FDA approves boceprevir for HCV genotype-1

FDA approves boceprevir for H

FDA approves boceprevir for HCV genotype-1

The FDA has approved boceprevir for the treatment of chronic hepatitis C virus genotype-1 infection combined with peginterferon alfa and ribavirin in adult patients with compensated liver disease previously untreated or who have failed previous therapy. As previously reported in Infectious Disease News, data from the HCV RESPOND-2 trial and the SPRINT-2 trial suggest that the addition of boceprevir (Victrelis, Merck) to peginterferon-ribavirin treatment resulted in significantly higher rates of sustained virologic response in patients previously treated and patients with previously untreated HCV genotype-1 vs. pegylated interferon and ribavirin alone. EDWARD COX, MD, MPH ADVERTISEMENT “Victrelis is an important new advance for patients with hepatitis C,” Edward Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products at the Center for Drug Evaluation and Research, said in a press release. “This new medication provides an effective treatment for a serious disease and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy.” Boceprevir should be taken orally three times daily with food. The most common adverse events include fatigue, anemia, nausea, headache and dysgeusia.

CV genotype-1

WEDNESDAY, MARCH 7, 2012CROI 2012: PSI-7977/ribavirin combo achieved rapid response in HCV genotype-1

Posted on InfectiousDiseaseNews.com March 6, 2012
SEATTLE — An interferon-free, experimental nucleotide analogue, PSI-7977, plus ribavirin for 12 weeks achieved rapid on-treatment response in hepatitis C virus genotype-1 patients and was well tolerated in this population, according to presenter Edward Gane, MD.
Gane, a hepatologist at Auckland City Hospital in New Zealand and principal investigator for the ELECTRON study, presented findings from a phase 2, multi-arm study aiming to assess the uridine nucleotide analogue, PSI-7977, combined with ribavirin currently in phase 3 development.
“Results on genotype-2 and genotype-3 patients were presented at the Liver meeting last fall, which demonstrated 100% rapid virologic response rates with interferon-free PSI-7977 plus ribavirin,” Gane said during a press conference today. “Following these results, we enrolled additional patients who were genotype-1 treatment-naive and null responders.”
For the current study, Gane and colleagues assigned 400 mg PSI-7977 plus ribavirin to 10 null responders and 25 treatment-naive patients with HCV genotype-1. Researchers compared early on-treatment data with data from treatment-naive patients with HCV genotype-2 and genotype-3 included in the ELECTRON study.
“Treatment-naive patients just completed treatment,” Gane said. “Therefore, results will not be available until next quarter and will be presented at the Liver meeting in Europe.”
However, overall data, thus far, indicate that patients achieved rapid treatment response, and among all participants, HCV RNA remained undetectable at 4 weeks and throughout the treatment regimen.
Of the nine null patients who have reached the 4-week treatment time point, eight patients relapsed. The one responder was a young, white woman who had the IL28 gene, a favorable predictor for response to interferon-based treatment, according to Gane.
“The majority of null responders have relapsed post-treatment. Further treatment options in this very difficult to treat group will either be longer duration of PSI-7977 plus ribavirin or the addition of another direct-acting antiviral,” he said.

For more information:

• Gane E. #54LB. Presented at: 19th Conference on Retroviruses and Opportunistic Infections; March 5-8, 2012; Seattle.

Disclosure: The researchers report no relevant financial disclosures.
Source

FDA approves boceprevir for HCV genotype-1

FDA approves boceprevir for H

FDA approves boceprevir for HCV genotype-1

The FDA has approved boceprevir for the treatment of chronic hepatitis C virus genotype-1 infection combined with peginterferon alfa and ribavirin in adult patients with compensated liver disease previously untreated or who have failed previous therapy. As previously reported in Infectious Disease News, data from the HCV RESPOND-2 trial and the SPRINT-2 trial suggest that the addition of boceprevir (Victrelis, Merck) to peginterferon-ribavirin treatment resulted in significantly higher rates of sustained virologic response in patients previously treated and patients with previously untreated HCV genotype-1 vs. pegylated interferon and ribavirin alone. EDWARD COX, MD, MPH ADVERTISEMENT “Victrelis is an important new advance for patients with hepatitis C,” Edward Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products at the Center for Drug Evaluation and Research, said in a press release. “This new medication provides an effective treatment for a serious disease and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy.” Boceprevir should be taken orally three times daily with food. The most common adverse events include fatigue, anemia, nausea, headache and dysgeusia.

CV genotype-1

PSI-7977/ribavirin combo achieved rapid response in HCV genotype-1

PSI-7977/ribavirin combo achieved rapid response in HCV genotype-1

PRESS RELEASE

March 7, 2012, 8:30 a.m. EST

Study Shows Nurses are Exposed to Risks from Blood Exposure During Insertion and Removal of Peripheral IV Catheter

SANDY, Utah, March 7, 2012 /PRNewswire via COMTEX/ -- About one in two nurses experience blood exposure, other than from a needlestick, on their skin or in their eyes, nose or mouth at least once a month when inserting a peripheral intravenous (IV) catheter, according to a new study by the International Healthcare Worker Safety Center at the University of Virginia.[1] Exposure to blood carries the risk of infection from pathogens such as human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) and MRSA.

Healthcare workers place more than 300 million short peripheral intravenous catheters (SPIVCs) every year in the United States alone[2]. The study shows nurses are at risk of exposure to blood pathogens in 128 of 100,000 IV catheter insertions. The more commonly recognized risk of exposure to bloodborne pathogens from a needlestick injury with non-safety catheters is 6.6 per 100,000 devices[1]. The Centers for Disease Control and Prevention (CDC) define at-risk blood exposure as "contact of mucous membrane (MME) or exposed skin (chapped, abraded, or afflicted with dermatitis) with blood, tissue, or other body fluids that are potentially infectious."

Yet, the majority of such exposures go unreported. Of the total mucous membrane exposures (MMEs) sustained by respondents in this study, 69% were not reported. In comparison, the CDC's underreporting rate for sharps injuries is 57%.

Almost nine in 10 of those nurses who did not report the incident said they did not think the exposure was significant enough to report; more than one third said they were too busy, and 9% said they were concerned about others' perceptions.

"The use of safety IV catheters has helped reduce needlestick exposures. This study demonstrates the need to consider technology and precautions to reduce the risk of all sources of blood exposure," said Janine Jagger, Ph.D., MPH, lead author of the study and director of International Healthcare Workers Safety Center at the University of Virginia. The study looked at the practices of 379 nurses nationwide who place IV catheters. It was published in the December issue of Nursing 2011.

Study respondents also report a monthly average of 10 incidents of blood contact to gloves during IV insertions and say they unexpectedly come into contact with blood in a patient's room (on bed rails, bedside trays, or pump touchpads) an average of 3.55 times per month, or almost once a week. Pathogens in blood residue on these surfaces can be transferred to healthcare workers, housekeeping staff and visitors who might come in contact with these surfaces.

BD has recently launched its latest innovation in safety peripheral IV catheter technology designed to keep healthcare workers safe from needlestick injuries and blood exposure. In addition to proven needlestick protection, BD Insyte(TM) Autoguard(TM) BC with Blood Control Technology has also been proven to reduce the risk of blood exposure by 95 percent, compared to a non-blood control IV catheter, according to a recently published study[2]. This latest technology joins the BD Nexiva(TM) Closed IV Catheter System and broadens the choice clinicians have in selecting a safety IV catheter that offers protection from sharps and non-sharps blood exposure.

BD Medical, a segment of BD (Becton, Dickinson and Company) and the world's leading provider of IV catheters, sponsored this research through an unrestricted educational grant to the authors. For additional information on healthcare worker safety or Making Safety Safer(SM), visit www.bd.com/IAGBC and www.bd.com/bloodcontrol .

About BD

BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com .

[1] Jagger J, Perry J, Parker G, Komblatt Phillips E. Blood exposure risk during peripheral IV catheter insertion and removal. Nursing 2011. 2011;41(12):45-49.[2] Onia R, Eshun-Wilson I, Arce C, et al. Evaluation of a new safety peripheral IV catheter designed to reduce mucocutaneous blood exposure. Curr Med Res Opin. 2011;27(7):1339-1346.

Contact: Barbara Kalavik BD Public Relations (201) 847-4209 Barbara_Kalavik@bd.com

SOURCE BD-Becton Dickinson

Copyright (C) 2012 PR Newswire. All rights reserved 

National Viral Hepatitis Roundtable (NVHR)

 

Call your member of Congress today about the CDC Hepatitis C Screening Guidelines!

 

 

 

 

Dear Viral Hepatitis Advocate:

Congressman Hank Johnson, one of our strongest champions for viral hepatitis screening, care and treatment, is asking his colleagues to sign onto a letter to the CDC asking for the speedy release of new screening guidelines for the Hepatitis C virus. The proposed age-based screening guidelines will identify many more Americans with Hepatitis C and enable them to access care and treatment, thereby reducing deaths and health care costs.

We urge you to help Congressman Johnson by calling YOUR member of Congress today to ask him or her to sign on to the letter (below and attached). You can reach your Representative by calling the Capitol Switchboard at 1-202-224-3121 or google their website for a direct office number. Sign on to the letter closes on Thursday, COB, so please call today!

Here’s a sample call script:

“My name is ____________ , I live in (city, state), and I care about viral hepatitis. Hepatitis is a serious health problem in the U.S., in my District, and is a very important issue to me. I urge Representative _____________ to show leadership in the fight against hepatitis and liver cancer by signing Congressman Hank Johnson’s Congressional sign on letter to the CDC regarding hepatitis C screening guidelines.”

If there is time, tell them why this issue is important to you. You will probably only have time for 2-3 sentences. Members of Congress and their staff pay attention to their constituents. They need to hear how viral hepatitis affects you, the people you care for, your friends, family, and co-workers. Our lawmakers are unaware of viral hepatitis and how it impacts people in their Districts so they really need to hear from you!

Begin forwarded letter:

Dr. Thomas R. Frieden
Director
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA 30333

RE: Release of Screening Guidelines for Hepatitis C

Dear Director Frieden:

We are writing to express our full support for the timely release of the Centers for Disease Control and Prevention’s (“CDC”) revised screening guidelines for the Hepatitis C virus (“HCV”). In particular, we urge the CDC to adopt new guidelines that would recommend a one-time screening for all Americans born between 1945 and 1965, the “baby boomer generation.” Existing risk-based screening is not effectively targeting a patient population where baby boomers account for 80 percent of all Americans infected with chronic HCV.[1]

HCV infection is the most common long-term blood-borne infection in the United States.[2] There are four million Americans currently infected with HCV, but 75% of these individuals are unaware of their condition.[3] Additionally, the incidences of chronic infection are disproportionately higher in minority populations. For example, HCV is twice as prevalent among African Americans as among Caucasians.[4]

Chronic HCV can result in long-term health problems, and is the leading cause of liver cancer and the most common reason for liver transplantation in the United States.[5] Despite new treatment options that can cure the disease, the mortality rate associated with HCV has now surpassed HIV/AIDS with 15, 106 deaths attributable to the virus in 2007 alone.[6] These are devastating numbers and that is why it is so important for the CDC to take action and release new age-based screening guidelines that will more effectively address this serious issue. Age-based screening may help to identify these HCV-infected patients prior to the onset of liver failure or liver cancer, allowing them to be adequately monitored and potentially treated.[7] Furthermore, by increasing efforts to detect HCV infection, screening may assist in reducing further transmission of the virus.

Recent studies offer evidence that this is sound public policy that will also save lives. An article in The Annals of Internal Medicine, authored by the CDC, provides a glimpse into the type of effect new guidelines could have. The article found that compared with the status quo, age-based screening would identify 808,580 additional cases of chronic HCV infection and, when followed by treatment, would reduce the number of deaths by 121,000. If implemented, this could be a transformative development given the study’s other finding that deaths from HCV are forecasted to increase to 35,000 annually by 2030.[8]

A similar peer-reviewed article on the cost-effectiveness of age-based screening was recently published in Hepatology. The study’s authors found that compared to the current strategy of risk-based screening, birth cohort screening followed by treatment reduced deaths by 78,000 compared to risk-based screening at a cost of $37,700 per quality-adjusted life year (QALY) gained. The study also found that birth cohort screening resulted in 84,000 fewer cases of cirrhosis, 46,000 fewer cases of liver cancer, and 10,000 fewer liver transplants.[9]

Deaths attributable to HCV are increasing, leading to a sense of urgency around the need to take action. We believe that the lessons from the HIV epidemic are applicable to combating HCV, that hepatitis C deaths can be prevented through promoting testing, early diagnosis & linkage to care. The CDC is to be commended for identifying the magnitude of the problem, but it is now imperative that it take further steps towards helping the millions of patients unaware of their condition to get screened and linked to care.

New CDC draft guidelines could offer an effective approach to reaching populations where the disease is most prevalent. We once again offer our full support for new HCV age-based screening guidelines, and urge the CDC to finalize their recommendations as soon as possible.

Sincerely,

Cc: The Honorable Kathleen Sebelius, Secretary, Department of Health and Human Services
Cc: Dr. Howard Koh, Assistant Secretary for Health, Department of Health and Human Services

Over-the-Counter Painkillers and the Liver

March 1st, 2012

Those with liver disease must be aware that the three most common pain relievers could be hazardous to a compromised liver – even at a reasonable dosage.

By Nicole Cutler, L.Ac.

Editor’s Note: The information below is for educational purposes only and is not intended to replace, supersede or substitute medical advice.

Whether it is for the flu, a headache, menstrual pain, muscle ache or any other type of discomfort, just about everyone has times when they seek pain relief. Over-the-counter staples for this purpose usually fall into one of three categories: acetaminophen, ibuprofen or aspirin. Unfortunate for those with chronic liver disease, all three of these medicines can be harmful to the liver. Because different doctors will favor different types of painkillers, it can be very confusing for someone with liver concerns to know what his or her best choice is. The preferred painkiller – and dosage – will vary depending on each individual, but understanding why each of these medications may be hazardous can help people make informed decisions.

As a general rule, the more advanced a person’s liver disease is, the greater caution is warranted when considering pain relief medications. Similar to how the food we eat and the beverages we drink must be processed by the liver, so too do most medications. By recognizing that drugs exert some degree of strain on the liver, it is easy to see why a severely damaged liver would have a harder time metabolizing medications. In addition, conditions that often result from liver disease make certain drugs particularly hazardous.

Occasional, restricted use of the over-the-counter painkillers listed below may be safe for those with chronic liver disease. However, since each individual is likely to have a different presentation of liver disease – a person must work with a physician in choosing the drug that is least likely to adversely affect his or her liver.

Acetaminophen
Known commonly as Tylenol, acetaminophen is a common, mild to moderate pain reliever. As published in a 2005 edition of the journal Hepatology, U.S. researchers found that over a six-year time span, more than 40 percent of acute liver failure cases were caused by an acetaminophen overdose. High doses of acetaminophen can cause liver injury, even to a healthy liver, so those with fewer functioning liver cells have an even greater risk of harm. In limited dosages, a physician will generally only suggest acetaminophen to someone whose hepatic metabolism is fully functioning.

Unfortunately, overdosing on acetaminophen is much easier than it should be because this ingredient is found in many types of pain-relieving drugs. Acetaminophen is also in several narcotic painkillers like Tylenol with Codeine, Oxycodone, Vicodin, Lortab and Percocet. Abbreviated on labels as APAP, acetaminophen is also in Anacin 3, Nyquil and thousands of other medicines used to treat headaches, fever and sore throats. If given an okay to take acetaminophen by a physician, make certain to avoid taking more than one acetaminophen-containing drug at a time. Those with liver disease are often advised to restrict the daily amount of acetaminophen to 2,000 mg per day, or even less if severe liver disease is present.

Ibuprofen
A non-steroidal anti-inflammatory drug (NSAID), ibuprofen reduces high body temperature, is an anti-inflammatory and inhibits normal platelet function. Available in products such as Motrin, Advil and Nuprin, ibuprofen is the painkiller of choice for millions of people. However, NSAIDS are known to cause gastrointestinal upset and bleeding. For those prone to portal hypertension (a common liver disease complication), the risk of gastrointestinal bleeding is intensified with NSAIDS. Studies have shown that at certain dosages, ibuprofen can stress the liver and elevate liver enzymes in people with chronic liver disease. As such, ibuprofen must be used with extreme caution (and always taken with food) in the later stages of liver disease.

Aspirin
Sometimes used as a preventative for cardiovascular disease, aspirin reduces fever, relieves pain, is an anti-inflammatory and a blood thinner. Also sold under the brand names Bayer, Anacin and Excedrin, aspirin limits the blood clotting process and prolongs bleeding. In chronic liver disease where the body’s production of clotting factors is naturally decreased, aspirin can increase the risk of bleeding. When taken in high doses (more than 2,000 mg per day) aspirin can cause liver injury.

Besides acetaminophen, ibuprofen and aspirin, there are other pain-relieving options. Especially for those with advanced liver disease, a doctor may suggest a prescription drug to relieve pain that is cleared more by the kidneys than the liver. As those with chronic liver disease do not have any great, totally safe options for pharmaceutical pain relief, make sure to consider non-medication pain treatments such as acupuncture, physical therapy, massage therapy, heat therapy, cold therapy, TENS (transcutaneous electrical nerve stimulation) and biofeedback.

The bottom line for people with liver disease is to consult with their physician before taking any type of pain-relieving pill – no matter how innocuous it may seem. Because the liver is targeted by most drugs, an ailing liver must be prioritized before any pill-popping begins – especially if it’s Tylenol, Advil or Bayer.

References

http://patients.gi.org/topics/medications-and-the-liver/, Medications and the Liver, Jorge L. Herrera, MD, FACG, Retrieved February 26, 2012, American College of Gastroenterology, 2012.

http://www.everydayhealth.com/health-questions/abdominal-pain/what-can-i-take-for-pain-with-cirrhosis-of-the-liver-4th-stage, What can I take for pain with cirrhosis of the liver (4th stage)?, Sarah Lewis, PharmD, Retrieved February 26, 2012, Everyday Health, Inc., 2012.

http://www.everydayhealth.com/health-questions/pain-management/what-pain-reliever-is-safe-for-the-liver, What Pain Reliever is Safe for the Liver?, Patti Brown, PharmD, Retrieved February 26, 2012, Everyday Health, Inc., 2012.

http://www.hepatitis-central.com/mt/archives/2007/05/is_there_pain_r.html, Pain Relievers and Hepatitis C, Nicole Cutler, L.Ac., Retrieved February 26, 2012, Hepatitis Central, 2012.

http://www.ncbi.nlm.nih.gov/pubmed/16317692, Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study, Larson AM, et al, Retrieved February 26, 2012, Hepatology, December 2005.

http://www.npr.org/blogs/health/2011/01/13/132903273/fda-clamps-down-on-acetaminophen-in-prescription-drugs, FDA Clamps Down On Acetaminophen In Prescription Drugs, Scott Hensley, Retrieved February 26, 2012, NPR, 2012.

http://www.physorg.com/news/2011-01-fda-lowering-pain-reliever-vicodin.html, FDA orders lower doses in prescription painkillers, Matthew Perrone, Retrieved February 26, 2012, The Associated Press, 2012.

http://www.washingtonpost.com/national/fda-moves-to-cut-strength-of-prescription-painkillers-citing-risk-of-liver-damage/2011/01/13/ABt45WR_story.html, FDA moves to Cut Strength of Prescription Painkillers – Citing Risk of Liver Damage, Rob Stein, Retrieved February 26, 2012, The Washington Post, 2012.