Research & Treatment News
April 30, 2009
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An interferon-free combination of four different drugs taken orally demonstrates encouraging initial results for reducing Hepatitis C viral load.
Business - Press Releases: PR Newswire
Saturday, Apr. 25, 2009
Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen
Roche; InterMune; Pharmasset
- Combination of R7227, protease inhibitor, and R7128, nucleoside polymerase inhibitor, shows significant potency in reducing viral load in patients with hepatitis C - NUTLEY, N.J., BRISBANE, Calif., and PRINCETON, N.J., April 25 /PRNewswire-FirstCall -- Roche, InterMune, Inc. (Nasdaq: ITMN) and Pharmasset (Nasdaq: VRUS) today announced the first results from their innovative, interferon-free regimen of direct acting antiviral (DAA) combination therapy for the treatment of patients chronically infected with the hepatitis C virus (HCV)(1). The study combined two oral DAAs, R7227 (also known as ITMN-191) and R7128, for the first time in patients. There were no serious adverse events reported during the 14 days of dosing, and the reductions in levels of HCV RNA were significant.
Results of the INFORM-1 study were presented today during the late-breaker session at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen.
The trial, conducted in centers in New Zealand and Australia, is the first to investigate the combination of two oral antiviral medicines in the absence of interferon and ribavirin. The results demonstrated for the first time that the combination of an oral protease inhibitor and an oral nucleoside polymerase inhibitor resulted in significant HCV viral load reduction in patients with HCV. Roche is developing R7227, a protease inhibitor, with InterMune, and R7128, a nucleoside polymerase inhibitor, with Pharmasset.
Further studies will test the activity and safety of the combination of R7227 and R7128 with and without interferon and/or ribavirin. The current standard of care for HCV is a combination of pegylated interferon plus ribavirin, which delivers overall sustained virologic response rates (SVR) of 50-60 percent.
"These are exciting times in our fight against hepatitis C, and the investigation of the innovative oral treatment regimen in INFORM-1, if validated in further study, may radically change future treatment strategies in our patients with chronic HCV infection," said Edward Gane, M.D., Associate Professor, University of Auckland and Director, Auckland Clinical Studies Limited. "The initial results from this study of the R7227/R7128 combination raise hopes of the possibility for an interferon-free treatment regimen, as well as the potential for a shorter, more potent interferon-based regimen."
INFORM-1 Results in Brief
INFORM-1 is a randomized, double-blind, ascending dose Phase I trial which has enrolled a total of 57 patients.
Patients receiving the combination of R7227 and R7128 for 14 days -- without pegylated interferon or ribavirin -- experienced a median reduction in viral levels of -4.8 to -5.2 log(10) IU/mL in the highest doses tested. The addition of R7128 to R7227 resulted in sustained viral load reductions over the dosing period, with aproximately 63 percent of patients experiencing a decrease in viral levels below the quantification limit of the diagnostic assay (less than 40 IU/mL). Furthermore, 25 percent of patients in the highest dosage groups were below the limit of detection of the virus in their blood (less than 15 IU/mL) after 14 days.
- Combination of R7227, protease inhibitor, and R7128, nucleoside polymerase inhibitor, shows significant potency in reducing viral load in patients with hepatitis C - NUTLEY, N.J., BRISBANE, Calif., and PRINCETON, N.J., April 25 /PRNewswire-FirstCall -- In the early low-dose groups, after only three days of dosing, the mean reduction in viral load levels was 0.6 log(10) IU/mL greater with combination treatment (-2.9), compared to the performance of the individual compounds when administered as a single agent (-0.46 and -1.84 for R7128 and R7227, respectively). This suggests an additive effect for the combination.
No treatment-related serious adverse events (SAEs), no dose reductions and no discontinuations were reported in the study. Pharmacokinetic analysis confirmed that there were no drug-drug interactions between the compounds.
Next Steps in the Development Program
The companies are now exploring twice-daily dosing of R7227 and higher total daily doses (600 mg twice-daily and 900 mg twice-daily) than those explored in the first patient cohorts of INFORM-1. The companies also plan to explore the innovative DAA combination therapy in "treatment-experienced" patients with HCV, or those who did not achieve SVR with a previous interferon-based treatment.
Other Clinical Studies with R7227 and R7128
In addition to clinical studies of combination DAA regimens such as those studied in INFORM-1, R7227 and R7128 each are proceeding rapidly in development in combination with Roche's PEGASYS(R) (peginterferon alfa-2a) and COPEGUS(R) (ribavirin). A Phase IIb study with R7128 has now begun, while a Phase IIb study with R7227 is slated to begin in the summer.
The Foundation and Future of HCV Treatment
Combination therapy of pegylated interferon and ribavirin is the current standard of care for HCV. PEGASYS is the leading treatment for HCV, and also is the pegylated interferon therapy of choice for most HCV antiviral agents in development -- including those developed through collaborations with Roche, as well as those developed by other companies. The collaborations with InterMune and Pharmasset position Roche as a leader in developing innovative treatments for HCV.
Dial-In and Webcast Details
InterMune and Pharmasset will host a live webcast of a discussion of the INFORM-1 results from the EASL conference today, Saturday, April 25, 2009, at 7:00 p.m. CEST (1:00 p.m. EDT). Participating in the discussion will be Dr. Ed Gane, principal investigator in the INFORM-1 trial. Members of management from Roche, InterMune and Pharmasset will also be available to answer questions. A live webcast and slide presentation will be available through the Investor Relations pages of both InterMune and Pharmasset at www.intermune.com or www.pharmasset.com, respectively. Alternatively, interested parties may access the discussion and ask questions by dialing 888-799-0528 (U.S. and Canada) or 973-200-3372 (international), conference ID # 95452531. A webcast replay will be available approximately three hours after the call and will be archived at www.intermune.com and at http://www.pharmasset.com.
- Combination of R7227, protease inhibitor, and R7128, nucleoside polymerase inhibitor, shows significant potency in reducing viral load in patients with hepatitis C - NUTLEY, N.J., BRISBANE, Calif., and PRINCETON, N.J., April 25 /PRNewswire-FirstCall -- The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 800-642-1687 (U.S. and Canada) or 706-645-9291 (international), and entering conference ID # 95452531.
The companies recommend logging on at least 15 minutes prior to the start of the webcast to ensure adequate time for any software downloads that may be required.
About R7227 (ITMN-191)
R7227 is a potent, macrocyclic inhibitor of HCV NS3/4A protease activity, and has produced multi-log(10) reductions in levels of HCV levels in chronic HCV patients, when administered for 14 days as monotherapy and when combined with PEGASYS and COPEGUS. R7227 was safe and well-tolerated in these studies.
About R7128
R7128, a cytidine nucleoside analog inhibitor of HCV RNA polymerase, is being developed for the treatment of chronic HCV infection. R7128 has shown potent in vivo activity against all of the most common HCV genotypes (1, 2 and 3). R7128 was safe and well-tolerated when given with PEGASYS and COPEGUS for up to 28 days.
About PEGASYS
PEGASYS, in combination with COPEGUS (ribavirin), is indicated for the treatment of adults with chronic HCV who have compensated liver disease and have not previously been treated with interferon alpha. Efficacy has been demonstrated in patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that are clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy). In addition, PEGASYS in combination with COPEGUS is the first and only FDA-approved regimen for the treatment of chronic HCV in patients coinfected with HCV and HIV. PEGASYS is the only pegylated interferon indicated for the treatment of adult patients with chronic hepatitis B (HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation).
PEGASYS is dosed at 180mcg as a subcutaneous injection taken once a week. COPEGUS is available as a 200mg tablet, and is administered orally two times a day as a split dose. Roche has backed PEGASYS with the most extensive clinical research program ever undertaken in HCV, with major studies initiated to advance treatment for HCV patients with unmet needs, including patients co-infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy.
Important Safety Information About PEGASYS
- Combination of R7227, protease inhibitor, and R7128, nucleoside polymerase inhibitor, shows significant potency in reducing viral load in patients with hepatitis C - NUTLEY, N.J., BRISBANE, Calif., and PRINCETON, N.J., April 25 /PRNewswire-FirstCall -- PEGASYS, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).
Alpha interferons, including PEGASYS(R) (Peginterferon alfa-2a), may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information).
Use with Ribavirin. Ribavirin, including COPEGUS(R), may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information).
PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment. PEGASYS is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment. PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal. PEGASYS and COPEGUS therapy is additionally contraindicated in patients with a hypersensitivity to COPEGUS or any of its components, in women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).
COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. If pregnancy should occur during treatment or during 6 months post-therapy, the patient must be advised of the significant teratogenic risk of COPEGUS therapy to the fetus. Healthcare providers and patients are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214.
Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. During treatment, patients' clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score greater than or equal to 6) is observed. Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including PEGASYS. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and causal relationship between interferon alfa-based therapies and these events is difficult to establish.
The most common adverse events reported for PEGASYS and COPEGUS combination therapy observed in clinical trials were fatigue/asthenia (65 percent), headache (43 percent), pyrexia (41 percent), myalgia (40 percent), irritability/anxiety/nervousness (33 percent), insomnia (30 percent), alopecia (28 percent), neutropenia (27 percent), nausea/vomiting (25 percent), rigors (25 percent), anorexia (24 percent), injection site reaction (23 percent), arthralgia (22 percent), depression (20 percent), pruritus (19 percent) and dermatitis (16 percent).
Serious adverse events in hepatitis C trials included neuropsychiatric disorders (homicidal ideation, suicidal ideation, suicide attempt, suicide, psychotic disorder and hallucinations), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, supraventricular arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis, lupus, rheumatoid arthritis and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema).
Adverse reactions reported during post-approval use of PEGASYS therapy, with and without ribavirin, include hearing impairment, hearing loss, serious skin reactions, including erythema multiforme major, and infections (bacterial, viral and fungal).
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. For additional information about the U.S. pharmaceuticals business, visit our website http://www.rocheusa.com. Product and treatment information for U.S. healthcare professionals is available at www.RocheExchange.com.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase III program, CAPACITY, which is evaluating pirfenidone as a possible therapeutic candidate for the treatment of patients with IPF and a research program focused on pirfenidone analog ITMN-520. The hepatology portfolio includes the HCV protease inhibitor compound R7227 (ITMN-191), a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Pharmasset is currently developing three product candidates. R7128, an oral treatment for chronic HCV infection, has completed a 4-week clinical trial in combination with PEGASYS plus COPEGUS through a strategic collaboration with Roche, and is initiating a Phase IIb trial. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase II clinical trial. PSI-7851, an unpartnered second generation HCV nucleotide analogue recently entered Phase I studies. Additional information is available on the Internet at http://www.pharmasset.com
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect the companies' judgments and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines. All forward-looking statements and other information included in this press release are based on information available to the companies as of the date hereof, and the companies assume no obligation to update any such forward-looking statements or information. Actual results could differ materially from those described in the forward-looking statements.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in the companies' most recent annual reports on Form 10-K filed with the SEC and in other periodic reports filed with the SEC. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the respective Forms 10-K and in the companies' other periodic reports filed with the SEC, all of which are available via their respective web sites at www.intermune.com and .
All trademarks used or mentioned in this release are protected by law.
- About INFORM-1: www.clinicaltrials.gov
(1) "First-In-Man Demonstration Of Potent Antiviral Activity with a Nucleoside Polymerase (R7128) and Protease (R7227/ITMN-191) Inhibitor Combination in HCV: Safety, Pharmacokinetics, and Virologic Results from INFORM-1," Abstract #1046: to be presented at 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark, April 22 - 26, 2009.
Contacts:
Linda Dyson
Roche
973-562-2231 (office)
973-986-5973 (mobile)
Linda.Dyson@roche.com
Jim Goff Sr. Director, Corp. Comm. & IR InterMune, Inc. 415-466-2228 jgoff@intermune.com
Richard E. T. Smith, Ph.D. VP, Investor Relations and Corporate Communications Pharmasset 609-613-4181 richard.smith@pharmasset.com
SOURCE Roche; InterMune; Pharmasset
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Posted by Editors at 1:24 PM --- Printer-friendly version
April 29, 2009
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Data from a clinical trial brings hope for a DNA-based therapeutic vaccine for Hepatitis C.
First evidence for DNA-based vaccination against chronic hepatitis C
April 23, 2009
The first-proof-of-concept for a DNA-based therapeutic vaccination against chronic hepatitis C was announced today at EASL 2009, the Annual Meeting of the European Association for the Study of the Liver in Copenhagen, Denmark.
In the first clinical trial of a therapeutic vaccination using naked DNA delivered by in vivo electroporation (EP), antiviral effects were shown in patients with hepatitis C (HCV). Researchers hope that this will encourage further clinical development. The data also provide further evidence for the antiviral role of the HCV-specific T cell response.
It is estimated that some 3% of the world's population is infected with HCV. In industrialised countries, hepatitis C accounts for 70% of chronic hepatitis cases. One of the main concerns is that HCV infection remains asymptomatic until advanced stages of the disease.
Clearance of HCV infection correlates with activation of the host T cell response. Therefore, in this study, researchers developed a T cell vaccine based on a codon-optimised HCV non-structural (NS) 3/4A DNA-gene expressed under the control of the cytomegalovirus immediate-early promoter (ChronVac-C®) delivered by in vivo electroporation (EP). A first phase I/IIa clinical trial in HCV infected patients is currently ongoing.
Professor Matti Sallberg of Laboratory Medicine, the Karolinska Institutet, Stockholm, Sweden, who led the study, said: "In 50-80% of adult cases, the immune system fails to eliminate the HCV virus and the disease becomes chronic. Given that only about 50% of HCV infected persons are diagnosed in most developed countries and that two-thirds need to undergo antiviral treatment, this new vaccination has huge implications in terms of the future management of this widespread disease."
In this study, a volume of 0.5 ml saline containing ChronVac-C® DNA was injected at 1 cm depth in the deltoid muscle. This was followed by two 60ms electrical pulses administered using a 1.5 cm four-electrode array (Medpulser DDS; Inovio, CA, US). The study aims were safety, immunogenicity, and effects on the viral load. Twelve treatment naive patients infected with HCV genotype 1 and a viral load <800,000 IU/ml were divided in four groups of 167 µg, 500 µg, and 1,500 µg given as four monthly doses of DNA.
In the 167µg group, no severe side effects were observed, two patients mounted transient T cell responses, and none had a reduced viral load. In the 500µg dose, no severe side effects were observed, and two developed better sustained HCV-specific T cell responses. Simultaneous with these responses, both patients had reductions in the viral load of up to 0.89 log10 and 1.5 log10, respectively. In the third patient, no immune response developed and no clear reductions in the viral load were seen. In the 1,500µg dose, no severe side effects were observed, and one patient developed HCV-specific T cell response. Two patients had reductions in the viral load of up to 1.2 log10 and 2.4 log10, respectively. Thus, 67% (four out of six) of patients in the two highest dose groups had reductions in the viral load exceeding 0.5 log10 lasting for two to >10 weeks. Of these, three had activations of the HCV-specific T cell responses at the time of the reductions in the viral load.
Source : European Association for the Study of the Liver
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URL for Article Source:
http://www.biologynews.net/archives/2009/04/23/first_evidence_for_
dnabased_vaccination_against_chronic_hepatitis_c.html
Posted by Editors at 4:40 PM --- Printer-friendly version
April 28, 2009
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Despite the claim that cleanliness is next to godliness, the products you use to keep your home clean may be worsening Hepatitis C. Particularly important for those with chronic liver disease, this informative article describes the most dangerous cleaning products and details how you can make toxin-free cleaning solutions.
by Nicole Cutler, L.Ac.
Without a successful course of treatment, Hepatitis C often causes gradual, progressive liver damage. Thus, anyone living with this virus must take additional steps to protect themselves from toxins capable of causing additional liver injury. Unfortunately, potential liver hazard items can be found in all aspects of modern day life. Inside most people’s homes, cleaning products harbor some of the most hazardous chemicals known. By reducing exposure to these toxins, those with Hepatitis C can protect themselves from unintentionally worsening their liver’s condition.
Because the chemicals in cleaning products are not dispersed as easily indoors as outdoors, concentrations of toxic chemicals are highest indoors. According to a United States Environmental Protection Agency (EPA) report, dangerous compounds in the home may exceed the toxins found outside by up to 100 times or more.
Those with chronic Hepatitis C are more vulnerable to the toxins in cleaning products because:
· Chronic liver disease may have damaged portions of their liver, leaving fewer functioning cells to detoxify poisons.
· Chronic liver disease can cause liver inflammation, which diminishes the liver’s ability to detoxify poisons.
· Scarring from chronic liver disease can interfere with circulation throughout the liver, leaving more toxins in the blood to further damage liver cells.
Dangerous Cleaning Products
While there is a long list of potentially hazardous ingredients in cleaning products, the following appear to be some of the worst offenders:
1. Air Fresheners and Deodorizers – These products can contain hormone-disrupting phthalates, cancer-causing chemicals such as formaldehyde and benzene, and other volatile organic compounds (VOCs) such as d-limonene that can irritate your eyes, skin and respiratory system, and cause headaches, nausea and dizziness.
2. Alkyl Phenol Ethoxylates (APEs) – Also known as surfactants, these chemicals are found in laundry detergents, all-purpose cleaners and stain removers. Unfortunate for those with diminished liver function, APEs break down into hormone-disrupting chemicals.
3. Glycol Ethers – Found in glass cleaners, floor cleaners and oven cleaners, glycol ethers can damage the nervous system, kidneys and liver, and be absorbed by the skin from the air.
4. Petroleum Distillates – Typically used as solvents, petroleum distillates are found in metal polishes and adhesive removers. They can cause temporary eye clouding, as well as long-term damage to the nervous system, kidneys and eyes.
5. Phenol and Cresol – Often found in disinfectants, phenol and cresol can cause diarrhea, fainting, dizziness and kidney and liver damage.
6. Toilet Bowl Cleaners – These emit naphthalene fumes, which can cause liver and kidney damage if ingested. Toilet bowl cleaners typically contain aradichlorobenzene, a toxin believed to cause cancer.
7. Citrus – Cleaners containing citrus can claim to be natural, but are often concocted with d’limonene, a chemical more toxic than toluene, which can damage bone marrow, liver and kidneys.
8. Laundry Aids – Fabric softeners and dryer sheets contain chemicals such as chloroform and benzyl acetate that are neurotoxic and carcinogenic. Exposure can be through inhalation or skin contact from dryer exhaust or from treated clothes, sheets and towels.
Toxin-Free Cleaning Solutions
Those who are alerted to the dangers posed by cleaning products often purchase products from their local health food store. Luckily, several environment-friendly companies have identified the negligence of traditional cleaning product manufactures and offer alternatives for those concerned with toxin exposure. However, those on a budget may find the prices of toxin-free cleaning products to be significantly pricier than their traditional counterparts.
Fortunately, making your own supply of cleaners is relatively easy and inexpensive. Below are some recipes that can be confidently and safely used in the home of someone with Hepatitis C:
· All-Purpose Cleaner – To clean many hard surfaces (excluding marble), combine equal parts of white vinegar and water in a spray bottle.
· Scouring Powder – Mix 3 parts baking soda with 1 part borax. Keep handy in a shaker jar and use gloves when using, but keep away from children as it should not be ingested and may cause skin irritation.
· Microwave Cleaner – Put several slices of lemon in 1 microwaveable cup of water. Heat on high for three minutes, then let it sit for three minutes. Open up the microwave and wipe clean; the steam loosens any grime and the lemon kills germs and has a pleasant scent.
· Mold and Mildew Remover – Combine two teaspoons of tea tree oil in two cups of water in a spray bottle. Shake to blend and spray on problem areas. Do not rinse. The smell of tea tree oil is very strong, but will dissipate in a few days.
· Furniture Polish – In a glass jar, mix ½ teaspoon olive or jojoba oil with ¼ cup vinegar or fresh lemon juice. Dab a soft rag into the solution and wipe onto wood surfaces to polish.
· Laundry Detergent – Use 1/3 cup washing soda plus 1 ½ cup natural soap flakes. Add ½ cup Borax for whitening and softening. You can reduce the amount of cleaner needed by magnetizing your water using magnetic laundry disks or balls; these rip apart water molecule bonds to create ‘activated’ or ‘structured’ water and make it easier to remove dirt.
· Dryer Sheets – To eliminate static cling, toss a small wet towel into the dryer a few minutes before the end of the cycle.
· Carpet Cleaner – Sprinkle cornstarch on a dry carpet, leave on for five minutes and then vacuum.
Undoubtedly, there are many toxins in the average person’s arsenal of household cleaners. Since the ingredients in many cleaning products put an additional toxic load on the liver, people with Hepatitis C are advised to use cleaners made with non-toxic ingredients whenever possible. Besides buying products devoid of dangerous chemicals, making several of these simple, homemade remedies can help individuals with Hepatitis C keep within a budget, maintain cleanliness and protect their liver.
References:
http://earth911.com/household/household-cleaners/facts-about-
cleaning-products/, Facts About Cleaning Products, Retrieved April 24, 2009, earth911.com.
http://today.msnbc.msn.com/id/26903507//, The Dirty Truth About Cleaning Products, Retrieved April 24, 2009, Microsoft, October 2008.
http://www.alive.com/1271a4a2.php?subject_bread_cramb=598, So Clean, It’s Sickening, Michael Downey, BSc, Retrieved April 24, 2009, Alive Publishing Group, 2009.
http://www.care2.com/greenliving/make-your-own-non-toxic-cleaning-
kit.html, How to Make a Non-Toxic Cleaning Kit, Annie B. Bond, Retrieved April 24, 2009, Care2.com Inc., 2009.
http://www.healthyhepper.com/liverhazzards.htm, Substances that are Harmful (or potentially harmful) to the Liver, Retrieved April 24, 2009, healthyhepper.com, 2009.
http://www.sierraclubgreenhome.com/uncategorized/green-household-
cleaning/, Green Cleaning Supplies, Retrieved April 24, 2009, Sierra Club Green Home, 2009.
Posted by Editors at 12:07 PM --- Printer-friendly version
April 27, 2009
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Learn about the details of a large clinical trial primarily conducted in Australia, that showed when treated early enough, up to 70 percent of those with Hepatitis C can be cured by conventional treatment.
Early treatment for hepatitis C offers a good chance of a cure
Published: Wednesday, 22-Apr-2009
Australian researchers say as many as 70% of hepatitis C carriers can possibly be cured of the disease with early treatment - this is excellent news as hepatitis C, if left untreated can lead to serious liver disease.
Although the hepatitis C virus (HCV) damages the liver, most people with the disease have no symptoms and when symptoms do appear, sometimes decades later, they are often mild and vague and come and go - unfortunately, by this stage the damage may be very serious.
Symptoms if they do appear are often flu-like and last a few weeks or months - they include nausea, vomiting, diarrhea, loss of appetite and fatigue, pain over the liver (on the right side of the abdomen, just under the rib cage), jaundice - where the skin and the whites of the eyes turn yellow, dark-colour urine (like cola or tea) and stools which become pale in colour (greyish or clay coloured).
Chronic hepatitis C can lead to cirrhosis of the liver, a condition usually associated with alcoholism where healthy liver tissue is replaced by fibrous tissue, followed by scarlike hardening and the liver gradually begins to fail, or lose its ability to carry out its normal functions and eventually, symptoms develop.
These symptoms include fluid retention causing swelling of the belly, legs, or whole body, jaundice, fatigue, disturbed sleep, itchy skin, loss of appetite, weight loss, wasting, vomiting with blood in the vomit and mental disturbances such as confusion, lethargy, extreme sleepiness, or hallucinations.
HCV is not related to the other viruses that cause hepatitis, however like the other hepatitis viruses, it is contagious and is transmitted mainly by contact with blood or blood products - the most common mode of transmission is the sharing of contaminated needles among IV drug users.
Transfusion with infected blood or blood products, hemodialysis, or transplantation of organs from infected donors was once a common method of transmission but is now rare as tests now ensure that they are not contaminated.
Less common causes of HCV transmission include from mother to infant at the time of childbirth, through sexual intercourse with an infected person, having multiple sex partners and accidental needle sticks with HCV-contaminated blood.
Hepatitis C is not contracted by living with, being near, or touching someone with the disease but can be passed on by sharing a razor, nail clippers, or other such items with an infected person - in about 10% of people with acute hepatitis C and in about 30% of people with chronic hepatitis C, the source of transmission is unknown.
Treatment includes rest, drinking plenty of fluids to prevent dehydration, a total avoidance of all alcohol and any medicines and substances that can cause harm to the liver such as acetaminophen (Tylenol) and other preparations that contain acetaminophen.
At least 75% of people infected with HCV develop chronic hepatitis, and 30% of these people go on to develop cirrhosis - Hepatitis Australia says more than 200,000 Australians have chronic hepatitis C and more than 278,000 are exposed to the virus, primarily through use of needles with traces of infected blood, but less than 2% of infected people receive treatment.
Chronic liver disease because of hepatitis C causes 10,000 deaths each year in the United States can lead to liver failure and liver cancer - if damage is severe, liver transplantation is the only treatment.
A doctor may prescribe IV fluids for dehydration and drugs to control nausea and vomiting.
The most successful treatment to date in dealing with chronic hepatitis C is called pegylated interferon alpha which is often combined with an antiviral drug called ribavirin (Virazole) and the decision to embark on medication to treat hepatitis C is usually made by a liver specialist (hepatologist), based on the results of lab tests of liver function, on results of tests for HCV and liver biopsy, and on the person's age and general medical condition.
According to Professor Stuart Roberts, director of gastroenterology and hepatology at The Alfred hospital in Melbourne, who led the research, without treatment people would eventually develop serious liver disease and a cure will prevent the development of liver disease.
Professor Roberts says hepatitis C is the main reason for liver transplants in Australia, and the results from a new study shows as many as 70% if sufferers can be cured - the study also showed that the standard combination drug treatment was as effective as a stronger regimen, which caused more serious side effects, in treating HCV.
The Australian-led clinical trial the CHARIOT study involved 702 Australian patients at 33 hospitals across the country and another 194 from New Zealand, Canada, Thailand, Argentina and Mexico - all were suffering from the most difficult type of hepatitis C to treat, hepatitis C genotype 1 - they were treated with a combination of interferon and the antiviral drug ribavarin.
Associate Professor Simone Strasser from the Royal Prince Alfred Hospital in Sydney, says the study was very important because it identified a group of patients who responded much better than expectations, and much better than other studies.
Dr Strasser says they found that patients who had minimal damage on their liver had very high chance of clearing the virus and a seven in 10 chance of actually clearing the infection and this significantly changes the thinking about when is the best time to start treatment.
The researchers say the study shows that early treatment of HCV, before it has caused significant damage to the liver, offers a very high chance of eradicating the virus permanently.
Hepatitis Australia says the results are a breakthrough for sufferers and could also have economic implications as the number of people with advanced liver disease has increased from nearly 36,000 to 47,000 in the last five years and people with Hepatitis C or anyone with risk factors should see a doctor as soon as possible.
Professor Roberts says because the disease often has no symptoms anyone who engaged in risky behaviour or had been treated with blood products prior to 1990 should be tested - he says the CHARIOT research shows that early treatment with a combination of interferon, to slow viral replication, and the antiviral drug ribavarin, was effective and produced a good outcome.
Professor Roberts will present the findings next Saturday at the congress of the European Association for the Study of the Liver, in Copenhagen.
The research is published in the journal Hepatology.
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Dosing has started for a Phase 2b study of Locteron®, an every-other-week, controlled release, interferon alpha-2b medication to treat Hepatitis C.
Biolex Therapeutics Commences Phase 2B Trial of Locteron(R) in Chronic Hepatitis C
Author: Biolex Therapeutics
Category: Press Release
PITTSBORO, NC -- 04/20/09 -- Biolex Therapeutics, Inc. announced today the commencement of patient dosing in the SELECT-2 Phase 2b trial of its lead product candidate Locteron for the treatment of chronic hepatitis C. Locteron, controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the side effects associated with pegylated interferons, the current standard of care, including flu-like symptoms. The Company also announced that the preliminary results of the recently completed United States Phase 2a Locteron trial ("PLUS" trial) will be presented at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) April 24, 2009 in Copenhagen, Denmark.
The Phase 2b trial is being conducted in the United States and Europe in 100 treatment-naïve, genotype-1, chronic hepatitis C patients. Patients will be randomized into one of four dosing cohorts, the 320, 480 or 640 µg dose of Locteron (administered once every two weeks) or a control arm consisting of PEG-Intron® (administered every week), with all patients receiving weight-based ribavirin. Patients will be treated for 48 weeks and will be followed for an additional 24 weeks to determine the sustained virologic response (SVR) rate. The interim results after 12 weeks of treatment are expected to be used as the basis for the selection of the Locteron dose(s) for Phase 3 trials.
"The primary objective of the SELECT-2 Phase 2b trial is to identify one or more doses of Locteron for advancement to Phase 3 trials based on an evaluation of viral response and safety and tolerability, including reductions in flu-like symptoms," said Mr. Jan Turek, Biolex's President and Chief Executive Officer. "We believe Locteron to be a valuable asset as it is the only controlled-release interferon alpha under development, and interferon alpha serves as the current standard of care for hepatitis C and provides the backbone for each of the new anti-viral candidates under development. Market research confirms that there is a substantial commercial opportunity for Locteron if a tolerability advantage is demonstrated in more advanced clinical testing."
Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.
Locteron Overview
Locteron is a controlled-release interferon alpha designed to improve patient care in the treatment of hepatitis C through a more favorable side-effect profile and dosing convenience compared to existing pegylated interferon products. In contrast to Locteron's controlled-release mechanism, the currently approved products, Pegasys® and PEG-Intron®, and the investigational product Albuferon®, are immediate-release products that lack a controlled-release mechanism. Interferon alpha serves as the foundation of current combination therapy for hepatitis C patients, and all major hepatitis C drug candidates currently in clinical trials are being studied in combination with interferon alpha. It is estimated that worldwide sales of interferon products for the treatment of hepatitis C will approach $6 billion by 2016.
Locteron combines BLX-883, a recombinant interferon alpha produced by Biolex in its patented LEX System(SM), with PolyActive®, an advanced controlled-release drug delivery technology developed by OctoPlus N.V. of Leiden, the Netherlands. Locteron is configured to allow dosing once every two weeks, more convenient than Pegasys® and PEG-Intron®, each of which require dosing every week. More importantly, Locteron's controlled-release mechanism results in the gradual release of interferon alpha 2b to patients over the duration of two weeks and avoids the early peak plasma levels of the active interferon that characterize the pegylated interferons and Albuferon. This controlled-release mechanism is designed to reduce the frequency, duration and severity of side effects, including flu-like symptoms, commonly experienced by patients treated with pegylated interferons and with Albuferon. The Company has completed three clinical trials of Locteron, and the results of the SELECT-1 Phase 2a trial were presented at the 43rd Annual Meeting of the European Association for the Study of the Liver in April 2008.
About Biolex Therapeutics
Biolex is a clinical-stage biopharmaceutical company that uses its patented LEX System(SM) to develop hard-to-make therapeutic proteins and to optimize monoclonal antibodies. The LEX System is a novel technology that genetically transforms the aquatic plant Lemna to enable the production of biologic product candidates. The company's product candidates are designed to provide superior efficacy/tolerability profiles and to address large, proven pharmaceutical markets. Biolex's lead product candidate, Locteron®, is in Phase 2b clinical testing for the treatment of chronic hepatitis C. Biolex has also developed two other product candidates that capitalize on the benefits of the LEX System which it is advancing toward clinical trials: BLX-155, a direct-acting thrombolytic designed to dissolve blood clots in patients; and BLX-301, an anti-CD20 antibody it is optimizing for the treatment of non-Hodgkin's B-cell lymphoma and other diseases.
Contacts:
Media:
Michelle Linn
Linnden Communications
508-362-3087
Email Contact
Investors:
Dale Sander
Chief Financial Officer
858-663-6993
Email Contact
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April 21, 2009
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Information about preventing a complication of advanced Hepatitis C infection is now available. Learn why scientists are considering beta blockers to be the best line of defense against bleeding varices, a condition prohibitive of a liver transplant and one that can also be life threatening.
by Nicole Cutler, L.Ac.
In the United States, Hepatitis C is the most prevalent cause of chronic liver disease and the most common reason for a liver transplant. Reserved for those who have run out of options, a liver transplant is the last resort for a person battling the most advanced stages of Hepatitis C infection. For one in need of a liver transplant, many obstacles must be overcome, including preventing bleeding varices.
There are many steps to be taken before a liver transplant can begin. Of the many hurdles leading to this surgery, below are three essential considerations:
1. Risky – A liver transplant is a major operation accompanied by many risks, and is therefore only considered when a person’s liver is no longer capable of sustaining life. Even though it is the most common reason to receive a liver transplant, a majority of Hepatitis C patients experience viral recurrence with their new liver.
2. Donor Matching – Being approved to be a recipient places someone on the donor list, a list that may involve a very long waiting period. Only a select few of those on the list are lucky enough to find an appropriate donor. Even though it is a last resort for those with liver disease, thousands of people are put on a liver donor recipient list every day.
3. Preventing Bleeding Varices – A flare-up of this common advanced liver disease problem will prohibit liver transplant surgery. When waiting for a new liver, one must work with his/her physician to prevent variceal bleeding in order to maintain transplant eligibility.
Bleeding Varices
Varices are dilated blood vessels typically located in the esophagus or stomach. If these vessels rupture and bleed, a dangerous situation is on hand. As a result of fibrosis from advanced liver disease, blood flow is inhibited in the liver. The circulatory inhibition that ensues causes pressure to build up in the vein carrying blood to the liver. Known as portal hypertension, this blood circulation backup causes the vessels to balloon, putting them at risk of rupturing and bleeding. A life-threatening complication of portal hypertension, bleeding from these varices is typically evidenced by blood in the vomit or stool.
Medical Intervention
Because bleeding varices can be a medical emergency, Western medicine relies on a handful of interventions to stop the bleeding. Among those are:
· Banding – By placing small rubber bands directly over the dilated blood vessels, this procedure can stop the bleeding and reduce the vessel’s dilation.
· Sclerotherapy – By injecting the dilated blood vessel with a blood-clotting solution, this method stops dangerous bleeding.
· Stent – By re-routing the blood vessels under pressure, a hollow tube is surgically inserted into the affected vasculature to reduce the high blood pressure.
· Devascularization – This surgical procedure literally removes the bleeding varices. This procedure is done when the other choices are not an option.
Prevention
While stopping the crisis of bleeding varices saves lives, preventing them is just as important. People living with an advanced case of Hepatitis C can benefit from taking prophylactic steps to avoiding a bleeding varices crisis.
According to a study published in the March 2006 edition of the American Journal of Gastroenterology, certain medications offer bleeding varices prevention. The authors concluded that pharmacologic reduction of portal hypertension is associated with a dramatic decrease in the risk of variceal bleeding in cirrhotic patients with esophageal varices.
According to an article published in the September 2007 issue of Liver Transplantation, beta blocker drugs should be the first choice treatment for preventing variceal bleeding in people with cirrhosis and portal hypertension. To compare the safety and efficacy of the two most popular therapies in preventing bleeding varices, banding and the use of beta blockers, Italian researchers conducted a randomized controlled trial among patients awaiting liver transplantation.
The researchers found that, while banding is similarly effective as beta blockers in reducing the incidence of bleeding varices, it can have fatal complications and is more expensive compared with the beta blocker, propranolol. Both propranolol and banding were found to reduce the expected incidence of bleeding by approximately 30 percent after one year. Although some patients in each group experienced adverse events related to their treatment, only banding had a fatal outcome. The authors concluded that although banding should be used when beta blockers are contraindicated, beta blockers should remain the first choice of prophylactic therapy in candidates for liver transplantation.
Even though the complications of portal hypertension must be kept under control to permit a liver transplant, anyone with advanced liver disease should aim for preventing a variceal bleed. Those with Hepatitis C who have advanced to cirrhosis with esophageal or gastric varices must speak with their physician about the best way to prevent a bleeding episode. Although beta blockers may not be the solution for everyone, they can reduce the risk of bleeding varices, a risk most people with liver disease cannot afford to take.
References:
www.clevelandclinic.org, Bleeding Varices, The Cleveland Clinic Department of Patient Education and Health Information, 2007.
www.hivandhepatitis.com, Prevention of Variceal Bleeding in Candidates Awaiting Liver Transplantation, hivandhepatitis.com, September 2007.
www.medscape.com, Long-Term Prophylaxis Can Prevent Variceal Bleeding in Cirrhotic Patients, Reteurs Ltd. 2006.
www.sciencedaily.com, Preventing Variceal Bleeding, John Wiley & Sons, Inc., ScienceDaily LLC, September 2007.
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April 17, 2009
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Already approved in Europe and the United States, Viraferonpeg combination therapy is now approved for re-treating Hepatitis C non-responders in India.
Schering-Plough wins Indian approval for hepatitis C combination therapy
Published:13-April-2009
By Datamonitor staff writer
Viraferonpeg, the pegylated interferon therapy in combination with Rebetol
Schering-Plough's majority owned affiliate in India, Fulford India, has received approval for its Viraferonpeg, the pegylated interferon therapy in combination with Rebetol, for re-treating adult patients with chronic hepatitis C whose prior treatment with interferon alpha and ribavirin combination therapy or interferon alpha monotherapy did not result in a sustained response.
The approval is based on results from the clinical study (EPIC3) in which 1,336 patients with moderate-to- severe fibrosis or cirrhosis who failed previous treatment with combination alpha interferon/ribavirin therapy were retreated with Viraferonpeg combination therapy.
In this study, virological response at week 12 of treatment was shown to be an important predictor for achieving a sustained virological response (SVR), with 57% of patients who had undetectable virus (HCV- RNA) at week 12 going on to achieve SVR with a 48-week course of therapy.
With this local approval in India, Viraferonpeg can now be used for re-treatment of a large and growing number of patients who failed previous hepatitis C (HCV) therapy and are in need of viable treatment options.
Viraferonpeg combination therapy is approved for re-treatment of HCV patients in Europe and US, and is the first pegylated interferon combination therapy to be approved for the re-treatment of chronic hepatitis C by the EU and FDA.
KG Ananthakrishnan, managing director of Fulford India, said: "The approval of Viraferonpeg for the re-treatment of chronic Hepatitis offers hope to millions in India and highlights Schering-Plough's steadfast commitment to ongoing research in the field of virology, with the aim of improving the health and quality of life for patients."
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April 16, 2009
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By investigating co-infection and interferon therapy, two Italian studies look into the future of Hepatitis B and Hepatitis C therapy.
New Studies Examine Elimination Of Hepatitis B And C
ScienceDaily (Apr. 10, 2009) — Two new studies in the April issue of Hepatology explore the ways that hepatitis B virus (HBV) and hepatitis C virus (HCV) can be cleared from patients’ bodies.
Both HBV and HCV are global health problems. They can lead to cirrhosis and liver cancer and they cause millions of deaths each year. Treatments to contain or cure these infections have been difficult to find. Researchers continue to explore potential therapies and the immune system response to the diseases.
The first new study sheds light on the immunological response to coinfection with HBV and HCV. Researchers led by Evangelista Sagnelli of Naples, Italy, report that for patients with chronic HCV, HBV superinfection can lead to clearance of the HCV.
They compared 29 HCV patients to 29 people, matched by age, gender and risk factors, who did not have HCV. All of the patients developed acute HBV during the same time period. The patients with HCV were more likely to have a severe course of illness, and one died of liver failure. However, nearly a quarter (six out of 24) emerged HCV-free.
“Extensive acute hepatocellular necrosis, although life-threatening, may lead to a clearance of chronic HCV infection,” the authors report. Still, the severity of acute HBV in HCV patients raises “the concern that this clinical event could become an emerging health care problem in countries with a wide spread of both HBV and HCV infection,” they write.
“Further efforts should be made to extend the use of HBV vaccination in patients with chronic HCV infection” they also suggest.
The second study, headed by Maurizia Brunetto of Pisa, Italy, recommends interferon-based therapies as a first-line approach for patients with chronic HBV, because these have the best chance of clearing hepatitis B virus surface antigen (HBsAg). The reduction of HBsAg serum levels leading to HBsAg clearance is the hallmark of a newly achieved immune control of the infection by mean of a significant reduction of virus infected hepatocytes.
The researchers retrospectively investigated the relationship between treatment regimens and changing levels of HbsAg in 386 patients in a multinational study.
“Significantly more patients treated with peginterferon alfa-2a (21 percent) or peginterferon alfa-2a plus lamivudine (17 percent) achieved HBsAg levels under 100 IU/mL at the end of treatment compared with lamivudine (1 percent),” they report.
“HBsAg clearance represents the best possible and closest to cure outcome of antiviral therapy in patients with chronic hepatitis B, but is realistic almost exclusively among patients receiving interferon-based regimens, which are recommended as a first-line therapeutic approach,” they conclude. Interferon therapy switches the chronic active hepatitis B patient in the non-active HBV carrier who lose serum HBsAg during the years after the end of therapy. If the case occurs before the development of liver cirrhosis it endows the patient with the same life expectancy of the non-HBV infected subject.
Article: “HBV Superinfection in HCV Chronic Carriers, A Disease That Is Frequently Severe But Associated With the Eradication of HCV.” Sagnelli, Evangelista; Coppola, Nicola; Pisaturo, Mariantonietta; Masiello, Addolorata; Tonziello, Gilda; Sagnelli, Caterina; Messina, Vincenzo; Filippini, Pietro. Hepatology; April 2009.
Article: “Hepatitis B Virus Surface Antigen Levels—A Guide to Sustained Response to Peginterferon Alfa-2a in HBeAg-negative Chronic Hepatitis B.” Brunetto, Maurizia; Moriconi, Francesco; Bonino, Ferruccio; Lau, George; Farci, Patrizia; Yurdaydin, Cihan; Piratvisuth, Teerha; Luo, Kangxian; Yuming, Wang; Hadziyannis, Stephanos; Wolf, Eva; McCloud, Philip; Batria, Richard; Marcellin, Patrick. Hepatology; April 2009.
Journal references:
1. Sagnelli, Evangelista; Coppola, Nicola; Pisaturo, Mariantonietta; Masiello, Addolorata; Tonziello, Gilda; Sagnelli, Caterina; Messina, Vincenzo; Filippini, Pietro. HBV Superinfection in HCV Chronic Carriers, A Disease That Is Frequently Severe But Associated With the Eradication of HCV. Hepatology, April 2009
2. Brunetto, Maurizia; Moriconi, Francesco; Bonino, Ferruccio; Lau, George; Farci, Patrizia; Yurdaydin, Cihan; Piratvisuth, Teerha; Luo, Kangxian; Yuming, Wang; Hadziyannis, Stephanos; Wolf, Eva; McCloud, Philip; Batria, Richard; Marcellin, Patrick. Hepatitis B Virus Surface Antigen Levels -- A Guide to Sustained Response to Peginterferon Alfa-2a in HBeAg-negative Chronic Hepatitis B. Hepatology, April 2009
Adapted from materials provided by Wiley-Blackwell.
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April 7, 2009
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Those with Hepatitis C likely know that their disease can get worse, but may want to know more about the average speed of liver disease progression.
by Nicole Cutler, L.Ac.
Upon receiving a Hepatitis C diagnosis, learning that the virus progressively damages the liver takes center stage. While there is no formula to compute the speed at which Hepatitis C advances in the body, understanding the stages of illness and whether alcohol is consumed can help someone assess where they lie in the scope of their illness.
Accounting for at least 25 percent of all cases of chronic liver disease, chronic Hepatitis C is a progressive condition. Although a significant portion of those infected have no symptoms, normal liver enzymes and normal liver histology, experts believe the virus still progresses – it just does so more slowly than in others. Because of this steady progression, slowing disease progression is a valid goal in chronic Hepatitis C management.
Once a liver is infected with the Hepatitis C virus, it becomes increasingly damaged. A basic progression of liver disease is described below:
· Inflammation – As the liver tries to fight infection, the liver becomes inflamed, tender and enlarged.
· Fibrosis – Known as fibrosis, an inflamed liver will eventually scar. As excess scar tissue grows, it replaces healthy liver tissue, causing a decrease in liver function.
· Cirrhosis – When the liver becomes so scarred that it can no longer heal itself, cirrhosis has occurred.
· Liver Cancer – With a liver struggling to perform its job of processing toxins, the ideal environment for cells to mutate into cancer exists.
· Liver Failure – Once the liver has completely lost its ability to function, the life-threatening condition of liver failure has arrived.
Chronic Hepatitis C progression is typically evaluated in one of three ways:
1. Retrospectively – A retrospective study identifies patients with established infection and correlates their current stage of liver disease to the duration of their infection. A problematic bias of retrospective studies is their inclination to select participants who have sought medical attention due to their symptoms. Because the actual duration of infection in these patients may be underestimated, disease progression approximates may be inaccurate.
2. Prospectively – A prospective study looks at an entire group of people with Hepatitis C from the time they first become infected. These studies typically involve those who received contaminated blood, since their time of viral acquisition can be accurately determined.
3. Retrospectively and Prospectively Combined – Retrospective/prospective studies identify a group of patients who were exposed to Hepatitis C in the past and then follow them prospectively. The advantage of these studies is that there is a head start to the follow-up as compared to a prospective study.
Although the statistics describing Hepatitis C progression are not necessarily straightforward, some generalized assumptions that have resulted from a combination of retrospective, prospective and retrospective/prospective studies include:
· After acquiring the Hepatitis C virus, it takes an average of between 10 to 14 years for biopsy evidence of chronic hepatitis to appear.
· After acquiring the Hepatitis C virus, it takes an average of about 20 years to develop cirrhosis.
· After acquiring the Hepatitis C virus, it takes an average of about 28 years to develop liver cancer.
· About 10 to 25 percent of people with chronic Hepatitis C develop cirrhosis within 10 to 15 years.
· While the overall rate of fibrosis progression in people with Hepatitis C is low, it is increased in those who are older or already have fibrosis as indicated on their index biopsy.
The combined results of dozens of studies confirm that the natural progression of the chronic Hepatitis C virus is slow and, in general, complications develop over decades, not years. Although a timeline for how Hepatitis C evolves covers a wide spectrum, scientists agree on three factors that favor rapid progression of the virus: 1.) alcohol use, 2.) co-infection with another hepatitis virus and 3.) duration of infection. While viral genotypes, co-infection with HIV and gender have been suspected of affecting Hepatitis C progression, these claims lack conclusive evidence.
Understanding how liver disease progresses from inflammation to liver failure confirms the importance of maintaining any healthy liver cells. Thankfully, this progression usually takes many years. If you’ve recently acquired Hepatitis C, this affords plenty of time to protect remaining liver cells. However, if you have been living with Hepatitis C for a long time, the only clear instruction is to completely abstain from alcohol, since it is the only definite route for accelerating Hepatitis C progression.
References:
Ryder, SD, MD, Progression of hepatic fibrosis in patients with hepatitis C: a prospective repeat liver biopsy study, Gut, 2004.
www.brown.edu, Hepatitis C: Epidemiology, Brown University, 2008.
www.medicinenet.com, Hepatitis C, MedicineNet Inc., 2008.
www.medpagetoday.com, Mortality from Hepatitis C-Related Disease at Near-Record High, Michael Smith, MedPage Today LLC, March 2008.
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April 6, 2009
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Sun exposure has health benefits specific to those with Hepatitis C, yet it may be cautioned for those on combination treatment. Knowing about photosensitivity can help you overcome this Catch-22.
by Nicole Cutler, L.Ac.
As one of the many amazing functions we are capable of, the human body can produce Vitamin D simply from its exposure to the sun’s ultraviolet rays. Since researchers have recognized that most people with chronic liver disease have a Vitamin D deficiency, it seems logical that those with chronic Hepatitis C seek opportunities where they can enjoy the sunshine. However, those undergoing treatment for Hepatitis C are at an increased risk of burning from the sun’s rays. Known as photosensitivity, one of the medications used in Hepatitis C combination therapy has been identified as having the potential to heighten sunburn vulnerability.
The Need for Vitamin D
Presented in October 2008 at the 73rd Annual Scientific Meeting of the American College of Gastroenterology, researchers from the University of Tennessee in Memphis measured the vitamin D levels in people with chronic liver disease. Of those evaluated, 85 percent of the study participants had chronic Hepatitis C, and 92.4 percent of those with chronic liver disease had some degree of vitamin D deficiency.
Since Vitamin D can be made in the body from sunshine, this study provides plenty of incentive for those with Hepatitis C to seek sunny destinations. But just as with anything that is seemingly beneficial, there are limits and safety issues associated with upping Vitamin D via the sun or via supplementation. For more information about Vitamin D, consequences of its deficiency and safe amounts to supplement with, read Caution: Hepatitis C and Vitamin D Deficiency.
Photosensitivity
Dozens of medications, both prescription and over-the-counter, can increase a person’s sensitivity to sunlight. Photosensitivity is a well-known side effect that causes some people to:
· burn more easily
· burn more quickly
· get hives or rashes
· have other skin eruptions
While this list is not exhaustive, some commonly used medications listing photosensitivity as a side effect include:
· Antihistamines
· Non-steroidal anti-inflammatories (NSAIDS)
· Antibiotics including tetracylcines and sulfa drugs
· Antidepressants
· Anti-psychotics
· Cardiovascular drugs
· Cancer chemotherapy drugs
· Oral diabetes medications
· Diuretics
· St. John’s wort (herbal remedy for depression)
Ribavirin
Although it is not categorized as a common medication, the antiviral drug ribavirin may cause or enhance photosensitivity. As an integral part of the prescribed treatment for Hepatitis C, some individuals develop a rash from ribavirin – and this side effect can be exacerbated by exposure to intense sunlight or other UV light, such as tanning beds. In addition, consumers are urged to be aware of the greater potential for a photosensitive reaction when combining ribavirin with one of the above listed drugs known for increasing sensitivity to the sun. For those especially sensitive, a photosensitive reaction may also be triggered by indirect sun exposure, such as light reflected off pavement.
Protect Yourself
Although the skin burns or rashes characteristic of photosensitivity can cause pain, itching and misery, combination therapy for Hepatitis C needn’t keep you confined indoors (unless advised by a physician or pharmacist). For the majority of individuals on photosensitive medications, several extra precautions can help prepare for sun exposure.
The following five tips will help you reap Vitamin D from the sun, even if you are on Hepatitis C medications:
1. Avoid prolonged exposure to sunlight during the high intensity hours between 10 a.m. and 4 p.m.
2. Use a broad-spectrum sunscreen with an SPF of at least 15, preferably 30 – which protects against both UVA and UVB rays. Although most sunburns are caused by UVB rays, some photosensitivity reactions are triggered by UVA rays.
3. Use at least one full ounce of sunscreen 30 minutes prior to sun exposure and reapply after swimming or excessive sweating.
4. Wear protective clothing such as wide-brimmed hats, sunglasses and sun-protective clothing such as tightly-woven, long-sleeved shirts and pants or clothes with a high SPF rating.
5. Women who wear makeup should use makeup containing a sunscreen of SPF 15 or higher.
Since those with chronic Hepatitis C are likely low on Vitamin D and sunshine helps produce it, the arrival of warm, sunny weather is especially embraced. However, those being treated with ribavirin must understand the additional photosensitivity risk of sun worshiping. By being reasonable with your sun exposure levels and properly protecting your skin from radiation, Hepatitis C treatment need not stop you from frolicking in the light.
References:
http://drugs.about.com/b/2008/07/18/sunlight-and-your-medications-may-not
-mix-staying-healthy-at-the-beach.htm, Sunlight and Your Medications May Not Mix: Staying Healthy at the Beach, Michael Bihari, MD, Retrieved April 2, 2009, About.com, July 2008.
http://www.eurekalert.org/pub_releases/2008-10/acog-vdd100308.php, Vitamin D deficiency common in patients with IBD, chronic liver disease, Retrieved April 4, 2009, American College of Gastroenterology, October 6, 2008.
http://www.hivandhepatitis.com/doctor/topics/hcv1.html, Questions from Readers and Answers by Medical Experts on Treatment and Care for Chronic Hepatitis C Virus (HCV) Infection, Mack Mitchell, MD, Retrieved April 2, 2009, hivandhepatitis.com, 2009.
http://www.sciencedaily.com/releases/2000/08/000807070850.htm, Medications May Increase Sensitivity To Sunlight, Retrieved April 2, 2009, ScienceDaily LLC, August 2000.
Palmer, Melissa, MD, Dr. Melissa Palmer’s Guide to Hepatitis and Liver Disease, Avery Publications, Revised Edition 2004; 194-195.
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April 1, 2009
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New research demonstrates that a man with Hepatitis C who smokes has a radically greater chance of getting liver cancer than those who steer clear of cigarettes.
by Nicole Cutler, L.Ac.
In order to prevent the worsening of liver disease, those living with chronic Hepatitis C must make the proper lifestyle changes. Since alcoholic drinks are a known liver toxin and have been shown to accelerate liver damage from Hepatitis C, alcohol abstinence is the most obvious change that can positively affect liver health. However, smoking is now believed to be one of the worst things you can do when living with the virus. New research shows that, especially in men, cigarette smoking can dramatically increase the likelihood of Hepatitis C leading to liver cancer.
Liver Disease Progression
Only about half of those infected with the most common type of Hepatitis C in America, genotype 1, can eliminate the virus with the current standard of therapy. Therefore, the remaining half must live with Hepatitis C and hope that the health of their liver does not worsen. Positive lifestyle changes that include alcohol abstinence, quitting smoking, avoiding toxins, eating a healthy diet and regular exercise appear to exert a powerful effect over stopping liver disease from getting worse. When it does advance, liver damage can be progressive and escalates from fibrosis to one of the following final stages of liver disease:
1. Cirrhosis - a worsening of fibrosis, when the liver becomes irreversibly scarred and blood can no longer flow through this organ
2. Liver Cancer - when damage to the liver alters the genes inside the liver's cells, the cells can become cancerous
Smoking and Liver Disease Progression
Because cigarette smoke contains so many toxins and known carcinogens, its cessation has been advised to people with Hepatitis C for many years. However, proof of liver damage from smoking has been slow to accrue. Nonetheless, several previous studies have examined the relationship between Hepatitis C and cigarette smoking:
· A French study published in the January 2003 edition of Gut found that smoking, independent of alcohol, could aggravate the histological activity of chronic Hepatitis C.
· In the June 2006 issue of Clinical Gastroenterology & Hepatology, California researchers found that smokers with chronic Hepatitis C may be more likely than non-smokers to develop liver fibrosis.
Smoking and Liver Cancer
While there has been evidence pointing to cigarette smoke's ability to injure the liver, there is now proof that it increases a man with Hepatitis C's risk for developing liver cancer. Published in the October 2008 edition of the International Journal of Cancer, researchers from Texas investigated smoking and other risky behaviors as risk factors for the most common type of liver cancer, hepatocellular carcinoma (HCC), with men and women who have chronic Hepatitis C. The researchers found the following:
· Differences between men and women were observed in smokers with Hepatitis C who develop HCC.
· Men with Hepatitis C who smoke have a more than 136-fold increased risk of HCC.
· Women with Hepatitis C who consume large amounts of alcohol have a more than 13-fold increased risk of HCC.
The researchers concluded that there appears to be a synergistic link between smoking and Hepatitis C infection in men, leading to a more than 136-fold increased risk of developing HCC. Since increasing the risk of liver cancer by over 100 times is so dramatic, there is no doubt of the evils of cigarettes. So for men with Hepatitis C who have the intent of preventing their liver disease from progressing to cancer, abstaining from smoking cigarettes should lie at the top of their to-do list.
References:
http://www.hcvadvocate.org/news/newsRev/2008/NewsRev-284.html#_
Cigarette_Smoking,_Hepatitis, Cigarette Smoking, Hepatitis C Virus Synergistic in Raising Liver Cancer Risk, Reuters Health, Retrieved November 23, 2008, medscape.com, Hepatitis C Support Project, 2008.
http://www.hivandhepatitis.com/hep_c/news/2006/070706_a.html, Smoking May Worsen Liver Fibrosis in Patients with Hepatitis C, Retrieved November 23, 2008, hivandhepatitis.com, July 2006.
http://www.medicinenet.com/script/main/art.asp?articlekey=18104, Smoking With Liver Disease - A No-No, Jay W. Marks, MD, Retrieved November 23, 2008, MedicineNet Inc., 2008.
http://www.ncbi.nlm.nih.gov/sites/entrez, Effect of different types of smoking and synergism with hepatitis C virus on risk of hepatocellular carcinoma in American men and women: case-control study, Hassan MM, et al, Retrieved November 23, 2008, International Journal of Cancer, October 2008.
http://www.ncbi.nlm.nih.gov/sites/entrez, Impact of smoking on histological liver lesions in chronic hepatitis C, Hezode C, et al, Retrieved November 23, 2008, Gut, January 2003.
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