Medication Adherence Trial In Hepatitis C Patients Launched

A new medication adherence application from emocha helps keep HCV patients on track.

According to the CDC, approximately three to four million individuals are chronically infected with Hepatitis C Virus (HCV) in the United States and at least three quarters of those who become infected will develop chronic infection which, if left untreated, can produce long-term complications and even death.

HCV therapy has been revolutionized by recent developments in treatments, including oral options that achieve high levels of HCV cure when taken as directed. That means medication adherence is a high priority for both healthcare providers and payers, both in terms of the potential benefits and because of the high costs of these medications, which can be up to $1,000 per pill or more than $80,000 for an entire course of treatment.

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AASLD / IDSA Guidance - Treat All Patients with Chronic Hepatitis C

WHEN AND IN WHOM TO INITIATE HCV THERAPY

Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. When the US Food and Drug Administration (FDA) approved the first IFN-sparing treatment for HCV infection, many patients who had previously been “warehoused” sought treatment, and the infrastructure (experienced practitioners, budgeted health-care dollars, etc) did not yet exist to treat all patients immediately. Thus, the panel offered guidance for prioritizing treatment first to those with the greatest need. Since that time, there have been opportunities to treat many of the highest-risk patients and to accumulate real-world experience of the tolerability and safety of newer HCV medications. More importantly, from a medical standpoint, data continue to accumulate that demonstrate the many benefits, within the liver and extrahepatic, that accompany HCV eradication. Therefore, the panel continues to recommend treatment for all patients with chronic HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy. Accordingly, prioritization tables are now less useful and have been removed from this section.

Despite the strong recommendation for treatment for nearly all HCV-infected patients, pretreatment assessment of a patient’s understanding of treatment goals and provision of education on adherence and follow-up are essential. A well-established therapeutic relationship between practitioner and patient remains crucial for optimal outcomes with new direct-acting antiviral (DAA) therapies. Additionally, in certain settings there remain factors that impact access to medications and the ability to deliver them to patients. In these settings, practitioners may still need to decide which patients should be treated first. The descriptions below of unique populations may help physicians make more informed treatment decisions for these groups. (See sections on HIV/HCV coinfection, cirrhosis, liver transplantation, and renal impairment).

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Cures for hepatitis C are an investment worth making

New cures for hepatitis C are helping Medicare beneficiaries live longer, healthier lives. It is disingenuous to look at Medicare spending on these treatments without considering the substantial rebates and competition in the program [“Medicare spending for hepatitis C drugs surges,” news, Oct. 18].

Competition and robust negotiation in Medicare Part D are controlling costs. Private plans command steep discounts on prescription prices under Part D, including groundbreaking cures for hepatitis C. In fact, additional treatment options approved in the past year led to competition-generated savings for a variety of payers, including Medicare. Average rebates on some of these products increased from 22 percent in 2014 to 46 percent in 2015. Average rebate levels in Part D have increased each year of the program. Even the 2015 Medicare trustees report that rebates are substantial.

Moreover, researchers at Harvard University suggest new hepatitis C therapies may generate cost savings for the health-care system over the long run. Medicare is uniquely positioned to take advantage of these savings, as beneficiaries remain in the program once they become eligible.

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Harm Reduction Is Essential to Combat the Addiction Epidemic

Talking about injection drug use is not comfortable for many people. Yet nearly 7 million U.S. citizens inject drugs every year. For those who suffer from debilitating addictions, our silence is deafening. The majority of injection drug users are infected with either HIV or hepatitis C, both devastating illnesses with life-long consequences. Medically, they are at high risk for overdose and a multitude of diseases. Socially, they face enormous stigma, homelessness and violence. Each of them is someone's family. All of their lives matter.

What is there to be done? The good news is that for decades, both injection drug users and doctors have been advocating for harm reduction, a rational and proven way to reduce infections. The idea is simple: lower the risks associated with using drugs. Doctors use these principles every day in the clinic, such as when they encourage patients to use condoms and birth control. We've learned the hard way that abstinence-based methods actually increase risky sexual activity. By instead providing knowledge and safer-sex supplies, they make the behavior safer. Drug use is no different.

The main example of harm reduction for injection drug users is needle exchange, and like harm reduction in general, it's easy to understand. A needle exchange provides a safe, anonymous way for needle users to throw away old syringes, thus keeping them out of public parks and trash cans, where they may wind up otherwise. Next, needle exchanges provide a way to obtain clean injection supplies, so that clients are protected from disease. These simple operating principles have incredible, proven results among clients: a 33% reduction in the risk of contracting HIV, a 61% reduction in hepatitis B, and a 65% reduction in hepatitis C. If needle exchange was a prescription, it would a blockbuster

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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.