Research & Treatment News
October 27, 2011
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Hoping to show its ability to cure Hepatitis C in a shorter period of time, Incivek will be evaluated for its effectiveness in just 12 weeks.
Vertex study will evaluate 12-week treatment period for some hepatitis C patients
10/24/11
By Chris Reidy, Globe Staff
Five months after it received regulatory approval for a potential blockbuster hepatitis C drug called Incivek, Vertex Pharmaceuticals Inc. said it is launching a study to evaluate whether some patients can benefit from 12 weeks of treatment rather than 24 or 48 weeks.
Incivek is currently being used as a component in a drug combination therapy that stretches from 24 to 48 weeks, but there is a subset of hepatitis C patients who tend to respond more quickly to treatment, and Cambridge-based Vertex said in a press release that is is now looking to evaluate the effectiveness of a 12-week treatment period for that patient group.
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http://www.boston.com/Boston/businessupdates/2011/10/vertex-study-will-evaluate-week-treatment-period-for-some-hepatitis-patients/4sotlXUEQLVJnlFp6jxnRI/index.html
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Based on early study results, Abbott's new CEO states they can offer future treatments capable of curing 90 percent of Hepatitis C virus cases - without interferon.
Abbott Announces Positive Data from Mid-Stage Trial of Hepatitis C Therapy
By Lianne Dane
Monday, October 24, 2011
Abbott on Friday announced interim data from mid-stage trials of its experimental hepatitis C drug combination that suggested patients could achieve a viral cure without use of interferon and that the duration of therapy could be about half as long as conventional therapies. Abbott's Richard Gonzales, who will take over as CEO of the company's new presecription drug business following its split, commented that the therapy could "dramatically change the treatment landscape" for the disease, adding that "we're on track to show patient cure rates in the 90 percent range."
In the trials, 44 previously untreated patients with hepatitis C were given ritonavir with Abbott's ABT-450 and one of two Abbott polymerase inhibitors, ABT-333 or ABT-072, and ribavirin for 12 weeks. All patients who remained in the studies achieved an early virologic response at 12 weeks, and of the 10 patients to date who were tested 24 weeks after completing the treatment course, nine had achieved a sustained virologic response, the company said. Abbott plans to present more detailed data on these and other trials of the drug regimen next year.
Continue reading this entire article:
http://www.pharmpro.com/News/2011/10/Business-Abbott-Announces-Positive-Data-from-Mid-Stage-trial-of-Hepatitis-C-Therapy/
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Based on its great treatment potential, Biotica has applied for a patent for Sangamides, a new class of drugs targeting the Hepatitis C virus.
Biotica breakthough in Hepatitis C virus
Monday, 24 October 2011
Biotica has identified a potential research breakthrough in the area of Hepatitis C virus (HCV) infection.
It has backed its confidence with a patent application and believes it is operating in clear space to commercialise the findings. The company, based at Chesterford Research Park near Cambridge UK, discovers and develops polyketide therapeutics.
It has announced the publication of a peer-reviewed article in Medicinal Chemistry Communications and of a patent application describing Sangamides, a new class of cyclophilin-inhibiting host-targeted antivirals for treatment of HCV.
Continue reading this entire article:
http://www.businessweekly.co.uk/biomedtech-/12936-biotica-breakthough-in-hepatitis-c-virus
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October 25, 2011
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After just three months of a Phase 2b study, Setrobuvir with pegylated interferon and ribavirin led to undetectable viral levels in over three quarters of previous Hepatitis C treatment non-responders.
Anadys achieves positive interim results in ongoing phase 2b hepatitis C study
October 13, 2011
by Olivia D'Orazio
Anadys Pharmaceuticals (NASDAQ:ANDS) announced Thursday positive interim results in its ongoing phase 2b study of setrobuvir, in combination with pegylated interferon and ribavirin (P/R), in patients with the hepatitis C virus.
The study dosed 283 patients suffering from hepatitis C, who were either treatment naive, or experienced either a relapse or no response to previous P/R treatments.
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http://www.proactiveinvestors.com/companies/news/19618/anadys-achieves-positive-interim-results-in-ongoing-phase-2b-hepatitis-c-study-19618.html
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October 21, 2011
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Results from a newly published study reveal a way to predict who can be cured of Hepatitis C, providing motivation for affected individuals to complete treatment.
by Nicole Cutler, L.Ac.
Receiving treatment for chronic Hepatitis C is not guaranteed to result in a cure. This can be devastating because of the treatment's great expense and capability for causing misery. Thus, the medical community has gone to great strides to figure out ways of predicting the chances that a certain individual can be cured of this viral disease. Claiming to fairly accurately predict who will successfully triumph over Hepatitis C after just a month of treatment, a new study delivers good news to those who are about to begin Hepatitis C treatment.
With the approval of two new medications in 2011, treatment for chronic Hepatitis C has made great progress. Prior to the recent FDA approval of the protease inhibitors Incivek and Victrelis, the standard treatment of pegylated interferon and ribavirin only achieved a 50 percent success rate. With the addition of one of these two new drugs to the therapeutic regimen, the chances of successful treatment have risen to 75 percent or higher.
Although a dramatic improvement over the year-long regimen for pegylated interferon and ribavirin, the new triple drug treatment still lasts six months for most people. The 25 percent of individuals who are not cured of Hepatitis C within six months must still pay for the pricey medications for half a year (if their health insurance doesn't cover it) and contend with a long list of potentially severe side effects - all for nothing. However, the results of a phase 3 study demonstrates that after just four weeks of triple drug therapy (pegylated interferon, ribavirin and Incivek), patients and their physicians should have a pretty good idea if the treatment will cure their Hepatitis C.
Incivek was approved by the FDA in May 2011 to treat chronic Hepatitis C genotype 1 in conjunction with pegylated interferon and ribavirin. This drug has been met by much excitement by the hepatitis community because it both shortens treatment duration and increases the likelihood of virus elimination. However, since this triple drug regimen relies on pegylated interferon and ribavirin, the side effects associated with these medications still apply. The most common side effects for pegylated interferon and ribavirin include:
• fatigue
• flu-like symptoms such as fever, headache and muscle aches
• anxiety
• skin rash
• depression
• gastrointestinal symptoms such as nausea and diarrhea
• anemia
• chest pain
• hair loss
When adding Incivek to the Hepatitis C drug regimen, the following side effects are added to the list:
• itching
• vomiting
• anal or rectal problems
• taste changes
Enduring any combination of the side effects listed above can be a major challenge, and many people quit treatment prematurely. As such, encouragement to persevere through these ailments is crucial for completing the treatment and having a chance at viral eradication. According to a study published in the September 15, 2011 issue of the New England Journal of Medicine, such motivation may exist.
Conducted on individuals new to Hepatitis C treatment, this phase 3 Incivek study identified a close similarity between patients who responded to the triple drug treatment after just four weeks and those who achieved successful viral eradication. According to Kenneth Sherman, MD, PhD, Professor of Medicine at the University of Cincinnati College of Medicine, Director of the Division of Digestive Diseases for UC Health and principal investigator of the study, "With Incivek, we know by week four how patients are initially responding and, for people who have not been treated before, we know by week 12 what their chances are of completing all therapy in 24 weeks. I believe these are important motivators for patients to start and stay on treatment."
Since Incivek has already been approved by the FDA, this recently published study may appear to provide little new information. However, closer evaluation reveals its clinical relevance. Patients who respond to treatment with Incivek, pegylated interferon and ribavirin within the first four weeks of treatment have a significant likelihood of being cured of Hepatitis C. Thus, a positive response after one month of Hepatitis C treatment provides substantial motivation to endure the drugs' side effects and complete another five months of triple drug therapy.
References:
http://scienceblog.com/41501/hepatitis-c-in-2011-a-predictive-marker-for-response-to-therapy/, Hepatitis C: In 2011, a predictive marker for response to therapy, Retrieved September 25, 2011, ScienceBlog.com, 2011.
http://www.drugs.com/clinical_trials/new-england-journal-medicine-publishes-data-phase-3-illuminate-study-incivek-telaprevir-hepatitis-c-12346.html, New England Journal of Medicine Publishes Data from Phase 3 ILLUMINATE Study of INCIVEK(telaprevir) in Hepatitis C, Retrieved September 25, 2011, drugs.com, 2011.
http://www.hepatitis.va.gov/provider/reviews/treatment-side-effects.asp, Interferon and Ribavirin Treatment Side Effects, Retrieved September 25, 2011, United States Department of Veteran Affairs, 2011.
http://www.hepatitis-central.com/mt/archives/2006/07/understanding_h.html, Understanding Hepatitis C Interferon Therapy, Nicole Cutler, L.Ac., Retrieved September 25, 2011, Hepatitis Central, 2011.
http://www.thirdage.com/news/incivek-phase-3-study-results-published-in-new-england-journal-of-medicine_09-15-2011, INCIVEK Phase 3 Study Results Published in New England Journal of Medicine, Roberta Seldon, Retrieved September 24, 2011, ThirdAge Media LLC, 2011.
Posted by Editors at 10:31 AM --- Printer-friendly version
October 13, 2011
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Due to continued positive results, Pharmasset's Hepatitis C trial for PSI-7977 has been expanded to include monotherapy.
Pharmasset expands hepatitis C trial; shares rise
Mon Oct 10, 2011
(Reuters) - Pharmasset Inc (VRUS.O) said it will expand a mid-stage trial of its experimental hepatitis C drug with the further addition of two arms, sending its shares to a life-high.
Pharmasset's PSI-7977, which belongs to a class of compounds called nucleotide analogues, will now be studied for 12 weeks as a single drug treatment, while the other arm will test the drug in combination with ribavirin.
In addition, a previously announced arm of the trial has been modified to an interferon-free 12-week regimen, the company said in a statement.
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http://www.reuters.com/article/2011/10/10/us-pharmassetinc-idUSTRE7993PD20111010
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A partnership has been formed between Inovio Pharmaceuticals and VGX International to co-develop therapeutic vaccines for both Hepatitis C and Hepatitis B.
Inovio Pharmaceuticals and VGX International to Advance Therapeutic Hepatitis C and Hepatitis B Synthetic Vaccines into Clinical Studies
Data published in Molecular Therapy indicates strong vaccine-generated T cell immune responses in monkeys to consensus multi-antigen HCV vaccine
BLUE BELL, Pa., Oct. 10, 2011 /PRNewswire via COMTEX/ -- Inovio Pharmaceuticals, Inc. INO +1.66% , a leader in the development of synthetic vaccines against cancers and infectious diseases, announced today that it has entered into a product development collaboration agreement with its affiliate, VGX International Inc. (kse:011000), to co-develop Inovio's SynCon® therapeutic vaccines for hepatitis B and C infections.
Under the terms of the agreement, VGX International will receive marketing rights for these vaccines in Asia, excluding Japan, and in return will fully fund IND-enabling and initial phase I and II clinical studies. Inovio will receive payments based on the achievement of clinical milestones and royalties based on sales in the licensed territories and retains all commercial rights in all other territories.
The first product to enter clinical testing will be a synthetic multi-antigen hepatitis C virus (HCV) vaccine covering genotypes 1a and 1b and targeting the antigens NS3/4A, which includes HCV nonstructural proteins 3 (NS3) and 4A (NS4A), as well as NS4B and NS5A proteins.
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http://www.marketwatch.com/story/inovio-pharmaceuticals-and-vgx-international-to-advance-therapeutic-hepatitis-c-and-hepatitis-b-synthetic-vaccines-into-clinical-studies-2011-10-10
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October 12, 2011
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Phase 2A human trial confirms that, when coupled with interferon and ribavirin, experimental drug BIT225 has strong antiviral effect against the Hepatitis C virus.
Hepatitis C Phase 2A Trial Positive Results
SYDNEY, Oct. 10, 2011 /PRNewswire via COMTEX/ -- Phase 2a trial validates Biotron's novel drug
First-in-class new, oral drug
Good results on tolerability and efficacy
Full data to be presented to scientific conference in December
Australian drug development company Biotron Limited (asx:BIT) has released headline results from its landmark Phase 2a trial of its lead drug candidate, BIT225 in Hepatitis C virus (HCV) infected patients.
Preliminary analysis of trial data confirms that BIT225, an orally administered, small molecule drug, has good antiviral activity against HCV. Patients receiving BIT225 in combination with interferon and ribavirin (the current standard of care for treating HCV) had greater reductions in HCV levels than patients receiving standard of care treatment alone.
Continue reading this entire article:
http://www.marketwatch.com/story/hepatitis-c-phase-2a-trial-positive-results-2011-10-10
Posted by Editors at 8:15 AM --- Printer-friendly version
October 6, 2011
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Applicable to many with chronic Hepatitis C, eating foods rich in these four elements has been shown to help depression sufferers lift their spirits.
by Nicole Cutler, L.Ac.
More than most other populations, people with chronic Hepatitis C are particularly prone to depression. Getting relief from clinical depression typically requires a physician's guidance; but eating the right foods is a relatively simple way to help those affected get started on feeling better. Food can be either beneficial or detrimental to one's health. As such, diet can be a powerful tool for lifting depression. Even more specifically, the four food groups described below are known to help boost emotional well-being.
About Depression and Hepatitis C
As if battling the Hepatitis C virus were not enough of a burden, a substantial percentage of chronic Hepatitis C patients also struggle with a major depressive disorder at some point during their illness. Moments of feeling down are normal, especially when dealing with a potentially life-altering disease. However, when feeling down turns into clinical depression - it should not be ignored.
According to the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV), a major depressive disorder:
1. persists for at least two consecutive weeks.
2. is characterized by depressed mood or anhedonia (inability to experience pleasure from normally pleasurable life events, such as eating, exercise, social or sexual interaction).
3. is accompanied by at least four of the following:
• Overwhelming sadness or emptiness
• Lack of interest or pleasure in daily activities
• Appetite or weight changes
• Disturbed sleep patterns
• Changes in psychomotor activity
• Fatigue or loss of energy
• Feelings of guilt or worthlessness
• Difficulty focusing, concentrating or making decisions
• Recurrent thoughts of death or suicidal ideation
According to the DSM-IV criteria, reported prevalence rates for major depressive disorder are higher in those with Hepatitis C than the general population:
• An estimated 24 to 70 percent of people with chronic Hepatitis C are clinically depressed.
• An estimated 6 to 10 percent of the general population is clinically depressed.
Food Can Help
While there's no specific diet capable of curing a major depressive disorder, certain foods can improve one's mood. It is important to note that any diet is not a substitute for proper medical care. However, these four food groups may assist a program to treat clinical depression:
1. The Right Carbohydrates - Whole grains such as brown rice, oats, kamut, spelt and quinoa rank high on the list of the right carbohydrates. There are two main reasons that the right carbohydrates are linked to good moods. The first is that carbohydrates boost serotonin - a chemical in the brain known to lift mood. The other major reason is that whole grains provide a steady supply of fuel, which helps avoid the blood sugar crash-and-burn that can lead to crabbiness and mood swings. As a plus to those with Hepatitis C, preventing high blood sugar levels helps protect the liver from fat accumulation in its cells.
2. Omega-3 Fatty Acid Foods - Participants in a 2002 study featured in the Archives of General Psychiatry took just a gram of omega-3 fish oil each day and noticed a 50 percent decrease in symptoms such as anxiety, sleep disorders, unexplained feelings of sadness, suicidal thoughts and decreased sex drive. Other studies show that people who infrequently eat fish, which is a rich source of omega-3 fatty acids, are more likely to suffer from depression. Some of the best sources for omega-3s are walnuts, flaxseed and oily fish like salmon, mackerel and sardines. In addition, omega-3s help ease the inflammatory process that can worsen Hepatitis C.
3. Vitamin Bs (6, 9 and 12) - In a Spanish study of nearly 9,000 people, the rates of depression tended to increase in men as folic acid (Vitamin B9) intake decreased. The same increase occurred for women but with a decreased intake of Vitamin B12. Folic acid is found in yeast, liver, green leafy vegetables, asparagus, strawberries and whole grain cereals. Vitamin B12 can be found in liver, meat, egg yolk, poultry and milk. In addition, Vitamin B6 may help depression since it is needed to produce the mood-enhancing neurotransmitters serotonin and dopamine. Foods that are rich in Vitamin B6 include liver, meat, brown rice, fish, butter, wheat germ, whole grain cereals, bell peppers, spinach, bananas and soybeans. In addition, a diet rich in the B vitamins helps those with liver disease by improving energy levels and preventing anemia during antiviral treatment.
4. Vitamin D - Various types of studies have demonstrated that low Vitamin D levels correlate with depression. Especially important for those who have limited exposure to sunlight, concentrated food sources of Vitamin D include salmon, sardines, shrimp, shitake mushrooms, milk, cod and eggs. Among salmon, wild-caught fish have been shown to average significantly more Vitamin D than non-organically farmed fish. Although requiring more evidence, some research has indicated a Vitamin D deficiency in those with chronic Hepatitis C, prompting investigation into adding Vitamin D to Hepatitis C antiviral therapy.
There is enough evidence to suggest that depression may stem from poor nutrition. However, individuals living with chronic Hepatitis C are vulnerable to a depressive disorder for several other reasons, such as medication side effects or psychological and biological impacts of the virus. From a multidimensional healing perspective, eating the right foods is one component of a solid depression treatment plan. Luckily, altering your diet to focus on the right carbohydrates, omega-3 fatty acids, as well as foods rich in the B vitamins and Vitamin D cannot only help lift your mood - but they also constitute a diet typically recommended for anyone with chronic Hepatitis C.
References:
http://www.care2.com/greenliving/7-mood-improving-foods.html, 7 Mood-Improving Foods, Sara Novak, Planet Green, Retrieved May 20, 2011, care2.com, Inc., 2011.
http://www.everydayhealth.com/depression/foods-that-fight-depression.aspx, Foods That Fight Depression, Chris Iliades, MD, Retrieved May 22, 2011, Everyday Health, Inc., 2011.
http://www.hepatitis-central.com/mt/archives/2009/01/why_depression.html, Why Depression is Likely with Hepatitis C, Nicole Cutler, L.Ac., Retrieved May 21, 2011, Hepatitis Central, 2011.
http://www.mamashealth.com/nutrition/vitaminb.asp, Vitamin B, Retrieved May 22, 2011, MamasHealth, Inc., 2011.
http://www.naturalnews.com/020611.html, The Top Five Foods for Beating Depression, Erin Bates, Retrieved May 21, 2011, Natural News Network, 2011.
http://www.webmd.com/depression/guide/diet-recovery, Depression and Diet, Retrieved May 20, 2011, WebMD, LLC, 2011.
http://www.weightandwellness.com/id41.html, Foods that Heal Depression, Retrieved May 21, 2011, Nutritional Weight and Wellness, Inc., 2011.
http://www.whfoods.com/genpage.php?tname=nutrient&dbid=110, Vitamin D, Retrieved May 22, 2011, The George Mateljan Foundation, 2011.
Posted by Editors at 3:30 PM --- Printer-friendly version
October 3, 2011
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A step forward in tackling the liver donor shortage, a new domino-like procedure helps two patients needing a liver transplant with just one liver donor.
One Donated Liver Saves Two Lives
UCSD performs world's first domino liver transplant on local men
By Lauren Steussy
Thursday, Sep 22, 2011
For the first time ever, doctors saved two lives with one liver.
A team of UC San Diego doctors successfully completed the procedure on two men by "domino-ing" livers from donor to patient, and then from patient to patient.
Rafael Bolanos, 28, suffered from a metabolic disease called MMA and received a donated liver. In a simultaneous surgery, James O'Gara, 61, received Bolanos' liver.
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http://www.nbcsandiego.com/news/local/130304633.html
Posted by Editors at 8:22 AM --- Printer-friendly version
