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November 29, 2004
Sho-saiko-to Clinical Study Results for Hepatitis C
The following report concerns a study done with Hepatitis C patients who underwent interferon therapy and are classified "non-responders" to interferon. This means they have no other choices of treatment in the medical mainstream.
The results of this Sho-saiko-to study are only preliminary. This is just the first ten of thirty two patients.
The fact that Memorial Sloan-Kettering Cancer Center is conducting this research is very encouraging. Clearly, they bring quite a bit of scientific credibility to this study.
Anti inflammatory and anti viral activity were clearly suggested by the outcomes.
The fact that two of the ten patients had a statistically relevant improvement in biopsy scores is quite impressive. It was not long ago that doctors considered fibrosis non-reversible unless the underlying cause was removed.
Incidentally, for more information about Sho-saiko-to can be found at here.
Initial Results Reported in Clinical Study of Honso Sho-saiko-to -H09- for Hepatitis C
Sunday November 28, 11:55 pm ET
Data Presented at the First Annual Society of Integrative Oncology Conference New York
PHOENIX--(BUSINESS WIRE)--Nov. 28, 2004--A Japanese herbal product, Sho-saiko-to (H09), is under a clinical phase II trial by Memorial Sloan-Kettering Cancer Center to determine its effect on hepatitis C patients. The preliminary results of the trial have been reported at the 1st Annual Society of Integrative Oncology Conference in New York on Nov. 18, 2004. The testing herbal product, Honso® Sho-saiko-to (H09), is manufactured and supplied by Honso Pharmaceutical Co. Ltd., headquartered in Nagoya, Japan, and branched in Phoenix.
Chronic hepatitis C is associated with significant morbidity (liver cirrhosis and hepatocellular carcinoma) and mortality. Current treatment is based on interferon and ribavirin. However, treatment options are limited for patients who are not candidates for interferon-based therapy. This study is titled "Sho-saiko-to for Patients with Chronic Hepatitis C Who Are Intolerant to Or Have Contraindication to Interferon-Based Therapy: A Phase II Study."
Sho-saiko-to has been demonstrated in anti-fibrotic effect by inhibition of lipid peroxidation in hepatocytes and stellate cells in animal studies. It has also been shown to reduce aminotransferase levels and the incidence of hepatocellular carcinoma in hepatitis and liver cirrhosis patients.
According to the design of the clinical trial, a total of 31 patients will receive Sho-saiko-to (H09) granules at 2.5 grams three times daily for 52 weeks.
Ten patients have already completed the treatment and the preliminary results have been reported. No serious adverse events have been attributed to Sho-saiko-to (H09) among all patients who enrolled in the trial.
Among the 10 patients who completed the study, reductions in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were observed in eight patients, and reduction of viral load was observed in four out of seven detectable patients. This suggests anti-inflammatory and anti-viral activity.
Liver biopsy response is defined as decrease in Knodell score of 2 points or more after the treatment in a blind fashion by an expert pathologist. The histologic responses were observed in two of the 10 patients who completed the study. This suggests anti-fibrotic effect in chronic hepatitis C patients.
Japanese herbal medicine also known as Kampo is part of the East Asian Chinese medicine tradition. Kampo is fundamentally a clinical system based on the classical medical literature dating back to the Han Dynasty in ancient China. In Japan today, fully 75% of physicians use at least some of the traditional Kampo formulas. In the United States, full strength Sho-saiko-to (H09) is available in granules or a lesser strength formula can be found in tablet form as Liver Kampo to consumers.
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November 27, 2004
Another Biopsy Alternative For Hepatitis C Patients
It seems doctors all want to do biopsies for liver patients, especially with Hepatitis C. In order to undergo interferon therapy doctors insist on a biopsy first.
Until recently there was no other way to get an exact measurement of fibrosis progression. We have already reported on a few blood tests that are currently approved for measuring fibrosis instead of undergoing a biopsy. One is Fibrospect and another is FibroTest.
Now, there is a report of yet another way to assess fibrosis without sticking a needle through your abdomen and into your liver.
This is great news for hemopheliacs and those of us who prefer to avoid the possible negative side effects of a biopsy (bleeding into the abdomen, liver damage, etc.).
Non-invasive Assessment of Liver Fibrosis by Liver Stiffness Measurement (LSM) in HCV Patients
Despite limitations such as sampling error and risks of complications, liver biopsy remains the gold standard for assessment of liver fibrosis. Among alternative non invasive methods, LSM based on transient elastography appears promising.
The purpose of this study was to investigate in comparison with histological staging in patients with chronic hepatitis C (CHC) focusing on patients with the largest liver biopsy samples.
French researchers prospectively included 327 patients with CHC who underwent both liver biopsy and LSM in four centers. LSM was performed with the FibroScan (Echosens Co, Paris, France) a non invasive device measuring liver stiffness in a volume of parenchyma of about 1,5 cm3.
In order to minimize the bias of histological evaluation, fibrosis stage was assessed according to METAVIR classification by two experienced pathologists. Moreover, biopsies were selected to have at least ten portal tracts or obvious cirrhosis.
The studied population was then split into two groups according to the biopsy sample length: biopsy sample larger than the median size (18 mm for F01, F2 and F3 patients and 13 mm for F4 patients) were considered separately.
Taking into account the whole studied population, LSM was significantly correlated with fibrosis stage (Kendall tau beta coefficient of correlation: 0.55, p < 0.0001) and the area under the ROC curves was 0.79 for F ≥ 2, 0.91 for F ≥ 3 and 0.97 for F = 4. These values were even improved when only the largest biopsies were considered: 0.81 for F ≥ 2, 0.95 for F ≥ 3 and 0.99 for F = 4.
The authors conclude, “LSM is a reliable, non invasive method for the evaluation of liver fibrosis in patients with CHC. The volume of liver parenchyma explored obviates the risk of sampling error present in liver biopsy.”
11/24/04
Reference
M Ziol and others. NON INVASIVE ASSESSMENT OF LIVER FIBROSIS BY LIVER STIFFNESS MEASUREMENT (LSM) IN PATIENTS WITH CHRONIC HEPATITIS C (CHC): THE IMPORTANCE OF SAMPLING. Abstract 263 (poster). 55th AASLD. October 29-November 2, 2004. Boston, MA.
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November 23, 2004
Hepatitis C and Quality of Life
The following article is about quality of life issues with Hepatitis C patients.
It is our opinion that anyone who knows they have a chronic and potentially deadly disease is going to have a negatively affected quality of life. Fear, anxiety, concerns about debilitating illness and mortality all take a toll on a persons outlook on life.
People infected prior to age 25, as well as male gender, seem to be the only factors that predicted a lesser impact on quality of life for Hepatitis C patients.
To make the leap of logic in the conclusion of this report that even those with little or no liver damage should consider anti viral therapy left us a bit incredulous. What pharmaceutical company funded this study, anyway?
Did the authors not consider the impact of interferon therapy on QoL (at least during therapy)? And, what of the other important factors, like a 30% success rate for genotype 1? Shouldn't that figure into the equation?
Food for thought, no?
The Quality of Life Among Patients with Chronic Hepatitis C in Relation to Host and Viral Factors
There is increasing evidence for impaired Quality of life (QoL) in patients with hepatitis C virus (HCV) infection even in the absence of liver disease. The aim of the study was to discriminate the role of viral and host factors in regard to QoL.
A cohort of 630 patients initially recruited in 1996/1997 in eight European Hepatology Centers to analyse epidemiology and immunogenetics of HCV infection were followed in 2002/2003. All patients answered an SF-36 questionnaire for the assessment of their QoL.
Two summary scores were analysed: the Physical Component Score (PCS) and the Mental Component Score (MCS). These patients are representative of what is usually seen in clinical practice since no restriction was made at inclusion.
Results
Patients with sustained virological response showed significantly better QoL than patients with either relapse or non-response (p<0.001 and p=0.001, for MCS and PCS respectively), even when limited to patients with only minimal fibrosis (F<2), p=0.001 for PCS.
An association was also found with age at infection and sex. Patients younger than 25 years at infection and males showed better PCS (p<0.001 and p=0.008) and MCS (p=0.063 and p=0.002), respectively.
None of the HLA alleles tested showed any association with QoL. Likewise genotype 1a vs. 1b or genotype 1 vs. non-1 had no significant relevance.
Conclusion
The authors conclude, “The better quality of life in patients with sustained virological response indicates that antiviral therapy might even be indicated in the absence of any liver disease.”
11/22/04
Reference
H L Tillmann and others (for the HENCORE group). QUALITY OF LIFE IN HEPATITIS C PATIENTS IN RELATION TO HOST AND VIRAL FACTORS. Abstract 1207 (poster). 55th AASLD. October 29-November 2, 2004. Boston, MA.
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November 22, 2004
Hepatitis C Treatment Progress?
The following announcement from Rigel Pharmaceuticals is disappointing. It is another step closer to a more effective treatment, but, on its own, it shows no breakthrough. In fact, the treatment needs to be rethought because of its minimal effectiveness.
Well, at least it seems safe.
Some of the most interesting information in pharmaceutical company announcements is regarding hepatitis C itself and the state of current treatment. Look at the "About Hepatitis C" section of the report. It clearly points out the shortcomings of current interferon combination therapy.
If you are currently considering therapy, you may want to share this with your doctor, to help keep the limited effectiveness and serious dangers of combination therapy in perspective.
Poor Bioavailability Results in Insignificant Clinical Effects for Rigel R803 in Phase I/II HCV Trial
Monday November 22, 5:00 am ET
Next Steps for Clinical Program to be Outlined at Analyst Day, December 1st
SOUTH SAN FRANCISCO, Calif., Nov. 22 /PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL - News) announced today the results from its Phase I/II clinical study of R803, a novel oral hepatitis C RNA polymerase inhibitor. The two-center, double-blind, dose-escalation study examined the safety and pharmacokinetics of R803 and its effectiveness in reducing viral levels in 32 patients infected with Hepatitis C Virus (HCV). The results demonstrated that R803 was well-tolerated and that there were no significant adverse effects. The study showed that the drug was only present in the blood stream at sufficient levels for a limited number of hours during the course of each dosing day. There was a decline in viral levels over the course of treatment and viral levels rose after dosing was discontinued. However, the decline in viral levels was not statistically significant or clinically meaningful. Rigel has continued to develop better delivery approaches of R803, such as a pro-drug of R803, and derivatives of R803 that it believes exhibit superior bioavailability. These potential improvements and next steps in the Rigel HCV clinical program will be discussed at Rigel's analyst day meeting in New York City on December 1, 2004.
"These results, although disappointing, have provided us with very useful clinical information on the improvements necessary to achieve significant results in HCV infection." said James M. Gower, chairman and CEO, Rigel Pharmaceuticals. "We have learned a great deal about how R803 is metabolized and its bioavailability. While viral loads were not meaningfully reduced, we believe that with an R803 pro-drug or derivatives the pharmacokinetics and drug exposure could be improved. We believe we have identified drug candidates with improved bioavailability and good anti-viral activity for our HCV program. We will be studying these issues in detail over the next several weeks before deciding on our future clinical direction."
R803 Phase I/II Clinical Trial Design
The study was a 32 patient Phase I/II randomized, placebo-controlled, double-blind multiple, dose escalation study, which took place in Miami and New Orleans. The objectives of the study were to evaluate the safety and pharmacokinetics of R803 in patients with HCV and to explore the effectiveness of R803 in reducing viral levels. Patients were divided into eight groups, with each group receiving an increasing dose or increasing number of days of treatment. Subjects were dosed for two to four days, plus the morning dose on the following day. HCV viral RNA levels were measured multiple time levels following the administration of R803.
About Hepatitis C
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. As the most common blood-borne infection in the U.S., HCV affects 4 million Americans and 170 million individuals worldwide. It is estimated that this difficult-to-treat disease, with 6 genotypes and no vaccine, will dramatically increase in prevalence. The disease is caused by an infection of hepatic cells by an RNA virus of the Flavivirus family. Approximately 85 percent of those with acute illness will go on to develop chronic hepatitis, a condition that has been linked to cirrhosis, hepatocellular carcinoma (liver cancer) and liver failure. HCV accounts for 30 percent of end-stage liver disease and liver cancer and is the leading cause of liver failure, which can result in the need for liver transplantation.
Current HCV Treatments and Market Opportunity
Currently available HCV therapies are only modestly effective at treating the disease. The most prevalent treatment regimen is with pegylated interferon alpha (IFN), usually in combination with ribavarin. IFN shows only an approximate 40 percent success rate in patients who complete therapy, and significant side effects result in up to half the patients either quitting treatment or moving to a lower dose regimen. Moreover, IFN is least effective against HCV genotype 1, the strain responsible for 70 percent of chronic HCV infection cases in the U.S. Rigel believes that its approach is substantially different than that of IFN: instead of working to boost the immune system, experiments indicate that its HCV compounds directly, rapidly, and selectively target HCV by interfering with a viral polymerase protein that is needed for replication. With the current high prevalence and projected increase in cases of HCV and related diseases, and with the limited success of currently available therapies, Rigel believes that the potential for new direct HCV therapeutics is large.
About Rigel (www.rigel.com)
Rigel's mission is to become a source of novel, small-molecule drugs to address large, unmet medical needs. We have initiated four development programs: asthma/allergy, hepatitis C, rheumatoid arthritis and oncology. Rigel has begun clinical testing of its first two product candidates, R112 for allergic rhinitis, which has completed a Phase II clinical trial, and R803 for hepatitis C, as discussed in this release. We expect to begin clinical trials of R406 for the treatment of rheumatoid arthritis by the end of 2004, to be followed by the anticipated initiation of clinical trials with additional product candidates for indications in oncology and asthma.
Information on the webcast of Rigel's analyst day presentation on December 1, 2004 is available on Rigel's website: www.rigel.com
Forward Looking Statements
This press release contains "forward-looking" statements, including statements related to Rigel's plans to evaluate alternative delivery approaches for R803 and derivatives of R803 and the potential efficacy thereof, the clinical development of product candidates and the timing thereof and the potential efficacy of product candidates. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "will," "plans," "intends," "expects" and similar expressions are intended to identify these forward-looking statements. There are a number of important factors that could cause Rigel's results to differ materially from those indicated by these forward-looking statements, including the risks associated with the timing and success of clinical trials and the commercialization of product candidates, as well as other risks detailed from time to time in Rigel's SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2004. Rigel does not undertake any obligation to update forward-looking statements.
Source: Rigel Pharmaceuticals, Inc.
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November 17, 2004
Hepatitis C and Fatigue
We have long noted the number one complaint of chronic Hepatitis C patients is fatigue. The following study, presented at the latest AASLD conference in Boston, verifies this observation.
Currently there is no real medical solution to the fatigue felt by Hepatitis c patients. The best natural fatigue intervention we have seen, to date, is Fatigue Relief Plus.
If you can relate to the information in this study, perhaps you should consider giving Fatigue Relief Plus a try. It has worked for others, it very well may work for you.
Sleep and Fatigue in Patients with Chronic Hepatitis C
Fatigue and disordered sleep have been shown to affect quality of life in patients with chronic illnesses. The purpose of this study was to evaluate fatigue and sleeping behavior reported by patients with Chronic Hepatitis C (CHC).
Subjects completed the Fatigue Severity Scale (FSS) resulting in a total average fatigue score derived from 9 Likert type scale items assessing disabling fatigue (range 1-7). Subjective sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI) in which a global score (ranging from 0-21) and 7 component scores were derived. In both cases a high score indicated more severe complaints.
Subjects were 59 CHC patients attending UCSD Adult Liver Clinics who completed both the FSS and PSQI questionnaires. CHC patients were 49% males, 57.6% Caucasian, 35.6% Latino, and 3.4% African-American. Mean age and education were 51.9 ± 9.18 and 12.4 ± 3.31 years respectively. 24 patients were non-cirrhotic, 31 were cirrhotic (Child-Turcotte-Pugh Score A=16, B=11, C=3, 1-unknown), and 4 were unknown. No patients were receiving antiviral therapy at the time of assessment.
Results
The mean FSS score was 4.69 ± 1.88 indicating greater fatigue than past reports of normal healthy adults (2.3) and patients with CHC (3.8). The mean PSQI global score was 8.97 ± 5.38.
64.4% of the patients were found to be ‘poor sleepers’ as defined by a global PSQI score of > 5. There was no significant difference between males and females on both measures.
Significant correlations were found between the FSS score and the global PSQI score (r=0.58, p < 0.01), and with 6 of the PSQI component scores: subjective sleep quality (r=0.46, p < 0.01), sleep latency (r=0.39, p < 0.01), sleep duration (r=0.26, p = 0.05), habitual sleep efficiency (r=0.44, p < 0.01), sleep disturbances (r=0.62, p < 0.01), and daytime dysfunction (r=0.65, p < 0.01).
There were no significant differences between cirrhotic and non-cirrhotic patients on the FSS and PSQI global score. Poor sleepers were 51.6% and 75% of the cirrhotic and non-cirrhotic patients respectively (p=0.10). Non-cirrhotic patients showed greater use of sleeping medications when compared to cirrhotic patients (p < 0.01).
Weekly use of sleeping medications was reported in 33% of non-cirrhotic versus 9.7% of cirrhotic patients.
In conclusion, the authors write:
(1) Patients with CHC suffer from poor quality of sleep regardless of their stage of liver disease.
(2) Fatigue is significantly correlated to poor sleep quality.
11/17/04
Reference
M 55th AASLD. October 29-November 2, 2004. Boston, MA.Carlson and others. SLEEP AND FATIGUE IN PATIENTS WITH CHRONIC HEPATITIS C. Abstract 19 (poster).
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Complementary Treatment Usage Among Hepatitis C Patients
The following article is about a survey presented at the American Association for the Study of Liver Diseases(AASLD) conference.
The survey found that nearly 60% of Hepatitis C patients use Alternative and or Complementary Therapies. Given the low success rate and high level of side effects with current accepted medical therapy, this result should not be surprising.
Also, more doctors are learning about and appreciating the beneficial effects of natural therapies for liver support and protection. Especially milk thistle. This is why Maximum Milk Thistle is still our number one recommendation for people with liver concerns.
Complementary and Alternative Treatments: A Survey of People Living with Hepatitis C
The objective of the present study was to provide quantitative measures of the prevalence, patterns, reasons for use and perceived benefits from complementary therapies (CAM) among individuals with hepatitis C (HCV).
A self-administered questionnaire was given to 300 HCV patients attending a community-based outpatient clinic at Vancouver Hospital. The questionnaire included 19 questions regarding demographics, conventional treatments received, specific CAM therapies used, reasons for use, perceived benefit, disclosure to physician and utilization of CAM information resources.
Data was entered into SPSS 10.0 and analyzed primarily for descriptives including frequencies and summary measures.
Users of CAM and non-users were compared by demographics (age, gender, marital status, education, employment status and ethnicity) and medical (time since diagnosis, type of conventional treatment) characteristics.
Contingency analysis between CAM use and potential determinants was performed to select variables to be included in modeling. A multiple logistic regression analysis including all the significant independent variables was then conducted to determine the strongest independent predictors of CAM use.
Results
Fifty-nine percent of patients used CAM therapies with the most common being the herbal supplement milk thistle, exercise, and multivitamins.
The most common reasons given for choosing to use CAM therapies were to
(1) Improve quality of life,
(2) Boost the immune system, and
(3) Slow disease progression.
Most patients felt that CAM therapies had improved their energy levels, reduced stress, and gave them a sense of control over the illness whereas only 43.9% felt that CAM therapies improved liver function.
The majority of those using CAM (81%) had told their physician(s) about their CAM use, but few utilized either their family physician (15%) or their specialist (7%) as sources of CAM information.
CAM users most commonly consulted friends or family (39%) for information about CAM.
CAM users were more likely than nonusers to delay or decline conventional treatment.
Respondents who had never used CAM had typically never thought about it or did not have enough information about the treatments.
Conclusions
Based on their study results, the authors conclude, “More than one half of recently diagnosed HCV patients utilize some form of CAM therapy, and the majority, disclose their use to their physician(s). However, they tend to rely on anecdotal information for their CAM decision-making.
“Dissemination of reliable CAM information is one key to helping patients navigate this difficult arena.
11/08/04
Reference
A L Mulkins and others. COMPLEMENTARY AND ALTERNATIVE MEDICINE: A SURVEY FOR PEOPLE DIAGNOSED WITH HEPATITIS C. Abstract 418 (poster). 55th AASLD. October 29-November 2, 2004. Boston, MA.
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November 11, 2004
New Treatment From Vertex in Trials
Here is another new treatment in testing for Hepatitis C. The pharmaceutical companies are scrambling to develop more effective treatments than those currently available.
With hundreds of millions of Hepatitis C patients around the world, the drug companies see a gold mine in developing treatments.
It may be greed-driven but it still offers real hope to Hepatitis patients everywhere.
Vertex begins phase Ib hepatitis C trial
Global biotech firm Vertex Pharmaceuticals (NASDAQ: VRTX - news) , a small-molecule drugs developer, has initiated a phase Ib clinical trial for its investigational oral protease inhibitor for the treatment of hepatitis C infection.
Global biotech firm Vertex Pharmaceuticals, a small-molecule drugs developer, has initiated a phase Ib clinical trial for its investigational oral protease inhibitor for the treatment of hepatitis C infection.
The double-blind, placebo-controlled study will evaluate the tolerability, pharmacokinetics and viral kinetics of multiple, ascending doses of VX-950 over a period of up to 14 days and will enroll approximately 60 subjects. This is the first reported initiation of a study that involves 14 days of administration of a hepatitis C virus (HCV) protease inhibitor in patients with chronic hepatitis C infection.
The clinical study will first assess healthy volunteers receiving multiple doses of VX-950 for a five-day period. Following this initial assessment, the study will evaluate three different doses of VX-950 in HCV patients, over 14 days of treatment in serially configured dose groups.
Pre-clinical studies have shown that VX-950 significantly reduces levels of HCV RNA in both an in vitro replicon system and infectious virus assays. In the phase Ia clinical study, VX-950 was well-tolerated and demonstrated oral bioavailability.
Furthermore, combined clinical and pre-clinical pharmacokinetic results indicate that VX-950 can be administered in a dose regimen that may achieve liver concentrations substantially greater than target concentrations (IC50 and IC90 in non-clinical studies).
"The phase Ib study is expected to provide us with important information on the ability of VX-950 to reduce viral load, which we expect will help to define the potential clinical impact of this new class of drugs," said Dr John Alam, senior vice president of drug evaluation and approval at Vertex.
Vertex anticipates that the phase Ib study will be completed in the first half of 2005.
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November 01, 2004
Pegasys Better Than PegIntron?
From the following article it seems there is a real advantage for Hepatitis c patients to choose Pegasys from Roche over PegIntron from Schering. The higher early response rates are encouraging. Of course, this is still comparing the best of two treatements that are considered by most people to be inadequate.
If one is deciding to undergo treatment for Hepatitis c, however, it is helpful to know that one choice might be better than another. Even if the difference is miniscule, any positive difference is important.
Bear in mind, this is just one study. Most researchers would not find this conclusive, just instructive.
If I were to choose to undergo interferon treatment for Hepatitis c (NOT currently on my list of things to do seeing as the success rate for genotype 1 is so miserably low) I would probably choose Pegasys for other reasons (I think Roche's patient support is better, for one). This recent information only reinforces the preference.
Drug Combination Shows Promise in Treating Hepatitis C
ST. LOUIS--October 30, 2004 -- Interim study results indicate a certain drug combination treatment may suppress the hepatitis C virus more quickly than another.
Researchers at Saint Louis University School of Medicine and six other research sites throughout the country found that combining the drug Pegasys® with ribavirin resulted in a greater reduction in hepatitis C viral levels than patients treated with Peg-Intron® and an equal dose of ribavirin.
Pegasys and Peg-Intron are types of pegylated alpha interferon--which is a longer lasting version of interferon, a naturally produced substance in the body that triggers the immune system. Combining these drugs with ribavirin enhances their efficacy and is the standard treatment for hepatitis C.
"It looks as though Pegasys is more potent during the early phase of treatment, which is critical for patients with chronic hepatitis C," said Adrian M. Di Bisceglie, M.D., professor of internal medicine in Saint Louis University School of Medicine's division of gastroenterology and hepatology, and the study's lead investigator. "It's critical because if patients are going to respond to treatment, it will happen during the first 12 weeks of care. Eight weeks into this trial we noticed lower viral levels in patients on the combination of Pegasys and ribavirin."
This is one of the first head-to-head studies in the United States comparing Pegasys and Peg-Intron when each are combined with equal doses of ribavirin. Pegasys is the most recent form of pegylated alpha interferon approved by the Food and Drug Administration (2002).
Di Bisceglie helped design the study and evaluate the preliminary results.
Di Bisceglie will present his findings at the 55th annual meeting of the American Association for the Study of Liver Diseases in Boston on Oct. 29.
Di Bisceglie said the ultimate goal of therapy is to clear patients of the blood-borne virus or have levels drop so low as to be undetectable. While the Pegasys results are positive, Di Bisceglie cautioned it is too soon to draw conclusions. The 12-week trial is still under way.
"Studies such as this one give us insight into how these drugs work and it might allow us to design better drugs in the future," said Dr. Di Bisceglie, one of the top liver disease experts in the world.
About 4 million Americans carry antibodies to the infection, which means they have been exposed to hepatitis C. Of that group, about 70 percent actually have the virus and will become symptomatic. The symptoms at first may be subtle: fatigue, abdominal discomfort, general malaise. While carriers ignore or misinterpret symptoms, the virus is eating away at their livers. If left undetected or untreated, chronic hepatitis C irrevocably damages the liver and a transplant may be necessary. Saint Louis University School of Medicine has one of the largest hepatitis C treatment and research programs in the country.
Source: Saint Louis University
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