Research & Treatment News
October 27, 2004
Printer-friendly version
The following report covers a recent letter sent to pharmaceutical companies by activists demanding a price freeze for HIV and HCV medications. The fact that AIDS activists have picked up the cause of Hepatitis C patients is a very positive development.
The Hepatitis c patient community has been marginalized and stigmatized by the mainstream press reports that the majority of chronic Hepatitis c patients have contracted the disease by intravenous drug use. There have also been very few spokespeople/activists representing the Hepatitis c patient community.
It is good to see a voice is emerging in defense of Hepatitis c patients.
Activists Demand Permanent Price Freeze on AIDS and Hepatitis C Medications
AIDS activists issued a strong letter to the CEOs of seven major pharmaceutical companies demanding a price freeze in the United States for medications used to treat AIDS and hepatitis C. The letter, addressed to the CEOs of each company and signed by 200 AIDS service organizations, hospitals, faith-based groups, and HIV provider groups across the country, opens with a strong call to action: “the time has come for a drastic change in your company’s drug pricing practices in the United States.”
The letter points to continuing company pricing practices that have resulted in mammoth profits, in the face of soaring health insurance premiums and decreased funding for lifesaving HIV/AIDS medications for people who cannot otherwise afford them.
New York,(PRWEB) October 20, 2004 - In a stunning move today, AIDS activists issued a strong letter to the CEOs of seven major pharmaceutical companies demanding a price freeze in the United States for medications used to treat AIDS and hepatitis C. The letter, addressed to the CEOs of each company and signed by 200 AIDS service organizations, hospitals, faith-based groups, and HIV provider groups across the country, opens with a strong call to action: “the time has come for a drastic change in your company’s drug pricing practices in the United States.” Citing price increases since 2003 that range from 4.8% to 400%, the AIDS Treatment Activists Coalition (ATAC) points to continuing company pricing practices that have resulted in mammoth profits, in the face of soaring health insurance premiums and decreased funding for lifesaving HIV/AIDS medications for people who cannot otherwise afford them.
"Why are newer, ‘second-generation’ drugs approved just 6 months ago increasing in price by 5% or more? Why should the price of a drug approved in 1996, which has netted millions in profits, suddenly increase by 400%?” asked Jen Curry, an ATAC member, who works on drug development and pricing policy. SAVE ADAP (the AIDS Drug Assistance Program) member and co-author of the letter, Lei Chou commented: “Companies charge obscenely high prices for medications in the US, and then they continue to increase their profit margin each year by taking 4% to 6% price increases, or in some cases 10% increases, on these drugs. These price increases are largely invisible, but have profound cumulative impact on programs like Medicaid and ADAP. This is an abuse of free enterprise and an inequity that unnecessarily burdens healthcare consumers."
HIV-treating physician Ben Young, who represents an organization of HIV healthcare providers, said “This is an important attempt to be proactive. The time has come for pharmaceutical companies to exercise corporate responsibility in their drug pricing policies.” Signed by several investment corporations, as well as faith-based AIDS groups and ministries across the country, this letter represents a broad coalition effort on behalf of people living with HIV/AIDS, and the organizations, doctors, hospitals, and ministries that serve them.
This letter should not come as a surprise to these companies, noted Anne Donnelly, Director of Public Policy at Project Inform in San Francisco. “Several of them have negotiated price freezes in the past with groups like the Fair Pricing Coalition, but agreements have been temporary and limited to single payers. In the past two years, we’ve seen freezes expire and a decreased capacity for programs like Medicaid, ADAP, prisons, and other public payers to absorb the costs.”
Indeed, the letter points out that when people with AIDS and hepatitis C cannot access the benefit of therapy, they eventually become sick with life-threatening illnesses, further burdening the public healthcare system. In the last couple of years, members of the HIV community across the US have died while on waiting lists to receive publicly funded medications. Activists fear that the death toll will rise as the number of people unable to access lifesaving medication grows.
They also say that growing numbers of uninsured individuals in the US and the soaring costs of health insurance are in part a result of the reckless pricing policies of pharmaceutical companies. The letter demands immediate price freezes on medications to treat AIDS and hepatitis C, a disease afflicting as many as a third of people living with AIDS. A notable exception to the demand is the clear request that two companies, Abbott and Roche, reduce the price of their respective drugs Norvir and Fuzeon, which activists say are so exorbitantly priced.
The AIDS Treatment Activists Coalition (www.atac-usa.org) is a national coalition of AIDS activists, many living with HIV/AIDS, working together to end the AIDS epidemic by advancing research on HIV/AIDS. The price freeze letter is currently available online at www.atac-usa.org/price.html#ceo.
Posted by Ralph at 11:02 AM --- Printer-friendly version
October 24, 2004
Printer-friendly version
Perhaps the most telling part of the following announcment is the acknowledgment of the fact that genotype is one of the key factors in determining current treatment success rates. And the most common genotype for 70% of people is also the most resistant to current treatment.
Of course, if Schering can show that longer treatment gives a higher success rate then they can sell more Pegintron plus Rebetol. Be sure to note that they are not concurrently checking to see what effect sustained use of their product might have on the patient with regard to side-effects. Not a surprising fact, but still noteworthy.
The second study being initiated is to determine whether or not Schering's product could help people that the Roche product could not. Schering has nothing to lose on this one. If their product doesn't help, it is no worse a result than Roche's. If it does work they can claim superiority (and also sell a lot more product to those who did not respond to Pegasys).
Also noteworthy is the fact that according to Professor Stefan Zeuzem, M.D. the therapeutic goal of the medical community is "eradication of the virus". This is in spite of the fact that 70-80% of people will never face life threatening ramifications from chronic Hepatitis c. Instead of finding ways to protect and support the liver and immune system until a more viable (and less toxic) treatment is found, the medical community is intent on "eradication" at almost any cost. Could it be because there is less money in fortification than there is in pharmaceutical treatment? I don't know, what do you think?
Schering-Plough Initiates Two Major Hepatitis C Studies With PegIntron(R) Plus Rebetol(R) Combination Therapy
BRUSSELS, October 22 /PRNewswire/ --
- International Clinical Trials To Assess PegIntron in Patients with Unmet Medical Needs
Schering-Plough announced today that it is initiating two large international clinical trials to evaluate the use of PegIntron(R) (peginterferon alfa-2b) and Rebetol(R) (ribavirin) combination therapy in patients chronically infected with hepatitis C virus (HCV) genotype 1 who have specific unmet medical needs.
The first study will involve patients identified as "slow" responders to HCV therapy; the second study will involve patients who were non-responders to previous treatment with Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) (Hoffmann-La Roche, Inc.) combination therapy. Currently, there are no approved products for treating these patient populations.
"We have made great advances over the past decade in the effective treatment of chronic hepatitis C, one of the most common blood borne infections in the world," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "Still, specific patient populations with difficult-to-treat forms of the disease remain resistant to therapy and need improved treatment options. Schering-Plough is undertaking these studies because it is critical to develop new strategies for improving treatment outcomes for these patients."
Of the six distinct known hepatitis C genotypes, HCV genotype 1 is the most common worldwide (about 70% of patients). It is considered the most difficult-to-treat strain of the virus and is associated with higher resistance to treatment (lower response rates) when compared with HCV genotypes 2 and 3.
Adjusting Treatment Duration for "Slow" Responders
Schering-Plough is sponsoring the SUCCESS trial: "A Study to Assess Treatment with PegIntron and Rebetol in Naïve Patients with Genotype 1 Chronic Hepatitis C and Slow Virological Response," that will evaluate whether extending treatment to 72 weeks instead of the standard 48 weeks will improve efficacy in genotype 1 chronic hepatitis C patients who respond slowly to treatment. Slow responders are defined as those patients who still have detectable virus levels after 12 weeks of treatment (PCR positive), but do show a significant (2 log10) drop in viral load. Such patients may ultimately achieve undetectable virus levels (PCR negative) between weeks 12 and 24, and may benefit from a longer overall course of therapy (72 weeks) than the current recommended duration of 48 weeks.
This prospective, controlled, randomized, parallel-group multicenter study is expected to enroll 1,200 previously untreated patients with chronic hepatitis C at more than 100 sites in Europe, Eastern Europe, Israel and Canada. The study hypothesis is that patients who become HCV-RNA negative (achieve undetectable levels of the virus) between treatment weeks 12 and 24 (slow responders) may need a longer period with undetectable virus to successfully clear the virus and ultimately achieve a sustained virologic response (SVR). SVR is defined as having undetectable virus 24 weeks after completing therapy. In the study, patients who achieve a late response to therapy (as measured at week 24) will be randomized at the end of 48 weeks of therapy with 1:1 ratio to either stop treatment or extend the trial to 72 weeks.
"Success in treating patients with chronic hepatitis C depends on a number of factors, with genotype considered one of the most important predictors for achieving sustained virologic response," said Professor Maria Buti Ferret, M.D., co-lead investigator of the study with Professor Rafael Esteban Mur, M.D., both of Vall d'Hebron Hospital, Barcelona, Spain. "We know from previous clinical studies that patients with HCV genotype 2 or 3 can achieve SVR with shorter 24-week courses of treatment. Conversely, this study will help us to determine if a longer 72-week course of PegIntron and Rebetol benefits those patients with difficult-to-treat genotype 1 who are slow to respond."
PegIntron plus Rebetol in Non-Responders to Pegasys plus Ribavirin
In the ESPECIAL trial: "Efficacy and Safety of PegIntron plus Rebetol in Subjects with Chronic Hepatitis C Genotype 1 Non-Responder to Pegasys plus Ribavirin," patients infected with HCV genotype 1 who did not respond or relapsed following an initial course of treatment with Pegasys (180 mcg/wk) plus Copegus (1,000/1,200 mg/day) will be treated with weight-based PegIntron (1.5 mcg/kg/wk) plus Rebetol (800-1,400 mg/day) combination therapy for 48 weeks. This international multicenter clinical trial will involve 200 patients.
"The therapeutic goal of treatment for chronic hepatitis C is the eradication of the virus with a halt in the progression of the disease," said Professor Stefan Zeuzem, M.D., Saarland University, Homburg, Germany, and lead investigator of the study. "We need effective alternatives for the sizable number of patients who did not clear the virus with initial treatment. PegIntron and Pegasys are different drugs, with different pharmacokinetic and pharmacodynamic properties. Patients who did not respond or relapsed to Pegasys plus Copegus may respond to PegIntron plus Rebetol," he said.
The primary endpoint of the study will be the proportion of patients who have achieved sustained virological response (SVR) at 24 weeks after the end of treatment. Secondary endpoints of the study include early virological response (EVR), defined as undetectable virus levels (PCR negative) at week 12 of treatment; the response rate at the end of 48 weeks of treatment (EOT); and sustained virological response (SVR) rates based on subject weight, viral load, presence of cirrhosis, insulin resistance status and creatinine clearance status.
The SUCCESS and ESPECIAL trials are consistent with Schering-Plough's research strategy to conduct and support clinical studies with weight-based PegIntron and Rebetol combination therapy in hepatitis patients with unmet medical needs, particularly for better efficacy in patients with difficult-to-treat forms of the disease such as HCV genotype 1, the most common genotype worldwide.
About PegIntron and Rebetol Combination Therapy
PegIntron and Rebetol combination therapy for chronic hepatitis C was approved in the European Union (EU) in March 2001, and is indicated in naïve patients as well as in patients who have previously responded to interferon alpha monotherapy but who have subsequently relapsed. PegIntron is indicated in the EU as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C. The recommended dose in the EU for combination therapy is PegIntron 1.5 mcg/kg once weekly plus Rebetol 800-1,200 mg daily, adjusted to body weight.
PegIntron, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy dosed according to patient body weight that is designed to achieve an effective balance between antiviral activity and elimination half-life. Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity.
Chronic hepatitis C is estimated to affect more than 10 million people in major world markets. In Europe, chronic hepatitis C is a leading cause of chronic liver disease and one of the most common reasons for liver transplant.
Schering-Plough Europe, based in Brussels, Belgium, is part of Schering-Plough Corporation (NYSE: SGP) of Kenilworth, N.J., USA.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., USA, and its Web site is http://www.schering-plough.com.
Posted by Ralph at 7:23 PM --- Printer-friendly version
October 22, 2004
Printer-friendly version
The following release is interesting but, unfortunately, not very detailed. The researchers give no numbers to put their findings into perspective. I'll try to help.
In 1991, 15 people per 100,000 were likely to contract NHL. If HCV patients are 6 times more likely to contract NHL then that means 90 HCV patients out of 100,000 might contract NHL.
90 people out of 100,000 (or about one in a thousand) is certainly no cause for panic, but instead something HCV patients and their doctors should be aware of.
SEATTLE--Patients infected with the hepatitis C virus (HCV) are six times as likely to develop non-Hodgkin's lymphoma (NHL) than individuals that are virus free, according to research presented today at the Third Annual Frontiers in Cancer Prevention Research meeting.
HCV infected patients have a seventeen fold higher risk for developing diffuse large B-Cell lymphoma, researchers from British Columbia documented. Diffuse large B-cell lymphoma is the most common variety of NHL, comprising approximately 30 percent of all NHL patients.
Compared to Europe and Japan, incidence of hepatitis C viral infection is fairly low in North America, and previous studies from Canada and the United States have not shown an association between the virus and development of NHL, said Ms Agnes Lai, lead author for the research. The British Columbia study examined HCV status in 550 NHL cases and 205 population controls. The study had the strength of numbers of patients to ascertain an association between HCV and NHL, confirming the viral-cancer link suspected in studies from other areas of the world where the virus is more prevalent.
"People who have been exposed to the virus comprise a high risk group for developing non-Hodgkin's lymphoma, particularly diffuse b-cell lymphoma," said John Spinelli, a cancer researcher from the British Columbia Cancer Agency, Vancouver, BC, and principal investigator of the research study.
The spread of hepatitis C in the United States has dropped significantly since the 1980s. Currently, the number of new cases per year is around 25,000. Approximately 3.8 million Americans have been infected with the virus. The most common means of infection in the past was blood transfusion, and in recent years is among drug users who share needles.
Approximately 53,000 patients were diagnosed with NHL in the United States in 2003. There were 23,000 deaths from the disease that year.
Spinelli and Lai conducted their research with colleagues Randy Gascoyne, Joseph Connors, Pat Lee, Rozmin Janoo-Galani, and Richard Gallagher, BC Cancer Agency; Anton Andonov, Health Canada National Microbiology Laboratories, Winnipeg, Manitoba, and Darrel Cook, British Columbia Centre for Disease Control.
Posted by Ralph at 2:44 PM --- Printer-friendly version
October 19, 2004
Printer-friendly version
According to this article, retreatment is not a very viable strategy in most cases of a failed first attempt to eradicate the virus with interferon therapy. This repeat approach only seems somewhat successful with people who were not treated with combination therapy to begin with.
It seems only some of those who received monotherapy (before the combo was developed) really have any chance of success with this subsequent combo treatment. And, only if they are not genotype 1, have a low viral load, do not have cirrhosis.
Reading between the lines here also reinforces our belief that the success rates being tossed about by doctors are misleading. This article states that nearly half do not respond. If this includes all genotypes then the higher rate for genotype 2 (supposedly around 80%) is clearly being reduced by the lower rate for genotype 1 (supposedly around 50% but more likely less than 30% to arrive at the "nearly half" statement). With 70% of the US chronic Hepatitis C having genotype 1, this is significant.
Retreatment of Non-Responders
Despite improvements in the treatment of chronic hepatitis C virus (HCV) infection, nearly half of all patients do not respond to initial therapy.
Retreatment of these patients with pegylated interferon and ribavirin has been successful in only a limited percentage of cases.
Factors associated with sustained virologic response (SVR) following retreatment include prior treatment with interferon monotherapy, HCV genotype 2 or 3, a low serum HCV RNA level, and the absence of cirrhosis.
Fewer than 6% of nonresponders who were previously treated with interferon and ribavirin and who have cirrhosis, genotype 1, and a high viral load achieve SVR following retreatment with pegylated interferon and ribavirin.
No therapy has been shown to yield SVR in patients who do not respond to pegylated interferon and ribavirin.
Long-term maintenance therapy with pegylated interferon is currently being evaluated in nonresponders with advanced fibrosis and cirrhosis. Its use should be considered investigational at this time.
Hepatology Section, Virginia Commonwealth University Medical Center, Richmond, VA.
10/18/04
Reference
M L Shiffman. Retreatment of patients who do not respond to initial therapy for chronic hepatitis C. Cleveland Clinical Journal of Medicine 71 (Suppl 3): S13-16. May 2004.
Posted by Ralph at 12:06 PM --- Printer-friendly version
October 18, 2004
Printer-friendly version
Are you confused about what viral load actually indicates regarding Hepatitis C? One of the most common misconceptions among Hepatitis C patients I speak with is that a higher viral load indicates a greater severity of the disease. This leads many to conclude that if their viral load is high they are in much more serious trouble than if it was low.
The study referenced at the bottom of this email finds that there is absolutely no correlation between viral load and the severity or progression of Hepatitis C.
It has previously been shown, in numerous studies, that lower viral load responds better to current interferon therapies. Doctors, therefore, often believe that people with higher viral load have a more serious condition---just because they are not good candidates for interferon.
High viral load does not, however, indicate that these patients have any more to worry about than anyone else with Hepatitis c.
In fact, I have spoken with people who have a viral load below 200,000 who could not get out of bed because of their physical reaction to the disease, as well as people in the tens of millions who feel just fine.
It seems, then, that viral load levels are only relevant as an indicator of possible interferon treatment success or when used to track treatment progress while trying to achieve a sustained virilogic response with interferon---NOT as an indicator of disease severity.
Incidentally, regardless of your viral load, Maximum Milk Thistle helps protect your liver 8 to 10x more effectively than any standardized milk thistle product. If you are taking any other milk thistle, you are not getting near the protection and support you should be. Go to MaximumMilkThistle.com for more info.
Is There a Correlation Between HCV Viral Load and Severity of Liver Disease?
The significance of hepatitis C virus (HCV) serum titers (HCV viral load) has been examined in several clinical situations. There is much evidence that patients with a lower viral load have better response rates to anti-viral therapy compared to those with higher levels.
Moreover, a direct association has been observed between serum titers of HCV and transmission rates of the virus.
The aim of the present study was to determine if there was any correlation between HCV viral load and the severity of liver disease.
Fifty patients with HCV infection were included in the study. These comprised of 34 subjects with a history of alcohol use and 16 non-alcoholics.
Quantitative serum HCV RNA assay was carried out using the branched DNA (bDNA) technique. Linear regression analysis was performed between serum viral titers and liver tests.
In addition, for the purpose of comparison, the subjects were divided into two groups: those with low viral titers (<=50 genome mEq/mL) and high titers (>50 mEq/mL).
Results
All subjects were men, with a mean+/-SD age of 47+/-7.8 years. The mean HCV RNA level in the blood was 76.3X10(5)+/-109.1 genome equivalents/mL.
There was no correlation between HCV RNA levels and age of the patients (r = 0.181), and the history or amount (g/d) of alcohol consumption (r = 0.07).
Furthermore, no correlation was observed between serum HCV RNA levels and the severity of liver disease as judged by the values of serum albumin (r = 0.175), bilirubin (r = 0.217), ALT (r = 0.06) and AST (r = 0.004) levels.
Similarly, no significant difference was observed between patients with low viral titers and high titers with respect to any of the parameters.
Conclusion
The authors conclude, “Our results indicate that the severity of liver disease is independent of serum levels of hepatitis C virus. These findings are important since they have a direct impact on the current debate regarding the role of direct cytopathic effect of hepatitis C virus versus immune-mediated injury in the pathogenesis of HCV-related liver damage.”
Digestive Diseases Section (111D), VA Medical Center, 2002 Holcombe Blvd. Houston, Texas.
Reference
B S Anand and M Velez. Assessment of correlation between serum titers of hepatitis c virus and severity of liver disease. World Journal of Gastroenterology 10(16):2409-12411. August 15, 2004.
Posted by Ralph at 3:54 PM --- Printer-friendly version
Printer-friendly version
One of the most frequent questions I hear from newly diagnosed Hepatitis c patients is whether or not they could pass this disease on to their loved ones through sexual intercourse. I am also frequently contacted by people in relationship with Hepatitis c patients. They have heard the disease was sexually transmitted and are afraid of contracting it themselves.
There has been much confusion and misinformation about this subject out there. Even the Centers for Disease Control (CDC) website states that sexual transmission is possible (although unlikely).
This new study (cited below) basically proves once and for all that there is no real risk of sexual transmission as long as blood to blood contact is avoided. This is good news, and it also points to the wisdom of staying up to date with emerging knowledge about hepatitis C. More is being discovered and clarified about this disease on an ongoing basis. Even the smallest of these discoveries can directly impact our lives as hepatitis c patients.
Incidenally, this finding does not mean you should be cavalier or nonchalant about the fact you have this infectious and potentially deadly disease. Sharing toothbrushes or razor blades are still considered risky activities. And high risk sexual behavior that might cause any blood to blood contact is to be rigorously avoided. To be safe, be sensible.
No Evidence of Sexual Transmission of Hepatitis C among Monogamous Couples: Results of a 10-Year Prospective Study
The risk of sexual transmission of hepatitis C virus (HCV) infection was evaluated among 895 monogamous heterosexual partners of HCV chronically infected individuals in a long-term prospective study, which provided a follow-up period of 8,060 person-years. Seven hundred and seventy-six (86.7%) spouses were followed for 10 yr, corresponding to 7,760 person-years of observation.
One hundred and nineteen (13.3%) spouses (69 whose infected partners cleared the virus following treatment and 50 who ended their relationship or were lost at follow-up) contributed an additional 300 person-years.
All couples denied practicing anal intercourse or sex during menstruation, as well as condom use. The average weekly rate of sexual intercourse was 1.8.
Three HCV infections were observed during follow-up corresponding to an incidence rate of 0.37 per 1,000 person-years. However, the infecting HCV genotype in one spouse (2a) was different from that of the partner (1b), clearly excluding sexual transmission.
The remaining two couples had concordant genotypes, but sequence analysis of the NS5b region of the HCV genome, coupled with phylogenetic analysis showed that the corresponding partners carried different viral isolates, again excluding the possibility of intra-spousal transmission of HCV.
The authors conclude, “Our data indicate that the risk of sexual transmission of HCV within heterosexual monogamous couples is extremely low or even null. No general recommendations for condom use seem required for individuals in monogamous partnerships with HCV-infected partners.”
Posted by Ralph at 10:22 AM --- Printer-friendly version
October 11, 2004
Printer-friendly version
The following report caught my eye for several reasons. First of all, I am surprised this study was even reported seeing as it is only about one patient. Apparently, the results are still significant.
Secondly, 76 months of treatment is a LONG time (over six years, to be exact). I can't help wondering what this treatment cost and if it would be covered by medical insurance if and when approved.
Third, I was really intrigued with the fact that this form of interferon is apparently closer to that found in nature.
And, finally, the fact that there were no substantial negative effects/side-effects from the therapy. Step by step, inch by inch, we make progress...
Highly Purified Natural Interferon Alfa (Multiferon) Could Be an Alternative Therapy in Difficult-to-treat HCV Patients
A currently 65-year-old patient with histologically proven chronic hepatitis C and chronic hepatitis B (seroconversion in 1990) and additional compensated cirrhosis of the liver (Child A) achieved sustained complete biochemical and viral response following 5 and 14 months respectively of therapy with highly purified natural leukocyte interferon-alfa (3 x 3 MU weekly, nIFN-alfa, Multiferon).
Prior to this treatment, various other therapy approaches including recombinant interferon-alfa-2b (rIFN-alfa-2b) or a combination of natural interferon-beta (nIFN-beta) and interferon-gamma (rIFN-gamma) had been carried out. Unfortunately, these had been unsuccessful.
After a total treatment period of 76 months with nIFN-alfa and a subsequent follow-up period of 30 months, no relapse of chronic hepatitis C occurred.
In conclusion, the authors write, "The patient's tolerance of the treatment was excellent and no substantial drug-related adverse events were observed. nIFN-alfa, which - unlike the recombinant IFN-alfa-2b preparations - is a mixture of various physiologically expressed IFN-alpha subtypes, could possibly be an alternative in the treatment of difficult-to-treat patients with chronic hepatitis C, according to German researchers."
Department of General Internal Medicine, Marienhospital Bottrop gGmbH, Germany.
Reference E Musch and others. Successful application of highly purified natural interferon alpha (multiferon) in a chronic hepatitis C patient resistant to preceding treatment approaches. Hepatogastroenterology 51(59): 1476-1479.
Posted by Ralph at 1:39 PM --- Printer-friendly version
October 9, 2004
Printer-friendly version
Blood Tests Provide Alternative to Liver Biopsy
A while back I wrote about a biopsy alternative called Fibrospect.
Here is yet another blood test based alternative that has been used successfully in Europe for a couple of years and is now available in the USA. While biopsies are not considered dangerous, they are not without risk. To have a dependable, non-invasive alternative is valuable.
Your gastro may not have the latest information always available to them so it could be helpful for you to bring this up for discussion if a liver biopsy is recommended.
Blood Tests Provide Alternative to Liver Biopsy for Assessing Status of Liver Disease in HCV Patients
Oneida TheraDiagnostics Ltd has launched two non-invasive blood tests for assessing the extent of liver disease in patients infected with hepatitis C virus (HCV). Developed by hepatologists at the Pitie-Salpetriere Hospital and BioPredictive in France, the two tests are called FibroTest and ActiTest.
The new tests provide easily accessible alternatives to liver biopsy, which is currently used to assess liver fibrosis and necroinflammatory activity in these patients. The tests do not replace the use of liver biopsy, however, which may be the appropriate diagnostic in many cases. Whether to use these new blood tests instead of a liver biopsy should be discussed between each individual patient and his/her primary care physician or liver specialist.
Although liver biopsy has long been considered the gold standard for monitoring the status of HCV and to determine therapy options, it is an invasive procedure that carries some risk of serious complications. The new assays use a combination of six serum biochemical markers, plus age and gender data, in a patented algorithm to determine the degree of liver fibrosis and the level of ongoing necroinflammatory activity.
The tests have been available in parts of Europe for the past two years and have recently been launched in the USA. Each test has been clinically validated in HCV patients to enable quantitative, reproducible assessment of fibrogenic and necrotic activity in the livers of HCV patients.
Oneida TheraDiagnostics Ltd. is a recently established company based in the UK offering molecular diagnostic services for clinical studies with particular emphasis on viral disease.
“Our intention is to establish a world-class portfolio of molecular diagnostics that will facilitate individual patient management and clinical trial studies performed in the UK and Ireland. The tests launched today are very well validated and address one of the major challenges in patients with chronic viral hepatitis. They will be the cornerstone of our viral hepatitis diagnostic service,” said Berwyn Clarke, CEO at Oneida.
FibroTest and ActiTest may be recommended by physicians for use in assessing liver status following a diagnosis of HCV. This provides a baseline determination of liver status before the initiation of HCV therapy and a post-treatment assessment of liver status six months after the completion of therapy.
The tests can also be applied for the non-invasive assessment of liver status in patients at risk of complications from a liver biopsy. The blood sample for the tests can be collected in minutes and results normally returned to the doctor within days.
Source
Oneida TheraDiagnostics. www.oneidathd.co.uk “Validated blood tests provide new alternative to liver biopsy for assessing status of liver disease in hepatitis C patients.” Press Release. October 8, 2004.
Posted by Ralph at 1:35 PM --- Printer-friendly version
October 5, 2004
Printer-friendly version
More Effective Interferon Dosing For HCV Genotype 1
This new trial result is very revealing. Especially given the fact that 70% of chronic Hepatitis c patients in the USA have genotype 1. Note the success rates (along with the failure rates). Apparently with this "improved" method of dosing they got up to 41%. and the drop out rate was only 19%. Now take a closer look at the rates they compare against. These are for the currently accepted standard dosing.
What happened to the 50% success rate that doctors keep talking about? 29% is much lower than that. And look the drop out rate. This is something that is seldom mentioned. 31% discontinue with current therapy because it is intolerable? Wow! So, only a 41% success rate after 31% drop out. Hmmm...
I'm no mathematician, but the final result for people who started the therapy and actually finished successfully seems like it is reduced by 31% first and THEN it's a 41% success rate of those left. Isn't that actually a much lower success rate than 41%?
If you are genotype 1, like me, it seems like these are very important numbers to be armed with when speaking with your doctor about current medical treatment options.
An Induction Dose of Peginterferon Is a More Effective and Better-tolerated Treatment for Patients with Genotype 1 Than Combination Therapy with High Dose Standard Interferon
In this randomized, controlled, multicenter trial, researchers assessed the effectiveness and safety of an induction dose of peginterferon alfa-2b/ PEG-IFN (Peg-Intron) plus ribavirin for initial treatment of patients with genotype 1 chronic HCV infection.
Three hundred and eleven naïve patients infected with genotype 1 and chronic hepatitis were randomly assigned to 48-week treatment with PEG-IFN once weekly (80–100 μg depending on body weight for 8 weeks, followed by 50 μg for the next 40 weeks), or standard interferon alfa-2b/ IFN (Intron A) 6 million units on alternate days, both in combination with ribavirin (1000–1200 mg/day).
Results
PEG-IFN plus ribavirin significantly increased sustained virological response (SVR) compared with IFN plus ribavirin (41.1 vs. 29.3% respectively, P=0.030). Fewer patients discontinued PEG-IFN than IFN (19 vs. 31%, P=0.010).
By logistic regression, SVR in the PEG-IFN group was independently associated with age less than 50 years, and mild fibrosis at liver biopsy.
Conclusions
Combination therapy with an induction dose of PEG-IFN was a more effective and better-tolerated treatment for treatment-naïve patients with genotype 1 than combination therapy with high dose standard IFN.
In patients aged less than 50 years with mild fibrosis, this schedule achieves a very high rate of SVR.
10-08-04
Reference
S Bruno and others. Peginterferon alfa-2b plus ribavirin for naïve patients with genotype 1 chronic hepatitis C: a randomized controlled trial. Journal of Hepatology 41(3): 474-481. September 2004.
Posted by Ralph at 1:20 PM --- Printer-friendly version
October 1, 2004
Printer-friendly version
From PhamaBiz.com we have a release about Hep C Awareness day.
What I find ironic is that the first notice I saw about this actually came on October 1. What good is an awareness day if nobody knows about it. The World Health Organization needs to do a better job getting the word out, don't you think?
Hepatitis support groups and activists here in the states could have really done something with this, if they only knew!
October 1 to be observed as world Hepatitis-C awareness day
Friday, October 01, 2004 10:00 IST
With the objective of educating people about hepatitis C, October 1 will be observed as the world Hepatitis-C awareness day by the WHO.
In India alone, it is estimated that 1.09 crore people have chronic hepatitis C. National trends indicate a sizeable concentration of hepatitis C cases in North Eastern India. Among the metros, 4 lakh Delhiites are suffering from Hepatitis C and Mumbai accounts for 3 lakh cases. Gujarat also carries a patient load of 3.37 lakh.
The objective of the World Hepatitis-C awareness day is to draw the attention of people towards a virus that has emerged as a major global healthcare problem, infecting approximately three per cent of the world's population.
Every year the number of people infected with the Hepatitis C virus (HCV) increases by 30-40 lakh worldwide, adding to the 17 crore people already infected. The spurt in number is primarily attributed to low awareness about the disease.
"Today, new therapies have been shown to successfully treat between to 50 to 80 per cent of people infected with Hep C. Currently Roche offers Pegylated Interferon Alpha 2A (40KD)," said Dr. G. L. Telang, Managing Director, Roche Scientific Company India Pvt. Ltd.
About Hepatitis C
Hepatitis C is a blood-born viral infection of the liver that was first identified only in 1989. Few people realise that they are infected as the symptoms are non-specific (such as fatigue) and people tend to become aware when their disease is quite advanced. Transmission by blood products has been reduced to almost zero due to screening for the virus so today the most common route of transmission is use of unsterilised needles (such as those used in tattooing and by intravenous drug users) and syringes.
Hepatitis C is the most infectious virus having 50 per cent chronicity and is responsible for large number of patients affected with cirrhosis. If not treated early may require liver transplant or may further develop to liver cancer.
If 100 people became infected with hepatitis C, approximately 25 people would be able to clear the virus without any medication within six months of being infected. The majority, however (the other 75 people), would develop ongoing (called "chronic") infection that will require medication to help get rid of it. Some people will unfortunately not know they are infected and will develop damage to their liver before the infection is diagnosed. Untreated, hepatitis C can lead to cirrhosis (scarring of the liver) or liver cancer and some may require a liver transplant
Posted by Ralph at 1:14 PM --- Printer-friendly version
Printer-friendly version
What Is the Best Treatment for Chronic Hepatitis C?
The treatment of hepatitis C is expensive, difficult and arduous from the patient's perspective. It is similarly difficult for the clinician to decide who and when to treat.
What Is the Best Treatment for Chronic Hepatitis C?
By JF Dillon, MD
The treatment of hepatitis C is expensive, difficult and arduous from the patient's perspective. It is similarly difficult for the clinician to decide who and when to treat.
If hepatitis C is viewed from the liver's perspective, we need only treat those patients who will develop the complications of chronic liver disease within their lifetimes. If we take a more holistic approach, then we have to consider the implications of being a carrier of a potentially transmissible blood borne virus on the patient themselves, their relationships, their families and their sense of well-being.
There is now evidence of the large impact HCV has on quality of life and we have to consider extra hepatic manifestations of hepatitis C infection, possibly including the syndrome of brain fog recently described.
An additional factor that has to be considered in the decision to treat is whether patients perceive hepatitis C as a significant problem for themselves.
For some patients, who have chaotic live styles, it is extremely difficult to get them to access healthcare. To then undergo the rigors and tribulations of hepatitis C therapy that is posing no current problem is unlikely to succeed.
However, failure to engage these patients with therapy will lead to a significant proportion of them presenting with serious complications of chronic liver disease, with its attendant mortality, morbidity and cost.
Underlying all these considerations is the tension between the costs of therapy and the benefits of therapy.
The author concludes, Good arguments can be made in terms of cost-effectiveness for treating patients with a high likelihood of progressing to chronic liver disease and its complications. These arguments become much less persuasive when all patients are concerned.
Department of Digestive Diseases and Clinical Nutrition, Ninewells Hospital and Medical School, Dundee, UK.
09/20/04
Reference
J F Dillon. What is the best treatment for Chronic Hepatitis C? Journal of Viral Hepatitis 11 Suppl 1:23-27. September 2004.
Posted by Ralph at 12:44 PM --- Printer-friendly version