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« October 2007 | Main | December 2007 »
November 29, 2007
HCV Treatment Aided by New Platelet-Boosting Drug
In collaboration with health centers across the globe, researchers at Duke University Medical Center are excited about a once daily pill for increasing blood platelet counts. To help patients complete antiviral therapy, the researchers found that eltrombopag effectively raises blood platelets in those with low platelet counts and cirrhosis of the liver due to Hepatitis C.
Drug boosts platelets in hepatitis C patients
www.eurekalert.org
November 28, 2007
DURHAM, N.C. – It’s not a cure, but this may be some of the best news patients infected with the hepatitis C virus (HCV) have heard in a long time: A new drug, eltrombopag, appears to be effective in boosting low platelet counts, one of the major reasons why patients can’t endure antiviral treatments.
Other drugs that can restore normal platelet functions are infusions or injections; eltrombopag is a pill taken just once a day.
Researchers at Duke University Medical Center and other centers world-wide studied eltrombopag (marketed as Promacta in the U.S. and Revolade in Europe by GlaxoSmithKline) in 74 patients with low platelet counts and cirrhosis of the liver due to HCV infection. They found that it boosted platelet counts in a majority of patients at each of three dosage levels, enabling most of them to continue or start conventional antiviral treatment.
The findings appear in the current issue of the New England Journal of Medicine.
“We feel this is an important development for many people infected with the hepatitis C virus world-wide,” says Dr. John McHutchison, professor of medicine and associate director of the Duke Clinical Research Institute. “A significant number of patients with HCV infection will at some point develop platelet problems that will compromise their getting the best treatments we have. Anything we can do to prevent that from happening would improve their care.”
It’s estimated that 4 million people in the U.S. and 170 million world-wide carry the hepatitis C virus. The virus causes inflammation and scarring in the liver, and while it is curable in about half of those who have it, it can lead to significant liver damage, liver cancer and death in others. HCV infection is a common cause of cirrhosis and the most common reason for a liver transplant.
Platelets are cells made in the bone marrow that are important in clot formation, and serious bleeding can occur if platelet levels fall too low. Some diseases, like HCV infection, can cripple the body’s ability to manufacture platelets, but so can some medical treatments. Cancer patients, for example, can experience plummeting platelet levels when undergoing chemotherapy.
In the phase II, multi-center trial, participants were randomized to a control group or to receive 30, 50, or 75 milligrams of eltrombopag daily. The patients had platelet levels ranging from 20,000 to 70,000 (145,000 to 450,000 is normal).
A phase II trial is designed to test the safety and efficacy of a drug at different doses, and the Duke study found that eltrombopag worked in a dose-dependent manner, meaning that patients got a better response with increasing amounts of the drug. Seventy-four percent of those in the trial who took the lowest dose saw their platelet counts go up significantly, while 79 percent and 95 percent of the participants saw increases with the higher doses.
Eltrombopag does cause side effects. Some of the patients complained of headaches, dry mouth, abdominal pain and nausea.
“We are encouraged by these results and are already working on another multi-center, international, phase III trial where we hope these results will be confirmed,” says McHutchison.
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The study was sponsored by GlaxoSmithKline, which manufactures eltrombopag. McHutchison and many of the coauthors also report having received grants, consulting, advisory or speaking fees from the company.
Colleagues who contributed to the study include Geoffrey Dusheiko, M.D., Royal Free Hospital, London; Mitchell Schiffman, M.D., Virginia Commonwealth University Medical Center; Maribel Rodriguez-Torres, M.D., Fundacion de Investigacion de Diego, San Juan; Samuel Sigal, M.D., Weill Medical College; Marc Bourliere, M.D., Hopital St. Joseph, Marseille; Thomas Berg, M.D., Charite, Berlin; Stuart Gordon, M.D., Henry Ford Hospital and Health System, Detroit; Fiona M. Campbell, B.Sc., GlaxoSmithKline, Greenford, UK; Dickens Theodore, M.D., M.P.H., GlaxoSmithKline, Research Triangle Park; Nicole Blackman, Ph.D. and Julian Jenkins, M.Sc.,GlaxoSmithKline, Philadelphia; and Nezam Afdhal, M.D., Beth Israel Deaconess Medical Center, Boston.
Contact: Michelle Gailiun
michelle.gailiun@duke.edu
919-660-1306
Duke University Medical Center
Posted by Editors at 12:05 PM --- Printer-friendly version
November 27, 2007
Invention Offers Sick Livers a Well-Needed Rest
Potentially giving the liver a chance to rest and recover, Scottish scientists are working to perfect their artificial liver machine. Conceptually similar to kidney dialysis, this invention temporarily gives the liver a break from its constant duty of filtering out toxins.
Artificial liver offers sufferers new hope
KATE FOSTER (kfoster@scotlandonsunday.com)
http://news.scotsman.com
SCOTTISH scientists are developing an artificial liver that could save the lives of hundreds of patients by avoiding the need for an organ transplant.
Researchers have created a 'bioartificial' liver using living cells in a machine that can filter blood and take over the functions of the natural organ.
They believe the artificial liver - which works outside the body in a way similar to kidney dialysis - could help patients suffering from acute liver disease such as hepatitis or those who have taken a paracetamol overdose, by giving their own liver the chance to 'rest' and heal itself.
They also say it could give a patient dying from chronic liver failure, such as cirrhosis, valuable extra time while they wait for an organ transplant. The team of University of Strathclyde researchers are at the forefront of the technology in the UK.
They have already created devices that replicate the functions of the liver and are now developing ways to allow the living cells used within the device to thrive better.
Deaths from liver disease are on the increase and researchers are trying to find alternatives to transplantation.
Each year in the UK, liver problems kill about 6,700 people but there are only about 650 transplants. Currently, 231,000 people have hepatitis C, which can lead to liver cancer and liver failure.
Over the past 30 years, deaths from chronic liver disease have increased eightfold in men aged between 35 and 44, and sevenfold in women.
Dr John Gaylor, from the Bioengineering Unit at the University of Strathclyde, has led the team responsible for developing the artificial liver.
He said patients could benefit from the treatment within a decade if sufficient funding is put into the research.
"We are looking at creating a device that would buy time for a patient with acute liver failure where the liver has the potential to regenerate.
"If you can buy time the patient can recover. This includes overdose of paracetamol as an attempted suicide and where they go into liver failure within days or weeks. Hepatitis is another big problem. We were also hoping to use the device as a bridge to transplantation where they have chronic liver failure, such as cirrhosis, and would buy time before transplantation. It is to provide some of the lost functions."
Gaylor and his team used live cells taken from rats' livers and placed them on plates in a specially constructed machine. They coated the inside of the plates with a special protein mixture that allowed them to stick and continue to thrive.
Animal blood was pumped into the bioartificial liver and it was shown to have been detoxified by the cells in a similar way to how the liver normally functions. The scientists then 'spiked' the blood with toxins usually found in the blood of patients suffering from liver disease and found this was successfully removed as well.
Gaylor and his team are now looking at how to make the liver cells work best.
In humans, blood would be taken from the patient directly into the bioartificial liver, allowing their own liver a rest from processing toxins. This could allow the patient's liver to heal itself. The treatment would take a number of weeks or months before the liver was repaired.
A spokeswoman for the British Liver Trust said of the developments: "This sounds particularly positive as there is currently nothing similar out there for liver patients. The benefits could be enormous.
"We would support anything that would benefit patients. Most people do not know they have liver disease until it is too late and the damage is done."
Posted by Editors at 02:56 PM --- Printer-friendly version
November 23, 2007
Phlebotomy Gaining Acceptance as HCV Treatment
Most people associate the removal of blood from their veins with donating to the Red Cross or getting tested for some ailment. However, the removal of blood from someone's body can serve many purposes. Learn how the safe ancient practice of bloodletting, or phlebotomy, has proven therapeutic value, and why it is gaining momentum as a treatment of chronic Hepatitis C.
by Nicole Cutler, L.Ac.
Helping to alleviate a variety of illnesses for over 3,000 years, bloodletting has been practiced in most ancient medicinal cultures. Known in the modern healthcare setting as phlebotomy, the removal of blood from someone’s body can have many applications. In addition to being a diagnostic technique and a method of transferring blood to those who need it, phlebotomy is also used therapeutically. While phlebotomy treatment has targeted different kinds of liver diseases over the years, recent research demonstrates its application in the fight against chronic Hepatitis C.
Why Phlebotomy May Help
Phlebotomy may benefit those with Hepatitis C because it lessens the amount of iron in the bloodstream. Toxic in excessive amounts, too much iron in the body contributes to liver damage. As this mineral’s primary storage site, the liver is most susceptible to iron’s toxicity. Our bodies have a limited ability to eliminate excessive amounts of iron.
Because of the liver damage associated with chronic Hepatitis C, people with the virus often have difficulty excreting even normal amounts of iron from their body. Further, those with chronic Hepatitis C are especially vulnerable because the virus inflicts most of its damage by creating free radicals in the liver. As soon as iron molecules collide with those free radicals, liver cell death is the likely result.
Increasing evidence indicates that iron toxicity plays an important role in the pathogenesis of chronic Hepatitis C. As published in the June 2004 edition of Journal of Gastroenterology, Japanese researchers demonstrated this relationship by examining whether iron removal by repeated phlebotomy improves serum alanine aminotransferase (ALT) levels in patients with chronic Hepatitis C. An enzyme produced in liver cells, ALT leaks into the bloodstream when liver cells are damaged. The results showed that people with chronic Hepatitis C receiving biweekly phlebotomy had improvements in their ALT levels compared with those not receiving phlebotomies.
Recent Evidence
Two studies published in 2007 present compelling evidence to include phlebotomy in modern Hepatitis C treatment protocols:
1. Better Than Diet – Knowing that iron likely plays an important role in the development of Hepatitis C, Japanese researchers examined which technique was best for lowering iron levels – phlebotomy or dietary restriction. As published in the May 2007 edition of Internal Medicine, these researchers conducted a randomized, controlled trial comparing phlebotomy with dietary iron reduction in people with chronic Hepatitis C. They concluded that phlebotomy is superior to dietary iron reduction in reducing liver damage from chronic Hepatitis C.
2. Best With Interferon – As published in the September 2007 edition of Digestive Diseases and Sciences, Michigan scientists analyzed six randomized controlled trials comparing phlebotomy and interferon treatment, to interferon alone, in patients with chronic Hepatitis C. All studies used sustained viral response (SVR) as its endpoint, the continued clearance of the Hepatitis C virus from the blood six months after therapy. Researchers found that SVR was attained in 27 percent of patients in the phlebotomy plus interferon group, compared to 12 percent of patients achieving SVR in the interferon group. Although the six trials had different parameters, the authors concluded that phlebotomy improved a person with chronic Hepatitis C’s chances of attaining SVR when combined with interferon treatment.
Previous Non-Responders
Considering the results of studies using phlebotomy to help Hepatitis C, one can surmise that iron may play a role in the persistence of Hepatitis C infection – particularly in interferon non-responders. By removing some of the blood laden with excessive levels of iron, the currently prescribed medications seem to have a better chance at destroying the Hepatitis C virus the second time around. Theoretically, high dose interferon therapy combined with phlebotomy may be a way for previous non-responders to achieve treatment success. However, only continued research will confirm or deny this proposal.
Hope
Iron reduction therapy holds great promise as an effective treatment for those infected with Hepatitis C. Although phlebotomy alone does not reduce Hepatitis C viral load, it increases the effectiveness of interferon therapy when used either before or during administration of this standard medication.
Whether being considered in combination with interferon therapy or alone as an alternative treatment for individuals who cannot tolerate interferon, removing blood regularly decreases iron levels in the body by reducing the number of iron-rich red blood cells. Universally recognized as an iron reduction therapy leading to improvements in liver enzyme levels, the simplicity and safety of phlebotomy is gaining momentum as a recommended technique for Hepatitis C therapy.
References:
Desai TK, et al., Phlebotomy Improves Therapeutic Response to Interferon in Patients with Chronic Hepatitis C: A Meta-Analysis of Six Prospective Randomized Controlled Trials, Digestive Diseases and Sciences, September 2007.
Girelli CM, et al., Effect of blood letting on serum aminotransferase levels of patients with chronic hepatitis C and iron overload, Recenti Progressi in Medicina, May 1998.
http://health.yahoo.com, Phlebotomy, Nancy Bateman, Yahoo Inc., 2007.
Sumida Y, et al., Effects of dietary iron reduction versus phlebotomy in patients with chronic hepatitis C: results from a randomized, controlled trial on 40 Japanese patients, Internal Medicine, May 2007.
www.natap.org, Iron and Hepatitis C, James E. Nelson, PhD and Kris V. Kowdley, MD, Current Hepatitis Reports, November 2004.
www.pbs.org, A Brief History of Bloodletting, Gilbert R. Seigworth, MD, The Educational Broadcast Association, 2007.
Yano M, et al., A significant reduction in serum alanine aminotransferase levels after 3-month iron reduction therapy for chronic hepatitis C: a multicenter, prospective, randomized, controlled trial in Japan, Journal of Gastroenterology, June 2004.
Posted by Editors at 02:27 PM --- Printer-friendly version
Extended Interferon Treatment Not Helpful for Hepatitis Delta
While most cases of chronic viral hepatitis present a treatment challenge, treating the Hepatitis Delta virus is even harder. Soured by its high relapse rate, the only approved treatment for this infection is one year of interferon therapy. In their search for better solutions, Turkish researchers found that doubling the treatment length has no effect on this viral strain's response rates.
Interferon for the Treatment of Chronic Hepatitis Delta
www.hivandhepatitis.com
By Liz Highleyman
Hepatitis delta virus (HDV) is a defective virus-like pathogen that can only replicate in the presence of hepatitis B virus (HBV). HDV is transmitted through the same routes as HBV (direct blood contact, sexual contact, mother-to-child). People may either become coinfected with HBV and HDV at the same, or may acquire HDV while already infected with HBV.
A 1-year course of high-dose interferon alpha is the only established treatment for chronic HDV infection, but it has a high relapse rate after therapy is completed.
As reported in the November 2007 Journal of Viral Hepatitis, researchers from the University of Ankara in Turkey conducted a study to determine whether treating HDV for 2 years would improve sustained response rates.
In this study, 23 patients were treated with 10 million unit (MU) of interferon alpha-2b (Intron-A) 3 times weekly for 2 years. Treatment response was assessed as follows at the end of treatment (24 months) and after a 6-month follow-up period (30 months total):
• Virological response: undetectable HDV RNA;
• Biochemical response: normal alanine aminotransferase (ALT);
• Histological response: at least 2-point decrease in the Knodell score (histological activity index measuring liver necroinflammation and fibrosis).
Results
• 15 patients completed the 2-year course of treatment and 6-month follow-up period.
• Out of these patients, 7 (47%) had a biochemical response, but only 2 (13%) still had normal ALT at the end of follow-up.
• ALT decreased from the mean baseline value of 143.1 to 39.7 IU/L at the end of treatment.
• 6 patients had a virological response at the end of treatment, but only 2 had sustained virological response at the end of the follow-up period.
• 2 patients lost hepatitis B surface antigen (HBsAg).
• Among the 12 patients with paired liver biopsies, 8 experienced histological improvement.
Conclusion
Based on these findings, the authors concluded, "Interferon treatment leads to a complete or partial response in a substantial number of patients, but 2 years of treatment does not appear to increase sustained response rates over 1 year treatment."
10/26/07
Reference
C Yurdaydin, H Bozkaya, H Karaaslan, and others. A pilot study of 2 years of interferon treatment in patients with chronic delta hepatitis. Journal of Viral Hepatitis 14(11): 812-816. November 2007.
Posted by Editors at 02:22 PM --- Printer-friendly version
November 13, 2007
How to Relieve HCV Symptoms
When you apply pressure to certain points on your body, it is possible to reduce pain and improve your health. Discover how acupressure can be used to relieve some common symptoms associated with Hepatitis C, including liver-area pain and fatigue.
by Nicole Cutler, L.Ac.
In martial arts, the secret to defeating an opponent who is larger and stronger than you lies with the knowledge and use of pressure points. The different ways to define a pressure point can widely vary, depending on the frame of reference. Regardless of these variations, pressure points are generally understood to be locations on the body that have a large impact on the recipient when pressed firmly. Although many disciplines of combat and self-defense use pressure points to cause discomfort, there are also points on the body capable of relieving discomfort. For people living with the Hepatitis C virus (HCV), there are a handful of pressure points that can be used for the latter purpose. Applying force to specific locations on the body can relieve some of the symptoms characteristic of this illness and ease the side effects known to accompany HCV anti-viral therapy.
Acupressure
Originating from Chinese medical theory, using finger pressure on points on the body to improve health is known as acupressure. Beginning five thousand years ago, Chinese people began using acupressure to improve the flow of energy within the body. By analyzing human pathology, the founders of Chinese medical theory discovered that certain locations on the body contained pools of energy close to the skin’s surface. These spots provided easy access for influencing the body’s energy. Additionally, these medical philosophers understood that blockages in the flow of energy led to imbalances that could result in illness. To regain and maintain health, acupressure is used to help keep energy flowing smoothly, thus encouraging the body towards balance.
Daily stress, muscular tension and illness create energetic imbalances that accumulate over time. Applying pressure to one of over 300 acupressure points can restore balance by improving the localized flow of blood and energy. This influx of circulation allows for nutrients to better reach and feed starved cells as well as increases the body’s efficacy of toxin removal. Additionally, studies show that stimulating specific pressure points reduces stress hormones and increases endorphins, the body’s natural pain-relieving and mood-enhancing chemicals.
How Much Pressure?
When experimenting with acupressure, many people wonder how much force they should use. According to Michael Reed Gach, author of Acupressure’s Potent Points and founder of the Acupressure Institute in Berkeley, California, “the amount of pressure should make the point ‘hurt good,’ somewhere between pain and pleasure.” Use prolonged finger pressure directly on the point – gradual, steady, penetrating pressure for approximately three minutes is ideal. Each point will feel somewhat different when pressed, with some feeling tense, while others feeling sore or achy. For best results, acupressure practitioners advocate relaxing and breathing deeply to further facilitate energy circulation.
Hepatitis C Applications
For some people living with chronic Hepatitis C, finding medication-free techniques to reduce this illness’ symptoms can be more valuable than any amount of money. Whether due to this virus’ strain on the liver or as a result of treatment aimed at squelching HCV, many of the complaints typically associated with Hepatitis C can be relieved by applying pressure to the right point on the body. Acupressure is known to improve energy level, build the immune system, support the liver, relieve nausea, alleviate headaches, enhance mental clarity, ease depression and reduce pain. Below are five pressure points deemed most useful for managing symptoms characteristic of HCV:
1. Nausea – Called Pericardium 6, this point is located on the forearm between the two main tendons, approximately one and a half to two inches above the wrist. This point is usually tender.
2. Fatigue – Called Stomach 36, this point is located on the outer part of the lower leg, in the tender area approximately one and a half to two inches below the knee, just one finger breadth to the outside of the bone. This point also strengthens the immune system.
3. Stress and liver-area pain – Called Liver 3, this point is located on the top of the foot, in the tender spot approximately one to one and a half inches above the toe web of the big toe and second toe.
4. Headaches – Called Large Intestine 4, this point is located on the top part of the hand, between the web of the thumb and index finger. Usually tender, Large Intestine 4 is at the highest point on the bulge formed when the thumb is next to the index finger.
5. Mental confusion and fatigue – Called Governing Vessel 20, this point is on the very top of the head. It is located at the intersection of the following two imaginary lines – (1) from the top point of the ear across to the top point of the other ear and (2) between the eyebrows back over the head to center of the spine.
Although the relief you are seeking may not be immediate, the daily, repeated application of pressure to a point over the course of a few weeks will often shift someone’s physical discomfort. When applying pressure to a point, you may find it possible to gradually work up to holding points for longer periods of time. However, limit yourself to ten minutes per point to avoid the complications of increasing circulation too much. Additionally, a person who is pregnant or severely ill should consult with their doctor prior to adding anything new to their daily routine.
You don’t need to have a black belt in karate to capitalize on the ancient wisdom of the body’s pressure points. Armed with knowing the location and purpose of the preceding five acupressure points, you can reduce your HCV symptoms without putting anything else in your medicine cabinet.
References:
Kallen, Ben, Acupressure for the active guy: this ancient healing art can boost your energy and relieve you pain—without needles, Men’s Fitness, September 2001.
www.acupressure.com, Glossary, Michael Reed Gach, PhD & Bantam Books, 2007.
www.acupressure.com, How to Apply Pressure, Michael Reed Gach, PhD & Bantam Books, 2007.
www.docmisha.com, Applying Chinese Medicine, Misha Ruth Cohen, 2007.
www.fightingarts.com, Pressure Points 1: Going to the Heart Of Pressure Points - What They Really Are, Bruce Everett Miller, PA-C, FightingArts.com, 2007.
www.hcvadvocate.org, Self-Help Acupressure for Hepatitis C, Ramona Draeger, Balancing Touch, Hepatitis C Support Project, 2007.
Posted by Editors at 10:14 AM --- Printer-friendly version
November 09, 2007
Eliminating HCV in Previous Non-Responders
Molecularly different than pegylated interferon, consensus interferon offers hope to non-responders. This retrospective study on U.S. veterans with Hepatitis C demonstrates that those with Hepatitis C RNA remaining after interferon-ribavirin therapy may have another option for future treatment.
Consensus Interferon in Hepatitis C Is an Option for Those Non-Responsive to Peginterferon/Ribavrin: Presented at AASLD
By Maria Bishop
BOSTON, MA -- November 7, 2007 -- In a recent retrospective study of veterans, 12% of hepatitis C virus (HCV) subjects remained HCV ribonucleic acid (RNA) undetectable at least 3 months post-treatment with consensus interferon (Infergen) following prior treatment with peginterferon and ribavirin, researchers reported here at the 58th Annual Scientific Meeting of the American Association for the Study of Liver Disease (AASLD).
Treatment-naïve veterans fared better, with 24% remaining HCV RNA undetectable at least 3 months post-treatment with consensus interferon, noted lead author Helen S. Yee, PharmD, Ambulatory Care Clinical Pharmacist, Pharmacy Service, Department of Veterans Affairs (VA) Medical Center, San Francisco, California, United States.
These data offer an alternative for patients who are nonresponders/relapsers to peginterferon plus ribavirin. At least 50% of chronic HCV patients who receive standard therapy are nonresponders to treatment, added Dr. Yee.
Seven-hundred seventy-six of the hepatitis C patients who were reviewed for this study had been prescribed consensus interferon with ribavirin (99.7%) or without ribavirin in the VA health care system from October 2003 to October 2006. Treatment duration varied significantly between prescribers, and over 57% of the patients in this study discontinued consensus interferon within less than 3 months of starting treatment. The mean treatment duration averaged 3.1 months.
Data were reviewed for documentation of the following: HCV antiviral treatment history and response; time between HCV antiviral treatments; consensus interferon dose, frequency, and duration; and HCV RNA results. Demographic data were also included. The mean age of patients (95.4% of whom were male) was 55.4 ± 5.57 years. The average prior peginterferon treatment duration (n = 646) was 8.9 months.
"Factors associated with outcomes and consensus interferon [with or without ribavirin] -- such as dosing, length of treatment, and other practice variations -- need to be further assessed," concluded Dr. Yee.
This trial was funded in part by the VA National HIV/Hepatitis C Program and a grant from Valeant Pharmaceuticals, makers of Infergen.
[Presentation title: Hepatitis C Virus (HCV) Treatment Outcomes with Consensus Interferon with or without Ribavirin in Peginterferon/Ribavirin Non-responders/Relapsers: Results from National Clinical Practice Settings. Abstract 355]
Posted by Editors at 02:59 PM --- Printer-friendly version
November 08, 2007
Locteron Showing Promise for Hepatitis C
OctoPlus has reported positive results from a Phase IIa trial for the Hepatitis C drug Locteron. Thus far, Locteron is encouraging due to its convenient dosing schedule, tolerability and Hepatitis C anti-viral activity.
OctoPlus says hepatitis C drug effective in study
Tue Nov 6, 2007
AMSTERDAM (Reuters) - Dutch biotechnology firm OctoPlus said on Tuesday European safety and efficacy Phase IIa studies have shown an antiviral effect for its chronic hepatitis C drug Locteron.
"A statistically significant dose response was observed in the study," the company said in a statement, adding that the drug was tolerated at all doses.
The company, which has four other products in pre-clinical and clinical development, said approximately 90 percent of adverse events were rated as mild.
OctoPlus is co-developing Locteron with its partner Biolex Therapeutics, which plans to commence a European safety and efficacy Phase IIb trial of the drug in mid-2008.
With Locteron, OctoPlus is aiming to develop a treatment for patients with chronic hepatitis C, with fewer side effects and a more convenient dosing schedule compared with current therapies.
(Reporting by Harro ten Wolde)
Posted by Editors at 02:44 PM --- Printer-friendly version
November 07, 2007
Encouraging HCV Results Issued by Roche
Delivering encouraging news, pharmaceutical giant Roche shares results of two of its leading HCV drugs. As the result of a Phase IIa trial that combined Pegasys and Copegus with R1626, the Hepatitis C virus was undetectable in 81 percent of the study's participants. In collaboration with Pharmasset, a Phase I study of R7128 also demonstrated great promise against the virus.
Roche Issues Hepatitis Drug Data
www.thestreet.com
By Elizabeth Trotta
Staff Reporter
11/2/2007
Roche said Friday that in a phase IIa study a triple-drug combination for treatment of hepatitis C showed a robust virological response and subsequently will proceed to a phase IIb study.
Presenting results at the American Association of the Study of Liver Diseases (AASLD) meeting in Boston, the Swiss drugmaker said its investigational hepatitis C drug R1626 showed promising antiviral activity in the phase IIa trial when given with Pegasys (peginterferon alfa-2a) and Copegus. The aforementioned Roche drugs are used together to treat adults with chronic hepatitis C whose liver still works normally and who haven't been previously treated with an interferon alpha.
After four weeks of treatment with the three-drug combination, the virus couldn't be detected in 81% of patients with a mean decrease in viral load of 5.2 log10 from the baseline, and Roche said most adverse events were mild to moderate.
Also, no resistance to R1626 was identified following intensive testing for either two weeks of treatment with R1626 as monotherapy or in patients treated with R1626 for four weeks in combination with the standard of care.
The phase IIb study, called POLI 1, which will further investigate R1626 in combination with standard or lower dose of Pegasys and standard dose of Copegus, is now open and enrolling patients in eight countries, including the U.S.
Pharmasset (VRUS - Cramer's Take - Stockpickr), which partners with Roche to develop chronic hepatitis C drug R7128, presented data Friday on a phase I 14-day monotherapy study of patients who failed to respond to standard therapy. Pharmassest said there was a 99% mean decrease in HCV with no serious adverse events. (Pharmasset divulged positive preliminary results for the study in September.) The companies are hoping those results will translate when the drug is used in combination with other therapies for a longer duration in a previously untreated population.
Gilead (GILD - Cramer's Take - Stockpickr - Rating), Idenix, (IDIX - Cramer's Take - Stockpickr - Rating) and ViroPharma (VPHM - Cramer's Take - Stockpickr - Rating) are also developing candidates in a class of antivirals called polymerase inhibitors for hepatitis C virus.
Vertex (VRTX - Cramer's Take - Stockpickr - Rating), which is presenting at AASLD as well, also dished hepatitis C data for its Telaprevir on Friday.
Posted by Editors at 01:58 PM --- Printer-friendly version