Hepatitis C Side Effect Management: Lauren Thomas, RN, NP-C with Liver Specialists of Texas
by Dr. Joe Galati on September 26, 2011
Lauren Thomas, RN, NP-C, discusses in the video the management of side effects associated with hepatitis C therapy. The triple therapy, which includes pegylated interferon, ribavirin and a protease inhibitor (either telaprevir or boceprevir) are discussed. This video is geared for patients, family members, and healthcare providers involved in the care of hepatitis C patients and their treatment. Proper management of the medication side effects if key to successful treatment, and clearance of the HCV virus. Your comments are welcomed, letting us know what additional topics you would like included in the educational series.
Also See Hepatitis C Drug Incivek (telaprevir); What are the side effects ?
Enanta's Lead NS5A Inhibitor Candidate for HCV, EDP-239, Selected as One of Windhover's Top 10 Infectious Disease Projects to Watch
WATERTOWN, Mass., Sept. 26, 2011 /PRNewswire/ --
Enanta Pharmaceuticals, Inc. announced today that its lead development candidate from its NS5A hepatitis C virus (HCV) inhibitor program, EDP-239, has been recognized on Windhover's list of the "Top 10 Most Interesting Infectious Disease Projects to Watch." EDP-239 was chosen by independent experts at Windhover Information and Herndon Company.
NS5A, a clinically-validated target, is a non-structural viral protein that is essential to viral replication. Research efforts have shown that targeting NS5A gives rise to profound antiviral activity, and as a result, this protein has emerged as an important target for antiviral drug development. Enanta's NS5A program and intellectual property estate in the HCV field were derived from its internal drug discovery efforts.
"Enanta appreciates Windhover's recognition of our EDP-239 program for HCV, which showcases the strength of our internal drug discovery efforts aimed against important infectious disease targets," said Jay Luly, Ph.D, president and chief executive officer, Enanta Pharmaceuticals. "We are on-track to initiate a Phase 1 clinical trial for EDP-239 in the coming months, following preclinical studies that demonstrated picomolar potency against multiple genotypes of the virus, an excellent safety profile and a preclinical pharmacokinetic profile amenable to once-a-day dosing in humans."
"Selected companies have been screened using a strict set of judging criteria for the Top 10 award and represent what our committees considered the most attractive infectious disease opportunities the industry has to offer," said David Cassak, Vice President, Content, Windhover Conferences, a division of Elsevier Business Intelligence. "Winners have met rigorous criteria, including: unmet medical need, market potential, diversity of indications, strong science, multi-level partnering opportunities (biotech and pharma), potential for new opportunities beyond initial indications and corporate stability."
About the Hepatitis C Virus
Hepatitis C is a liver disease affecting over 170 million people worldwide. The virus is spread through direct contact with the blood of an infected person. Hepatitis C increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer and death. Liver disease associated with HCV infection is growing rapidly, and there is an acute need for new therapies that are safer and more effective. Specifically targeted antiviral therapies for HCV, such as NS3/4a protease and NS5A inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.
Enanta Pharmaceuticals is a research and development company that uses its novel chemistry approach and drug discovery capabilities to create best in class small molecule drugs in the infectious disease field. Enanta is developing novel protease, NS5A, nucleoside(tide) polymerase, and cyclophilin-based inhibitors targeted against the Hepatitis C virus (HCV). Additionally, the Company has created a new class of macrolide antibiotics, called Bicyclolides, which overcomes bacterial resistance. Antibacterial focus areas include overcoming resistance to superbugs, treating respiratory tract infections, and developing intravenous and oral treatments for hospital and community MRSA infections. Enanta is a privately held company headquartered in Watertown, Mass. Enanta's news releases and other information are available on the company's web site at http://www.enanta.com/.
For Enanta Investor Relations, please contact:Paul Mellett617-607-0761
For Enanta Public Relations, please contact MacDougall Biomedical Communications:Kari Watson508-647-0209 or firstname.lastname@example.org
SOURCE Enanta PharmaceuticalsBack to top
RELATED LINKS http://www.enanta.com/
Recruiting A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-333 and Ribavirin (RBV) in Treatment-Naive and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Images in Clinical Medicine
Porphyria Cutanea Tarda
Chih-Chieh Chan, M.D., and Sung-Jan Lin, M.D., Ph.D.
N Engl J Med 2011; 365:1128
September 22, 2011
A 51-year-old man with a history of heavy alcohol use, chronic hepatitis C virus (HCV) infection, and hepatic cirrhosis presented to his physician with an 8-month history of periorbital hair growth. On examination, healing crusts and scars were evident in sun-exposed areas. He described skin photosensitivity and intermittent painful blistering over the nape of the neck, the forearms, and the backs of the hands (Panel A).
The patient's urine had pink fluorescence under a Wood's lamp, suggesting the presence of uroporphyrin (Panel B, a urine sample from the patient [indicated by an asterisk] and one from a normal control subject [N] under white light; Panel C, the same two urine samples under ultraviolet A light). A diagnosis of porphyria cutanea tarda was confirmed when marked uroporphyrinuria was shown on laboratory analysis. Porphyria cutanea tarda results from decreased activity of the uroporphyrinogen decarboxylase enzyme. Although the mechanism is unknown, the sporadic form of the disease is strongly associated with chronic HCV infection. Facial hypertrichosis is common and may serve as a diagnostic clue.
Although treatment of the patient's chronic HCV infection was considered inadvisable by his hepatologist, low-dose oral hydroxychloroquine, skin photoprotection, and alcohol cessation successfully controlled the cutaneous eruptions within 6 months.
Chih-Chieh Chan, M.D.Sung-Jan Lin, M.D., Ph.D.National Taiwan University Hospital, Taipei,
New Hepatitis C Drugs
Published on Sep 19, 2011 by wdsutv
According to the Centers for Disease Control, an estimated 3.2 million americans have chronic Hepatitis C infections. The FDA recently approved two new drugs for treatment.
Rapid Immune Test Cuts HIV Care Drop-Outs
By eliminating bottlenecks, a rapid immune system test sharply cut the proportion of people who dropped out of HIV care before starting treatment, researchers reported.
Old, diseased organs no barrier to donation
by: Marianne Betts
From: Herald Sun
September 26, 2011 12:00AM
ORGANS from old and diseased donors are increasingly being transplanted into gravely ill Australians.
The oldest donor last year was 84, and record numbers of organs are being transplanted from donors with cancer, diabetes and hepatitis, the Australian and New Zealand Organ Donation Registry 2011 Report reveals.
Despite an increase in organ donations, 1600 Australians are awaiting a transplant and many will die before they get one.
Last year, half the nation's 309 donors had been smokers, 14 had cancer, 20 had hepatitis B, two had hepatitis C, 29 had diabetes and 86 had high blood pressure.
In Australia, hepatitis B and C, cancer and the arenavirus have been passed on through infected donor organs and recipients have died.
Nine livers were transplanted from donors with hepatitis B or C.
Austin Hospital liver transplant unit director Professor Bob Jones said while some recipients might not have had hepatitis, others already would have had the disease.
He said there was a risk of hepatitis being passed from donor to recipient through a transplant.
"It's all about balancing the degree of risk - you have to balance these risks versus the risk of dying waiting," he said.
"If a patient is dying in ICU and has 24 hours to live and the only donor has hepatitis B, we will discuss it with the family."
Some elderly donors were suitable - a dying 30-year-old woman received a 78-year-old's liver, and two or three years later, it was still working "beautifully", he said.
Royal Australasian College of Surgeons transplant surgery chair Jonathan Fawcett said each year the average age of donors was rising.
"In the mid-1990s, (surgeons) were reluctant to use organs retrieved from donors over 50, but now it's common to use organs from donors well into their 60s," Mr Fawcett said.
Victorian medical director of organ and tissue donation Dr Helen Opdam said: "Ten years ago, we would not entertain using organs from someone who was a heavy smoker or a heavy drinker. "Now we will, as long as they are functioning well."
Prescription for Pot - A Debate on the Merits of Medical Marijuana
The use of marijuana for medicinal purpose has been a hotly debated topic in the United States. While cannabis is still listed as an illegal narcotic under Federal Law, 16 states and the District of Columbia have statutes decriminalizing medicinal marijuana as a therapy for specific ailments. Recently, the American Medical Association released a report urging review of marijuana as a Schedule 1 controlled substance, noting that physicians should be protected from prosecution for recommending marijuana and that further studies should be conducted into marijuana’s use as medicine.To provide further insight on this controversy, MD Magazine Peers & Perspectives convened two leading experts in the field to debate the merits or lack thereof of medical marijuana: Joel W. Hay, PhD, professor of clinical pharmacology and pharmaceutical economics and policy at the Shafer Center for Health Policy and Economics in the School of Pharmacy at the University of Southern California, and Joseph I. Sirven, MD, professor and chairman of the department of neurology at the Mayo Clinic in Arizona. The panel was moderated by Peter Salgo, MD. This transcript has been condensed and edited for clarity and length...Continue Reading
Podcast: Dollars for Docs Update
by Minhee ChoProPublica, Sep. 19, 2:44 p.m.
ProPublica’s Charles Ornstein, Tracy Weber and Dan Nguyen join the podcast this week to talk about their recently updated Dollars for Docs database – a project tracking big pharma’s payments to physicians.
ProPublica recently published a major update to our Dollars for Docs news application  – a database tracking money physicians have received from some of the pharmaceutical industry’s largest companies to promote their products.
Currently, the database lists $761.3 million in payments from 12 companies, which account for about 40 percent of U.S. sales. But in 2013, all drug and medical device companies will have to disclose what they are paying doctors for promotional talks, consulting, research, meals and more. Until then, ProPublica’s Dollars for Docs team – Charles Ornstein, Tracy Weber and Dan Nguyen – hope their project will shed some light on the industry’s ties to physicians. They join the podcast this week to explain the technical complexity of this project, why pharmaceutical companies enlist physicians to promote their products to begin with, and why patients have a right to know this information.
Click Below To Listen Or Read Transcript
UK-Man arrested over Nurofen contamination
Detectives investigating how packs of Nurofen Plus were found to contain antipsychotic and anti-epileptic drugs are questioning a man in custody.
Scotland Yard said the suspect, 30, from Bromley in south London, was arrested on Friday on suspicion of contamination of goods. He is being held in a south London police station.
Reckitt Benckiser, the drug's manufacturer, recalled the product on August 26 and halted distribution after discovering five boxes contained other companies' medicines.
It estimated some 250,000 packets were still in customers' hands.
Four of the affected boxes were found to contain the antipsychotic drug Seroquel XL 50mg and one packet contained Pfizer's anti-epileptic medication, Neurontin, in 100mg capsules.
The Met's Specialist Crime Directorate (SCD), which tackles serious and organised crime, is leading the probe and has been examining the entire production line of the drug as part of the inquiry.
AP IMPACT: Hospital drug shortages deadly, costly
By LINDA A. JOHNSONAP Business Writer
TRENTON, N.J. (AP) - A drug for dangerously high blood pressure, normally priced at $25.90 per dose, offered to hospitals for $1,200. Fifteen deaths in 15 months blamed on shortages of life-saving medications.
A growing crisis in the availability of drugs for chemotherapy, infections and other serious ailments is endangering patients and forcing hospitals to buy from secondary suppliers at huge markups because they can't get the medications any other way.
An Associated Press review of industry reports and interviews with nearly two dozen experts found the shortages - mainly of injected generic drugs that ordinarily are cheap - have delayed surgeries and cancer treatments, left patients in unnecessary pain and caused hospitals to give less effective treatments. That's resulted in complications and longer hospital stays.....
Nutrition experts out of the Harvard School of Public Health and Harvard Health Publications in Boston developed a blueprint for healthy eating that they call The Harvard Healthy Eating Plate
New On The Blog
Seeking Drugs to Fight and Prevent HCV Infection
Hepatitis C-Peregrine Phase II HCV Trial for Bavituximab
HCV genotype 3 is associated with a higher hepatocellular carcinoma incidence in patients with ongoing viral C cirrhosis
Chronic Fatigue Syndrome—Science and Controversy
Healthy You-8 Most Common Mistakes Americans Make With Their Meds
Hepatitis C Side Effect Management: Lauren Thomas, RN, NP-C with Liver Specialists of Texas
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Sofosbuvir for Hepatitis C: Simpler, Shorter, Safer?
Olysio (simeprevir) - Resistant Variant (Q80K)
Simeprevir and Sofosbuvir-The Next Wave of Hepatitis C Treatment
Prescribing and patient information, FDA articles, videos and important updates
Simeprevir Approved In The United States
OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C
Johnson & Johnson's protease inhibitor OLYSIO (Simeprevir) is approved for the treatment of HCV genotype 1, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non‑pegylated) with ribavirin.
Simeprevir was approved in Japan this past September , and in Canada on November 20th.
*Updated November 26:
HCV Drug Olysio (simeprevir) - The New Kid On The Block
OLYSIO (Simeprevir) Cost? - Janssen has priced Olysio at a wholesale acquisition price of $22,120 per bottle of 28 capsules (150 mg capsules), which is an approximately one-month supply. That's roughly $66,360 for a three-month course.
Lessons Learned - An important lesson we learned from these drugs may serve as a reminder for future DDAs, that is, once telaprevir and boceprevir were used in larger groups of patients, or in "real-life" settings - outside clinical trials, new response rates and adverse effects began to emerge.
Simeprevir drug–drug interactions - Simeprevir has a list of medications that can cause drug–drug interactions Other medications can interfere with the way DDAs are metabolized. The drug–drug interactions can either increase drug concentrations which may cause toxicity and lead to side effects, or decrease drug concentrations leading to a loss of efficacy.
Off Label Use - Simeprevir and Sofosbuvir? - Paul Sax, Editor-in-Chief at NEJM Journal Watch wrote an article this past summer on the possibility of combining simeprevir and sofosbuvir with or without ribavirin, to create an off label interferon-free regimen....
Important Safety Information
Olysio-simeprevir/Dosing & Uses, Drug Interactions, Adverse Effects
On November 22nd the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), supported Sovaldi® (sofosbuvir) for the Treatment of Chronic Hepatitis C
The CHMP opinion supports the approval of Sovaldi for the treatment of HCV in combination with other agents. The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union (EU).
FDA Updates - Sofosbuvir
In October the Antiviral Drugs Advisory Committee recommend the approval of Gilead's Sofosbuvir, a nucleotide analog NS5B polymerase inhibitor in combination with just ribavirin for treating adult HCV genotypes 2/3 and in combination with pegylated interferon/ribavirin for genotype 1 and 4 treatment-naive patients.
The FDA does not have to follow the advice of its panels, but most often does. The U.S. health regulators are scheduled to decide whether to approve sofosbuvir by December 8th 2013
For detailed information please download the FDA review package for sofosbuvir and simeprevir.
FDA Updates For Sofosbuvir
FDA Updates For Simeprevir
Quick Links - Hepatitis C Investigational Drugs
News, Research And Clinical Trials
See **Clinical Trials @ HCV Advocate For Enrollment Information
AbbVie is a new, independent biopharmaceutical company composed of Abbott’s former proprietary
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r = ritonavir
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To learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.
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Patient Assistance Program
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Prescribing Information for INCIVEK including the Medication Guide.
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Hepatitis C-New Protease Inhibitor (NS3/4A) Drug Resistance Test
LabCorp has begun offering nationwide its hepatitis C GenoSure NS3/4A assay, which is designed to identify NS3 and NS4A mutations and NS3-associated resistance to a pair of recently approved HCV protease inhibitors.
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How Soon Should I Get Tested After Exposure ?
After the exposure (especially if the blood exposure involved another person known to have the hepatitis C virus), it is recommended that testing for the hepatitis C antibody be performed at 4 to 6 months after the exposure OR that testing for the hepatitis C virus itself (a test often called an HCV PCR or hepatitis C viral load test) be performed 4 to 6 weeks after the potential exposure. These tests are done to determine whether or not hepatitis C infection has occurred as a result of the exposure.;
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- New HCV Drugs
- Keeping current on the potential arrival of new improved hepatitis C drugs. As once a hepatitis C patient myself (I successfully treated the virus with standard HCV therapy in 2000) I understand the difficult decisions and overwhelming fear that ensues after being diagnosed with this serious and life-changing disease. This blog serves as a starting point for information on the rapidly evolving number of new agents in development to treat hepatitis C. Tina