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Week Ending: April 30th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Haemophiliacs Blocked in Bid for Secret Files
• Partial Hepatectomy for Hepatocellular Carcinoma Increases Survival
• FDA Approves Roche's Cobas AmpliScreen Hepatitis B Test for Use in Screening Blood Donors
• Hepatitis C Can Be Sexually Transmitted
• Valeant Unveils Promising Hepatitis Drug Data
• Hepatitis C Scare Halts Use of Surgical Adhesive
• Wait Twelve Weeks before Treating Acute HCV in HIV-Positive Patients
• Westport to Begin Needle Exchange
• Idenix Announces Data Presentations at the 2005 Digestive Disease Week Meeting
• Hepatitis C Alert Leaves Mum Angry and Scared
• Wrong, Pamela, There Is a Cure
• Hospital's Hep C Scare
• Hepatitis C Deal Proposed
April 24th, 2005
Haemophiliacs Blocked in Bid for Secret Files
SourceURL:http://www.sundayherald.com
By Judith Duffy, Health Correspondent
Hepatitis-infected campaigners told handing over vital documents would be "too expensive"
HAEMOPHILIACS have been refused access to secret files which they believe could reveal how they were infected with hepatitis C through contaminated NHS blood products.
Campaigners requesting the release of classified documents under freedom of information legislation have had their demand turned down on the grounds of cost.
The Department of Health has also claimed that some of the documents have been destroyed. The 600 files contain information on blood policy decisions taken by the UK government between 1972 and 1986, during which time thousands became ill.
Mike Kenwright, a haemophiliac from Cheshire, is one of the individuals infected by hepatitis C who asked for the documents.
He first made the request last year, when he was told they were part of an internal review to “clarify the facts surrounding the drive for self-sufficiency products in blood products in the UK in the 1970s and 1980s.”
The response from the Department of Health said ministers felt that it would be “prudent to wait” for the informal review to be completed before they replied.
When the Freedom of Information Act came into effect in January this year, Kenwright repeated his request for the documents using the new legislation.
He said: “The reply came back saying because it would cost more than £600, we couldn’t have them. The second reason given was that documents I asked for have probably been destroyed.”
The files have been kept secret since 1990, when the government refused to reveal their contents to patients who were suing after contracting HIV through the NHS.
According to court papers, judges who saw the documents believed that the government had a case to answer. But at a time when hundreds were dying from Aids, the judges recommended that those infected accept compensation rather than face a lengthy court battle.
Kenwright believes the files would reveal the government failed to heed warnings from the US about the dangers of using imported blood plasma products.
He said: “There is no doubt that the government was aware of the dangers, yet did nothing about it until HIV came along.
“A lot of people had been infected before that with hepatitis C, but they didn’t see hepatitis C as a danger.
“The actual time they think I was infected was not a life-threatening bleed. We weren’t allowed to make an informed decision. For most of my bleeds, I wouldn’t have touched the stuff. “
Under the Freedom of Information Act, requests for information can be rejected where the cost to central government would exceed £600.
The reply from the Department of Health states that providing information on imported plasma in the early 1970s “would fall into this category”.
It explains this is because “officials would need to undertake a lengthy examination of the files for that period and consult with external organisations who were involved in the provision of imported plasma.”
The response goes on to say: “With regards to your request for documents which were subject to a Court of Appeal Hearing on September 20, 1990 in relation to the HIV litigation, following an extensive search of our records, we do not appear to have retained the documentation.
“Given that the litigation was settled nearly 15 years ago, it would appear the documents have been destroyed.”
Campaigners have repeatedly asked for a public inquiry into what has become known as “the biggest medical treatment disaster in the history of the NHS”.
Peter Mossman, the vice chairman of the Manor House Group, which was formed by haemophiliacs infected with hepatitis C, said he was “appalled” by the failure to release the documents.
He said: “I do not believe they have been destroyed. I think it is the biggest cover-up ever. What also appalls me is that they still insist they cannot have a public inquiry ““ it is just incredible.”
Bruce Norval, a haemophiliac from Fortrose, near Inverness, who was infected with hepatitis C, described it as a “total whitewash”.
He said: “This continual process of denying us access to information just proves that there is probably a case to be answered.”
He added:”We are talking about the deaths now of more than 200 Scots.
“If this was a railway crash, we would have eventually got a public inquiry.”
Norval added that refusing to release the documents due to cost reasons was an “obscenity”. He said: “Dying of old age is becoming a rare thing in haemophilia” the diseases we are infected with are myriad.
“They are telling us that £600 is a good enough excuse to deny us access to the truth about why we are dying.”
A spokeswoman for the Department of Health said the documents being used in the internal review had not been destroyed.
But she added: “There were some documents which were asked for in the Freedom of Information request relating to the court of appeal hearing with regards to the HIV litigation.
“We don’t seem to have retained these documents, given the fact that it was 1990.”
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April 25th, 2005
Partial Hepatectomy for Hepatocellular Carcinoma Increases Survival
SourceURL:http://www.gastrohep.com/
Hepatic resection for hepatocellular carcinoma with major portal or hepatic vein invasion is associated with a median survival exceeding historical survival in patients not treated surgically, finds a study in April’s Surgery.
The role of hepatic resection in patients with hepatocellular carcinoma and invasion of a main portal or hepatic vein branch is controversial.
Dr Vauthey and colleagues evaluated the efficacy of hepatic resection and the factors affecting survival after resection in such patients.
The research team reviewed the records of 102 patients who underwent resection for hepatocellular carcinoma with major vascular invasion between 1984 and 1999.
Prognostic factors were evaluated by univariate and multivariate analysis.
The researchers included included 87 men and 15 women with a median age of 59 years.
Patients who derive long-term benefit from resection have no or minimal underlying fibrosis – Surgery
The team reported that the perioperative mortality rate was 6% and the median survival was 11 months.
The investigators found that the 1, 3, and 5 year survival rates were 45%, 17%, and 10% with the longest-living survivor still alive at 15 years.
The research team showed that absence of moderate to severe fibrosis and absence of high nuclear grade were both associated with a better 5 year survival rate of 23 % versus 5 %, and 21 % versus 9 %, respectively.
On using multivariate analysis, the team noted that moderate to severe fibrosis remained a significant predictor of survival for both short-term of 6 months and long-term of more than 6 months.
Dr Vauthey's team concludes, “Hepatic resection for hepatocellular carcinoma with major vascular invasion is associated with a median survival, exceeding historical survival in patients not treated surgically.”
“Patients with hepatocellular carcinoma and major vascular invasion who derive long-term benefit from resection have no or minimal underlying fibrosis.”
Surg 2005: 137(4): 403
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FDA Approves Roche's Cobas AmpliScreen Hepatitis B Test for Use in Screening Blood Donors
SourceURL:http://biz.yahoo.com
Press Release Source: Roche Diagnostics
- Test is first nucleic acid Hepatitis B blood screening test approved by FDA
INDIANAPOLIS, April 25 /PRNewswire/ -- Today, Roche Diagnostics announced that the United States Food and Drug Administration (FDA) approved the COBAS AmpliScreen HBV Test for use in a mini-pool format as a screening test for the detection of Hepatitis B (HBV) in donated whole blood, blood components, source plasma and other living donors. The test is the first nucleic acid test designed for screening whole blood for HBV to be approved by the FDA.
The approval follows a decisive vote in favor of licensure at an earlier Blood Products Advisory Committee of the FDA in 2004, at which time Roche Diagnostics presented results from their related five-center clinical study. Roche Diagnostics submitted a Biologics License Application (BLA) to the FDA, for the COBAS AmpliScreen HBV Test to screen plasma samples from donors of whole blood and blood components, source plasma and other living donor organ components.
"This is an important day for the blood screening community and concludes a successful effort by Roche Diagnostics, the blood centers and FDA to bring this important test to market," said Heino von Prondzynski, CEO Division Roche Diagnostics and Member of the Executive Committee. "Implementation of the COBAS AmpliScreen HBV test based on PCR (polymerase chain reaction) ensures that a highly sensitive and robust technology is being used to keep our precious blood supply safe."
In the clinical study, the COBAS AmpliScreen HBV identified two HBV "window cases" (cases within the time between infection and detection of infection by antigen tests) which may have gone undetected by currently licensed HBsAg tests. In these tests, conducted at five blood centers in the US, Roche Diagnostics evaluated 581,790 individual donations in pools of 24. In addition, Roche Diagnostics presented non-clinical study data illustrating that the COBAS AmpliScreen HBV Test reduced the window period by an average of 17 days in 40 seroconversion panels when compared to the currently implemented Hepatitis B surface antigen test. Following the conclusion of the clinical study period, three of the five centers voluntarily chose to continue using Roche Diagnostics' test under a cost-recovery IND (Investigational New Drug) protocol.
Since conclusion of the clinical trial period in 2004, three additional "window cases" out of an additional one million donated blood units were identified using the COBAS AmpliScreen HBV Test.
"Memorial Blood Centers is proud to have been one of the first three centers to use the Roche Hepatitis B blood screening nucleic acid testing assay," said Jed Gorlin, M.D., Vice President of Medical and Quality Affairs, Memorial Blood Centers, Minneapolis. "The study clearly documented the necessity to be vigilant in continuing to screen the blood supply for Hepatitis B. The current Hepatitis B surface antigen assays are very sensitive, but on rare occasions, may still miss small, but potentially infectious amounts of Hepatitis B."
About Roche Diagnostics' Blood Screening Business
Roche Diagnostics' PCR-based tests are used to screen more units of blood worldwide than any other nucleic acid tests. Roche Diagnostics' COBAS AmpliScreen Tests for the detection of HIV-1 and Hepatitis C have been approved for use in the US and abroad for screening whole blood, source plasma, and potential organ donors. The COBAS AmpliScreen HBV Test is approved for use in the EU and is currently the only HBV nucleic acid test to have been approved by the FDA. The COBAS AmpliScreen Tests are also used in other countries. Roche's AMPLINAT multiplex assay -- the first single-tube assay to test for HIV-1, Hepatitis C, and Hepatitis B in a single triplex reaction -- has been used exclusively by the Japanese Red Cross (JRC) since 1999 to screen 100% of Japan's blood supply. In 2004, the JRC renewed their agreement with Roche Diagnostics for a four year period. Roche Diagnostics' TaqScreen West Nile Virus Test, the first in North America to fully automate the extraction, amplification, and detection steps of PCR, is currently in clinical trials in the US and Canada. Roche Diagnostics is also actively engaged in developing next-generation instrument systems and assays to further integrate and automate the blood screening process.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totaled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
For further information, please visit our websites http://www.roche.com and http://www.roche-diagnostics.com
For more information contact:
Lori LeRoy
Roche Diagnostics
317-521-7159
lori.leroy@roche.com
Source: Roche Diagnostics
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Hepatitis C Can Be Sexually Transmitted
SourceURL:http://au.health.yahoo.com
NEW YORK (Reuters Health) - The virus that causes hepatitis C (HCV) can be sexually transmitted and the risk is directly related to the frequency of intercourse, the findings from a new study suggest. However, the association does not seem to be very strong.
Contact with infected blood is the main route by which HCV is transmitted, lead author Dr. Veysel Tahan, from Marmara University in Istanbul, Turkey, and colleagues note. However, in up to 50 percent of cases, a transmission route is never identified.
Researchers have hypothesized that some of these unknown cases may be caused by sexual transmission. To investigate this controversial topic, Tahan's team assessed HCV transmission between 600 patients with chronic hepatitis C and their spouses.
In a subgroup of 216 spouses who were HCV-negative at the start of the study, the authors assessed transmission rates over an average period of 36 months. The findings appear in the current issue of the American Journal of Gastroenterology.
Antibodies against HCV, indicating exposure to the virus, were detected in two percent of the spouses, the researchers note. The average age and duration of marriage were not associated with the likelihood of detecting HCV antibodies.
In contrast, an association between the frequency of sexual intercourse and HCV transmission risk was observed. However, this relationship was not statistically significant, indicating the association was.
In the subgroup of 216 spouses, none of the HCV-negative subjects became positive during follow-up, the investigators note.
"The risk of HCV transmission between monogamous sex partners may be related to the number of sexual intercourse" events, the authors state. "The absence of any evidence of transmission in the three-year follow-up period suggests that this relation is not very strong."
In a related editorial, Dr. Norah A. Terrault, from the University of California at San Francisco, comments that the "low incidence of new infections among monogamous couples supports the clinical practice of not recommending that such couples change their sexual practices."
SOURCE: American Journal of Gastroenterology, April 2005.
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Valeant Unveils Promising Hepatitis Drug Data
SourceURL:http://uk.biz.yahoo.com
Metabasis Therapeutics (NASDAQ: MBRX - news) ' partner Valeant Pharmaceuticals has unveiled encouraging experimental results from clinical and preclinical studies of pradefovir in patients infected with hepatitis B virus.
Metabasis Therapeutics' partner Valeant Pharmaceuticals has unveiled encouraging experimental results from clinical and preclinical studies of pradefovir in patients infected with hepatitis B virus.
The clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of pradefovir (formerly called remofovir) in patients chronically infected with hepatitis B virus (HBV).
In the study, pradefovir, a prodrug of PMEA, was rapidly absorbed and rapidly converted into PMEA in a dose-dependent manner. Administration of the drug was associated with clinically and statistically significant reductions in serum HBV DNA, a measure of viral load.
Valeant also unveiled preclinical data comparing liver and kidney distribution of pradefovir and adefovir dipivoxil. Results showed that administration of pradefovir resulted in a three-fold higher radioactivity level in the liver but in only 1/6 of the radioactivity level in the kidneys, compared to the radioactivity levels in those organs after dosing with adefovir dipivoxil.
This liver-targeting may lead to improved efficacy with a reduced potential for renal toxicity as compared to adefovir dipivoxil.
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April 27th, 2005
Hepatitis C Scare Halts Use of Surgical Adhesive
SourceURL:http://www.yomiuri.co.jp
The Yomiuri Shimbun
The Health, Labor and Welfare Ministry on Tuesday ordered a pharmaceutical company to stop the sale of an imported surgical tissue adhesive after an elderly man was found to have contracted the hepatitis C virus after his liver functions weakened following an operation.
The man, who is in his 70s, suffered decreased liver function following an operation in May last year, during which the tissue adhesive Takokonbu was used.
One of the basic ingredients in Takokonbu is fibrinogen, which is found in human blood, and is culled from blood supplies in the United States. The adhesive is used to prevent blood and other bodily fluids from leaking from internal organs during surgery. Takokonbu has been shipped to medical institutions throughout the country.
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Wait Twelve Weeks before Treating Acute HCV in HIV-Positive Patients
SourceURL:http://www.aidsmap.com
Michael Carter
Treatment for primary hepatitis C virus infection is significantly less likely to be effective in coinfected HIV-positive individuals, than patients who are hepatitis C monoinfected, according to a study presented to the Eleventh Annual Conference of the British HIV Association in Dublin on April 21st. In addition, investigators found that a significant number of HIV-positive patients spontaneously cleared hepatitis C virus within the early weeks of infection, and accordingly they recommend that if treatment for hepatitis C is initiated during acute infection, it should be delayed for twelve weeks.
Approximately 90% - 98% of individuals who are monoinfected with hepatitis C virus achieve a sustained virological response after receiving anti-hepatitis C virus therapy consisting of pegylated interferon during the acute infection period.
There are limited data about the effectiveness of this strategy in HIV-positive patients. It is known however that during acute infection with hepatitis C virus, the HIV-positive individuals have significantly higher hepatitis C viral loads than individuals infected only with hepatitis C.
In a prospective, open label study investigators from the Chelsea and Westminster Hospital in London evaluated the efficacy and safety of treatment for hepatitis C virus during acute infection. Between 1997 and 2003, a total of 50 gay men with a mean age of 37 years were recruited for the study. Hepatitis C virus infection was confirmed by antibody testing. Hepatitis C virus viral load was measured at baseline, and at weeks four, twelve, 24, 32 and 48.
If an individual was still hepatitis C virus RNA-positive at week twelve they were treated with pegylated interferon and ribavirin for 24 weeks. The primary endpoint of the study was the proportion of patients with a sustained virological response to treatment (defined as a negative hepatitis C virus PCR test at 48 weeks). Data on CD4 cell count, HIV viral load, liver function, side-effects and laboratory abnormalities were also gathered.
Of the 50 men included in the investigators’ anaylsis, twelve (24%) spontaneously cleared hepatitis C virus infection by week twelve and therefore did not receive anti-hepatitis C therapy. Spontaneous clearance of hepatitis C virus was significantly associated with a CD4 cell count above 500 cells/mm3 (p = 0.03), and a lower hepatitis C viral load (p = 0.04).
A total of 27 men accepted anti-hepatitis C therapy, 16 (59%) of whom achieved a sustained virological response, and this was significantly associated with a lower mean peak ALT level (p < 0.001). Due to the small number of patients in the study, it was not possible to say if treatment outcome was significantly different between individuals infected with different hepatitis C virus genotypes.
Median CD4 cell count fell by 58 cells/mm3 on the completion of anti-hepatitis C therapy, and the level of HIV viral load did not change significantly. These are usual accounts for individuals receiving hepatitis C virus treatment.
No deaths or new opportunistic infections occurred.
Side-effects were widely reported, the most common being depression and anxiety (33 instances) and flu-like symptoms (22 individuals). In addition, 13 cases of neutropenia and three cases of anaemia were recorded. One patient had to discontinue his treatment because of side-effects.
The investigators concluded that as only 59% of HIV-positive patients who are treated for acute hepatitis C virus infection achieve a sustained virological response, this approach to the management of hepatitis C is less effective in coinfected patients than hepatitis C virus monoinfected-individuals.
Reference
Gilleece YC et al. Is the treatment of acute hepatitis C in HIV-positive individuals effective?. Eleventh Annual Conference of the British HIV Association, abstract O26, Dublin, April 20 – 23rd, 2005.
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Westport to Begin Needle Exchange
SourceURL:http://www.boston.com
By Stephen Smith, Globe Staff
Decision ignites protest, outrage
For the first time in nearly a decade, leaders of a Massachusetts town have voted to start a campaign encouraging illegal drug users to swap their tainted needles for clean syringes, an effort designed to reduce the spread of HIV, hepatitis C, and other blood-borne illnesses.
Concerned by drug use in the region, Westport's Board of Selectmen voted unanimously Monday night to implement a needle-exchange program.
By yesterday, the decision had ignited a firestorm of protest, with outraged callers flooding phone lines of talk radio stations, selectmen, and the drug treatment center that has agreed to run the initiative. They complained that the exchange would increase crime in the town and encourage drug use. One caller to WSAR in Somerset suggested that the five selectmen who endorsed the needle exchange should be taken out and shot.
The four Massachusetts communities with longstanding needle-exchange programs -- Boston, Cambridge, Northampton, and Provincetown -- all have histories of embracing expansive social and public-health policies.
Westport is the first town outside that orbit to adopt needle exchange, and it sits between two much larger cities, Fall River and New Bedford, that are confronting twin epidemics of drug use and HIV. Both have rejected needle-exchange programs.
''This means that people are seeing this as a realistic public-health policy that works, and it's not about progressive politics or conservative politics," said Rebecca Haag, executive director of the AIDS Action Committee of Massachusetts, New England's largest private provider of HIV prevention and education services. ''It's about doing the right thing to save people's lives."
But if yesterday's phone calls are any indication, plenty of people in Westport felt it was expressly the wrong thing.
''I'm tired. This has been a tough day," said Elizabeth Collins, chairwoman of the town's Board of Selectmen, who was inundated with calls both at Town Hall and at home from angry constituents.
Callers, Collins said, voiced fears that crime would follow drug users to and from the site where they will turn in used needles and pick up clean ones.
Still, she said, her training as a registered nurse left her with no sensible option other than voting for needle exchange, especially in a small town of 14,000 where about 43 percent of HIV cases can be traced to the use of injectable drugs.
''As a retired healthcare professional, it was one of my duties to preserve life," Collins said. ''I have to say that by doing a needle exchange, it would seem to me that we would be saving a great deal of lives."
The HIV epidemic in Massachusetts has different profiles in different parts of the state. In Boston, the burden falls disproportionately on gay men.
But in the hardscrabble fishing cities of Southeastern Massachusetts, AIDS is a disease of injecting drug users.
In New Bedford, from 2001 through 2003, two of every three newly diagnosed HIV patients contracted the virus because of dirty needles. In Fall River, it was 58 percent. In both cases, the figures are substantially above the statewide average of 25 percent.
Nancy Paull witnesses the consequences as chief executive officer of Stanley Street Treatment & Resources, a substance-abuse treatment center on the state's southern coast.
Paull said that despite decades of work in the field, she initially was hesitant to embrace needle exchange.
''I believe," she said, ''that the best kind of life for anybody is a life abstaining from addiction."
But in recent years, Paull said, she has witnessed the spread of drugs and disease in ways she had never imagined.
There was, for example, the teenager who celebrated his 16th birthday while in the detox center at Stanley Street.
So, Paull said, she underwent what she described as a metamorphosis and agreed to run Westport's needle-exchange program.
''It has taken me a long time to get to this place," Paull said. ''But over the years, I have seen that recovery is not a one-shot deal. We need to keep people safe until they can get recovery, and we need to prevent the spread of disease."
The needle exchange will take place in a building on heavily trafficked Route 6 in Westport and will be open to any user in the region.
Paull said she hopes that within a month, users will be able to come into the office and get help to kick their habit, receive treatment for any disease they might have, and obtain clean needles.
As part of a legislative mandate, the state Department of Public Health will underwrite the campaign, providing up to $30,000 in the current fiscal year.
Since needle-exchange programs began in the early 1990s, nearly 14,000 addicts have enrolled, and in 2004 about 615,000 clean needles were supplied in the four participating cities, said Kevin Cranston, director of the state HIV/AIDS Bureau.
''Our experience across the programs has been remarkably mundane and calm," Cranston said. ''I wish I could say there are dramatic tales that attend needle exchange, but participants really bend over backwards not to create any controversy for the program."
Statewide, injection drug users have constituted a shrinking proportion of newly diagnosed HIV cases, Cranston said, and that decline has been even steeper in the communities with needle-exchange campaigns.
Stephen Smith can be reached at stsmith@globe.com.
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April 28th, 2005
Idenix Announces Data Presentations at the 2005 Digestive Disease Week Meeting
SourceURL:http://www.prnewswire.com
CAMBRIDGE, Mass., April 28 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases, announced today that six abstracts have been accepted for presentation at the Digestive Disease Week (DDW) meeting, to be held in Chicago, Illinois from May 14-19, 2005. The abstract contents are available on the DDW web site (http://www.ddw.org).
Hepatitis B treatment abstracts:
Dr. Ching-Lung Lai, Professor of Medicine and Hepatology, Department of Medicine, University of Hong Kong will present "Phase IIb Extended-Treatment Trial of Telbivudine (LdT) vs Lamivudine vs Combination Treatment in Hepatitis B Patients: Two-Year Results" in a hepatitis B session on Monday, May 16 at 2:45 p.m. Central Daylight Time (CDT). The interim results of this phase IIb extended treatment trial demonstrate that the higher rates of efficacy responses seen after one year of treatment with telbivudine, compared with lamivudine, are sustained through two years.
Three posters will be presented during the hepatitis B session on Monday, May 16 from 12:00-2:00 p.m. CDT:
Dr. Maria Seifer, Idenix's Associate Director, Research, will present "Telbivudine (LdT) Preferentially Inhibits Second (+) Strand HBV DNA Synthesis." The data from this laboratory study, which explored the molecular mode of action of telbivudine, demonstrate that telbivudine has unique inhibitory effects on HBV DNA synthesis that may contribute to observed differences in clinical antiviral potency.
Dr. Xiao-Jian Zhou, Idenix's Associate Director, Clinical Pharmacology, will present "Absence of Pharmacokinetic Drug-Drug Interaction Between Telbivudine and Lamivudine or Adefovir in Healthy Subjects." The data from this clinical study demonstrate that following oral dosing, the uptake and plasma levels of telbivudine are not affected by simultaneous dosing with lamivudine or adefovir. These data provide support for clinical evaluation of combination therapy with telbivudine and these other agents as well as drug switching strategies involving telbivudine and these other agents.
Dr. Zhou will present "HBV Viral Dynamics of Telbivudine vs. Lamivudine and the Combination: Relevance of Early Viral Suppression to Better Long-Term Clinical Response." This analysis, which used data from the previously reported one-year phase IIb clinical trial comparing telbivudine with lamivudine, demonstrates that early and profound viral suppression appears to be associated with better efficacy on longer-term viral and clinical endpoints.
Idenix is developing its hepatitis B clinical drug candidates, telbivudine and valtorcitabine, in collaboration with Novartis Pharma AG under a development and commercialization arrangement established in May 2003. Idenix and Novartis are currently evaluating telbivudine in the largest hepatitis B registration trial to date (the GLOBE study). Idenix and Novartis anticipate using data from the GLOBE study as the basis for regulatory filings expected to begin in late 2005. A phase IIb trial evaluating telbivudine in combination with valtorcitabine is ongoing.
Hepatitis C treatment abstracts:
Dr. Maribel Rodriguez-Torres, Chief Medical Director, Fundacion de Investigacion de Diego, Santurce, Puerto Rico, will present "Valopicitabine (NM283) Alone And In Combination With Peg-Interferon In Patients With Genotype 1 Chronic Hepatitis C: Preliminary Results From An Ongoing Phase II, Multicenter Study" in a hepatitis C new therapies session on Tuesday, May 17 at 10:30 a.m. CDT. Dr. Rodrigues-Torres will present preliminary 12-week and 24-week results from the ongoing phase IIa trial evaluating valopicitabine in combination with pegylated interferon in treatment-naove patients with HCV genotype 1 infection, a historically difficult-to-treat group. The preliminary clinical data to date demonstrate consistent, marked anti-HCV activity with the combination of valopicitabine and pegylated interferon.
Dr. Zhou will present "Pharmacokinetics and Pharmacodynamics of Valopicitabine (NM283), a New Nucleoside HCV Polymerase Inhibitor: Results From a Phase I/II Dose-Escalation Trial in Patients with HCV-1 Infection" in the hepatitis C early clinical development poster session on Sunday, May 15 from 12:00-2:00 p.m. CDT. The data from this clinical trial demonstrate oral dosing of valopicitabine produces plasma drug concentrations and antiviral effects that are proportional to dose. This suggests that valopicitabine is efficiently absorbed into the blood stream after administration.
About Idenix
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). Idenix's headquarters are located in Cambridge, Massachusetts and it has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com.
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Statements in this press release other than those that are historical in nature are "forward-looking statements." Forward looking statements, which include statements with respect to the potential therapeutic benefits and successful development of the company's product candidates and the company's drug discovery and research, regulatory approval processes and commercialization activities, are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. These risks and uncertainties relate to the results of clinical trials and other studies with respect to the product candidates that the company has under development; the timing and success of submission, acceptance and approval of regulatory filings; the company's dependence on its collaboration with Novartis Pharma AG; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the ability of the company to attract and retain qualified personnel and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for its drug candidates and its discoveries. These and other risks are described in greater detail under the caption "Factors That May Affect Future Results" in Item 7 of the company's annual report on Form 10-K for the year ended December 31, 2004 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company's expectations only as of the date of this release and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
Idenix Pharmaceuticals' Contacts
Media: Teri Dahlman, 617-995-9905
Investors: Amy Sullivan, 617-995-9838
SOURCE Idenix Pharmaceuticals, Inc.
Web Site: http://www.idenix.com
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Hepatitis C Alert Leaves Mum Angry and Scared
SourceURL:http://www.hornseyjournal.co.uk
nlnews@inuk.co.uk
A MOTHER has expressed her outrage at the National Health Service after discovering she was treated by a gynaecologist who had Hepatitis C.
Michelle vonAhn, of Creighton Road, Tottenham, had to go to North Middlesex Hospital for a blood test on Friday to check she had not contracted the disease.
She gave birth by caesarean section in January 1991 at the hospital - during the period the gynaecologist was working there.
Ms vonAhn cannot believe the Department of Health does not make healthcare workers take regular blood tests.
She said: "I know intellectually that the risk is quite small but in reality the consequences are quite great and it's scary.
"It's quite shocking. Why should people be put in that situation at all?"
Department of Health Guidelines state that healthcare workers have a "professional duty to seek medical advice on the need to be tested for blood-borne viruses if they think they may have been exposed.
"If they are subsequently found to be infected they should then seek occupational health advice on the need to modify their working practices to protect patients".
Health checks on new members of staff for communicable diseases like Hepatitis C and HIV were strengthened in 2003 - but guidelines for existing employees have not changed.
The Department of Health refused to comment on the matter and referred to existing guidelines for screening employees.
Ms vonAhn is one of 468 women contacted by the Health Protection Agency (HPA) in a "look back exercise" when it was discovered the former employee, on the obstetrics and gynaecology ward, had Hepatitis C.
This was the second time this year North Middlesex Hospital has had to carry out a "look back exercise".
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Wrong, Pamela, There Is a Cure
SourceURL:http://www.telegraph.co.uk/
Lack of public awareness - and funding - is holding back the treatment of hepatitis C. Barbara Lantin reports on a medical 'timebomb'
Three years ago, when actress Pamela Anderson went public about being infected with hepatitis C, health education campaigners were delighted that a celebrity had brought the virus out of the shadows.
Pamela Anderson thought hepatitis C was incurable
But delight turned to dismay, however, when Anderson asserted - erroneously - that there was no treatment or cure for her condition.
In an interview last week, the former Baywatch star told a newspaper: "The doctor said 'you have a glitch with your blood.' He told me I had hepatitis C. I asked how I could get rid of it, and he said, 'Well, you can't'."
As those who work with hepatitis C patients know, that is no longer the case.
"We have a major problem in this country with very few people being treated," says Charles Gore, chief executive of the Hepatitis C Trust. "One of the reasons is that people are not aware that a cure is available. If you think you may have the disease, but believe there is no cure, you may feel there is no point in getting a diagnosis."
Of the estimated 200,000 to 500,000 people who are infected with the hepatitis C virus (HCV) in Britain, only 50,000 have been diagnosed. The rest are unaware that they are carrying the virus, which can lie apparently dormant but actually replicating - usually in the liver - for 30 years or more. By the time symptoms appear, chronic and sometimes fatal liver damage may have occurred. Last month, an all-party committee of MPs described the problem as a "time bomb".
HCV is carried in the blood and those most at risk are people who had a blood transfusion before 1991 - when screening was introduced - and intravenous drug users. Needles used more than once in tattooing, piercing and acupuncture can also spread the infection, as can shared razors, even toothbrushes. Indeed, last week, more than 2,000 women in England and Scotland were warned that they could have been infected with the virus after being treated by a gynaecologist with HCV.
"Only a small number of individuals have symptoms at the time of infection," says Dr Adrian Hamlyn, a consultant physician and liver specialist at the Dudley Group of Hospitals in the West Midlands. "Without treatment, a vast majority will develop chronic infection and about a third will have cirrhosis of the liver." In a few cases, cancer of the liver can develop.
In up to 15 per cent of patients, the virus clears itself. The rest will need treatment to eliminate HCV from the blood, ideally before it does serious damage, which is why early testing is so vital.
Treatment involves a tough regime of weekly interferon injections and daily anti-viral ribavarin tablets that bring unpleasant side effects. Some strains of HCV respond to treatment better than others: the overall success rate is around 60 per cent.
"Even when the virus cannot be eliminated, inflammatory activity in the liver can sometimes be suppressed," says Dr Hamlyn. "And new drugs are being developed that stop the virus from replicating. Trials have shown them to be very effective, but at the moment, they are too toxic for general release."
But the real problem is lack of funds, says Dr Hamlyn. He told the all-party Parliamentary Group on Hepatology, which reported last month, that he needs £750,000 worth of drugs a year but receives less than a third of that. "This under-funding is storing up trouble. Failure to identify and treat those with hepatitis C will result in thousands requiring expensive treatment for serious liver disease in the future."
The government action plan and awareness campaign, launched late last year, was branded as "slow, low-key and under-resourced" by the all-party group, which pointed out that in Scotland, 40 per cent of HCV patients have been identified - compared with
10 to 19 per cent in England. In France and Germany, at least five times as many patients are treated for HCV as in Britain, despite similar infection rates. According to the group's report: "An overriding requirement is for the Government to demonstrate greater urgency in dealing with this coming 'tidal wave' of disease."
For further information, call the Hepatitis Trust helpline, tel: 0870 200 1200, or see www.hepcuk.info. The Department of Health's Face It campaign; 0800 451451, www.hepc.nhs.uk
'I have probably gained 20 years'
When photographer Michele Martinoli began to get drunk after only two glasses of wine, and suffer from repeated kidney infections, she knew something was wrong. Swiss-born Martinoli, 55, had taken drugs as a young woman, but had led a healthy life for the past 30 years.
Michele Martinoli: treatment 'was worth it'
"Hepatitis C was something that happened to other people," she says.
A blood test confirmed hepatitis C, and further tests revealed severe liver scarring.
"I knew that treatment was really harsh, but no one could tell me how long I would live without it," she says. "I would probably have gone progressively, and quite quickly, downhill. With treatment, I had a 70 per cent chance of being cured after a six-month course."
After each weekly injection, flu-like symptoms would set in. "You get a fever, your brain feels fogged, and you can't concentrate. Over the course of the week, you feel better, until the next injection. I lost half my hair, and the skin on my back was so sensitive it became raw from scratching.
"My energy levels dropped to 40 per cent and I could only walk about 50 metres. I dragged myself around and slowed my life down."
At her last blood test, Martinoli - whose vast pictures of HCV patients were recently displayed in Leicester Square as part of the Government's Face It awareness campaign, and will soon tour the country - was clear of the virus.
"Only now, one year after treatment, do I feel I have 100 per cent of my energy back. But I have probably gained 20 years - no question, it was worth it."
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April 30th, 2005
Hospital's Hep C Scare
SourceURL:http://www.hounslowguardian.co.uk
By Sally Henfield
Female patients of the obstetrics and gynaecology wards of a hospital formerly on the Chiswick border have been asked to visit their GPs after a healthcare worker has been diagnosed with Hepatitis C.
The health worker had spent time between April and September, 1998, at the old Queen Charlotte's and Chelsea Hospital, which at the time was based in Goldhawk Road.
The health worker had also been in gynaecology and maternity at West Middlesex University Hospital for two weeks in December 1991. Only two patients are potentially at risk of having contracted the disease, both of whom have been contacted.
The Hammersmith Hospitals NHS Trust is now contacting 74 women who all gave birth by caesarean section or had a major gynaecological operation at the hospital during this period. So far 62 women have been traced, one woman has moved abroad and 11 have yet to be located.
All of the women have been asked to go to their GP and give a blood sample as there is a small risk they may have contracted Hepatitis C from the healthcare worker.
Like most people who are infected with hepatitis C the healthcare worker had no symptoms and was unaware of the infection. As soon as the infection was diagnosed, the healthcare worker transferred to other duties where there was no risk at all to patients.
Professor Rory Shaw, medical director of the Trust, said: "We have worked extremely hard to identify any patient who might have been at risk of contracting infection.
"I want to emphasise that the risk of infection is very small and that we have asked GPs to screen as a precaution."
Women who may have been at risk should have received a letter asking them to contact their GP for a blood test. A confidential helpline has been set up by the North West London Health Protection Unit which offers counselling, information and advice. The number is 020 8966 1051 and will be open 8.30am 5pm Monday to Friday. Alternatively women may contact the NHS Direct helpline on 0845 4647.
Any patient who attended the hospital during this time and has not received a letter but is concerned, can call 0845 8116633 which is open from 10am - 7pm Monday to Friday.
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Hepatitis C Deal Proposed
SourceURL:http://www.stuff.co.nz
By AMANDA WARREN
Haemophiliacs who contracted hepatitis C in the bad-blood saga have proposed a $170,000 Government compensation deal for each person affected.
The Haemophiliac Foundation of New Zealand (HFNZ) settlement proposal calls for a Government apology to ensure haemophiliacs who in the late 1980s contracted hepatitis C from contaminated blood "achieved closure".
The proposed settlement also calls for increased healthcare provisions and for legal costs to be covered.
Health officials this month agreed to consider a HFNZ paper outlining the case for compensation and allowing a proposition to be made to the Crown.
The Ministry of Health was not commenting yesterday, but HFNZ said a ministry working group had agreed to consider the submission, verify the facts and present the material to Crown Law for consideration.
It would then be up to Crown Law to recommend any settlement to the Minister of Health, who would have to seek Cabinet approval.
A response was expected by August.
An estimated 170 New Zealanders with haemophilia contracted hepatitis C, a potentially fatal liver disease, in the late 1980s from contaminated blood product before screening of donor blood was introduced here in 1992.
HFNZ said a further 28 people who were hepatitis C infected were also infected with HIV, resulting in a more rapid progression of their hepatitis condition.
Twelve people had already died as as result of their infection with hepatitis C, the foundation said.
HFNZ said members would accept a "fair and equitable" compensation package from the Government.
In the paper, HFNZ requested the Government consider delivering an acknowledgement of the wrong that had occurred to people with heamophilia as a result of the bad blood saga.
"Other governments have delivered an apology for the purposes of ensuring that persons infected have achieved closure in respect of the injuries sustained," the paper said.
"It is important for hepatitis C sufferers to appreciate that the state acknowledges the wrongdoing that occurred in order to prevent recurrence of the mistakes of the past."
HFNZ said in the paper that infection with hepatitis C has had serious impact upon the capacity of people with haemophilia to maintain a normal lifestyle.
The major effects of hepatitis C are debilitating tiredness, followed by the development of cirrhosis of the liver, which can lead to hepatocellular carcinoma, a form of cancer. International opinion says the effects for people with heamophilia are much more serious.
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