November 02, 2006

Telaprevir Monotherapy Induces Rapid Resistance

BOSTON, Nov. 1 -- Apparently telaprevir (VX-950) needed a little help to be effective against hepatitis C virus.

Drug-resistant viral strains developed rapidly when exposed to telaprevir, the investigational protease inhibitor against HCV, but both wild-type virus and mutants were controlled by follow-on therapy with interferon and Rebetol, researchers reported here.


Action Points

* Explain to patients who ask about telaprevir/VX-950 monotherapy that as with therapy for HIV/AIDS, antiviral drugs used alone often promote the rapid development of drug-resistant viral strains. This study shows that for patients treated with an investigational protease inhibitor against hepatitis C, follow-on with interferon and Rebetol (ribavirin) helped to suppress both wild-type and drug-resistant viral clones.

* These studies were published as abstracts and presented orally and as a poster at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.

In a phase Ib trial of telaprevir, also known as VX-950, drug resistant viral strains cropped up in six of eights patients within two weeks of starting on monotherapy with the protease inhibitor.

But both these new strains and wild-type virus were significantly suppressed when the patients received follow-on combination of Pegasys (pegylated interferon α-2a) and Rebetol (ribavirin), reported Tara Kieffer, Ph.D., of Vertex Pharmaceuticals. and colleagues, at the American Association for the Study of Liver Diseases meeting here.

The findings suggest that as with protease inhibitors for HIV infection, protease inhibitors against HCV are likely to be used as just one element in a cocktail of therapies aimed at knocking down virus while preventing the development of drug-resistant virus.

"In all patients, we have observed that telaprevir has demonstrated a rapid and profound reduction in HCV RNA," said Dr. Keefer. "In a subset of patients dosed with telaprevir alone we did see a clinical breakthrough associated with resistant variants. However, these variants were suppressed in all patients after they began interferon and ribavirin follow-on therapy."

No clinical breakthroughs were seen in patients who were initiated on telaprevir and interferon, including those in whom resistant variants were detected using a sensitive detection method, she noted.

The investigators used a highly sensitive sequencing assay to detect minor populations of viral variants (≥ 5%) in 14 patients. They isolated plasma HCV RNA was isolated at days four, eight, 12, and 14 during dosing, and at days seven and 10 after the end of the dosing phase. The NS3 protease domain cDNA targeted by telaprevir was amplified by nested polymerase chain reaction, cloned and sequenced with a lower limit of detection of 100 IU/mL. Sequence changes were analyzed from about 75 clones per patient per time point.

They found that in patients initially dosed with telaprevir/Pegasys, wild-type virus was detected at day four. On day eight, either wild-type or resistant virus was seen on in four of eight patients with HCV RNA levels above the lower limit of detection. All eight of these patients began standard therapy with Pegasys/Rebetol and their HCV RNA levels were undetectable three months after the 14-day study period, the authors reported.

All eight patients had undetectable HCV RNA at 24 weeks of follow-on treatment. Six of these patients stopped therapy at 24 weeks, and five of the six had undetectable HCV RNA at 12 weeks post-treatment. Two of the six eventually resumed follow-on therapy out to 48 weeks.

Only one of four patients initially treated with Pegasys alone had undetectable RNA at 12 weeks, while three of four had no discernible RNA at 24 weeks.

In a separate study presented in a poster session, Maribel Rodriguez-Torres, M.D., of the Fundacion de Investigacion de Diego in Puerto Rico reported on the status of 12 patients who were originally enrolled in a 28-day trial of telaprevir, Pegasys, and Rebetol.

At the end of 24 weeks of follow-on with Pegasys/Rebetol, eight patients who were continuing on the follow-on treatment had undetectable HCV RNA. These patients continue to receive the drugs out to 36 weeks of follow-on therapy.

One patient stopped treatment at week 18 and had no detectable HCV RNA six weeks after stopping therapy.

Two other patients had detectable HCV RNA and stopped treatment at week 24 of follow-on therapy. In these patients, viral sequencing analyses at week 24 showed predominantly wild-type virus, with a minority population of R155K variants also detected.

The remaining patient had undetectable HCV RNA at week 12, but had been lost to follow-up by week 18 of follow-on therapy, Dr. Rodriguez-Torres reported.

Dr. Kieffer is an employee of Vertex and owns company stock. Dr. Rodriguez-Torres receives grant support from the company.

November 01, 2006

Vertex presents mixed results in hepatitis C drug

30th October 2006
By Victoria Harrison

Vertex has presented mixed results from its phase Ib trial of its hepatitis C drug, saying that some patients still had the virus when combined with ribavirin.

The study examined Vertex's investigational hepatitis C virus protease inhibitor, telaprevir in combination with pegylated interferon (peg-IFN) with or without ribavirin.

The hepatitis C virus was suppressed in patients when pegylated interferon was added to telaprevir in the phase Ib clinical study.

When the follow on combination therapy of ribavirin was administered subsequent to telaprevir dosing some patients continued to show signs of the hepatitis C virus.

Clinical investigators said that some of these patients have stopped therapy, and that a proportion of them continued to have undetectable hepatitis C after stopping therapy.

When taken without ribavirin, the treatment alleviated both wild-type hepatitis C virus and resistant variants.

Vertex Pharmaceuticals is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

October 10, 2006

Vertex: A Promising Hep-C Play

Standard & Poor says the pharma company's VX-950 could not only become part of a new standard hepatitis C treatment, but also alter the treatment "paradigm"

The World Health Organization estimates that as many as 170 million people are infected with the hepatitis C virus (HCV) and that an additional 3 million to 4 million are infected each year. The American Association for the Study of Liver Disease has estimated that about 3.4 million people in the U.S. are infected with HCV and that 10,000 to 12,000 Americans die of the disease each year.

Based on preliminary clinical trial results, we believe that Vertex Pharmaceuticals' VX-950 protease inhibitor could become part of a new standard of care for the treatment of hepatitis C, and capture a large portion of an estimated $5 billion worldwide market. Additionally, we think VX-950 may have the potential to greatly improve patient compliance and may create a new paradigm in the treatment of HCV viral infection.

In our opinion, investor confidence would be boosted should forthcoming data remain positive. In turn, we think the share price would move higher. The stock carries Standard & Poor's highest investment recommendation, 5 STARS (strong buy). Vertex is a biotech company and, therefore, carries a relatively high degree of risk. We also note VX-950 is still several years away from Food & Drug Administration (FDA) approval.

"FAST TRACK" STATUS. Founded in 1989, Vertex Pharmaceuticals is a biotechnology company that is focused on discovering, developing, and commercializing small molecule drugs for the treatment of a variety of diseases. The company utilizes a drug design approach that integrates biology, biophysics, chemistry, and automation and information technologies throughout the research process, which the company believes makes the discovery process more efficient and productive. The company has an extensive pipeline of drug candidates targeting a broad array of diseases and several important industry partnerships.

Vertex's principal focus is on its VX-950 oral hepatitis protease inhibitor for the treatment of chronic hepatitis C viral infections. VX-950 is designed to inhibit NS3-4A serine protease, an enzyme needed for HCV replication. The FDA has granted "Fast-Track" designation to VX-950, because HCV infection is an unmet, life-threatening disease. VX-950 has partnered with Janssen Pharmaceutica, a Johnson & Johnson (JNJ: Strong Buy: $65) company.

The current standard of care for HCV infection is a combination of pegylated interferon and ribavirin, administered for up to 48 weeks. The regimen has significant side effects, however, including fatigue, flu-like symptoms, depression, and anemia, and most patients drop out of before completing the full course of treatment. As a result, even though HCV is a curable illness, only about 3% of diagnosed patients are actually cured. We believe there is a large market opportunity for a new drug if it can reduce treatment time and/or reduce or eliminate the side effects associated with the current standard of care.

POSITIVE TRIALS. In early 2006, Vertex reported preliminary results from a 28-day, Phase II trial of VX-950 in combination with pegylated interferon and ribavirin, which included 12 treatment-naive (i.e., not previously treated) patients infected with genotype 1 HCV (the most common type of infection in the U.S.). In the study, patients received VX-950 every eight hours for 28 days, in combination with standard pegylated interferon and ribavirin. Following the VX-950 dosing (after 28 days), all 12 patients showed undetectable viral load, with no treatment discontinuations, no serious adverse events, and no evidence of viral breakthrough.

In the second quarter of 2006, Vertex initiated the PROVE 1 (260 treatment-naive patients dosed with VX-950 compared with standard care in the U.S.) and PROVE 2 (320 patients in the EU) trials. The PROVE 1 trial is fully enrolled, and the company expects to release 12-week safety data for 80 patients by the mid- to late fourth quarter 2006. We believe that, based on prior safety data already presented, the odds favor a positive result from this trial. We think further positive results will have a favorable impact on the shares.

In the first quarter of 2007, the company expects to release three-month sustained viral response (SVR) data, which will measure the viral load 12 weeks after 12 weeks of treatment is stopped. In our view, this will be the key data for VX-950, as preliminary SVR is considered indicative of longer-term sustained response.


By mid-2007, Vertex expects to have 12-week treatment data for 180 patients and some follow-up data that it will use to design the Phase III trials. In all, the company believes that more than 1,000 patients will be enrolled in clinical trials by mid-2007.

DEVELOPMENT PIPELINE. Turning to the company's other compounds under development, VX-702 is its oral p38 MAP kinase inhibitor for the treatment of rheumatoid arthritis. Vertex is conducting a Phase II program to assess the efficacy of the drug, while its partner, Kissei Pharmaceuticals, is conducting a Phase I trial in Japan. Preliminary results from the first trial supported a second Phase II trial, which is expected to begin in late 2006.

VX-770 is an oral CFTR potentiator for the treatment of cystic fibrosis. It is a small molecule compound that targets the cystic fibrosis transmembrane regulator (CFTR) protein that is defective in patients with cystic fibrosis. The company expects to complete a proof-of-concept trial in 2007. VX-770 is being developed in conjunction with Cystic Fibrosis Therapeutics.

The company is collaborating with Merck (MRK: Buy; $37) in the development of VX-680, an aurora kinase inhibitor for the treatment of cancer. Vertex believes that VX-680 could be a "backbone" therapy as well as monotherapy in certain cancers. Anecdotal data recently published showed positive results in chronic myeloid leukemia (CML) and acute myelogenous leukemia (AML) patients who had failed standard treatment. Merck is conducting three Phase I trails of VX-680 in hematologic cancers and solid tumors.

The company also has an agreement with GlaxoSmithKline (GSK: Buy, $54) covering the development of HIV protease inhibitors. GSK currently pays Vertex a royalty on sales of Agenerase, Lexiva, and Telzir and will pay additional development milestones for the development of other candidates, including brecanavir.

FOCUSED ON R&D. Vertex receives royalties on several products marketed by its partners, but the company is still primarily engaged in research and development. In 2006, we expect Vertex to receive about $38 million in product royalties and approximately $171 million in collaborative R&D revenues and milestone payments, for total revenues of around $209 million. R&D should constitute the bulk of the company's expenses, coming in at approximately $385 million for the year. We see Vertex generating a net loss of about $239 million, or $2.14 per share for 2006. Our net loss per share forecast for 2007 is $1.88.

The company is well funded. At the end of June, 2006, the company had about $316 million in cash and marketable securities on hand. In addition, in July, Vertex received a payment of $165 million from Janssen Pharmaceutica for the development and commercialization of VX-950. Lastly, the company completed an offering of 9.1 million shares on Sept. 20, which netted an additional $281 million. Given the company's current cash burn rate, we believe that Vertex has sufficient funds for at least the next two years of operation.

We estimate peak potential sales for VX-950 in the U.S. at about $2.5 billion under the assumption that VX-950 becomes part of standard of care for HCV treatment. We derive this estimate by assigning a 25% premium to projected sales of current treatments PEG-INTRON (Schering-Plough: SGP: Buy; $22) and PEGASYS (Roche), which had combined 2005 sales of about $1.9 billion. We believe such a premium will be justified if VX-950 can produce SVR levels that are higher than those elicited by current regiments, and/or shorten duration of therapy. We estimate the global market potential for VX-950 at about $5 billion.

PROFIT PROJECTION. We see the company's first year of profitability in 2010. In that year, we expect U.S. sales of $600 million for the HCV treatment. We think total Vertex revenues could exceed $800 million in 2010, and that Vertex will report net income of $349 million and EPS of $2.88 per share.

To arrive at our 12-month target price of $42, we employ net present value analysis. We are assuming that VX-950 is launched in late 2008, and that sales reach about $1.6 billion in 2012. For 2012, we forecast that Vertex will earn $4.91 per share. We assigned a p-e multiple of 25 times to our 2012 EPS estimate and discounted this result by a 20% rate for five years. We believe a 20% discount is appropriate, given the high degree of risk inherent in the shares.


We view Vertex Pharmaceuticals' corporate-governance practices as generally sound. We view the following factors favorably. The board is controlled by a supermajority (greater than 75%) of independent outsiders, and the nominating and compensation committees are comprised solely of independent outside directors. Also, the company has a committee that oversees governance issues, a board-approved CEO succession plan is in place, and a simple majority of shareholders is required to approve a merger.

BIOTECH RISK. On the negative side, the company has a poison pill in place, and its auditors were not re-elected at the most recent annual meeting in March.

Risks to our recommendation and target price include any delay in the development timeline for VX-950, the possibility that VX-950 fails to gain FDA approval due to a lack of efficacy in larger clinical trials or other adverse developments, or any combination of these issues. Other risks include new competition in the HCV treatment market, possible need for additional financing to fund the development pipeline, and lower-than-expected sales for the company's current and prospective product candidates.

Lastly, Vertex is a biotech company and, therefore, carries a relatively high degree of risk. We also note VX-950 is still several years away from FDA approval. Additionally, while we view results from the small, preliminary clinical trial favorably, we note that outcomes from the subsequent larger trials could vary, given larger patient populations.

September 30, 2006

HCV RNA detected by TMA

Hepatitis C virus RNA can be detected by PCR-based test

Health & Medicine Week - Oct. 02, 2006

A study from the United States has reported that hepatitis C virus (HCV) RNA was detected by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial.

"For making treatment decisions related to chronic hepatitis C, the utility of HCV RNA tests with increased sensitivity has not been defined," wrote C. Morishima and colleagues, University of Washington.

"Prior interferon nonresponders with advanced fibrosis (n=1,145) were retreated with peginterferon alpha-2a and ribavirin. Patients who were HCV RNA-negative by a polymerase chain reaction (PCR)-based assay (Roche COBAS Amplicor HCV Test, v. 2.0; lower limit of detection [LOD] 100 IU/mL) at week 20 (W20) received treatment for 48 weeks.

"Stored specimens were tested using the Bayer VERSANT HCV RNA Qualitative (TMA) Assay (LOD 9.6 IU/mL) and compared to PCR results for the ability to predict sustained virological response (SVR, defined as undetectable HCV RNA by PCR at W72)," the investigators explained.

"Nearly all PCR-positive samples (1006/1007, 99.9%) were positive as assessed by TMA. Among 1,294 PCR-negative samples, 22% were TMA-positive. Negative TMA results were more predictive of SVR than were negative PCR results at W12 (82% vs. 64%, p<.001) and at W20 (66% vs. 52%, p=.001). SVR was more likely the earlier TMA had become negative during treatment (82% at W12, 44% at W20, 20% at W24). "Among 45 patients who were TMA-positive but were PCR-negative at W20 and W24, none achieved SVR (95% CI: 0%-8%). Approximately 10% of patients with a single positive TMA result at the end of treatment still achieved SVR," the researchers observed. The authors concluded, "Negative TMA results at or after W12 were superior to negative PCR results for predicting SVR. In patients with negative PCR results during treatment, a single positive TMA test did not exclude SVR, although persistently positive tests did."

Morishima and colleagues published the results of their research in Hepatology (HCV RNA detection by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial. Hepatology, 2006;44(2):360-367). For additional information, contact C. Morishima, University of Washington, Department of Laboratory Medicine, Box 359690, Seattle, WA 98104, USA. The publisher of the journal Hepatology can be contacted at: John Wiley & Sons Inc., 111 River St., Hoboken, NJ 07030, USA.

September 22, 2006

Positive data for hepatitis C DNA vaccine

Tripep reports positive data for hepatitis C DNA vaccine using Inovio's DNA delivery system

Inovio Biomedical Corporation (INO) announced that its partner, Tripep AB, Sweden, has reported added positive preclinical results showing its ChronVac-C DNA vaccine using Inovio's MedPulser DNA delivery system produced a strong immune response against hepatitis C virus (HCV) in a large animal model.

Ongoing toxicity studies of ChronVac-C delivered using Inovio's electroporation-based system showed that the combination induces a humoral response in rabbits that is comparable to results previously observed in mice.

Hepatitis is a disease characterized by inflammation of the liver. Hepatitis C virus (HCV) is a major cause of acute hepatitis. HCV is spread primarily by direct contact with human blood, the major causes worldwide being the use of unscreened blood transfusions, and re-use of needles and syringes that have not been adequately sterilized. As many as 70-90% of newly infected patients may progress to develop chronic infection (WHO: 2002). Of those with chronic liver disease, 5-20% may develop cirrhosis. About 5% of infected persons may die from the consequences of long term infection (due to liver cancer or cirrhosis).

Globally, an estimated 170 million people are chronically infected with HCV, which represents a reservoir sufficiently large for HCV to persist, and 3 to 4 million persons are newly infected each year. In the U.S., while new incidences of HCV have dropped dramatically, an estimated 4.1 million (1.6%) Americans have been infected with HCV, of whom 3.2 million are chronically infected (U.S. Centers for Disease Control and Prevention: 2006).

ChronVac-C is designed to be a therapeutic DNA vaccine that can stimulate the body's immune system. Animal experiments have demonstrated that ChronVac-C vaccination activates B cells and T-cells, the latter being regarded as the most significant to clearing the chronic infection relating to hepatitis C, that killed cells producing HCV protein. In humans, the ChronVac-C DNA plasmid would be injected into muscle tissue, where vaccinations are usually given, and taken up by muscle cells with the assistance of Inovio's electroporation-based DNA delivery system. These muscle cells would be expected to then produce predetermined proteins that may activate the body's immune system to attack all cells producing HCV proteins.

Tripep AB is a Swedish biotechnology research company that develops and commercialises candidate drugs based on patented and proprietary technologies. Its main focuses are research and clinical development of ChronVac-C.

Inovio Biomedical Corporation is a late stage biomedical company focused on commercializing its proprietary Selective Electrochemical Tumor Ablation (SECTA) therapy, which is a local treatment for solid tumors, with selective killing of cancer cells while preserving surrounding healthy tissue.

September 14, 2006

Hepatitis C Virus Genome Cloned

Near Full-Length Hepatitis C Virus Genome Cloned from Clinical Samples

Gene Therapy Weekly - Sep. 14, 2006

Sept. 14, 2006 - (NewsRx.com) -- A study from the United States has reported that near full-length hepatitis C virus (HCV) genome can be cloned from clinical samples.

"Long RT-PCR (LRP) amplification of RNA templates is sometimes difficult compared to long PCR of DNA templates. Among RNA templates, HCV represents an excellent example to challenge the potential of LRP technology due to its extensive secondary structures and its difficulty to be readily cultured in vitro," wrote X.F. Fan and colleagues, St. Louis University.

"The only source for viral genome amplification is clinical samples in which HCV is usually present at low titers. We have created a comprehensive optimization protocol that allows robust amplification of a 9.1 kb fragment of HCV, followed by efficient cloning into a novel vector. Detailed analyses indicate the lack of potential LRP-mediated recombination and the preservation of viral diversity," the authors reported.

The researchers concluded, "Thus, our LRP protocol could be applied for the amplification of other difficult RNA templates and may facilitate RNA virus research such as linked viral mutations and reverse genetics."

Fan and colleagues published their study in Biochemical and Biophysical Research Communications (Efficient amplification and cloning of near full-length hepatitis C virus genome from clinical samples. Biochem Biophys Res Commun, 2006;346(4):1163-1172).

For more information, contact X.F. Fan, St. Louis University, School of Medicine, Division of Gastroenterology & Hepatology, Center Liver, Department of Internal Medicine, St. Louis, MO 63110, USA.

Publisher contact information for the journal Biochemical and Biophysical Research Communications is: Academic Press Inc. Elsevier Science, 525 B St., Ste. 1900, San Diego, CA 92101-4495, USA.

September 13, 2006

Pot helps cure hepatitis C


By jrichman@angnewspapers.com

Medical marijuana users are more likely to finish hepatitis C treatment and so are more likely to be cured, according to a newly published study conducted in San Francisco and Oakland.

Other studies have shown marijuana relieves symptoms, but medical marijuana advocates said this could be the first to show improved cure rates for a life-threatening illness.

The study is by researchers at the University of California, San Francisco, and the Oakland-based Organization to Achieve Solutions in Substance Abuse (OASIS). It was published in the European Journal of Gastroenterology and Hepatology. It found marijuana users being treated for HCV three times more likely to have a "sustained virological response," meaning the virus can't be detected six months after treatment ends.

HCV treatment with ribavirin and interferon causes severe side effects, so many patients quit the long regimen too early.

Of 71 HCV patients studied, 21 finished with a sustained virological response: 12 of the 22 cannabis users and nine of the 49 nonusers.

"Modest cannabis use may offer symptomatic and virological benefit to some patients... by helping them maintain adherence to the challenging medication regimen," the study concluded.

Rob Kampia, executive director of the Marijuana Policy Project in Washington, D.C., issued a news release touting this as "a landmark study, showing that medical marijuana can literally save lives. Every day that our government continues punishing the sick for using this medicine is literally a crime against humanity."




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Additional Info:

Sometimes the disease remains at a point where it can be managed by lifestyle changes rather than medication — and that means giving up alcohol.

"Alcohol and hep C are a witches brew," said Dr. Rick Permutt, a gastroenterologist in Santa Rosa who developed its hepatitis C clinic 10 years ago. "It fuels the fire. Those who have hep C and are drinking go to complications sooner. You already have this disease insulting your liver, why add something more?"

September 06, 2006

T Cell-based Hepatitis C Vaccines

New Perspectives for T Cell-based Hepatitis C Vaccines Are the Focus of Review

Vaccine Weekly - Aug. 30, 2006

Aug. 30, 2006--(NewsRx.com) -- A researcher reviews new perspectives for T-cell-based hepatitis C vaccines in a recent issue of the Journal of Hepatology.

According to the review, "Three percent of the world's population is chronically infected with the hepatitis C virus (HCV) and at risk of developing liver cancer. Effective cellular immune responses are deemed essential for spontaneous resolution of acute hepatitis C and long-term protection. Here, we describe a new T-cell HCV genetic vaccine capable of protecting chimpanzees from acute hepatitis induced by challenge with heterologous virus."

"Suppression of acute viremia in vaccinated chimpanzees occurred as a result of massive expansion of peripheral and intrahepatic HCV-specific CD8+ T lymphocytes that cross-reacted with vaccine and virus epitopes," said Carlo Ferrari at the University of Parma.

"These findings show that it is possible to elicit effective immunity against heterologous HCV strains by stimulating only the cellular arm of the immune system, and suggest a path for new immunotherapy against highly variable human pathogens like HCV, HIV, or malaria, which can evade humoral responses," stated the author.

Ferrari published the review in the Journal of Hepatology (New perspectives for T-cell-based HCV vaccines. J Hepatol, 2006;45(1):163-165).

For more information, contact Carlo Ferrari, Division of Infectious Diseases and Hepatology, Azienda Ospedaliero-Universitaria di Parma, I-43100 Parma, Italy. E-mail: cafer@tin.it.

Publisher contact information for the Journal of Hepatology is: Elsevier Science BV, PO Box 211, 1000 AE Amsterdam, The Netherlands.

Keywords: Parma, Italy, Hepatitis C Vaccine, Vaccine Development, Vaccine Efficacy, Hepatitis C Virus, Hepatology, Immunology, Immunotherapy, Liver Cancer Vaccine, Oncology, Virology.

August 22, 2006

Phynova's PYN17 granted UK Patent

Botanical Hepatitis C treatment PYN17

LONDON (AFX) - Phynova Group PLC, which develops Western pharmaceuticals based on Chinese medicines, said it has received its first UK patent for PYN17, a botanical drug for the treatment of Hepatitis C.

PYN17 contains extracts of four plants that reduce liver inflammation, improves hepatic function and stimulates the immune system. It is designed to treat the symptoms of chronic hepatitis C viral infections.

There are no adequate treatments currently available to manage these disease symptoms. The global market for the treatment of Hepatitis C is estimated to be worth 9 bln usd by 2010.

Phynova is planning to have a multi-centred Phase IIb clinical trial underway in the US in early 2007.

Phynova currently has three other patent applications pending, PYN22, an anti-obesity product, PYN18, an antiviral for the treatment of Hepatitis C and PYN5c, a treatment for SARS.

August 13, 2006

HCV - Facts and Myths

HEPATITIS C – FACTS & MYTHS

Facts: In order to contract hepatitis C you must have blood-to-blood contact with a person who has hepatitis C.

Contact may have happened by:

  • Sharing needles and/or other “works” used to mix, cook or shoot drugs
  • Sharing straws for snorting drugs
  • Receiving blood, blood products, or solid organs
  • Being on long-term kidney dialysis, without knowing you may have shared supplies / equipment
  • Working at a job where you have a lot of contact with blood
  • Being born to a mother who had hepatitis C at the time of your birth
  • Having sex with an infected person without using a condom
  • Living with someone who was infected and sharing items such as razors and toothbrushes



Myths: Hepatitis C is spread by:

Casual contact: shaking or holding hands, skin-to-skin contact, sneezing, hugging, coughing

Sharing silverware or drinking glasses, or through food or water
WHAT SHOULD I LOOK FOR?

  • Always tired *
  • Mental confusion or foggy feeling *
  • Lack of concentration, attention / focus *
  • Eating problems *
  • Depression (feeling sad and hopeless) *
  • On-and-off nausea and vomiting *
  • Stomach pain and swelling *
  • Loss of appetite *
  • Mood swings
  • Night sweats
  • Flu-like illness
  • Muscle and joint pain
  • Jaundice (yellowing of the skin and whites of the eyes)
* Most common signs / symptoms


Always Keep in Mind
  • Don’t share needles, syringes, water, cotton or cookers for shooting drugs, medication or vitamins
  • Don’t share straws for snorting drugs
  • Don’t share toothbrushes, razors, or other personal care products
  • Make sure any tattoos or piercings are done by licensed professionals using sterile equipment and using clean latex gloves each time
  • Limit sexual activity to one partner
  • Use latex condoms every time you have vaginal, anal, or oral sex

August 10, 2006

New hope for Hepatitis C research

The mystery surrounding Hepatitis C, a disease that affects millions of people worldwide, is one step closer to being solved.

In a paper published in the August edition of Journal of Virology, scientists describe how they replicated, or reproduced the hepatitis C virus (HCV) in mouse cells. Working with different models, they showed a gene called protein kinase R (PKR) blocked the replication of HCV in mice.

"When a person becomes infected with HCV, the immune system produces a protein called interferon to fight the infection," said co-author and Director of the Monash Institute of Medical Research, Professor Bryan Williams.

"We now know genes interferon stimulates PKR to try to stop the virus spreading throughout the body."

HCV replicates at a very high rate – approximately one trillion viral particles are produced each day in an infected person. Professor Williams' research will provide a better understanding of how this replication occurs and how and why PKR blocks the production of the virus.

Hepatitis C affects 210,000 Australians. Worldwide, it is estimated more than 170 million people suffer from the disease. The virus attacks the liver, causing flu-like symptoms, fevers, abdominal pain, depression, and for two-thirds of patients, chronic liver disease.

The discovery may also shed light on why some hepatitis C patients respond better to treatment than others.

"As there is no vaccine or cure for HCV, the only treatment on offer for patients is interferon therapy, which aims to slow the progression of the disease. However, there are six different genotypes, or strains of HCV, which all react differently to treatment," Professor Williams said.

"We can now explore why some strains are more sensitive to interferon therapy, and how we can adapt treatment to the different strains of the disease."

"Our research is still in the early stages, but the research model we have created will be a valuable tool in understanding the underlying mechanisms of chronic HCV infection, and how the virus responds to interferon treatment" said Professor Williams.

###

Research collaborators were the Monash Institute of Medical Research, the Department of Microbiology, Immunology and Molecular Genetics, University of Kentucky College of Medicine, Kentucky, USA and the Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, USA.

A full copy of the research paper is available at: http://jvi.asm.org/current.dtl#VIRUS_CELL_INTERACTIONS
1. Hepatitis C Council of Victoria: http://www.hepcvic.org.au

More information / interview opportunities:
Contact Julie Jacobs
Public Relations Manager:
(+61 3) 9594 7109
0408 135 256.

July 28, 2006

HCV and Serum Proteome

Hepatitis C virologic response predicted using serum proteome

A study from France has reported on the use of the serum proteome to predict virologic response in patients with hepatitis C treated by pegylated interferon plus ribavirin.

"Surface-enhanced laser desorption ionization time-of-flight mass spectrometry is a proteomic technique that enables the global profiling of proteins. We used this approach to monitor the kinetics of serum proteome in patients with chronic hepatitis C virus infection receiving a standard bitherapy regimen to predict treatment response," wrote V. Paradis and colleagues, Department of Pathology.

They explained. "Ninety-six patients with chronic hepatitis C were retrospectively selected. All patients received complete treatment with pegylated interferon in combination with ribavirin. Patients had serum sampling before starting treatment and at the end of treatment. Results were validated in an independent cohort of 5:1 patients."

"Comparison of protein profiles in pretreatment and after-treatment serum allowed us to characterize 50 protein peaks, the level of which significantly varied. In the group of patients with sustained virologic response, 37 peaks displayed significant variation during treatment, whereas only one peak differed in nonresponders.

"A logistic regression analysis allowed us to define an algorithm composed of 2 protein peaks (fibrosis stage and genotype) that correctly predicted, in pretreatment serum, response to treatment in 89% of all patients with an area under the receiver operating characteristic curve of 0.92," the investigators wrote.

"In the independent testing group, the same difference in proteome kinetics was observed between sustained responders and nonresponders. The algorithm correctly predicted treatment response in 81% of patients in the testing group," the scientists observed.

They concluded, "This study suggests that the kinetics of proteome are significantly different in serum of patients according to treatment response. Serum protein profiling allows prediction of response to antiviral treatment in a significant proportion of patients."

Paradis and colleagues published their study in Gastroenterology (Serum proteome to predict virologic response in patients with hepatitis C treated by pegylated interferon plus ribavirin. Gastroenterology, 2006;130(7):2189-2197).

For more information, contact V. Paradis, Department of Pathology, Clichy, France.

Publisher contact information for the journal Gastroenterology is: W B Saunders Co-Elsevier Inc., Independence Square West Curtis Center, Ste. 300, Philadelphia, PA 19106-3399, USA.

July 08, 2006

Cholesterol drugs may treat hepatitis C

WASHINGTON (Reuters) - Cholesterol drugs called statins may help treat hepatitis C infections, Japanese researchers reported on Friday.

Tests in lab dishes suggest that some statin drugs may help stop the hepatitis C virus from replicating, they wrote in the journal Hepatology, published by the American Association for the Study of Liver Diseases.

An estimated 170 million people worldwide are infected with the hepatitis C virus. The standard treatment is a combination therapy of interferon and ribavirin but it only helps about 55 percent of patients.

The rest risk progression to cirrhosis and liver cancer.

Masanori Ikeda of Okayama University in Japan and colleagues tested several statin drugs against the virus in lab dishes.

All the drugs except pravastatin interfered with the virus to some degree. Fluvastatin, sold by Novartis under the name Lescol, had the strongest effect, they reported.

It may be that certain proteins are required for the hepatitis C virus to replicate and that some statins block the action of these proteins, the researchers said.

They tested the statins along with interferon, and found each worked even better when combined with the second drug.

"We clearly demonstrated that co-treatment of interferon and fluvastatin was an overwhelmingly effective treatment," the researchers wrote.

Statins -- which include Pfizer Inc.'s $10 billion-a-year Lipitor, Bristol-Myers Squibb Co.'s Pravachol and Merck and Co. Inc.'s Zocor -- are the world's best-selling drugs, taken by millions to reduce the risk of heart attack.

But they appear to affect many biological processes. An expert proposed last month that they may affect influenza viruses, including bird flu, and other research has shown they reduce the risk of cataracts.

Generic statins are available in many countries and have become increasingly inexpensive.


-----------------


Ed's Opinion:
When would the world start thinking about defeating the virus and not the profits of these big corporations? If it needs a revolution - let us get ready for it.

Human are a surplus commodity in today's world. 170 million HCV patients are all customers...


July 07, 2006

Goodbye Ribavirin?

OKAYAMA, Japan (UPI) -- Japanese scientists say they`ve found statins, typically used as anti-cholesterol medications, can inhibit the replication of the hepatitis C virus.

The findings mean statins might be able to replace ribavirin in combination therapy with interferon. There are 170 million people worldwide infected with HCV.

The standard HCV treatment is a combination therapy of interferon and ribavirin, which is effective in about 55 percent of patients. The remaining 45 percent face a threat of the disease progressing to cirrhosis and liver cancer.

Aware of recent studies showing one statin, lovastatin, inhibits HCV replication, researchers led by Masanori Ikeda of Okayama University tested other statins in search of a more effective anti-HCV therapy.

They evaluated the anti-HCV activities of five statins: atorvastatin, fluvastatin, lovastatin, pravastatin and simvastatin. When the statins were tested alone, all except pravastatin inhibited HCV replication, with fluvastatin having the strongest effect; atorvastatin and simvastatin had moderate effects and lovastatin had a weak effect.

The findings are reported in the July issue of the journal Hepatology.

June 22, 2006

Graphic hepatitis C ads raise ethical qualms

By John Sullivan
Inquirer Staff Writer

As the head of liver transplantation at Thomas Jefferson University Hospital, Victor J. Navarro has seen many ailing patients with hepatitis C. But they don't look like the man in a half-page, color newspaper ad with a battered and bruised face, his eyes glassy.

"If Hep C was attacking your face instead of your liver, you'd do something about it," the ad reads. "Ready to fight back?"

While Navarro and other experts applaud the ads for raising interest in the viral disease, they think the campaign by drugmaker Hoffmann-La Roche Inc. could cause unnecessary alarm, in part because the vast majority of hepatitis C patients will not die of it.

"It's a marketing tool to make people fearful of hep C," Navarro said.

Roche's drugs, which are improvements over past medications, also work on only half of all patients, and cause considerable side effects. The campaign could leave those who cannot benefit believing they will wind up like the man in the ad.

The ad also is part of a larger marketing effort by Roche to quietly sponsor hep C seminars for the public and support patient groups and many liver physicians. Ethicists say the financing raises questions about whether the advice at such seminars can be objective.

Roche spokesman Mike Nelson said the company was simply trying to get out the word about the disease so more people can be helped. Nelson says nearly 600,000 hepatitis C patients have been diagnosed but haven't been treated, and may not know about the company's current market-leading options: Pegasys (interferon and an antiviral substance) and Copegus (an antiviral).

Nelson also said the ad was meant to be strong "to break through the clutter."

Roche said nearly 56 million people had seen the ad as of April, and more would see the ad in the coming weeks, part of a national blitz Roche launched last year in 250 newspapers, including The Inquirer and Philadelphia Daily News, and seven major magazines, such as Time. The ads also are plastered on 4,000 billboards and in 40,000 posters.

Roche officials would not disclose the cost of the campaign, which will run through July, but such large newspaper ads cost as much as $50,000 a day.

Leonard B. Seeff, who oversees hepatitis research at the National Institutes of Health, originally thought the ad came from an advocacy group.

"I think the ad is awful. Patients with hepatitis C do not look like that," said Seeff, who has been working on a study partly funded by Roche. "On the other hand, if you're trying to get the message across, one way is to make it look bad."

Seeff, who said his opinion did not reflect that of the NIH, said that he also was concerned because only a few people will die from hepatitis C.

"They mostly die from all kinds of things other than chronic liver disease," he said. "They should not think it's a death sentence."

Some doctors and advocates see a strong profit motive behind the campaign. "Ultimately it sells more of their drug," said Sidney M. Wolfe, director of Public Citizen's Health Research Group.

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said it was not good policy for the United States to rely on companies to sponsor public-health campaigns. Such efforts tend to go to diseases for which companies have developed drugs, while other needy areas are ignored, he said.

Hepatitis C is a viral liver ailment that is the most common chronic blood-borne disease in the country.

The National Institutes of Health estimates that about four million people have hepatitis C in the United States. That number is expected to double in the coming decade as more people learn they are infected.

Many people got the disease from having received tainted blood or organs before adequate tests were developed in 1992. Most new cases are caused by intravenous drug use. A few contract the disease through high-risk sexual behavior, according to the Centers for Disease Control and Prevention.

Most people don't know they've been infected because the disease often doesn't cause symptoms for decades. The only way to confirm a diagnosis is to take a sample of the liver and examine it for scarring.

Only a fraction of those infected - from 1 percent to 5 percent - die of the disease. Yet it remains the No. 1 cause of liver transplants.

About 70 percent to 80 percent of those with the liver disease suffer from a stubborn genetic variant called genotype 1 that resists treatment.

The cocktail of antiviral drugs works in only 30 percent to 40 percent of those cases, and even less often in African Americans, according to the World Health Organization.

For the remaining 20 percent to 30 percent who have genotype 2 or 3, treatment works about 80 percent of the time. Averaging the two groups means that treatment only works in half the cases. Roche claims higher success rates.

While most insurance covers the therapy, uninsured patients must weigh that success rate against the cost, which can run up to $64,000 per year for some genotypes. The drugs are given several times a week, from 24 weeks to 48 weeks.

Still, hepatitis drug sales and advertising have been brisk. Over the last five years, drug company spending to advertise interferon, including Roche's drugs, has jumped from $14 million to $75 million. For Roche's Pegasys, ad spending rose from $30,000 in 2004 to more than $965,000 last year, according to Yardley, Pa.-based Verispan, which tracks pharmaceutical marketing.

The push has paid off. The company sold $1.4 billion worth of hepatitis C drugs, making it a top seller for the firm, according to its 2005 annual report.

Some hepatitis C activists, including those supported by the company, say the ads may seek to take advantage of a small window of opportunity. Roche now controls more than 60 percent of the hepatitis-therapy market, but that could change as other companies win approval for new antiviral treatments due out in coming years.

"We have been advising most people that they should probably wait for the next class of drugs," said Michael Ninburg, president of the National hepatitis C Advocacy Council, who heads the hepatitis Education Project in Seattle, which gets funding from Roche.

Also recommending that are HepTREC, a hepatitis education and support group started by Amy Jessop and a doctor and nurse at Temple University. Roche gave the group more than $250,000 in its first two years.

"I wish that there was public funding that we could turn to," said Jessop, who taught public health at Temple. "But the reality is there is no funding."

Earlier this year, about 15 people sat in a dimly lit auditorium at Graduate Hospital in Center City to hear a lecture on hepatitis C. Jessop told the group that Roche was a sponsor. She never promoted Roche products.

In the crowd sat Marc B. Saxe, a 46-year-old drug counselor from Philadelphia, who was diagnosed with hep C in 1998.

Saxe says he was "freaked out" by the diagnosis and went untreated until last year, about the time the Roche ad first appeared. It has worked, he said.

"I thought it was disgusting," he said of the ad. "But if it gets people to think about it, great."

"I just want to get fixed."

Hepatitis C At a Glance

About 3.9 million Americans are chronically infected with hepatitis C.

Prevalence rates are up to 8 percent to 10 percent of African Americans.

Dialysis patients, hemophiliacs, drug addicts and people transfused with blood before 1990 are particularly affected by the disease.

Injectable drug use remains the main route of transmission.

Sexual transmission is thought to be relatively infrequent.

Of every 100 people infected with hepatitis C:

About 55 to 85 people may develop long-term infection.

70 people might develop chronic liver disease.

5 to 20 people may develop cirrhosis over a period of 20 to 30 years.

1 to 5 people might die from the consequences of liver cancer or cirrhosis.

SOURCES: World Health Organization and the Centers for Disease Control and Prevention

Vertex verges on big time

But hepatitis drug faces competition and some investors wary of stock
By Stephen Heuser, Globe Staff | June 21, 2006

Earlier this year, Joshua Boger , chief executive of Vertex Pharmaceuticals Inc. , stood before several hundred scouts from the country's top mutual funds and drug companies and delivered a piece of news that could make his 17-year-old Cambridge biotech firm profitable for the first time.

An experimental Vertex pill, he said, had dramatic effects in a group of eight patients with hepatitis C, a virus that infects millions of Americans and can lie dormant for years before destroying the liver.

``It's a tremendous responsibility to live up to a molecule like VX-950," Boger told the crowd at the JP Morgan Healthcare Conference . In the shorthand of biotechnology, he meant that he had a drug on his hands that wouldn't just make large amounts of money, but would change society.

In the audience, an investor leaned over to a reporter and whispered: ``He certainly doesn't lack for confidence."

Since news of Vertex's hepatitis drug emerged last year, this company known for its expert chemistry has found itself among the highest fliers in the biotechnology world, soaring from less than $1 billion in market value in early 2005 to nearly $5 billion in March. Yesterday, value had slipped back to about $3.4 billion, after shares closed at $31.18.

Vertex now plans to test its drug in hundreds more people and hopes to file for federal approval in 2008 . If the drug works as well in the larger trial, analysts project it could bring in as much as $2 billion to $3 billion annually -- making it a global blockbuster and vaulting Vertex out of its research-driven niche into a prominent new role carrying the banner for the idea that new science can turn into real profits.

``There's a lot of excitement about Vertex's drug, and rightly so," said Dr. Nezam Afdhal , a liver specialist at Beth Israel Deaconess Medical Center in Boston who helps run one of the company's clinical trials.

But Vertex faces sharp competition from some of the biggest drug makers in the world, who are racing to develop their own hepatitis C treatments. And some investors are eyeing Vertex's stock price warily and asking: Haven't we seen this before?

Hatched in 1989 to exploit the new analytical tools that chemists and biologists were starting to master, Vertex -- like many biotechnology companies -- has survived years of red ink on the promise of a future payday. The company attracted early investors with stories of how its smarter, faster approach to attacking diseases would lead to a rapid flurry of new drug applications. The company was even the subject of a book, ``The Billion-Dollar Molecule," which highlighted the relentless scientific salesmanship of its founder, Boger. Buoyed by a bull market and a biotech boom, its price crested near $100 a share in 2000.

But by 2003, with no significant drugs on the market, its share price had dropped by a factor of 10. The ``billion-dollar molecule," a potential immune-suppressive drug, never materialized. The company has racked up more than $1 billion in losses, and its hepatitis pill won't come to market till 2009 at the earliest.

``I think there are a number of investors who've been burned in the past on Vertex shares, and that's going to make some investors nervous," said stock analyst Joshua Schimmer of Cowen & Co.

Vertex kept itself afloat, however, with a series of science deals with big pharmaceutical companies, helping to defray $200 million in annual research spending, and through a pair of timely debt financings in 2000 that added almost $500 million to its bank account.

Today, the value of the company hangs on its next set of trials for the hepatitis treatment, simultaneous human tests in the United States and Europe. As many as 1,000 people with hepatitis will get the drug, and results are expected to emerge later this year .

Meanwhile, Vertex is hiring as fast as any company in Cambridge, planning to grow from about 800 employees at the end of last year to 1,000 by the end of this year. It hires a car fleet to shuttle employees from its Cambridgeport campus to a big chunk of newly occupied lab space in Kendall Square. And in anticipation of a major launch of a product, it has even hired the former marketing manager of Lipitor, the best-selling drug in the world.

It may sound unlikely that an eight-patient test could drive billions in stock-market growth, but that's the nature of the biotechnology industry, in which investors bet not on a company's earnings, but on its potential. One big success can turn a company from a perennial also-ran into a global name.

``I like the idea that Joshua and the management team are really swinging for the fences," said Craig Millian, the former Lipitor marketer who arrived from Pfizer in January.

The hepatitis C virus has emerged in the past few years as a top new target for drug makers. Identified in 1989, it infects people through blood contamination -- injectable drug use and transfusion are the most common means -- and can lurk undetected for years before its liver damage is discovered by a doctor. There is no vaccine.

``When you think about organs you can do without, we still haven't found a way to reproduce the function of the liver," said Raymond Chung , the director of hepatology at Massachusetts General Hospital. ``If you're out of liver, you're pretty much out."

Currently, the disease is treated with a year's worth of injected interferon, which boosts the immune system enough to help about half of those treated with it to clear the virus on their own. It costs $18,000 and has unpleasant side effects, which doctors describe as a terrible flu that can trigger anemia, mood swings, and depression as therapy drags on.

Vertex's pill, by contrast, takes a leaf out of the playbook that was developed to fight HIV: It shuts down a protease, a key enzyme the virus needs to infect the body. Without the protease, the hepatitis C virus can't make the set of protein tools it needs to reproduce itself and hijack other cells.

In the test results disclosed in January, the drug appeared extremely effective in knocking the virus below detectable levels when used in combination with interferon. (If patients' viral levels stay undetectable for long enough, they are considered cured.) In four of eight patients who took Vertex's pill late last year, the hepatitis virus was undetectable within two weeks.

If it shows similar results in the longer trial, it could open the door to a treatment that helps more people, and takes less time, than the current therapy.

It could also open the door to huge growth for whichever drug company gets a product to market first. Global drug giant Schering-Plough is also testing a protease inhibitor, although Vertex's appears to be ahead in effectiveness. Behind them, several other companies have similar drugs in the pipeline, including Bristol-Myers Squibb Co.

It's uncertain whether Vertex's larger trials will replicate impressive early results. Drug resistance and side effects can always crop up in larger and longer trials; an earlier protease inhibitor was pulled by a German drug company after heart problems showed up in animal tests.

But analysts believe that the first company to bring a drug to market will have a chance to set the price -- up to $30,000 for a course of treatment -- and claim a big share of the estimated 8 million patients in the United States and Europe.

``There are obviously no guarantees in drug development, said Schimmer, but Vertex has ``never had a drug that shows such efficacy before. Few companies have."

Vertex does have other products in the pipeline, including a possible pill for rheumatoid arthritis, a cancer treatment being developed with Merck, and a cystic fibrosis pill. But for now it is the hepatitis C pill that has transfixed both doctors and Wall Street.

``This is a drug that we believe is not going to launch quietly. There's going to be worldwide demand, and it's a disaster if you have spectacular results but limited supply," said Boger.

In anticipation, Vertex has already contracted out large-scale manufacturing of the pill, and promises to have produced two tons by the end of the year.

Boger said he is pleased at the prospect that the company he founded could turn the corner to profitability around the time it turns 20.

``To me it's not a surprise that we're 17 years old and in this position," he said. ``That's about how long I thought it would take."

Stephen Heuser can be reached at sheuser@globe.com.



June 20, 2006

Treatment of Acute Hepatitis C

By Liz Highleyman

Past studies have shown that treatment of acute hepatitis C virus (HCV) infection is highly successful; a German study published in 2001, for example, found a sustained virological response (SVR) rate of 98% using conventional interferon monotherapy (Jaeckl 2001). However, many individuals with acute infection will clear HCV spontaneously, so if therapy is started too soon, there is a risk of treating patients who don't need it.

In the May 2006 issue of Hepatology, researchers reported on a study looking at the optimal duration of treatment for acute hepatitis C. The study initially evaluated 161 patients, of whom 30 refused treatment and 29 experienced spontaneous HCV clearance. The remaining 102 patients with persistent HCV were randomly assigned to 1.5 mcg weekly pegylated interferon alpha-2b (Peg-Intron) monotherapy for 8, 12, or 24 weeks.

Results

Using an intent-to-treat analysis, 67.6% patients who received treatment for 8 weeks achieved SVR; the rate was 82.4% after 12 weeks and 91.2% after 24 weeks.

All patients had undetectable HCV RNA 48 weeks after the end of therapy.

Treatment for 8 or 12 weeks was effective for patients with HCV genotypes 2, 3, or 4, but those with genotype 1 required 24 weeks.

Fewer adverse events were observed in patients receiving treatment for 8 or 12 weeks, compared with the 24-week group.

Conclusion

The authors concluded that pegylated interferon monotherapy "effectively induces high sustained virologic response rates in patients with acute hepatitis C virus infection, thus preventing development of chronic hepatitis C." They suggested that treatment duration should be further optimized based on genotype and rapid virological response at week 4.

Treating Acute HCV in Prison

The Hepatology study, and another recent study of HIV/HCV coinfected patients reported in the May 12, 2006 issue of AIDS, demonstrate that treatment of acute hepatitis C can be effective. However, many people with acute HCV infection do not experience symptoms, and most cases of hepatitis C are not identified at this stage.

A study reported in the June 15 issue of Clinical Infectious Diseases suggests that prisons and drug detoxification and treatment center may be appropriate settings for detecting and treating acute HCV infection among injection drug users.

In this study, on-site medical providers at prisons and detox facilities were educated about risk factors for and symptoms of hepatitis, and asked to refer all potential cases to a specialty clinic.

Results

During 30 months of observation, 21 individuals were diagnosed with acute hepatitis C, 3 with hepatitis B, and 1 with hepatitis A.

Of the 21 patients with acute hepatitis C, 19 were identified in prison shortly after incarceration.

Among 17 hepatitis C patients who received follow-up (for a mean 6.3 months), 8 experienced spontaneous HCV clearance.

5 patients with persistent HCV were treated with pegylated interferon monotherapy; 2 of these (40%) achieved SVR.

All patients agreed to receive HIV counseling and testing, as well as immunization against hepatitis A and B.

Conclusion

The authors concluded that, "Incarceration presents a unique opportunity to identify injection drug users with acute HCV infection, to initiate counseling regarding other blood-borne pathogens, and to facilitate immunizations and HCV treatment."

6/20/06

References

SM Kamal, KN Moustafa, J Chen, and others. Duration of peginterferon therapy in acute hepatitis C: a randomized trial. Hepatology. 43(5): 923-931. May 2006.

BH McGovern, A Wurcel, AY Kim, and others. Acute hepatitis C virus infection in incarcerated injection drug users. Clin Infect Dis. 42(12): 1663-1670. June 15, 2006.

E Jaeckel, M Cornberg, H. Wedemeyer, and others. Treatment of acute hepatitis C with interferon Alfa-2b. New England J Med. 345: 1452-1457. November 15, 2001.

Source: http://www.hivandhepatitis.com
Link: http://www.hivandhepatitis.com/hep_c/news/2006/062006_a.html

June 19, 2006

Hep C Stigma

In a world of profitable living, where choices are made purely based on profits alone - the life and existence of a HCV patient is of profit to the pharma/medical community.

When it comes to people outside the medical community, the fear of getting hold of this disease is way too much. Fear of an unknown virus starts with the hatred we all carry for the common flu. It is not easy to inform the common person that Hep C is only transmitted through blood...

A few months back, I read about a school teacher - who developed HCV after a student bit her. That is a very scary prospect, and one can understand the apprehensions of other people.

Social awareness of the disease (No one is at ease with any disease) is the first step in fighting this virus. I believe HCV carriers must reveal the info about their disease to their close relatives, especially the spouse/partner.

There is no point giving the virus to another person.

If children of HCV patients are asked to move out of a school, that's when we know the society has completely failed. The virus would have then succeeded not only in destroying the liver of a person but also the soul of a society.

The compulsion most HCV patients feel about keeping their health status a secret is understandable too. But, then, in the battle against this dreadful virus, a lot of good karma will help a long way.

Good karma being a lot of positive energy.

Some of the relatives and friends might distance from the HCV patient. That also gives us a good idea - who really the best friend is.

There is a certain reality - that the virus resides inside - which cannot be conveniently forgotten.

After almost six months of researching, I am yet to understand what the medical community is doing about HCV. If we have 170 Million people infected with this virus, and if the numbers are increasing... it is time to act - NOW.

Ayurveda has very effective treatment for rejuvenating liver. The roots of Henna has been used in South India as a medicine to cure liver ailments, especially severe jaundice.

More needs to be done about this, a lot more. We all need to do a lot more honest work about HCV, else this virus will be our third world war.

Japan's Hep C Crisis

First ruling near in suit over drug-caused hepatitis C debacle

By YOHEI SEKIand JUN NAGATA

OSAKA (Kyodo) Life changed drastically for Osaka resident Etsuko Morigami in 1987 when she was diagnosed with cirrhosis of the liver, some 13 years after being infected with hepatitis C through a tainted blood-clotting agent given to her while she was giving birth.

Morigami was treated with a blood-clotting product to stop her bleeding when she had her first son, Minoru, now 32.

After contracting cirrhosis, she developed diabetes and kidney damage. Insulin injections three times a day were a must.

"I often went out with my family and I was really in good shape," Morigami, 56, said of the time before the symptoms became severe, looking at the more than 10 kinds of drugs on a table beside her.

Considering her condition, treatment of hepatitis C with interferon, which eliminates the virus but whose side effects are severe, was halted. She developed liver cancer, and a long tube was inserted into her side to kill cancer cells with ethanol.

But she had relapses, with the intervals becoming shorter and shorter. Eventually she had no other option than a partial liver transplant, and Minoru was the donor.

"As you were infected when I was born, I will repay my debt to you," he told her.

Morigami underwent the transplant last June. To prevent rejection, she took an immuno-suppression drug, and to avoid infectious diseases she could not leave home, except to go to the hospital.

But her new liver gradually deteriorated, and the interferon treatments were resumed in February, now that there are more drugs available to control its side effects. Although she has also been diagnosed with lung cancer, it is inoperable.

"There is a time bomb inside you. If it explodes, you will blow up," a group of lawyers said in a statement aimed at trying to explain the plight of patients, many of them unwittingly infected with hepatitis C.

Although initial symptoms may not be critical, the hepatitis will eventually lead to cirrhosis and liver cancer.

"Swift measures should be taken before it is too late," said Morigami, one of the plaintiffs in a damages lawsuit against the government and Mitsubishi Pharma Corp.

Mitsubishi Pharma is the successor of Green Cross Corp., the firm that produced the blood product that caused her hepatitis C infection. The blood product was marketed under the brand name Fibrinogen-BBank.

The Osaka District Court will rule on the suit Wednesday in the first legal judgment involving tainted blood products leading to hepatitis C infections.

Besides the physical effects of hepatitis C, patients face discrimination often born out of ignorance and fear.

At a gathering in Tokyo's political center of Nagata-cho in late May, plaintiffs complained of discrimination and prejudice against them by employers and other sectors of society.

"I may not be employed if I tell (my employer) I am suffering from hepatitis C," a man in his 20s, one of the plaintiffs in a lawsuit filed with the Tokyo District Court, said.

A woman said, "I am hiding my disease because I fear that my children's friends' parents may tell them not to play with my kids."

Hepatitis C is caused mostly by direct infection of the blood and is not transmitted by ordinary social contact, but at the gathering many patients complained of the agony of not being able to tell people they have the disease.

Some reported having been refused dental treatment, and one woman was fired from her job in a company cafeteria. Management told her the disease was infectious.

Since the end of World War II, Japan has suffered several drug-induced disasters, including the childbirth deformities caused by thalidomide in the 1950s and '60s, SMON (a disease similar to polio), another disease caused by defective chloroquine in the 1950s, and the HIV/AIDS outbreak caused by contaminated blood products -- also marketed by Green Cross -- in the 1980s.

"The suffering can be said to be on a historically large scale, but the real situation is not well-known in society," said Kiyohiko Katahira, a professor of health and welfare at Toyo University.

Regarded as the largest of these drug-induced diseases is SMON, caused by the antiflatulence drug chinoform in the 1950s and 1960s, which affected some 10,000 people.

According to Mitsubishi Pharma, the number of patients since 1980 infected with hepatitis C as a result of taking the tainted blood product based on the naturally occurring protein fibrinogen is estimated at 10,000.

But as the product had been sold since its approval by the government in 1964, Katahira said, "The number of victims will be about 30,000 if the average annual number of victims before 1979 is assumed to be the same," making it much larger than the SMON disaster.

There is more than one similarity between this case and the HIV/AIDS fiasco, in which a doctor and a high-ranking official at the old Health and Welfare Ministry were prosecuted for allowing tainted products to stay on the market after being officially warned of their dangers. Victims in both cases have been plagued by discrimination and prejudice, and are waging lawsuits without revealing their real names.

In the case of hepatitis C, only 10 of the 96 plaintiffs across the country have made their real names public.

There are also many other victims who cannot become plaintiffs even if they wanted to, because their medical records have been lost and their link to tainted blood products cannot be proved.

Fibrinogen is a globulin in the blood that aids coagulation, and products containing it were widely used by obstetricians, gynecologists and surgeons. But the U.S. government canceled its approval for such blood products in 1977 because there was a danger that the products, made from donated blood, could be infected.

Despite that, 50,000 to 70,000 packages of the Green Cross product were sold annually between 1980 and 1986. When an epidemic of liver inflammation-infection cases erupted in Aomori Prefecture in 1987 and similar reports continued, Green Cross began to recall the product.

Although the government began to study ways to strengthen the medical examination and treatment system, Norio Hayashi, a professor at the graduate school of Osaka University, said the system is not satisfactory. "Hepatitis C patients are estimated to number 1.5 million in Japan, but there are only some 3,000 liver-specialist doctors," he said.

HCV treatment efficacy can be predicted

New findings in hepatitis C virus described from Canada, Sweden and Austria

Hepatitis Weekly - Jun. 19, 2006


2006 JUN 19 - (NewsRx.com) -- Data on hepatitis C virus are outlined in reports from Canada, Sweden and Austria.

Study 1:
According to scientists from Canada, hepatitis C virus treatment efficacy can be predicted.

"In the past, antiviral therapy has been given to 15% to 30% of patients infected with hepatitis C virus (HCV). The efficacy of therapy has recently improved with the addition of ribavirin and pegylated interferon. The aim of the present study was to identify the clinical, socioeconomic and health-system predictors of antiviral treatment for HCV," wrote M. Witkos and colleagues, University of Toronto. "A retrospective analysis of compensation claims data of patients who acquired HCV through blood transfusions between 1986 and 1990 was performed. The patients consisted of 2456 Canadian HCV-positive individuals."

The researchers wrote, "The authors reviewed narrative comments from physicians, and constructed univariate and multivariate logistic regression models, using receipt of antiviral therapy with interferon or interferon/ribavirin as the primary outcome. Of the 2456 patients, approximately 30% appeared to be eligible, but only 16% received treatment.

"Univariate analyses suggested that the disease severity, age, HIV status and province of residence were associated with the likelihood of receiving treatment (p<.01). The final, multivariable model indicated that in patients with HCV. Intermediate disease severity (eg, fibrosis, p<.0001); middle age (p<.0001); HIV-negative status (p<.0001); and province of residence (Quebec, p<.0001; and Saskatchewan, p<.0001) were independent predictors of treatment."

"Narrative comments of physicians emphasized the importance of age, HIV status and patient preferences in clinical decision-making. Given the efficacy and cost-effectiveness of current antiviral therapy, treatment rates of HCV patients may be suboptimal," reported the authors.

They concluded, "Further work is required to understand barriers to treatment related to geography, organization of medical care, age, medical provider and patient preferences."

Witkos and colleagues published their study in Canadian Journal of Gastroenterology (Predictors of antiviral therapy in a post-transfusion cohort of hepatitis C patients. Can J Gastroenterol, 2006;20(2):107-111).

For additional information, contact M.D. Krahn, University of Toronto, Toronto General Hospital, Department of Health Policy Management & Evaluation, 200 Elizabeth St., EN 14-207, Toronto, ON M5G 2C4, Canada.

Study 2:
According to recent research from Sweden, translation efficiency correlates with therapy outcome in chronic hepatitis C virus (HCV) infection.

"Combination therapy with interferon-alpha (IFN-alpha) and ribavirin (RBV) in chronic hepatitis C demonstrates the best responses against HCV of genotype 3. Still, it has proven to be ineffective in 20-30% of patients infected with this genotype.

"In the present study," wrote A. Yasmeen and colleagues, Karolinska Institute, "we analyzed the translation efficiency mediated by the internal ribosome entry site (IRES) region in HCV genotype 3 genomes isolated from sustained responders (SR) and non-responders (NR), assuming that this may influence the outcome of treatment."

The authors reported, "Pretreatment isolates of genotype 3 from 22 individuals (15 SR, seven NR) were selected for such analyses. The IRES region [nucleotide (nt) 1-407] was cloned into a dual luciferase vector and IRES activity assessed following transfection into various cell lines.

"Low relative translation efficiency was observed for IRES elements derived from SR patients, whereas those of NR patients showed significantly greater translation efficiency (29.7±13 vs 69.4±22; p<.01). Subsequently, the effect of IFN-alpha plus RBV on IRES-driven translation in vitro was determined. A greater suppressive effect was observed on IRES activity isolated from seven SR patients, when compared with seven NR patients."

"IRES efficiency in vitro correlated with treatment response for HCV genotype 3. Further studies are warranted to investigate whether IRES efficiency in vitro, or sequence motifs associated with IRES efficiency, will be worthwhile to explore as prognostic tools for other HCV genotypes in the treatment of chronic HCV infection," the investigators concluded.

Yasmeen and colleagues published their study in the Journal of Viral Hepatitis (Correlation between translation efficiency and outcome of combination therapy in chronic hepatitis C genotype 3. J Viral Hepat, 2006;13(2):87-95).

For additional information, contact M.A.A. Persson, Karolinska Institute, Center of Molecular Medicine, Karolinska Hospital, Department of Medicine, S-17176 Stockholm, Sweden.

Study 3:
According to recent research from Austria, interferon therapy is promising in treatment of chronic hepatitis C.

"Combination anti-viral therapy achieves a sustained virological response (defined as HCV-RNA negativity 6 months after the end of therapy) of 56% of patients with chronic hepatitis C. Little is known about long-term durability of HCV-RNA negativity in patients treated with pegylated interferon."

E. Formann and colleagues, Medical University of Vienna, wrote that the study was done "to evaluate the durability of virologic response in patients with sustained virological response to anti-viral therapy treated at our center."

"A total of 187 sustained virological responses (50% genotype 1, 42% genotype 2 or 3 and 8% genotype 4; 20% with cirrhosis) with a follow-up of >12 months post-therapy were studied. Twelve patients received monotherapy with interferon-alpha2a or -2b. One hundred and seventy-five received combination therapy with ribavirin and standard interferon-alpha (n=73) or pegylated interferon-alpha2a or 2b (n=102)."

"Qualitative serum HCV-RNA was tested by COBAS AMPLICOR HCV test, v2.0. Median follow-up time was 29 months (range 12-172)," explained the authors.

"Recurrence of HCV infection was not observed in any of the 187 sustained virological responders. Ala aminotransferase values were normal in 90% and two patients showed minimal elevation of alpha-fetoprotein levels. No recurrence of HCV infection was seen in any patient."

"Thus," concluded the researchers, "longterm prognosis in chronic hepatitis C patients with a sustained virological response to therapy with pegylated interferon ± ribavirin is promising, but long-term studies need to continue."

Formann and colleagues published their study in Alimentary Pharmacology & Therapeutics (Long-term follow-up of chronic hepatitis C patients with sustained virological response to various forms of interferon-based anti-viral therapy. Aliment Pharmacol Ther, 2006;23(4):507-511).

For additional information, contact P. Ferenci, Department of Internal Medicine IV, Gastroenterology and Hepatology, Medical University of Vienna, Austria, Vienna, Austria.

Sexual Transmission of Hepatitis C

Mike Youle, MBBS

We have spent the last 21 years fighting an emerging epidemic of HIV across the globe with a modicum of success, at least on the treatment front. Highly active antiretroviral therapy (HAART) has now allowed us some breathing room in which to develop better therapies and to address prevention issues that have been rather less successfully tackled in most countries. We have been slow to realize that hepatitis C virus (HCV) represents our next challenge; in fact, surveillance systems are not properly in place in most countries. In the United Kingdom there are an estimated 300,000 HCV cases, over 90% of which are as yet undiagnosed, in comparison to approximately 33,500 people living with HIV, about 30% of whom are undiagnosed. The significance of sexual transmission in the HCV epidemic has been a matter of controversy,[1] although there is some evidence that it may be an important method of acquisition, at least among men who have sex with men (MSM).[2]

In a study from a large UK hospital, Browne and colleagues[3] presented circumstantial evidence that sexual transmission is responsible for an increasing incidence of HCV in HIV-infected individuals. Cases of HCV were identified among individuals with a previously negative HCV antibody result who attended sexual health services between 1997 and 2002. The number of these HCV seroconverters increased from zero during 1997 to 10 during the first half of 2002. A total of 23 cases were seen, of whom only 1 was female, and 21 of these were known to be HIV-infected, including 2 who seroconverted to both viruses concurrently. Although 4 subjects gave a classic history of injection-drug use and needle sharing, 19 did not; these were all MSM, 15 of whom reported recent unsafe sex. Eight subjects in this cohort developed syphilis temporarily associated with HCV seroconversion.

Further details were presented on the 21 subjects known to be coinfected with HIV and HCV. All of the HIV-infected individuals diagnosed with HCV were identified by screening for HCV RNA among those with abnormal liver function, using stored blood samples to try to identify the date of acquisition. Routine antibody tests were also performed which were initially negative, and the median time from detection of HCV RNA to HCV antibody positivity was 4 months (range, 3.0-9.5 months). The rate of diagnosis of HCV among HIV-infected subjects found to have elevated liver function tests increased during the study period from 10.7% to 40%, a statistically significant change (P = .035, Chi-squared test). Among this population of HIV-infected patients with elevated liver function tests, the rate of diagnosis of HCV in 2002 was 5.1 cases per 1000 patient-years (95% confidence interval [CI], 2.2-10.1), which appeared to be significantly higher than the rate in 1997 (0 cases per 1000 patient-years; 95% CI, 0-1.2). This would suggest that the HCV infection burden within the HIV-infected population increased during the study period.

This study raises a concern that the use of HCV antibody tests alone may not be sufficient to identify individuals who acquire HCV with only sexual risk factors or even in low incidence areas, potentially delaying the diagnosis of active infection and thus increasing the risk of onward transmission. The use of stored blood to retrospectively identify HCV seroconversion allows for an accurate identification of time of infection in epidemiologic studies, and further work addressing sexual acquisition is required to identify more clearly the risk factors for transmission as well as the outcomes of these infections. From a public health perspective, more aggressive surveillance studies should be performed, and health promotion messages need to be developed to educate those at risk.

References

  1. Bernard EJ. Sexual transmission of hep C. In: AIDS Treatment Update.
    London: NAM Publications. September 2002; Issue 117. Available at: http://www.aidsmap.com/publications/atu/atu117.pdf Accessed December 16, 2002.
  2. Craib KJP, Sherlock CH, Hogg RS, O'Shaughnessy MV, Schechter MT. Evidence of sexual transmission of hepatitis c virus (HCV) in a cohort of homosexual men. Program and abstracts of the 8th Conference on Retroviruses and Opportunistic Infections; February 4-8, 2001; Chicago, Illinois. Abstract 561.
  3. Browne R, Asboe D, Gilleece Y, et al. Increased incidence of HIV-positive individuals with acute hepatitis C due to sexual transmission: a new epidemic? Program and abstracts of the Sixth International Congress on Drug Therapy in HIV Infection; November 17-21, 2002; Glasgow, Scotland. Abstract P283.

June 16, 2006

Herbal solution underway

Herbal solution undergoes Phase II clinical trial for hepatitis C

World Disease Weekly - Jun. 20, 2006

Chronic hepatitis C is associated with significant morbidity (liver cirrhosis and hepatocellular carcinoma) and mortality.

Current treatment is based on interferon and ribavirin. However, treatment options are limited for patients who are not candidates for interferon-based therapy, particularly for those who suffer from HCV genotype 1 infection.

Sho-saiko-to (SST), a standardized herbal formula, is under a clinical phase II trial by a leading New York cancer research institute to determine its effect on hepatitis C patients. The research group reported the preliminary results of 15 patients at the 2nd Society of Integrative Oncology Conference in San Diego on November 10, 2005. This study was titled "Sho-saiko-to for Patients with Chronic Hepatitis C Who Are Intolerant to or Have Contraindication to Interferon-Based Therapy: A Phase II Study."

SST is known to have anti-fibrotic effect by inhibition of lipid peroxidation in hepatocytes and stellate cells in animal studies. It has also been shown to reduce aminotransferase levels and the incidence of hepatocellular carcinoma in hepatitis and liver cirrhosis patients.

According to the design of the clinical trial, 31 patients will receive SST daily for 52 weeks. Fifteen patients have completed the treatment and the preliminary results have been reported. No serious adverse events have been attributed to SST among any patients who enrolled in the trial. Among the 15 patients who completed the study, reductions in alanine aminotransferase (ALT) were observed in 11 patients and aspartate aminotransferase (AST) in 10 patients. In 10 patients, the liver biopsy showed 20% improvement on histological assessment of the liver.

This is consistent with the findings by the Japanese researchers for its anti-inflammatory effect. More interestingly, the majority of the patients whom participated in the clinical trial were genotype 1 infection.

In Japan, over 75% of physicians use at least some of the traditional herbal formulas. Over 1.5 million Japanese patients with hepatitis have been treated with Sho-saiko-to. SST is available in capsules through HepCare Inc., a Phoenix-based company that has licensed the marketing right of SST from Honso Pharmaceutical Co. Ltd., the Nagoya-based Japanese manufacturer of the standardized herbal formula.

This article was prepared by World Disease Weekly editors from staff and other reports. Copyright 2006, World Disease Weekly via NewsRx.com.

June 13, 2006

US scientists isolate liver stem cells

A stable line of human fetal liver stem cells has been isolated and characterized for the first time, U.S. scientists reported on Monday.

The liver stem cells, which have shown the ability to repopulate damaged livers in mice, could be valuable for the treatment of liver diseases in the future, said a research team at the University of Washington.

Their findings appeared in the June 12 issue of the Proceedings of the National Academy of Sciences.

The adult liver contains a reservoir of progenitor cells, which provide the organ with a high regenerative potential. But so far these cells have not been successfully isolated from human livers.

According Nelson Fausto, a professor at the University of Washington who led the study, the researchers derived for the first time progenitor cells from livers in human fetuses of 74 to 108 days.

First, they removed and maintained human fetal livers in culture. Then the researchers treated the colonies with a selective antibiotic, and mechanically isolated stem cells from the liver cells.

Like other stem cells, these liver progenitors displayed the ability for long-term self-renewal, and the capacity to differentiate into multiple cell types.

In laboratory conditions, the liver stem cells can differentiate into not only liver tissue cells (hepatocytes) and bile duct cells, but also fat, bone, and cartilage tissue cells, the researchers said.

When transplanted into mice with damaged livers, the human stem cells survived and repopulated part of the damaged tissue. "They can differentiate into functional hepatocytes in vivo, suggesting liver repopulation potential," the researchers wrote in the paper.

The liver stem cells have durable proliferative capability, according to the researchers. Even after being kept in culture for 6 months, the cells can still be induced to differentiate into functional hepatocytes and biliary duct cells in experiments.

"We anticipate that human fetus multipotent progenitor cells (liver stem cells) will be a valuable tool to study differentiation pathways in the human liver and may have important therapeutic applications in patients with liver failure," the researchers said.

They suggested that other organs, such as the pancreas and the kidney, in human fetuses may have similar stem cells.

"We are also exploring the use of this approach to isolate similar cell populations from other embryonic organs, such as the pancreas and the kidney."

Source: Xinhua

June 09, 2006

We must beat hepatitus C stigma

People at risk include those who have used intravenous drugs, shared spoons, had blood transfusion before 1991, snorted cocaine, had unprotected sex, tattoos or body piercings where non sterile equipment was used.

A man who lived with the Hepatitis C virus for 20 years without knowing it is now at the centre of a campaign to raise awareness about the illness.

Mark McKay, who lives in Newmarket Road, Norwich, was diagnosed with Hepatitis C six years ago, but has no idea how he contracted the virus.

He was horrified when, on his 45th birthday, he received a letter from the Blood Transfusion Service to say it had detected the virus after he had given blood.

Mr McKay, 51, said: “When I first read the letter I did not know too much about Hepatitis C but when I found out later that it was potentially fatal I did get a bit worried. Information is also hard to come by.”

Mr McKay is one of several people with Hepatitis C who have agreed to appear in a national campaign to try to reduce the stigma attached to the virus.

An exhibition featuring giant photographic portraits of people living with Hepatitis C will be launched in Gentleman's Walk, Norwich, from tomorrow and will stay up for two days.

It is part of the Government's new Hepatitis C Action Plan for England launched in March 2005, which aims to improve the prevention, diagnosis and treatment of Hepatitis C.

It is estimated that 200,000 people in England have chronic Hepatitis C infection but the majority are unaware of their condition which can cause serious damage to the liver.

Mr McKay, a business analyst at Norwich Union, said: “I don't have any symptoms at all, but I know there has been liver damage.

“I don't know how I got it. I used to work in operating theatres at a hospital and I may have picked it up from a needle stick injury.”

He said he had agreed to take part in the campaign because he wanted to help raise awareness of the illness.

“If you can get people to consider what they have done in the past, they might think it was worth getting tested.

“I would rather know I had it than not know because at least then I can take steps to mitigate it.”

The father-of-three said he was discussing his treatment options at present with his doctors at the N&N because the first treatment he had tried had left him with nasty side effects.

Dr Martin Phillips, consultant gastroenterologist at the Norfolk and Norwich University Hospital, said he was treating more and more patients for Hepatitis C in Norfolk but there were many others who had not been diagnosed.

“I am treating all ages men women and children, but the problem is there are often no symptom until the disease is very advanced,” he added.

People at risk include those who have used intravenous drugs, shared spoons, had blood transfusion before 1991, snorted cocaine, had unprotected sex, tattoos or body piercings where non sterile equipment was used.

But Dr Phillips said the latest treatments had a 50 to 80 per cent success rate in curing it, depending on the type.

He said people who thought they may have put themselves at risk should have a simple blood test at their GP surgery.

For more information ring the Hepatitis C Information line on (0800) 451 451 or go to www.hepc.nhs.uk

Are you campaigning to raise the profile of an illness? Call Evening News health reporter Sarah Hall on 01603 772426 or email sarah.hall2@archant.co.uk