Journal of Clinical Pharmacy and Therapeutics
Early View (Articles online in advance of print)
P. V. Dicpinigaitis MD, F. R. Weiner MD
Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA
*Correspondence: Peter Dicpinigaitis, MD, Weiler Division/Montefiore Medical Center, 1825 Eastchester Road, Bronx, NY 10461, USA. Tel.: (718) 904 2676; fax (718) 904 2880; e-mail: pdicpinigaitis@pol.net
Article first published online: 30 SEP 2010
DOI: 10.1111/j.1365-2710.2010.01182.x
© 2010 Blackwell Publishing Ltd
Summary
What is known and Objective: The combination of pegylated interferon and ribavirin has become standard therapy for chronic hepatitis C infection. The occurrence of chronic cough associated with this treatment regimen has been reported, but the mechanism by which cough occurs has not previously been investigated. We measured cough reflex sensitivity, during and after completion of therapy, in four patients who developed chronic cough associated with interferon/ribavirin therapy.
Case summary: Four patients without history of respiratory symptoms developed chronic cough temporally related to initiation of therapy with pegylated interferon and ribavirin for chronic hepatitis C infection. Cough resolved within 2–6 weeks after completion of a 48-week course of therapy. To measure cough reflex sensitivity, capsaicin cough challenge testing was performed 1 month prior to cessation of therapy, and 1 and 2 months after completion of treatment. In all patients, cough reflex sensitivity, as measured by C5, the concentration of capsaicin inducing 5 or more coughs, was significantly enhanced during treatment compared to 1 month after completion of therapy (P = 0·016).
What is new and Conclusion: Previous studies have observed that cough occurs more commonly in patients receiving the combination of interferon and ribavirin compared to interferon alone, thus implicating ribavirin as the causal agent. Our data demonstrate that it does so by reversible enhancement of cough reflex sensitivity. Clinicians should be aware of this potential treatment-related effect, so as to avoid unnecessary and costly diagnostic evaluations seeking an alternative aetiology of cough.
Source
Showing posts with label Infergen/Ribavirin. Show all posts
Showing posts with label Infergen/Ribavirin. Show all posts
October 1, 2010
August 29, 2010
Therapure Biopharma Inc.'s Drug Delivery Program for the Treatment of Cancer and Infectious Disease Receives Support from the National Research Council’s Industrial Reseach
Therapure Biopharma Inc. (Therapure) today announced receipt of a financial contribution from the National Research Council’s Industrial Research Assistance Program (NRC-IRAP). The funding is to support Therapure’s drug delivery program for the treatment of liver cancer and hepatitis C infection.
Toronto, ON (Vocus) August 27, 2010
Therapure Biopharma Inc. (Therapure) today announced receipt of a financial contribution from the National Research Council’s Industrial Research Assistance Program (NRC-IRAP). The funding is to support Therapure’s drug delivery program for the treatment of liver cancer and hepatitis C infection.
Therapure’s lead product for infectious disease is a stable protein-drug conjugate of hemoglobin and ribavirin designed to selectively target the delivery of ribavirin to the liver for the treatment of hepatitis C virus (HCV) infection. Therapure’s lead cancer product is a similar conjugate of hemoglobin and floxuridine, which delivers the powerful chemotherapy drug floxuridine directly to the liver as treatment for primary liver cancer. Both products are based on a core expertise in protein chemistry and cell biology that Therapure scientists have pioneered and applied to the natural and highly specific pathway for hemoglobin metabolism as a means of treating chronic and acute liver diseases with high unmet medical need.
Both drug delivery products are in the pre-clinical stage of development. Therapure has recently completed pre-IND and pre-CTA submissions to the US FDA and Health Canada, respectively, as a key step in defining the clinical and regulatory paths for both products and advancing them products to the clinic and the treatment of patients sooner.
In addition to technical and business advisory services, the financial assistance provided by NRC-IRAP will support funding for continued pre-clinical safety and efficacy studies, and bioanalytical method development.
“Therapure is very proud to have been chosen by NRC-IRAP” said Thomas Wellner, President and CEO of Therapure. “This demonstrates the breadth of Therapure’s capabilities in Product and Method Development.”
About Therapure Biopharma Inc.:
Therapure Biopharma Inc. is an integrated biopharmaceutical company that develops, manufactures, purifies and packages therapeutic proteins. As a contract development and manufacturing organization (CDMO) Therapure Biopharma applies scientific, manufacturing, and downstream purification expertise with an intimate understanding of advanced biology, complex proteins, and regulatory processes to develop effective and innovative solutions to advance products from discovery to market for its clients. Therapure’s Health Canada licensed 130,000 sq. ft. facility, includes manufacturing, research and quality control laboratories and a cGMP warehouse, and is built to U.S. FDA, EMEA, MHRA and Health Canada standards for the aseptic handling and purification of proteins.
For more information, please visit: http://www.therapurebio.com/
Company Contacts:
Thomas Wellner, President and CEO
Therapure Biopharma Inc.
+1 905 286-6204
ceo(at)therapurebio(dot)com
Source
Toronto, ON (Vocus) August 27, 2010
Therapure Biopharma Inc. (Therapure) today announced receipt of a financial contribution from the National Research Council’s Industrial Research Assistance Program (NRC-IRAP). The funding is to support Therapure’s drug delivery program for the treatment of liver cancer and hepatitis C infection.
Therapure’s lead product for infectious disease is a stable protein-drug conjugate of hemoglobin and ribavirin designed to selectively target the delivery of ribavirin to the liver for the treatment of hepatitis C virus (HCV) infection. Therapure’s lead cancer product is a similar conjugate of hemoglobin and floxuridine, which delivers the powerful chemotherapy drug floxuridine directly to the liver as treatment for primary liver cancer. Both products are based on a core expertise in protein chemistry and cell biology that Therapure scientists have pioneered and applied to the natural and highly specific pathway for hemoglobin metabolism as a means of treating chronic and acute liver diseases with high unmet medical need.
Both drug delivery products are in the pre-clinical stage of development. Therapure has recently completed pre-IND and pre-CTA submissions to the US FDA and Health Canada, respectively, as a key step in defining the clinical and regulatory paths for both products and advancing them products to the clinic and the treatment of patients sooner.
In addition to technical and business advisory services, the financial assistance provided by NRC-IRAP will support funding for continued pre-clinical safety and efficacy studies, and bioanalytical method development.
“Therapure is very proud to have been chosen by NRC-IRAP” said Thomas Wellner, President and CEO of Therapure. “This demonstrates the breadth of Therapure’s capabilities in Product and Method Development.”
About Therapure Biopharma Inc.:
Therapure Biopharma Inc. is an integrated biopharmaceutical company that develops, manufactures, purifies and packages therapeutic proteins. As a contract development and manufacturing organization (CDMO) Therapure Biopharma applies scientific, manufacturing, and downstream purification expertise with an intimate understanding of advanced biology, complex proteins, and regulatory processes to develop effective and innovative solutions to advance products from discovery to market for its clients. Therapure’s Health Canada licensed 130,000 sq. ft. facility, includes manufacturing, research and quality control laboratories and a cGMP warehouse, and is built to U.S. FDA, EMEA, MHRA and Health Canada standards for the aseptic handling and purification of proteins.
For more information, please visit: http://www.therapurebio.com/
Company Contacts:
Thomas Wellner, President and CEO
Therapure Biopharma Inc.
+1 905 286-6204
ceo(at)therapurebio(dot)com
Source
July 29, 2010
Hepatitis C retreatment offers hope if initial one fails
by paige varner pvarner@post-dispatch.com 314-340-8018
Posted: Thursday, July 29, 2010 12:00 am
For the 40 percent to 50 percent of patients who aren't cured of hepatitis C after their initial treatment, Dr. Bruce R. Bacon of St. Louis University and his team of researchers have increased the chances of a cure upon re-treatment.
About 11 percent of the 515 people retreated in Bacon's trials were cured using the Food and Drug Administration-approved medication combination, Infergen with an antiviral pill.
Of those with milder strains of hepatitis C, about 35 percent in the trials were cured.
In the first round of treatment, patients are given weekly shots of an alpha interferon — in larger amounts than that which the body normally makes to fight pathogens — along with the antiviral pill ribavirin.
This combination cures 50 percent to 60 percent of cases, but others can start another round, this time injecting the interferon medicine Infergen daily, along with taking the ribavirin, for up to 48 weeks.
Bacon, who holds the endowed chair in gastroenterology at SLU School of Medicine, and his team published their findings last summer after researching from 2004 to 2006.
For those with the virus who feel the 11 percent cure rate in the second round isn't high enough, Bacon said they will still have hepatitis C if they don't at least try re-treatment.
Another concern about the medicine combination is the side effects, which are similar to the flulike symptoms the virus already causes, such as fatigue, anemia, troubled breathing, irritability.
"But more than the side effects, you don't want to have hepatitis C," Bacon said.
Interferon and ribavirin are the only treatments for hepatitis C, which inflames the liver and after many years can lead to cirrhosis, or liver scarring, in 20 percent to 30 percent of patients.
Those with the virus can prevent cirrhosis development by not drinking excessive amounts of alcohol.
Some won't know they have the virus. Bacon said the flulike symptoms can set in gradually, making them feel sick for decades before they are diagnosed.
Contracting hepatitis C requires a blood-to-blood transmission, and Bacon said most cases have a history of one of three things:
• A blood transfusion before 1992.
• Sharing needles or illicit drugs — "even teenagers at a party who did something stupid," Bacon said
• Working in the health care field. Paramedics, physicians and nurses come into contact with blood daily. Just one needle stick could cause hepatitis C.
Acute cases of the virus can clear on their own. Infergen with ribavirin is FDA-approved in chronic cases, or for people who have had the virus for at least six months.
Infergen cannot be taken by anyone under 18 years old or with compensated liver disease due to cirrhosis complications.
Source
Posted: Thursday, July 29, 2010 12:00 am
For the 40 percent to 50 percent of patients who aren't cured of hepatitis C after their initial treatment, Dr. Bruce R. Bacon of St. Louis University and his team of researchers have increased the chances of a cure upon re-treatment.
About 11 percent of the 515 people retreated in Bacon's trials were cured using the Food and Drug Administration-approved medication combination, Infergen with an antiviral pill.
Of those with milder strains of hepatitis C, about 35 percent in the trials were cured.
In the first round of treatment, patients are given weekly shots of an alpha interferon — in larger amounts than that which the body normally makes to fight pathogens — along with the antiviral pill ribavirin.
This combination cures 50 percent to 60 percent of cases, but others can start another round, this time injecting the interferon medicine Infergen daily, along with taking the ribavirin, for up to 48 weeks.
Bacon, who holds the endowed chair in gastroenterology at SLU School of Medicine, and his team published their findings last summer after researching from 2004 to 2006.
For those with the virus who feel the 11 percent cure rate in the second round isn't high enough, Bacon said they will still have hepatitis C if they don't at least try re-treatment.
Another concern about the medicine combination is the side effects, which are similar to the flulike symptoms the virus already causes, such as fatigue, anemia, troubled breathing, irritability.
"But more than the side effects, you don't want to have hepatitis C," Bacon said.
Interferon and ribavirin are the only treatments for hepatitis C, which inflames the liver and after many years can lead to cirrhosis, or liver scarring, in 20 percent to 30 percent of patients.
Those with the virus can prevent cirrhosis development by not drinking excessive amounts of alcohol.
Some won't know they have the virus. Bacon said the flulike symptoms can set in gradually, making them feel sick for decades before they are diagnosed.
Contracting hepatitis C requires a blood-to-blood transmission, and Bacon said most cases have a history of one of three things:
• A blood transfusion before 1992.
• Sharing needles or illicit drugs — "even teenagers at a party who did something stupid," Bacon said
• Working in the health care field. Paramedics, physicians and nurses come into contact with blood daily. Just one needle stick could cause hepatitis C.
Acute cases of the virus can clear on their own. Infergen with ribavirin is FDA-approved in chronic cases, or for people who have had the virus for at least six months.
Infergen cannot be taken by anyone under 18 years old or with compensated liver disease due to cirrhosis complications.
Source
July 12, 2010
FDA Approves Infergen Combo Therapy for Retreating HCV
Yael Waknine
July 12, 2010 — The US Food and Drug Administration (FDA) has approved an expanded indication for interferon alfacon-1 subcutaneous injection (Infergen; Three Rivers Pharmaceuticals, LLC), in combination with ribavirin, for retreatment of chronic hepatitis C (HCV) viral infection.
The action was based on data from the United States–based Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy clinical trial of nonresponders to prior pegylated interferon plus ribavirin therapy who were randomly assigned to receive active treatment or placebo for up to 48 weeks.
Results showed that 9% of patients receiving 15 μg interferon alfacon-1/ribavirin achieved a sustained virologic response, defined as undetectable HCV RNA levels at 24 weeks posttherapy (vs placebo, 0%).
The retreatment strategy was especially effective for interferon-sensitive patients with lower baseline fibrosis scores. According to a company news release, up to 38% of noncirrhotic patients who were sensitive to pegylated interferon/ribavirin and who did not modify their interferon alfacon-1/ribavirin dosages achieved a sustained virologic response. Cirrhotic patients were less likely to benefit from treatment unless they displayed previous interferon sensitivity or a minimum 1 log10 drop in HCV RNA on prior therapy.
"Approximately 50 percent of patients with chronic hepatitis C do not respond to their initial course of therapy," stated Bruce Bacon, MD, in the company news release. "The FDA's recognition of this expanded label allows patients failing therapy a safe and efficacious retreatment strategy. The results from this study legitimize how we properly treat these patients helping them to achieve [a sustained virologic response]." Dr. Bacon was the lead investigator for the registration trial.
Adverse events most commonly reported with 15 μg interferon alfacon-1/ribavirin included fatigue, nausea, influenza-like symptoms, headache, arthralgia, myalgia, neutropenia, leukopenia, insomnia, and depression. Dose modifications were required in 52% of patients, primarily because of neutropenia/leukopenia, thrombocytopenia, and fatigue/weakness.
Interferon alfacon-1 previously was approved as monotherapy for chronic HCV in adults with compensated liver disease.
Source
Also See:
Consensus Interferon (Infergen) Label Changed to Include Data on Dosing with Ribavirin
Three Rivers Pharmaceuticals Announces FDA Approval Of Expanded Labeling of INFERGEN®
July 12, 2010 — The US Food and Drug Administration (FDA) has approved an expanded indication for interferon alfacon-1 subcutaneous injection (Infergen; Three Rivers Pharmaceuticals, LLC), in combination with ribavirin, for retreatment of chronic hepatitis C (HCV) viral infection.
The action was based on data from the United States–based Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy clinical trial of nonresponders to prior pegylated interferon plus ribavirin therapy who were randomly assigned to receive active treatment or placebo for up to 48 weeks.
Results showed that 9% of patients receiving 15 μg interferon alfacon-1/ribavirin achieved a sustained virologic response, defined as undetectable HCV RNA levels at 24 weeks posttherapy (vs placebo, 0%).
The retreatment strategy was especially effective for interferon-sensitive patients with lower baseline fibrosis scores. According to a company news release, up to 38% of noncirrhotic patients who were sensitive to pegylated interferon/ribavirin and who did not modify their interferon alfacon-1/ribavirin dosages achieved a sustained virologic response. Cirrhotic patients were less likely to benefit from treatment unless they displayed previous interferon sensitivity or a minimum 1 log10 drop in HCV RNA on prior therapy.
"Approximately 50 percent of patients with chronic hepatitis C do not respond to their initial course of therapy," stated Bruce Bacon, MD, in the company news release. "The FDA's recognition of this expanded label allows patients failing therapy a safe and efficacious retreatment strategy. The results from this study legitimize how we properly treat these patients helping them to achieve [a sustained virologic response]." Dr. Bacon was the lead investigator for the registration trial.
Adverse events most commonly reported with 15 μg interferon alfacon-1/ribavirin included fatigue, nausea, influenza-like symptoms, headache, arthralgia, myalgia, neutropenia, leukopenia, insomnia, and depression. Dose modifications were required in 52% of patients, primarily because of neutropenia/leukopenia, thrombocytopenia, and fatigue/weakness.
Interferon alfacon-1 previously was approved as monotherapy for chronic HCV in adults with compensated liver disease.
Source
Also See:
Consensus Interferon (Infergen) Label Changed to Include Data on Dosing with Ribavirin
Three Rivers Pharmaceuticals Announces FDA Approval Of Expanded Labeling of INFERGEN®
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