Showing posts with label Hepatitis C treatment. Show all posts
Showing posts with label Hepatitis C treatment. Show all posts
Thursday, April 26, 2012
Duke University program integrates Hepatitis C and alcohol addiction treatment...
Posted 4/26/12 on the Center for Health Policy & Inequities Research at Duke University website. This is just all-around good stuff - A Duke study published in the April issue of the journal 'Digestive Diseases and Sciences' shows some positive outcomes in getting Hepatitis C patients to stop or significantly cut down alcohol consumption while on treatment. This integrative model pairs both a Hepatologist and an Addiction Specialist and serves as a template on which to base similar programs. For the six month program, 44% of patients stopped drinking alcohol by the end of the period and those that didn't stop, reduced consumption by 30%. Long term follow-up will be needed, but this data seems promising.
Integrated Health Care Model Shows Promise for Hepatitis C Patients in Durham
Posted by Anna Both on Apr 26, 2012 in Faculty, Rae Jean Proeschold Bell, Research
Reported by the Duke Global Health Institute:
Four in ten hepatitis C patients who drank alcohol refrained from it as part of a Duke pilot program that integrates alcohol and hepatitis C treatments. Led by DGHI researcher Rae Jean Proeschold-Bell and Duke physician Andrew Muir, the dual model of care may be a viable option for steering these patients away from alcohol, who may otherwise develop serious health complications that lead to liver failure or death.
The Duke study, featured in the April issue of Digestive Diseases and Sciences, involved hepatitis C patients from the Duke Liver Clinic who received both alcohol treatment and medical care over a six-month period. Of the 53 alcohol-drinking patients in the study, 44 percent had stopped drinking alcohol by the end of the six months. Patients who did not become abstinent by six months still reported a 30 percent drop in alcohol consumption, spending on alcohol and urges to drink.
“We were able to show that integrated hepatitis C-alcohol care is feasible,” said Proeschold-Bell, a DGHI faculty member at the Center for Health Policy and Inequalities Research. “More than that, the study shows that such integrated care results in alcohol reductions that benefit patient health.”
Researchers say the intervention worked in part because it focused on liver health, rather than simply reducing alcohol use. It involved weekly group therapy and bi-weekly individual sessions customized to each patient that address alcohol use, nutrition, stress and family support. Because knowledge alone does not change behavior, the addictions specialist taught patients practical ways to improve other aspects of their lives based on their individual circumstances. Study participants were also evaluated for mental illness and had access to a psychiatrist for care, if needed.
The research team also found ways to increase communication and collaboration between the patient’s hepatologist and addictions specialist, a critical part of the study.
“We didn’t know the extent to which we could get busy medical providers and addictions specialists to collaborate. We had to find ways to fit the collaboration into the clinic flow,” said Proeschold-Bell. “In some instances, we had the addictions specialist use a laptop outside the patient exam rooms so medical providers could easily access her and her knowledge about the patient’s alcohol use and behavior changes.”
To date, studies have shown that adults with hepatitis C are three times more likely to have at least one alcoholic drink a day and almost eight times more likely to have at least three drinks a day, compared to adults without hepatitis C. The combination of alcohol use and hepatitis C speeds the time to liver failure and increases rates of liver fibrosis and cancer.
As strong proponents of clinic-based alcohol treatment, Proeschold-Bell and Muir hope to pursue a larger study that recruits patients from the Duke Liver Clinic, the UNC Liver Clinic and the Durham Veterans Affairs Medical Center.
“Alcohol treatment needs to occur in a trusted and known setting,” said Muir. “This study shows that patients will attend alcohol treatment offered in the liver clinic setting and try to change their behaviors in the context of their lives beyond alcohol use.”
Tuesday, February 21, 2012
G&E News: Patients’ Expectations About New HCV Direct-Acting Antivirals Often Unrealistic...
Lovingly pinched on 2/21/12 from Gastroenterology & Endoscopy News. Ms. Frangou interviews three well-regarded giants of Hepatology, Andrew Muir, Raymond Chung and Gary Davis about the disconnects that often occur between patient expectations with triple therapy and reality. An excellent article about the realities of treatment, definitely worth the read. It would be great to see more attention paid to the mid-level practitioners who are really doing the majority of heavy lifting in this disease state. Getting their perspective on treating patients would be hugely valuable, as they are the ones that often manage the patients day-to-day, manage the patients support systems and often have the frustrating role of pushing through the prior authorizations to get these drugs for patients in the first place. They are definitely the heroes on the front lines fighting this disease.
Hepatology in Focus
ISSUE: FEBRUARY 2012 | VOLUME: 63
Patients’ Expectations About New HCV Direct-Acting Antivirals Often Unrealistic
Careful Patient Selection, Education Is Key for Success
by Christina Frangou
San Francisco—Soon after the FDA approved two direct-acting antiviral agents (DAAs) last spring for treating infection with hepatitis C virus (HCV), a 57-year-old black man came to see gastroenterologist Andrew Muir, MD.
The man had been diagnosed with hepatitis C in 2001. A liver biopsy one year later revealed he had stage II fibrosis. At the time, the patient declined treatment, saying the duration was too long and offered too few benefits.
But recently, he came back to Dr. Muir wanting to try a new protease inhibitor. Based on his reading, the man believed he could avoid interferon (IFN) and ribavirin (RBV), take a protease inhibitor as monotherapy for 24 weeks and expect a 75% chance of achieving a sustained virologic response (SVR).
Unfortunately, the patient’s expectations were unrealistic on all counts. The new protease inhibitor can only be given in conjunction with IFN and RBV, and the treatment duration varies. For blacks, therapy usually lasts a full 48 weeks, and in clinical trials, only 30% of black patients achieved an SVR with 28 weeks of therapy. Moreover, among black patients in the Phase III trials, SVR rates fell short of the 75% that the patient expected, and in treatment-naive blacks, only 62% receiving telaprevir and 53% on boceprevir achieved an SVR.
Educate To Encourage Adherence
Unrealistic expectations are common among patients with HCV infection who, after years of waiting for better therapies, are eager to try treatment with the new DAAs, said Dr. Muir. The DAAs on the market today are complex, with varied stoppage rules, monitoring points and some serious adverse events and drug–drug interactions.
“This is a real problem for clinicians. There’s tremendous excitement about these new therapies, but oftentimes, patients’ expectations are not in line with what these drugs can deliver,” said Dr. Muir, clinical director of hepatology at Duke University Medical Center, Durham, N.C.
In a presentation at The Liver Meeting 2011, Dr. Muir stressed that clinicians need to take time to carefully prepare patients for DAA therapy. Physicians must have clear, detailed discussions with their patients before and throughout treatment to optimize the benefits of DAA therapy, he said.
“The major challenges are preparing patients for the rigors of therapy, checking in frequently to make decisions about the duration of treatment and managing any issues as the patient goes along,” said Dr. Muir.
When patients come into the office considering treatment with DAAs, the first step is to clarify their expectations, said Dr. Muir. Patients need to learn the reality about DAAs if they want treatment to succeed.
Dr. Muir outlines for patients the complex prescribing rules, the contraindications, the lifestyle changes and duration of treatment with DAAs. The lifestyle changes can be significant, he cautions patients. Both telaprevir and boceprevir must be taken three times a day, or once every eight hours, and always with a meal. Dr. Muir then asks if the patient still wants treatment when these things are taken into account.
“That’s no small feat. Patients must adhere to that regimen because lapses in the concentration of telaprevir and boceprevir have historically been the risk period for breakthrough variants on therapy,” said Raymond Chung, MD, chief of hepatology and vice-chief of gastroenterology at Massachusetts General Hospital, Boston. Many of Dr. Chung’s patients limit or reschedule their work hours while on DAA therapy to help with adherence.
The key to getting patients through DAA treatment successfully is to select patients carefully and prepare them assiduously, said Gary L. Davis, MD, director of general and transplant hepatology at Baylor University Medical Center, Dallas. “This means that any issues that might impact compliance, tolerance and drug access should be dealt with before treatment starts. Educating the patient is essential. Patients and their support person need to clearly understand the importance of dosing compliance, lab monitoring and treatment stopping rules/end points.”
The treatment care team then needs to remain in close contact with the patient throughout treatment to reinforce adherence and offer feedback on their process, he added. At Dr. Chung’s office at Massachusetts General Hospital, one nurse practitioner has been assigned full-time to managing patients on DAAs. She works with them on everything from managing possible reactions like rash and anemia to helping them set up a daily schedule for taking the medications.
“We have 50 to 100 patients in varying stages of DAA treatment,” said Dr. Chung. “Every one of these patients is coming in for frequent visits—weekly in the beginning—and they are very much in need of monitoring, not just for adverse events like rash but also for fatigue and their ability to carry out work.”
Begin With a Thorough History
Before patients start the new therapies, gastroenterologists and hepatologists should consider getting a liver biopsy to help guide treatment, said Dr. Muir. Physicians also should confirm a patient’s history of treatment for HCV. If patients were previously on antiviral therapies, physicians need to find out as much as they can about that experience.
“You must ask whether we can improve upon previous treatment,” said Dr. Muir. “Were there adverse events with treatments? Were there dose reductions? If so, were they appropriate? How was patient adherence to medications? Did they use alcohol?”
Based on that information, physicians should outline the likelihood of each individual patient achieving an SVR, he said. The key predictors of SVR are whether patients are treatment-naive or treatment-experienced, whether they have cirrhosis and their race. Another important issue for patients is treatment duration. Duration will vary depending on each patient’s characteristics. “It’s important to speak with every patient about their likelihood of a shorter duration of treatment,” said Dr. Muir.
The American Association for the Study of Liver Diseases recommends 48 weeks of treatment for all patients with cirrhosis, as fewer patients with cirrhosis were included in the clinical trials that led to approval of the new drugs. Among those included, virologic response levels were lower than for patients without cirrhosis. For treatment-naive patients, 46% of non-black and 29% of black patients in the boceprevir SPRINT-2 (Serine Protease Inhibitor Therapy 2) trial achieved undetectable levels of HCV by 28 weeks, making them eligible for the shortened course of treatment (Poordad F et al. N Engl J Med 2011;364:1195-1206). In the telaprevir trial, 58% of patients had an early rapid virologic response (Jacobson IM et al. N Engl J Med 2011;364:2405-2416).
Patients’ interleukin-28B (IL28B) genotype also affects the expected duration of treatment. For both boceprevir and telaprevir, patients with the IL28B CC genotype are most likely to attain an early virologic response, more likely to receive a shortened course of therapy and more likely to have an SVR, according to studies presented at last year’s annual meeting of the European Association for the Study of the Liver.
Follow Through: Monitor for Response, Resistance, Reactions, Interactions
When the new HCV drugs were first approved, physicians’ offices reported some trouble getting approval from third-party payers for the full course of treatment, said Dr. Chung. His office had to provide documentation of successful early virologic response to get the go-ahead from payers to approve continuation of treatment with a protease inhibitor.
“You can imagine that if any gaps occur in the virologic tests or their reporting, this could lead to interruption of protease inhibitor therapy. It’s been a real challenge,” he said.
Experts recommend following patients very carefully over the course of treatment, monitoring any virologic breakthroughs or adverse reactions to the medications, particularly rash and anemia. Dr. Chung sees patients after the first, second and fourth week of therapy, and every four weeks thereafter if patients are having an uneventful course. Treatment monitoring is essential to prevent unwarranted continuation of treatment in patients when a breakthrough has occurred, he said.
“That would signal the emergence of resistant variants. Upon discovery, it would be paramount to discontinue the entire regimen to prevent selection of additional resistance mutations,” he said.
Equally important is the need to monitor patients closely for adverse reactions and drug–drug interactions. As IFN and RBV remain the backbone of this HCV regimen, the same contraindications exist as with standard dual therapy: decompensated cirrhosis, renal insufficiency, advanced cardiac/pulmonary disease, active depression, severe mental illness, anemia/neutropenia/thrombocytopenia and noncompliance.
Additionally, there are important drug–drug interactions with boceprevir and telaprevir. Both DAAs inhibit the CYP3A4/5 enzyme. Drugs metabolized by CYP3A4/5 may have increased effect in the presence of boceprevir or telaprevir. The DAAs themselves are metabolized by this cytochrome. As a result, other drugs that induce or inhibit CYP3A4/5 could affect HCV levels.
“Planning is key to deal with drug–drug interactions,” said Dr. Muir. It’s very important to do a risk–benefit analysis of treatment with boceprevir and telaprevir, taking into account patients’ comorbidities, he added.
It is important to review all drugs that the patient is taking, including over-the-counter and herbal medications. Check with the patient’s primary care provider, cardiologist and psychiatrist about medication use, Dr. Muir said. “It’s a good time to revisit the need for all medications. Ask if the antidepressant can be changed, the blood pressure medicines. Can the patient hold their statin for 12 weeks?” he said.
Women taking oral contraceptives should be advised to try other methods of contraception, such as an intrauterine device or barrier methods. Additionally, pregnant women should not take either drug, as both are considered pregnancy category X, meaning the risks “clearly outweigh potential benefits,” according to the FDA.
Anemia and rashes are the two most common adverse events associated with the new therapies. Experts suggest physicians be proactive about managing both.
Before a patient starts therapy, do a pretreatment evaluation for anemia and consider the impact on comorbidities, such as cardiac and pulmonary disorders. Weigh the benefits of reducing the dose versus increasing or starting erythropoietin.
For rashes, patients should be proactive by moisturizing twice a day, limiting sun exposure and wearing loose-fitting clothing. Dr. Chung recommends including a dermatologist on the treatment team.
Keep an Eye on the ‘Holy Grail of Therapy’
One other important element that needs to be taken into account when considering patients for DAA therapy is whether patients should wait for something else to be approved, said Dr. Chung. Recent results from Phase II studies of second-generation DAAs suggest that some combination of these could be approved in the next three years (see “New Polymerase Inhibitor Could Become Cornerstone of Interferon-free HCV Treatment Regimen,” by Christina Frangou. Gastroenterology & Endoscopy News 2012;63[2]:16 and “Second Study of New Hep C Drug Is Promising for Difficult-to-Treat HCV Genotype 1 Patients,” by Christina Frangou. Gastroenterology & Endoscopy News 2012;63[2]:17-19). These therapies omit IFN from the treatment regimen and can generally be taken orally once a day, with or without food.
“That’s something critical to consider. With all the complexities of therapy—the issues of tolerability, adherence, drug–drug interactions, quality of life—there’s another equally important set of events going on, and that’s the emerging data on all-oral, interferon-free treatments,” said Dr. Chung. “It’s clear that the promise of interferon-sparing therapy is very real. For all of us, that would be the holy grail of therapy.”
Dr. Chung currently recommends that all patients with HCV infection who have advanced-stage disease, regardless of whether they are treatment-naive or experienced, should be considered for boceprevir or telaprevir, provided the benefits outweigh the risks. Patients who can reasonably defer treatment because of early-stage disease or who cannot tolerate IFN may be able to wait for investigational therapies to be approved. These patients also may be eligible for investigational studies, which are ongoing.
Dr. Muir disclosed that he is on advisory committees or review panels for Merck & Co., and Vertex Pharmaceuticals; is a consultant for Inhibitex, Merck & Co., and Vertex Pharmaceuticals; and receives grant/research support from Abbott Laboratories, Anadys, Bristol-Myers Squibb, Gilead, Medtronic, Merck & Co., Pfizer, Roche, Santaris, Scynexis and Vertex Pharmaceuticals. Dr. Chung receives grant/research support from Gilead, Merck & Co., Pfizer and Romark. Dr. Davis is a consultant for Vertex Pharmaceuticals and receives grant/research support from Abbott Laboratories, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead, Novartis, Pharmasset, Tibotec and Vertex Pharmaceuticals.
Hepatology in Focus
ISSUE: FEBRUARY 2012 | VOLUME: 63
Patients’ Expectations About New HCV Direct-Acting Antivirals Often Unrealistic
Careful Patient Selection, Education Is Key for Success
by Christina Frangou
San Francisco—Soon after the FDA approved two direct-acting antiviral agents (DAAs) last spring for treating infection with hepatitis C virus (HCV), a 57-year-old black man came to see gastroenterologist Andrew Muir, MD.
The man had been diagnosed with hepatitis C in 2001. A liver biopsy one year later revealed he had stage II fibrosis. At the time, the patient declined treatment, saying the duration was too long and offered too few benefits.
But recently, he came back to Dr. Muir wanting to try a new protease inhibitor. Based on his reading, the man believed he could avoid interferon (IFN) and ribavirin (RBV), take a protease inhibitor as monotherapy for 24 weeks and expect a 75% chance of achieving a sustained virologic response (SVR).
Unfortunately, the patient’s expectations were unrealistic on all counts. The new protease inhibitor can only be given in conjunction with IFN and RBV, and the treatment duration varies. For blacks, therapy usually lasts a full 48 weeks, and in clinical trials, only 30% of black patients achieved an SVR with 28 weeks of therapy. Moreover, among black patients in the Phase III trials, SVR rates fell short of the 75% that the patient expected, and in treatment-naive blacks, only 62% receiving telaprevir and 53% on boceprevir achieved an SVR.
Educate To Encourage Adherence
Unrealistic expectations are common among patients with HCV infection who, after years of waiting for better therapies, are eager to try treatment with the new DAAs, said Dr. Muir. The DAAs on the market today are complex, with varied stoppage rules, monitoring points and some serious adverse events and drug–drug interactions.
“This is a real problem for clinicians. There’s tremendous excitement about these new therapies, but oftentimes, patients’ expectations are not in line with what these drugs can deliver,” said Dr. Muir, clinical director of hepatology at Duke University Medical Center, Durham, N.C.
In a presentation at The Liver Meeting 2011, Dr. Muir stressed that clinicians need to take time to carefully prepare patients for DAA therapy. Physicians must have clear, detailed discussions with their patients before and throughout treatment to optimize the benefits of DAA therapy, he said.
“The major challenges are preparing patients for the rigors of therapy, checking in frequently to make decisions about the duration of treatment and managing any issues as the patient goes along,” said Dr. Muir.
When patients come into the office considering treatment with DAAs, the first step is to clarify their expectations, said Dr. Muir. Patients need to learn the reality about DAAs if they want treatment to succeed.
Dr. Muir outlines for patients the complex prescribing rules, the contraindications, the lifestyle changes and duration of treatment with DAAs. The lifestyle changes can be significant, he cautions patients. Both telaprevir and boceprevir must be taken three times a day, or once every eight hours, and always with a meal. Dr. Muir then asks if the patient still wants treatment when these things are taken into account.
“That’s no small feat. Patients must adhere to that regimen because lapses in the concentration of telaprevir and boceprevir have historically been the risk period for breakthrough variants on therapy,” said Raymond Chung, MD, chief of hepatology and vice-chief of gastroenterology at Massachusetts General Hospital, Boston. Many of Dr. Chung’s patients limit or reschedule their work hours while on DAA therapy to help with adherence.
The key to getting patients through DAA treatment successfully is to select patients carefully and prepare them assiduously, said Gary L. Davis, MD, director of general and transplant hepatology at Baylor University Medical Center, Dallas. “This means that any issues that might impact compliance, tolerance and drug access should be dealt with before treatment starts. Educating the patient is essential. Patients and their support person need to clearly understand the importance of dosing compliance, lab monitoring and treatment stopping rules/end points.”
The treatment care team then needs to remain in close contact with the patient throughout treatment to reinforce adherence and offer feedback on their process, he added. At Dr. Chung’s office at Massachusetts General Hospital, one nurse practitioner has been assigned full-time to managing patients on DAAs. She works with them on everything from managing possible reactions like rash and anemia to helping them set up a daily schedule for taking the medications.
“We have 50 to 100 patients in varying stages of DAA treatment,” said Dr. Chung. “Every one of these patients is coming in for frequent visits—weekly in the beginning—and they are very much in need of monitoring, not just for adverse events like rash but also for fatigue and their ability to carry out work.”
Begin With a Thorough History
Before patients start the new therapies, gastroenterologists and hepatologists should consider getting a liver biopsy to help guide treatment, said Dr. Muir. Physicians also should confirm a patient’s history of treatment for HCV. If patients were previously on antiviral therapies, physicians need to find out as much as they can about that experience.
“You must ask whether we can improve upon previous treatment,” said Dr. Muir. “Were there adverse events with treatments? Were there dose reductions? If so, were they appropriate? How was patient adherence to medications? Did they use alcohol?”
Based on that information, physicians should outline the likelihood of each individual patient achieving an SVR, he said. The key predictors of SVR are whether patients are treatment-naive or treatment-experienced, whether they have cirrhosis and their race. Another important issue for patients is treatment duration. Duration will vary depending on each patient’s characteristics. “It’s important to speak with every patient about their likelihood of a shorter duration of treatment,” said Dr. Muir.
The American Association for the Study of Liver Diseases recommends 48 weeks of treatment for all patients with cirrhosis, as fewer patients with cirrhosis were included in the clinical trials that led to approval of the new drugs. Among those included, virologic response levels were lower than for patients without cirrhosis. For treatment-naive patients, 46% of non-black and 29% of black patients in the boceprevir SPRINT-2 (Serine Protease Inhibitor Therapy 2) trial achieved undetectable levels of HCV by 28 weeks, making them eligible for the shortened course of treatment (Poordad F et al. N Engl J Med 2011;364:1195-1206). In the telaprevir trial, 58% of patients had an early rapid virologic response (Jacobson IM et al. N Engl J Med 2011;364:2405-2416).
Patients’ interleukin-28B (IL28B) genotype also affects the expected duration of treatment. For both boceprevir and telaprevir, patients with the IL28B CC genotype are most likely to attain an early virologic response, more likely to receive a shortened course of therapy and more likely to have an SVR, according to studies presented at last year’s annual meeting of the European Association for the Study of the Liver.
Follow Through: Monitor for Response, Resistance, Reactions, Interactions
When the new HCV drugs were first approved, physicians’ offices reported some trouble getting approval from third-party payers for the full course of treatment, said Dr. Chung. His office had to provide documentation of successful early virologic response to get the go-ahead from payers to approve continuation of treatment with a protease inhibitor.
“You can imagine that if any gaps occur in the virologic tests or their reporting, this could lead to interruption of protease inhibitor therapy. It’s been a real challenge,” he said.
Experts recommend following patients very carefully over the course of treatment, monitoring any virologic breakthroughs or adverse reactions to the medications, particularly rash and anemia. Dr. Chung sees patients after the first, second and fourth week of therapy, and every four weeks thereafter if patients are having an uneventful course. Treatment monitoring is essential to prevent unwarranted continuation of treatment in patients when a breakthrough has occurred, he said.
“That would signal the emergence of resistant variants. Upon discovery, it would be paramount to discontinue the entire regimen to prevent selection of additional resistance mutations,” he said.
Equally important is the need to monitor patients closely for adverse reactions and drug–drug interactions. As IFN and RBV remain the backbone of this HCV regimen, the same contraindications exist as with standard dual therapy: decompensated cirrhosis, renal insufficiency, advanced cardiac/pulmonary disease, active depression, severe mental illness, anemia/neutropenia/thrombocytopenia and noncompliance.
Additionally, there are important drug–drug interactions with boceprevir and telaprevir. Both DAAs inhibit the CYP3A4/5 enzyme. Drugs metabolized by CYP3A4/5 may have increased effect in the presence of boceprevir or telaprevir. The DAAs themselves are metabolized by this cytochrome. As a result, other drugs that induce or inhibit CYP3A4/5 could affect HCV levels.
“Planning is key to deal with drug–drug interactions,” said Dr. Muir. It’s very important to do a risk–benefit analysis of treatment with boceprevir and telaprevir, taking into account patients’ comorbidities, he added.
It is important to review all drugs that the patient is taking, including over-the-counter and herbal medications. Check with the patient’s primary care provider, cardiologist and psychiatrist about medication use, Dr. Muir said. “It’s a good time to revisit the need for all medications. Ask if the antidepressant can be changed, the blood pressure medicines. Can the patient hold their statin for 12 weeks?” he said.
Women taking oral contraceptives should be advised to try other methods of contraception, such as an intrauterine device or barrier methods. Additionally, pregnant women should not take either drug, as both are considered pregnancy category X, meaning the risks “clearly outweigh potential benefits,” according to the FDA.
Anemia and rashes are the two most common adverse events associated with the new therapies. Experts suggest physicians be proactive about managing both.
Before a patient starts therapy, do a pretreatment evaluation for anemia and consider the impact on comorbidities, such as cardiac and pulmonary disorders. Weigh the benefits of reducing the dose versus increasing or starting erythropoietin.
For rashes, patients should be proactive by moisturizing twice a day, limiting sun exposure and wearing loose-fitting clothing. Dr. Chung recommends including a dermatologist on the treatment team.
Keep an Eye on the ‘Holy Grail of Therapy’
One other important element that needs to be taken into account when considering patients for DAA therapy is whether patients should wait for something else to be approved, said Dr. Chung. Recent results from Phase II studies of second-generation DAAs suggest that some combination of these could be approved in the next three years (see “New Polymerase Inhibitor Could Become Cornerstone of Interferon-free HCV Treatment Regimen,” by Christina Frangou. Gastroenterology & Endoscopy News 2012;63[2]:16 and “Second Study of New Hep C Drug Is Promising for Difficult-to-Treat HCV Genotype 1 Patients,” by Christina Frangou. Gastroenterology & Endoscopy News 2012;63[2]:17-19). These therapies omit IFN from the treatment regimen and can generally be taken orally once a day, with or without food.
“That’s something critical to consider. With all the complexities of therapy—the issues of tolerability, adherence, drug–drug interactions, quality of life—there’s another equally important set of events going on, and that’s the emerging data on all-oral, interferon-free treatments,” said Dr. Chung. “It’s clear that the promise of interferon-sparing therapy is very real. For all of us, that would be the holy grail of therapy.”
Dr. Chung currently recommends that all patients with HCV infection who have advanced-stage disease, regardless of whether they are treatment-naive or experienced, should be considered for boceprevir or telaprevir, provided the benefits outweigh the risks. Patients who can reasonably defer treatment because of early-stage disease or who cannot tolerate IFN may be able to wait for investigational therapies to be approved. These patients also may be eligible for investigational studies, which are ongoing.
Dr. Muir disclosed that he is on advisory committees or review panels for Merck & Co., and Vertex Pharmaceuticals; is a consultant for Inhibitex, Merck & Co., and Vertex Pharmaceuticals; and receives grant/research support from Abbott Laboratories, Anadys, Bristol-Myers Squibb, Gilead, Medtronic, Merck & Co., Pfizer, Roche, Santaris, Scynexis and Vertex Pharmaceuticals. Dr. Chung receives grant/research support from Gilead, Merck & Co., Pfizer and Romark. Dr. Davis is a consultant for Vertex Pharmaceuticals and receives grant/research support from Abbott Laboratories, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead, Novartis, Pharmasset, Tibotec and Vertex Pharmaceuticals.
Thursday, December 8, 2011
HCV p7 inhibitor BIT225 posts strong EVR results....
...but is it viable in the new zeitgeist of interferon-free therapies?
Sydney-based Biotron (ASX:BIT) has presented encouraging results from a trial of the use of its prospective Hepatitis C treatment, when coupled with existing therapies.
Patients treated in a phase IIa trial of Biotron's BIT225 drug candidate, combined with approved standard of care (SOC) treatments, mostly demonstrated improvement at three month follow-up.
Of the subjects to have been treated with BIT225, 87% showed a complete early viral response (EVR) – defined as virus levels in the blood below the level of detection.
This compares to 63% who received only SOC treatments interferon alfa-2b plus ribavirin, and backs up data from the four week point of the study showing significantly reduced levels of HCV virus in BIT225-treated patients.
The extent of virus reduction was dose-dependent, with the higher dose having the most effect.
Patients involved in the trial received either 200mg or 400mg doses of BIT225 for 28 days, and then remained on the SOC treatments for another 44 weeks.
Biotron CEO Dr Michelle Miller said the results of the trial were “extremely encouraging.” She said they also show that BIT225 was generally well-tolerated in patients, with the most common potential side effect being nausea, which may be solved by tweaks to the formulation.
Biotron is also in the middle of a phase 1b/IIa trial for BIT225 as a treatment for HIV.
Biotron (ASX:BIT) shares climbed 18.18% to a seven-month high of $0.130 after the results were released on Wednesday.
Sydney-based Biotron (ASX:BIT) has presented encouraging results from a trial of the use of its prospective Hepatitis C treatment, when coupled with existing therapies.
Patients treated in a phase IIa trial of Biotron's BIT225 drug candidate, combined with approved standard of care (SOC) treatments, mostly demonstrated improvement at three month follow-up.
Of the subjects to have been treated with BIT225, 87% showed a complete early viral response (EVR) – defined as virus levels in the blood below the level of detection.
This compares to 63% who received only SOC treatments interferon alfa-2b plus ribavirin, and backs up data from the four week point of the study showing significantly reduced levels of HCV virus in BIT225-treated patients.
The extent of virus reduction was dose-dependent, with the higher dose having the most effect.
Patients involved in the trial received either 200mg or 400mg doses of BIT225 for 28 days, and then remained on the SOC treatments for another 44 weeks.
Biotron CEO Dr Michelle Miller said the results of the trial were “extremely encouraging.” She said they also show that BIT225 was generally well-tolerated in patients, with the most common potential side effect being nausea, which may be solved by tweaks to the formulation.
Biotron is also in the middle of a phase 1b/IIa trial for BIT225 as a treatment for HIV.
Biotron (ASX:BIT) shares climbed 18.18% to a seven-month high of $0.130 after the results were released on Wednesday.
Monday, September 5, 2011
Gilead Sciences amends study by haltting doseing of GS 9190...
Gilead amends HCV study by halting dosing of polymerase inhibitor GS 9190 in combination with SOC and protease inhibitors...
(Because of two serious advents in two different studyies looking a a 'quad' combination of polymerase inhibitor GS 9190 + peg-INF-RBV + either investigational protease inhibitors GS 9451 or GS 9256, Gilead has halted dosing of GS 9190 in those particular studies. Studies of a interferon-free, all-oral regimen continue, however. )
Sept. 4, 2011, 11:00 a.m. EDT
Gilead Amends Study Design for Ongoing Hepatitis C Clinical Trials That Include GS 9190, Pegylated Interferon and Ribavirin, and Another Direct-Acting Antiviral Agent
Change Does Not Affect Ongoing "All Oral" Clinical Trials Evaluating Multiple Direct-Acting Antivirals in Combination
FOSTER CITY, Calif., Sep 04, 2011 (BUSINESS WIRE) -- Gilead Sciences, Inc. /quotes/zigman/72849/quotes/nls/gild GILD -1.90% today announced that, in consultation with the U.S. Food and Drug Administration (FDA), the company will amend the design of ongoing clinical trials to discontinue dosing of GS 9190 in hepatitis C-infected patients who are receiving that compound in combination with pegylated interferon and ribavirin, and another direct-acting antiviral agent.
This decision follows reports of two serious adverse events in patients enrolled in two separate studies who were receiving a four-drug regimen of GS 9190, an investigational HCV NS5B polymerase inhibitor; pegylated interferon and ribavirin; and one of two protease inhibitors (GS 9451 in one study and GS 9256 in the second study). Patient safety is Gilead's top priority, and the company will therefore immediately halt the dosing of GS 9190 in patients receiving this combination of medications.
Pegylated interferon in combination with ribavirin is currently part of the standard of care treatment for patients with chronic hepatitis C. Because of the side effects that can be associated with interferon, Gilead is working to develop multiple oral antivirals that, when used in combination, may be able to reduce or eliminate the need for interferon.
Gilead does not anticipate any impact on the timelines for or goals of its planned and ongoing clinical studies evaluating an "all oral" regimen for the treatment of chronic hepatitis C. Studies that include GS 9190 but do not include pegylated interferon will continue as planned. Similarly, studies that include the combination of GS 9451 (an investigational protease inhibitor), GS 5885 (an investigational NS5A) and pegylated interferon and ribavirin will continue.
Please click on the attached link for entire press release.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements, including the risk that further analysis of the laboratory abnormalities, adverse events and other data obtained to date may not support the continued development of GS 9190 and the risk that further clinical testing of Gilead's developmental compounds (including GS 9190, GS 9451, GS 5885 and GS 9256) and all oral regimens containing such compounds result in laboratory abnormalities, adverse events and other clinical data that may not support the continued development of such compounds or regimens. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
SOURCE: Gilead Sciences, Inc.
(Because of two serious advents in two different studyies looking a a 'quad' combination of polymerase inhibitor GS 9190 + peg-INF-RBV + either investigational protease inhibitors GS 9451 or GS 9256, Gilead has halted dosing of GS 9190 in those particular studies. Studies of a interferon-free, all-oral regimen continue, however. )
Sept. 4, 2011, 11:00 a.m. EDT
Gilead Amends Study Design for Ongoing Hepatitis C Clinical Trials That Include GS 9190, Pegylated Interferon and Ribavirin, and Another Direct-Acting Antiviral Agent
Change Does Not Affect Ongoing "All Oral" Clinical Trials Evaluating Multiple Direct-Acting Antivirals in Combination
FOSTER CITY, Calif., Sep 04, 2011 (BUSINESS WIRE) -- Gilead Sciences, Inc. /quotes/zigman/72849/quotes/nls/gild GILD -1.90% today announced that, in consultation with the U.S. Food and Drug Administration (FDA), the company will amend the design of ongoing clinical trials to discontinue dosing of GS 9190 in hepatitis C-infected patients who are receiving that compound in combination with pegylated interferon and ribavirin, and another direct-acting antiviral agent.
This decision follows reports of two serious adverse events in patients enrolled in two separate studies who were receiving a four-drug regimen of GS 9190, an investigational HCV NS5B polymerase inhibitor; pegylated interferon and ribavirin; and one of two protease inhibitors (GS 9451 in one study and GS 9256 in the second study). Patient safety is Gilead's top priority, and the company will therefore immediately halt the dosing of GS 9190 in patients receiving this combination of medications.
Pegylated interferon in combination with ribavirin is currently part of the standard of care treatment for patients with chronic hepatitis C. Because of the side effects that can be associated with interferon, Gilead is working to develop multiple oral antivirals that, when used in combination, may be able to reduce or eliminate the need for interferon.
Gilead does not anticipate any impact on the timelines for or goals of its planned and ongoing clinical studies evaluating an "all oral" regimen for the treatment of chronic hepatitis C. Studies that include GS 9190 but do not include pegylated interferon will continue as planned. Similarly, studies that include the combination of GS 9451 (an investigational protease inhibitor), GS 5885 (an investigational NS5A) and pegylated interferon and ribavirin will continue.
Please click on the attached link for entire press release.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements, including the risk that further analysis of the laboratory abnormalities, adverse events and other data obtained to date may not support the continued development of GS 9190 and the risk that further clinical testing of Gilead's developmental compounds (including GS 9190, GS 9451, GS 5885 and GS 9256) and all oral regimens containing such compounds result in laboratory abnormalities, adverse events and other clinical data that may not support the continued development of such compounds or regimens. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
SOURCE: Gilead Sciences, Inc.
Wednesday, April 6, 2011
Telaprevir, Boceprevir pricing in Europe....
Given the rather large sum of 22,000 euros or $31,271 to treat a patient with HCV in France (under the current expanded access conditions), some experts predict most European countries to restrict the drugs to patients who have failed previous therapy. With a short 2-3 year window of time, Both Vertex and Merck are anxious to recoup their costs and make a profit before the next generation of drugs hit the market. In an economic sense, this is as good a reason as any for commercial for-profit enterprises to charge a premium on their product, especially in an environment of limited competition. All this can lead one to speculate on how much the drugs will cost here in the States and, ultimately, who will have access.
Bloomberg. New hepatitis C drugs from Merck & Co. and Johnson & Johnson (JNJ) are being sold in France for 22,000 euros ($31,271) and more, a precedent some doctors say may limit access after the medicines are approved throughout Europe.
J&J and Vertex Pharmaceuticals Inc. (VRTX)'s telaprevir costs 22,000 euros under a French program for seriously ill patients for whom there is no other effective treatment on the market, according to patient association SOS Hepatites. Merck & Co. said its boceprevir costs 30,000 euros under the same program.
The price may drop once the drugs are approved for the broader market, Merck and J&J executives said. Still, the French model shows the new drugs may triple the cost of hepatitis C treatment, leaving England, Russia and eastern Europe likely to delay use or restrict which patients are allowed access, said Antonio Craxi, director of gastroenterology and internal medicine at the University of Palermo.
"It may be that we can't use it at all until the price comes down," Mark Thursz, professor of hepatology at Imperial College London, said in an interview at a conference in Berlin over the weekend. "It's not the best economic environment to launch an expensive new drug."
The U.K.'s National Institute for Health and Clinical Excellence may restrict the new drugs to patients who have tried existing treatments without success, Thursz said. The agency may also require genetic tests to determine whether patients are likely to respond to the medicines, he said at the meeting of the European Association for the Study of the Liver.
Italy and Spain also may delay or restrict use, Craxi said. Italy spends about 350 million euros a year on existing hepatitis C treatments, he said. "If you triple the cost, that would be more than 1 billion euros," he said.
Under Review
The new drugs are being reviewed by regulators at the European Medicines Agency. Both are scheduled for U.S. Food and Drug Administration hearings at the end of this month.
In France, telaprevir and boceprevir received special temporary authorization in December, under a program designed for seriously ill patients for whom there is no other effective treatment on the market, according to French pharmaceutical regulator AFSSAPS. This allowed the drugs to bypass the usual approval procedures, the regulator said.
About 500 patients are being treated in France now, said Michel Bonjour, spokesman for SOS Hepatites. The new drugs are prescribed together with the current standard therapy of interferon and generic ribavirin, and the total cost of a yearlong cycle of treatment may reach 45,000 euros to 70,000 euros per patient, Bonjour said in an interview. The cost is covered in full by France's national health insurance program.
'Cost Effective'
"It's not a good indication of price elsewhere," Patrick Bergstedt, senior vice president for vaccines and infectious diseases at Whitehouse Station, New Jersey-based Merck, said in an interview.
The very sick patients in the French program get 44 weeks of treatment with boceprevir, while a more typical course of therapy is 24 weeks to 32 weeks, he said. There's a "high likelihood" the eventual commercial price for a course of treatment will be less than the 30,000 euros Merck charges under the French program, he said.
"It's black and white that these drugs are cost- effective," Bergstedt said. "The challenge will be how do you stratify treatment, and how do you use these drugs responsibly to ensure the patients with the greatest need are treated first."
12-Week Treatment
Vertex, based in Cambridge, Massachusetts, referred questions to partner J&J, which will market telaprevir in Europe. J&J hasn't decided on a final price, said Isabelle Lonjon-Domanec, global medical affairs leader for telaprevir at the New Brunswick, New Jersey-based company's Tibotec Therapeutics unit.
Patients take telaprevir for 12 weeks together with standard treatment, then continue on the older standard drugs for a total of six months to a year of therapy.
Both new hepatitis C drugs are protease inhibitors crafted from the same technologies that led to discoveries in HIV research. Used in addition to existing therapies, they boost the chance of a cure from half of patients to between two-thirds and three-quarters of those treated, studies have shown.
In the U.S., the new drugs may be priced at $35,000 to $40,000, estimates Howard Liang, a Boston-based analyst at Leerink Swann & Co.
"A cure saves a lot of money down the road," Liang said in an interview. "It's a shock to physicians, but I think it can be justified because it's a cure."
Next Generation
Hepatitis C, spread through contact with infected blood, is a virus that often lingers as a chronic condition, causing nausea and exhaustion as it destroys the liver over the course of years or decades. About 170 million people are infected, according to the World Health Organization.
Meanwhile, the next generation of drugs with even higher cure rates and fewer side effects is likely to reach the market within three years, Liang said.
Swedish drugmaker Medivir AB (MVIRB) has said it expects to begin selling a competitor pill to be used with interferon by 2013. Boehringer Ingelheim GmbH, Gilead Sciences Inc. (GILD) and Bristol- Myers Squibb Co. are among a dozen companies aiming for drug cocktails to replace the existing interferon combination.
Looming competition leaves Merck, Vertex and J&J without much time to recoup their investment, said Charles Gore, president of the Geneva-based patient advocacy group World Hepatitis Alliance.
"There is no easy answer to this," Gore said in an interview. "We've got to have a way to give people access but incentivize the drug companies to research in this area."
To contact the reporters on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net; Carol Matlack in Paris at cmatlack@bloomberg.net
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net;
Bloomberg. New hepatitis C drugs from Merck & Co. and Johnson & Johnson (JNJ) are being sold in France for 22,000 euros ($31,271) and more, a precedent some doctors say may limit access after the medicines are approved throughout Europe.
J&J and Vertex Pharmaceuticals Inc. (VRTX)'s telaprevir costs 22,000 euros under a French program for seriously ill patients for whom there is no other effective treatment on the market, according to patient association SOS Hepatites. Merck & Co. said its boceprevir costs 30,000 euros under the same program.
The price may drop once the drugs are approved for the broader market, Merck and J&J executives said. Still, the French model shows the new drugs may triple the cost of hepatitis C treatment, leaving England, Russia and eastern Europe likely to delay use or restrict which patients are allowed access, said Antonio Craxi, director of gastroenterology and internal medicine at the University of Palermo.
"It may be that we can't use it at all until the price comes down," Mark Thursz, professor of hepatology at Imperial College London, said in an interview at a conference in Berlin over the weekend. "It's not the best economic environment to launch an expensive new drug."
The U.K.'s National Institute for Health and Clinical Excellence may restrict the new drugs to patients who have tried existing treatments without success, Thursz said. The agency may also require genetic tests to determine whether patients are likely to respond to the medicines, he said at the meeting of the European Association for the Study of the Liver.
Italy and Spain also may delay or restrict use, Craxi said. Italy spends about 350 million euros a year on existing hepatitis C treatments, he said. "If you triple the cost, that would be more than 1 billion euros," he said.
Under Review
The new drugs are being reviewed by regulators at the European Medicines Agency. Both are scheduled for U.S. Food and Drug Administration hearings at the end of this month.
In France, telaprevir and boceprevir received special temporary authorization in December, under a program designed for seriously ill patients for whom there is no other effective treatment on the market, according to French pharmaceutical regulator AFSSAPS. This allowed the drugs to bypass the usual approval procedures, the regulator said.
About 500 patients are being treated in France now, said Michel Bonjour, spokesman for SOS Hepatites. The new drugs are prescribed together with the current standard therapy of interferon and generic ribavirin, and the total cost of a yearlong cycle of treatment may reach 45,000 euros to 70,000 euros per patient, Bonjour said in an interview. The cost is covered in full by France's national health insurance program.
'Cost Effective'
"It's not a good indication of price elsewhere," Patrick Bergstedt, senior vice president for vaccines and infectious diseases at Whitehouse Station, New Jersey-based Merck, said in an interview.
The very sick patients in the French program get 44 weeks of treatment with boceprevir, while a more typical course of therapy is 24 weeks to 32 weeks, he said. There's a "high likelihood" the eventual commercial price for a course of treatment will be less than the 30,000 euros Merck charges under the French program, he said.
"It's black and white that these drugs are cost- effective," Bergstedt said. "The challenge will be how do you stratify treatment, and how do you use these drugs responsibly to ensure the patients with the greatest need are treated first."
12-Week Treatment
Vertex, based in Cambridge, Massachusetts, referred questions to partner J&J, which will market telaprevir in Europe. J&J hasn't decided on a final price, said Isabelle Lonjon-Domanec, global medical affairs leader for telaprevir at the New Brunswick, New Jersey-based company's Tibotec Therapeutics unit.
Patients take telaprevir for 12 weeks together with standard treatment, then continue on the older standard drugs for a total of six months to a year of therapy.
Both new hepatitis C drugs are protease inhibitors crafted from the same technologies that led to discoveries in HIV research. Used in addition to existing therapies, they boost the chance of a cure from half of patients to between two-thirds and three-quarters of those treated, studies have shown.
In the U.S., the new drugs may be priced at $35,000 to $40,000, estimates Howard Liang, a Boston-based analyst at Leerink Swann & Co.
"A cure saves a lot of money down the road," Liang said in an interview. "It's a shock to physicians, but I think it can be justified because it's a cure."
Next Generation
Hepatitis C, spread through contact with infected blood, is a virus that often lingers as a chronic condition, causing nausea and exhaustion as it destroys the liver over the course of years or decades. About 170 million people are infected, according to the World Health Organization.
Meanwhile, the next generation of drugs with even higher cure rates and fewer side effects is likely to reach the market within three years, Liang said.
Swedish drugmaker Medivir AB (MVIRB) has said it expects to begin selling a competitor pill to be used with interferon by 2013. Boehringer Ingelheim GmbH, Gilead Sciences Inc. (GILD) and Bristol- Myers Squibb Co. are among a dozen companies aiming for drug cocktails to replace the existing interferon combination.
Looming competition leaves Merck, Vertex and J&J without much time to recoup their investment, said Charles Gore, president of the Geneva-based patient advocacy group World Hepatitis Alliance.
"There is no easy answer to this," Gore said in an interview. "We've got to have a way to give people access but incentivize the drug companies to research in this area."
To contact the reporters on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net; Carol Matlack in Paris at cmatlack@bloomberg.net
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net;
Sunday, March 20, 2011
Conatus Pharmaceuticals - Phase II data on Hepatitis C MMP inhibitor CTS-1027 to be presented at EASL
Privately-held Conatus Pharmaceuticals will have two posters on the Phase II trial of it's inhibitor of matrix metalloprotease (MMP) activity, CTS-1027 - the only MMP inhibitor currently in development for HCV at this time.
Conatus Pharmaceuticals Inc. today announced the acceptance of two poster presentations of Phase 2 clinical trial data of CTS-1027 for the treatment of hepatitis C virus-infected patients at the 46th annual meeting of the European Association for the Study of the Liver (EASL) to be held in Berlin, Germany, on March 30 to April 3, 2011.
Specifically, abstract 562 entitled: 24-WEEK TREATMENT WITH CTS-1027 IN COMBINATION WITH RIBAVIRIN REDUCES HCV-RNA IN TREATMENT NAIVE GENOTYPE-1 PATIENTS will be presented.
In addition, abstract 549 entitled: UNIQUE PATTERN OF VIROLOGIC RESPONSE IN PATIENTS WITH GENOTYPE-1 HCV: A PHASE II STUDY OF CTS-1027 IN COMBINATION WITH PEGINTEFERON/RIBAVIRIN (SOC) IN NULL RESPONDERS will also be presented.
"This will be the first public disclosure of these exciting clinical results and represents a significant step forward to raise awareness of CTS-1027 for the treatment of HCV," said Alfred P. Spada, Ph.D., Senior Vice President, Research and Development at Conatus.
"CTS-1027 is a first-in-class oral, small molecule inhibitor of host matrix metalloprotease (MMP) activity. There are no other drugs under development for HCV that operate by the same mechanism of action. Most other approaches to treat HCV infection are direct-acting anti-viral drugs whose activity is directed against virus proteins or enzymes with the objective of reducing the production of virus in infected cells. CTS-1027 by comparison is distinctly different in that its activity is hypothesized to facilitate the immune clearance of virus-infected cells and decrease the frequency of new infections, both of which are of key importance in curing HCV infections," said Steven J. Mento, Ph.D, President and CEO of Conatus.
Conatus Pharmaceuticals Inc. is a privately-held biopharmaceutical company engaged in the development of innovative human therapeutics to treat liver disease and oncology. Conatus' lead drug candidate, CTS-1027 is in multiple Phase 2 clinical trials for the treatment of hepatitis C virus (HCV). Conatus was founded by the executive management team of Idun Pharmaceuticals in July 2005 following the sale of Idun to Pfizer.
SOURCE Conatus Pharmaceuticals Inc.
Conatus Pharmaceuticals Inc. today announced the acceptance of two poster presentations of Phase 2 clinical trial data of CTS-1027 for the treatment of hepatitis C virus-infected patients at the 46th annual meeting of the European Association for the Study of the Liver (EASL) to be held in Berlin, Germany, on March 30 to April 3, 2011.
Specifically, abstract 562 entitled: 24-WEEK TREATMENT WITH CTS-1027 IN COMBINATION WITH RIBAVIRIN REDUCES HCV-RNA IN TREATMENT NAIVE GENOTYPE-1 PATIENTS will be presented.
In addition, abstract 549 entitled: UNIQUE PATTERN OF VIROLOGIC RESPONSE IN PATIENTS WITH GENOTYPE-1 HCV: A PHASE II STUDY OF CTS-1027 IN COMBINATION WITH PEGINTEFERON/RIBAVIRIN (SOC) IN NULL RESPONDERS will also be presented.
"This will be the first public disclosure of these exciting clinical results and represents a significant step forward to raise awareness of CTS-1027 for the treatment of HCV," said Alfred P. Spada, Ph.D., Senior Vice President, Research and Development at Conatus.
"CTS-1027 is a first-in-class oral, small molecule inhibitor of host matrix metalloprotease (MMP) activity. There are no other drugs under development for HCV that operate by the same mechanism of action. Most other approaches to treat HCV infection are direct-acting anti-viral drugs whose activity is directed against virus proteins or enzymes with the objective of reducing the production of virus in infected cells. CTS-1027 by comparison is distinctly different in that its activity is hypothesized to facilitate the immune clearance of virus-infected cells and decrease the frequency of new infections, both of which are of key importance in curing HCV infections," said Steven J. Mento, Ph.D, President and CEO of Conatus.
Conatus Pharmaceuticals Inc. is a privately-held biopharmaceutical company engaged in the development of innovative human therapeutics to treat liver disease and oncology. Conatus' lead drug candidate, CTS-1027 is in multiple Phase 2 clinical trials for the treatment of hepatitis C virus (HCV). Conatus was founded by the executive management team of Idun Pharmaceuticals in July 2005 following the sale of Idun to Pfizer.
SOURCE Conatus Pharmaceuticals Inc.
Friday, February 11, 2011
Medivir Announces Start of Phase 1a Trial of the Hepatitis C Polymerase Inhibitor TMC649128
Medivir Announces Start of Phase 1a Trial of the Hepatitis C Polymerase Inhibitor TMC649128
10-Feb-11 Huddinge, Sweden - Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases,today announces the start of a phase 1a clinical trial with TMC649128 intended for the treatment of chronic hepatitis C virus infection.
TMC649128 is a nucleoside NS5B polymerase inhibitor that has already demonstrated an attractive pre-clinical profile. It is anticipated that this profile would see TMC649128 be used in combination with HCV directly acting antiviral agents, given their high genetic barrier to resistance and antiviral activity across multiple HCV genotypes.
In pre-clinical studies, TMC649128 displayed in vitro activity across multiple HCV genotypes and a high genetic barrier to resistance.
The phase 1a trial is a double-blind, randomized, placebo-controlled single-ascending dose trial to assess the safety, tolerability and pharmacokinetics in healthy volunteers and will be conducted in Belgium. TMC649128 is being developed in collaboration with Tibotec Pharmaceuticals.
Milestone payment
Medivir entered a Research and Development agreement in the field of hepatitis C virus polymerase with Ortho Biotech Products LP, an affiliate of Tibotec in May 2008. The development of TMC649128 falls under this agreement and by entering clinical development, a milestone payment of Euro 7 million has been triggered for payment to Medivir.
“We are extremely excited to see TMC649128, our first HCV nucleoside inhibitor, move into clinical development”, stated Bertil Samuelsson, CSO of Medivir. "The start of this phase 1a trial underlines Medivir’s commitment to the development of novel and innovative hepatitis C treatments. We view nucleoside inhibitors as cornerstone components of future HCV treatment paradigms in combination with directly acting antiviral agents and a TMC649128 component could set them apart from other HCV drug classes.”
For more information about Medivir, please contact;
Medivir (www.medivir.se) Rein Piir, CFO & VP Investor Relations Mobile: +46 708 537 292
M:Communications Europe: Mary-Jane Elliott / Amber Bielecka / Nick Francis Medivir@mcomgroup.com (Medivir@mcomgroup.com)
+44(0)20 7920 2330
USA: Jason Marshall +1 212 897 5497
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
About Medivir’s Commitment of the HCV Area
Medivir and Tibotec are also jointly developing the once daily protease inhibitor TMC435 for treatment of hepatitis C virus infections (HCV).
About Medivir
Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for 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 Xerese™/Xerclear®. Medivir’s key pipeline asset, TMC435, a protease inhibitor, is in phase 2b clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.
Xerese™/Xerclear® is an innovative treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GlaxoSmithKline to be sold OTC in Europe and Russia and with Meda AB in North America. Medivir has retained the Rx rights for Xerclear® in Sweden and Finland.
For more information about Medivir, please visit the Company’s website: www.medivir.se.
10-Feb-11 Huddinge, Sweden - Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases,today announces the start of a phase 1a clinical trial with TMC649128 intended for the treatment of chronic hepatitis C virus infection.
TMC649128 is a nucleoside NS5B polymerase inhibitor that has already demonstrated an attractive pre-clinical profile. It is anticipated that this profile would see TMC649128 be used in combination with HCV directly acting antiviral agents, given their high genetic barrier to resistance and antiviral activity across multiple HCV genotypes.
In pre-clinical studies, TMC649128 displayed in vitro activity across multiple HCV genotypes and a high genetic barrier to resistance.
The phase 1a trial is a double-blind, randomized, placebo-controlled single-ascending dose trial to assess the safety, tolerability and pharmacokinetics in healthy volunteers and will be conducted in Belgium. TMC649128 is being developed in collaboration with Tibotec Pharmaceuticals.
Milestone payment
Medivir entered a Research and Development agreement in the field of hepatitis C virus polymerase with Ortho Biotech Products LP, an affiliate of Tibotec in May 2008. The development of TMC649128 falls under this agreement and by entering clinical development, a milestone payment of Euro 7 million has been triggered for payment to Medivir.
“We are extremely excited to see TMC649128, our first HCV nucleoside inhibitor, move into clinical development”, stated Bertil Samuelsson, CSO of Medivir. "The start of this phase 1a trial underlines Medivir’s commitment to the development of novel and innovative hepatitis C treatments. We view nucleoside inhibitors as cornerstone components of future HCV treatment paradigms in combination with directly acting antiviral agents and a TMC649128 component could set them apart from other HCV drug classes.”
For more information about Medivir, please contact;
Medivir (www.medivir.se) Rein Piir, CFO & VP Investor Relations Mobile: +46 708 537 292
M:Communications Europe: Mary-Jane Elliott / Amber Bielecka / Nick Francis Medivir@mcomgroup.com (Medivir@mcomgroup.com)
+44(0)20 7920 2330
USA: Jason Marshall +1 212 897 5497
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
About Medivir’s Commitment of the HCV Area
Medivir and Tibotec are also jointly developing the once daily protease inhibitor TMC435 for treatment of hepatitis C virus infections (HCV).
About Medivir
Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for 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 Xerese™/Xerclear®. Medivir’s key pipeline asset, TMC435, a protease inhibitor, is in phase 2b clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.
Xerese™/Xerclear® is an innovative treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GlaxoSmithKline to be sold OTC in Europe and Russia and with Meda AB in North America. Medivir has retained the Rx rights for Xerclear® in Sweden and Finland.
For more information about Medivir, please visit the Company’s website: www.medivir.se.
Wednesday, December 1, 2010
Further info on the GI-5005 HCV vaccine study presented at AASLD... hope for those with the IL28 T/T allele?
Synopsis of the GI-5005 study presented at AASLD 2010. Overall, the numbers for GI-5005 aren't extraordinary, but certainly worth further studies. The true benefit for this vaccine may be how it appears to illicit a T-cell response in patients carrying the T allele of the IL28 gene, which didn't occur when the same patients were given standard of care
By: DIANA MAHONEY, Internal Medicine News Digital Network
12/01/10
BOSTON – A therapeutic vaccine against the hepatitis C virus was associated with a significantly higher sustained virologic response rate when added to standard-of-care treatment, and the findings justify further development of the vaccine, Dr. Paul Pockros reported at the annual meeting of the American Association for the Study of Liver Diseases.
In the proof-of-concept trial, 133 patients infected with hepatitis C virus (HCV) genotype 1 were randomized to either triple therapy comprising the experimental GI-5005 vaccine, which is designed to elicit a T-cell response specific to HCV, along with pegylated interferon alfa-2b plus ribavirin (P/R), or the standard P/R therapy alone.
The primary outcome measure was sustained virologic response (SVR), defined as undetectable HCV RNA at 6 months after treatment, said Dr. Pockros of the Scripps Clinic in La Jolla, Calif.
The 68 patients in the experimental group initially received monotherapy with the vaccine, consisting of five weekly injections followed by two monthly injections for a 12-week lead-in period, before progressing to the standard-of-care P/R treatment and once-monthly injections. The 65 patients in the control group received standard-of-care P/R treatment alone.
In both groups, the treatment duration was 48 weeks for treatment-naive patients and 72 weeks for those who had a poor or partial response to prior P/R treatment, said Dr. Pockros. Patients in whom prior P/R therapy induced no notable decrease in HCV viral load, as well as those in whom prior treatment initially resulted in undetectable HCV RNA followed by a viral rebound, were excluded from the analysis.
Among the study’s treatment-naive patients, 58% of those who received the vaccine achieved SVR, compared with 48% of those who received P/R alone. Among the prior poor and partial responders, the respective SVR rates in the vaccine and control groups were 17% and 5%, Dr. Pockros reported.
"There was a slight benefit in the treatment-naive and nonresponders, [but] this was numerical only and was not statistically significant," he said. However, the overall benefit in the vaccine vs. control groups was statistically significant, with respective SVR rates of 47% and 35%, he noted.
The vaccine strategy appears to be safe. "The most common associated adverse events were mild, transient injection-site reactions," said Dr. Pockros. Additionally, he stated, "the discontinuation rates due to adverse events were comparable [13%] in both the triple-therapy and standard-of-care arms."
Of particular interest, Dr. Pockros noted, was the T-cell response in a subgroup of difficult-to-treat patients receiving the vaccine. Previous studies have suggested that patients carrying the T allele of the IL28 gene are at high risk of treatment failure with the standard interferon-based therapy. The T-cell response in vaccine-treated patients, as measured by interferon-gamma enzyme-linked ImmunoSpot assay, "mimicked what we saw with a virologic response," he said.
"Four of five T/T allele patients had a T-cell response – one did not actually get treated – but none of the patients who received standard of care had a T-cell response."
This finding is consistent with the hypothesis that the GI-5005 vaccine corrects a fundamental deficit in cellular immunity in IL28B T/T genotype patients, he said. Although the findings need to be confirmed in additional studies with larger patient populations, the vaccine will likely be genotype specific, he noted.
Because the immune response is similar to that observed in HCV-infected patients who are able to clear the virus without treatment, future studies will evaluate the efficacy of monotherapy with the vaccine in genotype-specific patients, Dr. Pockros said.
The proof-of-concept study was funded by GlobeImmune, manufacturer of the vaccine. Dr. Pockros disclosed financial relationships with GlobeImmune, Genentech, Vertex, Merck, Gilead, Abbott, Pfizer, Phenomix, Tibotec, Pharmasset, 3RT, Novartis, Johnson & Johnson, Achillon, Regulus, Debio, Zymogenetics, and Human Genome Sciences.
By: DIANA MAHONEY, Internal Medicine News Digital Network
12/01/10
BOSTON – A therapeutic vaccine against the hepatitis C virus was associated with a significantly higher sustained virologic response rate when added to standard-of-care treatment, and the findings justify further development of the vaccine, Dr. Paul Pockros reported at the annual meeting of the American Association for the Study of Liver Diseases.
In the proof-of-concept trial, 133 patients infected with hepatitis C virus (HCV) genotype 1 were randomized to either triple therapy comprising the experimental GI-5005 vaccine, which is designed to elicit a T-cell response specific to HCV, along with pegylated interferon alfa-2b plus ribavirin (P/R), or the standard P/R therapy alone.
The primary outcome measure was sustained virologic response (SVR), defined as undetectable HCV RNA at 6 months after treatment, said Dr. Pockros of the Scripps Clinic in La Jolla, Calif.
The 68 patients in the experimental group initially received monotherapy with the vaccine, consisting of five weekly injections followed by two monthly injections for a 12-week lead-in period, before progressing to the standard-of-care P/R treatment and once-monthly injections. The 65 patients in the control group received standard-of-care P/R treatment alone.
In both groups, the treatment duration was 48 weeks for treatment-naive patients and 72 weeks for those who had a poor or partial response to prior P/R treatment, said Dr. Pockros. Patients in whom prior P/R therapy induced no notable decrease in HCV viral load, as well as those in whom prior treatment initially resulted in undetectable HCV RNA followed by a viral rebound, were excluded from the analysis.
Among the study’s treatment-naive patients, 58% of those who received the vaccine achieved SVR, compared with 48% of those who received P/R alone. Among the prior poor and partial responders, the respective SVR rates in the vaccine and control groups were 17% and 5%, Dr. Pockros reported.
"There was a slight benefit in the treatment-naive and nonresponders, [but] this was numerical only and was not statistically significant," he said. However, the overall benefit in the vaccine vs. control groups was statistically significant, with respective SVR rates of 47% and 35%, he noted.
The vaccine strategy appears to be safe. "The most common associated adverse events were mild, transient injection-site reactions," said Dr. Pockros. Additionally, he stated, "the discontinuation rates due to adverse events were comparable [13%] in both the triple-therapy and standard-of-care arms."
Of particular interest, Dr. Pockros noted, was the T-cell response in a subgroup of difficult-to-treat patients receiving the vaccine. Previous studies have suggested that patients carrying the T allele of the IL28 gene are at high risk of treatment failure with the standard interferon-based therapy. The T-cell response in vaccine-treated patients, as measured by interferon-gamma enzyme-linked ImmunoSpot assay, "mimicked what we saw with a virologic response," he said.
"Four of five T/T allele patients had a T-cell response – one did not actually get treated – but none of the patients who received standard of care had a T-cell response."
This finding is consistent with the hypothesis that the GI-5005 vaccine corrects a fundamental deficit in cellular immunity in IL28B T/T genotype patients, he said. Although the findings need to be confirmed in additional studies with larger patient populations, the vaccine will likely be genotype specific, he noted.
Because the immune response is similar to that observed in HCV-infected patients who are able to clear the virus without treatment, future studies will evaluate the efficacy of monotherapy with the vaccine in genotype-specific patients, Dr. Pockros said.
The proof-of-concept study was funded by GlobeImmune, manufacturer of the vaccine. Dr. Pockros disclosed financial relationships with GlobeImmune, Genentech, Vertex, Merck, Gilead, Abbott, Pfizer, Phenomix, Tibotec, Pharmasset, 3RT, Novartis, Johnson & Johnson, Achillon, Regulus, Debio, Zymogenetics, and Human Genome Sciences.
Tuesday, November 30, 2010
Caleco Pharma Corp amends IP patents for compounds to treat HCV...
LONG VALLEY, NEW JERSEY--(Marketwire - 11/30/10) - Caleco Pharma Corp. (www.calecopharmacorp.com), a diversified healthcare company with biopharmaceutical and consumer health product development programs that develop products derived from natural sources such as plant extracts, today reports that it has amended its intellectual property (IP) filing with the European Patent Office in The Hague to further secure and strengthen Caleco's anti-viral pipeline.
In response to the EU Patent Office's Examination Report, Caleco reports that the company's European Patent Application number 08725530.3 is amended with regard to compositions comprising derivatives and derivative combinations of Lamiridosin and Iridoid for treatment of Hepatitis C. The molecular specifications required in these amendments resulted in the exclusion of certain derivative claims. However, these claims will not be abandoned, but instead, these claims will be pursued through one or more divisional applications.
John Boschert, Caleco's CEO, said, "By amending our filing we are seeking to solidify our intellectual property position in the billion dollar Hepatitis C and anti-viral marketplace. We plan to continue to pursue a broader pipeline of semi-synthetic derivatives that will be prepared for further testing in 2011. The Hepatitis C patient population remains greatly underserved by existing treatment options and we are eager to move these compounds into the next stage of development."
About Caleco Pharma Corp.
Caleco is focused on the ongoing research and development of its pipeline of over-the-counter and prescription medications including its proprietary antiviral and "Liver Health" OTC formulations. In addition Caleco is developing Dermatological Products based on the active ingredients found in its proprietary formulation. Caleco's intellectual property covering the Liver Health formulations and derivatives consists of patent applications in the United States, Europe and Canada and four European Drug Master File applications.
Caleco's shares are traded in the United States on the OTC Bulletin Board (OTC.BB:CAEH - News) and in Germany on the Frankfurt Stock Exchange (Frankfurt:T3R - News)(WKN: A0N9Y0).
In response to the EU Patent Office's Examination Report, Caleco reports that the company's European Patent Application number 08725530.3 is amended with regard to compositions comprising derivatives and derivative combinations of Lamiridosin and Iridoid for treatment of Hepatitis C. The molecular specifications required in these amendments resulted in the exclusion of certain derivative claims. However, these claims will not be abandoned, but instead, these claims will be pursued through one or more divisional applications.
John Boschert, Caleco's CEO, said, "By amending our filing we are seeking to solidify our intellectual property position in the billion dollar Hepatitis C and anti-viral marketplace. We plan to continue to pursue a broader pipeline of semi-synthetic derivatives that will be prepared for further testing in 2011. The Hepatitis C patient population remains greatly underserved by existing treatment options and we are eager to move these compounds into the next stage of development."
About Caleco Pharma Corp.
Caleco is focused on the ongoing research and development of its pipeline of over-the-counter and prescription medications including its proprietary antiviral and "Liver Health" OTC formulations. In addition Caleco is developing Dermatological Products based on the active ingredients found in its proprietary formulation. Caleco's intellectual property covering the Liver Health formulations and derivatives consists of patent applications in the United States, Europe and Canada and four European Drug Master File applications.
Caleco's shares are traded in the United States on the OTC Bulletin Board (OTC.BB:CAEH - News) and in Germany on the Frankfurt Stock Exchange (Frankfurt:T3R - News)(WKN: A0N9Y0).
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