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PROGRESS AGAINST HEPATITIS C,A SNEAKY VIRUS

2/24/2014

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Personal Health February 24, 2014, 12:01 am Comment

By JANE E. BRODY  years ago, a beloved neighbor was bedridden for weeks at a time with a mysterious ailment. She knew only that it involved her liver and that she must never drink alcohol, which would make things worse.It was decades before the cause of these debilitating flare-ups was discovered: a viral infection at first called non-A, non-B hepatitis, then properly identified in 1989 as hepatitis C. The apparent source of her infection was a blood transfusion she had received decades earlier.

A screening test was soon developed, making it possible to check all blood products for the hepatitis C virus. But that by no means put an end to the infection. Transmission persists today, commonly the result of intravenous drug abuse with shared needles, sexual and especially anal intercourse, and, among health care workers, accidental needlesticks or other contact with infected blood.

“An estimated 3.2 million people in the United States are infected, but the vast majority of them don’t know it,” Dr. Mark S. Sulkowski, a liver specialist at Johns Hopkins University School of Medicine, said in an interview.

For several decades, only people at high risk for the infection were advised to be screened for it. That meant anyone who had ever injected illegal drugs; recipients of blood transfusions or organ transplants before 1992, or of clotting factor concentrates made before 1987; children born to infected mothers; patients who underwent long-term kidney dialysis; anyone infected with H.I.V. or with symptoms of liver disease or an abnormal liver enzyme test; organ transplant recipients whose donors were later found to have the virus; and health care workers possibly exposed to infected blood.

But even this wide net has missed huge numbers of infected individuals, Dr. Sulkowski said.

Many at high risk are reluctant to identify themselves for screening. Others are unaware that they might be infected, including those exposed as infants or children. In more than half of infected people, the abnormality does not show up in routine blood tests until serious damage has occurred. A chronic infection can cause cirrhosis and liver cancer, and often necessitates a liver transplant.

Recognizing that deaths from hepatitis C are rising and more than three-fourths of infections are being diagnosed in baby boomers, the Centers for Disease Control and Prevention now recommends that everyone born from 1945 through 1965 be screened for the virus.

But what about other people who are walking around with undiagnosed hepatitis C infections? Should they wait until their livers are seriously damaged?

“I would recommend that everyone who comes in for a checkup be screened for hepatitis C,” said Dr. Hillel Tobias, a liver specialist at New York University Medical Center. “It can be added to a blood test and is covered by insurance.” A test for the virus can also be done with a cheek swab.

Thomas Carley, a 39-year-old resident of Mahopac, N.Y., and father of 7-year-old twins, knows the value of early detection. Apparently infected with hepatitis C as a child, he was diagnosed with Stage 4 liver cirrhosis in his 20s and eventually needed a liver transplant.

He is now an enthusiastic volunteer for the American Liver Foundation, which, he said in an interview, “taught me everything I needed to know to fight this disease.”

In about 20 percent of cases, the virus disappears on its own within six months of the initial infection. But the remaining 80 percent develop into a chronic infection that can slowly destroy the liver.

“The younger you are when you’re infected, the longer it takes to develop cirrhosis,” Dr. Tobias said. “It could take 25 years or more in someone infected at age 20. But a 50-year-old can develop cirrhosis in just 10 to 15 years.”

The earlier an infection is diagnosed and treated, the less likely that liver damage will occur. But even in people who already have cirrhosis, eradicating a hepatitis C infection “markedly reduces the chances of it progressing or of developing liver cancer,” Dr. Tobias said. “Even with advanced cirrhosis, people can live longer lives if you get rid of the virus.”

Until late last year, the standard treatment for hepatitis C infection was a challenging 48-week regimen of weekly injections with interferon along with one or two oral antiviral drugs, ribavirin and a protease inhibitor. The treatment almost invariably caused fatigue, depression, irritability, nausea and other debilitating side effects, prompting many infected individuals to refuse it unless obvious liver damage had occurred.

But with two newly approved drugs and a few more in the pipeline, a new era in treatment of hepatitis C is at hand. These regimens are more effective at curing patients and generally work much more quickly than previous treatments.

Hepatitis C has a variety of genetic forms — at least six. Most American patients are infected with genotype 1. The new treatments must be carefully selected for each patient, because some drugs are more effective than others against particular genotypes.

The new drugs, sofosbuvir (Sovaldi) and simeprevir (Olysio), are each approved for use with interferon and ribavirin for treatment of genotype 1 infection. Sovaldi already can be used without injected interferon to treat people infected with genotypes 2 and 3 — about a quarter of all hepatitis C patients in this country.

The Food and Drug Administration is expected to approve an all-oral drug treatment for genotype 1 infection, without interferon, toward the end of this year. But many patients are already taking oral combinations of the newer antivirals, prescribed off-label by their doctors or obtained in clinical trials.

A major study of the new drugs, called the Cosmos trial, found them effective even in patients who could not be cured by previous treatments. One very grateful recipient, John DiFazio, 62, a Vietnam vet and retired firefighter living on Staten Island, said that since the late 1990s he had tried half a dozen different treatments for hepatitis C, all various combinations with interferon, and none had cleared his body of the virus.

He started the new drugs in January and within seven days, his viral count had dropped to 938 per milliliter from 2.8 million. Now six weeks out, it is 104 per milliliter.

“I’ve had no side effects,” Mr. DiFazio said. “I can do everything I want to do.”

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NEW HEPATITIS C DRUGS: DISAPPOINTMENT OR HOPE ??

2/8/2014

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HEALTHWISE: New Hepatitis C Drugs: Disappointment or Hope? —Lucinda K. Porter, RN

 

Last month the Food and Drug Administration (FDA) approved the newest hepatitis C drug. Sovaldi (sofosbuvir) is the first polymerase inhibitor approved for hepatitis C treatment.

 

Sovaldi combined with ribavirin became the first interferon-free hepatitis C treatment, but the all-oral application is for those with genotypes 2 or 3, and special cases. I’ll say more about that later. Sovaldi with peginterferon and ribavirin was approved for patients with genotypes 1 and 4.

 

After the FDA announced the approval, messages from upset patients arrived. “@*#! I have genotype 1 (or 4). I thought the FDA was going to approve all-oral treatments.” Tweets and facebook posts expressed similar sentiments.  One patient asked if the FDA had just signed his death warrant. 

 

I understand this reaction. For more than 15 years, interferon was the basis of hepatitis C treatment. The drugs improved in that more people were cured, but this cure had a high price with even more side effects. Some patients couldn’t or wouldn’t take interferon, or ribavirin for that matter. Patients had to make a risky choice—hope they didn’t progress to cirrhosis or endure a potentially grueling treatment that might not even work.  Both are lousy options.

 

When clinical trial results showed high cure rates using interferon-free regimens, hepatitis C patients began to hope. The big question was—would these drugs be here soon enough? Well, one of the drugs is here, sort of.  Let’s review who Sovaldi can technically be prescribed for, if one’s medical provider stuck to the label.

 

Sovaldi in combination with ribavirin and/or peginterferon can be prescribed to nearly everyone with hepatitis C. It doesn’t matter if you are new to treatment or a prior treatment failed to work for you. The only restrictions are the usual one, such as children, nursing mothers, pregnant women, and men with pregnant partners. Also, there are the usual warnings about ribavirin and pegylated interferon. However, the FDA opened the door for all-oral treatment for genotype 1 patients who are “interferon ineligible.”  

 

Other special populations for whom Sovaldi may be used:

  • Patients with hepatocellular carcinoma (liver cancer) who are waiting for a liver transplant (all-oral using Sovaldi and ribavirin/up to 48 weeks or until liver transplantation)
  • Patients with cirrhosis (safety not established in patients with decompensated cirrhosis)
  • HCV/HIV-1 co-infected patients
  • Patients with renal impairment
  • Adults age 65 and over
Here is a brief summary of Sovaldi. I’ve provided the Sovaldi Prescribing Information for those who want to read more.

Sovaldi in combination with peginterferon and ribavirin for adults with genotype 1 or 4

 

Pros

  • Short 12-week treatment duration, with limited exposure to peginterferon and ribavirin, which translates into an easier to tolerate side effect profile
  • High cure rate at around 90% overall
    • Genotype 1, 89%; genotype 4, 96%
    • Cirrhosis 80%
    • Hardest to treat (genotype 1, cirrhosis, IL28B non-C/C, high viral load) 71%
  • Highest rate of response in Blacks 87% vs. Non-blacks at 91%
  • Low drug-resistance profile
  • Sovaldi is a once-a-day pill with no food requirements
  • Fewer known drug interactions than other direct-acting antivirals (Incivek, Victrelis, and Olysio)
Cons

  • Peginterferon and ribavirin side effects
  • Cost ($84,000 for 12 weeks of treatment just for Sovaldi; pegylated interferon and ribavirin costs are additional)
  • Too soon to know if insurance will cover it
  • Treatment not approved for genotypes 5 or 6 yet (although the FDA didn’t approve this application, some providers may use it anyway)
Sovaldi with ribavirin for the treatment of adults with genotypes 2 or 3

Pros

  • No peginterferon
  • Short 12-week treatment duration for genotype 2, with limited exposure to ribavirin (24 weeks of treatment for genotype 3 patients)
  • High cure rate at around 93-95% overall for genotype 2
    • Cirrhosis 60-94%
  • Improved cure rate at around 84% overall for genotype 3
    • Cirrhosis 60-92%
  • Easier to tolerate side effect profile
  • Highest rate of response in Blacks 87% vs. Non-blacks at 91%
  • Low drug-resistance profile
  • Sovaldi is a once-a-day pill with no food requirements
  • Fewer known drug interactions than other direct-acting antivirals (Incivek, Victrelis, and Olysio)
 

Cons

  • Ribavirin side effects
  • Cost ($84,000 for 12 weeks of treatment just for Sovaldi; ribavirin costs are additional)
  • Too soon to know if insurance will cover it
Treat or Wait  

Despite this progress, genotype 1 patients are still saddled with big decisions. Should they:

  • Go with one of these new, shorter interferon-based treatments
  • Ask their medical provider to prescribe Sovaldi and ribavirin without pegylated interferon
  • Wait for all-oral, interferon-free hepatitis C treatments, which will likely be available in late 2014 or early 2015
  • Wait until ribavirin-free regimens are available
  • Discuss off-label options, such as combining Sovaldi and Olysio
  • Look for a clinical trial
Here is some information to help you make your decision. In a small study, 60 participants received sofosbuvir and ribavirin for 24 weeks. The highest response rate was 68%. The most common side effects were headache, anemia, fatigue, and nausea. (Sofosbuvir and Ribavirin for Hepatitis C Genotype 1 in Patients with Unfavorable Treatment Characteristics: A Randomized Clinical Trial – A. Osinusi, et al. JAMA August 2013)   

 

As for off-label use of Sovaldi and Olysio, results of a small study (COSMOS) showed excellent preliminary results. Patients with advanced liver fibrosis or cirrhosis had 96% to 100% SVR4 rates after 12 weeks of simeprevir and sofosbuvir with or without ribavirin. Note that SVR4 rates are not as meaningful as SVR12 or SVR24. The most frequent complaints were fatigue, headache, nausea and insomnia.

 

The sticky problems of using off-label hepatitis C drugs are: a) finding a provider who will prescribe the two, and b) getting insurance to cover it.  Twelve weeks of Olysio and Sovaldi would cost more than $150,000. Insurance companies will likely want solid evidence about this treatment before forking over that kind of money. SVR12 data should be released in January.

If you are waiting, these words are for you

 

I am deeply concerned that patients are delaying hepatitis C treatment too long. A study presented at the 2013 Liver Meeting showing that a virological cure for patients who had previously developed significant fibrosis, could continue to be at risk for fibrosis/cirrhosis and liver cancer. In short, those that delay treatment may go through treatment, clear the virus, but still suffer some of the tragic consequences. (AASLD 2013: Long term survival of liver fibrosis after virological cure in patients with chronic hepatitis C: The avenue of the scars? by Thierry Poynard)

 

If you think you are immune to progressive liver disease because previous biopsies have been good, think again. Fibrosis often accelerates with age and duration of infection, and is not a linear progression. Additionally, those with hepatitis C have added risks of stroke, heart disease, diabetes, kidney problems, and cancer.

 

It’s a hard decision to make. Don’t let fear of side effects be the main reason for your delay. Although the current hepatitis C treatments are hard, they are doable. With support and good side effect management, twelve weeks will be over before you know it.

 

If you can’t or don’t want to take pegylated interferon and/or ribavirin, use this time to build your health. Commit to a plan of living the healthiest lifestyle you can.  Aim to be physically active, maintain a normal weight, don’t smoke, wear your seat belts, floss your teeth, and laugh a lot. 

 

I’ve seen far too many people die from hepatitis C, and I am sick over it. We are on the brink of changing the future for those affected by hepatitis C. Hope is here, but without action, hope is just hope.

Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time. Her blog is www.LucindaPorterRN.com

Further Information:

  • HCV Advocate News and Pipeline Blog (includes links to clinical trials)
  • A Guide to Hepatitis C: Making Treatment Decisions
  • A Guide to Hepatitis C: Preparing for Treatment
  • How to Evaluate a Clinical Trial
  • Making Sense of Hepatitis C: Research and Medical Literature


Source:
HCV Advocate Newsletter: January 2014


 

 

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HEPATITIS C GUIDELINES:THE RIGHT TREATMENT FOR THE RIGHT PERSON,FOR RIGHT AMOUNT OF TIME

2/5/2014

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HCV New Drug Research

Tuesday, February 4, 2014 Hepatitis C Guidelines: The Right Treatment, For the Right Person, For The Right Amount Of Time Dr Michael Charlton, medical director of Intermountain Medical Center's Transplant Program  talks about the new national guidelines issued this week to manage and treat the hepatitis C virus The new guidelines will have a complex algorithm for practitioners around the country to follow and see whats the right right treatment, for the right patients, for the right about of time.



AASLD/IDSA Launches up-to-date guidance for the treatment of hepatitis C

Online Expert Advice for Clinicians Treating Hepatitis C Now Available at HCVguidelines.org

Last week the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), in collaboration with the International Antiviral Society- USA (IAS-USA), announced the launch of a new website, HCVguidelines.org, that will offer up- to-date guidance for the treatment of hepatitis C virus (HCV) infection.

It is estimated that between 3 and 4 million Americans are infected with HCV and have chronic liver disease as a result. The most recent generation of direct-acting antivirals has the potential to cure most patients with HCV. However, the rapid pace of drug development has left medical providers and insurance companies unsure what the optimal treatments are. The guidance provided through HCVguidelines.org will assist clinicians in using these and other treatments in the care of their patients. HCVguidelines.org is the result of an ongoing collaboration between the two medical professional societies and IAS-USA.

New sections will be added, and the recommendations will be updated on a regular basis as new information becomes available. An ongoing summary of "recent changes" will also be available for readers who want to be directed to updates and changes.
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