Updates: Idenix FDA's No New 'Nuc' Attitude and Interferon Free Drugs Near Approval

 

Website Updates:

In The News June 27

Investment Commentary
Idenix Maintains HCV Hopes Despite FDA's No New 'Nuc' Attitude
On June 20, the company announced that the FDA asked for additional preclinical safety  information on IDX20963. Initiating clinical trials for this one will need to  wait until the FDA is finished playing the wait-respond-wait game.

Idenix's recently shelved IDX20963 is a uridine nucleotide prodrug. Although Idenix insists that it is significantly different than BMS-094, I don't think the FDA is about to allow any "nucs" to enter clinical trials without excessive preclinical safety data. Luckily, Idenix is still in the HCV race with its NS5A  inhibitor samatasvir.

Fruit Company recalls pomegranate kernels in 12 states due to Hepatitis A risk
In a press release this morning, The FDA announced the voluntary recall of Woodstock Frozen Organic Pomegranate Kernels, produced by the Scenic Fruit Company of Gresham, Oregon

All-oral HCV therapies near approval
Source: Nature Reviews Drug Discovery
Published online May 31 2013

Delivering a cure for hepatitis C infection
MedNous  June 2013
Business strategy
This article was prepared by the editors on the basis of a literature review and interviews and email correspondence with Medivir AB; Janssen Research & Development LLC; Gilead Sciences Inc; AbbVie Inc; Inovio Pharmaceuticals Inc; and the European Medicines Agency

Interferon Free Therapies In Development To Treat Hepatitis C

In Case You Missed It - Review Article: Hepatitis C Virus Infection: Looking for Interferon Free Regimens
Recent developments of new drugs' combinations are changing the treatment paradigm in hepatitis C virus infection. Due to the side effect profile of pegylated interferons, interferon-sparing regimens have become the main target in chronic hepatitis C treatment research.

FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide.

Related@CNN
FDA shuts down 1,677 online pharmacies
The FDA said it has shut down 1,677 sites for selling counterfeit or substandard medication, or for selling drugs without appropriate safeguards. Other sites received regulatory warnings. Officials said they also arrested 58 people and seized more than $41 million worth of illegal medicines.

Many experts agree the problem is daunting. The National Association of Boards of Pharmacy recently performed an analysis of more than 10,000 websites, and found that 97% did not fully comply with state and federal regulations. It said 88% did not require a valid prescription, and almost half sold medicines lacking FDA approval

HCV triple therapy post-liver transplant yields moderate response, significant adverse events

Presentation, Outcomes, and Response to Therapy Among Patients with Acute Exacerbation of Chronic Hepatitis C - spikes in ALTs in chronic infection

HHS releases new Public Health Service guideline to reduce disease transmission through organ transplantation

Hepatitis C Treatment – A Five Part Series: Part One – The Evolution of Hepatitis C Treatment 
Lucinda K. Porter, RN, author of Free from Hepatitis C and the upcoming Hepatitis C Treatment One Step at a Time (Sept release by Demos Health) blogs at www.LucindaPorterRN.com

The debate is over – hepatitis C is curable. When I was infected in 1988, this virus didn’t even have a name, let alone a treatment for it. Not only is there treatment for hepatitis C, there is more than one, and many more in development.

Read article here...

In part 2, I will discuss the most common side effects of current hepatitis C treatment. In part 3 I will suggest tips to manage common side effects, and in part 4 I will give some specific, tried and true suggestions for managing the most common side effects that occur during triple therapy.  Part 5 is devoted to what is ahead for hepatitis C treatment. 

 

Emerging Therapeutic Targets for Hepatitis C Virus Infection

The era of DAA therapy in the treatment of hepatitis C is evolving rapidly. The leap forward from the initial proof of concept that HCV infection can be cured without IFN to showing that cure can be attained in an extraordinarily high proportion of patients has occurred more quickly than most observers had anticipated

NICE issues guideline on the diagnosis and management of chronic hepatitis B
NICE has published its clinical guideline on the diagnosis and management of chronic hepatitis B. It aims to ensure the growing number of people with this potentially life-threatening disease are referred to a specialist and receive the right treatments.

Book raises alarms about alternative medicine - USA Today
The 12-year-old girl arrived at the hospital wracked with abdominal pain.
Doctors diagnosed her with acute pancreatitis, in which pancreatic enzymes begin digesting not just food, but the pancreas itself.
The most likely cause of the girl's condition: toxic side effects from more than 80 dietary supplements, which the girl's mother carried in a shopping bag, says Sarah Erush, clinical pharmacy manager at Children's Hospital of Philadelphia, where the girl was treated last summer

Of Interest
How do you sleep?

Modern sleep patterns cause ill health, so it is time to work out how much rest we really need.

Additional updates on the website:

2013 - HCV Triple-therapy Side Effects
HCV triple therapy post-liver transplant yields moderate response, significant adverse events
Webcast - Managing Rashes Associated with Anti-HCV Triple Therapy
Hep C Treatment: Ten Factors Make a Difference with Side Effects
Video- Hepatologist Urges caution among clinicians in the administration of telaprevir
HCV treatment improves survival among anemic patients

Stem Cells
A Science First: Japanese researchers grow human liver using stem cells
Death of 3 politicians following stem cell treatment probed
New Liver Cell for Cellular Therapy to Aid in Liver Regeneration

2013/HCV Multimedia Videos Podcasts
Contemporary Clinical Medicine: Great Teachers: Hepatitis C: From Hippocrates to Cure

Liver Health
Nature - Gut microbes spur liver cancer in obese mice

Intestinal bacteria of obese mice brew up carcinogens to trigger liver cancer.