Tuesday, August 5, 2014

FDA - Faster, Easier Cures for Hepatitis C

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products

Faster, Easier Cures for Hepatitis C

A Preventable and Curable Disease

Hepatitis (inflammation of the liver) refers to a group of viral infections that affect the liver. The most common types are hepatitis A, hepatitis B and hepatitis C. Each is caused by a different virus.

Hepatitis C is the most common chronic blood-borne infection in the United States. There is no vaccine for this disease, but hepatitis C can be prevented by avoiding behaviors that can spread the virus—including sharing needles, syringes or other equipment to inject drugs.

A diagnosis of hepatitis C no longer means months and months of painful drug injections, which for decades were the only option. Science is making strides in therapies, giving patients new alternatives.

“Interferon-based injections often make patients feel ill and give them flulike symptoms,” Murray says. The treatment by interferon also lasts six months to a year, and cures only 40% to 50% of hepatitis C patients.

“Patients with very advanced liver disease couldn’t take the traditional treatment because often those injections could make them worse,” he adds. “Now, patients can treat their hepatitis C with only pills– drug combinations that are faster and have a higher cure rate.”

Today’s pills have double the viral cure rates—90% to 100%—in just in 12 weeks’ time. Reducing the treatment from a year to three months is a huge advantage for people with hepatitis C, especially because it’s easier to swallow a pill than to get an injection, Murray says.

The new regimens include Sovaldi (sofosbuvir), which is the first drug approved to treat certain types of hepatitis C infection without the need to co-administer interferon. In recent years, FDA has also approved three protease inhibitors—Olysio (simeprevir), Victrelis (boceprevir) and Incivek (telaprevir)—to treat chronic hepatitis C virus infection. Olysio is a protease inhibitor that blocks a specific protein the hepatitis C virus needs to replicate. The drug is a component of a combination antiviral treatment regimen.

Get Updates
FDA provides information through a Hepatitis e-mails list, along with notices of upcoming public events, such as advisory committee meetings, and opportunities to comment on policies and issues that affect people with hepatitis B or C.

Helpful Links
Complex debate on the decision to treat HCV with currently available therapies or wait for more options.

Podcast August 2014: Evolution of Hepatitis C Virus Treatment



New FDA process speeds approval of high-priced breakthrough drugs

Gilead's Sovaldi prescribed more than all other hepatitis C drugs combined

Why Hepatitis C Still Kills 16,000 Americans Per Year, and What We Can Do About It

Baby boomers targeted for Hepatitis C testing
If you’re age 50 or older, ask your doctor to be screened for Hepatitis C

The diagnosis was a surprise for Claudia Dionne: testing during her yearly check-up revealed hepatitis C. The liver-damaging virus was not causing symptoms but for the 4 million people in the United States with hepatitis C it can lead to liver cirrhosis, liver cancer and is the most common reason people need a liver transplant.

But research is changing what comes next for those who learn their diagnosis early. Four new drugs – Victrelis, Incivek, Olysio and Sovaldi — approved in the past three years make treatment easier and more effective. Additional medicines are expected to be approved this year.

Without injections or side effects, treatments have become so simple that 12 weeks of pills alone have a 90 to 95 percent success rate for most people — provided they are diagnosed early. All it takes is a simple blood test.
Who is at risk for Hepatitis C?

Anyone who received a blood transfusion before 1990 is at risk for infection. Widespread screening of the blood supply for hepatitis C began in 1991, so anyone who was transfused before then could have been exposed to the virus.

Another source of infection is infected needles used for acupuncture or tattoos performed at unlicensed locations that do not meet federal safety guidelines.

You should be tested if:
• Your mother had Hepatitis C when you were born
• You were born between 1945 and 1965
• You used injection drugs in the past even if it was just one time many years ago
• You had a blood transfusion before 1990
What you should know about testing?

The only way to tell if you are infected is to have a blood test for the hepatitis C virus. If you have your blood tested regularly by your primary care doctor, you shouldn’t assume you have been tested for Hepatitis C. You should specifically ask to have a screening test, which tests for the virus antibody. If the hepatitis C antibody is detected, a confirmation PCR (polymerase chain reaction) test for the virus RNA (genetic material) is recommended.

The CDC recommends testing, regardless of exposure, if you were born between 1945 and 1965. It’s possible to have a risk factor but to have forgotten about it. Requesting a screening based on your age also bypasses the discomfort of having to talk to your doctor about potentially embarrassing things such as admitting to taking drugs and sharing needles.

The CDC estimates that people born in this period are five times more likely to test positive than people who are younger or older. This group accounts for 70 percent of people with Hepatitis C so screening becomes a very efficient way to detect and treat.
Why should you be tested?

If you are treated and your body responds, you can get rid of the virus before liver damage and liver failure. You stop the progression of liver disease. As long we have people who are infected, they are a source of infection for other people. With every patient we treat, we diminish the pool of people who can become ill or can infect others.

Continue reading

Monday, August 4, 2014

U.S. hepatitis C burden may ease in coming decades: study

U.S. hepatitis C burden may ease in coming decades: study

BY ANDREW M. SEAMAN NEW YORK
Mon Aug 4, 2014 5:15pm EDT

(Reuters Health) - Hepatitis C may become a “rare” disease in the U.S. in about 20 years, according to a new computer model.

About one in 100 people are currently infected with the hepatitis C virus in the U.S. but that may drop to about one in 1,500 people by 2036 thanks to new medicines and increased screening regimens, researchers suggest.

“We were pleasantly surprised that in the next 22 years we could make this a rare disease,” said Jagpreet Chhatwal, the study’s senior author from The University of Texas MD Anderson Cancer Center in Houston.

Hepatitis C is a viral infection of the liver that is typically transmitted when the blood of an infected person enters the body of a healthy person. Its symptoms include fever, nausea, stomach and joint pain, dark urine, vomiting and a yellowing of the skin and eyes.

If left untreated, hepatitis C can lead to liver damage, liver failure and cancer, according to the Centers for Disease Control and Prevention (CDC). It may also lead to death.

The researchers write in the Annals of Internal Medicine that about 3.2 million people in the U.S. have chronic hepatitis C infections that cost the country about $6.5 billion per year.

Treatment of hepatitis C infections recently changed with the availability of new antiviral medicines in 2011 and the more recent release of pill from Gilead Sciences known as Sovaldi to treat the virus.

And the CDC and the government-backed U.S. Preventive Services Task Force recently endorsed expanded hepatitis C screenings for every adult born between 1945 and 1965.

“We were curious how the trend will change,” Chhatwal said. “How will it dip or drop?”

For the study, he and his colleagues used a computer model to estimate how the benefits of the new medicines and expanded screenings might change the burden of hepatitis C infection in the U.S. during the coming decades.

Under current conditions, hepatitis C would become a “rare” disease, defined as a condition affecting no more than one in 1,500 people, by 2036. The U.S. could reach that goal by 2026 by adopting a more aggressive screening protocol, they add.

The researchers write that the current screening regimen would identify about 487,000 cases of hepatitis C infection within the next 10 years. That could increase to 933,700 cases if a one-time, universal screening policy is adopted.

Chhatwal said additional research is needed about the effects of expanded screening for hepatitis C infections.

Still, under current conditions, he and his team found that 124,200 cases of severe liver cirrhosis, 78,800 cases of liver cancer, 126,500 liver-related deaths and 9,900 liver transplants may be prevented by 2050.

“We are moving in a positive direction,” Chhatwal said. “These updates and advances we expect will help patients and the healthcare system as well.”

He cautions that it will only be possible if people have timely and affordable treatment for hepatitis C infections.

SOURCE: bit.ly/1fRUN8c Annals of Internal Medicine, online August 4, 2014.

Changing burden of Hepatitis C virus infection in the United States
The latest issue of the Annals of Internal Medicine makes predictions on the changing burden of Hepatitis C virus infection.Chronic hepatitis C virus (HCV) infection causes a substantial health and economic burden in the United States. With the availability of direct-acting antiviral agents, recently approved therapies and those under development, and 1-time birth-cohort screening, the burden of this disease is expected to decrease.

Dr Chhatwal and colleagues from Texas, USA predicted the effect of new therapies and screening on chronic HCV infection and associated disease outcomes.

The research team evaluated existing and anticipated therapies and screening for HCV infection in the United States.

The team assessed the total HCV-infected population in the United States.

Outcomes included the number of cases of chronic HCV infection and outcomes of advanced-stage HCV infection.

The number of cases of chronic HCV infection decreased from 3.2 million in 2001 to 2.3 million in 2013.

The researchers report that 1-time birth-cohort screening beginning in 2013 is expected to identify 487,000 cases of HCV infection in the next 10 years.

In contrast, 1-time universal screening could identify 933,700 cases.
With the availability of highly effective therapies, HCV infection could become a rare disease in the next 22 years.

The team found that recently approved therapies for HCV infection and 1-time birth-cohort screening could prevent approximately 124,200 cases of decompensated cirrhosis, 78,800 cases of hepatocellular carcinoma, 126,500 liver-related deaths, and 9900 liver transplantations by 2050.
Increasing the treatment capacity would further reduce the burden of HCV disease.

Dr Chhatwal's team concludes, "New therapies for HCV infection and widespread implementation of screening and treatment will play an important role in reducing the burden of HCV disease."
"More aggressive screening recommendations are needed to identify a large pool of infected patients."
Ann Intern Med 2014; 161(3): 170-180
06 August 2014

This Issue Of HCV Next -Treat Now or Wait, Millennials, Drugs and HCV

Hello folks, I just returned from a great trip with the family. Maybe you had a chance to do the same? A bit of camping, or a holiday somewhere special, I sure hope so.

If you're in the mood for some summer reading, the July-August edition of "HCV Next" is available online over at Healio.com.

"HCV Next" offers information on a range of topics, which include diagnosis, new combination therapies, side effects, drug/drug interaction, guidelines, fatty liver disease and more.


In This Issue

Millennials, Drugs and HCV
Editorial
A surge in injection drug use is shifting the epidemiology of HCV. In recent years, the number of new cases of hepatitis C virus among people younger than 30 years has increased at an alarming rate. A shift in patterns of injection drug use appears to be driving the changes in HCV epidemiology.

The upsurge in new cases has been observed in US states including Alabama, Colorado, Connecticut, Georgia, Indiana, Massachusetts, New York and West Virginia, among others. HCV infection among injection drug users is increasingly reported in suburban and rural settings, whereas, traditionally, infection has largely been concentrated in urban areas, according to data from Morbidity & Mortality Weekly Report.....

Complex debate on the decision to treat HCV with currently available therapies or wait for more options.

A conversation has developed in the hepatitis C virus community surrounding the necessity of treating certain patients with HCV right away or delaying treatment. In short, there is consensus that some patients require immediate intervention, whereas others can be monitored until further complications occur.

The clinical developments at the patient level include the development of fibrosis or more severe complications of HCV. The nonclinical developments at the market level will come in the form of greatly anticipated FDA approvals of new therapies that are currently moving through the pipeline. However, the nuances of the “treat-or-wait” discussion can become convoluted and warrant further investigation....

Also In This Issue

HCV News at your Fingertips


5 Questions


HCV patients had better outcomes on sofosbuvir-based treatment without interferon


HCV patients had better outcomes on sofosbuvir-based treatment without interferon
August 4, 2014

Patient-reported outcomes and work productivity were more negatively affected by hepatitis C treatment regimens that included pegylated interferon compared with interferon-free regimens, according to recent study data.

Zobair Younossi, MD, of the Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Virginia, and colleagues evaluated the patient-reported outcomes (PROs) obtained from questionnaires completed during two recent phase 3 clinical trials of sofosbuvir-based treatments with and without interferon. The FUSION study included 201 patients infected with HCV who received sofosbuvir and ribavirin for 12 or 16 weeks. The NEUTRINO study included 327 patients infected with HCV who received sofosbuvir and ribavirin plus interferon for 12 weeks.

Full Story »

Daclatasvir plus asunaprevir
HALLMARK, COSMOS: New HCV regimens show high cure rates
Novel direct-acting antiviral agents were effective in treating infection with hepatitis C virus genotype 1 — even in the hardest-to-treat patients — according to results from two major clinical trials published in the Lancet

15 hepatitis C patients die of drug’s side effects

15 hepatitis C patients die of drug’s side effects

2:48 am, August 05, 2014 
The Yomiuri Shimbun Fifteen hepatitis C patients who were prescribed a drug manufactured by Mitsubishi Tanabe Pharma Corp. have died after developing serious side effects such as liver failure and whole-body dermatitis, according to the drug company and other sources.

About a quarter of the patients who took Telavic, a drug for hepatitis C also sold under the generic name Telaprevir, suffered serious side effects after the drug went on the market in 2011. Mitsubishi Tanabe Pharma, based in Chuo Ward, Osaka, produces and sells Telavic.

Medical experts had pointed out the risk of side effects during clinical tests before the drug was released onto the market. Because of such concerns, it was prohibited to prescribe the drug to liver cancer patients and those who suffer from serious liver cirrhosis.

But in many of the fatal cases, the medicine was prescribed according to doctors’ judgment to patients for whom it was inappropriate.

According to the company, 11,135 people were prescribed the medicine from November 2011, when it went on sale, to September of last year. Among them, 2,588 people, or 23 percent, suffered serious side effects.

Of them, 13 died of liver failure, skin inflammation, kidney disorders or other conditions. By February of this year, two more had died. In all of the fatal cases, medical experts voiced suspicion that the medicine’s side effects had a causal relationship with the deaths.

Because the serious side effects had often been seen during Telavic’s clinical tests, the Health, Labor and Welfare Ministry ordered the company to set up a third-party committee when releasing the drug. The committee found that the medicine had been prescribed to patients who should not have received it.

According to the committee’s report, one doctor began prescribing the medicine to an elderly woman had previously been diagnosed with liver cirrhosis. Though she developed symptoms such as loss of appetite, the treatment continued for about three months.

Although the hepatitis virus could no longer be detected in her body, she died of acute liver failure.

In the case of a man in his 60s, he developed symptoms such as skin inflammation immediately after he began taking the medicine, and the symptoms initially disappeared. But he redeveloped the symptoms on the 50th day after starting to take the medicine, and his condition got worse and worse. Finally, he died due to sores all over his body.

The committee decided it was possible that his doctor had overlooked signs of side effects from the medicine.

Clinical tests have found that side effects of the medicine can be prevented from worsening if doctors monitor skin conditions carefully. Thus the ministry limited authorization to prescribe the medicine to about 800 medical institutions with doctors that specialize in liver and skin diseases.

According to the company, there were problems aside from the fatalities. For example, there were cases in which patients who took the medicine developed skin symptoms—a sign of side effects—but in which doctors, despite specializing in skin diseases, failed to take sufficient measures to prevent worsening of the symptoms.

http://the-japan-news.com/news/article/0001453154

Hepatitis C Could Become Rare Disease in 20 Years: Study

Hepatitis C Could Become Rare Disease in 20 Years: Study

Newer medications, better screening would fuel the trend, researcher says

By Amy Norton
HealthDay Reporter

MONDAY, Aug. 4, 2014 (HealthDay News) -- The once tough-to-treat liver infection hepatitis C could become a rare disease in the United States in the next two decades, a new study estimates.

Hepatitis C, a viral infection that harms the liver, is usually passed through infected blood. For most people, the infection becomes chronic and it can eventually lead to scarring of the liver (cirrhosis) or liver cancer.

U.S. health officials estimate that over 3 million Americans currently have chronic hepatitis C -- most of whom don't know it because the infection usually causes no symptoms.

But with recent treatment advances, hepatitis C could become rare by 2036, researchers report in the Aug. 5 issue of the Annals of Internal Medicine.

"Rare" refers to a disease that affects one in 1,500 people at most, said senior researcher Jagpreet Chhatwal, who conducted the study while at the University of Pittsburgh Graduate School of Public Health. Right now, around one in 100 Americans has chronic hepatitis C.

But that could quickly shift, since new drugs are changing the landscape of hepatitis C treatment, according to Chhatwal's team.

"We're in the middle of a very interesting time for hepatitis C patients," said Chhatwal, who is now an assistant professor at the University of Texas MD Anderson Cancer Center in Houston.

For decades, the only treatment for the disease involved the drug interferon -- which had to be injected and taken for up to a year. It also often caused fatigue and flu-like side effects. After all that, the cure rate was only 40 percent to 50 percent, according to the U.S. Food and Drug Administration.

But in just the past few years, new drugs have been approved and more are on the way, Chhatwal said.

One is Sovaldi (sofosbuvir), a pill the FDA approved last December. The treatment lasts just 12 weeks, with no need for interferon injections.

"There are highly effective drugs becoming available, with a shorter duration of treatment," Chhatwal said. "So, patients should be more amenable to taking them."

Besides the treatment advances, more hepatitis C cases could be caught. Since 2012, U.S. health officials have recommended that all "baby boomers" -- Americans born between 1945 and 1965 -- get a one-time blood test to screen for hepatitis C.

Baby boomers are targeted because they account for about 80 percent of chronic hepatitis C cases, Chhatwal said.

That's partly because of experimentation with injection drugs decades ago, and partly from exposure to contaminated blood before widespread screening of the blood supply in 1992.

For the new study, which was funded by the U.S. National Institutes of Health, Chhatwal's team used a computer model to estimate the future effects of both hepatitis C screening and new drug regimens.

The researchers predict that within the next 22 years, hepatitis C could become rare. What's more, nearly 79,000 cases of liver cancer, over 124,000 cases of cirrhosis and 126,500 deaths could be averted by 2050.

"Those are certainly reasonable predictions. I don't think they're overstating the situation at all," said Dr. Eugene Schiff, director of the Schiff Center for Liver Diseases at the University of Miami Miller School of Medicine.

Schiff, who was not involved in the study, explained that traditionally people with hepatitis C have not been automatically treated, because the drugs were so hard to take and not very effective.

"Now we're moving toward an era of 'test and treat,'" Schiff said. "Cure rates are approaching 100 percent with these new regimens, and they're very well-tolerated."

Treatment could also get even easier, Schiff noted. Gilead Sciences, maker of Sovaldi, has another pill in the pipeline. It combines Sovaldi and another drug, called ledipasvir, into a once-daily tablet that can be taken for as few as eight weeks.

The FDA is expected to make a decision on that drug in October, Schiff said.

The obstacle in all of this is money. Sovaldi costs $1,000 a day, or $84,000 for the typical 12-week course. Some insurers and state Medicaid programs are restricting coverage to certain patients, saying the drug's huge price tag could break the bank.

"As a clinician, the big hurdle right now is being able to get this medication to patients," Schiff said. But he added that payers' worries are understandable -- with an influx of people who'd been living with chronic hepatitis C now wanting treatment.

Costs should come down, Schiff noted, as competitors come onto the market.

Chhatwal's team also looked at what could happen if all Americans -- not just baby boomers -- got a one-time hepatitis C screening test. They say that would nearly double the number of cases detected in the next decade -- from 487,000 to almost 934,000.

What the study does not address, Chhatwal said, is costs. He said more research is needed to see whether the costs of screening and treatment could be offset by the reduction in liver disease and liver transplants.

More information

The U.S. Centers for Disease Control and Prevention has more on hepatitis C.

SOURCES: Jagpreet Chhatwal, Ph.D., assistant professor, health services research, University of Texas MD Anderson Cancer Center, Houston, Texas; Eugene Schiff, M.D., director, Schiff Center for Liver Diseases, University of Miami Miller School of Medicine, Miami, Fla.; Aug. 5, 2014 Annals of Internal Medicine

Last Updated: Aug 4, 2014

Podcast August 2014: Evolution of Hepatitis C Virus Treatment

Podcast August 2014: Evolution of Hepatitis C Virus Treatment

An editorial in the August issue of CGH discusses changing treatment methods for Hepatitis C Virus infection over the last several years. Dr. Kuemmerle speaks to first author Dr. Fasiha Kanwal of Baylor College of Medicine; Plus, summaries of top stories from this month's issue of GI and Hepatology News.

Kanwal F, El-Serag HB. Hepatitis C Virus Treatment: The Unyielding Chasm Between Efficacy and Effectiveness. Clinical Gastroenterology & Hepatology 2014; August 12(8): 1381-1383
Abstract

Listen Here....




What Will the new Hepatitis C Medicines do to Medicare Part D?

What Will the new Hepatitis C Medicines do to Medicare Part D?

By Ed Silverman

In the latest salvo fired over the cost of hepatitis C treatments, a new report projects that the cost of these drugs – including the Sovaldi medication sold by Gilead Sciences GILD +0.74% – will increase 2015 federal spending by Medicare Part D between $2.9 billion to $5.8 billion.

Continue Reading..

In The News
Gilead struggles to shift debate over $1,000 hepatitis pills from costs to cures
When Gilead Sciences Inc. President John Milligan recently told Wall Street analysts that he expected more stories centering on the growing number of patients benefitting from the company’s pricey hepatitis C drug Sovaldi, he wasn’t kidding....

Blue Shield of California CEO: Hepatitis C pill shows drug pricing is ‘broken’
The head of Blue Shield of California on Monday said Gilead Sciences’ controversial hepatitis C drug is unsustainable at $1,000 a day, joining a growing chorus of payers who are unhappy with the price.

“How much can we afford to pay for one drug? How much profit does one company deserve for producing that drug?” wrote President and CEO Paul Markovich in an editorial that appeared exclusively in The Chronicle. “With last month’s release of record earnings for Gilead Sciences — nearly $6 billion in profits in half a year from the hepatitis C drug, Sovaldi, these questions need to be answered.”

Headquartered in San Francisco, Blue Shield of California serves about 3 million members statewide...

Link
Click  here, for an index of articles pointing the reader to the current controversy over the high price of Sovaldi