Passed by the Illinois Senate, Hepatitis C is among the ailments included in a controversial bill to legalize medical marijuana.
Medical marijuana bill heads to Illinois House
By Jason Nevel
jason.nevel@lee.net
SPRINGFIELD -- A proposal to legalize medical marijuana squeaked through the Illinois Senate on Wednesday and will now head to the House for further debate.
The measure would allow patients to use marijuana to alleviate chronic pain and nausea when other treatments have failed. The list of applicable conditions includes cancer, glaucoma, HIV/AIDS, Hepatitis C, Crohn's disease and Alzheimer's disease.
"This bill allows the use of marijuana in limited circumstances," said Senate sponsor William Haine, D-Alton, who was the former state's attorney for Madison County. "Someone doesn't have to go down the criminal element to buy marijuana."
The controversial issue sparked heated debate on the Senate floor but reached the necessary 30 votes to move to the House. Supporters noted the benefits of alternative treatment for ailing patients and that it's more natural than synthetic drugs.
"God grows these seeds," said state Sen. Mike Jacobs, D-East Moline, who voted for the legislation.
Opponents claimed the legislation lacked the police supervision and that the number of marijuana users could potentially increase.
"This is an invitation for trouble," said state Sen. Dale Righter, R-Mattoon.
State Sen. Tim Bivins, R-Dixon, added, "Once you say something is legal usage will go up."
The proposal would allow qualified patients to grow three plants in their home.
Along with Bivins and Righter other senators voting "no" included: Larry Bomke, R-Springfield; Bill Brady, R-Bloomington; and Dan Rutherford, R-Chenoa.
The legislation is Senate Bill 1381.
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After four months of adding boceprevir to peginterferon alfa-2b and ribavirin, a whopping 75 percent of treatment-naïve individuals with Hepatitis C genotype 1 had undetectable viral levels.
Boceprevir eliminated Hep C virus in unprecedented number of patients
Patients that received a 48-week boceprevir regimen achieved a 75 per
cent SVR rate, nearly twice the efficacy rate provided by current
standard therapies
KIRKLAND, QC, May 26 /CNW/ - Schering-Plough Canada announced today that
final results of the HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1)
study showed boceprevir - its investigational oral hepatitis C protease
inhibitor - in combination with PEGETRON(R) (peginterferon alfa-2b and
ribavirin), significantly increased sustained virologic response (SVR)(1)
rates with either 28- or 48-week therapy regimens in treatment-naive genotype
1 patients, compared to current standard of care, peginterferon and ribavirin
(P/R) for 48 weeks.
When boceprevir was added to PEGETRON(R), 75 per cent (77/103) of
hepatitis C patients assigned to a 48-week regimen had undetectable levels of
virus after treatment completion. That was nearly double the 38 per cent
(39/104) response rate of patients who only received current standard of care
treatment (p(less than)0.0001)(2).
"I am very excited about the response. The response rates from this study
are extremely encouraging, especially when you consider the challenges
associated with hepatitis C management and the difficult nature of the
hepatitis C virus genotype 1 infection in this study's patient population,"
said Dr. Frank Anderson MD FRCP(C), one of the SPRINT-1 Investigators and
presentation co-author. "I believe that the findings of this study will help
further develop and improve hepatitis C treatment. The Phase III boceprevir
studies are currently underway in naive and treatment failure patients, both
are fully enrolled."
The results from this Phase II study - involving 595 patients who were
infected with the virus but had not previously been treated - were presented
at the 44th European Association for the Study of the Liver 2009 Annual
Meeting in Copenhagen, Denmark(3).
"Each HCV-infected patient responds differently to treatment. The results
of the SPRINT-1 study shed important light on response-guided therapy with
boceprevir," said Dr. Jenny Heathcote MD FRCP(C), Professor of Medicine at
University of Toronto and Toronto Western Hospital and a SPRINT-1 study
investigator. "Importantly, the results of SPRINT-1 show how one may best
individualize treatment duration based on the patients' week 4 and week 12
responses to boceprevir therapy. Based on the rate of response observed in
SPRINT-1, the majority of G1-infected treatment naive patients may have the
potential to be treated for a total of 28 weeks."
The HCV SPRINT-1 study was a randomized, controlled, multinational study
conducted at sites across the United States, Canada and Europe. The study
enrolled trial participants infected with HCV genotype 1, the most common and
hardest to treat form of hepatitis C, as well as patients with severe liver
disease, including cirrhosis.
Boceprevir works through a novel mechanism, by inhibiting the function of
a viral protein called 'protease' that the virus needs to replicate. Hepatitis
C is a serious and potentially life-threatening chronic liver disease caused
by the hepatitis C virus (HCV). An estimated 250,000 individuals are infected
with HCV in Canada(4) and there are 3,200 to 5,000 newly infected individuals
each year(5). It is the leading cause of liver transplants in Canada(6).
ABOUT THE HCV SPRINT-1 STUDY
During the first month of the study, all patients received PEGETRON(R),
which is a combination therapy of the two standard hepatitis C treatments: a
long-acting form of interferon called peginterferon alfa-2b and the anti-viral
pill ribavirin. Some patients also received PEGETRON(R) in combination with
boceprevir from the beginning of the study.
After four weeks, one group of PEGETRON(R)-only patients then added
boceprevir for 44 weeks and another group added boceprevir for 24 weeks.
Patients who received a 48-week boceprevir regimen achieved a 75 per cent
SVR rate (n=77/103) in patients who received four weeks of (P/R) followed by
the addition of boceprevir for 44 weeks (boceprevir P/R lead-in regimen). This
represents a near doubling of the 38 per cent SVR rate (n=39/104) for patients
in the control group (p(less than)0.0001). In a 28-week boceprevir P/R lead-in
regimen 56 per cent of patients (n=58/103) achieved SVR (p=0.005)(2).
In the HCV SPRINT-1 study, anemia occurred in approximately half of the
patients in the boceprevir arm and over a third of patients in the control
arm. A key finding of the HCV SPRINT-1 study is that treatment-emergent anemia
appeared to be associated with higher SVR, with anemic patients (hemoglobin
decreasing to less than 10 g/dL) having higher SVR rates than those without
anemia (hemoglobin did not decrease to less than 10 g/dL). Anemia is a known
adverse event with combination therapy for hepatitis C and this association
with higher SVR has been seen in other clinical studies with peginterferon and
ribavirin, including the IDEAL study(7). Boceprevir is associated with about a
1 g/dL incremental decrease in hemoglobin. Erythropoietin (EPO)
supplementation was allowed in the study at the discretion of the investigator
and was used by 26 per cent of patients in the control arm and 39 to 51 per
cent of patients in the boceprevir arms with standard-dose ribavirin.
ABOUT SCHERING-PLOUGH
Schering-Plough Canada Inc. is a country operation of Schering-Plough
Corporation that employs more than 950 people across Canada. Schering-Plough
Canada Inc.'s web site is WWW.SCHERING-PLOUGH.CA.
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription, animal health and consumer health care
products. Schering-Plough's vision is to "Earn Trust, Every Day" with the
doctors, patients, customers and other stakeholders served by its colleagues
around the world. The company is based in Kenilworth, N.J., and its Web site
is WWW.SCHERING-PLOUGH.COM.
References:
-----------
1. SVR, the protocol specified primary efficacy endpoint, is defined as
achievement of undetectable HCV-RNA at 24 weeks after the end of
treatment. Per protocol, if a patient does not have a 24-week post-
treatment assessment, the patient's 12-week post-treatment assessment
will be utilized.
2. Intention-To-Treat (ITT) analysis - includes any patient who has
taken at least one dose of any study drug.
3. Kwo P, Lawitz E, McCone J, et al. HCV SPRINT-1 Final Results: SVR 24
from a Phase 2 study of Boceprevir Plus PegIntron (Peginterferon
alfa-2b)/Ribavirin in Treatment-Naive Subjects with Genotype.
4. Health Canada. http://www.phac-aspc.gc.ca/hepc/index-eng.php Accessed
April 27, 2009.
5. Health Canada.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/diseases-maladies/hepc-eng.php.
Accessed April 29, 2009.
6. Canadian Liver Foundation. http://www.liver.ca/Liver_Disease/
Accessed April 27, 2009.
7. Sulkowski M, Shiffman M, Afdhal N, et al. Hemoglobin decline is
associated with SVR among HCV genotype 1 infected persons treated
with peginterferon (PEG)/ribavirin (RBV): Analysis from the IDEAL
Study. 44th European Association for the Study of the Liver (EASL)
2009 Annual Meeting; April 22-26, Copenhagen, Denmark; oral
presentation, Abstract No. 126.
For further information: Media Contact: Mona Aubin, Schering-Plough
Canada, mona.aubin@spcorp.com, (514) 428-8833; Julia Alter, Edelman, (416)
979-1120 ext. 340, julia.alter@edelman.com; Schering-Plough Canada Inc., 16
750, route Transcanadienne, Kirkland, QC, H9H 4M7, www.schering-plough.ca
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URL for Article Source:
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Putting her dialysis days in the past, R & B singer and Hepatitis C survivor Natalie Cole receives a kidney transplant.
Natalie Cole receives new kidney
Wed May 20, 2009
LOS ANGELES (Reuters) - Rhythm and blues singer Natalie Cole, who has been battling Hepatitis C, received a new kidney in Los Angeles and is resting comfortably, her spokeswoman said on Wednesday.
Cole, the 59-year-old daughter of R&B legend Nat "King" Cole, underwent surgery at Cedars-Sinai Medical Center in Los Angeles on Tuesday. The kidney came from a deceased organ donor, the spokeswoman said in a statement.
She has been receiving kidney dialysis three times a week since September, even as she toured the world to promote her new album, "Still Unforgettable." Cole will recuperate for the next three to four months, forcing her to postpone a summer tour, the statement said.
The singer revealed her Hepatitis C diagnosis last July, saying she probably contracted the liver disease from drug use more than 30 years ago.
Hepatitis C is a blood-borne infectious disease that can cause inflammation of the liver, and in extreme cases, liver cancer. It is usually contracted through transfusions of unscreened blood, or by injecting or inhaling drugs.
Cole has won nine Grammys in a 30-year career that has included albums such as "Everlasting" and "Unforgettable ... With Love," which featured her singing a duet with her late father via electronic technology.
(Reporting by Dean Goodman; editing by Paul Simao)
Although often dismissed as non-crucial medical jargon, understanding the stages of development provides a more realistic appreciation of potential new Hepatitis C drugs.
by Nicole Cutler, L.Ac.
Keeping current on the potential arrival of new, improved Hepatitis C drugs is a regular research venture for many who are living with the Hepatitis C virus (HCV). Because the current standard of care for HCV works for less than 50 percent of those infected, doctors, scientists and pharmaceutical companies are feverishly searching for a solution that is more effective and has fewer side effects than interferon combination therapy. However, keeping up with the seemingly endless announcements of discoveries and successes demands a layman’s road map for deciphering what it all means.
The testing of new drugs is a long process that typically takes about 12 years from pre-clinical testing, through clinical trials, to U.S. Food and Drug Association (FDA) approval until it can finally reach the general public.
Pre-Clinical
Drug companies continuously analyze thousands of compounds, seeking ones of therapeutic value. During the average six to seven years of pre-clinical testing, the manufacturer completes synthesis and purification of the drug and conducts limited animal testing. Under FDA requirements, a drug company must first submit data showing that their drug is reasonably safe before it can be evaluated by humans in initial, small-scale clinical studies.
Only after proving its safety and efficacy in vitro (in a test tube) or in laboratory animal testing can a drug be administered to humans in clinical trials. During pre-clinical drug development, the following is evaluated:
1. Toxicity
2. Pharmacologic effects
3. Genotoxicity – genotoxic substances cause cancer, through genetic mutation or contribution to tumor development
4. Absorption and metabolism
5. Speed of excretion
If any evidence surfaces that it is unsafe or ineffective, the drug will likely never make it to human testing. Actually, only about 1 in 1,000 investigational compounds survives pre-clinical testing favorably and proceeds to clinical studies. Of those drugs that make it to human testing, approximately 1 in 5 will persevere through the many steps and receive FDA marketing approval. Therefore, a person living with HCV who hopes to find a new medicine may be disappointed if he/she gets too excited about drugs in the pre-clinical testing phase.
When a company is ready to proceed to clinical trials, it files an investigational new drug application with the FDA. Most clinical trials are designated as Phases I, II or III, and sometimes IV based on the type of questions that the study is seeking to answer. Although the phases of human clinical studies are generally conducted sequentially, there are cases when the phases overlap.
Clinical Trial: Phase I
Once granted approval by the FDA as an investigational new drug, testing can begin on humans. Phase I studies are typically conducted in healthy volunteer subjects, with the intent of determining:
· Metabolic and pharmacologic actions
· Side effects with increasing doses
· If possible, early insight into drug effectiveness
Typically considered to be smaller trials, Phase 1 studies generally recruit between 20 to 80 human subjects. Typically the drug remains in Phase I for one to two years.
Clinical Trial: Phase II
Instead of recruiting solely healthy people, Phase II clinical trials begin to evaluate the drug’s effectiveness in the target population. This stage of testing is where the preliminary data on a potential drug’s effectiveness for HCV emerges. Additionally, Phase II helps determine the common short-term side effects and risks associated with the drug. Several hundred people are usually enrolled in a Phase II clinical study. At the end of this round of studies, the manufacturer meets with FDA officials to discuss the development process, continued human testing, any concerns the FDA may have and the protocols for Phase III.
Clinical Trial: Phase III
Usually the most extensive and expensive part of drug development, Phase III studies are intended to evaluate the overall benefit-risk relationship of the drug. By gathering additional information about the drug’s effectiveness, safety, side effects and comparison to commonly used treatments, Phase III studies involve large groups of participants. Usually tested on several thousand people, Phase III studies also provide the basis for extrapolating results for physician labeling should the drug be granted FDA approval.
Once Phase III is complete, the manufacturer may file a new drug application. Review of the new drug application typically lasts one to two years, bringing drug development time after pre-clinical trials to approximately nine years. If the FDA approves the new drug, it may be marketed with FDA regulated labeling. The FDA also gathers safety information as the drug is used and adverse events are reported, and it will occasionally request changes in a labeling or will submit press releases as new contraindications arise. If adverse events appear to be systematic and serious, the FDA may withdraw a product from the market at any time.
Clinical Trial: Phase IV
In Phase IV studies, the drug is already on the market for a particular indication, but is now being tested for a different indication, use or disease.
Fast Track Status
During the phases of investigational drug development, the manufacturer can obtain accelerated development or review of its drug. If granted fast track status by the FDA, the timelines for clinical trials can take some shortcuts. Geared towards facilitating the development and expedition of new drugs that have the potential to address an unmet medical need for serious or life-threatening conditions, many HCV potential drugs are granted fast track status.
Once a drug receives fast track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
Having a general concept of the many steps and length of time involved in the approval of a new medication gives us a greater appreciation of what it takes to develop a drug. Patience is definitely required to see a potential cure come to fruition. While it may be premature to place all of your hope in a compound with promising pre-clinical trial results, go ahead and visualize how a drug emerging positively from Phase III will help you defeat HCV.
Discover all there is to know about Hepatitis E, including its transmission, symptoms, treatment and prevention.
by Nicole Cutler, L.Ac.
When it comes to infectious diseases affecting the liver, there seems to be no shortage of possibilities. Joining the ranks of Hepatitis A, B, C and D, Hepatitis E (HEV) has been the culprit of several cases of acute hepatitis across the globe. Caused only by infection with the Hepatitis E virus, HEV has only been recognized as a distinct human disease since 1980.
Although the symptoms may be similar, the genetics of each hepatitis virus are unique, with differing modes of transmission, infection course and treatment per disease. However, most experts agree that infection with one or more types of hepatitis viruses simultaneously carries a worse prognosis. Especially when laden with chronic Hepatitis C, infection with another hepatitis virus typically leads to an increased potential for liver damage.
HEV Transmission
Similar to how Hepatitis A is contracted, HEV is transmitted via the fecal-oral route. Primarily a waterborne disease, most Hepatitis E outbreaks have been associated with consumption of contaminated water or food supplies. Drinking water contaminated with fecal matter and ingestion of raw or uncooked shellfish have been implicated in cases of HEV in endemic areas. Since the virus is shed in feces, HEV could potentially be transmitted when infected animals meet poor sanitation practices. There is no evidence that Hepatitis E is transmitted through sexual contact, from needles or blood transfusions.
Where Is Hepatitis E?
The highest rates of Hepatitis E infection occur in regions where low standards of sanitation promote the transmission of the virus. Epidemics of Hepatitis E have been reported in the following locations where fecal contamination of drinking water is common:
· Central Asia
· South-East Asia
· North Africa
· West Africa
· India
· Mexico
In addition to the natives, travelers visiting the above locations are susceptible to this infection. Epidemics normally happen after water supplies are contaminated with sewage following monsoons or local flooding. Infected individuals in the United States have usually returned from travel to an area where the virus is more common. Although primarily affecting regions with poor sanitation, sporadic cases of Hepatitis E have been reported elsewhere, and serological surveys suggest a global distribution of strains of HEV.
Symptoms and Disease Course
As a viral infection targeting the liver, symptoms of Hepatitis E are similar to other types of hepatitis:
· Jaundice
· Fatigue
· Abdominal Pain
· Loss of Appetite
· Nausea and Vomiting
· Dark Urine
· Fever
· Bodyaches
In general, Hepatitis E is a self-limiting viral infection. As such, HEV is typically limited to an acute course. Although HEV infection is typically mild, one to two percent of those infected develop a sudden and severe form of liver disease known as fulminant hepatitis. Occurring more frequently in pregnancy, fulminant hepatitis is associated with a mortality rate of 20 percent among pregnant women in their third trimester.
Some additional facts about the Hepatitis E virus include:
· Once exposed to Hepatitis E, the infection takes hold within one to two months.
· Infected persons are presumed contagious for up to two weeks after symptoms appear.
· There have been no cases of chronic Hepatitis E reported.
· Symptomatic HEV infection is most common in young adults aged 15 to 40 years.
· Although HEV infection is frequent in children, it is mostly asymptomatic and goes undiagnosed.
Treatment and Prevention
Once infected with HEV, the only treatment is rest and increased fluid intake – similar to how you would recuperate from the flu. Since Hepatitis E is a viral disease, antibiotics are of no value in the treatment of this infection. Unlike Hepatitis A and B, there is no immune globulin to protect or recover from HEV.
Since no specific therapy is capable of altering the course of acute Hepatitis E infection, prevention is the most effective approach against the disease. As almost all HEV infections are spread by the fecal-oral route, good personal hygiene, high quality standards for public water supplies and proper disposal of sanitary waste can prevent most Hepatitis E infections.
For travelers to highly endemic areas, the usual elementary food hygiene precautions are recommended. These include:
· Avoid drinking water and/or ice of unknown purity.
· Do not eat uncooked shellfish, or fruits or vegetables not peeled or prepared by the traveler.
At present, no commercially available vaccines exist for the prevention of Hepatitis E. However, several studies for the development of an effective vaccine against Hepatitis E are in progress.
Of Most Concern
While Hepatitis E infection does not pose a major health threat, it can be dangerous for pregnant women and those already infected with another hepatitis virus.
· Pregnancy – When infected with HEV, pregnant women in their third trimester are most susceptible to developing fulminant hepatitis, a potentially fatal condition.
· Co-Infection – Belgian researchers presented an overview of co-infection with multiple hepatitis viruses in the December 2006 issue of European Journal of Gastroenterology and Hepatology. The authors wrote, “Co-infection with other hepatitis viruses modifies the viral profile in serum and leads to more liver damage and more rapid progression during the course of Hepatitis C virus infection.” Although not specific to HEV, the combined effects of co-infection with more than one hepatitis virus are attributable to an enhanced immune response. This immune response is responsible for a majority of the liver damage associated with viral hepatitis.
Nobody wishes to fall ill and be bedridden with an illness such as Hepatitis E. However, any serious risks from this illness are confined to the special populations of pregnant women and those already infected with a hepatitis virus. Until a vaccine is available to prevent HEV, any members of these special populations should pay keen attention to food hygiene, especially if traveling to a country where Hepatitis E is endemic.
References:
http://english. chosun.com, New Hepatitis E Virus Flares Up in Korea, Digital Chosun, June 2007.
www.cdc.gov, Hepatitis E: Fact Sheet, US Department of Health and Human Services, 2007.
www.hivandhepatitis.com, Impact of Coinfection with more than one Hepatitis Virus, Liz Highleyman, hivandhepatitis.com, 2007.
www.emedicine.com, Hepatitis E, Jonathan M. Schwartz, MD, WebMD, 2007.
www.sciencedaily.com, Hepatitis E Takes a Piggyback, ScienceDaily LLC, May 2007.
www.thirdworldtraveler.com, Hepatitis E, Third World Traveler, 2007.
www.webmd.com, Hepatitis E Vaccine Shows Promise, Miranda Hitti, WebMD Inc., 2007.
www.who.int, Hepatitis E, World Health Organization, 2007.
Find out about the Hepatitis B vaccine and whether or not it is everlasting.
by Nicole Cutler, L.Ac.
Hepatitis B is a nasty virus because of its potential to turn into chronic, progressive liver disease. With the possibility of leading to severe liver damage, such as cirrhosis and hepatocellular carcinoma, monumental efforts have been launched to prevent infection with Hepatitis B. Thankfully, the Hepatitis B vaccine is over 95 percent effective in protecting infection in those who have never contracted the virus before. Part of the routine vaccination requirements for infants since the early 1980s, nearly every baby in the U.S. receives this protection. However, there is some evidence that the immunity provided by the Hepatitis B vaccine may begin to wear off with time.
Consisting of a series of three injections, the Hepatitis B vaccine is required by most U.S. states for children prior to beginning daycare or public school. Over the past decade, the mandated vaccination of American children has been directly linked to the dramatic reduction of new Hepatitis B infections.
Immune Memory
While there is little data regarding the duration of protection provided by the Hepatitis B vaccination, scientists believe the immune system’s memory is at the heart of vaccination longevity. A successful primary immune response results in the production of immune system B-cells that have high affinities for the pathogen causing the response. Typically these B-cells are short-lived, making us believe that elimination of the pathogen also ends in B-cell death. If this were always the case, another exposure to the same pathogen would have to begin the propagation of specialized B-cells all over again. However, the immune system can avoid this repetitive process by retaining a memory of the pathogen’s information in the adapted B-cells.
Because of immune memory, the primary response to new pathogens is typically slow, while memory of previously encountered pathogens allows the immune system to mount a much faster attack. The presence of immune memory can be evaluated indirectly by measuring the immune response to a booster dose of the vaccine. Known as an anamnestic response, immune memory is determined when a renewed rapid production of antibodies on the second (or subsequent) encounter occurs with the same antigen.
Taiwan Leads the Way
Twenty years ago, Taiwan was the first country to successfully implement a universal Hepatitis B vaccination program for infants. As evaluated by scientists, two Taiwanese studies investigated Hepatitis B immune memory and demonstrated that the vaccine may be less effective for certain individuals.
Study 1 – As published in the April 2007 issue of Gastroenterology, researchers from Taiwan evaluated the long-term effectiveness of the Hepatitis B vaccine. After assessing nearly 19,000 study participants, the authors concluded the following:
· For most people, universal Hepatitis B vaccination provides immune memory, and therefore long-term protection for up to 20 years.
· For those receiving vaccination as infants, universal Hepatitis B booster is not necessary before adulthood.
· Maternal transmission of Hepatitis B is the primary reason for vaccine failure.
· In the future, high-risk infants may require amended vaccination programs.
Study 2 – As reported in the June 2007 issue of Journal of Hepatology, Taiwanese researchers evaluated the booster response of adolescents without Hepatitis B who had received infant vaccination. The researchers found that the following factors significantly increased the risk of non-response to booster vaccination:
The authors concluded that Hepatitis B booster vaccine may be insufficient to provide protection to people of Malay-Polynesian ethnicity or in those with recent cigarette smoking, alcohol consumption and/or betel-quid chewing.
Alaska Study
In a study published in the July 16, 2007 online edition of Pediatrics, researchers enrolled 378 healthy participants recruited at the Alaska Native Medical Center between October 2001 and January 2004. All subjects were born to mothers without the Hepatitis B virus and received their first dose of the Hepatitis B vaccine within seven days after birth. By evaluating the immune memory of participants, study investigators found that differences in immunity existed.
According to the Alaskan researchers’ findings, only 60 percent of 14 year-olds had an anamnestic response to a Hepatitis B vaccine booster dose, compared with 97 percent of five year-olds. The authors concluded, “Although most participants responded to a booster dose of Hepatitis B vaccine, the significance of the increased proportion of non-responders among older adolescents might indicate waning immune memory.”
Most physicians do not recommend a booster dose of the Hepatitis B vaccine for a person who has received the infant vaccination until adulthood. However, some of the recent evidence suggests we take a closer look at how long the Hepatitis B vaccine immune memory actually lasts. Factors such as ethnicity, people with compromised immunity, cigarette smoking, alcohol consumption or maternal transmission, are all being looked at as possible precursors to fading Hepatitis B immunity. Until more information is gathered, experts agree that further studies are needed before booster doses of Hepatitis B vaccine intended to maintain long-term immunity are recommended.
References:
http://medicine.com.my, Do You Need a Booster for Hepatitis B?, Palmdoc, Malaysian Medical Resources, May 2007.
Samandari, MD, PhD, Taraz, et al., Differences in Response to a Hepatitis B Vaccine Booster Dose Among Alaskan Children and Adolescents Vaccinated During Infancy, Pediatrics, August 2007.
www.cdc.gov, Vaccines & Immunizations, Centers for Disease Control and Prevention, 2007.
www.cs.unm.edu, Immune Memory, Steven A. Hofmeyr, University of New Mexico, 2007.
www.hivandhepatitis.com, Differences in Response to a Hepatitis B Vaccine Booster among Children and Adolescents Vaccinated during Infancy, hivandhepatitis.com, August 2007.
www.hivandhepatitis.com, Hepatitis B Vaccination Provides Long-term Protection, but All Do Not Respond Equally, Liz Highleyman, hivandhepatitis.com, 2007.
www.medpagetoday.com, Hepatitis B Vaccine Protection May Not Be Long-Lasting, Peggy Peck, August 2007.
YH Ni, LM Huang, MH Chang, et al., Two Decades of Universal Hepatitis B Vaccination in Taiwan: Impact and Implication for Future Strategies, Gastroenterology, April 2007.
Learn how Hepatitis A can be transmitted and some of the virus’ most common symptoms. Also find out some helpful tips on self-administered symptom relief, ways to prevent transmitting it to others and how to protect yourself from infection.
by Nicole Cutler, L.Ac.
One of the three most common hepatitis viruses in the United States, Hepatitis A is a self-limiting viral infection of the liver. Unlike the other two common types of hepatitis, Hepatitis B and Hepatitis C, Hepatitis A typically does not cause chronic disease. One of the liver’s amazing capabilities is its ability to heal and recover from injury. While Hepatitis A does cause liver inflammation, most people’s livers can fully recover without any long-term damage. However, people already afflicted with chronic liver disease are more susceptible to serious illness as a result of Hepatitis A infection.
Transmission
The Hepatitis A virus (HAV) is transmitted primarily through the fecal-oral route. Hepatitis A viral particles are found in the feces of people infected with Hepatitis A. It is transmitted when a person puts something in his or her mouth that has been contaminated with the feces of an affected person. Because of the way it is spread, HAV frequently occurs in outbreaks. Some situations resulting in outbreaks include:
· Inadequate hand washing or poor sanitary conditions of an infected person can contaminate food or drinking water. Once food or water is tainted with the virus, it can quickly spread to anyone ingesting it.
· The virus can be spread by eating raw or undercooked shellfish collected from bodies of water contaminated by sewage.
· If attention to hygiene becomes lax at a location where direct fecal-oral transmission is likely to occur, such as daycare centers, prisons and mental institutions, there is a greater chance of an outbreak.
Symptoms
Many people with HAV infection have no symptoms at all, or symptoms are so mild that they go unnoticed. While older people are more likely to have symptoms than children, even an asymptomatic person can spread the virus. Symptoms of Hepatitis A usually develop between two to six weeks after contracting the virus. Although symptoms are usually mild and go away on their own, the most common ones include:
· Nausea and vomiting
· Diarrhea, especially in children
· Low-grade fever
· Loss of appetite
· Rash
· Fatigue
· Jaundice – yellow discoloration of the skin and the whites of the eyes
· Dark urine
· Liver pain – pain on the right side of the abdomen, just under the rib cage
If the vomiting is severe, dehydration may occur. Dehydration is a serious condition and must receive immediate medical care. If a healthcare provider cannot be reached, and one of the following applies, seek emergency health services:
· Unstoppable vomiting and inability to keep down any liquids
· Severe pain or high fever
· Confusion, delirium or difficulty awakening
Symptom Relief
There are no specific medicines to cure infection with Hepatitis A. Most people only require temporary symptom relief. The following measures can be taken for self-administered symptom relief:
· Rest – curtail normal activities and spend time resting at home.
· Hydrate – drink plenty of clear fluids to prevent dehydration.
· Avoidance – do not take medicines or substances that can cause harm to the liver. These include, but are not limited to, acetaminophen (Tylenol), preparations that contain acetaminophen and alcoholic beverages.
· Hygiene – be extra careful about personal hygiene to avoid fecal-oral transmission to other members of the household.
Prevention
If you have Hepatitis A, strict personal hygiene and hand washing help prevent its transmission to others.
· Wash your hands thoroughly every time you use the bathroom, before touching or preparing food and before touching others. Wash carefully with soap and warm water and dry thoroughly.
· Contaminated surfaces should be cleaned with household bleach, and food or water should be heated to 185°F or 85°C to kill the virus.
· Milk thistle may aid the liver in a quicker recovery. Studies demonstrate that extract of milk thistle helps the liver neutralize toxins and produce new, healthy liver cells. While this supplement will not cure or prevent HAV, it can support your liver during an attack.
· Avoid sexual activity to protect your partner from infection. Many kinds of sexual activities can transmit HAV – and condoms don’t offer adequate protection.
If you are not infected with HAV, you can help protect yourself from becoming infected:
· Wash your hands carefully with soap and warm water several times a day, including every time you use the bathroom, every time you change a diaper and before preparing food.
· Do not eat raw or undercooked seafood or shellfish such as oysters from areas of questionable sanitation (just about everywhere).
· Travelers to developing countries should not drink untreated water or beverages with ice in them. Fruits and vegetables should not be eaten unless cooked or peeled.
· Get vaccinated for Hepatitis A. The vaccines, Havrix and VAQTA, contain no live virus and are very safe. People with existing chronic liver disease are advised to consider the HAV vaccine because they are likely to become seriously ill if exposed.
· If you have never had Hepatitis A and are exposed to the virus, call your health care provider immediately. Although it only offers short-term protection, an injection of immune globulin within two weeks of HAV exposure may prevent infection.
Once someone has Hepatitis A, lifelong immunity is established preventing re-infection with the disease.
While HAV is a completely different pathogen than Hepatitis B or Hepatitis C, it remains a highly contagious virus targeting the liver. A person currently living with liver disease must know the basics of Hepatitis A, including how this illness is transmitted, its symptoms and how to protect themselves and others from it. For some people, getting vaccinated is the best choice, while others may benefit from supplementing with milk thistle and refraining from alcohol use. Since each person’s situation is unique, being educated on the details of this common type of hepatitis can help you stay as healthy as humanly possible.
References:
www.cfsan.fda.gov, Hepatitis A Virus, Center for Food Safety and Applied Nutrition, 2007.
www.emedicinehealth.com, Hepatitis A, WebMD, 2007.
www.mayoclinic.com, Hepatitis A Prevention, Mayo Foundation for Medical Education and Research, 2007.
www.medicinenet.com, Preventing Hepatitis A, Diana Kohnle, ScoutNews, LLC, 2007.
www.webmd.com, Hepatitis A Virus Test, WebMD, Inc., 2007.
Although not yet tested in humans, Massachusetts researchers have found an antibody to the Hepatitis C virus that can prevent and help clear Hepatitis C infection.
New Antibody Prevents Infection By Hepatitis C Virus
Wednesday, May 06, 2009
Taking aim at a leading cause of liver failure in the United States, a team of scientists at the Massachusetts Biologic Laboratories (MBL) of the University of Massachusetts Medical School (UMMS) has developed a human monoclonal antibody that neutralizes the Hepatitis C virus (HCV). The new antibody effectively neutralized the virus in culture, and then prevented infection by the virus in a pre-clinical animal model of the disease.
Details of the research were presented April 23 in Copenhagen, Denmark at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL). "We are pleased with the progress of this program," said Donna Ambrosino, MD, executive director of the MBL and a professor of pediatrics at the Medical School. "This antibody shows significant efficacy against the virus."
In the current study, MBL scientists injected transgenic mice (HuMAb Mouse® technology, Medarex, Inc.) with elements of HCV and then painstakingly searched for individual human antibodies produced in the mice that would recognize and bind to the HCV's outer coat, known as the glycoprotein. Once they found human antibodies that looked promising, they evaluated in vitro the ability of those antibodies to neutralize the virus and selected a lead candidate antibody for further characterization. Collaborative work with clinical researchers from the Department of Medicine at the Medical School's Worcester campus demonstrated that this antibody, now known as MBL-HCV1, was able to bind tightly with all genotypes of HCV tested from infected patient samples.
MBL-HCV1 was then tested off-site on three non-human primates. In that study, one animal received no antibody, one a low dose of the new antibody, and one a higher dose. Then all three animals were exposed to HCV. The animals with low or no antibody dosages developed HCV infections, but the animal with the higher dose was protected. Subsequently, researchers gave the high-dose of the antibody to the animal that originally received no antibody, and in that case the HCV was cleared from that animal's system. "These results are encouraging as a possible treatment for HCV infected patients, but more work needs to be done before we know how effective it will be in people," Dr. Ambrosino noted.
HCV attacks the liver and can eventually lead to liver failure. According to the U.S. Centers for Disease Control and Prevention, 3.2 million Americans are chronically infected with HCV and some 10,000 die annually of the disease. Globally, as many as 170 million people are estimated to suffer from HCV infection. For the most serious cases of HCV that do not respond to antiviral drugs, liver transplantation is the only option.
Typically 2,000 to 4,000 liver transplants are done each year in the United States (far less than the number of people on the waiting list for available organs). Transplantation can be a life saving treatment; however, in nearly all cases the patient's new liver is eventually infected by HCV because the virus remains in the patient's bloodstream during surgery. The powerful antiviral drugs now used to attack HCV prior to end-stage liver failure are not routinely used during surgery due to the patients' weakened condition and because of the strong medication used to avoid rejection of the new liver. After re-infection with HCV, nearly 40 percent of patients suffer rapid liver failure.
To close that clinical gap, the new antibody developed at MBL is designed to be a therapy shortly before and after transplant surgery. By giving a patient the new antibody before and during the time when the donor liver is implanted, researchers hope the HCV virus left in the bloodstream will be neutralized and rendered unable to infect the new liver. Then, because monoclonal antibodies are highly specific and typically have little or no side-effects, additional dosages of the new antibody could, theoretically, be given immediately after transplant surgery to continue neutralizing any remaining virus.
It is also possible, researchers theorize, that the antibody could be used in combination with new antiviral drugs for treatment in patients with newly diagnosed HCV infection. Use of the new antibody for both liver transplant patients and in newly diagnosed HCV patients will now be further evaluated. A Phase 1 human clinical trial of MBL-HCV1 in healthy subjects is expected to begin later this year.
Source-Eurekalert
SRM
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URL for Article Source:
http://www.medindia.net/news/New-Antibody-Prevents-Infection-By-Hepatitis-C-Virus-50949-2.htm
Following a yearlong trial of Vertex's oral protease inhibitor, telaprevir's high success rate in clearing Hepatitis C from previous non-responders has landed it in the final stretch for FDA approval.
Vertex’s Hepatitis C Drug Helps Sickest Patients Get Relief
By Michelle Fay Cortez and Lisa Rapaport
April 25 (Bloomberg) -- Vertex Pharmaceuticals Inc.’s experimental hepatitis C drug telaprevir wiped out signs of the infection in half of patients with hard-to-treat forms of the disease in a yearlong study.
The Prove 3 trial, presented at the European Association for the Study of the Liver in Copenhagen, found adding the drug to Roche Holding AG’s Pegasys and Copegus improved response to therapy. The study also showed Copegus is essential. Researchers left it out of one arm of the trial in an effort to reduce side effects, and netted lower patient response as well.
The study tracked 453 patients who failed to benefit from previous treatment or suffered a relapse after therapy, giving them few treatment options. Fifty-two percent of those who got therapy including telaprevir for 48 weeks experienced a sustained response -- with no signs of the virus that causes hepatitis C -- compared with 14 percent of those given the Roche drugs alone.
“Previously treated patients who didn’t achieve sustained viral response represent the hardest to treat patient population in physicians’ practices,” said lead investigator Michael Manns, director of gastroenterology, hepatology and endocrinology at the Medical School of Hannover, Germany, in a statement. “This represents an exciting potential medical advance.”
The study, from the second of three phases needed for regulatory approval, was funded by Vertex and its partner, New Brunswick, New Jersey-based Johnson & Johnson.
Final Stage Testing
Studies from the final stage needed for U.S. Food and Drug Administration approval are under way, and should be completed in the first half of next year, said Robert Kauffman, senior vice president of clinical development at Cambridge, Massachusetts-based Vertex, in a telephone interview.
“These are unprecedented results, with the highest sustained viral response rates ever reported,” Kauffman said.
Few patients relapse months after they finish treatment, suggesting a potential cure for those who respond, he said.
“You want to follow patients over the long term just to be sure,” he said. “Based on everything we know, we’re optimistic these patients will maintain their responses.”
Telaprevir is an oral protease inhibitor, which works by targeting an enzyme the virus needs to replicate. The Roche drugs work by an indirect method, bolstering the patient’s immune system and their own ability to fight off the disease.
170 Million Infected
About 170 million worldwide, and 3.4 million in the U.S., have hepatitis C, a liver disease that is spread mainly through contact with the blood of infected patients, according to the World Health Organization. Symptoms include stomach pain, fever and fatigue, and can increase the risk of cirrhosis and death.
“Vertex’s long-term growth story looks more secure with each HCV conference we attend,” Thomas J. Russo, an analyst at Robert W. Baird in Chicago, wrote in an April 24 note to clients.
To contact the reporters on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net; Lisa Rapaport in New York at Lrapaport1@bloomberg.net.
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URL for Article Source:
http://www.bloomberg.com/apps/news?pid=20601087&sid=a1X1GQmuz41c&refer=home
Through documenting Hepatitis C re-infection and superinfection in IV drug users, researchers better understand why a vaccine or cure has been so elusive.
by Nicole Cutler, L.Ac.
Hepatitis C is the most common blood-borne infection in the United States. It is also extremely prominent in intravenous drug users. Even with all of the ongoing research into Hepatitis C prevention and therapy, the current treatment is generally only effective in approximately half of those infected. The scientific community has uncovered a variety of stumbling blocks in their quest to create a Hepatitis C vaccine or a cure. Two of the barriers complicating their search for improved Hepatitis C treatment are that the largest population of people with Hepatitis C, intravenous drug users, is often prone to re-infection or superinfection.
Hepatitis C in Intravenous (IV) Drug Users
Considered to be approximately seven times more infectious than HIV in a single drop of blood, Hepatitis C is extremely likely to be acquired if contaminated needle and syringe sharing is occurring. Investigators know the following:
· Within only six months to a year after beginning intravenous drug use, 50 to 80 percent of IV drug users test positive for the Hepatitis C antibody.
· Intravenous drug users account for about 30 to 40 percent of all identified Hepatitis C cases, and about 50 percent of all new cases.
Representing the largest single risk group for Hepatitis C, many studies have attempted to determine the percentage of IV drug users infected. While trial results vary, they all demonstrate that over half of IV drug users have the virus. And some researchers even claim that nearly 100 percent of those using needles to inject drugs have antibodies to Hepatitis C.
Hepatitis C Is Mysterious
Most experts believe that finding an effective Hepatitis C vaccine or therapy is such a challenge because of the virus’ ability to mutate. The following facts have made this infectious disease harder for scientists to eliminate:
· Hepatitis C is an RNA virus that lacks an efficient proofreading ability as it replicates.
· This inefficient proofreading allows the virus to evolve, creating a collection of quasi-species. There are currently 11 major genotypes, many subtypes and 100 different strains of Hepatitis C.
· Because it constantly mutates, many believe Hepatitis C escapes host immunologic detection and elimination.
Re-Infection
The immune system’s memory is credited for building up resistance to various diseases and is the theoretical basis behind most preventative vaccines. Many infectious diseases teach the immune system how to combat a particular pathogen so that subsequent exposure does not cause re-infection. To aid the investigation into vaccine development, researchers are trying to confirm or deny immune memory with Hepatitis C.
Superinfection
A reasonable path for the highly mutable Hepatitis C virus, superinfection is when a cell previously infected by one virus becomes co-infected with a different strain of the virus. Unfortunately, viral superinfections are common causes of treatment resistance – where a previously effective therapy loses its efficacy. In addition, superinfections have been known to reduce the overall effectiveness of the immune response.
Study
As described in an oral presentation at the 13th International Symposium on Viral Hepatitis and Liver Disease in April of 2009, investigators studied intravenous drug users to assess Hepatitis C re-infection and superinfection. Based on their results, the researchers concluded that Hepatitis C re-infection and superinfection “are common among actively injecting drug users.” They proclaimed further that these findings demonstrate Hepatitis C does not create protective immunity and further complicates the quest for developing a Hepatitis C vaccine.
Because of Hepatitis C’s high transmission rate in those sharing contaminated needles and syringes, studying IV drug users can yield very important information. By recognizing the existence of Hepatitis C re-infection and superinfection and understanding how it impedes vaccine and drug development, researchers are that much closer to unraveling the mystery of Hepatitis C.
References:
http://en.wikipedia.org/wiki/Superinfection, Superinfection, Retrieved April 14, 2009, Wikimedia Foundation, Inc., 2009.
http://www.drugabuse.gov/HepatitisAlert/HepatitisAlert.html, NIDA Community Drug Alert Bulletin – Hepatitis, Alan I. Leshner, PhD, Retrieved April 15, 2009, National Institute on Drug Abuse, 2009.
http://www.epidemic.org/theFacts/theEpidemic/USRiskGroups/, High Risk Groups – United States, Retrieved April 15, 2009, Trustees of Dartmouth College, 2009.
http://www.hivandhepatitis.com/hep_c/news/2009/032409_a.html, HCV Reinfection and Superinfection Are Common among Injection Drug Users, Retrieved April 13, 2009, hivandhepatitis.com, March 2009.
http://www.knowcrystal.org/hiv/crystalhiv_p4.htm, What is Superinfection?, Retrieved April 14, 2009, knowcrystal.org, 2009.
http://www.ncbi.nlm.nih.gov/pubmed/15378431, Frequent hepatitis C virus superinfection in injection drug users, Herring BL, et al, Retrieved April 14, 2009, The Journal of Infectious Diseases, Infectious Diseases Society of America, October 2004.
http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index2.html, The Hepatitis C Virus, Retrieved April 16, 2009, World Health Organization, 2009.