FDA Warns of Serious Liver Injury Risk with AbbVie's (ABBV) Viekira Pak

FDA warns of serious liver injury risk with Viekira Pak, according to Bloomberg headlines. The FDA will require Abbvie (NYSE: ABBV) to add new safety risk to its labels.

UPDATE - The FDA issued the following safety announcement on Thursday:

The U.S. Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, we are requiring the manufacturer to add new information about this safety risk to the drug labels.

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FDA UPDATE - VIEKIRA PAK & TECHNIVIE SAFETY WARNING & LABEL CHANGE

Information about FDA Hepatitis product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.

The U.S. Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, new information about this safety risk was added to the Viekira Pak and Technivie labels. Please refer to the FDA Drug Safety Communication for specific details [http://www.fda.gov/Drugs/DrugSafety/ucm468634.htm] In addition, FDA approved changes to the DOSAGE AND ADMINSTRATION, CONTRAINDICATIONS AND WARNINGS AND PRECAUTIONS sections of the Viekira Pak and Technivie labeling and to the respective patient package insert with information on postmarketing reports of hepatic decompensation and hepatic failure including liver transplantation or death among patients with cirrhosis. The specific changes to the each label are summarized below. Major revisions to the Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), co-packaged for oral use label include: 2 DOSAGE AND ADMINISTRATION 2.1 Testing Prior to Initiation of VIEKIRA PAK Prior to initiation of VIEKIRA PAK, assess for laboratory and clinical evidence of hepatic decompensation 2.4 Hepatic Impairment VIEKIRA PAK is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) 4 CONTRAINDICATIONS VIEKIRA PAK is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity. Additionally, colchicine was added to the list of contraindicated drugs due to potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment. 5 WARNINGS AND PRECAUTIONS 5.1 Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with VIEKIRA PAK. Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy with VIEKIRA PAK. Reported cases typically occurred within one to four weeks of initiating therapy and were characterized by the acute onset of rising direct serum bilirubin levels without ALT elevations in association with clinical signs and symptoms of hepatic decompensation. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. VIEKIRA PAK is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C). For patients with cirrhosis: Monitor for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal hemorrhage). Hepatic laboratory testing including direct bilirubin levels should be performed at baseline and during the first 4 weeks of starting treatment and as clinically indicated. Discontinue VIEKIRA PAK in patients who develop evidence of hepatic decompensation. 6 ADVERSE REACTIONS 6.2 Post-Marketing Adverse Reactions The following adverse reactions have been identified during post approval use of VIEKIRA PAK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hepatobiliary Disorders: Hepatic decompensation, hepatic failure 8 USE IN SPECIFIC POPULATIONS 8.6 Hepatic Impairment No dosage adjustment of VIEKIRA PAK is required in patients with mild hepatic impairment (Child-Pugh A). VIEKIRA PAK is contraindicated in patients with moderate to severe (Child-Pugh B and C) hepatic impairment Major revisions to the Technivie (ombitasvir, paritaprevir and ritonavir) tablet label include: The updated label will be available at drugs@fda or dailymed. Richard Klein Office of Health and Constituent Affairs Food and Drug Administration Steve Morin Office of Health and Constituent Affairs Food and Drug Administration For more information about the Hepatitis Liaison Program visit the FDA Patient Network

The Five: The Flu —Alan Franciscus, Editor-in-Chief

This year’s strains of influenza are particularly virulent, and unfortunately the vaccine developed this year does not provide protection against all of the strains.  The flu is a nasty virus that causes 36,000 deaths and 200,000 hospitalizations each year in the United States. The largest and deadliest flu outbreak was the Spanish flu pandemic of 1918-1919 that caused 20 to 40 million deaths.  Now we are lucky to have a healthcare system that prevents most deaths, and vaccines that provide protection against most strains of the flu. 

1. Symptoms:  Many people confuse the symptoms of flu with the cold, but the flu has definite symptoms, such as: 

• A fever of 100 degrees or higher (but not everyone gets a fever)
• A cough and/or sore throat
• A runny or stuffy throat
• Headache and/or body aches
• Chills
• Fatigue or feeling tired
• Nausea (feeling sick to your stomach), vomiting, and/or diarrhea

2. People who are at risk for severe complications:

• Children younger than 5, especially those younger than 2 years old
• Adults 65 years and older
• People who have medical conditions including liver disease (such as hepatitis B and C)

3. Prevention:

• The best prevention is the flu vaccination.  It is safe and is usually effective; but this year’s flu has mutated so the vaccine is not protective against this year’s most virulent flu strain.  Even so, it is protective against 50% of the strains infecting people this year.
• Basic hand washing can help to protect people from the cold, flu and other infections—wash the hands for at least 20 seconds with soap and water. 
• Watch what you touch, especially other people’s items—phones, iPads, remote controls, etc.

4. The Flu:

• If you get the flu, the best advice is to get bed rest, and monitor your temperature and drink lots of fluids.
• There are many over-the-counter medicines that can help lessen some of the symptoms
• Your medical provider can prescribe antiviral medications to reduce the symptoms and shorten the duration of the flu
• Seek medical attention if you experience any of the following:
• Difficulty breathing or shortness of breath
• Purple or blue discoloration of the lips
• Pain or pressure in the chest or abdomen
• Sudden dizziness
• Confusion
• Severe or persistent vomiting
• Seizures
• Flu-like symptoms that improve but then return with fever and worse cough

5. The Bottom Line:

• There is still time to get the flu vaccine, but if you don’t get vaccinated, be prepared to take precautions to protect yourself against getting the flu. 

Nursing Home Blamed for Hep C Outbreak

MINOT, N.D. (CN) - An "unprecedented outbreak" of hepatitis C at a North Dakota nursing home made at least 44 people sick, at least four of whom died, 13 people, including representatives of the estates, claim in court.
   
Lead plaintiff Richard Kerzman claims he was one of the elderly patients who contracted hepatitis C from 2003 through 2013 due to the negligence of ManorCare Nursing Home and Trinity Health.
   
Kerzman et al. say at least 52 people in and around Minot contracted hepatitis C during the outbreak. The lawsuit says that state investigators traced 44 of the infections to the ManorCare Nursing Home.

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Vincent McKay: Action needed tackle death toll from viral hepatitis

Last month, Glasgow’s Scottish Exhibition and Conference Centre (SECC) played host to the World Hepatitis Summit – the world’s first response to last year’s World Health Assembly Resolution calling for concerted action to reverse the ever-rising death toll from viral hepatitis.

The summit was a joint World Health Organisation (WHO) and World Hepatitis Alliance (WHA) event hosted by the Scottish Government and supported by Glasgow Caledonian University (GCU) and Health Protection Scotland.

At GCU, in association with Health Protection Scotland, researchers have led a broad programme on the burden of hepatitis C and interventions to prevent infection and associated disease, which provided the key evidence for the Scottish Government’s Hepatitis C Action Plan.

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Medicare spending for hepatitis C cures surges

Medicare’s prescription drug program spent nearly $4.6 billion in the first half of this year on expensive new cures for the liver disease hepatitis C — almost as much as it paid for all of 2014.

Rebates from pharmaceutical companies — the amounts of which are confidential — will reduce Medicare’s final tab for the drugs, by up to half. Even so, the program’s spending will likely continue to rise, in part because of strong demand.

Medicare’s stunning outlays, spelled out in data requested from the government by ProPublica, raise troubling questions about how the taxpayer-funded program can afford not only these pricey medications but a slew of others coming on the market

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HCV Advocate Eblast: October 15, 2015

Check out what we have in store for you in the October Mid-Month Newsletter

 Hello,

You have probably noticed a lot of changes on the HCV Advocate Website in the last couple of months. We launched the newly designed and organized HCV Advocate website.  We will be fine tuning the website for the next few months as we continue to roll out all the services. We appreciate the feedback we have received and thank you for your patience.

In this month’s issue we have the follow articles:

• Dr. David Mazoff has retired from HCSP/HCVAdvocate—read about his accomplishments and why he will be missed.
• Disability Column Open Enrollment Final – this is a must-read for everyone who will be signing up for new insurance, Obamacare and Medicare.
• The Five Clinical Trials: What Patients Need to Know: Are you considering volunteering for a clinical trial? If so, this will help you sift through the information to make an informed choice.
• Snapshots: This issue features a study of the risk of hepatitis C and miscarriages and another study that comes closer to the real number of people chronically infected with hepatitis C.
• What’s New? We are including our tattoo fact sheets from www.hepatitistattoos.org on our www.hcvadvocate.org. The tattoo fact sheets will be housed under our Fact Sheet tab.

We would also like to welcome our new Webmaster—Judy Barlow—who officially joined us in August 2015 and who has been working with David to ensure a smooth transition.

Cheers,

Alan