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January 27, 2005
HCV Market Analysis Redux
Here is another press release regarding the state of the market for Hepatitis B and C treatment. The press release is about the industry report available from Research and Markets, an industry research organization. It is the same report referenced by DataMonitor in my January 12th update.
Incidentally, the price of this report is $15,200.
Please note, this report states that "the needs of non-responders, genotype 1 and intolerant patients will not be satisfied in the short term." It also suggests that the pharmaceutical companies look to "tap into a substantial amount of unidentified cases or meet the needs of non-responder or difficult to treat patients.
Press ReleaseSource: Research and Markets
Hepatitis B and C - Winning Battles But Not The War
Thursday January 27, 8:01 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Jan. 27, 2005--Research and Markets (http://www.researchandmarkets.com/reports/c12272) has announced the addition of Stakeholder Insight: Hepatitis B & C - Winning Battles But Not The War to their offering
According to the WHO, 350-400 million are chronically infected with HBV and 170-200 million with HCV. Although HBV vaccination and routine screening of donated blood has decreased incidence, the death toll resulting from chronic disease, cirrhosis and HCC is as high as one million per year (WHO, 2002). For HCV related conditions, this number will increase further over the next 10-20 years.
Despite substantial prevalence for both HBV and HCV, the incidence of new infections within the seven major markets has reduced over the last decade due to HBV vaccination, increased blood and pre-natal screening along with awareness campaigns regarding routes of transmission. Our recent physician survey indicates that while diagnosis rates of HBV have remained flat since 2002, HCV diagnosis rates have increased 2-4 fold, with highest growth in Japan
Increased uptake and aggressive life-cycle management of peginterferons (plus ribavirin) have driven the current standard of care to 73% of first-line choice for HCV. Our physician research (180 respondents) reveals higher use of branded peginterferon plus ribavirin packages, where consistency was cited as key selection criterium. Again, the treated patient pool will be increased by higher diagnosis, redefinition of 'normal' ALT and maintenance therapy. However, the needs of non-responders, genotype 1 and intolerant patients will not be satisfied in the short term.
Scope of Report
• Comprehensive overview of HBV and HCV epidemiology with comment on latest dynamics
• Analysis of drug treatment choice per line therapy per region for both HBV and HCV
• Discussion with key opinion leaders with regard to clinical and non-clinical attributes of therapy
• Future outlook for new HBV and HCV therapies along with unmet needs assessment
Highlights
• While diagnosis rates of HBV have remained flat since 2002, HCV diagnosis rates have increased 2-4 fold with highest growth in Japan.
• Based on current estimates of prevalence, diagnosis and treatment current patient pools of between 1.8-2.0 million per disease.
• To increase the treatment pool, manufacturers of hepatitis treatments can either tap into a substantial amount of unidentified cases or meet the needs of non-responder or difficult to treat patients.
Posted by Ralph at 12:14 PM --- Printer-friendly version | Comments (0)
Caffeine, HCV and Liver Health
The following report is of interest because I've heard for many years that liver patients need to abstain from caffeine consumption. To be honest, I've consistently included about a cup a day in my diet (along with a pot of green tea and lots of water).
This article makes me feel better, still, about my choice. I never thought of it as being therapeutic, I just figured that one cup would not do much damage (if any).
Even though it is only one study, this is a fairly large study.
Incidentally, I do not drink any alcohol at all anymore. It is common knowledge that alcohol is a potent liver toxin. In fact, it is used in a medical procedure to kill small liver cancer tumors. They actually inject alcohol into the specific site of the tumor because alcohol is such and effective and efficient liver cell killer.
Coffee and Caffeine Consumption Reduce the Risk of Elevated Serum Alanine Aminotransferase Levels
Based on experimental and epidemiologic studies, researchers at the National Institute of Diabetes and Digestive and Kidney Diseases investigated whether coffee and caffeine consumption reduced the risk of elevated alanine aminotransferase (ALT) activity in persons at high risk for liver injury in a national, population-based study.
Participants were 5,944 adults in the Third US National Health and Nutrition Examination Survey, 1988–1994, with excessive alcohol consumption, viral hepatitis, iron overload, overweight, or impaired glucose metabolism.
Liver injury was indicated by abnormal serum ALT activity (>43 U/L).
Results
Elevated ALT activity was found in 8.7% of this high-risk population.
In unadjusted analysis, lower ALT activity was associated with increasing consumption of coffee (P = .001) and caffeine (P = .001). Multivariate logistic regression analyses showed that the risk of elevated ALT activity declined with increasing intake of coffee (P for trend = .034) and caffeine (P < .001).
Comparing persons who drank more than 2 cups per day with non coffee drinkers, the odds ratio was .56 (95% confidence interval, .31–1.0). Comparing persons in the highest caffeine quintile with the lowest, the odds ratio was .31 (95% confidence interval, .16–.61).
These relationships were consistent across subgroups at risk for liver injury and were relatively unchanged when analyses included the entire population or when limited to persons without impaired liver function or right upper quadrant pain.
Fasting insulin concentrations did not mediate the effects.
In conclusion, the authors write, “In this large, national, population-based study, among persons at high risk for liver injury, consumption of coffee and especially caffeine was associated with lower risk of elevated ALT activity.”
This study was supported by a contract from the National Institute of Diabetes and Digestive and Kidney Diseases.
01/21/05
Reference
C E Ruhl and J E Everhart. Coffee and caffeine consumption reduce the risk of elevated serum alanine aminotransferase activity in the United States. Gastroenterology 128(1): 24-32. January 2005.
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January 24, 2005
Magic Bullet For Hepatitis C?
The following article from the Forbes magazine website is very informative.
The fact that Vertex is so far along with their protease inhibtor is very exciting. As is the sheer number of companies working on their own Hepatitis C treatment.
Given the potential size of this market (pegged at $4 billion by 2009) it is no wonder that pharmaceutical companies are falling all over themselves (and each other) to develop a more viable treatment than currently exists.
I have felt for quite a while that the protease inhibitors were a development to watch. This article gives more more information to illustrate why that is so.
Magic Bullet For Hepatitis CScott Gottlieb, M.D., Forbes/Gottlieb Medical Technology Investor, 01.24.05, 10:23 AM ET
When I was a resident in medicine, there was a virus that frightened doctors who had to handle needles and scalpels. Doctors were afraid that in the hurried delivery of emergency care, a hand would slip or a scalpel would fall, and a doctor would accidentally stick herself. If a patient had the virus, chances were good that a doctor could soon have it, too.
But I'm not talking about HIV, the virus that causes AIDS. I'm talking about hepatitis C.
There are about 200 million people in the world who are infected with the hepatitis C virus (HCV)--almost five million in the U.S. alone. The virus causes your liver to swell and stops it from working. Eventually, the liver can become incapable of functioning because constant inflammation kills the organ. HCV is spread by contact with the blood of an infected person, and it is extremely contagious, even more contagious than AIDS.
In industrialized countries, hepatitis C causes 40% of all of the advanced liver disease and 60% of liver cancers. When patients reach these advanced stages, there are not many cures. Short of a liver transplant, many patients with advanced liver disease soon die.
Today, the standard treatment for hepatitis C is the combination of an antiviral medicine that targets the virus and an immune system-boosting drug that helps the body fight the infection. This elixir works for about half of all patients, but many patients can't tolerate the regimen or their bodies don't respond to it.
But there is new hope in the development of a class of drugs known as protease inhibitors. This isn't the same kind of protease inhibitor that has been used to successfully treat AIDS. In the case of HCV, the drug is targeted at a unique kind of protease enzyme only used by the hepatitis C virus.
The most advanced and most promising protease inhibitor for hepatitis C belongs to the Cambridge, Mass.-based biotechnology company Vertex Pharmaceuticals (nasdaq: VRTX - news - people ).
Scientists at Vertex used structure-based drug design to create the drug, known as VX-950. Structure-based design means that scientists use special equipment to make computer models of a three-dimensional structure of the enzyme they are targeting. This enables more rational attempts to design drugs to stick inside the enzyme's active site, by building the ideal drug one atom at a time, like a microscopic Lego set.
The small trial is going to compare the safety and effectiveness of VX-950 to a sugar pill in about 60 healthy volunteers and patients with hepatitis C. The study is expected to finish up this year. It should give Vertex a good look at just how potent the new drug is, as well as a peek at whether it is safe.
If VX-950 works, it will be a big advance for patients with hepatitis C. It could also be a blockbuster medicine--a first-in-class, broad-spectrum antiviral drug that could work for many, if not most, patients infected with hepatitis C. The market for drugs that treat hepatitis C was worth $1.6 billion last year and is expected to grow to $4 billion by 2009.
Doctors have high expectations for this drug class. But there is plenty of caution. At least one other protease inhibitor that was targeted against hepatitis C has failed in development, largely because it had too many side effects.
Keep in mind how protease inhibitors all work. They block an enzyme that belongs exclusively to the hepatitis C virus. There isn't a human protein that is closely related to hepatitis C protease, so the drug should not be interfering with any human cellular processes at all.
That means that the only way these drugs could cause side effects in people is if the liver doesn't break them down very well. This seems to be precisely the problem with older, early formulations of protease inhibitors that were developed by another company, Boehringer Ingelheim. These kinds of problems with metabolism are most often related to the way the drug is designed, not the underlying mechanism of the drug itself.
Schering-Plough (nyse: SGP - news - people ) is also believed to be in early clinical testing with a protease inhibitor of its own that targets hepatitis C. Several other companies have research programs focused on HCV protease inhibitors, including Gilead Sciences (nasdaq: GILD - news - people ), Merck (nyse: MRK - news - people ), Pfizer (nyse: PFE - news - people ), GlaxoSmithKline (nyse: GSK - news - people ) and InterMune (nasdaq: ITMN - news - people ). By all accounts, however, Vertex is farthest along.
There are also some other promising drugs in development for hepatitis C. But the protease inhibitors alone hold out some of the best near-term promise to fulfill the holy grail of hepatitis C therapy--a single potent pill that can destroy the virus all on its own, or in a small cocktail where the drug is used in combination with older medicines.
Vertex thinks it might have found the magic bullet. A clinical trial expected to finish this year could provide doctors, patients and investors with the first sure sign of whether Vertex is right.
Dr. Gottlieb is a practicing physician and a fellow at the American Enterprise Institute. He recently left the FDA, where he was Director of Medical Policy Development and a senior adviser for medical technology to the FDA Commissioner.
Posted by Ralph at 11:43 AM --- Printer-friendly version | Comments (7)
Hepatitis C Treatment Study Being Questioned
To me, the study referenced in the article below is unnecessary. There appears to be negligible difference between the two main treatments for Hepatitis C. While Roche has been shown to have an advantage regarding side effects and effectiveness, this difference seems to be somewhat insignificant (although, if I were to choose to intiate therapy at this time, I would choose the Roche product, Pegasys).
A lot of time, money and effort is being spent on this study when other (more effective and less toxic) treatments could be being developed, instead. It seems like comparing two brands of aspirin. In the long run, there is so little difference that it just comes down to what the marketing people choose to advertise and how.
Also, I am suspect of any
study funded by an entity that has a vested interest in the final
result. Call me suspicious, call me skeptical, but conflict of interest
is a known problem wherever it exists. If the study shows the Roche
product is better can we really expect Schering not to put some kind of
spin on it to do major damage control? We are talking about a billion
dollar annual business (Hepatitis C treatment). What do you think?
Schering-Plough Defends Design of “IDEAL” Study Comparing Peg-Intron with Pegasys
By Ronald Baker, PhD, HIVandHepatitis.com
Supported by Schering-Plough (Schering), manufacturer of Peg-Intron (pegylated interferon alfa-2b), the IDEAL trial will compare the efficacy of Peg-Intron versus Roche Pharmaceuticals’ Pegasys (pegylated interferon alfa-2a), both in combination with ribavirin.
A recent Reuters News wire story raised the issue that the IDEAL study protocol calls for ribavirin starting doses and ribavirin dose reduction rates that are not equivalent in two arms of the study (Peg-Intron/ribavirin versus Pegasys/ribavirin combination therapy).
The Reuters reporter quoted John McHutchison, MD, one of the principal investigators of the trial, as saying that the study's design will probably allow more patients receiving Peg-Intron to stay on higher doses of ribavirin than those taking Pegasys, and further, “The dose reductions for ribavirin are not equivalent in the two arms of the study and could therefore introduce a potential ‘bias’ in favor of the Peg-Intron arm of the trial.”
The decision on the size of the ribavirin dose reductions in the Pegasys arm appears to have been made by the FDA, not Schering. The FDA insisted that instructions on the Pegasys drug label be followed—any ribavirin reductions must be to 600 milligrams, according to the Reuters story. “The FDA wouldn’t allow it (smaller ribavirin dose cutbacks), and unfortunately that’s the way it stands,” McHutchison said.
The IDEAL study is a large trial that when fully enrolled, will involve nearly 3,000 patients at approximately 100 medical sites in the US. The results of the trial, not expected until 2007, could influence the choice of peginterferon treatment (Pegasys or Peg-Intron) selected by chronic hepatitis C patients and their doctors. For this reason alone, both Roche and Schering have a big stake in the final study results. Of course, it’s possible that the safety and efficacy differences between the two drugs may turn out not to be statistically significant.
Schering feels that the Reuters news story neglected to point out that the IDEAL trial focuses on the different treatment approaches inherent in the two combination regimens being evaluated (Pegasys/ribavirin versus Peg-Intron/ribavirin) and further that “the study is powered to show differences between the Peg-Intron and Pegasys regimens.”
“Unfortunately,” says Schering Communications Director Robert Consalvo, “the Reuters story neglected this point and instead focused on the potential for bias caused by the different ribavirin doses.”
Following is the text of a statement by Schering on the IDEAL study that the company says is intended to clarify possible confusion about the trial generated by the Reuters article. Following is the text of the statement from Schering, released on January 21, 2005.
Schering-Plough Statement on the “IDEAL” Study
The IDEAL study is a three-arm clinical trial involving nearly 3,000 U.S. patients with chronic hepatitis C genotype 1, the most difficult form of the virus to treat and most common worldwide. The study is designed to address two separate issues: 1) a comparison of two doses of PEG-INTRON (1.0 vs. 1.5 mcg/kg weekly) used in combination with ribavirin, and 2) a head-to-head comparison of treatment regimens with PEG-INTRON versus PEGASYS, both used in combination with ribavirin.
The IDEAL study compares the efficacy and safety of these different treatment regimens in the same patient population.
The PEG-INTRON and REBETOL (ribavirin) regimens use an individualized approach to therapy in which both products are dosed according to patient body weight: PEG-INTRON (1.0 and 1.5 mcg/kg weekly) and REBETOL (800-1,400 mg/day). PEGASYS and COPEGUS (ribavirin) are dosed in accordance with the FDA-approved labeling: the same dose of PEGASYS (180 mcg weekly) to all patients regardless of individual body weight, and COPEGUS dosed either at 1,000 mg or 1,200 mg daily.
Based on these different treatment approaches (weight-based dosing vs. flat dosing), interferon and ribavirin dosing will differ for many patients. All patients in the PEGASYS arm will receive more interferon for their starting dose than patients in the PEG-INTRON arms. Ribavirin dosing is different for some patients in the study, but the ribavirin dosing is not expected to favor any one dosing regimen overall. Additional analyses will examine the effect of these different treatment approaches.
The results of the IDEAL study will provide physicians and their patients with important information that will help them make informed treatment decisions.
Status of Study
The IDEAL study (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy) will involve up to 100 U.S. sites. Enrollment for the study is on schedule. At the end of 2004, more than 90 centers in the study had screened approximately 1,500 patients and enrolled more than 700 patients. Final study results are expected in 1H 2007.
Full-study results will be reviewed by a panel of international experts in liver disease and presented at appropriate medical meetings.
01/24/05
Sources
R Consalvo. Statement from Schering-Plough on the IDEAL Study. January 21, 2004.
R Pierson. Researcher Cites “Bias” Toward Peg-Intron in Trial. Reuters News. January 7, 2004.
Posted by Ralph at 06:46 AM --- Printer-friendly version | Comments (2)
Biopsy Unnecessary for Successful Hepatitis C Treatment
This article reports on a study that shows biopsy need not be required to treat chronic Hepatitis C. The statistically significant results show that other indicators (ultrasound, fibrosis blood tests, etc.) can suffice when measuring liver damage and treatment success. Because biopsy is an invasive medical procedure with known risks, proceeding successfully without biopsy would be a preferred approach.
Also
of note in this report are the success rates. Sustained virologic
response was seen in 41 to 43.6% of patients. I keep seeing
results like this and can't help wondering how the common knowledge
(and that preached by most doctors) is better than a 50% success rate.
Treatment of Patients with Chronic Hepatitis C with or without Liver Biopsy
Expert consensus recommends liver biopsy before therapy for chronic hepatitis C. A cost effectiveness analysis suggested that the best strategy in the management of patients was to treat without biopsy.
In this study, researchers compared therapy in patients who did, or did not undergo biopsy.
Hepatitis C virus (HCV)-positive patients (78) who did not agree to (n = 57) or with contraindications to liver biopsy (n = 21) (group A) were matched for age, sex and genotype with those who consented (group B).
Before therapy (interferon/ribavirin for 12 months), all patients must have received a clinical diagnosis of chronic hepatitis, on the basis of standard biochemical and ultrasonographic parameters. The two groups showed similar baseline characteristics.
A noninvasive, diagnosis of chronic hepatitis was made in 75.6% of group A, and in 83.3% of group B (P = 0.26). Concordance between clinical and histological diagnosis in group B amounted to 91%.
End-of-therapy virological response was 52.6% in group A, and 57.7% in group B (P = 0.63). Sustained virological response was 41.0% and 43.6% in the two groups (P = 0.87).
Predictors of sustained response were noninvasive diagnosis of chronic hepatitis (P = 0.006), lack of portal hypertension (P = 0.037), platelets >105/mm3 (P = 0.007), prothrombin >70% (P = 0.02), and genotype 2 or 3 (P < 0.0001). At multivariate analysis, genotype (P < 0.0001) and platelets (P = 0.004) maintained their predictive power.
The authors conclude, “In most patients with HCV infection, virological clearance after therapy can be achieved irrespective of whatever a liver biopsy might show.”
01/19/04
Reference
A Andriulli and others. Treatment of patients with HCV infection with
or without liver biopsy. Journal of Viral Hepatitis 11(6): 536-541.
November 2004.
Posted by Ralph at 06:19 AM --- Printer-friendly version | Comments (0)
January 22, 2005
Another Hepatitis C Drug Development
The following article is from the Orange County Business Journal. I am posting it for a few reasons. First of all, the article shows that pharmaceutical companies are working hard at coming up with other viable therapies for Hepatitis C. This is enouraging for all us patients.
The second reason is that the article also gives
insight into the business of drug development for Hepatitis C and any
other disease. The article touches on some of the hows and whys.
Valeant is developing Viramidine because their other drug, Ribavirin is
losing sales to competitors. They are looking for a replacement drug to
slow their loss of sales in the Hepatitis C marketplace. It is a
competitive business decision, not a compassionate humanitarian one.
Which is okay. Either way they are helping patients. In fact, their
desire for profits and business growth is probably a more dependable
and powerful motivator than humanitarinaism anyway. It still ultimately
works to the patients advantage.
Let's face it, pharmaceutical companies are not non-profit
charity organizations, they are businesses. I, for one, have no problem
with that---as long as they are ethically looking for better ways to
help people get healthy (the key word here is ethically). As patients,
though, we need to keep this reality in mind and not think that
pharmaceutical companies, or doctors for that matter, are sitting at
the right hand of God.
The third reason I'm posting the story is the lawsuit they
mention. This woman joined a clinical trial. They key word here is
"trial". Right in this description there is a tacit understanding that
the risks and rewards of the drug are not entirely known. How could she
have ever thought for a moment there was no risk? Even the current
approved treatment for Hepatitis C has very serious possible side
effects that are clearly outlined before treatment begins.
From my perspective, there is no way she could have thought this was risk-free, unless she was purposely lied to and mislead by the doctors and researchers (which I highly doubt. Remember, Valeant is a business in a high risk industry with lots of litigation. They know their high level of possible liabilities. They get plenty of people to participate without lying, so why would they lie?)
Unless this woman lives on another planet, she had to know there were very real risks involved. People's refusal to take personal responsibility for their own decisions and quickness to blame someone else for their own lapse in judgement has become one of my pet peeves. This seems like another classic case of responsibility avoidance. Yes, it is tragic that she was hurt. But, no one did it to her. She chose to participate in a clinical trial. It was her decision. Nuff said.
Posted date: 1/21/2005
Valeant's Study of Viramidine Drug: Comparable Efficacy to Ribavirin
Drug Is Critical Plank in Growth Strategy
Valeant Pharmaceuticals International said a key drug undergoing testing has proven to be similiarly effective at treating hepatitis C as its fading flagship ribavirin.
The Costa Mesa-based drug maker also said it has enrolled patients in a third-phase study of Viramidine. A filing of a new drug application with the Food and Drug Administration could follow the third phase.
"We are excited about Viramidine's potential and look forward to continuing the phase three pivotal trials, which both finished enrollment in record time," said Chief Executive Timothy Tyson in a release.
Valeant's study, conducted through the liver transplant program at the California Pacific Medical Center in San Francisco, involved 180 patients with chronic hepatitis C.
The company has a lot riding on Viramidine. Ribavirin has been Valeant's key product but has lost sales of late as competiting drugs have taken away sales.
The second-phase trial of Viramidine, meanwhile, has led to a lawsuit against the drug maker from a Bay area woman who alleges she suffered brain damage and permanent disabilities.
In her complaint, Linda Iacovetta said that while seeking treatment for hepatitis C at California Pacific, she was encouraged to be in the trial, which looked at how Viramidine and pegylated interferon worked in concert to fight the liver disease.
Iacovetta's suit said that she was on the drug combination for five months in 2003. She alleged that Valeant and California Pacific doctors who conducted the trial failed to warn users of the risks of taking the drug.
Valeant spokesman Jeff Misakian said earlier this week that Iacovetta's complaint was “completely without merit,” but didn't comment further because it is active litigation.
Posted by Ralph at 07:46 AM --- Printer-friendly version | Comments (1)
January 19, 2005
New Hepatitis C Combination Therapy Looking Good
This press release has more encouraging news for those of us waiting for a more potent and less toxic treatment for Hepatitis C, genotype 1.
Current therapy is least effective for this genotype. Genotype 1 is the most prevalent in the US, Europe and Japan. It is estimated that 70% of Americans are infected with genotype 1 (a or b).
More and more drug therapies are under development as pharmaceutical
companies scramble to get a piece of this multi billion dollar market.
While this treatment is still in fairly early stages of testing, the results are nonetheless encouraging.
Encouraging Interim Results of Phase II Study of Valopicitabine
(NM-283) in Combination with Peginterferon Alfa in Patients with HCV
Genotype 1
The double combination of valopicitabine (NM-283) plus peginterferon alfa produced a 99.94 percent (3.2 log10) mean reduction of HCV RNA (viral load), according to interim results of a Phase II clinical study in treatment-naïve patients with HCV genotype 1. Indenix Pharmaceuticals announced results of the interim analysis, which include data on 19 patients who have completed 12 weeks of combination treatment with valopicitabine plus peginterferon alfa.
Nine of 12 patients receiving combination therapy in this small study
experienced an early viral response (EVR) with a greater than 2 log10
decrease in levels of HCV RNA at week 12. No serious adverse events
have been reported so far. To date, valopicitabine has
demonstrated a satisfactory safety profile with mild to moderate
gastrointestinal side effects and no treatment-related discontinuations.
There is a pressing need for more potent and less toxic therapies for the treatment of chronic hepatitis C, especially for individuals with HCV genotypes 1 or 4, who are difficult to treat successfully. Among patients with these two HCV genotypes, only about 50% achieve a sustained virological response (SVR) from use of the current standard of care, peginterferon alfa in combination with ribavirin. Novel new compounds such as valopicitabine offer hope for better outcomes from combination treatment in the future.
An oral nucleoside analog, valopicitabine is Idenix
Pharmaceuticals’ lead drug candidate for the treatment of hepatitis C.
Now under development in combination with peginterferon alfa,
valopicitabine was co-discovered by Idenix and the University of
Cagliari through a cooperative laboratory agreement under the direction
of Dr. Paolo LaColla, Director of the Department of Biomedical Sciences
and Technologies of the University.
“In patients infected with HCV genotype 1 – a difficult-to-treat strain of hepatitis C virus and the most prevalent strain in the U.S., Western Europe and Japan – virologic response to the current standard therapy of ribavirin and peginterferon alfa is inconsistent,” commented Nathaniel Brown, M.D., Idenix’s executive vice president, clinical development and chief medical officer. “However, the consistency of response to the combination of valopicitabine and peginterferon alfa appears promising: eleven of twelve patients receiving this combination treatment had significant HCV RNA reductions of 1.7 to 6.2 log10 by week 12.
Phase IIa Trial Design and 12-Week Interim Results
Based on these encouraging interim data, Idenix will enroll a total of 30 patients in the phase IIa clinical trial, which is designed to assess the safety, antiviral activity and pharmacokinetics of the combination of valopicitabine and peginterferon alfa compared to valopicitabine alone. Key entry criteria for this clinical trial include treatment-naïve patients with HCV genotype 1, baseline viral load greater than 5 log10 copies/ml and alanine aminotransferase (ALT) levels less than 5 times the upper limit of normal.
In this phase IIa clinical trial, patients are being randomized
to one of two treatment arms so that 12 patients will receive
valopicitabine monotherapy and 18 patients will receive valopicitabine
plus peginterferon alfa.. After 12 weeks of treatment, mean HCV RNA
reductions from baseline were 0.9 log10 IU/mL, or 87.4 percent, for the
7 patients in the NM283 monotherapy group, and 3.2 log10 IU/mL, or
99.94 percent, for the 12 patients in the combination treatment group.
Nine of twelve patients receiving combination treatment have achieved an early viral response with a greater than 2 log10 decrease in levels of HCV RNA at week 12. Tolerance of both treatment regimens has been satisfactory to date, with no serious adverse events.
Four-week data from a study of these same 19 patients were
presented by Dr. Nezam Afdhal at the annual meeting in November 2004 of
the American Association for the Study of Liver Diseases (AASLD 2004).
About Hepatitis C
There are approximately 170 million people worldwide with chronic HCV infection, of which approximately 2.7 million are in the United States. Chronic HCV infection accounts for 40 percent of end-stage cirrhosis, 60 percent of liver cancer and 30 to 40 percent of liver transplants in the United States and other industrialized countries.
Responses to current treatment options are frequently inadequate
due to the inability of some patients to tolerate these treatments and
by their limited effectiveness, particularly in patients infected with
HCV genotype 1. The genotype 1 strain of HCV is the most
treatment-resistant HCV genotype and is estimated to cause more than 70
percent of the reported cases of hepatitis C in the U.S. and Japan, and
more than 65% of the reported cases of hepatitis C in Western Europe.
Hepatitis C Drug Development Program at Idenix
Idenix’s hepatitis C development program is initially seeking to
address the large patient population that has failed to respond to the
current standard treatment, peginterferon alfa plus ribavirin, and for
whom no other treatment option is currently available. Idenix expects
to subsequently target the treatment-naïve patient population for whom
treatment with the current standard of care is only successful in
approximately 50% of patients.
“Hepatitis C patients confront many unmet treatment needs, with
several hundred thousand having failed prior treatment with no
therapeutic options, and millions of people infected with difficult to
treat strains of HCV,” said Jean-Pierre Sommadossi, Ph.D., Idenix’s
chairman and chief executive officer. “Idenix is committed to rapidly
advancing the valopicitabine clinical program, which seeks to address
the medical needs of all individuals infected with hepatitis C.”
Drug Development for Patients Who Experience Treatment Failure
Idenix has initiated a Phase IIb clinical trial for valopicitabine in
patients who have previously failed peginterferon alfa and ribavirin
and expects to begin enrolling patients in this study in early 2005.
The company anticipates that this 6-month head-to-head trial, comparing
the combination of valopicitabine plus peginterferon alfa to the
current standard therapy (ribavirin plus peginterferon alfa), will
enroll approximately 170 HCV genotype 1 patients who have previously
failed at least 3 months of treatment with current standard therapy.
The Phase IIb clinical trial will also include a monotherapy arm of
valopicitabine.
Drug Development for Treatment-naïve Patients
Encouraging results from the ongoing Phase IIa clinical trial,
summarized above, will support initiation of a larger Phase IIb
clinical trial of valopicitabine in combination with peginterferon alfa
in treatment-naïve patients, the majority of whom are expected to be
infected with HCV genotype 1. Idenix anticipates beginning this trial
in mid-2005.
About Idenix
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company
engaged in the discovery and development of drugs for the treatment of
human viral and other infectious diseases. Idenix’s current focus is on
the treatment of infections caused by hepatitis B virus, hepatitis C
virus and human immunodeficiency virus (HIV). Idenix’s headquarters are
located in Cambridge, Massachusetts and it has drug discovery
operations in Montpellier, France and Cagliari, Italy.
Safety, Activity and Pharmacokinetics of the Combination of New Anti-HCV Compound NM-283 Plus Pegylated Interferon
For further information about Idenix, visit http://www.idenix.com/
01/19/05
Source
IDENIX REPORTS INTERIM ANALYSIS OF A PHASE IIA CLINICAL TRIAL OF VALOPICITABINE (NM283) IN COMBINATION WITH PEGYLATED INTERFERON IN TREATMENT-NAÏVE HEPATITIS C GENOTYPE 1 PATIENTS. Press Release. January 10, 2005.
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January 14, 2005
Hepatitis C Treatment Depression May Affect Outcome
This article surprised me. I'm not sure what to think of emotional depression as an indicator of treatment success. What is it about the virus or the treatment that causes non-responders to become more clinically depressed than responders during treatment?
Incidentally, this study was co-funded by Schering and the CDC. And, yet, it only claims a 40-50 percent rate of clearing the virus among patients. This is with a supposed 80 percent clearance for genotype 2. How low must the clearance rate actually be for genotype 1? Closer to 30 percent is my guess.
Depression caused by common treatment for hepatitis C may affect outcome
ATLANTA–An article appearing in the January 2005 issue of Brain, Behavior and Immunity suggests that developing depression while on interferon-alpha plus ribavirin may impact how well the medications work.
In a study conducted in the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine, Charles L. Raison, MD, Andrew Miller, MD, and colleagues, observed that patients who develop depressive symptoms during interferon-alpha plus ribavirin therapy were significantly less likely to have cleared the hepatitis C virus from their blood following six months of treatment.
"Hepatitis C infection affects three to five million Americans, and is the leading cause of liver transplantation," said Dr. Raison. "With advances in treatment, 40-50 percent of patients can be cleared of the virus. Unfortunately, however, the current treatment for hepatitis C – interferon-alpha plus ribavirin – produces a high rate of psychiatric side effects that have long been recognized as impediments to successful antiviral therapy. In the past we primarily worried that depression interfered with quality of life, or would cause patients to stop taking the medicine. These new data suggest that even if patients stay on treatment, they are less likely to have a good outcome if they develop depressiom."
The study examined 103 participants who received pegylated interferon-alpha-2b plus ribavirin (PEG IFN/ribavirin). All participants were psychiatrically evaluated prior to initiation of the medication and at 4, 8, 12 and 24 weeks of PEG IFN/ribavirin treatment.
Only 34% of the patients who had a significant increase in depression cleared the hepatitis C virus from their blood at 24 weeks, as compared to 59%-69% of patients with milder increases in depression. The effect of depression on viral clearance persisted even after adjusting for factors known to affect treatment outcome, such as viral genotype, or whether medications had to be reduced.
"The findings of this study provide preliminary evidence that baseline mood state should be assessed in patients prior to commencing treatment," said Dr. Raison. "Significant deviations from this state may increase the likelihood of treatment failure. Moreover, these findings provide further support that the development of depression can have a negative impact on health outcomes in medically ill subjects."
Researchers from the Rollins School of Public Health, Emory University and the Department of Medicine, Gasteroenterology and Hepatology, Weill Medical College of Cornell University were also involved in the study. The study was supported by grants from the National Institute of Mental Health, Schering–Plough, and the Centers for Disease Control and Prevention.
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January 12, 2005
Chronic Hepatitis B and C: Chronic Lack of Effective Treatment
The following article is from Pharmalive.com (The Pulse of the Pharmaceutical Industry).
The first interesting statistic I noticed is the statement that with the easier to treat genotypes they claim an 80% success rate and when factoring in the harder to treat (read genotype 1) the overall rate is around 50%.
While admitting I am no math whiz, it appears that the success rate for Genotype 1 must be well below 50% to end up with a 50% success rate when combined with the 80% claimed for other, more treatable, genotypes.
The authors of this article call current pharmaceutical therapies for chronic viral hepatitis b and c "inadequate", "sub-optimal" and "far from perfect". Remember, this is the "Pulse of the Pharmaceutical Industry" speaking.
Certainly, in my opinion, if I were to choose between the Roche or Schering therapies, I would choose Roche. For a few reasons, it seems to be the superior choice.
The authors are pointing out opportunity for pharmaceutical companies to come up with better solutions than currently exist. Especially for the harder to treat varieties like HCV genotype 1. This opportunity is what will drive these drug companies to continue to scramble to develop new treatments.
As I've said all along, their shareholder-driven need for profits will, ultimately, work to the advantage of patients.
Chronic Hepatitis B and C: Chronic Lack of Effective Treatment
350-400million chronically infected patients globally. Most of these patients reside in
Viral hepatitis – a significant public health problem
Globally, HCV infection is less common than HBV infection. However in the west, HCV (7.5m chronic carriers in the seven major markets) is more common than HBV. Historically this has been due to transmission through contaminated blood or blood products and is currently a result of shared utensils used for intravenous drug use.
Recently completed research by independent market analyst Datamonitor** has revealed that despite increasing HBV and HCV disease awareness and diagnosis, treatment rates of patients with chronic viral hepatitis remain low, and despite the large pool of CHB and CHC patients, less than one-third of these are currently receiving medical treatment. One underlying reason is the low rate of disease diagnosis, on average 54% for HBV and 40% for HCV, says Datamonitor infectious diseases analyst Brigitte de Lima. “Chronic liver disease (CLD) is a long-term consequence of HBV and HCV and commonly leads to liver cirrhosis or hepatic decompensation within 10-40 years following primary infection.”
“Furthermore, long-term CHB and CHC cause a type of liver cancer known as hepatocellular carcinoma (HCC). Both diseases combined account for over 80% of HCC cases and almost half a million lives annually. Once diagnosed, prognosis for HCC can be as low as six to eight months.”
Diagnosis and treatment – still sub-optimal in the seven major markets
Although HCV diagnosis rates are lower than those for HBV, they have increased considerably in the past two years, while those for HBV have remained flat. Key to the enhanced identification of new patients among both high-risk groups and the general population has been education and awareness campaigns organized by both the private and the public sector, de Lima says.
“In addition to the low rates of diagnosis, inadequate therapies also account for the sub-optimal treatment levels. Although up to 80% of CHC patients with the easy-to-treat viral genotypes 2 and 3 can currently be cured, the larger prevalence of the less responsive genotype 1 translates into only half of the total patient pool achieving virus eradication.”
“In the case of CHB the scenario is even worse, with viral eradication occurring in less than 5% of all patients. Current CHB therapy therefore focuses on long-term suppression of virus replication rather than virus clearance. Similar to CHC, the proportion of patients less responsive to treatment, namely those infected with the HBeAg-negative variant of HBV, is increasing globally.”
Sub-optimal current first-line therapies for CHB and CHC are unable to benefit the already predominant and increasing pools of difficult-to-treat patients, leaving ample scope for opportunistic manufacturers willing to invest in potent, tolerable drugs in a market largely driven by therapy cost, de Lima says.
Prescription choice – largely driven by cost-considerations
The pharmaceutical HBV market is currently dominated by two antivirals, GlaxoSmithKline (GSK)’s Zeffix (lamivudine, LAM) and
“Similarly, the HCV market consists of two major players; Schering-Plough, who markets PegIntron and Rebetol, and Roche, with its drugs Pegasys and Copegus. The lack of clinical differentiation between the two rival pegIFNs and the absence of any alternative anti-HCV drugs has led to physician prescription choice being driven almost exclusively by cost and special deals provided by the manufacturers.”
Current therapies – compromise is necessary
Current therapies for either disease are far from being perfect solutions. None of the HBV drugs cure the disease and long-term therapy with LAM is associated with development of resistance, while ADV entails a high financial expenditure. Pegylated IFN combination therapy might be effective in some forms of CHC disease, but it is also a therapy dreaded by most patients due to the injectable mode of delivery and the high incidence of severe side effects elicited over the entire course of the treatment, de Lima says.
“Given the clear limitations of the current HBV and HCV therapies, major players in both pharmaceutical markets have developed different strategies aimed at increasing treatment rates. In the case of CHC, these focus on treating patients with normal alanine aminotransferase (ALT) levels, prolonging treatment for slow responders and maintaining non-responders on pegIFN monotherapy. The main strategy for CHB patients is the extension of therapy, especially for HBeAg-negative patients, as most patients relapse following cessation of therapy.”
The current stalemate in the CHB and CHC treatment markets is only susceptible to being broken with the launch of new developmental drugs, which will have to combine high potency and good tolerability at a reasonable cost. Crucially, new drugs are more likely to gain market share if, in addition to winning the battles against the more responsive variants of the diseases, they are also effective in the difficult-to-treat CHB and CHC patients. Drugs with high potency in the latter patients are the key to meeting the growing therapeutic needs and consequently boosting treatment rates, de Lima says.
“The future viral hepatitis treatment landscape is predicted to follow the HIV precedent, in that drug monotherapy is likely to become obsolete and novel, potent drugs will be administered simultaneously as part of a combination. Furthermore, the focus needs to shift from patients with easily treatable variants of the disease to those that obtain little benefit from current therapies, as these are steadily accumulating in the total patient pools. New strategies are awaited to take the lead in this long-standing battle against the hepatitis viruses.”
*The seven major pharmaceutical markets are the
**Stakeholder Insight: Hepatitis B and C
Datamonitor plc (DTM.L) is a premium business information company specialising in industry analysis. We help our clients, 5000 of the world's leading companies, to address complex strategic issues. Through our proprietary databases and wealth of expertise, we provide clients with unbiased expert analysis and in-depth forecasts for six industry sectors: Automotive, Consumer Markets, Energy, Financial Services, Healthcare, Technology. Datamonitor maintains its headquarters in
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January 10, 2005
New Hepatitis C Drug (NM283) Clinical Trial Report
This is a report on yet another new drug for the treatment of Hepatitis
C. The exciting news for most patients in the US, Europe and Japan is that
this drug is specifically targeted toward genotype 1. Genotype 1 is the
most common genotype in these areas and is also the hardest to treat
with current therapy.
Pharmaceutical companies are rushing to develop new and better treatments for Hepatitis C because they see huge profits. They know that current therapy is inadequate or inappropriate for most patients in the US, Europe and Japan. Ultimately, the greed of the pharma companies works to our benefit.
Incidentally, the results of this trial are apparently very good.
Press Release Source: Idenix Pharmaceuticals, Inc.
Idenix Reports Interim Analysis of a Phase IIa Clinical Trial of Valopicitabine (NM283) in Combination with Pegylated Interferon in Treatment-Naive Hepatitis C Genotype 1 Patients
Monday January 10, 8:30 am ET
Patients receiving the combination treatment achieved a mean viral load reduction of 3.2 log10, or 99.94 percent, after 12 weeks of treatment
SAN FRANCISCO, Calif., Jan. 10 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today announced interim clinical trial data for valopicitabine (NM283), the company's lead drug candidate for the treatment of hepatitis C.
In this phase IIa trial, patients are randomized to one of two treatment arms, valopicitabine (NM283) monotherapy, or valopicitabine (NM283) plus pegylated interferon. This interim data analysis includes all 19 patients who have completed 12 weeks of treatment in this trial. The patients receiving the combination of NM283 and pegylated interferon achieved a mean reduction of serum HCV RNA of 3.2 log10, or 99.94 percent, at week 12.
These data will be included in the company's presentation at the JPMorgan Healthcare Conference on Wednesday, January 12, 2005 at 8:30 a.m. in San Francisco.
"In patients infected with HCV genotype 1 -- a difficult-to-treat strain of hepatitis C virus and the most prevalent strain in the U.S., Western Europe and Japan -- virologic response to the current standard therapy of ribavirin and interferon is inconsistent," commented Nathaniel Brown, M.D., Idenix's executive vice president, clinical development and chief medical officer. "However, the consistency of response to the combination of valopicitabine and interferon appears promising: eleven of twelve patients receiving this combination treatment had significant HCV RNA reductions of 1.7 to 6.2 log10 by week 12.
Based on these encouraging interim data, we have extended this phase IIa trial to 6 months in order to investigate longer duration treatment." Phase IIa Trial Design and 12 Week Interim Results: Idenix will enroll a total of 30 patients in the phase IIa clinical trial, which is designed to assess the safety, antiviral activity and pharmacokinetics of the combination of NM283 and pegylated interferon compared to NM283 alone.
Key entry criteria for this clinical trial include treatment-naive patients with HCV genotype 1, baseline viral load greater than 5 log10 copies/ml and alanine aminotransferase (ALT) levels less than 5 times the upper limit of normal.
In this phase IIa clinical trial, patients are being randomized to one of two treatment arms so that 12 patients will receive NM283 monotherapy and 18 patients will receive NM283 plus pegylated interferon. After 12 weeks of treatment, mean HCV RNA reductions from baseline were 0.9 log10 IU/mL, or 87.4 percent, for the 7 patients in the NM283 monotherapy group, and 3.2 log10 IU/mL, or 99.94 percent, for the 12 patients in the combination treatment group. Nine of twelve patients receiving combination treatment have achieved an early viral response with a greater than 2 log10 decrease in levels of HCV RNA at week 12.
Tolerance of both treatment regimens has been satisfactory to date, with no serious adverse events. Four- week data from these same 19 patients were presented by Dr. Nezam Afdhal at the American Association for the Study of Liver Diseases' annual meeting in November 2004.
Hepatitis C Development Program
Idenix's hepatitis C development program is initially seeking to address the large patient population that has failed to respond to the current standard treatment, pegylated interferon plus ribavirin, and for whom no other treatment option is currently available. Idenix expects to subsequently target the treatment-naive patient population for whom treatment with the current standard of care is only successful in approximately 50% of patients.
"Hepatitis C patients confront many unmet treatment needs, with several hundred thousand having failed prior treatment with no therapeutic options, and millions of people infected with difficult to treat strains of HCV," said Jean-Pierre Sommadossi, Ph.D., Idenix's chairman and chief executive officer. "Idenix is committed to rapidly advancing the NM283 clinical program, which seeks to address the medical needs of all individuals infected with hepatitis C."
Development for Treatment-failure Patients: Idenix has initiated a phase IIb clinical trial for NM283 in patients who have previously failed treatment with pegylated-interferon and ribavirin and expects to begin enrolling patients in this study in early 2005. The company anticipates that this 6- month head-to-head trial, comparing the combination of NM283 plus pegylated interferon to the current standard therapy (ribavirin plus pegylated interferon), will enroll approximately 170 HCV genotype 1 patients who have previously failed at least 3 months of treatment with current standard therapy.
This phase IIb clinical trial will also include a monotherapy arm of NM283. Development for Treatment-naive Patients: Encouraging results from the ongoing phase IIa clinical trial, summarized above, will support initiation of a larger phase IIb clinical trial of valopicitabine (NM283) in combination with pegylated interferon in treatment-naove patients, the majority of whom are expected to be infected with HCV genotype 1. Idenix anticipates beginning this trial in mid-2005.
About Valopicitabine (NM283)
Valopicitabine (NM283) is an oral, novel nucleoside analog that was co- discovered by Idenix and the University of Cagliari through a cooperative laboratory agreement under the direction of Dr. Paolo LaColla, Director of the Department of Biomedical Sciences and Technologies of the University. Valopicitabine (NM283) is being developed in combination with pegylated interferon. To date, valopicitabine (NM283) has demonstrated a satisfactory safety profile with mild to moderate gastrointestinal side effects and no treatment-related discontinuations.
About Hepatitis C
There are approximately 170 million people worldwide with chronic HCV infection, of which approximately 2.7 million are in the United States. Chronic HCV infection accounts for 40 percent of end-stage cirrhosis, 60 percent of liver cancer and 30 to 40 percent of liver transplants in the United States and other industrialized countries. Responses to current treatment options are frequently inadequate due to the inability of some patients to tolerate these treatments and by their limited effectiveness, particularly in patients infected with HCV genotype 1.
The genotype 1 strain of HCV is the most treatment-resistant HCV genotype and is estimated to cause more than 70 percent of the reported cases of hepatitis C in the U.S. and Japan, and more than 65% of the reported cases of hepatitis C in Western Europe.
About Idenix
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV).
Idenix's headquarters are located in Cambridge, Massachusetts and it has drug discovery operations in Montpellier, France and Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com.
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. Statements in this press release other than those that are historical in nature are "forward- looking statements."
Such forward looking statements, which include statements with respect to the potential therapeutic benefits and successful development of the company's drug candidates and the company's drug discovery, research and clinical development activities, are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. These risks and uncertainties relate to the results of clinical trials and other studies with respect to the drug candidates that the company has under development; the timing and success of submission, acceptance and approval of regulatory filings; the company's dependence on its collaboration with Novartis Pharma AG; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the ability of the company to attract and retain qualified personnel, and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for its drug candidates and its discoveries.
These and other risks are described in greater detail in the "Risk Factors" section of the company's quarterly report on Form 10-Q for the quarter ended September 30, 2004 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company's expectations only as of the date of this release and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
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January 05, 2005
Hepatitis C With Fatty Liver Increases Risk
The following article comments on a study published in the January issue of the medical journal, Hepatology.It starts out saying that the usefulness of antiviral therapy in patients with mild Hepatitis C is debatable. This indicates that the degree of steatosis in Hepatitis C patients should be one of the metrics in deciding on proceeding with interferon combination therapy.
Again, doctors will tend to prescribe therapy to 100% of patients who present with chronic Hepatitis C (because it is the only medical treatment available to them). This study is one more that calls into question this approach. Assessment of risk/reward ratio before proceeding with therapy needs to take this criterion into consideration, as well as others.
What is not stated in the author's conclusion is that they would not necessarily recommend antiviral therapy in patients with mild chronic Hepatitis C who do not present steatosis. Impact of Steatosis on the Progression of Fibrosis in Patients with Mild Hepatitis
In patients with mild hepatitis C, the usefulness of antiviral therapy is a subject of debate, as a low risk for progression of fibrosis is assumed. Several studies have shown that steatosis (fatty liver) is a strong and independent predictor of the severity as well as the progression of fibrosis in chronic hepatitis C.
The present study assessed the impact of steatosis on the progression of fibrosis between paired liver biopsies in untreated patients with mild hepatitis on index biopsy.
One hundred thirty-five untreated patients (mean age, 38 years; M/F sex ratio, 1.43) with one known risk factor of infection (68 transfusions, 67 injecting drug use) had 2 liver biopsies after a median interval of 61 months (18-158). All had METAVIR score of A1F1 or lower at first liver biopsy.
Unequivocal progression of fibrosis was considered if patients had a fibrosis score of 3 or 4 at the second liver biopsy. The probability of progression of fibrosis was estimated by using the Kaplan-Meier method.
During follow-up, progression of fibrosis occurred in 21 patients (16%) after a median delay of 65 months. Cumulative probabilities of the progression of fibrosis at 4 and 6 years were 5.2% and 19.8%, respectively.
In multivariate analysis, steatosis was the only independent factor predictive of progression of fibrosis. Probability of progression of fibrosis was significantly related to the percentage of hepatocytes with steatosis.
The authors conclude, “Steatosis is a major determinant of the progression of fibrosis in mild hepatitis C, regardless of the genotype. Our results argue for antiviral treatment in the subgroup of patients with mild hepatitis and steatosis.”
01/05/05
Reference
L Fartoux and others. Impact of steatosis on progression of fibrosis in patients with mild hepatitis. Hepatology 41(1): 82-87. January 2005.
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