HEPCnet Forums

Kathy 44 (7 replies)

scat — Wed, 08 Sep 2010 19:18:58 -0700

Just talked to Tommy, Kath is being kept alive with life support, as soon as Cain is able to get there they will probably disconnect her, looks like Tyler will be able to come home from Guam.
scat

Just wondering:dunno (3 replies)

snowmane — Wed, 08 Sep 2010 18:57:29 -0700

Poll: If you were me with 4/4 would you try infergeon?

who take my poll

Does anyone know how Frankie is? (1 reply)

snowmane — Wed, 08 Sep 2010 19:00:30 -0700

:disappointed

Vertex - REALIZE trial - hard to treat patients (no replies)

Gill — Wed, 08 Sep 2010 14:02:20 -0700

(From the UK site)

Vertex hepatitis C drug helps the hard-to-treat

CAMBRIDGE, Mass.

Vertex Pharmaceuticals Inc. said Tuesday that a late-stage clinical trial showed its hepatitis C drug candidate telaprevir proved effective for patients who hadn't been helped by other treatments.

Vertex said 65 percent of patients who were treated with a drug cocktail including telaprevir were cured, meaning the hepatitis C virus could not be detected in their bodies. That compares with just 17 percent of patients who were treated with only the drugs pegylated interferon and ribavirin.

The 48-week study included 662 people split up into three groups: some who were treated successfully in the past but later relapsed, some who had a partial response to other therapies, and some who had almost no response to other treatments. The study, called REALIZE, is the third and last of the planned late-stage trials of telaprevir. The others involved patients who had not taken other hepatitis C drugs.

For telaprevir and for the standard therapies, the best results came in patients who previously suffered relapses. The partial responders were the second most likely to be cured, followed by those who had almost no response to other drugs.

The most common side effects for telaprevir were fatigue, itching, rash, flulike symptoms, nausea and anemia.

The trial was conducted by Vertex's partner Tibotec, which has the commercial rights to telaprevir in Europe, South America, Australia, the Middle East, and some other countries. Mitsubishi Tanabe Pharma has the rights to sell the drug in Japan and some other Asian countries.

Vertex said it plans to complete regulatory filings for telaprevir later this year.

Analysts have estimated the total market for hepatitis C drugs at $9 billion. About 300,000 people in the U.S. have hepatitis C, a virus that can cause liver damage. Other potential hepatitis C drugs in development include Merck & Co.'s boceprevir. Merck acquired the drug when it merged with Schering-Plough.

[www.businessweek.com]

To All.....About Kathy 44....she's back in the hospital (4 replies)

scat — Wed, 08 Sep 2010 14:53:16 -0700

Tommy just called me, Kath is in the hospital, she has been feeling poorly all week, before the ambulance got to her home she had become incoherent. They saw her in her hometown hospital and knew that she was too sick for them to care for. She was transferred to Mobile. She is currently in ICU, and is non-responsive on life support. She does have a kidney stone, but they really don't know yet what is going on with her. Cain is coming home from Florida to be with her, and Tyler had just flown out to Guam and was still on the plane when Tommy got in touch with him. The Navy will hopefully allow him to come back and be with his mother.
This sounds very very serious folks, so please pray to your god to help our sister whom so many of us love so dearly.
As Tommy continues to call me, I will update here her condition.
Please please pray for our dear dear sister, I know I am not handling this well, as I'm sure many here won't....please pray!!
scat

Happy Heppo Birfday, Sniperkitty :birthday (4 replies)

rocky — Wed, 08 Sep 2010 18:45:14 -0700

May there be many more, my friend :ballons

:jester "Quote Of The Day" (no replies)

T-Man — Wed, 08 Sep 2010 01:29:38 -0700

"Don't let your mind bully your body into believing it must carry the burden of its worries."

:jester Out!!!

back from the doc, lol ...(must be something in the heppo water I see...) (3 replies)

Denise — Wed, 08 Sep 2010 14:56:21 -0700

Well, I too have just returned from liver doc land. My six monthly cirrhosis/HCC monitoring.

Liver still functioning normally. Normal portal flow etc. Spleen, upper end of normal in size, and no nodular malformations on liver. Gall bladder still polyped but with same amount as ever.

Blood work not so great, but nothing to worry about really, in the big picture of things. ALT a bit down to 191....GGT up by one over normal..WBC quite low, neutrophils tipping over the normal/low range and for the first time, my lymphocytes were low. I succumbed to the much insisted upon Flu jab, as I said I would if the neutrophils dropped low enough to warrant it, and because I am full time studying at a school full of plague carrying young people ... ;) .........I'd kick my own arse if I got the flu knowing the neutrophils had dropped like that. Not a fan of flu jabs...avoid them almost as much as the plague.

In general, all is once again, stable. I really thought perhaps the big travel and the full time studying would affect my condition adversely. Some things on the blood work even improved, like my AFP, dropping from 28 to 21. Stable has become the holy grail word for me. I remember once upon a time it was 'normal'.........all blood work and functions are 'normal'.......or 'cured'....aiming for a cure on tx was the holy grail once...Now, nearly 10 years down the track from tx, fibrosis and progression to cirrhosis, I am happy at the word 'stable'....IT has become the holy grail. Stable is good.

The unidentified nodules I carried on my liver for the last 4 years leading to higher monitoring by my doc, have disappeared and stayed that way. No one knows what or why they were or weren't...but as long as they are gone...I'm happier still.

So, college is big, coming up for the end of my third term and two weeks holiday. Much homework and it was a very long term this last one, and in winter too. Cirrhotic people in general do not tolerate weather extremes....The winter hurt...literally, physically hurt. We are still getting much rain and wild weather. The worse in over 15 years...flooding of rivers that were drought ridden. I think it has poured rain for the whole season, and Spring is officially here, but certainly not reflected outside. I look forward to the warmth of the sun. My study has suffered this last term as I suffered from the cold..........but I have the holidays to make up for it, and the next term will be shorter and warmer....

So all up...life is exhausting and exhilerating as per usual. Life keeps throwing up strange things in the middle of all this, but, as most heppos will attest to, you keep going. And I am astounded, at how much this one body has taken and continues to take in this one lifetime, and STILL allow me to kick personal goals. Sometimes the wheels fall off, but that's ok.......I am so grateful to still be around.

Cheers

Denise.

Back from the Doc (5 replies)

sniperkitty — Wed, 08 Sep 2010 12:31:41 -0700

Saw my new gastro today. CT scan showed no cancer, yea! Showed some fluid, Acities, I know that. Last blood work put my ammonia at 41, 30 is high normal so they are putting me on Xafian. Sounds to good to be true. Would be the first time I had a clear head in a long time. Can hardly wait to see if it does any good. Also salt restricted diet. I will try. Told me to stop SAMe as there is no evidence it is safe for someone with Cirrhosis and may be causing my high LFT numbers.. I don't think I want to stop taking that. My elevated LFTs have been that way for years and I have only taken SAMe for less then a year. I don't ever want the dark cloud of depression back in my life...I will just stop talking about it with doctors. I was told that my present cirrhosis could remain stable for years or I could go down hill very fast. No way to tell...I guess that is some good news but I already know that. Anyway, got another endoscope scheduled for December. That's about it for now. Just enjoying life and working way to much. Tomorrow I will be 56. I was diagnosed with HCV and Cirrhosis at age 37 and given 5 to 6 years to live...Ha Ha Ha Ha ( insane laughter). I am going to keep on living in spite of my dragon....I may not have slain it but I am still battling. It's not who is right that wins the war, it's who is left....Don

:jester "Quote Of The Day" (no replies)

T-Man — Tue, 07 Sep 2010 02:27:34 -0700

:jester Out!!!

:jester "Quote Of The Day" (no replies)

T-Man — Mon, 06 Sep 2010 02:20:44 -0700

[/God give me work, till my life shall end
And life, till my work is done.
b]

:jester Out!!!

Doctor visit report (3 replies)

Tfish — Wed, 08 Sep 2010 10:16:06 -0700

Saw gastro doctor Thursday. Saw him, not just his assistant.
Went over results from San Antonio and what we do next.
My MELD score has moved up some.
He was adament about me staying on the meds for maintance. Staying true to the course and keep on doing what I've been doing the past two years. Then he looked up at me puzzled and said,"We've been together that long?"
Am trying a new drug and suppose to let him know what it does. Also changed my acid reflux meds.
Mike also asked him if there is anything we can do about the gallstones and the two hernias so I wouldn't be so miserable.
No cutting on me until liver transplant. But I feel that if I were to bleed to death...it would have been during the dentist surgeries.
And he explained that with the large amount of adema and ascites...if they made the wrong move on me, the bile (ascites@edema) could do some major damage. I don't ever want to go thru that again.
A doubleedged sword.
We are back to the hurry up and wait stage again. I'm starting to get use to it.
Asked him about starting treatment again and he said no way, I wouldn't make it.
And that was all folks.
T :fish

:jester "Quote Of The Day" (no replies)

T-Man — Sun, 05 Sep 2010 01:31:39 -0700

:jester Out!!!

:jester "Quote Of The Day" (no replies)

T-Man — Sat, 04 Sep 2010 04:39:08 -0700

Found this on my keyboard?Now how does that work on my disertation`s LOL

:jester Out!!!

Checking up on old friends (6 replies)

scorpio 51 — Wed, 08 Sep 2010 02:20:06 -0700

This site helped me through my treatment in 2003. I had hep c (3a) and took the pegatron treatment. The hardest thing I have ever done.
my wife left with my baby boy and I was left with pegatron sickness to deal with on my own. A year later and ever since I am undetectable (cured) healthier and stronger than I have ever been. I am at the top of my field in business and my son is 10. I am almost 56 now and I am so grateful to Lyric and the team of heppos for the daily support that helped me through the agony. It was a messge like this that inspired me not to quit treatment and see the light at the end of the tunnel. It was from a guy in Oregon. Slay that dragon, fight the good fight and stay together. I don't know if they have a better treatment, the ribavarin and pegulated interferon made me sick and depressed. Now I am happy, healthy and wise.

Scorpio

Bad Belly (4 replies)

RScott — Sun, 05 Sep 2010 16:06:25 -0700

I've been having more pain in my gut lately than I am used to, so I gave in to my wife and went back to the doctors. After a colonoscopy, an endoscopy, a sonogram, and twice having blood sampled, I am told that I have an enlarged spleen driving down my platelet count and stones in my gall bladder. They want to remove my gall bladder, but are concerned about bleeding due to low platelets (77 as of last month). Does all of this sound kosher to you folks, or do I trust my instincts that doctors just see me as an opportunity to bill my insurance company? I know - I've become very cynical in my old age!

:jester "Quote Of The Day" (no replies)

T-Man — Fri, 03 Sep 2010 01:39:02 -0700

The Only Pills I Need!!!

:jester Out!!!

INX-189 Phase 1a - promising for hepatitis in the future? (no replies)

Gill — Thu, 02 Sep 2010 12:58:38 -0700

(From the UK site)

The first clinical trials on a new investigational drug being developed to treat infections caused by Hepatitis C virus have been successfully completed.

Completion of the initial phase (phase 1a) of trials of INX-189, discovered and first prepared by researchers at Cardiff University’s Welsh School of Pharmacy in 2008, means the chances of it becoming an approved medicine have significantly improved.

Approximately 170 million people worldwide are affected with Hepatitis C, which can lead to liver cancer, cirrhosis and death. It is the leading cause of liver transplantation in western countries. The current treatment involves two drugs – ribavirin and interferon, which has to be given as an injection. Side effects are often severe and lead to patients failing to complete the treatment.

Professor Chris McGuigan of the Welsh School of Pharmacy, academic lead on the project, said: “This is still a very early stage of the trials process but none the less a significant development. Successfully completing phase 1a demonstrates that the drug is safe, with no drug-related side effects at all in a single dose of 100mg.

“The efficiency of drug release in this study has also confirmed that one single dose a day is most likely enough in treating the virus.

“We believe that INX-189 offers the possibility of more potency against Hepatitis, more rapid action in the liver, and fewer side effects than existing treatments.”

In 2008, laboratory tests showed INX-189 killed 90 per cent of the virus at very low (nanomolar) concentration, making it the most potent compound of its kind developed to date.

US pharmaceutical company Inhibitex, which owns the licence to INX-189 and has been working with the Cardiff team, has announced it is looking forward to a second trial (phase 1b), which would evaluate the compound’s effectiveness in Hepatitis C patients.

Cardiff University and Inhibitex filed a patent on INX-189 earlier this year. It has been cleared for human clinical trials by the Food and Drug Administration in the US.

[www.welshicons.org.uk]

:jester "Quote Of The Day" (no replies)

T-Man — Thu, 02 Sep 2010 02:17:23 -0700

:jester Out!!!

Weird stuff.......... (2 replies)

pebbles — Thu, 02 Sep 2010 19:27:07 -0700

I got the referal for my liver Biopsy in the mail. i faxed it to the hospital in Tucson because they said they did not get one. I called later to make the appt and she said that the referal I have is questionable because it is not my doctors signature! What? She sadi she has gotten many referals from him and knows his signature. Also she said my referal says no pre autherization needed but has an expire date for the preautherization! Weird! Now i awaiting while they get a new referal from my doctor. Why would anyone want to sign my doctors name for him? Strange!

:jester "Quote Of The Day" (no replies)

T-Man — Wed, 01 Sep 2010 04:54:32 -0700

"If a man who cannot count finds a four-leaf clover, is he lucky?"

:jester Out!!!

:jester "Quote Of The Day" (no replies)

T-Man — Tue, 31 Aug 2010 02:32:43 -0700

"Home computers are being called upon to perform many new functions, including the consumption of homework formerly eaten by the dog:doggy"

:jester Out!!!

Infergeon every day! No transplant in site but need help! (7 replies)

snowmane — Thu, 02 Sep 2010 19:21:40 -0700

Ok, first my new Hepotoligist said I do Not need a new liver for quite some time now. Old docs have been given me numbers such as death in 5 years, 3 years, etc. So since 2002 my family and I have thought I was going to die. What do I tell my children now? Those docs were a piece of :dung
I am going to get a black rasta wig (spell check please) and go on with life. Freak everyone out. So what I always do.

Now here is the problem, I have to hunt and peck for Xfaxan 550 x 2. My GI sometimes has samples. Her associate said they should call there pharmaceutical people but noooooo. My caregiver went to one of their satellite offices and scored me a 7 day supply. Then when I get home from the hospital, I start calling around and none of the offices had any. So I call the GI back and speak directly to her. She said I was ABUSING the system. LOL I told her if she was associated with these offices it was most certainly not abuse and I have NEVER been acused of abuse. My new doc, was my old one and he can't get the paramedical companies to come to Atlanta Medical.

I have severe encephalopathy it is awful. I have bones that have been broken in places I didn't even have after a bout. Not to mention talking to friends and not knowing what I have said, short term memory loss also. Funny a pill will keep from hurting myself, or become demented and live that to my children to handle.

My question here is do you guys know how to get a hold of Xifaxan. I have Rx of course and the makers of Xifaxan thought they were helping by giving everyone a card with $100.00 off co-pay. If I fill it one time I would get a 30 day supply of the magic pill, but with my part D I do not qualify.:confused

Could you guys let me know how infergeon works, will I be weirder than I already am? And is there a site where I could buy the stuff in another state or county by ordering on line.

Thanks for hanging in there with me.

Love and Light

:jester "Quote Of The Day" (no replies)

T-Man — Mon, 30 Aug 2010 02:31:59 -0700

:jester Out!!!

Chronic Hepatitis C Virus Infection Is Associated with Early Atherosclerosis (no replies)

Denise — Sun, 29 Aug 2010 03:50:17 -0700

Chronic Hepatitis C Virus Infection Is Associated with Early Atherosclerosis

SUMMARY: People with chronic hepatitis C are more likely than those never infected to have diabetes and visceral fat accumulation, but have lower levels of LDL "bad" cholesterol, according to a study described in the June 28, 2010 advance online issue of Gut. After HCV clearance, LDL levels rose to match those of never-infected individuals, but glucose levels and abdominal fat remained similar. After adjusting for other risk factors, chronic hepatitis C patients had greater carotid intima-media thickness, an indicator of the early stages of atherosclerosis.

By Liz Highleyman

Previous research has found that people with chronic hepatitis C virus (HCV) infection have an elevated risk for cardiovascular disease. While HCV has been linked to insulin resistance or diabetes -- known risk factors for heart disease -- it is also typically characterized by favorable blood lipid levels.

In the present study, Aya Mostafa from AinShams University in Cairo and colleagues looked at the effect of this paradoxical risk profile on metabolism and atherosclerosis (hardening of the arteries and build-up of plaque) in the setting of HCV infection and clearance.

This cross-sectional analysis included more than 1200 participants in Egypt aged 35 years or older. Within this study population, 329 had chronic hepatitis C, 173 had cleared HCV infection, and 795 were never infected with HCV; a subset of 192, 115, and 187 participants, respectively, from the 3 groups underwent ultrasound imaging.

The investigators evaluated presence of diabetes, fasting blood glucose, lipid levels, and body fat deposition using ultrasound. Carotid intima-media thickness (IMT), or width of the inner lining of the carotid arteries supplying the brain, was used as a measure of atherosclerosis.

Results

Diabetes was more common among participants with chronic hepatitis C and cleared HCV infection (both with a prevalence of 10.1%) than among those who never had HCV (6.6%; P = 0.04 for chronic, 0.08 for cleared).
The amount of mesenteric or visceral fat was greater in people with chronic hepatitis C (36.4 mm) and cleared infection (37.8 mm) relative to those never infected (32.7 mm; P = 0.004 for chronic, < 0.0001 for cleared).
Low-density lipoprotein (LDL) cholesterol levels were lower in the chronic hepatitis C group (2.69 mmol/L; P < 0.001), but similar in those with cleared infection (3.56 mmol/L; P = 0.4) and those never infected (3.45 mmol/L).
Carotid IMT did not differ significantly according to HCV infection status, at 0.73, 0.71, and 0.71 mm, respectively.
After adjustmenting for traditional cardiovascular risk factors, however, IMT was greater in people with chronic infection (0.76 mm) compared with never infected individuals (0.70 mm; P = 0.02).

Based on these findings, the researchers proposed, "Hepatic function normalization with HCV clearance may account for reversal of favorable lipids observed with HCV infection." However, they added, glucose levels and visceral fat accumulation "appear less amenable to HCV resolution."

"These different cardiovascular risk patterns may determine equivalent atherosclerosis risk by infection status," they suggested. "However, once these factors were accounted for, those with chronic infection had raised IMT, suggesting a direct effect of infection."

Department of Community Medicine, Faculty of Medicine, AinShams University, Cairo, Egypt; Department of Tropical Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt; Viral Hepatitis Reference Laboratory, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt; Institut Pasteur, Paris, France; Department of Metabolic Medicine, Imperial College NHS Healthcare Trust, London, UK; International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College NHS Healthcare Trust, London, UK; Faculty of Medicine, Minia University, Minia, Egypt.

7/30/10

Reference
A Mostafa, MK Mohamed, M Saeed, and others. Hepatitis C infection and clearance: impact on atherosclerosis and cardiometabolic risk factors. Gut (Abstract). June 28, 2010 (Epub ahead of print).

HCV Polymerase Inhibitor PSI-7977 Receives FDA Fast Track Designation (no replies)

Denise — Sun, 29 Aug 2010 03:47:50 -0700

PSI-7977 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection

Princeton, N.J. -- August 12, 2010 -- Pharmasset, Inc. (Nasdaq: VRUS) has received fast track designation from the U.S. Food and Drug Administration (FDA) for PSI-7977 for the treatment of chronic hepatitis C virus (HCV) infection. PSI-7977 is an oral uridine nucleotide analog polymerase inhibitor of HCV. Pharmasset recently completed dosing in a 28 day Phase 2a trial to evaluate PSI-7977 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in treatment-naive patients chronically infected with HCV genotype 1. Pharmasset expects to initiate a 12-week Phase 2b study of PSI-7977 in the fourth quarter of 2010.

Under the FDA Modernization Act of 1997, fast track designation may facilitate the development and expedite the review of a drug candidate that is intended for the treatment of a serious and life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. PSI-7977 was granted the fast track designation primarily due to the need for HCV treatments with novel mechanisms of action, oral administration, different resistance profiles and improved safety and efficacy over the existing standard of care for both treatment-naive and treatment-experienced patients.

"The FDA's fast track designation for PSI-7977 acknowledges the urgent need for new HCV drugs," stated Dr. Michael Rogers, Pharmasset's Chief Development Officer. "Currently, there are no HCV nucleoside/tide inhibitors approved for the treatment of chronic HCV infection. We continue to work closely with the FDA on the development and regulatory review of PSI-7977, which has demonstrated compelling antiviral activity, a high barrier to resistance and has been generally well-tolerated in clinical trials to date."

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV) and, secondarily, on the development of Racivir for the treatment of human immunodeficiency virus (HIV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have four clinical-stage product candidates. RG7128, a cytosine nucleoside analog for chronic HCV infection, is in two Phase 2b clinical studies in combination with Pegasys plus Copegus and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys and Copegus to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage HCV candidates include PSI-7977, an unpartnered uracil nucleotide analog that has recently completed 28 days of dosing in a Phase 2a study, and PSI-938, an unpartnered guanosine nucleotide analog in a Phase 1 study. We also have in our pipeline an additional purine nucleotide analog, PSI-661, in advanced preclinical development. Racivir, for the treatment of HIV, has completed a Phase 2 clinical study.

For more information, see www.pharmasset.com.

8/20/10

Source
Pharmasset, Inc. PSI-7977 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection. Press release. August 12, 2010.

Silymarin Milk Thistle Extract May Inhibit Hepatitis C Virus Entry into Cells (no replies)

Denise — Sun, 29 Aug 2010 03:45:21 -0700

SUMMARY: Silymarin, an extract from the milk thistle plant, has an inhibitory effect on the hepatitis C virus (HCV) polymerase in laboratory studies, but its anti-HCV action also appears to include blocking HCV from entering cells and preventing cell-to-cell transmission, according to research described in the June 2010 issue of Hepatology.

Milk thistle (Silybum marianum) has an extensive history of use as a remedy for liver problems in both Eastern and Western traditional medicine. Silymarin is a flavonoid comprised of a mix of milk thistle components including silibinin. Most silymarin studies have looked at its effect on liver fibrosis, but in recent years researchers have studied its direct activity against HCV in the laboratory and in vivo.

A survey of participants in the HALT-C trial -- which evaluated the benefits of long-term pegylated interferon for patients who did not respond to standard treatment with pegylated interferon plus ribavirin -- found that participants who said they used silymarin did not have lower HCV viral load on average than non-users. Another recent study, however, showed that silymarin inhibited activity of the HCV polymerase, which copies viral genetic material as part of replication.

In the present study, Jessica Wagoner from the University of Washington in Seattle and colleagues further characterized the antiviral action of silymarin in the laboratory.

Results

Silymarin had antiviral effects against HCV in cell cultures, including inhibition of virus entry into cells, HCV RNA and protein expression, and production of infectious virus particles.
Silymarin did not block HCV binding to cells, but did inhibit entry of viral pseudoparticles and fusion of HCV pseudoparticles with liposomes, or fat bubbles.
Silymarin -- but not silibinin -- inhibited activity of the HCV genotype 2a NS5B RNA-dependent RNA polymerase at concentrations 5-10 times higher than required for an anti-HCV effect in cell culture.
Silymarin had only minimal activity against genotype 1b isolate BK and 4 genotype 1b polymerases derived from HCV-infected patients, however.
Silymarin did not inhibit HCV replication in 5 independent genotype 1a, 1b, and 2a replicon model cell lines that did not produce infectious virus.
Silymarin inhibited microsomal triglyceride transfer protein activity, apolipoprotein B secretion, and infectious virion production in cell culture medium.
Silymarin also blocked cell-to-cell spread of HCV.

Based on these findings, the study authors concluded, "Although inhibition of in vitro NS5B polymerase activity is demonstrable, the mechanisms of silymarin's antiviral action appear to include blocking of virus entry and transmission, possibly by targeting the host cell."

Investigator affiliations: Departments of Laboratory Medicine, Microbiology, and Global Health, University of Washington, Seattle, WA; Center for Engineering in Medicine, Massachusetts General Hospital, Boston, MA; Department of Pediatrics, University of Texas Medical Branch, Galveston, TX; School of Medicine, University of Texas Southwestern Medical Center, Dallas, TX; Hepatitis C Virus Research Group, Institute of Biomedical Research, University of Birmingham, Birmingham, UK; Institut de Biologie et Chimie des Protéines, Université Lyon 1, IFR128 Lyon Biosciences Gerland, CNRS-Universite Claude Bernard, Lyon, France; Department of Chemistry and Biochemistry, University of North Carolina at Greensboro, Greensboro, NC; Department of Molecular Virology, University of Heidelberg, Heidelberg, Germany; Department of Molecular Microbiology and Immunology, Saint Louis University School of Medicine, St. Louis, MO.

8/20/10

Reference
J Wagoner, A Negash, OJ Kane, and others. Multiple effects of silymarin on the hepatitis C virus lifecycle. Hepatology 51(6): 1912-1921 (Abstract). June 2010.

Medivir Announces Phase 2b 24-week Interim Results (no replies)

Denise — Sun, 29 Aug 2010 03:43:43 -0700

Below is the text of Medivir's press release describing the research and its findings to date.

Medivir Announces Phase 2b 24-week Interim Results
of TMC435 in Treatment-naive Patients
Chronically Infected with Genotype-1 Hepatitis C Virus

Potent and consistent antiviral efficacy was demonstrated at 24-week end-of-treatment and in interim SVR4 and SVR12 results. There were no clinically relevant differences between TMC435 treatment groups and placebo for adverse events.

July 12, 2010 -- Medivir announced today 24-week end-of-treatment interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naive patients with hepatitis C virus (HCV) genotype-1 (TMC435-C205).

TMC435 is a protease inhibitor jointly developed by Medivir and Tibotec Pharmaceuticals, dosed as one pill once daily (q.d.) to treat hepatitis C virus infections (HCV).

In the PILLAR study, 75 mg or 150 mg TMC435 was given for either 12 weeks or 24 weeks in combination with 24 weeks of ribavirin [RBV] and pegIFNalpha-2A [pegylated interferon alpha-2a, or Pegasys], the current standard of care (SoC). Patients stopped all treatment at week 24 when HCV RNA levels at week 4 were < 25 log10 IU/mL detectable or undetectable and HCV RNA levels at week 12, week 16 and week 20 were < 25 log10 IU/mL undetectable. Patients who did not meet the above response-guided criteria continued with SOC until week 48. The results showed that in the TMC435 treatment groups 83% of patients were able to stop all therapy at Week 24.

Potent and consistent antiviral efficacy was demonstrated at 24-week end-of-treatment and in interim SVR4 and SVR12 rates with no major differences between TMC435 doses or length of triple therapy. 92% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels at week 4 and 92% at week 12 after cessation of treatment, i.e. SVR4 and SVR12. SVR4 and SVR12 data were available for 82% and 42% of the TMC435-treated patients respectively who had stopped all therapy before or at Week 24 and had completed the follow-up visits. Both the viral breakthrough rate (4.9%) and relapse rate (1.6%) were low in the TMC435 treatment groups.

TMC435 was generally safe and well tolerated with no relevant differences in adverse events (AEs) between placebo and TMC435 treatment groups. Most AEs were mild to moderate in severity and the discontinuation rate due to AEs was low and not different from placebo.

When looking at particular adverse events of interest, the incidence of rash, pruritis, GI side effects and anemia were similar in TMC435 groups and placebo and were generally mild to moderate in nature. Use of erythropoetin-stimulating agents (ESAs) was not allowed during the trial.

In laboratory parameters, there were no clinically relevant differences between any TMC435 groups and placebo except for mild bilirubin elevations. Significant decreases in transaminases (ALT and AST) were observed in all treatment groups.

Further safety and efficacy data will be presented at future scientific meetings later in 2010.

"We are extremely encouraged and excited by the efficacy and safety demonstrating that TMC435 is truly a second-generation HCV protease inhibitor," stated Bertil Samuelsson, CSO of Medivir. "We also are looking forward to the top-line data coming up from the phase 2b trial C206 (ASPIRE) in treatment-experienced patients later this year as well as start of phase 3 clinical trials in treatment-naive patients early next year."

Frequency of Undetectable* HCV RNA Levels During and After Treatment
Treatment week TMC12
PR24 TMC2
PR24 TMC1
PR24 TMC2
PR24 SoC
75mg q.d. 75mg q.d. 150mg q.d. 150mg q.d.
N (%) N=78 N=75 N=77 N=79 N=77
Week 24, EoT*** 67/73 (92%) 65/67 (97%) 68/74 (92%) 73/78 (94%) 4/18 (22%)**
Follow-up at Week 4 and Week 12 after EoT
SVR4 59/65 (91%) 56/60 (93%) 57/61 (93%) 63/68 (93%) NA****
SVR12 32/33 (97%) 27/29 (93%) 32/36 (89%) 29/32 (91%) NA
* < 25 log10 IU/mL undetectable
** End of treatment
***EoT: End of Treatment
****Patients in the control arm continue SoC till Week 48 and SVR data are not available
q.d.: once daily; PR: pegylated interferon alpha-2a and ribavirin; SVR4: undetectable HCV RNA at EoT & undetectable HCV RNA 4 weeks after planned EoT; SVR12: undetectable HCV RNA at EoT & undetectable HCV RNA 12 weeks after planned EoT

About TMC435 clinical trial programs

TMC435 is a protease inhibitor jointly developed by Medivir and Tibotec Pharmaceuticals to treat hepatitis C virus infections (HCV).

TMC435 is currently being developed in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. Safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2010.

TMC435-C205 is a global phase 2b study in 386 genotype-1 treatment-naive patients. It is a once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.

TMC435-C215 is a Japan phase 2b study in 92 genotype-1 treatment-naive patients. It is a once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.

TMC435-C206 is a global phase 2b study in 463 genotype-1 treatment-experienced patients. It is a once daily treatment of TMC435 in with different doses of given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.

For more information on Medivir, please see the company website: www.medivir.se.

8/24/10

Source
Medivir. Medivir Announces Phase 2b 24-week Interim Results of TMC435 in Treatment-naïve Patients Chronically Infected with Genotype-1 Hepatitis C Virus. Press release. July 12, 2010.

Tom Hardy and Sadie Frost launch film competition with Steel Mill Pictures and Hepatitis C Trust (no replies)

Denise — Sun, 29 Aug 2010 03:38:46 -0700

A national short film competition has been launched by actor Tom Hardy and Sadie Frost in partnership with Steel Mill Pictures and The Hepatitis C Trust, to challenge current misconceptions of hepatitis C.

A national short film competition launches today in partnership with Steel Mill Pictures and The Hepatitis C Trust. Students and graduates are invited to submit a film concept to Chooselife@virgohealth.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it , that challenges current misconceptions of hepatitis C, and ensures it is recognised as a national health priority by policy makers and healthcare professionals. The deadline for submission is 17 September 2010.

Hepatitis C, which damages the liver, may affect as many as half a million people in the UK [1] although 80% of people with the condition are unaware that they have it.[2] It is often thought that hepatitis C is only an issue amongst drug users, who contract the virus through unsterilised needle sharing. In fact, there are many more ways the virus can be passed on including:[3]

· The use of unsterilised tattoo, piercing or barber equipment

· Sharing of razors or toothbrushes with an infected person

· Sharing rolled banknotes or straws to snort drugs such as cocaine

· Blood transfusions prior to 1991 when screening was introduced

· Receiving medical/dental treatment abroad

The competition called Choose Life is supported by funding from Roche Products Ltd and aims to uncover the best in up-and-coming British film talent whilst helping to make hepatitis C a national health priority. The judging panel includes actor Tom Hardy, Sadie Frost, Charles Gore (CEO of The Hepatitis C Trust), Mat Whitecross (Director of the 2010 award-winning film, Sex & Drugs & Rock & Roll starring Andy Serkis), Paul Andrew Williams (2007 BAFTA nominee for ‘London to Brighton’) and Jo Sweby (E1 Entertainment, distributors of The Twilight Saga). The winning team will receive mentoring and production support to make their film from Steel Mill’s critically acclaimed writer director Paul Andrew Williams.

Paul Andrew Williams comments: “The Choose Life competition provides students with an exciting opportunity to get involved in a worthwhile and challenging project whilst providing a platform to showcase their work to film industry professionals. Film is a great way to make hard-hitting health messages accessible and relevant to the public, and we are looking forward to mentoring and working with new film making talent.”

Charles Gore, Chief Executive of The Hepatitis C Trust said, “Hepatitis C awareness and diagnosis is astoundingly low in the UK, even though it is a cancer-causing virus. There are many people living with this life-threatening disease who do not even know it. Furthermore, many people don't know that hepatitis C can actually be treated and the virus completely eradicated. The aim of this competition is to bring hepatitis C to the forefront of people’s minds, to help improve awareness and make it a national health priority, so people that think they may be at risk get tested and treated.”

Early diagnosis and treatment of Hepatitis C is important to help reduce the risk of disease progression, [2] including cirrhosis, liver disease, and liver failure which can lead to death.[4]

Show your support for the campaign and share the competition with friends on Facebook www.facebook.com/chooselifefilmcomp

For more information or to request an interview contact:

Katy Mortimer or Kam Pearce

Tel: 020 8939 2450

Katy.Mortimer@virgohealth.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it or Kam.Pearce@virgohealth.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it

:jester "Quote Of The Day" (no replies)

T-Man — Sun, 29 Aug 2010 01:59:26 -0700

:jester Out!!!