Research & Treatment News
May 31, 2007
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Now in Phase II clinical trials, a new, oral HCV protease inhibitor, SCH 503034, may defeat the virus in interferon non-responders. Find out how well the drug is tolerated and how it is able to reduce the viral load of non-responders with genotype 1.
New HCV Protease Inhibitor Effective Against Hepatitis C
NEW YORK (Reuters Health) May 15 - A new, oral HCV protease inhibitor, SCH 503034, is well tolerated and may be effective against hepatitis C (HCV) genotype 1 that is refractory to interferon treatment, according to a report in the April issue of Gastroenterology.
SCH 503034 is a specific inhibitor of NS3 protease, which plays an essential role in the replication of HCV, the authors explain.
Dr. Christoph Sarrazin from Saarland University Hospital, Hamburg, Germany and associates evaluated the safety and tolerability of SCH 503034, alone and in combination with pegylated interferon-alpha-2b (IFN), in 26 patients with chronic HCV infection that had not responded to treatment with IFN with or without ribavirin.
Both as monotherapy and in combination with IFN, SCH 503034 was generally well tolerated, the authors report.
One week of treatment with SCH 503034 alone resulted in a mean maximal reduction in HCV RNA of 1.08 log10 at 200 mg 3 times daily, and 1.61 log10 at 400 mg 3 times daily, the investigators say.
Combination therapy with SCH 503034 and IFN resulted in greater decreases in HCV RNA than with IFN alone, the researchers note. The best results (a mean decrease in HCV RNA of 2.68 log10 after 2 weeks) were seen with the combination of SCH 503034 400 mg 3 times daily and IFN.
"Evaluation of virologic response during monotherapy and combination therapy suggests that combination SCH 503034 plus IFN was associated with anti-HCV activity in these patients who had previously not responded to IFN with or without ribavirin," the authors report.
"Phase II clinical trials with HCV genotype 1 nonresponders are underway to determine the optimum dosing and exposure levels for this potentially important therapeutic regimen," the researchers add.
"Novel oral antiviral approaches are exciting and fashionable," writes Dr. Jean-Michel Pawlotsky from Hopital Henri Mondor, Creteil, France in a related editorial. "The spectacular antiviral efficacy of some of these drugs should not, however, be allowed to mask the specific new problems they raise."
"Although adjunction of an oral HCV inhibitor may give interesting results, other options are already available for the treatment of chronic hepatitis C, including optimization of the current pegylated IFN-alpha-ribavirin combination," the editorial concludes. "All these options should be explored, as they may benefit patients in the near future."
Gastroenterology 2007;132:1270-1278,1611-1615
Posted by Editors at 11:35 AM --- Printer-friendly version
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Healthcare workers confirm that the Hepatitis C virus does not discriminate and lurks everywhere. While it is only transferred through blood, two nurses from Massachusetts review the many possible routes of Hepatitis C transmission and admit that most people have no idea they are infected.
Nurses say many may have hepatitis C and not know it
www.milforddailynews.com
By Jennifer Lord/Daily News staff
May 23, 2007
In their years treating patients at MetroWest Medical Center, nurses Kelly Lindebald and Lynn Dempsey have learned there is no such thing as a typical hepatitis C patient.
Drug users who have shared needles may have it. So might a suburban stay-at-home mom who had a blood transfusion before 1990.
"It's the most common blood-borne illness in the country - more than 4 million are infected," said Dempsey, coordinator for the hospital's hepatitis C clinic.
"And most don't know," added Lindebald, the co-coordinator. "There are probably many more people walking around that have absolutely no idea they have it."
Hepatitis C is a virus that causes inflammation of the liver, leading to chronic liver disease and cirrhosis. It is the most common cause of liver transplants. The virus is transmitted when blood from an infected person enters the body of a person who is not infected, most commonly through sharing drug needles, needle sticks in health workers or from mother to child during childbirth.
Some patients may have contracted hepatitis C by getting a tattoo or a body piercing under non-hygenic conditions or even sharing a razor or toothbrush with an infected person. Sexual transmission is also possible but considered rare.
"About 10 percent of the population doesn't even know how they got it," Lindebald said. "They're starting to suspect snorting drugs may be a risk factor as well. Anything that can transfer blood-to-blood."
To help determine who might be infected with hepatitis C, the hospital is offering free testing tomorrow beginning at 2:30 p.m. as part of an all-day hepatitis C awareness event. The test requires a simple blood draw and results will be sent to patients' primary care doctors or the hospital's clinic if the patient does not have a main doctor.
"A lot of people don't find out (they have it) until they give blood and get a letter in the mail," Lindebald said. "It's a horrible way to find out."
Symptoms typically don't appear until 10 to 20 years after infection and about 80 percent never have signs or symptoms. Some symptoms may include jaundice, fatigue, dark urine, abdominal pain, loss of appetite and nausea.
Unlike hepatitis A and B, there is no vaccine against hepatitis C and it is considered incurable, although treatment with interferon and ribavirin can bring the viral load down to an undetectable level, Dempsey said.
The number of new infections each year declined from an average of 240,000 in the 1980s to about 26,000 in 2004, the latest year for which statistics are available. The number of hepatitis C-related deaths could increase to 38,000 a year by 2010, surpassing annual HIV/AIDS deaths, according to the U.S. Centers for Disease Control and Prevention.
While the typical patient is over the age of 40, figures released recently by the state Department of Public Health found hepatitis C cases on the upswing among 15- to 25-year-olds, rising from 254 in 2001 to 784 in 2005. The jump was attributed to an increase in young people experimenting with injectable drugs.
"It's important to say it's not passed on by casual contact," Dempsey said. "Hepatitis C carries the same kind of stigma as HIV - in fact, hepatitis C and HIV often go hand-in-hand."
(Jennifer Lord may be reached at 508-626-3880 or jlord@cnc.com.)
Posted by Editors at 11:31 AM --- Printer-friendly version
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Here is an example of an article on the recent claims of a Hepatitis C "cure." Readers should take note that the study included those who have already beaten the virus with interferon combination therapy (ICT). The good news is that once you beat the virus with ICT, you are likely to remain virus-free. The bad news is that ICT only helps approximately one quarter of those infected with the most common strain of the virus, when you take into account those who had to stop or adjust their treatment due to the severe side effects.
Drug combination found effective against hepatitis C, but there's a catch
www.kentucky.com
By Bob Lamendola
SOUTH FLORIDA SUN-SENTINEL
FORT LAUDERDALE, Fla. --
Doctors and researchers almost never use the word "cure," but they came as close as they ever do Monday when describing a combination of two drugs used to treat the severe liver disease hepatitis C.
Among some patients, the drug cocktail of pegylated interferon and ribavirin completely kills the virus that causes hepatitis C, and keeps it from coming back, doctors said in reporting their new study at a Digestive Disease Weekly conference in Washington, D.C.
The catch is, the drug combo does not work in about half of people with hepatitis C, and researchers still are not sure why it works so completely for some but fails in others. Also, the combo has difficult side effects.
"I call it a cure. It doesn't work for everyone but it has the ability to eradicate this virus, and this study is the best evidence to prove that," said Dr. Eugene Schiff, director of the center for liver diseases at the University of Miami medical school, who was attending the conference but not involved in the study.
The findings of the six-nation study, headed in the United States by Virginia Commonwealth University, solidifies the drug combination as the top treatment for the virus, which has infected about 4 million Americans.
The virus spreads only via direct contact with infected blood. Most cases stem from blood transfusions before 1992 and intravenous needle use, but the virus also can occasionally be passed through sex.
Long-term infection of hepatitis C has caused a leap in the incidence of liver cancer and liver damage, and is the leading cause of people needing liver transplants. The virus kills more people than HIV/AIDS.
The new study followed 997 patients who had cleared the virus from their systems while taking the drug combo for almost a year. Of those, 99 percent remained virus-free an average of four years after they stopped taking the drugs, and as long as seven years later.
That kind of success is not seen with other viruses, such as hepatitis B and HIV, which hide in the body and come back strong if the patient stops taking the medicine, said Dr. John Vierling, a Baylor College professor and past president of the American Association for the Study of Liver Diseases.
"This is a virus we can beat," said Vierling, who was not associated with the study.
But the drug combo only defeats the virus in about 40 percent of those infected with the most common strain of hepatitis C, which accounts for two-thirds of cases. Blacks and those with serious cirrhosis of the liver are less likely than average to do well. The drugs succeed about 80 percent of the time against other strains of the virus.
The side effects from the drugs can be serious. Most people experience little more than flulike symptoms, but small numbers report hair loss, depression, moodiness, sharp anemia, and in rare cases, heart and kidney failure, suicidal thoughts and even death.
"People don't like to take it if they don't have to," Schiff said.
Plantation, Fla., patient Andi Thomas, who founded the nationwide advocacy group Hep-C Alert, said she has been virus-free since taking the combo in 2004, with only headaches as a side effect. The group is funded in part by Roche Inc., which makes the interferon drug.
"I would like to hope I am cured forever and ever," Thomas said. "I would like for them to have better drugs, but right now they don't. It's the best tool we have."
Are you looking for further clarification on genotypes and success rates of combination therapy? Be sure to also read the article, A Cure for Hepatitis C posted on Hepatitis-Central.com
Posted by Editors at 11:28 AM --- Printer-friendly version
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Read about one columnist's personal experience with Hepatitis C and discover why, regardless of how someone is infected, early detection and treatment offer the greatest hope for surviving the disease.
Surviving Hepatitis C — Do You Harbor this Silent Killer?
www.bloggernews.net
21 May, 2007
By Carol Bogart
Five years ago, a woman named Sally in Seattle called me in Ohio to talk about her Hepatitis C. She was, as I recall, nearing 70 and a retired teacher. Her niece, an adult lawyer, had taken me to lunch to talk to me about her. She said Sally was the dearest sweetest woman; one whose husband was gone, had not had children, and was now alone.
I was a columnist for the local newspaper and had been writing about my own Hepatitis C. For a year, I endured a clinical trial that was very much like chemotherapy. The niece told me Sally was afraid to have a liver biopsy, and wondered if I’d mind if her aunt called me.
As a result of my weekly column, many people you would never suspect to have this “dirty” disease often linked with injecting illegal drugs had come forward to either get tested and start treatment, or to simply thank me for giving voice to a condition about which so many are ashamed.
Like me, Sally had no idea how she’d gotten Hepatitis C. A diabetic, she wondered whether she’d been infected during a blood draw to check her sugar. I wondered whether it was a single acupuncture session for my herniated disk. I don’t remember, either, how Sally found out she had it. That I did was a lucky twist of fate.
I was symptom-free in 1995 (the liver is an “uncomplaining” organ) and covering a terrible story for a Cleveland television station. It was about a paramedic who, coming home from work, had flipped the light switch, not knowing that in the basement, the leaking furnace had filled the house with gas. A small spark from the switch triggered an explosion that blew him out the door into his backyard, burned over 75 percent of his body.
As the videographer and I swung into the parking lot at Metro Health Center, paramedics, firefighters and cops filled the waiting room and halls. Throughout the night, it was touch and go as their friend and co-worker needed so many transfusions that the hospital was starting to run out of platelets.
Two days later, the firefighters staged an emergency blood drive. I urged the TV station’s assignment editor to let me cover what was to me a poignant human interest story: the coming together as one of those whose occupations so often put them in harm’s way.
The first person I interviewed was the paramedic’s dad, a retired firefighter and, usually, self-contained stoic man. Now, with his son hovering at death’s door, he could barely hold back his tears. I talked, too, to the paramedic’s partner on the ambulance, a man so broken up he could barely speak.
When I learned that the paramedic’s blood type was O-negative, the same as mine, I set my reporter’s notebook aside - signing up on the spot to donate blood, despite my lifelong fear of needles.
God moves in mysterious ways.
Two weeks later, a letter from the Red Cross arrived. It said in bold capital letters across the top: “THIS IS NOT A LETTER ABOUT AIDS BUT … .” I was informed that my blood had tested positive for Hepatitis C and had been discarded. I was never again to give blood, the letter said, nor was I to be an organ donor. I thought about the organ donor sticker that had been on my driver’s license for many years.
A visit to my internist confirmed the diagnosis.
The paramedic made a slow recovery. I might have died but for that decision to give blood. That’s not to say I instantly started treatment. I didn’t. In 1995, despite country singer Naomi Judd’s success with Interferon for her Hepatitis C, for many, it meant terrible side effects, but no eradication of the virus. I had a young boy at home. I decided to wait until medicine could offer something better.
By 2001, though, I was feeling very fatigued. Regular monitoring of my liver enzymes – a barometer of how much damage the Hep C is doing in your liver – found that they were getting worse. My son was now 16. It was time.
Like Sally, the idea of a liver biopsy terrified me. It was, however, required of those who wanted to take part in a clinical trial being offered by the Cleveland Clinic. For the first time, those with Hepatitis C had a shot at a new “combination” therapy – a three-drug treatment it was hoped might up their odds of surviving what some call a silent epidemic.
The day of my biopsy, I was grateful to my doctor, head of the clinic’s gastroenterology department, for coming in early to hold my hand as the “routine” procedure was performed. I would later assure Sally it really wasn’t all that bad. When asked afterward if I needed pain relief, I truthfully answered, “No.”
The result, though, was pretty scary. Stage 3 liver fibrosis (scarring): bridging and portal. One stage away from full blown cirrhosis. I’d be starting the trial just in time.
For a year, I injected Pegylated Interferon into fatty tissue in my tummy once a week and took Ribavarin and Amantadine capsules every day. I lost 60 pounds and handfuls of hair and, by the 10th month, once failed to recognize a friend I saw at Kroger’s. At the same time the drugs were attacking the virus, healthy stuff was dying, too.
At night, I ached so much I couldn’t sleep. In the last month, the side effects were so bad that, with the approval of my research nurse, I started cutting back the dose of both the Interferon and the pills. It was either that, or just stop taking everything altogether.
I’d been getting the meds and supplies for free thanks to the clinical trial – a good thing because, otherwise, I couldn’t have afforded to get treated. Pegylated Interferon alone costs a fortune.
Once a month I’d drive the two hours to Cleveland to have eight vials of blood drawn to monitor my liver enzymes. I wasn’t allowed to take Advil during those 12 months (an anti-inflammatory, it could have skewed the results) – but that meant no relief for my osteoarthritis.
As I was going through my clinical trial, two very close friends were enduring what would prove to be their final unsuccessful round of chemotherapy – one for breast cancer, one for leukemia. We told each other that which we didn’t tell those we loved: We were in so much misery, we really didn’t care if we died, but we worried what would happen to those we left behind; in my case, my 16 year old son. My friends, farm wives, had both been married for more than 40 years.
Dolores and Shirley finally decided: No more chemo. One after the other, they passed away. At the end of my treatment, my blood work came back “clean.” No trace at all of the Hepatitis C. My enzymes were back to normal.
Every six months, I get the liver panel done. To date – and it’s been four years – I remain Hepatitis free. I’m a Type 2. Ninety percent of the Type 2s in the clinical trial had the same result. For Type 1’s, who are more resistant to treatment, the success rate was 60 percent. In the ’90s, when I was first diagnosed, Interferon, the sole drug available at the time, cleared the virus in only 10-15 percent of those treated for Hep C. I felt like a living miracle.
Sally, after we talked at length several times, did have her biopsy and started treatment. She’d waited too long. She died.
Dr. William Carey, my gastroenterologist, warned me often that the longer I waited, the more opportunity the virus had to “replicate” and become stronger.
Hep C is a quiet killer. Health officials estimate 4.1 million Americans are infected. Many are unaware. If you think there’s any chance you might have it, get tested. It could save your life.
For information on testing for Hepatitis C, contact your state or local health department.
Carol Bogart blogs at http://carolbogart.blogspot.com. Contact her at 3bogart@sbcglobal.net.
Posted by Editors at 9:19 AM --- Printer-friendly version
May 25, 2007
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Spring 2007 brought a wave of health-related news professing a cure for Hepatitis C. While this publicity inspired hope in millions of people living with chronic HCV, it also sparked frustration and confusion. Learn more about the recent announcement that implied a cure for this disease, as well as what the details of the newsworthy study actually mean for you and your loved ones.
by Nicole Cutler, L.Ac.
According to Mitchell Shiffman, MD, professor in the Virginia Commonwealth University (VCU) School of Medicine, and chief of hepatology and medical director of the Liver Transplant Program at the VCU Medical Center:
“The use of peginterferon alone, or in combination with ribavirin, points to a cure for Hepatitis C, the leading cause of cirrhosis, liver cancer and the need for liver transplant. This paper strongly suggests, for the first time, that Hepatitis C is a curable disease. After treatment, 99.6 percent of the patients remained virus undetectable for over five years.”
Shiffman is one of the lead investigators in a study that was presented in May 2007 at the 38th annual Digestive Disease Week conference in Washington, D.C. Virginia Commonwealth University was among about 40 institutions worldwide studying pegylated interferon alfa-2a, manufactured by Roche, Inc.
The Study
The results are based on a long-term follow-up study designed to determine if the Hepatitis C virus reemerges in patients who have achieved treatment success. The study reviewed 997 patients, either infected with chronic Hepatitis C or co-infected with Hepatitis C and HIV. Those evaluated had already achieved a sustained virologic response following treatment with either PEGASYS (peginterferon alfa-2a) monotherapy or combination therapy with PEGASYS and ribavirin.
After successful treatment, researchers monitored blood levels of Hepatitis C once a year for an average of 4.1 years (range 0.4 to 7 years). Of the 997 patients, 989 maintained undetectable levels of the virus. Although the remaining eight patients tested positive for Hepatitis C at an average of two years following treatment completion, it is unknown why this occurred. Researchers have not determined if these eight patients experienced a relapse of the virus or if they were re-infected.
Sustained Virologic Response
Virginia Commonwealth University’s results are definitely cause for celebration among those who have persevered through PEGASYS treatment and achieved sustained virologic response (SVR). A course of treatment for Hepatitis C is considered successful when Hepatitis C RNA can no longer be detected in the blood. While Hepatitis C RNA may be undetectable immediately following treatment, this test must be repeated six months later to determine if any of the virus remained and reproduced. When the virus remains undetectable in the blood six months (or more) following Hepatitis C therapy, SVR is considered to be achieved.
The longer a person remains free of the virus, the more convinced health officials are that the person is not just in remission, but is actually cured of Hepatitis C. While most studies following Hepatitis C patients for two to three years after they’ve reached SVR reflect a low relapse rate, the results from VCU cement the notion of a cure. By following and testing Hepatitis C patients with SVR for an average of four years, the realization that SVR is permanent is more believable.
The Catch
Understanding what VCU’s study results mean to people with Hepatitis C is creating a great deal of confusion.
· What it DOES mean – Those who have achieved SVR with PEGASYS therapy have a 99 percent chance of being cured of Hepatitis C.
· What it DOES NOT mean – Anyone with Hepatitis C can currently be cured.
While the pharmaceutical industry continues to concentrate on new and improved treatments for Hepatitis C, the fact remains that less than half of patients with the most common genotype in the U.S. undergoing PEGASYS treatment attain SVR. According to the manufacturer, two large clinical trials have been conducted to show the effectiveness of PEGASYS with ribavirin combination therapy in patients with Hepatitis C. These studies found, after 48 weeks of unaltered treatment:
· SVR was achieved by 53 percent of participants in one trial and 61 percent in the other.
· Among patients with genotype 1, the most prevalent genotype in the U.S., 44 percent of participants in one trial and 51 percent in the other achieved SVR. For those who had a high viral load, the success rate was even lower – 41 and 47 percent.
The percentage of trial participants achieving SVR does not include those who, due to side effects, dropped out of the study or who had their medication dosages lowered. Again, according to the PEGASYS manufacturer:
· In Hepatitis C monoinfection trials, 11 percent of patients discontinued therapy.
· In Hepatitis C monoinfection trials, 39 percent required modification of therapy.
· In the HCV/HIV coinfection trial, 16 percent of patients discontinued therapy.
· In the HCV/HIV coinfection trial, 39 percent of patients required modification of therapy.
Considering the overall statistics and likelihood of achieving SVR with PEGASYS therapy, the computations demonstrate that people with genotype 1 have approximately a 25 percent chance of being cured. This is because roughly 50 percent of people with Hepatitis C cannot complete the therapy at the full dosage level. Of the 50 percent who complete treatment, about half of those with genotype 1 achieve SVR.
Hope
Even though the majority of those who undergo the rigors of PEGASYS therapy do not attain sustained virologic response, the idea that Hepatitis C can be eliminated inspires hope. Now that we know that SVR lasts for four or more years and is likely permanent, researchers will shift their focus on making this cure attainable for everyone infected with Hepatitis C.
References:
www.forbes.com, Study Suggests Cure for Hepatitis C, HealthDay News, Forbes.com, LLC, May 2007.
www.pegasys.com, Effectiveness of PEGASYS (detailed), Hoffman- La Roche, Inc., 2007.
www.pegasys.com, Safety and Tolerability, Hoffman-La Roche, Inc., 2007.
www.sciencedaily.com, Cure For Hepatitis C Announced By Researcher, ScienceDaily, LLC, 2007.
www.terradaily.com, Total Hepatitis C Cure Possible, Ed Susman, United Press International, 2007.
Posted by Editors at 2:33 PM --- Printer-friendly version
May 10, 2007
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People with chronic Hepatitis C suffer from the same sprains, strains, and body aches as everyone else. In addition, Hepatitis C symptoms can include musculoskeletal pain, joint pain, headache, episodic abdominal pain and liver pain. However, many typical, over-the-counter pain medications can damage an already vulnerable liver. For those with Hepatitis C, finding a way to ease their pain without encouraging liver injury can feel like an uphill battle.
by Nicole Cutler, L.Ac.
According to a 2005 ABC News/USA Today/Stanford University Medical Center poll, more than 50 percent of Americans live in chronic or recurrent pain. Fortunately, the pharmaceutical industry has provided a variety of solutions to relieve many painful conditions. Despite this, a significant number of people with Hepatitis C who experience periodic or chronic pain are limited in their pain relief options.
Prior to attempting to self-treat pain or discomfort, Hepatitis C patients must discuss symptoms and pain management with their doctors. Because all drugs exert some type of strain on the liver and can also suppress the immune system, a well-informed physician will assess each individual situation and advise their patients appropriately. When living with Hepatitis C, it is a good idea to discuss pain relief medication with your physician as soon as possible so that when pain strikes, you will be ready with appropriate medicine on hand.
Alternatives
Chronic or recurrent pain is typically your body’s way of alerting you that a problem exists. Only attempt self-treatment with alternatives if you are sure your pain is not an emergency. When in doubt, always check with your physician first.
Since every medication taken can jeopardize an already struggling liver, many people with Hepatitis C rely on non-medication options. Before opening a bottle of pills, try these seven, safe alternatives first:
1. Apply a heat pack on sore muscles, joints or over the liver for pain relief.
2. Soak in a warm bath with Epsom salts.
3. Following all directions, rub a natural, topical pain reliever onto the area of pain.
4. Make sure you have adequate rest. Fatigue always worsens pain.
5. For muscular pain, gentle stretching or mild physical activity can deliver the oxygen and blood flow needed for relief.
6. Find a credentialed massage therapist with experience in Hepatitis C and chronic pain. Massage therapy enhances circulation, helping to reduce physical pain.
7. Some patients achieve pain relief with complementary and alternative therapies, such as herbal medicine, chiropractic or acupuncture. Only seek advice or treatment by a qualified professional, and be sure to discuss any of these therapies with your physician and liver specialist.
Medications
The most common way to manage pain in our society is with over-the-counter painkillers. Also known as analgesics, these drugs may place additional liver strain on people with Hepatitis C. Anyone with chronic hepatitis should discuss the use of analgesics first with their doctor. Always follow your doctor’s suggestions and the manufacturer’s advice when using over-the-counter pain medication. Never exceed the recommended dosage and never combine medications.
The primary over-the-counter painkillers contain acetaminophen, ibuprofen or aspirin. All three of these have some impact on the liver, and can cause liver damage when taken in excess. While occasional, restricted use may be safe for those with Hepatitis C, a doctor will choose the drug based on which is least likely to adversely affect you.
1. Acetaminophen – (Tylenol, Anacin 3, Panadol, Paracetamol and others) is a common, mild to moderate pain reliever and fever reducer. A liver afflicted with Hepatitis C may not be able to metabolize this drug. High doses of acetaminophen can cause liver injury, even to a healthy liver. In limited dosages, a physician will generally only suggest this class of analgesic to a person whose hepatic metabolism is fully functioning.
2. Ibuprofen – (Motrin, Advil, Nuprin and others) reduces high body temperature, is an anti-inflammatory and inhibits normal platelet function. A non-steroidal anti-inflammatory drug (NSAID), ibuprofen can cause gastrointestinal upset and bleeding. Those at risk of portal hypertension are already at risk for gastrointestinal bleeding, intensifying this risk. Studies have demonstrated that at certain dosages, ibuprofen can stress the liver and elevate liver enzymes in people with Hepatitis C. Ibuprofen must be used with extreme caution in the later stages of liver disease and for those on interferon therapy.
3. Aspirin – (Bayer, Anacin, Excedrin and others) reduces fever, relieves pain, and acts as an anti-inflammatory and blood thinner. In addition to influencing liver test results, aspirin’s effect on blood platelets temporarily limits the clotting process and prolongs bleeding. In chronic liver disease where the body’s production of clotting factors is naturally decreased, aspirin can increase the risk of bleeding. Although there is no actual drug interaction between aspirin and the drugs used in interferon therapy, both can disrupt blood clotting, which must be monitored if used together. When taken in high doses (more than 2,000 mg per day) aspirin can cause liver injury.
While relieving aching muscles requires little thought for those without liver disease, it is obviously a complex process for someone with Hepatitis C. Since no one wants to purposefully worsen the condition of his/her liver, having a plan to deal with pain wisely serves people with Hepatitis C. Make sure to discuss your options with your doctor and consider alternatives to medication. Because many people with Hepatitis C experience pain at one point or another, experiment with the seven alternatives listed above. If you are lucky, you may not need analgesics after all.
References:
www.hepatitismag.com, Balancing Act: Drugs that can Help and Hurt, Jason E. Moore, hepatitismag.com, 2007.
www.hepatitis-central.com, Hepatitis C & Drug Use, Hepatitis-Central.com, 2007.
www.hepcawareness.net.au, Pain Management, Australian Hepatitis Council, 2007.
www.hcvadvocate.org, A Guide to Hepatitis C Treatment Side Effect Management, Hepatitis C Support Project, 2007.
www.medicinenet.com, Common Cold, William C. Shiel, Jr., MD, FACP, FACR, MedicineNet, Inc., 2007.
www.medicinenet.com, Pain Poll: Many Americans in Pain, Miranda Hitti, WebMD Inc., 2007.
www.pkids.org, Ibuprofen vs. Acetaminophen: Which Painkiller is better for Children with Viral Hepatitis?, Thomas R. Riley III MD, Jill P. Smith, MD, Parents of Kids with Infectious Diseases, 2007.
Posted by Editors at 9:04 AM --- Printer-friendly version
May 9, 2007
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Human Genome Sciences and Novartis are working together to improve Hepatitis C treatment with the long acting version of interferon, Albuferon. The ongoing, Phase II study demonstrated that Albuferon has a success rate equal to, or better than pegylated interferon. Learn why Albuferon becoming the preferred treatment over pegylated interferon is good news for Hepatitis C patients.
Albumin Interferon May Be as Effective as Pegylated Interferon with Less Frequent Dosing
By Liz Highleyman
www.hivandhepatitis.com
Standard therapy for chronic hepatitis C using pegylated interferon plus ribavirin is often limited by drug-related toxicities such as flu-like symptoms and depression.
Both available forms of pegylated interferon alfa (Pegasys and PegIntron) are injected once weekly -- which is a considerable improvement over conventional interferon, which was administered 3 times per week. For some patients, less frequent injection is associated with fewer side effects and improved quality of life.
Human Genome Sciences and Novartis are collaborating on the development of an even longer-acting form of interferon alfa -- albumin interferon (Albuferon) -- which can be injected once every 2 weeks. Data from studies of albumin interferon were presented at the 42nd Annual Meeting of the European Association for the Study of the Liver last month in Barcelona, Spain.
Genotype 1 Patients
In a late-breaker session, Stefan Zeuzem, MD, presented data from an ongoing Phase IIb study evaluating the safety and efficacy of albumin interferon in treatment-naive genotype 1 chronic hepatitis C patients. A total of 458 subjects in 8 countries were randomly assigned to receive 1 of 3 doses of subcutaneous albumin interferon -- 900 or 1200 mcg once every 2 weeks (Q2W) or 1200 mcg once every 4 weeks (Q4W) – or else 180 mcg once-weekly Pegasys for 48 weeks; all patients also received ribavirin.
Interferon efficacy is usually assessed based on sustained virological response (SVR), or undetectable HCV RNA 24 weeks after the completion of therapy. Here, the researchers reported interim “SVR12” results 12 weeks after the end of therapy; follow-up is continuing.
Results
By intention-to-treat analysis, SVR12 rates in the various arms were as follows:
o Albumin interferon Q2W 900 mcg: 59.3%;
o Albumin interferon Q2W 1200 mcg: 55.5%;
o Albumin interferon Q4W 1200 mcg: 52.6%;
o Pegylated interferon: 54.4%.
Among subjects who achieved at least 80% adherence to prescribe interferon and ribavirin doses, SVR12 rates were higher across all arms, but the improvement was most pronounced in the Q2W albumin interferon arms:
o Albumin interferon Q2W 900 mcg: 73.8%;
o Albumin interferon Q2W 1200 mcg: 72.0%;
o Albumin interferon Q4W 1200 mcg: 67.5%;
o Pegylated interferon: 63.0%.
Among heavier patients (75 kg or more, a group that responds more poorly to therapy) with optimal adherence, SVR12 rates were maintained in the albumin interferon arms, but lower in the pegylated interferon arm:
o Albumin interferon Q2W 900 mcg: 80.6%;
o Albumin interferon Q2W 1200 mcg: 70.4%;
o Albumin interferon Q4W 1200 mcg: 66.7%;
o Pegylated interferon: 56.7%.
Among adherent patients, relapse rates were reduced in all albumin interferon arms, especially Q2W 900 mcg (13.0%), compared with pegylated interferon (29.7%).
Rates of premature discontinuation due to adverse events in the 4 arms were as follows:
o Albumin interferon Q2W 900 mcg: 9.3%;
o Albumin interferon Q2W 1200 mcg: 19.1%;
o Albumin interferon Q4W 1200 mcg: 12.1%;
o Pegylated interferon: 6.1%.
Quality of life as measured by the SF-36 scale was most favorable in the albumin interferon Q2W 900 mcg arm.
Conclusion
The researchers concluded that, “These data suggest that the Q2W albumin interferon regimens may offer at least comparable or increased efficacy, with an improved dosing schedule and the potential for less impairment in quality of life compared with Q1W pegylated interferon. The Q4W 1200 results warrant further investigation of Q4W dosing in clinical trials.”
J.W. Goethe-University Hospital, Germany; Hopital Pitie-Salpetriere, France; University of Alberta, Canada; Hadassah University, Israel; Monash University, Australia; Medical University of Bialystok, Poland; Spitalul Clinic de Adulti Cluj-Napoca, Romania; Nuselská poliklinika – Remedis, Czech Republic; University of British Columbia, Canada; University Of Manitoba, Canada; Duke Clinical Research Institute, Durham, NC; Human Genome Sciences, Rockville, MD.
Genotype 2 or 3 Patient
In a second study, V.G. Bain and colleagues assessed albumin interferon in treatment-naive patients with genotype 2 or 3 HCV. In this multicenter, open-label Phase II trial, 43 subjects were randomly assigned to receive subcutaneous albumin interferon at a dose of 1500 mcg either Q2W or Q4W plus 800 mg/day ribavirin. Patients were treated for 24 weeks, the standard duration of pegylated interferon therapy for these genotypes.
Rapid virological response rates at week 4 were 76% in the Q2W arm and 68% in the Q4W arm; after 24 weeks, however, the end-of-treatment response rates were 71% and 82%, respectively. Albumin interferon was well tolerated overall, with similar safety profiles in the 2 dose groups. There were no dose reductions in the Q4W arm compared with 10% in the Q2W. SVR data from this study are pending.
University of Alberta, Edmonton, Canada; University of Western Ontario, London, ON, Canada; University of Manitoba, Winnipeg, MB, Canada; University of British Columbia, Vancouver, BC, Canada; University of Calgary, Calgary, AB, Canada; Bar Ilan University, Ramat-Gan, Israel; Duke Clinical Research Institute, Durham, NC; Human Genome Sciences, Inc., Rockville, MD.
05/04/07
References
S Zeuzem, Y Benhamou, VG Bain, and others. Antiviral response at week 12 following competion of treatment with albinterferon alfa-2b plus ribavirin in genotype 1, IFN-naive, chronic hepatitis C patients. 42nd Annual Meeting of the European Association for the Study of the Liver (42nd EASL). Barcelona, Spain. April 11-15, 2007.
VG Bain, P Marotta, K Kaita. Comparable antiviral response rates with albumin interferon alfa-2b dosed at Q2W or Q4W intervals in naive subjects with genotype 2 or 3 chronic hepatitis C. 42nd EASL.
Posted by Editors at 1:42 PM --- Printer-friendly version
May 8, 2007
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As part of Hepatitis Awareness Month, events are being planned in four major cities to offer disease management education, especially for Asian Americans, a demographic with high rates of Hepatitis B infection. Learn what cities are hosting this public health awareness initiative as well as how education can help remove the stigma associated with the disease.
'AIM for the B' Public Education Program To Raise Awareness of Chronic Hepatitis B Among Communities Most Affected by the Disease
'AIM for the B' Events Planned in Four Major Cities to Offer Disease Management Education to Asian American Populations
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PRINCETON, N.J. and DOYLESTOWN, Pa., May 7 /PRNewswire-FirstCall/ --
Today, Bristol-Myers Squibb and the Hepatitis B Foundation announced the launch of the fourth annual "AIM for the B: Awareness, Involvement and Mobilization for Chronic Hepatitis B" program, a public education initiative taking place during National Hepatitis B Awareness Week (May 7-11). "AIM for the B" events in San Francisco, Los Angeles, Honolulu and New York this week will provide a forum to increase awareness of chronic hepatitis B as a serious health issue in the United States and emphasize the importance of active disease management, especially among Asian Americans who are disproportionately affected by the disease.
"Education is essential to helping patients and their families understand hepatitis B, its health effects and the options available to them to manage the disease," said Molli Conti, executive director of the Hepatitis B Foundation. "The 'AIM for the B' events will teach people more about chronic hepatitis B and help them understand the importance of talking about the disease as a way to overcome the stigma that can be associated with it."
This year's program will feature educational events in four cities where prevalence of chronic hepatitis B is high -- San Francisco, Los Angeles, Honolulu and New York. At these events, a panel of well-regarded physicians, chronic hepatitis B patients and representatives from patient advocacy organizations will share their personal experiences with the disease, and discuss the importance of increasing education and awareness of liver health. The panel will also discuss the benefits of early diagnosis and appropriate care.
"As we enter the fourth year of the 'AIM for the B' program, BMS and the Hepatitis B Foundation are committed to increasing dialogue within the most affected communities through these important educational events," said Ann Kolokathis, M.D., vice president, virology, global medical affairs, Bristol- Myers Squibb. "As a company, BMS aims to support people combating serious diseases such as hepatitis B. With the care of a doctor and a commitment to treatment, many patients have seen positive results."
Hepatitis B Background
In the United States, approximately one out of every 10 Asian Americans is chronically infected with hepatitis B. Asian Americans account for more than half the chronic hepatitis B cases, many of which can result in serious liver damage. Today, only a small percentage of diagnosed chronic hepatitis B patients are being actively managed for their disease.
About the Hepatitis B Foundation
The Hepatitis B Foundation is dedicated to finding a cure and improving the quality of life for those affected by hepatitis B worldwide through a comprehensive program of research, education, and patient advocacy. The organization is committed to raising funds for focused research, promoting disease awareness, supporting immunization and treatment initiatives, and serving as the primary source of hepatitis B information for patients and their families, the medical and scientific community, and the general public. Visit the Hepatitis B Foundation at http://www.hepb.org.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb at http://www.bms.com.
SOURCE Bristol-Myers Squibb
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