with an underperforming heart for more than two decades. At age 28, he underwent the first of five open-heart surgeries. In early 2017, UW Medicine cardiac specialists recognized that his heart, despite earlier repairs, was failing. Hayes’ health was so dire that they implanted him with a total artificial heart, a high-tech device that keeps blood circulating and is powered by a percussive external pump. The device is a bridge to transplant for people who would likely die without it.

The device kept him going for 17 months – about a year longer than most UW Medicine patients wait for a donor heart. Hayes was grateful to be alive but said it was emotionally harrowing to wait so long for a match while being tethered 24/7 to the machine.

“It takes a lot of mental strength to live that way. Your whole body pulsates with artificial heart. It’s in your ears. It’s loud inside and out. And I was starting to get to a point where I was getting worried about still having my job and my health insurance.”

Just two weeks after Hayes consented to be considered for a HCV-donor organ, the call came with a matching organ. There was no doubt about accepting it, he said. The transplant went smoothly, and tests showed he developed HCV within two weeks of the transplant. On Aug. 4 he started the eight-week course of the antiviral Mavyret.

Hayes was cooking dinner Dec. 20 when got a phone call from Renuka Bhattacharya, the liver specialist overseeing his post-transplant care. She said his most recent blood draw detected no HCV and that Hayes had achieved a 12-week “sustained virologic response” to the Mavyret. He was cured.

“My wife was out, so I was alone. I sent a text to my whole family – my kids and brother and sisters and my mom,” he said.

Hayes’ outcome suggests that the antivirals can be well tolerated by heart-transplant recipients, Bhattacharya said. “We didn’t see significant interactions with the anti-rejection meds.” Additionally, UW Medicine’s liver-transplant program just had its first patient complete the HCV protocol, with similar success, she said.

If a patient's first round of antivirals does not eradicate the HCV, the team would re-treat with a longer course, Bhattacharya added.

It was more than two years ago, as the HCV curative regimens were becoming more readily available, that Smith, Bhattacharya and colleagues started discussing an expanded use of infected donor organs.

Devising a protocol meant addressing myriad what-ifs. Stakeholders in cardiac surgery, transplant and liver-care services needed to feel very confident about patient safety. And it was unknown whether insurance would cover the antivirals, which in 2016 cost upward of $80,000 per patient. Those prices have dropped considerably, making the protocols viable.

“Now it’s just about spreading the word to organ-procurement organizations around the U.S. that we’re willing to take HCV-positive donors,” Smith said. UW Medical Center could see as much as a 10 percent increase in transplants because of the new protocol, he estimated.

For patients like Hayes who are wait-listed for a heart transplant, the benefit of an increased donor pool is obvious. But there is also an upside for the families of intended donors whose organs have, in the past, had no chance of transplant because of hepatitis C.

“Transplant is a great social gift that donors and donor families give back to society,” Smith said. “One thing I’ve learned over the years in transplant: I don’t think donor families see donation as a sacrifice. They see it as an opportunity. So anything we can do to make better use of that gift can give them solace.”

Successful hepatitis C treatment decreases the incidence of complications associated with type 2 diabetes.

Sustained virological response to hepatitis C treatment decreases the incidence of complications associated with type 2 diabetes. 
Li J, et al. Aliment Pharmacol Ther. 2019 
Li J1, Gordon SC2, Rupp LB3, Zhang T1, Trudeau S1, Holmberg SD4, Moorman AC4, Spradling PR4, Teshale EH4, Boscarino JA5, Schmidt MA6, Daida YG7, Lu M1; CHeCS Investigators.

Version of Record online: 16 January 2019

Full-text article
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The present analysis from a large and diverse cohort of patients with type 2 diabetes shows that successful HCV treatment reduced the risks of acute coronary syndrome, end‐stage renal disease, ischaemic stroke, and retinopathy by 39%‐66%; this effect was independent of patients’ baseline fibrosis status, and consistent in subgroup analyses restricted to patients with and without cirrhosis. Chronic HCV infection, independent of diabetic status, is known to confer an increased risk of extrahepatic complications; treatment status and outcome have been associated with improvement in some, but not all, of these conditions. The magnitude of risk reduction we observed within HCV patients with T2D supports the importance of antiviral therapy among diabetic patients to reduce risk of these extrahepatic outcomes.

Abstract
BACKGROUND:
The role of hepatitis C (HCV) eradication on the long-term complications of type 2 diabetes mellitus remains incompletely studied.

AIM: 
We investigated whether antiviral treatment impacted risk of acute coronary syndrome, end-stage renal disease, ischaemic stroke, and retinopathy among diabetic patients from the four US health systems comprising the Chronic Hepatitis Cohort Study (CHeCS).

METHODS: 
We included CHeCS HCV patients with diagnosis codes for type 2 diabetes who were on antidiabetic medications. Patients were followed until an outcome of interest, death, or last health system encounter. The effect of treatment on outcomes was estimated using the competing risk analysis (Fine-Gray subdistribution hazard ratio [sHR]), with death as a competing event.

RESULTS: 
Among 1395 HCV-infected patients with type 2 diabetes, 723 (52%) were treated with either interferon-based or direct-acting antivirals (DAAs); 539 (75% of treated) achieved sustained virological response (SVR). After propensity score adjustment to address treatment selection bias, patients with SVR demonstrated significantly decreased risk of acute coronary syndrome (sHR = 0.36; P < 0.001), end-stage renal disease (sHR = 0.46; P < 0.001), stroke (sHR = 0.34; P < 0.001), and retinopathy (sHR = 0.24; P < 0.001) compared to untreated patients. Results were consistent in subgroup analyses of DAA-treated patients and interferon-treated patients, an analysis of cirrhotic patients, as well as in sensitivity analyses considering cause-specific hazards, exclusion of patients with on-treatment retinopathy, and treatment status as a time-varying covariate.

CONCLUSION: 
Successful HCV treatment among patients with type 2 diabetes significantly reduces incidence of acute coronary syndrome, end-stage renal disease, ischaemic stroke, and retinopathy, regardless of cirrhosis. Our findings support the importance of HCV antiviral therapy among patients with type 2 diabetes to reduce the risk of these extrahepatic outcomes.

© 2019 John Wiley & Sons Ltd.

Undiagnosed HBV, HCV, HIV prevalent in newly diagnosed cancer cases


Undiagnosed HBV, HCV, HIV prevalent in newly diagnosed cancer cases ...
Healio
Researchers discovered a substantial proportion of patients with newly diagnosed cancer and concurrent hepatitis C or hepatitis B were unaware of their viral infection and many had no identifiable risk factors, according to a recently published study.

Level Maps Showing Impact of Hepatitis C Epidemic Across the U.S.

HepVu Releases State-Level Maps Showing Impact of Hepatitis C Epidemic Across the U.S.

ATLANTA, Jan. 16, 2019 – Today, HepVu launched new interactive maps visualizing state-level estimates of people living with Hepatitis C across the United States that highlight a concentration of infections in some states most impacted by the opioid epidemic. Published in JAMA Network Open, the data reveal an estimated 2.3 million people living with Hepatitis C infection in the U.S. between 2013 and 2016, with a high burden in the West and in some Appalachian states.

“We still have more than 2 million people living with Hepatitis C at a time when ending this epidemic is possible,” said Patrick Sullivan, Ph.D., DVM, Professor of Epidemiology at Emory University’s Rollins School of Public Health and Principal Scientist for AIDSVu. “Hundreds of thousands of Americans have been cured of Hepatitis C with newly available treatments, yet new Hepatitis C infections have nearly tripled in recent years as a consequence of increasing injection drug use associated with the opioid epidemic. At the same time, many older Americans, who have been living with Hepatitis C for decades, still remain undiagnosed and untreated. Halting the Hepatitis C epidemic requires a commitment across the nation to diagnose and cure people living with the virus and stop new infections before they erode our significant progress.”

Three-fourths of Americans living with Hepatitis C are Baby Boomers (those born between 1945 and 1965). However, the largest increases in Hepatitis C infections over the last decade have been among individuals less than 40 years old and particularly among persons who inject drugs.

“Hepatitis C and other infectious diseases are often-overlooked consequences of America’s opioid crisis,” said Eli Rosenberg, Ph.D., Associate Professor of Epidemiology and Biostatistics, University at Albany School of Public Health, State University of New York. “Our analysis helps to pinpoint the concentration of the disease geographically and shows the burden of Hepatitis C is greater in places highly affected by the opioid epidemic.”

Key findings include:
-The Western U.S. has the highest rate of people with evidence of Hepatitis C infection, with 10 of the region’s 13 states having an estimated Hepatitis C prevalence above the national median.
-There is also a concentration of Hepatitis C in Appalachia, likely related to the opioid epidemic in these states. Kentucky, West Virginia, and Tennessee are now among the 10 hardest-hit states.
-Nine states (California, Florida, Michigan, New York, North Carolina, Ohio, Pennsylvania, Tennessee, and Texas) represent more than half, or 52 percent of all persons with Hepatitis C nationally – and five of the nine states are in Appalachia.

“One of the most critical challenges in our national response to viral hepatitis is limited data that we can use to understand and monitor the epidemic,” continued Sullivan. “Accurate estimates of the burden of Hepatitis C infection in each state are essential to inform policy, programmatic, and resource planning for elimination strategies across the U.S. By mapping Hepatitis C in the U.S., HepVu seeks to provide a comprehensive picture of the disease’s impact on states to inform researchers and public health decision-makers’ prevention and care efforts.”

HepVu is a Powered By AIDSVu project presented by Emory University’s Rollins School of Public Health in partnership with Gilead Sciences, Inc. State-level Hepatitis C prevalence estimates on HepVu can be viewed alongside social determinants of health and data related to the opioid epidemic, including opioid prescription rate, narcotic overdose mortality rate, and pain reliever misuse prevalence. HepVu also visualizes data on Hepatitis C-related mortality (2016) obtained from the Centers for Disease Control and Prevention’s (CDC) WONDER Online Database System. Additionally, HepVu offers downloadable datasets for researchers and health departments to utilize in their own analyses, infographics on Hepatitis B and C, and state-specific factsheets.

The state-level Hepatitis C prevalence estimates displayed on HepVu are produced by the Emory University Coalition for Applied Modeling for Prevention (CAMP) project with researchers from the University of Albany and developed with CDC. Findings were published in the peer-reviewed Journal of the American Medical Association (JAMA) Network Open in an article titled, “Prevalence of Hepatitis C Virus Infection, US States and District of Columbia, 2013 – 2016”.

The new data are derived using an updated approach to the previously published methodology for 2010 state-specific Hepatitis C prevalence estimation that reflects current changes to the epidemic. To estimate state-level Hepatitis C prevalence, researchers analyzed blood test results from the nationally representative National Health and Nutrition Examination Survey (NHANES) and vital statistics data from 2013 through 2016, and incorporated data on Hepatitis C-related deaths and narcotic overdose deaths. The researchers also estimated the number of Hepatitis C infections among populations not included in NHANES, including incarcerated, unsheltered homeless, and nursing home resident populations. For more information on the data methods, please visit HepVu.org.

Wednesday, January 16, 2019

No-haggle policy on drug pricing cost Medicare at least $14.4B

Becker's Hospital Review

No-haggle policy on drug pricing cost Medicare at least $14.4B, study finds
Written by Alia Paavola | January 15, 2019
Medicare Part D could have saved $14.4 billion on the top 50 medications covered in 2016 if the program had been able to pay the same prices as the Department of Veterans Affairs, which often negotiates discounts...
In particular, the VA spent $1.7 billion of Gilead's Harvoni hepatitis C treatment in 2016, compared to Medicare Part D, which spent $3 billion on the drug...

Dr. Luis Balart, who helped develop a cure for hepatitis C, dies at 70

Dr. Luis Balart, who helped develop a cure for hepatitis C, dies at 70
Dr. Luis A. Balart, a specialist in diseases of the liver who helped develop a cure for hepatitis C, died of leukemia Monday (Jan. 14) in Boston. He was 70.

Dr. Balart, who had lived in New Orleans since 1961, was in Boston for treatment at Dana-Farber Cancer Institute.

During his four-decade career, which included liver transplantation, Dr. Balart was chief of the gastroenterology departments at LSU and Tulane University medical schools, and he worked at Ochsner Medical Center, Southern Baptist Hospital and Tulane Medical Center.

Among his accomplishments was the development of a cure for hepatitis C, a viral affliction that can lead to liver disease, cirrhosis, liver failure and cancer. It is primarily spread through blood-to-blood contact, and about 2.7 million Americans are estimated to suffer from chronic hepatitis C, according to the federal Centers for Disease Control and Prevention.

Monday, January 14, 2019

Study - Vitamin D supplements are of no benefit to those over 70

Study shows vitamin D supplements are of no benefit to the over 70s  
Article ID: 706433
Released: 14-Jan-2019 1:15 PM EST
Source Newsroom: Newcastle University

Newswise — There is little benefit for those over 70 taking higher dose vitamin D supplements to improve their bone strength and reduce the risk of falls, new research has revealed.

Older people are often encouraged to take supplements of vitamin D to keep bones, teeth and muscles healthy.

But a Newcastle University-led study, published in the American Journal of Clinical Nutrition, has backed previous research which shows there is no gain for older people taking vitamin D.

Aim of study
Almost 400 people, aged 70 years or older, were randomly allocated to one of three doses of vitamin D given once a month for a year - the doses were 300 μg, 600 μg or 1200 μg (equivalent to a daily dose of 10 μg, 20 μg or 40 μg).

The study's aim - funded by Versus Arthritis - was to measure in these older people the effect of vitamin D supplementation on the change in bone mineral density (BMD), a recognised indicator of bone strength, and changers in markers of bone metabolism.

The findings revealed that there was no change in BMD over 12 months between the three doses. However, the study did show that doses equivalent to 40 μg a day are safe in an older population and there was a beneficial effect on bone metabolism up to the highest dose.

Dr Terry Aspray, Honorary Clinical Senior Lecturer at Newcastle University's Institute of Cellular Medicine, UK, who is supported by the NIHR Newcastle Biomedical Research Centre, led the Vitamin D supplementation in older people study (VDOP).

He said: "Vitamin D deficiency is common in older people, and it may lead to bone loss, impairment of muscle function and an increased risk of falls and fractures.

"The results from previous studies assessing the effect of vitamin D on bone mineral density have yielded conflicting results, and our study is a significant contribution to the current debate.

"While our findings do not support evidence of the benefit of high dose vitamin D supplements, at least on bone mineral density, we do, however, identify that higher doses of the vitamin may have beneficial effects on bone metabolism and that they are safe for older people.

"I would suggest that older people should focus on maintaining a healthy, balanced diet, adequate sun exposure and take regular exercise to keep their bones as strong as possible.

"While some may need to take vitamin D supplements, there is little benefit to taking more than 10 μg a day."

Further studies

Further analysis is underway, including by a Newcastle University PhD student, on the effects sun exposure on vitamin D levels in older people and the impact of vitamin D supplements on muscle strength.

Experts are also looking at the impact of genes and kidney function on vitamin D levels and their function in the blood.

Benjamin Ellis, Versus Arthritis Senior Clinical Policy Adviser, said: "Older people are at increased risk of falls and fractures, which are debilitating and erode people's self-confidence, depriving them of their independence.

"Vitamin D helps build and maintain strong bones and muscles. People who are deficient in vitamin D are at increased risk of falls and fractures.

"In the summer months, Vitamin D is manufactured by the body when sunlight falls on the skin. We can also get vitamin D from certain foods, or dietary supplements.

"Over the one year of this study, higher doses of vitamin D neither improved measures of bone strength nor reduced falls among older people.

"The current guidance is still that people at risk of low vitamin D should consider taking a daily vitamin D supplement, as should everyone during the winter months.

"Work is needed to implement effective strategies to prevent falls and fractures among older people, and to understand the role of medications and dietary supplements in this."

###
Reference
Randomised controlled trial of vitamin D supplementation in older people (VDOP) to optimise bone health
Terry J Aspray et al
American Journal of Clinical Nutrition. Doi: 10.1093/ajcn/nqy280
SEE ORIGINAL STUDY

A Surgeon Reflects On Death, Life And The 'Incredible Gift' Of Organ Transplant

NPR heard on Fresh Air 

A Surgeon Reflects On Death, Life And The 'Incredible Gift' Of Organ Transplant
Dave Davies 
When Joshua Mezrich was a medical student on the first day of surgical rotation, he was called into the operating room to witness a kidney transplant.

What he saw that day changed him.....

He went on to become a transplant surgeon and has since performed hundreds of kidney, liver and pancreas transplants. He also has assisted in operations involving other organs.

Each organ responds to transplant in a different way.

"The liver will start pouring bile. The lungs start essentially breathing," Mezrich says. "Maybe the most dramatic organ, of course, is the heart, because you put it in and you kind of hit it like you hit a computer, maybe you give a little shock and it just starts beating, and that's pretty darn dramatic."

Read the article, here …..

Americans have greater chance of dying of an accidental opioid overdose than in a car crash

For the First Time, We're More Likely to Die From Accidental Opioid Overdose Than Motor Vehicle Crash - 

A person is more likely to die from an accidental opioid overdose than from a motor vehicle crash, according to the National Safety Council analysis, per a report labeled "Injury Facts"

ITASCA, Ill., Jan. 14, 2019 /PRNewswire/ -- For the first time in U.S. history, a person is more likely to die from an accidental opioid overdose than from a motor vehicle crash, according to National Safety Council analysis. The odds of dying accidentally from an opioid overdose have risen to one in 96, eclipsing the odds of dying in a motor vehicle crash (one in 103). The National Safety Council unveiled the analysis on Injury Facts – the definitive resource for data around unintentional, preventable injuries – commonly known as "accidents." The nation's opioid crisis is fueling the Council's grim probabilities, and that crisis is worsening with an influx of illicit fentanyl.

"We've made significant strides in overall longevity in the United States, but we are dying from things typically called accidents at rates we haven't seen in half a century," said Ken Kolosh, manager of statistics at the National Safety Council. "We cannot be complacent about 466 lives lost every day. This new analysis reinforces that we must consistently prioritize safety at work, at home and on the road to prevent these dire outcomes."

NSC analysis also shows that falls – the third leading cause of preventable death behind drug overdose and motor vehicle crashes – are more likely to kill someone than ever before. The lifetime odds of dying from an accidental fall are one in 114 – a change from one in 119 just a year ago.

To keep the public up to date on the latest injury and fatality trends, the Council has added "Poisonings," "Older Adult Falls," "Fire-Related Fatalities and Injuries," and "Deaths by Transportation Mode" to Injury Facts. To demonstrate why Americans should be more concerned about preventable injuries than headline-grabbing catastrophes, the Council also added designated pages about airplane crashes, railroad deaths and consumer products – all issues that tend to spark nationwide anxiety but lead to far fewer fatal incidents than routine, everyday activities such as taking medication, driving or getting out of bed.

Preventable injuries are the third leading cause of death, claiming an unprecedented 169,936 lives in 2017 and trailing only heart disease and cancer. Of the three leading causes of death, preventable injuries were the only category to experience an increase in 2017, according to NSC analysis of the CDC data issued in December. A person's lifetime odds of dying from any preventable, accidental cause are one in 25 – a change from one in 30 in 2004.

https://www.prnewswire.com/news-releases/for-the-first-time-were-more-likely-to-die-from-accidental-opioid-overdose-than-motor-vehicle-crash-300777184.html

Saturday, January 12, 2019

HCV requires serious policies and affordable insurance coverage

Of Interest
Q&A: DAA restrictions impact patient care
January 14, 2019
Infectious Disease News spoke with Breskin about why DAAs restrictions were enacted, the current state of treatment denials and how DAA policies should be changed.

The paper draws on participant interview data from a qualitative research study based on a participatory research design that included a peer researcher with direct experience of both hepatitis C DAA treatment and injecting drug use at all stages of the research process.

The role of insurance providers in supporting treatment and management of hepatitis C patients
Masoud Behzadifar, Hasan Abolghasem Gorji, Aziz Rezapour, Meysam Behzadifar and Nicola Luigi Bragazzi

BMC Health Services Research201919:25
https://doi.org/10.1186/s12913-019-3869-8

Excerpt from the article:
In order to cope with the high costs of the new DAA regimens, some insurers are restricting access to medications, establishing selective criteria for reimbursement. Gowda and collaborators performed a prospective cohort study among American HCV patients (Open Access Published online 2018 Jun 7). Authors found that absolute denials of DAA regimens by insurers have remained high and increased over time.

Received: 24 April 2018
Accepted: 4 January 2019
Published: 10 January 2019

Full-text article
Read Online
Download PDF

The role of insurance providers in supporting treatment and management of hepatitis C patients
Abstract
Today, one of the most important global public health challenges is represented by hepatitis C virus (HCV), which imposes relevant costs. Globally speaking, the median cost of HCV-related complications ranges from $280 for an uncomplicated hepatitis to $139,070 for a liver transplantation. There are effective therapies for HCV patients worldwide, which has increased the hope of improving the process of managing and curing these patients. The adherence of patients to the pharmacological treatment and the use of effective drugs in the management of HCV disease are of crucial importance for health policy- and decision-makers. Studies show that, globally, insurance coverage for patients with HCV is not adequate in that still many patients are not covered by insurance programs. This issue as well as the economic conditions of countries are very serious challenges for ensuring an effective treatment. The most important and greatest help currently available to ensure HCV treatment is to implement plans to reduce costs and support patients. Some studies have shown that the expansion of coverage by private payers seems able to generate positive spillover benefits to public insures. Insurers, in addition to maintaining and increasing their own interests, are trying to increase their social status as a sponsor of patients. In conclusion, HCV disease requires serious policies and affordable insurance coverage.

Read the full article: 
https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-019-3869-8

On This Blog
Controversy over the cost of hepatitis C drugs
Link to research and news articles addressing insurance restrictions; private insurers/Medicaid - and -availability of generic versions of hepatitis C medications. 

Friday, January 11, 2019

Three-part series: What’s the Difference: Hepatitis B vs Hepatitis C?

Hepatitis B Foundation


With five different types of viral hepatitis, it can be difficult to understand the differences between them. Some forms of hepatitis get more attention than others, but it is still important to know how they are transmitted, what they do, and the steps that you can take to protect yourself and your liver!

This is part one in a three-part series. 

At JPM, the NASH flood gates start to crack

J.P. Morgan Healthcare Conference in San Francisco

At JPM, the NASH flood gates start to crack 
Jacob Bell
Four companies are within striking distance of filing NASH drugs for approval, but the competitive landscape is more nuanced than simply crossing the finish line first...

While JPM didn't bring data updates for the later-stage NASH pipeline, drugmakers did give more color on their mindset heading into such a pivotal year....

John McHutchison, Gilead's head of R&D, told investors at JPM he anticipates "waves of approval," with the first being highly potent treatments for patients who have more advanced fibrosis, and then subsequent waves that work on less severe NASH and have better safety profiles.....
Read the article:
https://www.biopharmadive.com/news/nash-2019-jpm-readouts-deals-market-competition/545772/

Hepatitis C Virus Is Major Predictor of Liver Cancer in Hemophilia, U.S. Inpatient Data Reveals

Hepatitis C Virus Is Major Predictor of Liver Cancer in Hemophilia, U.S. Inpatient Data Reveals
by Ana Pena
Past infection with the hepatitis C virus (HCV) is the major risk factor for hepatocellular carcinoma (HCC), the most common type of liver cancer, a large study analyzing more than 18,000 U.S. inpatients with hemophilia reported.

HCV infection is also a major risk factor for the general population, but the study stresses that hemophiliacs can be particularly vulnerable, given their past exposure to clotting factor infusions that might have been infected.

Because of its large sample size, the report also provides baseline data to help establish the impact of new antiviral therapies for hepatitis C in the future, researchers say.


Iowa Medicaid Expands Care To Hepatitis C Patients, But Restrictions Remain

Iowa Medicaid Expands Care To Hepatitis C Patients, But Restrictions Remain
Starting this month more hepatitis C patients can qualify for care under Iowa Medicaid. But some doctors and advocates argue the remaining restrictions are immoral and illegal.

Previously, only Iowans with more advanced liver disease, a fibrosis score of F3 or above, would qualify for treatment. As of January 1, 2019, those with a score of F2 and above can request the treatment from their doctor through a process known as prior authorization, which requires they meet certain criteria beyond their need for the treatment.
Continue reading:
http://www.iowapublicradio.org/post/iowa-medicaid-expands-care-hepatitis-c-patients-restrictions-remain 

On This Blog
Controversy over the cost of hepatitis C drugs
Link to research and news articles addressing insurance restrictions; private insurers/Medicaid - and -availability of generic versions of hepatitis C medications.

Hepatitis C: What happens when the doctor blames you for your own cancer?

The Washington Post
What happens when the doctor blames you for your own cancer?
By Monica Bhargava
As a trainee at an academic medical center, I observed weekly conferences where the care plans of new cancer patients were determined by a large team of expert physicians. The words “lung cancer” — followed by “nonsmoker” — often elicited murmurs of sympathy. I wondered whether this sympathy would lead to longer and more meaningful clinic visits with the patient in question, and whether the opposite would be true for the Vietnam veteran who had smoked for 40 years. The tight link between tobacco and lung cancer has hardened into stigma, and the potential for care disparities is real...
Those dealing with addiction and hepatitis C, a blood-borne virus often transmitted through sharing needles or other equipment to inject drugs, face a similar stigma. A high percentage of health-care professionals exhibit negative attitudes toward patients with substance use disorders, perceiving them as morally deficient or lacking self-control, and leading to reduced access to care...
Continue reading: 

NASH update: 6 recent reports on treatment development


NASH update: 6 recent reports on treatment development
Researchers continue efforts to study and develop safe and effective therapeutics to treat nonalcoholic fatty liver disease and its progressive form, nonalcoholic steatohepatitis, including several collaborative efforts between clinical development companies and societies.

Healio Gastroenterology and Liver Disease presents the following reports on recent NASH studies including data on a newly formed “NASH Roundtable,” positive results from recent clinical trials, and a new LiverMultiScan tool for identifying NASH....

Louisiana adopts ‘Netflix’ model to pay for hepatitis C drugs

Washington Post: To Your Health - January 10, 2019 

Louisiana adopts ‘Netflix’ model to pay for hepatitis C drugs
Louisiana will use the 'Netflix' model, with the goal of treating 10,000 people with hepatitis C in its Medicaid and prison population by 2020.
By Carolyn Y. Johnson January 10 at 5:49 PM

Instead of paying for each prescription individually, Louisiana Gov. John Bel Edwards (D) said the state would essentially pay a subscription fee to a drug company, an alternative payment arrangement that has become known as the “Netflix model.” The state would then get unlimited access to the drug, similar to how consumers pay a monthly fee to stream unlimited television shows and movies.
Continue reading: 
https://www.washingtonpost.com/health/2019/01/10/louisiana-adopts-netflix-model-pay-hepatitis-c-drugs/?utm_term=.02763a658c7b 

On This Blog
Controversy over the cost of hepatitis C drugs
Link to research and news articles addressing insurance restrictions; private insurers/Medicaid - and -availability of generic versions of hepatitis C medications.

Thursday, January 10, 2019

CDC - Rising rates of drug overdose deaths among women

Morbidity and Mortality Weekly Report (MMWR)
Drug Overdose Deaths Among Women Aged 30–64 Years — United States, 1999–2017
Weekly / January 11, 2019 / 68(1);1–5
Summary

What is already known about this topic?
The U.S. drug epidemic is evolving, including among women. Studies have highlighted rising rates of drug overdose deaths among women aged 45–64 years.

What is added by this report?
From 1999 to 2017, the death rate from drug overdose among women aged 30–64 years increased by 260%. Drug overdose deaths involving antidepressants, benzodiazepines, cocaine, heroin, prescription opioids, and synthetic opioids all increased. Among women aged 30–64 years, the average age at death for drug overdose deaths increased by nearly 3 years.

What are the implications for public health practice?
Overdose deaths continue to be unacceptably high, and targeted efforts are needed to reduce the number of deaths in this evolving epidemic, including those among middle-aged women

Link:

Discussion Only:
From 1999 to 2017, the crude rate of drug overdose deaths among women aged 30–64 years in the United States increased by 260%. The rates of overdose deaths increased for all drug categories examined, with a notable increase in rates of deaths involving synthetic opioids (1,643%), heroin (915%), and benzodiazepines (830%). These findings are consistent with recent reports highlighting an overall increasing trend in deaths involving drugs, especially with shifts in the type of drugs involved (e.g., heroin) (4).

Other reports have highlighted the overall increase in overdose deaths and emergency department visits related to drug use, especially among women aged 45–64 years (1). In addition to demonstrating the varying drug overdose rate increases by age group, this study determined that the age distribution of decedents shifted from 1999 to 2017, and the average age of women aged 30–64 years dying from drug overdoses increased for every drug class analyzed except synthetic opioids. Prevention programs might need to shift response options as the overdose epidemic experiences demographic shifts. Further, as women progress through life, individual experiences can change in the type of substance used or misused and in the experiences of pain that might result in an opioid prescription (5–8).

The findings in this report are subject to at least three limitations. First, rate estimates of specific drugs involved with deaths might be affected by factors related to death investigation, such as the substances tested for or the circumstances under which tests are performed. For example, toxicology testing cannot distinguish between pharmaceutical fentanyl and illicitly manufactured fentanyl. Second, drug categories presented are not mutually exclusive, and deaths might have involved more than one substance. Increases in deaths involving certain drugs might be the result of increases in certain drug combinations. Finally, the percentage of deaths with specific drugs identified on the death certificate varies over time. Changes in testing and reporting of drugs might have led to observed increases in some drug entities involved in drug overdose deaths.

Substantial work has focused on informing women of childbearing age about the risk and benefit of the use of certain drugs, particularly for the risk posed by neonatal abstinence syndrome as a result of opioid use during pregnancy (9,10). The current analysis demonstrates the remaining need to consider middle-aged women who remain vulnerable to death by drug overdose. A multifaceted approach involving the full spectrum of care services is likely necessary. For example, health care providers who treat women for pain, depression, or anxiety can discuss treatment options that consider the unique biopsychosocial needs of women (2). Providers can consider implementing the CDC Guideline for Prescribing Opioids for Chronic Pain (3), and Medicaid programs can also examine whether prescribing of controlled substances to their clients meets established guidelines. Access to gender-responsive substance use disorder treatment services, especially for pregnant women and women with drug use disorders, can reduce harmful outcomes. Overdose deaths continue to be unacceptably high, and targeted efforts are needed to reduce the number of deaths in this evolving epidemic among middle-aged women.

Read Full Report: 

African-Americans may live longer after liver transplant if their donors are the same race

African-Americans may live longer after liver transplant if their donors are the same race
Journal of the American College of Surgeons study authors report that donor race-matching may aid in future organ allocation

American College of Surgeons
CHICAGO (January 10, 2019): Among African-American adults undergoing liver transplant to treat liver cancer, patients whose organ donor was also African-American lived significantly longer than those with a racially unmatched donor, report authors of a new study using national data. The study is published online as an "article in press" on the Journal of the American College of Surgeons website in advance of print publication.

These research findings suggest a possible way to improve long-term survival in a patient population that typically fares worse than other racial groups with liver cancer, which is the second deadliest cancer worldwide.1 Compared with other races, African-American patients with hepatocellular carcinoma (HCC)--the most common form of liver cancer--tend to have the poorest long-term survival and have worse outcomes after liver transplant.2 A liver transplant is the preferred and curative treatment option for some patients with early-stage HCC, according to the study authors.

Although past studies have linked unmatched donor-recipient race to worse overall survival in recipients of kidney, lung, and heart transplants, the role of donor race in liver transplantation has not been well defined, said principal investigator T. Clark Gamblin, MD, MS, MBA, FACS, professor and chief of surgical oncology at the Medical College of Wisconsin, Milwaukee.

For this study, Dr. Gamblin and his colleagues used the Organ Procurement and Transplantation Network's (OPTN's) national database. The researchers identified 15,141 adults with first-time HCC who received a transplant of a whole liver from a deceased donor between 1994 and 2015. Of those transplant recipients, 1,384 (9.1 percent) were African-American, and their records were further analyzed for the donor's race. A total of 325 patients (23.5 percent) received livers from African-American donors--labeled "matched"--and the other 1,059 patients (76.5 percent) were unmatched.

Five years after transplant, 64.2 percent of race-matched patients were still alive compared with 56.9 percent of unmatched patients, the researchers found. On average, race-matched patients lived 4.75 years longer after transplant than the unmatched patients, with a median overall survival of 135 months versus 78 months.

This effect of donor race continued even after the researchers statistically matched the two groups on multiple donor and recipient characteristics that are important to transplant success and patient survival. On these adjusted analyses, a race-matched transplant independently predicted improved overall survival, the investigators reported. Specifically, African-American transplant recipients had 34 percent greater odds of long-term survival when the donor's race was the same. African-Americans who received a liver from a white person--the most common race among donors--had a reported 53 percent increased risk of death.

The survival advantage with race-matching reportedly did not become apparent until after one year.

"Our data are intriguing," said Dr. Gamblin. "But our results require validation through further investigation of the role of race in optimizing outcomes of liver transplant for treatment of HCC."

"It is certainly premature to recommend a change in compatibility screening criteria based on our findings alone," continued Dr. Gamblin, who noted that race is not currently a consideration during compatibility screening of donors for liver transplant. "Likewise, recipients should not turn down a liver based on the race of the donor because they may not get another one," he added, referring to the nationwide organ shortage.

Less than one-fourth of the African-American liver transplant recipients in this study had race-matched donors, which corresponds to national statistics showing low organ donation rates by African-Americans. Although 29.8 percent of all U.S. candidates waiting for an organ transplant are African-American, only 13.5 percent of all organ donors in 2015 were African-American.3

Asked if their study might encourage more African-Americans to become organ donors, Dr. Gamblin replied, "It is my hope that everyone consider liver donation. There are not enough donors, and people on the waiting list are dying every day waiting for an organ."

More than 13,500 people are on the liver transplant waiting list based on OPTN data as of December 18, 2018.4

Nearly 33,000 Americans were diagnosed with liver cancer and liver bile duct cancer in 2015, the Centers for Disease Control and Prevention estimates.5 Risk factors for HCC include persistent infection with hepatitis B or C and cirrhosis of the liver. A liver transplant not only treats liver cancer but also allows the liver to function normally again.

Dr. Gamblin's coauthors are Jack P. Silva, MD, formerly a research fellow at the Medical College of Wisconsin and now a general surgery resident at the University of Southern California, Los Angeles, as well as Meghan N. Maurina; Susan Tsai, MD, MHS, FACS; Kathleen K. Christians, MD, FACS; Callisia N. Clarke, MD, FACS; Harveshp D. Mogal, MD, FACS; and Kia Saeian, MD, all from the Medical College of Wisconsin.

"FACS" designates that a surgeon is a Fellow of the American College of Surgeons.

This study was presented in August 2018 at the Sixth Annual Solid Organ Transplant Symposium in Milwaukee, Wis.

Citation: The Effect of Donor Race-Matching on Overall Survival for African American Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma. Journal of the American College of Surgeons. Available at: https://www.journalacs.org/article/S1072-7515(18)32235-X/fulltext.

1 Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136(5):E359-E386.
2 Artinyan A, Mailey B, Sanchez-Luege N, Khalili J, Sun CL, Bhatia S, et al. Race, ethnicity, and socioeconomic status influence the survival of patients with hepatocellular carcinoma in the United States. Cancer. 2010;116(5):1367-1377.
3 US Department of Health and Human Services Office of Minority Health. Organ donation and African Americans. 2016. Available at: https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=27. Accessed December 17, 2018.
4 Organ Procurement and Transplantation Network. Data. Available at: https://optn.transplant.hrsa.gov/data/. Accessed December 18, 2018.
5 Centers for Disease Control and Prevention. Liver and Intrahepatic Bile Duct Cancer, United States--2006-2015. United States Cancer Statistics (USCS) data brief, No. 5. Atlanta, GA: Centers for Disease Control and Prevention; 2018.

About the American College of Surgeons
The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 80,000 members and is the largest organization of surgeons in the world. For more information, visit http://www.facs.org.

The science is clear—with HIV, undetectable equals untransmittable


The science is clear—with HIV, undetectable equals untransmittable

NIH/National Institute of Allergy and Infectious Diseases

WHAT:
In recent years, an overwhelming body of clinical evidence has firmly established the HIV Undetectable = Untransmittable (U=U) concept as scientifically sound, say officials from the National Institutes of Health. U=U means that people living with HIV who achieve and maintain an undetectable viral load—the amount of HIV in the blood—by taking and adhering to antiretroviral therapy (ART) as prescribed cannot sexually transmit the virus to others. Writing in JAMA, officials from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) review the scientific evidence underlying U=U and discuss the implications of widespread acceptance of the message.

In the new commentary, NIAID Director Anthony S. Fauci, M.D., and colleagues summarize results from large clinical trials and cohort studies validating U=U. The landmark NIH-funded HPTN 052 clinical trial showed that no linked HIV transmissions occurred among HIV serodifferent heterosexual couples when the partner living with HIV had a durably suppressed viral load. Subsequently, the PARTNER and Opposites Attract studies confirmed these findings and extended them to male-male couples.

Validation of the HIV treatment as prevention strategy and acceptance of the U=U concept as scientifically sound have numerous behavioral, social and legal implications, the NIAID officials note. U=U can help control the HIV pandemic by preventing HIV transmission, and it can reduce the stigma that many people with HIV face.

The success of U=U as an HIV prevention method depends on achieving and maintaining an undetectable viral load by taking ART daily as prescribed. Numerous factors, including lack of access to quality health care, can make ART adherence difficult. To enhance the overall success of U=U, the authors emphasize the importance of implementing programs that help patients remain in care and address the barriers to daily therapy.

ARTICLE:
RW Eisinger, CW Dieffenbach, AS Fauci. HIV viral load and transmissibility of HIV infection: undetectable equals untransmittable. Journal of the American Medical Association DOI: 10.1001/jama.2018.21167 (2019).

WHO:
NIAID Director Anthony S. Fauci, M.D., is available for comment.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH…Turning Discovery Into Health®
https://www.nih.gov/news-events/news-releases/science-clear-hiv-undetectable-equals-untransmittable

Low hepatitis C prevalence in Belgium: implications for treatment reimbursement and scale up

Low hepatitis C prevalence in Belgium: implications for treatment reimbursement and scale up Amber Litzroth Email author View ORCID ID profile , Vanessa Suin, Chloé Wyndham-Thomas, Sophie Quoilin, Gaëtan Muyldermans, Thomas Vanwolleghem, Benoît Kabamba-Mukadi, Vera Verburgh, Marjorie Jacques, Steven Van Gucht and Veronik Hutse

BMC Public Health 201919:39
https://doi.org/10.1186/s12889-018-6347-z
© The Author(s). 2019
Received: 21 September 2018
Accepted: 19 December 2018
Published: 8 January 2019

Abstract
Background
Prevalence data of chronic hepatitis C virus (HCV) infection are needed to estimate the budgetary impact of reimbursement of direct-acting antivirals (DAAs). In Belgium, the restricted reimbursement criteria are mainly guided by regional seroprevalence estimates of 0.87% from 1993 to 1994. In this first Belgian nationwide HCV prevalence study, we set out to update the seroprevalence and prevalence of chronic HCV infection estimates in the Belgian general population in order to guide decisions on DAA reimbursement.

Methods
Residual sera were collected through clinical laboratories. We collected data on age, sex and district. HCV antibody status was determined with ELISA and confirmed with a line-immunoassay (LIA). In specimens with undetermined or positive LIA result, HCV viral load was measured. Specimens were classified seronegative, seropositive with resolved infection, indicative of chronic infection and with undetermined HCV status according to the test outcomes. Results were standardized for age, sex and population per district, and adjusted for clustered sampling.

Results
In total 3209 specimens, collected by 28 laboratories, were tested. HCV seropositivity in the Belgian general population was estimated to be 0.22% (95% CI: 0.09–0.54%), and prevalence of chronic HCV infection 0.12% (95% CI: 0.03–0.41). In individuals of 20 years and older, these estimates were 0.26% (95% CI: 0.10–0.64%) and 0.13% (95% CI: 0.04–0.43), respectively. Of the total estimated number of HCV seropositive individuals in Belgium, 66% were between 50 and 69 years old.

Conclusions
Prevalence of HCV seropositivity and chronic infection in the Belgian general population were low and comparable to many surrounding countries. These adjusted prevalences can help estimate the cost of reimbursement of DAAs and invite Belgian policy makers to accelerate the scaling up of reimbursement, giving all chronically infected HCV patients a more timely access to treatment.

Full-text available online:

Baby Boomers and the Flu

Preliminary In-Season U.S. Influenza Burden Estimates
Jan 11, 2019
The 2018-2019 flu season is the first season CDC has reported in-season burden estimates of flu in the U.S. These in-season estimates will be updated over the course of the flu season.

Summary
- Close to 7.3 million people have been sick with flu this season
- 50% of those people have seen their physician for influenza-like illness
- With 83,500 influenza-associated hospitalizations

Click on image to enlarge

Read the report, here...….

Jan 11, 2019
Weekly View Report - 2018-2019 Influenza Season Week 1 ending January 5, 2019
Influenza activity remains elevated in the United States. Influenza A(H1N1)pdm09, influenza A(H3N2), and influenza B viruses continue to co-circulate. Below is a summary of the key influenza indicators for the week ending January 5, 2019:
Viral Surveillance: The percentage of respiratory specimens testing positive for influenza viruses in clinical laboratories decreased slightly. Influenza A viruses have predominated in the United States since the beginning of October. Influenza A(H1N1)pdm09 viruses have predominated in most areas of the country, however influenza A(H3) viruses have predominated in the southeastern United States (HHS Region 4).

Virus Characterization: The majority of influenza viruses characterized antigenically and genetically are similar to the cell-grown reference viruses representing the 2018–2019 Northern Hemisphere influenza vaccine viruses.

Antiviral Resistance: All viruses tested show susceptibility to the neuraminidase inhibitors (oseltamivir, zanamivir, and peramivir).

Influenza-like Illness Surveillance: The proportion of outpatient visits for influenza-like illness (ILI) decreased from 4.0% to 3.5%, but remains above the national baseline of 2.2%. All 10 regions reported ILI at or above their region-specific baseline level.
ILI State Activity Indictor Map: New York City and 15 states experienced high ILI activity; 12 states experienced moderate ILI activity; the District of Columbia, Puerto Rico and eight states experienced low ILI activity; and 15 states experienced minimal ILI activity.

Geographic Spread of Influenza: The geographic spread of influenza in 30 states was reported as widespread; Puerto Rico and 17 states reported regional activity; two states reported local activity; the District of Columbia, the U.S. Virgin Islands and one state reported sporadic activity; and Guam did not report.

Influenza-associated Hospitalizations A cumulative rate of 9.1 laboratory-confirmed influenza-associated hospitalizations per 100,000 population was reported. The highest hospitalization rate is among adults 65 years and older (22.9 hospitalizations per 100,000 population).

Pneumonia and Influenza Mortality: The proportion of deaths attributed to pneumonia and influenza (P&I) was below the system-specific epidemic threshold in the National Center for Health Statistics (NCHS) Mortality Surveillance System.

Influenza-associated Pediatric Deaths: Three influenza-associated pediatric deaths were reported to CDC during week 1.

Read more: summary of the key influenza indicators for Week 1 ending January 5, 2019.  Additional information is available on the CDC Seasonal Influenza (Flu) website.

Flu News & Spotlights
2018-2019 Flu Season: Flu Activity Elevated Nationally
Dec 21, 2018
December 21, 2018 – Increases in flu activity summarized in CDC’s most recent FluView report, including increases in influenza-like-illness and the proportion of laboratory-confirmed flu cases nationally, have signaled the start of the 2018-2019 influenza season. In addition, a seventh flu-related pediatric death was reported this week.
News Updates @ CDC

Public Health Agency of Canada:
The most up-to-date influenza information from Canada is available at http://www.phac-aspc.gc.ca/fluwatch

British Columbia Influenza Surveillance Bulletin Influenza 
Season 2018-19, Number 7, Week 1 December 30, 2018 to January 5, 2019 
Some indicators suggest that influenza activity may have peaked but further monitoring is required. 

Joint ECDC - WHO/Europe Weekly Flu Update:
https://flunewseurope.org/Severity

January - In The News
Jan 11, 2019
CDC: Flu Has Sickened Millions So Far
New federal estimates offer insight into the severity of the ongoing flu season.

Harnessing multiple data streams and artificial intelligence to better predict flu

Jan 9, 2019
Pregnant women with influenza are more likely to experience complications, but how this affects infants is unclear. A new Birth Defects Research study uncovers the potential risks to infants.

Jan 6, 2019
Flu symptoms, Ejnes says, usually start abruptly — though you can spread the virus before symptoms surface. "Patients can pretty much tell you when the symptoms hit them — after lunch, for example, or yesterday afternoon," says Ejnes. A cold, on the other hand, takes a couple of days to build up. You may have a scratchy throat one day and then the nose starts to get stuffy the next day....

Jan 5, 2019
Research: In-Hospital Morbidity, Mortality Up With Flu in Heart Failure
For patients with heart failure, influenza infection is associated with increased in-hospital morbidity and mortality, according to a study published online Jan. 3 in JACC: Heart Failure.

Jan 4, 2019
CDC: Pediatric flu deaths now at 13, flu widespread in 24 states

Jan 1, 2019
CDC: Could be a tough flu season based on early viruses, hospitalizations
By Anne-Gerard Flynn
The country could be in for another challenging flu season. There are already 11 pediatric deaths associated with the flu and hospitals rates among very young children are high, according to the Centers for Disease Control and Prevention.

Dec 22, 2018
Flu has arrived for the holidays, CDC head says
According to the CDC, flu is being seen throughout the country, but activity is highest in Colorado and Georgia. Getting a flu shot is putting science into action, according to Redfield. "Nothing frustrates me more than seeing science left on the shelf," he said. "People who don't get the flu vaccine are leaving science on the shelf." 

Dec 16, 2018
Why You Should Definitely Get Your Kids A Flu Shot
Last year, a record number of children died from influenza. As the flu begins to ramp up this month, experts stress the importance of getting the vaccine.

Dec 15, 2018
(Reuters Health)People with heart failure who get flu shots may be less likely to die prematurely than their counterparts who don't get vaccinated, a Danish study suggests.

Racial Disparities Seen Among Teens Undergoing Flu Vaccination
December 14, 2018 
Hispanics have higher odds of vaccination, blacks have lower odds compared with whites 

DECEMBER 05, 2018
Cecilia Pessoa Gingerich
The 2018-2019 influenza season is upon us, but while there’s no way to predict when this season will peak, over the years, data has shown that the influenza season in the United States picks up in October and peaks from December to February, sometimes lasting as late as May.. 

Study analyzes all severe influenza cases in 12 Catalan hospitals between the 2010-2011 and 2015-2016 campaigns

Nov 16, 2018

Nov 12, 2018
First Universal Flu Vaccine to Enter Phase 3 Trial
Numerous experimental vaccines that aim to provide multi-season protection are in human studies.
Ashley P. Taylor
For decades, scientists have been trying to develop a universal vaccine that would protect people against seasonal flu for years, and also against pandemics, which emerge when viral strains completely novel to people’s immune systems start spreading. “A universal flu vaccine is often referred to as ‘The Holy Grail’ of influenza research, and like the Holy Grail, it is challenging to achieve,” Tamar Ben-Yedidia, chief scientific officer of BiondVax, whose universal flu vaccine is now in Phase 3 clinical trials, tells The Scientist in an email.

It has been about 20 years in the making to get to the point of a Phase 3 study—the first universal flu vaccine to have progressed to that stage—and there are numerous others following behind. All of these vaccines employ variations on a similar strategy, which is to generate immunity to parts of the virus that are the least variable from strain to strain...

Maryn McKenna
At first glance, that response makes sense: If a vaccine won’t protect you from illness, why take it? But the effectiveness of flu vaccine is more complex than the binary of Sick or Not Sick. People who get the shot may still end up with flu infection, yet because they got the shot, they are less likely to experience grueling symptoms, be admitted to the hospital, or die.

Nov 8, 2018
Are you prepared for another flu season? 
Test yourself on essential core components of influenza and refresh your knowledge of best practices with this quick quiz. Although the quiz is aimed at physicians, patients may find the information beneficial as well.
Begin here: https://reference.medscape.com/viewarticle/904316

Video:
Nov 4, 2018
This flu season should serve as a wake-up call – we need to redouble our efforts to prevent and treat the flu
Seasonal outbreaks of the flu cause thousands of deaths even in a good year, and the last flu season, 2017-2018, was a terrible one. It killed 80,000 Americans and sent 900,000 to the hospital, making it the worst influenza season in decades.


Baby Boomers and the Flu 
Did you know that you are more susceptible to flu-related complications if you're over 65, living with chronic liver disease, or viral hepatitis? Yep, I knew it too. 

Currently information on this blog is aimed at people living with or treating hepatitis C, for the most part that is the baby boomer generation; born between 1946 to1964. 

Speaking of baby boomers, if you haven't read the CDC's eye- opening report on last years flu season, it was reported 80,000 flu-related deaths occurred in the US, the highest in 40 years. The death rate among young baby boomers, aged 50 to 64 were shocking as well; 
"Death rates were highest in the over-65 age group, which is typical, but the second most affected group comprised those aged 50 to 64 years old; normally, the second highest death rates occur in children, from birth through age 4 years. The ferociousness of the flu season overall, combined with above-average impacts on younger baby boomers, made 2017-2018 one for the record books."
Read the article: Flu Season 2017-2018: A Look at What Happened and What's to Come, CDC report, here. Or read this more recent article, updated Oct 19, 2018: 80,000 Americans died of the flu last winter.That’s more than the number killed in traffic collisions, from gun violence, or from opioid overdoses.

Liver Disease & The Flu
As we age our immune system is less effective in fighting infections, and new infections can have a severe impact on the liver. This can be especially serious for liver transplant recipients and people who have cirrhosis. Flu-related complications could develop into bronchitis or pneumonia, which in rare cases can also be fatal.

Even though the flu vaccine won’t keep everyone from getting sick, it helps prevent serious flu complications. For instance people over 65 who were vaccinated had a lower rate of flu-related death, according to a 2017 study, found on the CDC's website.
"Flu vaccination reduced deaths, intensive care unit (ICU) admissions, ICU length of stay, and overall duration of hospitalization among hospitalized flu patients; with the greatest benefits being observed among people 65 years of age and older."
October - In The News
October 29, 2018
Getting Flu Vaccine One Year Doesn't Reduce Vaccine Effectiveness the Next Year
By Amy Orciari Herman
Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
Getting the flu vaccine every year doesn't reduce its effectiveness — and might even boost its performance — suggests a study in JAMA Network Open.

Researchers examined the vaccination status of nearly 3400 children who presented with acute febrile respiratory illness during one of three successive flu seasons between 2013 and 2016. About one-fourth had flu confirmed on reverse-transcription polymerase chain reaction testing; the rest were considered negative for flu.

The researchers found that while vaccine effectiveness varied by vaccine type (e.g., live attenuated influenza vaccine [LAIV) or inactivated influenza vaccine) and flu virus strain, past-season vaccination did not reduce vaccine effectiveness. In fact, in some cases — for example, the effectiveness of LAIV against influenza A(H3N2) — previous vaccination appeared to improve the vaccine's effectiveness.

Of note, residual protection from past-season flu vaccine alone was observed only for influenza B.
A commentator writes, "The results thus suggest additional support for the current Advisory Committee on Immunization Practices' recommendation that children be vaccinated annually against influenza."
LINK(S):
JAMA Network Open article (Free)
JAMA Network Open commentary (Free)
Background: Physician's First Watch coverage of American Academy of Pediatrics recommendation of inactivated flu vaccine over LAIV (Free)

Oct 28, 2018
New Flu Drug Offers Convenience, Fast Activity, and a Novel Mechanism — at a Price
Last week, the FDA approved a new drug for treatment of influenza, baloxavir marboxil (Xofluza).
The drug is indicated for treatment of symptomatic influenza in patients 12 years of age or older. As with existing treatments, it should be started within 48 hours of symptom onset....

Oct 24, 2018
"I figured [the flu] was something that's dangerous to the elderly and the young, not somebody who is healthy and in their 30s," says Hinderliter, who is 39 and the director of government affairs at the St. Louis Realtors association
"Turns out, I was wrong," he says
Read the article, here.....

Should I or Shouldn't?
September 27, 2018
"People say they never had the flu until they got the shot. That argument doesn’t hold water. Either you got your shot too late, you got a strain of the flu that isn’t covered by the vaccine, or you had a one-day immune response which may make you feel like crap for the day, but isn’t anywhere like having the flu. If you are over 65, high dose flu shots are recommended, and some people feel a bit low and fluish the next day. This is not the flu – it is an immune system reaction"
Read the article: The Flu Shot Debate, written by HCV advocate Lucinda Porter.

CDC Information
People 65 years and older should get a flu shot and not a nasal spray vaccine.
They can get any flu vaccine approved for use in that age group with no preference for any one vaccine over another. There are regular flu shots that are approved for use in people 65 and older and there also are two vaccines designed specifically for people 65 and older:
High Dose Flu Vaccine:
The “high dose vaccine” contains 4 times the amount of antigen as a regular flu shot. It is associated with a stronger immune response following vaccination (higher antibody production). Results from a clinical trial of more than 30,000 participants showed that adults 65 years and older who received the high dose vaccine had 24% fewer influenza infections as compared to those who received the standard dose flu vaccine. The high dose vaccine has been approved for use in the United States since 2009.
Learn more about high dose flu vaccine here.

Adjuvanted Flu Vaccine:
The adjuvanted flu vaccine, Fluad, is made with MF59 adjuvant an additive that creates a stronger immune response to vaccination. In a Canadian observational study of 282 people aged 65 years and older conducted during the 2011-12 season, Fluad was 63% more effective than regular-dose unadjuvanted flu shots. There are no randomized studies comparing Fluad with Fluzone High-Dose. This vaccine was available for the first time in the United States during the 2016-2017 season. Learn more about adjuvanted flu vaccine here.

For Adults with LIVER DISEASE: Important information about a dangerous infection
If you have chronic liver disease, you are more likely to have serious complications if you get pneumococcal disease

Get pneumococcal vaccines 
People who are 65 years of age and older should also be up to date with pneumococcal vaccination to protect against pneumococcal disease, such as pneumonia, meningitis, and bloodstream infections. Talk to your doctor to find out which pneumococcal vaccines are recommended for you. Pneumococcal pneumonia is an example of a serious flu-related complication that can cause death. 

You can get the pneumococcal vaccine your provider recommends when you get the flu vaccine.

CDC - Got Questions?
Flu vaccines recommended this season.

Detailed flu and flu vaccine information specific to the current flu season

If you have HIV, you are at high risk of serious influenza-related complications and should get an injectable influenza vaccine (a flu shot).

Stay healthy!
Tina