No recognized risk factors can be identified in 10-40% of hepatitis C virus (HCV)-infected patients suggesting that the modes of transmission involved could be underestimated or unidentified. Invasive diagnostic procedures, such as endoscopy, have been considered as a potential HCV transmission route; although the actual extent of transmission in endoscopy procedures remains controversial.
Most reported HCV outbreaks related to nosocomial acquisition have been attributed to unsafe injection practices and use of multi-dose vials. Only a few cases of likely patient-to-patient HCV transmission via a contaminated colonoscope have been reported to date.
Nosocomial HCV infection may have important medical and legal implications and, therefore, possible transmission routes should be investigated. In this study, a case of nosocomial transmission of HCV from a common source to two patients who underwent colonoscopy in an endoscopy unit is reported.
Results: A retrospective epidemiological search after detection of index cases revealed several potentially infective procedures: sample blood collection, use of a peripheral catheter, anesthesia and colonoscopy procedures.
The epidemiological investigation showed breaches in colonoscope reprocessing and deficiencies in the recording of valuable tracing data. Direct sequences from the NS5B region were obtained to determine the extent of the outbreak and cloned sequences from the E1-E2 region were used to establish the relationships among intrapatient viral populations.
Phylogenetic analyses of individual sequences from viral populations infecting the three patients involved in the outbreak confirmed the patient pointed out by the epidemiological search as the source of the outbreak. Furthermore, the sequential order in which the patients underwent colonoscopy correlates with viral genetic variability estimates.
Conclusions: Patient-to-patient transmission of HCV could be demonstrated although the precise route of transmission remained unclear.
Viral genetic variability is proposed as a useful tool for tracing HCV transmission, especially in recent transmissions
Author: Fernando Gonzalez-CandelasSilvia GuiralRosa CarboAna ValeroHermelinda VanaclochaFrancisco GonzalezMaria Bracho
Credits/Source: Virology Journal 2010, 7:217
Published on: 2010-09-08
Source
September 9, 2010
Hepatitis C sufferers tell how 'manky' blood devastated their lives
Published Date: 09 September 2010
By Lyndsay Moss
Health Correspondent
SCOTTISH patients infected with hepatitis C or HIV through blood products have revealed the devastating impact on their lives as the first stage of a major inquiry ended.
The victims, who received the contaminated blood or blood products in the 1970s and 1980, told of long delays in getting their diagnosis, the stigma associated with their infection and the terrible symptoms.
Their testimonies came as the Penrose Inquiry into the blood scandal published its preliminary report, setting out the evidence it had gathered so far.
The 600-page report, produced after the inquiry team analysed over 80,000 documents and took more than 100 witness statements, also sets out the next stages of the investigation.
This includes looking at the use of commercial blood products in Scotland and the information given to patients after their diagnosis.
Lord Penrose and his team will also look at the introduction of heat treatment to inactivate hepatitis C in blood products in Scotland in 1987 - two years after it was implemented in England and Wales. But campaigners yesterday called for the inquiry to go even further, to include other possible illnesses spread in blood.
Hundreds of people in Scotland - many with haemophilia as well as other patients - were infected after receiving contaminated blood.
As part of the Penrose Inquiry, patients were asked to come forward to reveal their own experiences. Many patients with haemophilia - which means their blood does not clot - spoke of the positive effects treatment with new blood factor products had had on their lives, with one describing it as a "miracle cure".
But the majority of witnesses said they were not warned about the risks linked to the treatment at a time when less was known about hepatitis C and HIV and testing of products not possible. Elsewhere in the report, witnesses voiced concern that they were not being informed when they were being tested for hepatitis C and HIV.
One witness said he was invited for a hepatitis C test in 1996, but found his own medical records suggested he had been diagnosed in 1992. He claimed he had not been told then.
Patients reported "horrendous" side-effects from treatment for hepatitis C, as well as the stigma associated with their diagnosis.
One patient had to move villages for a "fresh start" after parents stopped inviting their children to play. Others reported problems getting insurance and financial problems caused by not being able to work.
Bruce Norval, a trustee of the Haemophilia Society and a victim of contaminated blood, said the inquiry should be widened to look at what other contaminants victims could have been exposed to through clotting products.
"There was all kinds of crap in that stuff.
This stuff was manky, it was filthy, it was dirty and they knew it, but they still stuck it in the arms of children," he said.
Solicitor Advocate Patrick McGuire, of Thompsons Solicitors, the recognised legal representative of families and sufferers, said the report was "a milestone" for families after their struggle for answers.
CASE STUDY
Philip Dolan is not sure when he was infected with hepatitis C during his treatment for haemophilia.
While he may have been diagnosed as early as 1978, he was not informed until 1991 when he asked a consultant.
The Haemophilia Society trustee from Glasgow said: "That is the same for a lot of people - they did not know until years later."
Mr Dolan said he had suffered fatigue due to his condition, while getting insurance was also a problem.
Source
By Lyndsay Moss
Health Correspondent
SCOTTISH patients infected with hepatitis C or HIV through blood products have revealed the devastating impact on their lives as the first stage of a major inquiry ended.
The victims, who received the contaminated blood or blood products in the 1970s and 1980, told of long delays in getting their diagnosis, the stigma associated with their infection and the terrible symptoms.
Their testimonies came as the Penrose Inquiry into the blood scandal published its preliminary report, setting out the evidence it had gathered so far.
The 600-page report, produced after the inquiry team analysed over 80,000 documents and took more than 100 witness statements, also sets out the next stages of the investigation.
This includes looking at the use of commercial blood products in Scotland and the information given to patients after their diagnosis.
Lord Penrose and his team will also look at the introduction of heat treatment to inactivate hepatitis C in blood products in Scotland in 1987 - two years after it was implemented in England and Wales. But campaigners yesterday called for the inquiry to go even further, to include other possible illnesses spread in blood.
Hundreds of people in Scotland - many with haemophilia as well as other patients - were infected after receiving contaminated blood.
As part of the Penrose Inquiry, patients were asked to come forward to reveal their own experiences. Many patients with haemophilia - which means their blood does not clot - spoke of the positive effects treatment with new blood factor products had had on their lives, with one describing it as a "miracle cure".
But the majority of witnesses said they were not warned about the risks linked to the treatment at a time when less was known about hepatitis C and HIV and testing of products not possible. Elsewhere in the report, witnesses voiced concern that they were not being informed when they were being tested for hepatitis C and HIV.
One witness said he was invited for a hepatitis C test in 1996, but found his own medical records suggested he had been diagnosed in 1992. He claimed he had not been told then.
Patients reported "horrendous" side-effects from treatment for hepatitis C, as well as the stigma associated with their diagnosis.
One patient had to move villages for a "fresh start" after parents stopped inviting their children to play. Others reported problems getting insurance and financial problems caused by not being able to work.
Bruce Norval, a trustee of the Haemophilia Society and a victim of contaminated blood, said the inquiry should be widened to look at what other contaminants victims could have been exposed to through clotting products.
"There was all kinds of crap in that stuff.
This stuff was manky, it was filthy, it was dirty and they knew it, but they still stuck it in the arms of children," he said.
Solicitor Advocate Patrick McGuire, of Thompsons Solicitors, the recognised legal representative of families and sufferers, said the report was "a milestone" for families after their struggle for answers.
CASE STUDY
Philip Dolan is not sure when he was infected with hepatitis C during his treatment for haemophilia.
While he may have been diagnosed as early as 1978, he was not informed until 1991 when he asked a consultant.
The Haemophilia Society trustee from Glasgow said: "That is the same for a lot of people - they did not know until years later."
Mr Dolan said he had suffered fatigue due to his condition, while getting insurance was also a problem.
Source
Two Hepatitis C Drug Candidates on Hold Because of Adverse Events
Robert Lowes
September 8, 2010 — The US Food and Drug Administration (FDA) has ordered drug maker Idenix to suspend development of 2 candidate drugs to treat hepatitis C virus after 3 individuals treated with a combination of these drugs in a clinical trial experienced liver function abnormalities, the company announced yesterday.
The 2 investigational drugs are a nucleoside polymerase inhibitor called IDX184 and a protease inhibitor called IDX320.
The FDA verbally notified Idenix on September 3 that the agency had placed IDX184 and IDX320 programs on clinical hold, pending a review of all clinical and preclinical data for the programs, according to the company. An Idenix press release quoted Chief Executive Officer and Chairman Jean-Pierre Sommadossi, PhD, as saying that the company had not yet received a formal letter from the FDA.
A clinical hold means that a study sponsor must delay a proposed investigation or suspend an ongoing one. When an ongoing study is on clinical hold, no new participants may be recruited or given an investigational medication, and patients already enrolled should stop receiving the treatment unless the FDA specifically authorizes it.
Idenix has completed its planned studies of IDX184 and IDX320, and no healthy trial participants or patients are receiving either experimental drug, the company stated.
In a 2-week phase 1 randomized, double-blind, placebo-controlled trial, 16 of 20 healthy individuals were randomly assigned to receive a combination of IDX184 and IDX320. Half of them received IDX184 plus placebo for the 2 full weeks and IDX320 just for the last week, and the other half received IDX320 for 2 weeks and IDX184 for the last week.
Although the drug duo was generally safe and tolerated, elevated liver function tests (LFTs) in 3 participants were deemed serious adverse events, according to Idenix, which reported these findings to the FDA. During follow-up, LFTs in these 3 participants returned to nearly normal.
In a conference call with stock analysts yesterday, Idenix Chief Medical Officer Douglas Mayers, MD, said that the 3 participants with elevated LFTs were later evaluated by liver specialists and screened for hepatitis, drugs and alcohol, and any potentially confounding medications. The elevated LFT in 1 patient, he said, appeared to be related to gallstones. No explanation has yet emerged for the adverse events experienced by the other 2 participants.
Idenix will investigate the adverse events and provide the FDA with the information it needs, said Dr. Sommadossi. "We remain committed to the future potential of these drug candidates."
Source
September 8, 2010 — The US Food and Drug Administration (FDA) has ordered drug maker Idenix to suspend development of 2 candidate drugs to treat hepatitis C virus after 3 individuals treated with a combination of these drugs in a clinical trial experienced liver function abnormalities, the company announced yesterday.
The 2 investigational drugs are a nucleoside polymerase inhibitor called IDX184 and a protease inhibitor called IDX320.
The FDA verbally notified Idenix on September 3 that the agency had placed IDX184 and IDX320 programs on clinical hold, pending a review of all clinical and preclinical data for the programs, according to the company. An Idenix press release quoted Chief Executive Officer and Chairman Jean-Pierre Sommadossi, PhD, as saying that the company had not yet received a formal letter from the FDA.
A clinical hold means that a study sponsor must delay a proposed investigation or suspend an ongoing one. When an ongoing study is on clinical hold, no new participants may be recruited or given an investigational medication, and patients already enrolled should stop receiving the treatment unless the FDA specifically authorizes it.
Idenix has completed its planned studies of IDX184 and IDX320, and no healthy trial participants or patients are receiving either experimental drug, the company stated.
In a 2-week phase 1 randomized, double-blind, placebo-controlled trial, 16 of 20 healthy individuals were randomly assigned to receive a combination of IDX184 and IDX320. Half of them received IDX184 plus placebo for the 2 full weeks and IDX320 just for the last week, and the other half received IDX320 for 2 weeks and IDX184 for the last week.
Although the drug duo was generally safe and tolerated, elevated liver function tests (LFTs) in 3 participants were deemed serious adverse events, according to Idenix, which reported these findings to the FDA. During follow-up, LFTs in these 3 participants returned to nearly normal.
In a conference call with stock analysts yesterday, Idenix Chief Medical Officer Douglas Mayers, MD, said that the 3 participants with elevated LFTs were later evaluated by liver specialists and screened for hepatitis, drugs and alcohol, and any potentially confounding medications. The elevated LFT in 1 patient, he said, appeared to be related to gallstones. No explanation has yet emerged for the adverse events experienced by the other 2 participants.
Idenix will investigate the adverse events and provide the FDA with the information it needs, said Dr. Sommadossi. "We remain committed to the future potential of these drug candidates."
Source
Medivir Presenting at the National Swedish Hepatitis Meeting - Clinical Update on TMC435 HCV-Protease Inhibitor
Sept. 9, 2010, 3:41 a.m. EDT
STOCKHOLM, Sep 09, 2010 (BUSINESS WIRE) -- Medivir AB (STO:MVIRB), the biopharmaceutical company focused on infectious diseases caused by viruses, will today present a clinical update on its key drug, TMC435, a potential blockbuster therapy against Hepatitis C which is partnered with Tibotec, at the National Swedish Hepatitis Meeting.
Medivir's CSO, Prof Bertil Samuelsson, will give a presentation entitled 'Clinical update of TMC435 HCV-protease inhibitor' at 12:30 CEST on 9 September 2010 at the Nordic Sea Hotel in Stockholm. A copy of the presentation will be available on Medivir's website (http://www.medivir.se/) after the meeting.
About Medivir
Medivir is an established biopharmaceutical company focused on the development of high-value treatments mainly in infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product, an innovative treatment for cold sores.
Xerese(TM)/Xerclear(TM) is a treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GSK to be sold OTC in Europe and Russia and by Meda in North America. Medivir have retained the Rx rights for Xerclear(TM) in Sweden and Finland.
Medivir's key pipeline asset, TMC435, a protease inhibitor, is in Phase IIb clinical development for Hepatitis C and is partnered with Tibotec.
For more information on Medivir, please see the company website: http://www.medivir.se/
This information was brought to you by Cision http://www.cisionwire.com/
SOURCE: Medivir
Medivir
Rein Piir, CFO & VP Investor Relations
Office: +46 8 546 831 23
Mobile: +46 708 537 292
or
M:Communications
Mary-Jane Elliott / Emma Thompson
Medivir@mcomgroup.com
+44(0)20 7920 2345
Copyright Business Wire 2010
Source
STOCKHOLM, Sep 09, 2010 (BUSINESS WIRE) -- Medivir AB (STO:MVIRB), the biopharmaceutical company focused on infectious diseases caused by viruses, will today present a clinical update on its key drug, TMC435, a potential blockbuster therapy against Hepatitis C which is partnered with Tibotec, at the National Swedish Hepatitis Meeting.
Medivir's CSO, Prof Bertil Samuelsson, will give a presentation entitled 'Clinical update of TMC435 HCV-protease inhibitor' at 12:30 CEST on 9 September 2010 at the Nordic Sea Hotel in Stockholm. A copy of the presentation will be available on Medivir's website (http://www.medivir.se/) after the meeting.
About Medivir
Medivir is an established biopharmaceutical company focused on the development of high-value treatments mainly in infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product, an innovative treatment for cold sores.
Xerese(TM)/Xerclear(TM) is a treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GSK to be sold OTC in Europe and Russia and by Meda in North America. Medivir have retained the Rx rights for Xerclear(TM) in Sweden and Finland.
Medivir's key pipeline asset, TMC435, a protease inhibitor, is in Phase IIb clinical development for Hepatitis C and is partnered with Tibotec.
For more information on Medivir, please see the company website: http://www.medivir.se/
This information was brought to you by Cision http://www.cisionwire.com/
SOURCE: Medivir
Medivir
Rein Piir, CFO & VP Investor Relations
Office: +46 8 546 831 23
Mobile: +46 708 537 292
or
M:Communications
Mary-Jane Elliott / Emma Thompson
Medivir@mcomgroup.com
+44(0)20 7920 2345
Copyright Business Wire 2010
Source
September 7, 2010
Alcoholic Liver Disease More Aggressive
Tuesday September 7, 2010
Although many advances have been made in the detection and treatment of chronic liver disease in the past 40 years, the prognosis for patients with alcohol liver disease has not improved significantly. While advances have improved the outcomes for non-alcoholic liver disease patients, outcomes for alcohol liver disease patients remain bleak.
Researchers believe the prognosis for alcohol-related liver patients would improve if as much effort was placed in treating their alcohol dependence as is spent treating their liver disease.
Advances in treatment for hepatitis C and autoimmune hepatitis have improved outcomes for those patients in the past 40 years, and new diagnostic tools have increased early detection of the development of cirrhosis. These changes have been effective in improving outcomes for non-alcohol-related chronic liver disease patients.
Prognosis Unchanged for Alcohol Liver Patients
A new Swedish study of 36,462 patients hospitalized with alcoholic liver diseases and 95,842 patients hospitalized with non-alcoholic liver diseases found that the prognosis for alcohol-liver disease patients has remained basically unchanged.
The main difference is the alcohol dependence of the alcohol liver disease patients, said lead researcher Knut Stokkeland, of the Visby Hospital in Sweden. Since almost all alcohol liver disease patients are also alcohol dependent or alcoholics it affects their prognosis.
"Alcohol dependence increases the risks of social problems, being a smoker, and severe psychiatric diseases," Stokkeland said in a news release. "It also inhibits staying sober, which may stop disease progression."
Need Treatment for Alcoholism
The researchers believe that patients with alcohol liver disease should receive more attention, specifically they should be offered treatment for their alcohol problem as well as for their liver disease. The problem, they said, is that the lack of coordination between the hepatology and gastroenterology specialists who treat the liver and those who treat substance abuse.
Because drinking alcohol doubles the risk of developing a serious liver problem, any efforts to reduce alcohol consumption would improve the outcomes for those with alcohol-related liver disease, the researchers concluded.
In short, if you or someone you know develops liver disease, the best thing they can do to improve their chances of surviving is to stop drinking immediately.
Source
Although many advances have been made in the detection and treatment of chronic liver disease in the past 40 years, the prognosis for patients with alcohol liver disease has not improved significantly. While advances have improved the outcomes for non-alcoholic liver disease patients, outcomes for alcohol liver disease patients remain bleak.
Researchers believe the prognosis for alcohol-related liver patients would improve if as much effort was placed in treating their alcohol dependence as is spent treating their liver disease.
Advances in treatment for hepatitis C and autoimmune hepatitis have improved outcomes for those patients in the past 40 years, and new diagnostic tools have increased early detection of the development of cirrhosis. These changes have been effective in improving outcomes for non-alcohol-related chronic liver disease patients.
Prognosis Unchanged for Alcohol Liver Patients
A new Swedish study of 36,462 patients hospitalized with alcoholic liver diseases and 95,842 patients hospitalized with non-alcoholic liver diseases found that the prognosis for alcohol-liver disease patients has remained basically unchanged.
The main difference is the alcohol dependence of the alcohol liver disease patients, said lead researcher Knut Stokkeland, of the Visby Hospital in Sweden. Since almost all alcohol liver disease patients are also alcohol dependent or alcoholics it affects their prognosis.
"Alcohol dependence increases the risks of social problems, being a smoker, and severe psychiatric diseases," Stokkeland said in a news release. "It also inhibits staying sober, which may stop disease progression."
Need Treatment for Alcoholism
The researchers believe that patients with alcohol liver disease should receive more attention, specifically they should be offered treatment for their alcohol problem as well as for their liver disease. The problem, they said, is that the lack of coordination between the hepatology and gastroenterology specialists who treat the liver and those who treat substance abuse.
Because drinking alcohol doubles the risk of developing a serious liver problem, any efforts to reduce alcohol consumption would improve the outcomes for those with alcohol-related liver disease, the researchers concluded.
In short, if you or someone you know develops liver disease, the best thing they can do to improve their chances of surviving is to stop drinking immediately.
Source
PolyTherics Moves Lead Candidate Into Development and Manufacturing With DSM BioSolutions
PR Newswire
DELFT, Netherlands, Sept. 7
DELFT, Netherlands, Sept. 7 /PRNewswire/ -- DSM BioSolutions ("DSM"), DSM's microbial fermentation CMO business unit and PolyTherics Limited ("PolyTherics"), an innovator in precision engineering of proteins, today announced that they have entered into an agreement for the process development and manufacture of PolyTherics' lead biobetter product, HiPEG™ IFN alpha-2a.
PolyTherics has applied its HiPEG™ site-specific PEGylation technology to interferon alpha to produce a product (HiPEG™ IFN alpha-2a) that has eight-fold higher activity than a marketed PEGylated interferon in vitro and a comparable half-life in a preclinical study.
HiPEG™ specifically attaches poly(ethylene) glycol (PEG) to a histidine tag at the end of the protein; histidine tags are commonly used to improve protein stability and to facilitate the purification of proteins. PolyTherics is seeking partners for the development of HiPEG™ IFN alpha-2a for hepatitis C.
DSM has successfully started development, scale-up and manufacture of the recombinant his-tagged IFN alpha-2a. PolyTherics will transfer its proprietary HiPEG PEGylation method to DSM so that the process can also be scaled-up. The companies intend to develop a robust process to produce sufficient material for preclinical development and then for cGMP production of HiPEG™ IFN alpha-2a for clinical development.
Keith Powell, CEO of PolyTherics, stated that, "The transfer of the production of our lead product to a contract manufacturer is a major milestone for PolyTherics and is the beginning of the development stage of its first biobetter drug."
Villaume Kal, Vice-President of DSM BioSolutions stated, "We are delighted to work with PolyTherics on this promising biobetter compound. Our technology, operational excellence, and outstanding cGMP and compliance record with the EMA and FDA allows us to serve this important customer and to develop, scale-up and manufacture their preclinical and clinical material".
No financial terms will be disclosed.
PolyTherics Limited
PolyTherics is a biopharmaceutical company that applies precision chemistry to develop improved protein and peptide-based drugs. It received investment of 2.3 million pounds Sterling from Imperial Innovations Group plc, Longbow Capital LLP and The Capital Fund in June 2007 and a further 3.0 million pounds Sterling investment from the same syndicate in February 2010.
PolyTherics has developed three proprietary technologies for attaching the polymer poly(ethylene glycol) (PEG) to any therapeutic peptide or protein in a targeted fashion. PEGylation slows elimination from the body, thereby improving half-life and potentially reducing drug treatment frequency, decreasing side effects and improving patient compliance.
PEGylated products derived from PolyTherics' technologies are more homogeneous than those derived from traditional methods, resulting in reduced complexity of downstream processing, more consistent product quality and cost-effective manufacture. PEGylation is an established method for improving drugs and nine PEGylated products are already approved for therapeutic use worldwide.
For more information, please visit: http://www.polytherics.co.uk/
DSM BioSolutions – Microbial Fermentation
DSM BioSolutions, part of the DSM Pharma cluster, offers a wide range of customer services ranging from process development to large scale production, all in the field of microbial fermentation. Expertise covers microbial strain construction and improvement, fermentation process development and product recovery and purification. DSM's production infrastructure for fermentation and associated product recovery and purification is based in a multipurpose facility in Capua, Italy, which currently produces pharmaceutical intermediates and APIs (with the exception of beta-lactams) and food/nutrition-related products. In the Pharma area, production lines are available for cGMP manufacturing of small molecules and pharmaceutical proteins. The facilities comply with all relevant regulations and are regularly inspected by the respective authorities (e.g. EMA and FDA).
For more information, please visit http://www.dsmbiosolutions.com/
DSM – the Life Sciences and Materials Sciences Company
Royal DSM N.V. creates solutions that nourish, protect and improve performance. Its end markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrical and electronics, life protection and housing. DSM manages its business with a focus on the triple bottom line of economic performance, environmental quality and social responsibility, which it pursues simultaneously and in parallel. DSM has annual net sales of about euro 8 billion and employs some 22,700 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam.
For more information, please visit http://www.dsm.com/
Forward-looking statements
This press release may contain forward-looking statements with respect to DSM's future (financial) performance and position. Such statements are based on current expectations, estimates and projections of DSM and information currently available to the company. DSM cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. DSM has no obligation to update the statements contained in this press release, unless required by law.
For more information:
DSM BioSolutions:
Villaume Kal
Vice-President DSM BioSolutions
Tel: +31 15 279 2173
Email villaume.kal@dsm.com
Marco Oomen
Sr. Director Business Development Europe & Japan
Tel: +31 15 279 2251
Email marco.oomen@dsm.com
PolyTherics:
College Hill:
Tim Watson, Tony Stephenson
Tel: +44 (0)207 866 7861
Email: polytherics@collegehill.com
SOURCE DSM BioSolutions
Source
DELFT, Netherlands, Sept. 7
DELFT, Netherlands, Sept. 7 /PRNewswire/ -- DSM BioSolutions ("DSM"), DSM's microbial fermentation CMO business unit and PolyTherics Limited ("PolyTherics"), an innovator in precision engineering of proteins, today announced that they have entered into an agreement for the process development and manufacture of PolyTherics' lead biobetter product, HiPEG™ IFN alpha-2a.
PolyTherics has applied its HiPEG™ site-specific PEGylation technology to interferon alpha to produce a product (HiPEG™ IFN alpha-2a) that has eight-fold higher activity than a marketed PEGylated interferon in vitro and a comparable half-life in a preclinical study.
HiPEG™ specifically attaches poly(ethylene) glycol (PEG) to a histidine tag at the end of the protein; histidine tags are commonly used to improve protein stability and to facilitate the purification of proteins. PolyTherics is seeking partners for the development of HiPEG™ IFN alpha-2a for hepatitis C.
DSM has successfully started development, scale-up and manufacture of the recombinant his-tagged IFN alpha-2a. PolyTherics will transfer its proprietary HiPEG PEGylation method to DSM so that the process can also be scaled-up. The companies intend to develop a robust process to produce sufficient material for preclinical development and then for cGMP production of HiPEG™ IFN alpha-2a for clinical development.
Keith Powell, CEO of PolyTherics, stated that, "The transfer of the production of our lead product to a contract manufacturer is a major milestone for PolyTherics and is the beginning of the development stage of its first biobetter drug."
Villaume Kal, Vice-President of DSM BioSolutions stated, "We are delighted to work with PolyTherics on this promising biobetter compound. Our technology, operational excellence, and outstanding cGMP and compliance record with the EMA and FDA allows us to serve this important customer and to develop, scale-up and manufacture their preclinical and clinical material".
No financial terms will be disclosed.
PolyTherics Limited
PolyTherics is a biopharmaceutical company that applies precision chemistry to develop improved protein and peptide-based drugs. It received investment of 2.3 million pounds Sterling from Imperial Innovations Group plc, Longbow Capital LLP and The Capital Fund in June 2007 and a further 3.0 million pounds Sterling investment from the same syndicate in February 2010.
PolyTherics has developed three proprietary technologies for attaching the polymer poly(ethylene glycol) (PEG) to any therapeutic peptide or protein in a targeted fashion. PEGylation slows elimination from the body, thereby improving half-life and potentially reducing drug treatment frequency, decreasing side effects and improving patient compliance.
PEGylated products derived from PolyTherics' technologies are more homogeneous than those derived from traditional methods, resulting in reduced complexity of downstream processing, more consistent product quality and cost-effective manufacture. PEGylation is an established method for improving drugs and nine PEGylated products are already approved for therapeutic use worldwide.
For more information, please visit: http://www.polytherics.co.uk/
DSM BioSolutions – Microbial Fermentation
DSM BioSolutions, part of the DSM Pharma cluster, offers a wide range of customer services ranging from process development to large scale production, all in the field of microbial fermentation. Expertise covers microbial strain construction and improvement, fermentation process development and product recovery and purification. DSM's production infrastructure for fermentation and associated product recovery and purification is based in a multipurpose facility in Capua, Italy, which currently produces pharmaceutical intermediates and APIs (with the exception of beta-lactams) and food/nutrition-related products. In the Pharma area, production lines are available for cGMP manufacturing of small molecules and pharmaceutical proteins. The facilities comply with all relevant regulations and are regularly inspected by the respective authorities (e.g. EMA and FDA).
For more information, please visit http://www.dsmbiosolutions.com/
DSM – the Life Sciences and Materials Sciences Company
Royal DSM N.V. creates solutions that nourish, protect and improve performance. Its end markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrical and electronics, life protection and housing. DSM manages its business with a focus on the triple bottom line of economic performance, environmental quality and social responsibility, which it pursues simultaneously and in parallel. DSM has annual net sales of about euro 8 billion and employs some 22,700 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam.
For more information, please visit http://www.dsm.com/
Forward-looking statements
This press release may contain forward-looking statements with respect to DSM's future (financial) performance and position. Such statements are based on current expectations, estimates and projections of DSM and information currently available to the company. DSM cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. DSM has no obligation to update the statements contained in this press release, unless required by law.
For more information:
DSM BioSolutions:
Villaume Kal
Vice-President DSM BioSolutions
Tel: +31 15 279 2173
Email villaume.kal@dsm.com
Marco Oomen
Sr. Director Business Development Europe & Japan
Tel: +31 15 279 2251
Email marco.oomen@dsm.com
PolyTherics:
College Hill:
Tim Watson, Tony Stephenson
Tel: +44 (0)207 866 7861
Email: polytherics@collegehill.com
SOURCE DSM BioSolutions
Source
Teleflex Introduces The PICC WAND(TM)
Sept. 7, 2010, 9:00 a.m. EDT
All in One Vascular Access Device Provides Faster, Safer, Simpler Insertion for PICC or Midline Placements
LIMERICK, Pa., Sep 07, 2010 (BUSINESS WIRE) -- Teleflex has partnered with Access Scientific Incorporated, San Diego, California to become the U.S. distributor of The PICC WAND(TM) Safety Introducer with ARROW(R) peelable sheath. This new, all- in-one vascular access device provides clinicians a faster, safer, simpler way to insert a peel away sheath for PICC or Midline catheter placements.
Using the new Accelerated Seldinger Technique, The PICC WAND combines an echogenic needle, nitinol wire, sheath and dilator into an all in one safety introducer that eliminates the need to reach for separate components, improving sterile technique and reducing the risks associated with Modified Seldinger Technique (MST). These risks include accidental needle stick injury, loss of cannulation, vessel trauma, blood exposure, contamination of components and air and wire embolism. The PICC WAND actually reduces the risk of air emboli by 50% compared to MST.(1)
The passive needle safety mechanism of The PICC WAND automatically shields the contaminated needle during the procedure reducing the risk of accidental needle stick injury. This is important as there are 385,000 reported accidental sharps injuries occurring in hospitals annually, exposing healthcare workers to bloodborne pathogens that include Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV).(2)
Teleflex, a leader in providing innovative vascular access technologies, anticipates this device will become the new standard of care reducing risk to both patients and healthcare workers. "We are delighted to be partnering with Access Scientific to bring this truly innovative technology to market," said Cary Vance, Executive Vice President, Teleflex North America. "The PICC WAND provides significant benefits to both patients and caregivers and is an outstanding addition to our vascular access product portfolio."
Steve Bierman, M.D., CEO of Access Scientific said, "Having now seen The PICC WAND in operation, in some of the most challenging cases, I can assert without any doubt that the Accelerated Seldinger Technique establishes a new standard of care. Both patients and healthcare workers benefit significantly from the Wand's safety and efficiency features." He continued, "Access Scientific is proud to be introducing this game changing technology with our partner, Teleflex."
The PICC WAND will be available as a stand alone product and inside new ergonomically designed PICC kits from Teleflex. These new kits include a pressure injectable PICC line as well as maximal barrier and sharps safety components that reduce the risk of infection and accidental needle sticks.
About Teleflex Incorporated
Teleflex Incorporated /quotes/comstock/13*!tfx/quotes/nls/tfx (TFX 51.68, +0.48, +0.94%) is a global provider of medical technology products that enable healthcare providers to improve patient outcomes, protect against infections and support patient and provider safety. Teleflex, which employs approximately 12,600 people worldwide, also has niche businesses that serve segments of the aerospace and commercial markets with specialty engineered products. Additional information about Teleflex can be obtained from the company's website at http://www.teleflex.com/.
1 Data on File 2 NIOSH ALERT: Preventing Needlestick Injuries in Health Care Settings, Pub. 2000-108, Nov. 1999
The PICC WAND is a trademark of Access Scientific, Inc.
SOURCE: Teleflex Incorporated
Teleflex Incorporated
Jake Elguicze, 610-948-2836
Vice President, Investor Relations
Copyright Business Wire 2010
Source
All in One Vascular Access Device Provides Faster, Safer, Simpler Insertion for PICC or Midline Placements
LIMERICK, Pa., Sep 07, 2010 (BUSINESS WIRE) -- Teleflex has partnered with Access Scientific Incorporated, San Diego, California to become the U.S. distributor of The PICC WAND(TM) Safety Introducer with ARROW(R) peelable sheath. This new, all- in-one vascular access device provides clinicians a faster, safer, simpler way to insert a peel away sheath for PICC or Midline catheter placements.
Using the new Accelerated Seldinger Technique, The PICC WAND combines an echogenic needle, nitinol wire, sheath and dilator into an all in one safety introducer that eliminates the need to reach for separate components, improving sterile technique and reducing the risks associated with Modified Seldinger Technique (MST). These risks include accidental needle stick injury, loss of cannulation, vessel trauma, blood exposure, contamination of components and air and wire embolism. The PICC WAND actually reduces the risk of air emboli by 50% compared to MST.(1)
The passive needle safety mechanism of The PICC WAND automatically shields the contaminated needle during the procedure reducing the risk of accidental needle stick injury. This is important as there are 385,000 reported accidental sharps injuries occurring in hospitals annually, exposing healthcare workers to bloodborne pathogens that include Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV).(2)
Teleflex, a leader in providing innovative vascular access technologies, anticipates this device will become the new standard of care reducing risk to both patients and healthcare workers. "We are delighted to be partnering with Access Scientific to bring this truly innovative technology to market," said Cary Vance, Executive Vice President, Teleflex North America. "The PICC WAND provides significant benefits to both patients and caregivers and is an outstanding addition to our vascular access product portfolio."
Steve Bierman, M.D., CEO of Access Scientific said, "Having now seen The PICC WAND in operation, in some of the most challenging cases, I can assert without any doubt that the Accelerated Seldinger Technique establishes a new standard of care. Both patients and healthcare workers benefit significantly from the Wand's safety and efficiency features." He continued, "Access Scientific is proud to be introducing this game changing technology with our partner, Teleflex."
The PICC WAND will be available as a stand alone product and inside new ergonomically designed PICC kits from Teleflex. These new kits include a pressure injectable PICC line as well as maximal barrier and sharps safety components that reduce the risk of infection and accidental needle sticks.
About Teleflex Incorporated
Teleflex Incorporated /quotes/comstock/13*!tfx/quotes/nls/tfx (TFX 51.68, +0.48, +0.94%) is a global provider of medical technology products that enable healthcare providers to improve patient outcomes, protect against infections and support patient and provider safety. Teleflex, which employs approximately 12,600 people worldwide, also has niche businesses that serve segments of the aerospace and commercial markets with specialty engineered products. Additional information about Teleflex can be obtained from the company's website at http://www.teleflex.com/.
1 Data on File 2 NIOSH ALERT: Preventing Needlestick Injuries in Health Care Settings, Pub. 2000-108, Nov. 1999
The PICC WAND is a trademark of Access Scientific, Inc.
SOURCE: Teleflex Incorporated
Teleflex Incorporated
Jake Elguicze, 610-948-2836
Vice President, Investor Relations
Copyright Business Wire 2010
Source
Epidemiological study of phylogenetic transmission clusters in a local HIV-1 epidemic reveals distinct differences between subtype B and non-B infections
The number of HIV-1 infected individuals in the Western world continues to rise. More in-depth understanding of regional HIV-1 epidemics is necessary for the optimal design and adequate use of future prevention strategies.
The use of a combination of phylogenetic analysis of HIV sequences, with data on patients'demographics, infection route, clinical information and laboratory results, will allow a better characterization of individuals responsible for local transmission.
Methods: Baseline HIV-1 pol sequences, obtained through routine drug-resistance testing, from 506 patients, newly diagnosed between 2001 and 2009, were used to construct phylogenetic trees and identify transmission-clusters. Patients'demographics, laboratory and clinical data, were retrieved anonymously.
Statistical analysis was performed to identify subtype-specific and transmission-cluster-specific characteristics.
Results: Multivariate analysis showed significant differences between the 59.7% of individuals with subtype B infection and the 40.3% non-B infected individuals, with regard to route of transmission, origin, infection with Chlamydia (p=0.01) and infection with Hepatitis C virus (p=0.017). More and larger transmission-clusters were identified among the subtype B infections (p<0.001).
Overall, in multivariate analysis, clustering was significantly associated with Caucasian origin, infection through homosexual contact and younger age (all p<0.001). Bivariate analysis additionally showed a correlation between clustering and syphilis (p<0.001),higher CD4 counts (p=0.002), Chlamydia infection (p=0.013) and primary HIV (p=0.017).
Conclusions: Combination of phylogenetics with demographic information, laboratory and clinical data, revealed that HIV-1 subtype B infected Caucasian men-who-have-sex-with-men with high prevalence of sexually transmitted diseases, account for the majority of local HIV-transmissions.
This finding elucidates observed epidemiological trends through molecular analysis, and justifies sustained focus in prevention on this high risk group.
Author: Kristen ChalmetDelfien StaelensStijn BlotSylvie DinakisJolanda PelgromJean PlumDirk VogelaersLinos VandekerckhoveChris Verhofstede
Credits/Source: BMC Infectious Diseases 2010, 10:262
Published on: 2010-09-07
Source
The use of a combination of phylogenetic analysis of HIV sequences, with data on patients'demographics, infection route, clinical information and laboratory results, will allow a better characterization of individuals responsible for local transmission.
Methods: Baseline HIV-1 pol sequences, obtained through routine drug-resistance testing, from 506 patients, newly diagnosed between 2001 and 2009, were used to construct phylogenetic trees and identify transmission-clusters. Patients'demographics, laboratory and clinical data, were retrieved anonymously.
Statistical analysis was performed to identify subtype-specific and transmission-cluster-specific characteristics.
Results: Multivariate analysis showed significant differences between the 59.7% of individuals with subtype B infection and the 40.3% non-B infected individuals, with regard to route of transmission, origin, infection with Chlamydia (p=0.01) and infection with Hepatitis C virus (p=0.017). More and larger transmission-clusters were identified among the subtype B infections (p<0.001).
Overall, in multivariate analysis, clustering was significantly associated with Caucasian origin, infection through homosexual contact and younger age (all p<0.001). Bivariate analysis additionally showed a correlation between clustering and syphilis (p<0.001),higher CD4 counts (p=0.002), Chlamydia infection (p=0.013) and primary HIV (p=0.017).
Conclusions: Combination of phylogenetics with demographic information, laboratory and clinical data, revealed that HIV-1 subtype B infected Caucasian men-who-have-sex-with-men with high prevalence of sexually transmitted diseases, account for the majority of local HIV-transmissions.
This finding elucidates observed epidemiological trends through molecular analysis, and justifies sustained focus in prevention on this high risk group.
Author: Kristen ChalmetDelfien StaelensStijn BlotSylvie DinakisJolanda PelgromJean PlumDirk VogelaersLinos VandekerckhoveChris Verhofstede
Credits/Source: BMC Infectious Diseases 2010, 10:262
Published on: 2010-09-07
Source
FDA Puts Hold on Idenix Study Due to Safety Concerns
By Jennifer Booton
Published September 07, 2010
FOXBusiness
Idenix Pharmaceuticals (NASDAQ:IDIX) tumbled nearly 50% Tuesday on news that safety concerns led to the suspension by the US Food and Drug Administration of a drug interaction study involving a treatment for Hepatitis C.
The decision emerged after Idenix notified the FDA of three serious adverse events related to liver function that occurred during a drug-to-drug interaction study of the combination of IDX184 and IDX320 in healthy volunteers.
The liver function tests have since returned to normal, the company said, and no healthy volunteers or patients are currently receiving the treatment.
“We will work closely with independent experts and our external safety committee to better understand the cause of these serious adverse events in the combination study of IDX184 and IDX320 and to provide the FDA with more information in order to expedite their review and resolve this matter as quickly as possible,” CEO Jean-Pierre Sommadossi, Ph.D. said.
Based on the studies, he said, the company remains committed to the “future potential” of the drugs.
Source
Published September 07, 2010
FOXBusiness
Idenix Pharmaceuticals (NASDAQ:IDIX) tumbled nearly 50% Tuesday on news that safety concerns led to the suspension by the US Food and Drug Administration of a drug interaction study involving a treatment for Hepatitis C.
The decision emerged after Idenix notified the FDA of three serious adverse events related to liver function that occurred during a drug-to-drug interaction study of the combination of IDX184 and IDX320 in healthy volunteers.
The liver function tests have since returned to normal, the company said, and no healthy volunteers or patients are currently receiving the treatment.
“We will work closely with independent experts and our external safety committee to better understand the cause of these serious adverse events in the combination study of IDX184 and IDX320 and to provide the FDA with more information in order to expedite their review and resolve this matter as quickly as possible,” CEO Jean-Pierre Sommadossi, Ph.D. said.
Based on the studies, he said, the company remains committed to the “future potential” of the drugs.
Source
Vertex Cures Hard-to-Treat Hep C Patients
By Adam Feuerstein 09/07/10 - 04:02 PM EDT
CAMBRIDGE, Mass. (TheStreet) -- Vertex Pharmaceuticals (VRTX) released new late-stage clinical data Tuesday demonstrating that 65% of hepatitis C patients whose prior therapy was unsuccessful were able to later achieve a viral cure following treatment with the company's experimental drug telaprevir plus the current standard of care.
By comparison, only 17% of these hard-to-treat hepatitis C patients were cured after being treated again with the current standard of care -- long-acting interferon plus ribavirin. The results were statistically significant.
These results come from the last of three major phase III studies of telaprevir conducted by Vertex and partner Johnson & Johnson(JNJ). Previous, positive results from the other two late-stage telaprevir studies in newly treated hepatitis C patients were released in May and August. The companies intend to seek regulatory approval for telaprevir later this year.
This last phase III study, dubbed "Realize," was set up to confirm previous, earlier findings that showed telaprevir could cure a significant number of hepatitis C patients without treatment options because they failed to respond to the current standard of care.
The Realize study enrolled 662 so-called treatment resistant hepatitis C patients split into three different groups: Those who respond to treatment but then relapse during the follow-up period; patients who partially respond to treatment but whose virus never completely disappears; and patients who never respond well to treatment at all.
Since these patients have a form of the hepatitis C virus that is more stubborn or harder to treat, Vertex extended the total treatment duration in the Realize study to 48 weeks, compared to just 24 weeks in the previous studies of newly treated patients. [Like in other studies, telaprevir was still dosed for only 12 weeks.]
The overall results showed that 65% of patients treated with telaprevir plus the standard of care achieved a cure, or sustained viral response, compared to 17% of patients in the control arm who were re-treated with just the standard of care.
Breaking the results down into the different groups, 86% of relapsers were cured after telaprevir treatment compared to 24% in the control arm.
Among partial responders, the cure rate for the telaprevir-treated patients was 57% compared to 15% for the control arm.
Finally, in the null responder patients, the most difficult to treat patients, telaprevir achieved a 31% cure rate compared to 5% for the control arm.
Results across all three patients types were statistically significant in favor of telaprevir over standard of care.
Wall Street has been waiting for the data from the Realize study, generally expecting overall cure rates for telaprevir in the 60-70% range. The data are important because the competitive race towards approval of the first new hepatitis C drug that acts directly against the virus is heating up.
Merck (MRK) is developing its own hepatitis C drug boceprevir and is the closest competitor to Vertex. In August, Merck announced results from phase III studies showing that treatment with boceprevir led to a 66% cure rate in treatment-resistant patients.
Optically, it would appear that boceprevir and telaprevir are equally effective in curing treatment-resistant patients, which would be a letdown for Vertex and its investors given that expectations have clearly favored Vertex's drug over Merck's.
However, Vertex allowed truly non-, or null, responders into the Realize study of telaprevir, which made it more difficult for the drug to prove efficacy. Merck, on the other hand, used a less stringent definition of null response that essentially helped boceprevir achieve a higher cure rate.
If null responders are removed from analysis of the Realize study, the cure rate for partial responders and relapsers to telaprevir was 78%, which is a more accurate comparison to the 66% cure rate seen in the Merck study of boceprevir.
This doesn't mean that all went swimmingly for Vertex in the Realize results. The 31% cure rate in the null responders group treated with telaprevir was lower than what Wall Street was expecting given prior results from earlier studies.
Some analysts, including Bank of America's biotech analyst (and hepatitis C axe) Rachel McMinn, were expecting to see null responder cure rates for telaprevir in the 50% range.
Vertex said that the null responders enrolled in the Realize study had higher rates of cirrhosis and high hepatitis C viral load than the other patients in the study, which could help explain why the cure rate among these patients was lower. Despite that, telaprevir still cured five times more null responders than re-treatment with the standard of care.
Likewise, the 57% cure rate for telaprevir in partial responder patients was also a bit lower than Wall Street expectations, which means the overall, high response rate to Vertex's drug was driven largely by relapsers, considered to be the easiest of the treatment-resistant patients to respond to follow-on therapy.
On the safety side of the ledger, the new telaprevir data appear to be little changed from what's been released from the previous phase III studies. Adverse events leading to patients dropping out of the study were 4% in the telaprevir arm compared to 3% in the control arm. The most common adverse events attributed to telaprevir were fatigue and rash.
Vertex intends to make a full presentation of the Realize study data at a future medical meeting or by publication in a medical journal. Both Vertex and Merck will be among the companies presenting hepatitis C drug data at the American Association for the Study of Liver Disease annual meeting at the end of October.
--Written by Adam Feuerstein in Boston
Source
CAMBRIDGE, Mass. (TheStreet) -- Vertex Pharmaceuticals (VRTX) released new late-stage clinical data Tuesday demonstrating that 65% of hepatitis C patients whose prior therapy was unsuccessful were able to later achieve a viral cure following treatment with the company's experimental drug telaprevir plus the current standard of care.
By comparison, only 17% of these hard-to-treat hepatitis C patients were cured after being treated again with the current standard of care -- long-acting interferon plus ribavirin. The results were statistically significant.
These results come from the last of three major phase III studies of telaprevir conducted by Vertex and partner Johnson & Johnson(JNJ). Previous, positive results from the other two late-stage telaprevir studies in newly treated hepatitis C patients were released in May and August. The companies intend to seek regulatory approval for telaprevir later this year.
This last phase III study, dubbed "Realize," was set up to confirm previous, earlier findings that showed telaprevir could cure a significant number of hepatitis C patients without treatment options because they failed to respond to the current standard of care.
The Realize study enrolled 662 so-called treatment resistant hepatitis C patients split into three different groups: Those who respond to treatment but then relapse during the follow-up period; patients who partially respond to treatment but whose virus never completely disappears; and patients who never respond well to treatment at all.
Since these patients have a form of the hepatitis C virus that is more stubborn or harder to treat, Vertex extended the total treatment duration in the Realize study to 48 weeks, compared to just 24 weeks in the previous studies of newly treated patients. [Like in other studies, telaprevir was still dosed for only 12 weeks.]
The overall results showed that 65% of patients treated with telaprevir plus the standard of care achieved a cure, or sustained viral response, compared to 17% of patients in the control arm who were re-treated with just the standard of care.
Breaking the results down into the different groups, 86% of relapsers were cured after telaprevir treatment compared to 24% in the control arm.
Among partial responders, the cure rate for the telaprevir-treated patients was 57% compared to 15% for the control arm.
Finally, in the null responder patients, the most difficult to treat patients, telaprevir achieved a 31% cure rate compared to 5% for the control arm.
Results across all three patients types were statistically significant in favor of telaprevir over standard of care.
Wall Street has been waiting for the data from the Realize study, generally expecting overall cure rates for telaprevir in the 60-70% range. The data are important because the competitive race towards approval of the first new hepatitis C drug that acts directly against the virus is heating up.
Merck (MRK) is developing its own hepatitis C drug boceprevir and is the closest competitor to Vertex. In August, Merck announced results from phase III studies showing that treatment with boceprevir led to a 66% cure rate in treatment-resistant patients.
Optically, it would appear that boceprevir and telaprevir are equally effective in curing treatment-resistant patients, which would be a letdown for Vertex and its investors given that expectations have clearly favored Vertex's drug over Merck's.
However, Vertex allowed truly non-, or null, responders into the Realize study of telaprevir, which made it more difficult for the drug to prove efficacy. Merck, on the other hand, used a less stringent definition of null response that essentially helped boceprevir achieve a higher cure rate.
If null responders are removed from analysis of the Realize study, the cure rate for partial responders and relapsers to telaprevir was 78%, which is a more accurate comparison to the 66% cure rate seen in the Merck study of boceprevir.
This doesn't mean that all went swimmingly for Vertex in the Realize results. The 31% cure rate in the null responders group treated with telaprevir was lower than what Wall Street was expecting given prior results from earlier studies.
Some analysts, including Bank of America's biotech analyst (and hepatitis C axe) Rachel McMinn, were expecting to see null responder cure rates for telaprevir in the 50% range.
Vertex said that the null responders enrolled in the Realize study had higher rates of cirrhosis and high hepatitis C viral load than the other patients in the study, which could help explain why the cure rate among these patients was lower. Despite that, telaprevir still cured five times more null responders than re-treatment with the standard of care.
Likewise, the 57% cure rate for telaprevir in partial responder patients was also a bit lower than Wall Street expectations, which means the overall, high response rate to Vertex's drug was driven largely by relapsers, considered to be the easiest of the treatment-resistant patients to respond to follow-on therapy.
On the safety side of the ledger, the new telaprevir data appear to be little changed from what's been released from the previous phase III studies. Adverse events leading to patients dropping out of the study were 4% in the telaprevir arm compared to 3% in the control arm. The most common adverse events attributed to telaprevir were fatigue and rash.
Vertex intends to make a full presentation of the Realize study data at a future medical meeting or by publication in a medical journal. Both Vertex and Merck will be among the companies presenting hepatitis C drug data at the American Association for the Study of Liver Disease annual meeting at the end of October.
--Written by Adam Feuerstein in Boston
Source
Vertex Nails Third Big Trial With Hepatitis C Drug, In Toughest Patients to Treat
Luke Timmerman 9/7/10
Vertex Pharmaceuticals stepped up to the plate this year with three big swings for the fence, and it can now say it has gone 3-for-3.
The Cambridge, MA-based biotech company (NASDAQ: VRTX), which has significant operations in San Diego, is announcing today that a combination of standard treatment and its novel drug for hepatitis C was able to cure two-thirds of patients who had failed to respond to a prior round of the standard drugs alone. That response rate for patients on Vertex’s telaprevir (65 percent) far exceeded that of the comparison group, in which just 17 percent of patients were cured after getting the usual combination of pegylated interferon alpha and ribavirin. Vertex is making the announcement today, based on findings from more than 660 patients who enrolled in a study called “Realize.”
“The Realize data represent a major milestone in the development of new treatments for hepatitis C,” Stefan Zeuzem, a professor of medicine at the JW Goethe University Hospital in Frankfurt, Germany and principal investigator of the trial, said in a Vertex statement. “These results may provide hope to people who have not been cured and who are in need of new treatment options.”
This is the third major batch of study results from Vertex this year, and part of its quest to shake up the standard of care for patients with hepatitis C, a chronic liver disease. The company showed back in May, in a study of more than 1,000 patients, that about three-fourths of people getting their first round of treatment were considered cured after getting telaprevir in combination with the standard meds. A second study, released last month, showed that the drug could cut the treatment time in half, which is important because it means patients don’t have to endure the flu-like symptoms caused by the other drugs in the regimen for nearly as long. And today’s announcement reinforces findings from small trials that says the telaprevir-based regimen has far greater ability to kill the virus in the toughest patients to treat.
The business opportunity, which we’ve written about a lot in these pages, is huge. An estimated 6 million people in the U.S. and Europe have chronic hepatitis C infections, and an estimated 650,000 of them have failed a prior round of the standard treatment. If the FDA clears the drug for sale based on the latest clinical trials, telaprevir could generate more than $2.6 billion in U.S. sales by 2013, according to analyst Rachel McMinn of Cowen & Co.
Based on the results of the three pivotal trials, Vertex plans to file an application for FDA approval by the end of this year.
The drug’s side effect profile appeared to be similar to what researchers have already seen from telaprevir. Patients in the trial reported cases of fatigue, itching, headache, rash, flu-like symptoms and nausea. About 4 percent of patients in the telaprevir group dropped out of the study because of adverse events, while about 3 percent discontinued in the control group, Vertex said.
The latest results from the Realize study are not just important to patients, but also to Vertex from a competitive standpoint. The company is preparing to face off against Merck’s boceprevir, another drug from the class of anti-viral drugs known as protease inhibitors. Merck released results from a pair of Phase III clinical trials last month, one in which patients were getting their first round of therapy, and another in which patients were getting re-treatment. The re-treated patients had a clinical cure rate of 59 percent to 66 percent, according to this recap from TheStreet.com.
Of course, the Merck and Vertex trials were designed differently, and didn’t test the drugs head to head, so it’s really an apples to oranges comparison. But Vertex offered some insight in this feature back in September 2008 about how it designed the Realize trial to hopefully provide a little extra advantage for its product in the minds of physicians.
Now that Vertex has cleared all three major trials that it needed to run to fill out its FDA application, the question of how telaprevir stacks up against the Merck drug and how it will be received by physicians and patients will take on even greater significance than before. You can be sure that patients are going to be hounding the company and the FDA about exactly when this drug might become commercially available in the U.S.
Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. You can e-mail him at ltimmerman@xconomy.com, or follow him at twitter.com/ldtimmerman
Source
Vertex Pharmaceuticals stepped up to the plate this year with three big swings for the fence, and it can now say it has gone 3-for-3.
The Cambridge, MA-based biotech company (NASDAQ: VRTX), which has significant operations in San Diego, is announcing today that a combination of standard treatment and its novel drug for hepatitis C was able to cure two-thirds of patients who had failed to respond to a prior round of the standard drugs alone. That response rate for patients on Vertex’s telaprevir (65 percent) far exceeded that of the comparison group, in which just 17 percent of patients were cured after getting the usual combination of pegylated interferon alpha and ribavirin. Vertex is making the announcement today, based on findings from more than 660 patients who enrolled in a study called “Realize.”
“The Realize data represent a major milestone in the development of new treatments for hepatitis C,” Stefan Zeuzem, a professor of medicine at the JW Goethe University Hospital in Frankfurt, Germany and principal investigator of the trial, said in a Vertex statement. “These results may provide hope to people who have not been cured and who are in need of new treatment options.”
This is the third major batch of study results from Vertex this year, and part of its quest to shake up the standard of care for patients with hepatitis C, a chronic liver disease. The company showed back in May, in a study of more than 1,000 patients, that about three-fourths of people getting their first round of treatment were considered cured after getting telaprevir in combination with the standard meds. A second study, released last month, showed that the drug could cut the treatment time in half, which is important because it means patients don’t have to endure the flu-like symptoms caused by the other drugs in the regimen for nearly as long. And today’s announcement reinforces findings from small trials that says the telaprevir-based regimen has far greater ability to kill the virus in the toughest patients to treat.
The business opportunity, which we’ve written about a lot in these pages, is huge. An estimated 6 million people in the U.S. and Europe have chronic hepatitis C infections, and an estimated 650,000 of them have failed a prior round of the standard treatment. If the FDA clears the drug for sale based on the latest clinical trials, telaprevir could generate more than $2.6 billion in U.S. sales by 2013, according to analyst Rachel McMinn of Cowen & Co.
Based on the results of the three pivotal trials, Vertex plans to file an application for FDA approval by the end of this year.
The drug’s side effect profile appeared to be similar to what researchers have already seen from telaprevir. Patients in the trial reported cases of fatigue, itching, headache, rash, flu-like symptoms and nausea. About 4 percent of patients in the telaprevir group dropped out of the study because of adverse events, while about 3 percent discontinued in the control group, Vertex said.
The latest results from the Realize study are not just important to patients, but also to Vertex from a competitive standpoint. The company is preparing to face off against Merck’s boceprevir, another drug from the class of anti-viral drugs known as protease inhibitors. Merck released results from a pair of Phase III clinical trials last month, one in which patients were getting their first round of therapy, and another in which patients were getting re-treatment. The re-treated patients had a clinical cure rate of 59 percent to 66 percent, according to this recap from TheStreet.com.
Of course, the Merck and Vertex trials were designed differently, and didn’t test the drugs head to head, so it’s really an apples to oranges comparison. But Vertex offered some insight in this feature back in September 2008 about how it designed the Realize trial to hopefully provide a little extra advantage for its product in the minds of physicians.
Now that Vertex has cleared all three major trials that it needed to run to fill out its FDA application, the question of how telaprevir stacks up against the Merck drug and how it will be received by physicians and patients will take on even greater significance than before. You can be sure that patients are going to be hounding the company and the FDA about exactly when this drug might become commercially available in the U.S.
Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. You can e-mail him at ltimmerman@xconomy.com, or follow him at twitter.com/ldtimmerman
Source
65% of People Whose Prior Treatment for Hepatitis C Was Unsuccessful Achieved SVR (Viral Cure) with Telaprevir-Based Therapy in Phase 3 REALIZE Study
-17% of people achieved SVR with pegylated-interferon and ribavirin alone in the control arm-
-Safety and tolerability results were consistent with prior Phase 3 studies-
-Completion of rolling New Drug Application submission on track for the fourth quarter 2010-
CAMBRIDGE, Mass., Sep 07, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 65% of people overall achieved a sustained viral response (SVR or viral cure) with a telaprevir-based regimen in the pivotal Phase 3 REALIZE study, as compared to 17% of people in the control arm who received pegylated-interferon and ribavirin alone. REALIZE enrolled three groups of patients with genotype 1 hepatitis C who had undergone at least one prior treatment course with pegylated-interferon and ribavirin but did not achieve SVR: (1) those who relapsed, (2) those who achieved a partial response and (3) those who had almost no response, known as a null response. REALIZE is the only Phase 3 hepatitis C study to date of an investigational direct-acting antiviral therapy that was designed to evaluate all major subgroups of people whose prior treatment was unsuccessful, including those who had a null response. The safety and tolerability results were consistent with results from the other two Phase 3 studies of telaprevir. The REALIZE study was conducted by Vertex's collaborator, Tibotec.
"The REALIZE data represent a major milestone in the development of new treatments for hepatitis C, as patients who received telaprevir-based therapy had a viral cure rate almost four times greater than the cure rate in those treated with available medicines," said Stefan Zeuzem, M.D., Professor of Medicine and Chief of the Department of Medicine at the JW Goethe University Hospital, Frankfurt, Germany and Principal Investigator of the trial. "These results may provide hope to people who have not been cured and who are in need of new treatment options, including those with advanced liver disease."
"Along with results from ADVANCE and ILLUMINATE, the REALIZE data provide us with a strong understanding of telaprevir's potential role in helping many people with hepatitis C achieve a cure, regardless of their treatment history," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "With these data, we look forward to completing our rolling New Drug Application submission for telaprevir later this year."
Overview of SVR Results
The primary endpoint of the study was SVR in each of the two telaprevir arms compared to the control arm, as well as across the three subgroups of people included in the study. One of the telaprevir treatment arms was designed to evaluate, for the first time, whether there was any further improvement in viral cure rates when delaying the start of telaprevir by four weeks, during which time patients received four weeks of pegylated-interferon and ribavirin alone, compared to a simultaneous start. The SVR rates between these two arms were similar and there was no clinical benefit to the telaprevir delayed start treatment arm in any of the subgroups of patients. The table below combines the two telaprevir arms compared to the control.
Telaprevir- based Treatment Arms+
Relapsers (n=354)
86%*
(n=245/286)
Partial Responders (n=124)
57%*
(n=55/97)
Null Responders (n=184)
31%*
(n=46/147)
Overall (ITT) (n=662)
65%*
(n=346/530)
Pooled Analysis: 78% (n=300/383)**
Control Arm++
Relapsers (n=354)24%
(n=16/68)
Partial Responders (n=124)
15%
(n=4/27)
Null Responders (n=184)
5%
(n=2/37)
Overall (ITT) (n=662)
17%
(n=22/132)
Pooled Analysis: 21% (n = 20/95)**
* Combined endpoint analysis: The SVR rates observed in the overall combined telaprevir-based arms were statistically significant when compared with the control arm (p < 0.0001). Additionally, the SVR rates observed in each of the three groups of patients evaluated were statistically significant when compared with the control arm (relapsers and partial responders (p<0.0001) and null responders (p<0.001)).
+ Reflects SVR rates from the combined telaprevir-based treatment groups. There were two telaprevir-based treatment groups:
1. 12 weeks of telaprevir (750 mg, q8h), pegylated-interferon (Peg-IFN) & ribavirin (RBV), followed by 36 weeks of Peg-IFN & RBV alone or
2. 4 weeks of Peg-IFN & RBV alone followed by 12 weeks of telaprevir (750 mg, q8h), Peg-IFN & RBV, followed by 32 weeks of Peg-IFN & RBV alone
++12 weeks of placebo, Peg-IFN & RBV, followed by 36 weeks of Peg-IFN and RBV alone
**Supplemental analysis
Null Responder: Defined as a person who achieved a less than 2 log10 reduction in HCV RNA at week 12 of a prior course of therapy.
Relapser: Defined as a person whose hepatitis C virus was undetectable at the completion of at least 42 weeks of a prior course of therapy but whose virus became detectable during the follow-up period.
Partial Responder: Defined as a person who achieved at least a 2 log10 reduction at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy.
Backgrounders on hepatitis C treatment response and the REALIZE study (including trial design diagram) can be found at http://investors.vrtx.com/press.cfm
SVR rates for the telaprevir simultaneous start arm and the delayed start arm were 64% and 66%, respectively, overall, based on an intent-to-treat (ITT) analysis. For the primary analysis, the SVR rates for the telaprevir simultaneous start arm, delayed start arm and control arm, respectively, were 83%, 88% and 24% in relapsers (p<0.0001); 59%, 54% and 15% in partial responders, (p<0.0001); and 29%, 33% and 5% in null responders, (p<0.001).
Safety & Tolerability Results
The safety and tolerability results of the telaprevir-based regimens in the REALIZE study were consistent with results reported from the Phase 3 ADVANCE and ILLUMINATE studies. The most common adverse events, reported in any treatment arm during the telaprevir dosing periods and up to week 16 to account for the telaprevir delayed start arm in order of frequency, were fatigue, pruritis, headache, rash, flu-like symptoms, nausea and anemia, with the majority being mild to moderate. Of these, fatigue, pruritis, rash, flu-like symptoms, nausea and anemia were more common in the telaprevir-based treatment arms compared to control. Adverse events leading to discontinuation of all study drugs during the telaprevir dosing period and up to week 16 occurred in 4% of people in the combined telaprevir arms and 3% in the control arm during the same period. Discontinuation of all drugs due to anemia and rash during the telaprevir dosing period and up to week 16 occurred in 0.6% and 0.4% of patients, respectively, in the combined telaprevir arms, while discontinuation of all three drugs due to rash and anemia did not occur in the control arm during the same period. As in ADVANCE and ILLUMINATE, the use of erythropoiesis-stimulating agents (ESAs) was not allowed in this study.
Telaprevir is an investigational, oral inhibitor of HCV protease, an enzyme essential for viral replication, and is being developed by Vertex Pharmaceuticals in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. With results from the three Phase 3 studies of telaprevir - ADVANCE, ILLUMINATE and REALIZE - Vertex is on track to complete its rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2010.
Patient Demographics
REALIZE enrolled people with hepatitis C who did not achieve a viral cure after receiving at least one course of prior treatment with pegylated-interferon and ribavirin. Patients in the study were enrolled based on their response to prior treatment: 53% were prior relapsers, 19% were prior partial responders and 28% were prior null responders. In this study, 26% of patients overall had cirrhosis and 89% of patients overall had a high viral load (HCV RNA greater-than or equal to 800,000 IU/mL) when entering the study. Specifically in the null responder population, there were an even greater number of people with cirrhosis (33%) and high viral load (95%). Approximately 50% of patients were genotype 1a and 50% were genotype 1b.
About the Study
REALIZE was a pivotal Phase 3, randomized, double-blind, placebo-controlled study conducted in 662 people at more than 100 international clinical trial sites with the majority in Europe and North America. The study was designed to evaluate the efficacy, safety and tolerability of telaprevir-based regimens in people infected with genotype 1 chronic hepatitis C who did not achieve a viral cure after at least one prior treatment with interferon-based therapy. There were two telaprevir-based arms (simultaneous and delayed start) and one control arm. Patients were randomized 2:2:1 to the two telaprevir arms and the control arm, respectively.
The primary endpoint of the REALIZE study was SVR, defined as the proportion of people who had undetectable HCV RNA (<25IU/mL undetectable by Roche COBAS Taqman HCV test) 24 weeks after the end of all treatment. REALIZE was designed to compare the SVR rates for each of the telaprevir-based regimens with the control arm, separately for the prior response subgroups of relapsers and non-responders (null and partial responders), and then for the two subgroups of non-responders. The secondary endpoint was to evaluate the safety and tolerability of telaprevir in combination with pegylated-interferon and ribavirin.
As in all Phase 3 studies of telaprevir, patients received no more than 12 weeks of telaprevir given in combination with pegylated interferon and ribavirin. In REALIZE, the telaprevir arms included 12 weeks of telaprevir in combination with pegylated-interferon and ribavirin with 36 weeks of pegylated-interferon and ribavirin alone for a total of 48 weeks of treatment.
About the Telaprevir Development Program
To date, more than 2,500 people with hepatitis C have received telaprevir-based therapy as part of Phase 2 studies and the Phase 3 ADVANCE, ILLUMINATE and REALIZE studies. Together, these studies enrolled people with genotype 1 hepatitis C who had not been treated for their disease previously as well as people who had been treated before but did not achieve a viral cure.
Vertex retains commercial rights to telaprevir in North America. Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of people with the disease.2 According to a 2010 report from the Institute of Medicine, up to 3.9 million people in the United States have chronic hepatitis C and 75% of those infected are unaware of their infection.3 Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved treatment regimen, do not achieve SVR, 4,5,6 or viral cure.1
Hepatitis C is spread through direct contact with the blood of infected people.2 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.2 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.2 If treatment is not successful and a person does not achieve a viral cure, they remain at risk for progressive liver disease.7,8,9,10,11 In the United States, hepatitis C is the leading cause of liver transplantations and is reported to contribute to 4,600 to 12,000 deaths annually.8 The majority of people with hepatitis C were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.11 By 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.11
Additional resources for media, including a hepatitis C backgrounder and glossary of common terms, are available at: http://investors.vrtx.com/press.cfm
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, epilepsy, cancer and pain.
Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of companies.
References:
1Ghany, m.G., Strader, d.B., Thomas, d.L., Seeff, Leondard B. Diagnosis, Management and Treatment of Hepatitis C; An Update. 2009. Hepatology. 2009;49 (4):1-40.
2 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed May 25, 2010.
3 Institute of Medicine. Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Available at http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Accessed May 25, 2010.
4 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
5 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
6 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
7 Morgan T.R, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138: 513-521
9 Volk, Michael I., Tocco, Rachel, Saini, Sameer, Lok, Anna S.F. Public Health Impact of Antiviral Therapy for Hepatitis C in the United States. Hepatology.2009;50(6):1750-1755.
10 Veldt, B.J., Heathcote, J., Wedmeyer, H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
11 Pyenson, B., Fitch, K., Iwasaki, K. Consequences of Hepatitis C Virus (HCV): Costs of a Baby Boomer Epidemic of Liver Disease. Milliman, Inc. This report was commissioned by Vertex Pharmaceuticals, Inc. May, 2009.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, including statements regarding (i) the Company being on track to complete the NDA for telaprevir in the fourth quarter of 2010 and (ii) the REALIZE data providing the Company with a strong understanding of telaprevir's potential role in helping many people with hepatitis C achieve a cure, regardless of their treatment history. While the Company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the Company could experience unforeseen delays in submitting the NDA for telaprevir and/or obtaining approval to market telaprevir; that there may be varying interpretations of the data from the telaprevir clinical trials; that future outcomes from clinical trials of telaprevir may not be favorable; and that future scientific, clinical, competitive or other market factors may adversely affect the potential for telaprevir-based combination therapy and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the Company's website at http://www.vrtx.com/. The Company disclaims any obligation to update the information contained in this press release as new information becomes available.
Investor Conference Call Today at 4:30 p.m. ET
Vertex Pharmaceuticals will host a conference call and webcast today, September 7, at 4:30 p.m. ET. This call and webcast will be broadcast via the Internet at www.vrtx.com/finances. It is suggested that webcast participants go to the web site at least 10 minutes in advance of the call to ensure that they can access the slides. The link to the webcast is available on the Events & Presentations button. To listen to the call on the telephone, dial (888) 634-7543 (U.S. and Canada) or (719) 457-2573 (International) and use conference ID number ID 5433422. Vertex is also providing a podcast MP3 file available for download on the Vertex website at http://www.vrtx.com/.
The call will be available for replay via telephone commencing September 8, 2010 at 8:00 p.m. ET running through September 22, 2010 at 5:00 p.m. ET. To listen to the replay dial (888) 203-1112 (U.S. and Canada) or (719) 457-0820 (International) and use conference ID number 5433422. Following the live webcast, an archived version will be available on Vertex's website until 5:00 p.m. on September 15, 2010.
New York City Investor and Analyst Webcast Tomorrow, September 8, at 8:00 a.m. ET
Vertex Pharmaceuticals will also webcast its investor and analyst meeting from New York City on Wednesday, September 8, 2010 at 8:00 a.m. ET. This webcast will be broadcast via the Internet at www.vrtx.com/finances. The link to the webcast is available on the Events & Presentations button. The New York City webcast will not be available via telephone. It is suggested that webcast participants go to the web site at least 10 minutes in advance of the call to ensure that they can access the slides.
(VRTX-GEN)
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6419968&lang=en
SOURCE: Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Media:
Zachry Barber, 617-444-6992
or
Amy Pasqua, 617-444-6992
or
Investors:Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755
or
Matthew Osborne, 617-444-6057
Copyright Business Wire 2010
Source
-Safety and tolerability results were consistent with prior Phase 3 studies-
-Completion of rolling New Drug Application submission on track for the fourth quarter 2010-
CAMBRIDGE, Mass., Sep 07, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 65% of people overall achieved a sustained viral response (SVR or viral cure) with a telaprevir-based regimen in the pivotal Phase 3 REALIZE study, as compared to 17% of people in the control arm who received pegylated-interferon and ribavirin alone. REALIZE enrolled three groups of patients with genotype 1 hepatitis C who had undergone at least one prior treatment course with pegylated-interferon and ribavirin but did not achieve SVR: (1) those who relapsed, (2) those who achieved a partial response and (3) those who had almost no response, known as a null response. REALIZE is the only Phase 3 hepatitis C study to date of an investigational direct-acting antiviral therapy that was designed to evaluate all major subgroups of people whose prior treatment was unsuccessful, including those who had a null response. The safety and tolerability results were consistent with results from the other two Phase 3 studies of telaprevir. The REALIZE study was conducted by Vertex's collaborator, Tibotec.
"The REALIZE data represent a major milestone in the development of new treatments for hepatitis C, as patients who received telaprevir-based therapy had a viral cure rate almost four times greater than the cure rate in those treated with available medicines," said Stefan Zeuzem, M.D., Professor of Medicine and Chief of the Department of Medicine at the JW Goethe University Hospital, Frankfurt, Germany and Principal Investigator of the trial. "These results may provide hope to people who have not been cured and who are in need of new treatment options, including those with advanced liver disease."
"Along with results from ADVANCE and ILLUMINATE, the REALIZE data provide us with a strong understanding of telaprevir's potential role in helping many people with hepatitis C achieve a cure, regardless of their treatment history," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "With these data, we look forward to completing our rolling New Drug Application submission for telaprevir later this year."
Overview of SVR Results
The primary endpoint of the study was SVR in each of the two telaprevir arms compared to the control arm, as well as across the three subgroups of people included in the study. One of the telaprevir treatment arms was designed to evaluate, for the first time, whether there was any further improvement in viral cure rates when delaying the start of telaprevir by four weeks, during which time patients received four weeks of pegylated-interferon and ribavirin alone, compared to a simultaneous start. The SVR rates between these two arms were similar and there was no clinical benefit to the telaprevir delayed start treatment arm in any of the subgroups of patients. The table below combines the two telaprevir arms compared to the control.
Telaprevir- based Treatment Arms+
Relapsers (n=354)
86%*
(n=245/286)
Partial Responders (n=124)
57%*
(n=55/97)
Null Responders (n=184)
31%*
(n=46/147)
Overall (ITT) (n=662)
65%*
(n=346/530)
Pooled Analysis: 78% (n=300/383)**
Control Arm++
Relapsers (n=354)24%
(n=16/68)
Partial Responders (n=124)
15%
(n=4/27)
Null Responders (n=184)
5%
(n=2/37)
Overall (ITT) (n=662)
17%
(n=22/132)
Pooled Analysis: 21% (n = 20/95)**
* Combined endpoint analysis: The SVR rates observed in the overall combined telaprevir-based arms were statistically significant when compared with the control arm (p < 0.0001). Additionally, the SVR rates observed in each of the three groups of patients evaluated were statistically significant when compared with the control arm (relapsers and partial responders (p<0.0001) and null responders (p<0.001)).
+ Reflects SVR rates from the combined telaprevir-based treatment groups. There were two telaprevir-based treatment groups:
1. 12 weeks of telaprevir (750 mg, q8h), pegylated-interferon (Peg-IFN) & ribavirin (RBV), followed by 36 weeks of Peg-IFN & RBV alone or
2. 4 weeks of Peg-IFN & RBV alone followed by 12 weeks of telaprevir (750 mg, q8h), Peg-IFN & RBV, followed by 32 weeks of Peg-IFN & RBV alone
++12 weeks of placebo, Peg-IFN & RBV, followed by 36 weeks of Peg-IFN and RBV alone
**Supplemental analysis
Null Responder: Defined as a person who achieved a less than 2 log10 reduction in HCV RNA at week 12 of a prior course of therapy.
Relapser: Defined as a person whose hepatitis C virus was undetectable at the completion of at least 42 weeks of a prior course of therapy but whose virus became detectable during the follow-up period.
Partial Responder: Defined as a person who achieved at least a 2 log10 reduction at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy.
Backgrounders on hepatitis C treatment response and the REALIZE study (including trial design diagram) can be found at http://investors.vrtx.com/press.cfm
SVR rates for the telaprevir simultaneous start arm and the delayed start arm were 64% and 66%, respectively, overall, based on an intent-to-treat (ITT) analysis. For the primary analysis, the SVR rates for the telaprevir simultaneous start arm, delayed start arm and control arm, respectively, were 83%, 88% and 24% in relapsers (p<0.0001); 59%, 54% and 15% in partial responders, (p<0.0001); and 29%, 33% and 5% in null responders, (p<0.001).
Safety & Tolerability Results
The safety and tolerability results of the telaprevir-based regimens in the REALIZE study were consistent with results reported from the Phase 3 ADVANCE and ILLUMINATE studies. The most common adverse events, reported in any treatment arm during the telaprevir dosing periods and up to week 16 to account for the telaprevir delayed start arm in order of frequency, were fatigue, pruritis, headache, rash, flu-like symptoms, nausea and anemia, with the majority being mild to moderate. Of these, fatigue, pruritis, rash, flu-like symptoms, nausea and anemia were more common in the telaprevir-based treatment arms compared to control. Adverse events leading to discontinuation of all study drugs during the telaprevir dosing period and up to week 16 occurred in 4% of people in the combined telaprevir arms and 3% in the control arm during the same period. Discontinuation of all drugs due to anemia and rash during the telaprevir dosing period and up to week 16 occurred in 0.6% and 0.4% of patients, respectively, in the combined telaprevir arms, while discontinuation of all three drugs due to rash and anemia did not occur in the control arm during the same period. As in ADVANCE and ILLUMINATE, the use of erythropoiesis-stimulating agents (ESAs) was not allowed in this study.
Telaprevir is an investigational, oral inhibitor of HCV protease, an enzyme essential for viral replication, and is being developed by Vertex Pharmaceuticals in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. With results from the three Phase 3 studies of telaprevir - ADVANCE, ILLUMINATE and REALIZE - Vertex is on track to complete its rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2010.
Patient Demographics
REALIZE enrolled people with hepatitis C who did not achieve a viral cure after receiving at least one course of prior treatment with pegylated-interferon and ribavirin. Patients in the study were enrolled based on their response to prior treatment: 53% were prior relapsers, 19% were prior partial responders and 28% were prior null responders. In this study, 26% of patients overall had cirrhosis and 89% of patients overall had a high viral load (HCV RNA greater-than or equal to 800,000 IU/mL) when entering the study. Specifically in the null responder population, there were an even greater number of people with cirrhosis (33%) and high viral load (95%). Approximately 50% of patients were genotype 1a and 50% were genotype 1b.
About the Study
REALIZE was a pivotal Phase 3, randomized, double-blind, placebo-controlled study conducted in 662 people at more than 100 international clinical trial sites with the majority in Europe and North America. The study was designed to evaluate the efficacy, safety and tolerability of telaprevir-based regimens in people infected with genotype 1 chronic hepatitis C who did not achieve a viral cure after at least one prior treatment with interferon-based therapy. There were two telaprevir-based arms (simultaneous and delayed start) and one control arm. Patients were randomized 2:2:1 to the two telaprevir arms and the control arm, respectively.
The primary endpoint of the REALIZE study was SVR, defined as the proportion of people who had undetectable HCV RNA (<25IU/mL undetectable by Roche COBAS Taqman HCV test) 24 weeks after the end of all treatment. REALIZE was designed to compare the SVR rates for each of the telaprevir-based regimens with the control arm, separately for the prior response subgroups of relapsers and non-responders (null and partial responders), and then for the two subgroups of non-responders. The secondary endpoint was to evaluate the safety and tolerability of telaprevir in combination with pegylated-interferon and ribavirin.
As in all Phase 3 studies of telaprevir, patients received no more than 12 weeks of telaprevir given in combination with pegylated interferon and ribavirin. In REALIZE, the telaprevir arms included 12 weeks of telaprevir in combination with pegylated-interferon and ribavirin with 36 weeks of pegylated-interferon and ribavirin alone for a total of 48 weeks of treatment.
About the Telaprevir Development Program
To date, more than 2,500 people with hepatitis C have received telaprevir-based therapy as part of Phase 2 studies and the Phase 3 ADVANCE, ILLUMINATE and REALIZE studies. Together, these studies enrolled people with genotype 1 hepatitis C who had not been treated for their disease previously as well as people who had been treated before but did not achieve a viral cure.
Vertex retains commercial rights to telaprevir in North America. Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of people with the disease.2 According to a 2010 report from the Institute of Medicine, up to 3.9 million people in the United States have chronic hepatitis C and 75% of those infected are unaware of their infection.3 Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved treatment regimen, do not achieve SVR, 4,5,6 or viral cure.1
Hepatitis C is spread through direct contact with the blood of infected people.2 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.2 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.2 If treatment is not successful and a person does not achieve a viral cure, they remain at risk for progressive liver disease.7,8,9,10,11 In the United States, hepatitis C is the leading cause of liver transplantations and is reported to contribute to 4,600 to 12,000 deaths annually.8 The majority of people with hepatitis C were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.11 By 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.11
Additional resources for media, including a hepatitis C backgrounder and glossary of common terms, are available at: http://investors.vrtx.com/press.cfm
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, epilepsy, cancer and pain.
Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of companies.
References:
1Ghany, m.G., Strader, d.B., Thomas, d.L., Seeff, Leondard B. Diagnosis, Management and Treatment of Hepatitis C; An Update. 2009. Hepatology. 2009;49 (4):1-40.
2 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed May 25, 2010.
3 Institute of Medicine. Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Available at http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Accessed May 25, 2010.
4 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
5 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
6 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
7 Morgan T.R, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138: 513-521
9 Volk, Michael I., Tocco, Rachel, Saini, Sameer, Lok, Anna S.F. Public Health Impact of Antiviral Therapy for Hepatitis C in the United States. Hepatology.2009;50(6):1750-1755.
10 Veldt, B.J., Heathcote, J., Wedmeyer, H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
11 Pyenson, B., Fitch, K., Iwasaki, K. Consequences of Hepatitis C Virus (HCV): Costs of a Baby Boomer Epidemic of Liver Disease. Milliman, Inc. This report was commissioned by Vertex Pharmaceuticals, Inc. May, 2009.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, including statements regarding (i) the Company being on track to complete the NDA for telaprevir in the fourth quarter of 2010 and (ii) the REALIZE data providing the Company with a strong understanding of telaprevir's potential role in helping many people with hepatitis C achieve a cure, regardless of their treatment history. While the Company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the Company could experience unforeseen delays in submitting the NDA for telaprevir and/or obtaining approval to market telaprevir; that there may be varying interpretations of the data from the telaprevir clinical trials; that future outcomes from clinical trials of telaprevir may not be favorable; and that future scientific, clinical, competitive or other market factors may adversely affect the potential for telaprevir-based combination therapy and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the Company's website at http://www.vrtx.com/. The Company disclaims any obligation to update the information contained in this press release as new information becomes available.
Investor Conference Call Today at 4:30 p.m. ET
Vertex Pharmaceuticals will host a conference call and webcast today, September 7, at 4:30 p.m. ET. This call and webcast will be broadcast via the Internet at www.vrtx.com/finances. It is suggested that webcast participants go to the web site at least 10 minutes in advance of the call to ensure that they can access the slides. The link to the webcast is available on the Events & Presentations button. To listen to the call on the telephone, dial (888) 634-7543 (U.S. and Canada) or (719) 457-2573 (International) and use conference ID number ID 5433422. Vertex is also providing a podcast MP3 file available for download on the Vertex website at http://www.vrtx.com/.
The call will be available for replay via telephone commencing September 8, 2010 at 8:00 p.m. ET running through September 22, 2010 at 5:00 p.m. ET. To listen to the replay dial (888) 203-1112 (U.S. and Canada) or (719) 457-0820 (International) and use conference ID number 5433422. Following the live webcast, an archived version will be available on Vertex's website until 5:00 p.m. on September 15, 2010.
New York City Investor and Analyst Webcast Tomorrow, September 8, at 8:00 a.m. ET
Vertex Pharmaceuticals will also webcast its investor and analyst meeting from New York City on Wednesday, September 8, 2010 at 8:00 a.m. ET. This webcast will be broadcast via the Internet at www.vrtx.com/finances. The link to the webcast is available on the Events & Presentations button. The New York City webcast will not be available via telephone. It is suggested that webcast participants go to the web site at least 10 minutes in advance of the call to ensure that they can access the slides.
(VRTX-GEN)
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SOURCE: Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
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Copyright Business Wire 2010
Source
September 6, 2010
15 Tips for Managing Interferon-Ribavirin Side Effects
Posted on: Sep 6, 2010
Many people abandon this challenging HCV treatment mid-course. Here are 15 ways to help manage the side effects of Hepatitis C combination therapy, to help patients' likelihood of completing the extremely challenging treatment. Share this article among patients contemplating and/or already undergoing chemotherapy for Hepatitis C, so they can help increase their likelihood of conquering the virus.
by Nicole Cutler, L.Ac.
Although it affects an estimated four to five million Americans, there is still no easy formula to eliminate the Hepatitis C virus (HCV). At best, infected individuals have a 50 percent chance of triumphing over the virus by enduring standard combination therapy, a notoriously challenging treatment with pegylated interferon and ribavirin medications. Most experts believe that the success rate of these drugs would be much higher without the burden of their potentially serious side effects. In cooperation with a physician, those with HCV who can manage standard combination therapy’s side effects are more likely to complete the drug regimen at full strength – and thus have a better chance of ridding the virus from their body.
Especially apparent in the first several weeks of treatment, the side effects of these drugs range from mild to severe. Managing these effects can be simple, involving lifestyle modifications, logical home remedies and taking some routine medications. Beyond these basics, working with a knowledgeable physician is important for customizing a plan to help someone manage their side effects.
The side effects from interferon and ribavirin therapy often lead to lowered dosages or even discontinuation of these drugs. Physicians agree that the more a dosage is reduced, the less of a chance the therapy has at successfully killing HCV. However, dose reduction or discontinuation of interferon or ribavirin may be indicated immediately if severe side effects develop.
Fifteen suggestions to discuss with your physician for managing the most common side effects of combination therapy are outlined below:
1. Getting a full night’s sleep helps the body recover from physical and emotional stressors. Being fully rested lessens the side effects of fatigue, headache, fever, myalgia (muscle pain), irritability and insomnia.
2. Keeping hydrated is helpful to counteract the drying properties of combination therapy. Keeping hydrated is advised to improve fatigue, headache, fever, myalgia and dry mouth.
3. Eating well-balanced meals helps the body bounce back from fatigue, headache, fever and myalgia.
4. Engaging in regular exercise keeps your circulation going and thus helps prevent fatigue, headache, fever and myalgia.
5. Taking a hot bath or using hot packs is recognized for helping relieve myalgia.
6. Taking acetaminophen (Tylenol) or NSAIDS can reduce fatigue, headaches, fever, myalgias or liver pain. However, dosage and safety considerations must be confirmed by your doctor since these drugs may place an additional burden on the liver.
7. Include ginger in your day by drinking it in tea, ale or snacking on ginger baked goods to relieve nausea.
8. Taking ribavirin with food and eating small, frequent meals helps ease ribavirin-related nausea.
9. Prochlorperazine (compazine) may stop nausea but should only be done under a physician’s guidance.
10. Avoiding stimulants like caffeine at night can reduce insomnia and irritability.
11. Practicing relaxation techniques, such as taking a deep breath and counting to ten, can significantly help reduce irritability.
12. Taking selective serotonin reuptake inhibitors (SSRIs) have been proven effective in treating the depression associated with interferon therapy for certain individuals. The additional side effects of SSRIs and treatment guidelines must be carefully evaluated by your physician.
13. Sharing feelings with friends, family or a support group can help many people cope with the irritability and depression often accompanying HCV therapy.
14. Being gentle with your hair can help minimize hair loss. This includes not pulling on or braiding the hair, avoiding vigorous combing or brushing and only using natural (not harsh) hair products.
15. Avoiding hot or spicy foods minimizes mouth irritation. For those dealing with the side effects of a dry mouth or mouth sores, avoiding these types of foods is a must.
Some of these tips for managing side effects are easily accomplished at home while others require collaboration with your physician. However it is accomplished, reducing side effect severity helps people endure a full course of combination therapy, a feat that increases their odds of eliminating the Hepatitis C virus.
References:
http://www.clevelandclinic.org/, Managing Side Effects of Hepatitis C Treatment, The Cleveland Clinic Department of Patient Education and Health Information, 2008.
http://www.hepatitis.va.gov/, Clinical Manual: Interferon and Ribavirin Treatment Side Effects, United States Department of Veteran Affairs, 2008.
http://www.hepcawareness.net.au/, Treatment Side Effects, Australian Hepatitis Council, 2008.
Source
Many people abandon this challenging HCV treatment mid-course. Here are 15 ways to help manage the side effects of Hepatitis C combination therapy, to help patients' likelihood of completing the extremely challenging treatment. Share this article among patients contemplating and/or already undergoing chemotherapy for Hepatitis C, so they can help increase their likelihood of conquering the virus.
by Nicole Cutler, L.Ac.
Although it affects an estimated four to five million Americans, there is still no easy formula to eliminate the Hepatitis C virus (HCV). At best, infected individuals have a 50 percent chance of triumphing over the virus by enduring standard combination therapy, a notoriously challenging treatment with pegylated interferon and ribavirin medications. Most experts believe that the success rate of these drugs would be much higher without the burden of their potentially serious side effects. In cooperation with a physician, those with HCV who can manage standard combination therapy’s side effects are more likely to complete the drug regimen at full strength – and thus have a better chance of ridding the virus from their body.
Especially apparent in the first several weeks of treatment, the side effects of these drugs range from mild to severe. Managing these effects can be simple, involving lifestyle modifications, logical home remedies and taking some routine medications. Beyond these basics, working with a knowledgeable physician is important for customizing a plan to help someone manage their side effects.
The side effects from interferon and ribavirin therapy often lead to lowered dosages or even discontinuation of these drugs. Physicians agree that the more a dosage is reduced, the less of a chance the therapy has at successfully killing HCV. However, dose reduction or discontinuation of interferon or ribavirin may be indicated immediately if severe side effects develop.
Fifteen suggestions to discuss with your physician for managing the most common side effects of combination therapy are outlined below:
1. Getting a full night’s sleep helps the body recover from physical and emotional stressors. Being fully rested lessens the side effects of fatigue, headache, fever, myalgia (muscle pain), irritability and insomnia.
2. Keeping hydrated is helpful to counteract the drying properties of combination therapy. Keeping hydrated is advised to improve fatigue, headache, fever, myalgia and dry mouth.
3. Eating well-balanced meals helps the body bounce back from fatigue, headache, fever and myalgia.
4. Engaging in regular exercise keeps your circulation going and thus helps prevent fatigue, headache, fever and myalgia.
5. Taking a hot bath or using hot packs is recognized for helping relieve myalgia.
6. Taking acetaminophen (Tylenol) or NSAIDS can reduce fatigue, headaches, fever, myalgias or liver pain. However, dosage and safety considerations must be confirmed by your doctor since these drugs may place an additional burden on the liver.
7. Include ginger in your day by drinking it in tea, ale or snacking on ginger baked goods to relieve nausea.
8. Taking ribavirin with food and eating small, frequent meals helps ease ribavirin-related nausea.
9. Prochlorperazine (compazine) may stop nausea but should only be done under a physician’s guidance.
10. Avoiding stimulants like caffeine at night can reduce insomnia and irritability.
11. Practicing relaxation techniques, such as taking a deep breath and counting to ten, can significantly help reduce irritability.
12. Taking selective serotonin reuptake inhibitors (SSRIs) have been proven effective in treating the depression associated with interferon therapy for certain individuals. The additional side effects of SSRIs and treatment guidelines must be carefully evaluated by your physician.
13. Sharing feelings with friends, family or a support group can help many people cope with the irritability and depression often accompanying HCV therapy.
14. Being gentle with your hair can help minimize hair loss. This includes not pulling on or braiding the hair, avoiding vigorous combing or brushing and only using natural (not harsh) hair products.
15. Avoiding hot or spicy foods minimizes mouth irritation. For those dealing with the side effects of a dry mouth or mouth sores, avoiding these types of foods is a must.
Some of these tips for managing side effects are easily accomplished at home while others require collaboration with your physician. However it is accomplished, reducing side effect severity helps people endure a full course of combination therapy, a feat that increases their odds of eliminating the Hepatitis C virus.
References:
http://www.clevelandclinic.org/, Managing Side Effects of Hepatitis C Treatment, The Cleveland Clinic Department of Patient Education and Health Information, 2008.
http://www.hepatitis.va.gov/, Clinical Manual: Interferon and Ribavirin Treatment Side Effects, United States Department of Veteran Affairs, 2008.
http://www.hepcawareness.net.au/, Treatment Side Effects, Australian Hepatitis Council, 2008.
Source
September 3, 2010
H.I.V. Prevention Gel Hits Snag: Money
Joao Silva for The New York Times
Volunteers who took part in a trial of a microbicide listened to results in Vulindlela, Kwazulu-Natal Province, South Africa.
JOHANNESBURG — When scientists celebrated the announcement in July that a vaginal microbicide had finally been found that significantly reduced H.I.V. infections in women, there was still a prosaic — though essential — piece of the puzzle missing: money.
Donors have not committed enough money for even one of the two studies needed to confirm a promising South African trial of the microbicide and get it into women’s hands. Only about $58 million of the $100 million needed for follow-up research has been pledged, according to Unaids, the United Nations AIDS agency. Experts say shifting global health priorities and tight finances in the West are making it hard to raise the rest.
Advocates say any delay could be deadly. Most of the 22 million people infected with H.I.V. in sub-Saharan Africa are women, and about a million women on the continent are infected each year. If subsequent studies find the gel effective, women could use it to protect themselves even when men refuse to use condoms.
“We have to keep our eye on the prize,” said Dr. Catherine Hankins, chief scientific adviser to Unaids. “It’s in reach. We have to close the funding gap and get the gel to women.”
Dozens of scientists and public health experts at a conference here last week agreed on the research needed to speed the microbicide to widespread use. They called for two more trials in southern Africa and steps to promote and distribute the vaginal gel, infused with the antiviral drug tenofovir, through family planning programs.
The original study of the gel found that women who used it before and after sex were 39 percent less likely over all to contract H.I.V. than those who used a placebo. Those who used the gel most regularly cut their odds of infection by 54 percent.
Researchers have tried for two decades to find a microbicide to fight H.I.V. transmission. So far, the American and South African governments have come up with a vast majority of the additional research money, while Britain’s Department for International Development, a major supporter of microbicide research, has committed nothing.
Participants in the conference said an agency official said the British government’s priorities were shifting away from AIDS and toward maternal and child health, malaria and tuberculosis.
“H.I.V./AIDS is perceived to be very expensive research, and there’s a sentiment in the U.K. that it’s time to shift priorities,” said Tim Farley, a World Health Organization scientist who attended the conference.
The British agency was noncommittal in a statement, saying that future spending “will be made based on impact on poverty eradication on the ground.”
Researchers also worry that the Bill and Melinda Gates Foundation, the most important philanthropic supporter, has not committed major financing for the additional studies on the gel. Dr. Stefano Bertozzi, who heads the foundation’s AIDS programs, said the gel — with a solid study showing its effectiveness — was just the kind of project that rich countries could justify to taxpayers. “It should be an easy case for South Africa, ourselves and others to make,” Dr. Bertozzi said.
He said the foundation was excited about the results, but tried to focus on riskier, longer-term research. The foundation has committed more than $250 million to microbicide research.
The hope is that two additional studies would provide the evidence to adopt the gel on a large scale. Three rigorous studies have established that male circumcision reduces a man’s risk of H.I.V. infection by at least half, and governments across Africa are beginning to offer it.
For the microbicide, researchers plan to lead one of the confirmatory studies in South Africa, where an estimated 5.7 million people are infected, more than in any other nation. Scientists would conduct the second study in five southern African nations.
Experts say investing in AIDS prevention is fiscally far preferable to the costs for lifelong treatment. Mead Over, a health economist at the Center for Global Development, says that providing antiretroviral therapy to the five million people with AIDS in Africa already receiving it will cost $72 billion over the next four decades. That amount rises to $225 billion if the number of people on treatment continues to grow.
“Donors should not be nickel and diming this research because by spending only $100 million they have a prospect of saving billions of dollars in treatment costs,” Mr. Over said.
Advocates make the case on humanitarian grounds.
“We see every day women getting infected by H.I.V.,” said Nomfundo Eland of the Treatment Action Campaign, an advocacy group here. “The sooner we can get a method in the control of women the better.”
Source
Week 4 Rapid Virological Response Predicts Sustained Response to Interferon-based Hepatitis C Treatment
SUMMARY: Rapid virological response (RVR), or undetectable plasma hepatitis C virus (HCV) RNA at 4 weeks after starting treatment with pegylated interferon plus ribavirin, has been confirmed as a good indicator of which patients will go on to achieve sustained virological response (SVR) at 6 months after completion of therapy, according to a review article published in the June 2010 issue of Alimentary Pharmacology and Therapeutics.
By Liz Highleyman
Standard treatment for chronic hepatitis C using pegylated interferon (Pegasys or PegIntron) plus ribavirin produces sustained response -- considered to be a cure -- about half the time, with HCV genotypes 2 and 3 (treated for 24 week) showing better response rates than hard-to-treat genotypes 1 or 4 (treated for 48 weeks).
Treatment is expensive and can cause difficult side effects, however, so it is useful to have an early indicator to enable patients to stop treatment that likely will not turn out to be successful.
F. Fred Poordad from Cedars-Sinai Medical Center in Los Angeles and colleagues collected data from previous published clinical trial reports in order to evaluate the predictive value of RVR as an indicator of SVR and viral relapse.
Results
Investigator affiliation: Hepatology and Liver Transplantation, Cedars-Sinai Medical Center, Los Angeles, CA.
9/3/10
Reference
FF Poordad. Review article: the role of rapid virological response in determining treatment duration for chronic hepatitis C. Alimentary Pharmacology and Therapeutics 31(12): 1251-1267 (Abstract). June 2010.
Source
By Liz Highleyman
Standard treatment for chronic hepatitis C using pegylated interferon (Pegasys or PegIntron) plus ribavirin produces sustained response -- considered to be a cure -- about half the time, with HCV genotypes 2 and 3 (treated for 24 week) showing better response rates than hard-to-treat genotypes 1 or 4 (treated for 48 weeks).
Treatment is expensive and can cause difficult side effects, however, so it is useful to have an early indicator to enable patients to stop treatment that likely will not turn out to be successful.
F. Fred Poordad from Cedars-Sinai Medical Center in Los Angeles and colleagues collected data from previous published clinical trial reports in order to evaluate the predictive value of RVR as an indicator of SVR and viral relapse.
Results
- Data supported a 24-week regimen for HCV genotype 1 patients who achieved RVR.
- The positive predictive value -- or how often RVR accurately predicted SVR -- was 77.8% for patients treated for 24 weeks versus 85.7% for those treated for 48 weeks, not a significant difference.
- However, lack of RVR among genotype 1 patients "should not be viewed as a criterion for extending treatment duration beyond 48 weeks."
- Negative predictive values -- or how often lack of RVR predicted failure to achieve SVR -- were 60.9% for genotype 1 patients treated for 48 weeks and 52.7% for those treated for 72 weeks, not a significant improvement with longer therapy.
- Among people with HCV genotypes 2 or 3, RVR also had a high positive predictive value.
- Negative predictive value, however, varied according to treatment duration, indicating that a 24-week regimen is warranted for genotype 2 or 3 patients who did not achieve RVR.
Investigator affiliation: Hepatology and Liver Transplantation, Cedars-Sinai Medical Center, Los Angeles, CA.
9/3/10
Reference
FF Poordad. Review article: the role of rapid virological response in determining treatment duration for chronic hepatitis C. Alimentary Pharmacology and Therapeutics 31(12): 1251-1267 (Abstract). June 2010.
Source
First Medical Marijuana Ad on TV (Video)
Friday, September 3rd, 2010 at 6:20 am
In Sacramento, California, the first medical marijuana ad was aired on television. The local Fox affiliate, KTXL, FOX40, aired the 30 second ad on Monday for CannaCare. The commercial (see video below) features testimonials for patients as the text ‘crawl’ describes how cannabis can relieve symptoms of illnesses such as hypertension, diabetes, HIV, hepatitis C and others. The commercial is believed to be the first in the United States for medical marijuana. CannaCare is not a medical marijuana dispensary, which are the places patients go to purchase cannabis.
The acting general manager of KTXL, Mike Armstrong, defends the station’s decision to run the ad during it’s 10pm local news broadcast. “It is a matter of record within the medical community that medical marijuana can have positive results in helping relieve nausea and vomiting among cancer patients receiving chemotherapy and increasing appetites among AIDS patients.”
CannaCare is a medical marijuana advocacy group. They do NOT sell marijuana! They primarily offer patients and the general public information on the medical use of marijuana as well as the legal details regard state and community laws. CannaCare does provide information on growing and cultivating marijuana, plus a list of suppliers of growing equipment.
Based in Seattle, CannaCare has branches in several states that have adopted medical marijuana laws. The TV ad does not use the term ‘marijuana’ at all during it, instead calling the product cannabis. Medical Marijuana relieves diseases such as AIDS/HIV, MS, diabetes, as well as chronic pain from arthritis. It’s benefits to assisting cancer patients ravaged by the side effects of chemotherapy are well documented.
KTXL, the Fox affiliate in Sacramento, has broken ground airing the first medical marijuana ad in the nation. There is no word yet if CannaCare intends to expand the ad campaign to include other states that allow the use of cannabis. Watch the commercial yourself (below) and decide for yourself if it will destroy Western Civilization.
Related Articles:
Fox Affiliate Airs Nation’s ‘First’ TV ad For Medical Marijuana
Medical Marijuana Hits the Small Screen
CannaCare Home Page
Source
Why DNA Vaccines May Be Commercially Viable
By: Jim Nelson Friday, September 03, 2010 11:13 AM
In the early 1990s, DNA vaccines for the treatment and prevention of diseases first emerged. Excitement about this technology was matched only by unrealistic expectations regarding the timeline to market. Interest was driven, however, by the real potential of the technology. For the first time, unvaccinatable targets like HIV and hepatitis C were in the bull's-eye. Traditional vaccine technology, using live or inactivated viruses, simply did not provide a viable way to provoke a protective immune response against these diseases.
Moreover, DNA vaccines could be used against diseases other than their historical target, viruses. Early on, it dawned on researchers that this new generation of vaccines could be used to train the immune system to attack cancers and a wide range of other malignancies that act like foreign invaders inside the body.
Conventional vaccines work by having the body's immune system recognize unique antigenic proteins that are part of the virus, triggering an immune response against the invader. The elegance of DNA vaccines is that, rather than introducing into the body an actual virus, only the antigen that would be recognized as foreign is introduced. Scientists realized that they could turn cells in the body into protein-manufacturing plants. By isolating the DNA responsible for producing ONLY the foreign antigenic protein associated with a specific virus, they could get around various issues associated with live or weakened viruses.
Big Pharma companies like Merck, Wyeth and GlaxoSmithKline as well as national labs and academic research facilities poured billions into a "first wave" attempt at producing commercially viable DNA vaccines. Problems delivering the DNA vaccines in a way that provoked a sufficient immune response soon dampened their enthusiasm.
Two basic problems prevented the development of truly effective DNA vaccines. The first was an immature understanding of genetics. In those days, researchers were only beginning to learn how to optimize the DNA sequences to produce antigens with maximum impact. Additionally, there was the familiar "delivery" problem. Cells didn't absorb enough of the DNA plasmids to become effective antigen factories. Since the amount of antigens produced by the body was therefore low, the immune response was insufficient to form the basis of viable drugs.
As a result, early DNA vaccine trials in humans were disappointing. The flow of research dollars slowed. Behind the scenes, however, determined scientists in dedicated startups never lost confidence in the core science. As importantly, alliances were formed and diverse discoveries merged. In recent years, their work has finally begun to bear fruit. I have been aware of this fact for some time. Until now, however, I hadn't identified a company that fits in the Breakthrough Technology Alert portfolio.
But thanks to a series of mergers, a single company holds all the talent and IP needed to deliver on the breakthrough potential of DNA vaccine technology. In fact, they appear to have solved the problems faced by early DNA vaccine researchers.
Source
In the early 1990s, DNA vaccines for the treatment and prevention of diseases first emerged. Excitement about this technology was matched only by unrealistic expectations regarding the timeline to market. Interest was driven, however, by the real potential of the technology. For the first time, unvaccinatable targets like HIV and hepatitis C were in the bull's-eye. Traditional vaccine technology, using live or inactivated viruses, simply did not provide a viable way to provoke a protective immune response against these diseases.
Moreover, DNA vaccines could be used against diseases other than their historical target, viruses. Early on, it dawned on researchers that this new generation of vaccines could be used to train the immune system to attack cancers and a wide range of other malignancies that act like foreign invaders inside the body.
Conventional vaccines work by having the body's immune system recognize unique antigenic proteins that are part of the virus, triggering an immune response against the invader. The elegance of DNA vaccines is that, rather than introducing into the body an actual virus, only the antigen that would be recognized as foreign is introduced. Scientists realized that they could turn cells in the body into protein-manufacturing plants. By isolating the DNA responsible for producing ONLY the foreign antigenic protein associated with a specific virus, they could get around various issues associated with live or weakened viruses.
Big Pharma companies like Merck, Wyeth and GlaxoSmithKline as well as national labs and academic research facilities poured billions into a "first wave" attempt at producing commercially viable DNA vaccines. Problems delivering the DNA vaccines in a way that provoked a sufficient immune response soon dampened their enthusiasm.
Two basic problems prevented the development of truly effective DNA vaccines. The first was an immature understanding of genetics. In those days, researchers were only beginning to learn how to optimize the DNA sequences to produce antigens with maximum impact. Additionally, there was the familiar "delivery" problem. Cells didn't absorb enough of the DNA plasmids to become effective antigen factories. Since the amount of antigens produced by the body was therefore low, the immune response was insufficient to form the basis of viable drugs.
As a result, early DNA vaccine trials in humans were disappointing. The flow of research dollars slowed. Behind the scenes, however, determined scientists in dedicated startups never lost confidence in the core science. As importantly, alliances were formed and diverse discoveries merged. In recent years, their work has finally begun to bear fruit. I have been aware of this fact for some time. Until now, however, I hadn't identified a company that fits in the Breakthrough Technology Alert portfolio.
But thanks to a series of mergers, a single company holds all the talent and IP needed to deliver on the breakthrough potential of DNA vaccine technology. In fact, they appear to have solved the problems faced by early DNA vaccine researchers.
Source
Cardiff trial for new hepatitis C drug 'successful'
2 September 2010 Last updated at 10:52 ET
Scientists say the first human clinical trials on a new drug to treat infections caused by the Hepatitis C virus have been successfully completed.
The oral medication INX-189, prepared at Cardiff University's Welsh School of Pharmacy in 2008, could now become an approved medicine, the school said.
Around 170m people worldwide have the condition which can cause liver cancer, cirrhosis and death.
Prof Chris McGuigan said the Cardiff trial showed "the drug is safe".
Hepatitis C is the leading cause of liver transplantation in western countries, explained Prof McGuigan, the academic lead on the trials.
The current treatment involves two drugs - ribavirin and interferon, which has to be given as an injection.
Side effects are often severe and lead to patients failing to complete the treatment.
But Prof McGuigan said the INX-189 trials process, though still at a very early stage, represented a significant development.
"Successfully completing phase 1a demonstrates that the drug is safe, with no drug-related side effects at all in a single dose of 100mg," he said.
He said the study, which began in May, had also confirmed that one single dose of the drug a day was most likely to be enough in treating the virus.
Second trial
In 2008, laboratory tests showed INX-189 killed 90% of the virus at very low concentration, making it the most potent compound of its kind developed to date.
The licence to INX-189 is owned by US pharmaceutical company Inhibitex, which has been working with the Cardiff team.
The company has announced it is looking forward to a second trial to evaluate the compound's effectiveness in Hepatitis C patients.
Cardiff University and Inhibitex filed a patent on INX-189 earlier this year.
It has been cleared for human clinical trials by the Food and Drug Administration in the US.
Source
Scientists say the first human clinical trials on a new drug to treat infections caused by the Hepatitis C virus have been successfully completed.
The oral medication INX-189, prepared at Cardiff University's Welsh School of Pharmacy in 2008, could now become an approved medicine, the school said.
Around 170m people worldwide have the condition which can cause liver cancer, cirrhosis and death.
Prof Chris McGuigan said the Cardiff trial showed "the drug is safe".
Hepatitis C is the leading cause of liver transplantation in western countries, explained Prof McGuigan, the academic lead on the trials.
The current treatment involves two drugs - ribavirin and interferon, which has to be given as an injection.
Side effects are often severe and lead to patients failing to complete the treatment.
But Prof McGuigan said the INX-189 trials process, though still at a very early stage, represented a significant development.
"Successfully completing phase 1a demonstrates that the drug is safe, with no drug-related side effects at all in a single dose of 100mg," he said.
He said the study, which began in May, had also confirmed that one single dose of the drug a day was most likely to be enough in treating the virus.
Second trial
In 2008, laboratory tests showed INX-189 killed 90% of the virus at very low concentration, making it the most potent compound of its kind developed to date.
The licence to INX-189 is owned by US pharmaceutical company Inhibitex, which has been working with the Cardiff team.
The company has announced it is looking forward to a second trial to evaluate the compound's effectiveness in Hepatitis C patients.
Cardiff University and Inhibitex filed a patent on INX-189 earlier this year.
It has been cleared for human clinical trials by the Food and Drug Administration in the US.
Source
New Partnership forms to Address the Hepatitis B and C Epidemic in Europe
LUXEMBOURG, September 2, 2010 /PRNewswire/ -- At least 23 million European Union (EU) citizens are currently living with hepatitis B or hepatitis C[i]. In a direct response to the health burden this presents and the recent recognition by the WHO of the seriousness of hepatitis as a global health issue, a unique Partnership comprising key international public and private stakeholders has formed to drive the first EU-wide initiative on hepatitis B and C.
The new Partnership will work to achieve the formation of a European-wide strategy on the communication, prevention and management of viral hepatitis as a healthcare priority. As a first step towards this, the Partnership will host the Hepatitis B and C Summit Conference on 14-15th October 2010, where the latest research and advances will be presented and used to inform and drive future EU strategies and action plans in this neglected disease area. New studies will assess the impact of mobility of populations and patient self-help programmes in relation to the hepatitis epidemic.
Professor Angelos Hatzakis of Athens University Medical School and one of the co-chairs of the Partnership Steering Group said: "The burden and challenges associated with viral hepatitis across Europe require the active and concerted involvement of a broad range of stakeholders. Patients, specialists, primary health care providers, epidemiologists, policy makers, those responsible for health budgets, the general public, advocates, donors and the pharmaceutical sector should all work together to deliver the results so needed for these urgent diseases."
The new Partnership involves the European Association for the Study of Liver Disease (EASL) and the European Liver Patient Association (ELPA). Other contributors include the Viral Hepatitis Prevention Board (VHPB), the World Hepatitis Alliance (WHA) and the European Centre for Disease Prevention and Control (ECDC). The conference is supported by the European Commission's Directorate-General for Health and Consumer Protection (DG SANCO) and is being held under the auspices of the current EU Belgian presidency.
Nadine Piorkowsky, President of the European Liver Patients Association (ELPA) and co-chair of the Partnership Steering Group stated: "The development and implementation of specific policies to prevent, diagnose and control hepatitis B and C are long overdue as the burden of these diseases has significantly increased for the last ten years. This conference constitutes an important step forward as we will bring all the latest research to the table with a view to collectively evaluating the findings. The aim of this conference will be to present EU Member States with concrete policy recommendations on hepatitis B and C that can be implemented in their future health programmes."
References
[i] WHO Europe Region. Hepatitis Fact and Figures.
http://www.euro.who.int/en/what-we-do/health-topics/diseases-and-conditions/hepatitis/facts-and-figures.
Accessed 20.08.10
(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.)
Notes to editors
Contact details
For more information on attending the event and to arrange interviews, journalists should contact our press office:
Isabelle Scali
+44-207-331-2324
Isabelle.scali@cohnwolfe.com
For more details on the conference and the full list of members of the Steering Group visit: http://www.hepsummit2010.org/
Distributed by PR Newswire on behalf of Hepatitis B and C Summit Conference
Source
The new Partnership will work to achieve the formation of a European-wide strategy on the communication, prevention and management of viral hepatitis as a healthcare priority. As a first step towards this, the Partnership will host the Hepatitis B and C Summit Conference on 14-15th October 2010, where the latest research and advances will be presented and used to inform and drive future EU strategies and action plans in this neglected disease area. New studies will assess the impact of mobility of populations and patient self-help programmes in relation to the hepatitis epidemic.
Professor Angelos Hatzakis of Athens University Medical School and one of the co-chairs of the Partnership Steering Group said: "The burden and challenges associated with viral hepatitis across Europe require the active and concerted involvement of a broad range of stakeholders. Patients, specialists, primary health care providers, epidemiologists, policy makers, those responsible for health budgets, the general public, advocates, donors and the pharmaceutical sector should all work together to deliver the results so needed for these urgent diseases."
The new Partnership involves the European Association for the Study of Liver Disease (EASL) and the European Liver Patient Association (ELPA). Other contributors include the Viral Hepatitis Prevention Board (VHPB), the World Hepatitis Alliance (WHA) and the European Centre for Disease Prevention and Control (ECDC). The conference is supported by the European Commission's Directorate-General for Health and Consumer Protection (DG SANCO) and is being held under the auspices of the current EU Belgian presidency.
Nadine Piorkowsky, President of the European Liver Patients Association (ELPA) and co-chair of the Partnership Steering Group stated: "The development and implementation of specific policies to prevent, diagnose and control hepatitis B and C are long overdue as the burden of these diseases has significantly increased for the last ten years. This conference constitutes an important step forward as we will bring all the latest research to the table with a view to collectively evaluating the findings. The aim of this conference will be to present EU Member States with concrete policy recommendations on hepatitis B and C that can be implemented in their future health programmes."
References
[i] WHO Europe Region. Hepatitis Fact and Figures.
http://www.euro.who.int/en/what-we-do/health-topics/diseases-and-conditions/hepatitis/facts-and-figures.
Accessed 20.08.10
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Notes to editors
Contact details
For more information on attending the event and to arrange interviews, journalists should contact our press office:
Isabelle Scali
+44-207-331-2324
Isabelle.scali@cohnwolfe.com
For more details on the conference and the full list of members of the Steering Group visit: http://www.hepsummit2010.org/
Distributed by PR Newswire on behalf of Hepatitis B and C Summit Conference
Source
Prevalence and risk factors of hepatitis B and C viruses among haemodialysis patients in Gaza strip, Palestine
The prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) and its associated risk factors among haemodialysis (HD) patients in Gaza strip was investigated using serological and molecular techniques.
Results: The overall prevalence of HBV among the four HD centers was 8.1%. The main risk factors were HD center (p=0.05), history of blood transfusion (p<0.01), and treatment abroad (p=0.01).
The overall prevalence of HCV among the four HD centers was 22%. The main risk factors were HD center (p<0.01), time duration on HD (p<0.01), history of blood transfusion (p<0.01), treatment abroad (p<0.01), and history of blood transfusion abroad (p<0.01).
Serum aminotransferases levels decreased in HD patients compared with normal population but still there was a direct association between the activity of liver enzymes and both HBV (p<0.01) and HCV (p<0.01) infection.
Conclusion: The much higher prevalence of Hepatitis viruses among HD patients compared to the normal population of Gaza strip indicates a causative relation between HD and hepatitis viruses transmission. Therefore extremely careful observation of preventive infection control measures is essential to limit Hepatitis viruses'transmission in HD centers.
Author: Abed El-kader El-OttolAbdelraouf ElmanamaBasim Ayesh
Credits/Source: Virology Journal 2010, 7:210
Published on: 2010-09-01
Source
Results: The overall prevalence of HBV among the four HD centers was 8.1%. The main risk factors were HD center (p=0.05), history of blood transfusion (p<0.01), and treatment abroad (p=0.01).
The overall prevalence of HCV among the four HD centers was 22%. The main risk factors were HD center (p<0.01), time duration on HD (p<0.01), history of blood transfusion (p<0.01), treatment abroad (p<0.01), and history of blood transfusion abroad (p<0.01).
Serum aminotransferases levels decreased in HD patients compared with normal population but still there was a direct association between the activity of liver enzymes and both HBV (p<0.01) and HCV (p<0.01) infection.
Conclusion: The much higher prevalence of Hepatitis viruses among HD patients compared to the normal population of Gaza strip indicates a causative relation between HD and hepatitis viruses transmission. Therefore extremely careful observation of preventive infection control measures is essential to limit Hepatitis viruses'transmission in HD centers.
Author: Abed El-kader El-OttolAbdelraouf ElmanamaBasim Ayesh
Credits/Source: Virology Journal 2010, 7:210
Published on: 2010-09-01
Source
Will Aging Chimps Get to Retire, or Face Medical Research?
Sinbad, thought to be at least 35, is now at a sanctuary in Florida.
By DAN FROSCH
Published: September 1, 2010
ALAMOGORDO, N.M. — Flo the chimpanzee bounds about her enclosure, hurls a rubber ball then stares quizzically at the New Mexico green chili pepper that will be her morning snack.
It has been a long time since Flo was on exhibit at the Memphis Zoo, even longer since she learned to smoke cigarettes during a stint with the circus. Most recently, she was a research chimpanzee here in New Mexico, part of an expansive biomedical testing program for hepatitis C and H.I.V.
At the moment, though, she is out of a job — but perhaps not for long.
Flo and the 185 other chimpanzees who live at the Alamogordo Primate Facility at Holloman Air Force Base have not been research subjects for nearly a decade — part of an agreement between the National Institutes of Health and the military, which prohibits using the animals for biomedical tests on the base.
But recently, the health institute decided it wanted to use the chimp colony for medical research again, primarily to help develop the elusive hepatitis C vaccine. This past June, the institute began shipping some of the animals by special trucks to the Southwest National Primate Research Center in San Antonio and plans on moving the remaining chimpanzees by the end of 2011.
The move has spurred outrage among animal rights advocates, primate experts and politicians, who say the chimpanzees — many of them middle-aged and elderly — should get to live out the rest of their lives in peace after years of invasive research. It has also cast a fresh light on the debate over the tipping point between science and ethics, with everyone from the legendary primatologist Dr. Jane Goodall to Gov. Bill Richardson of New Mexico weighing in.
“These chimpanzees have given up their freedom, if not their natural environment, their bodies, their health, their children to research,” said Laura Bonar, program director for Animal Protection of New Mexico, which wants the government to turn the Alamogordo facility into a retirement sanctuary for the chimps. “And at the end of their lives, we can give them something back.”
For the health institute, though, the Alamogordo chimpanzees represent an invaluable resource. As per the agreement with the Air Force, biomedical research cannot be conducted on the animals. That agreement was forged after the institute acquired the chimpanzees from the Coulston Foundation, an infamous New Mexico research laboratory that was found by federal officials to have abused and neglected the animals.
In 2001, the institute gave the private Charles River Laboratories a 10-year contract to provide medical care to the chimps, most of whom have been infected or exposed to hepatitis C and H.I.V. through prior research.
These days, chimps like Flo, who at 53 is the oldest of the Alamogordo colony, spend their days living in small groups in geodesic domes: foraging for food, swinging from structures and whooping greetings at visitors and one another.
Harold Watson, who heads the chimpanzee research program for the National Center for Research Resources, said that with the end of the contract, it only makes sense to use the chimps for their original purpose. The research — which will most likely entail drawing periodic blood samples, liver biopsies and in some cases inoculations of hepatitis C — will be carefully monitored, he said.
“I think people envision pictures of monkeys with electrodes in their heads,” Dr. Watson said. “This is not what we’re talking about.”
The history of primate research, however, has been long and controversial. Because of their genetic closeness to humans, chimpanzees are considered well-suited for studies of how various infectious diseases or psychological environments might affect mankind.
But some have questioned whether that research has yielded any substantive breakthroughs, and the United States is currently the only developed country that continues large-scale confinement of chimps in laboratories, according to the Humane Society of the United States. Supporters of the research say the animals have been critical in the development of hepatitis A and B vaccines.
Pending Congressional legislation known as the Great Ape Protection Act would retire about 500 federally owned chimpanzees currently in laboratories to permanent sanctuary. The Alamogordo colony traces its lineage to the Air Force’s space chimp experiments in the late 1950s. A decade later, the toxicologist Frederick Coulston set out to build the world’s largest captive colony of chimpanzees for research, in New Mexico. His foundation’s tenure was marred by charges of severe mistreatment.
That legacy still haunts the health institute, which got 288 of the chimpanzees around 2001 and has tried to distance itself from the Coulston Foundation.
John Gluck, a professor emeritus of psychology at the University of New Mexico, who has visited the Alamogordo colony at least four times since the 1970s, is worried what a move to Texas would mean for the animals’ physical and mental health, particularly given “the tremendous price” paid by most of the chimpanzees while research subjects of the Coulston Foundation, he said.
“N.I.H., in general, is a place I respect,” Dr. Gluck said. “But it seems to me that they’ve lost both their ethical and scientific compass here.”
Governor Richardson has also urged the institute to reconsider, and Dr. Goodall wrote to the institute that the chimpanzees “will surely suffer considerable physical and emotional distress from this plan.”
Dr. Lon Lammey, the director of the Alamogordo primate facility for Charles River, the private contractor, disputed the notion that the move would be harmful, and said he was “confident the animals would continue to receive optimal medical care.”
Despite the mounting pressure, the institute has shown little sign of changing its plan.
Some 15 miles from the base, a separate group of 82 chimpanzees are also waiting to be moved, but to a lush Florida sanctuary run by Save the Chimps, a rescue group.
The animals were part of a larger group handed over to the rescue organization by the Coulston Foundation after its demise and have gradually been moved to Florida over the past few years. Save the Chimps wants the institute to permanently retire the rest of the Alamogordo chimpanzees to a sanctuary as well.
At the old Coulston facility, which has been transformed into a temporary sanctuary itself, a 13-year-old chimp named JJ clutched a bundle of security blankets while readying for lunch. As a worker placed bushels of fruit in the enclosures, the chimpanzees began to yelp in unison, their cries carrying across the high desert.
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