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HCV & Cell Death
A new report from the University of Alberta is helping scientists understand the relationship between the hepatitis C virus and what causes the damage to the liver cell. In the past it was believed that the hepatitis C virus indirectly caused damage to liver cells—that is, that the virus itself didn’t kill the liver cell, but that the body’s adaptive immune system would attack and kill the entire liver cell that was infected with hepatitis C. In a study published in the February edition of PLoS Pathogens, Michael Joyce and colleagues transplanted human liver cells into mice and infected the liver cells with the hepatitis C virus. What they found was that the virus directly damaged the liver cell which could eventually lead to the death of the liver cell. This is noteworthy because mice do not have an adaptive immune system and proves that the virus itself can cause cell inflammation and death.
Source: PLoS Pathogens
ITX5061
In a somewhat related news story to the above, a new class of drugs believed to prevent the hepatitis C virus from entering the liver cell has just recently entered into a clinical trial. A new study of ITherX’s HCV inhibitor, ITX5061, is the first study of this type of inhibitor. The trial is a proof of concept study that will enroll about 40 HCV positive people who are treatment-naïve or treatment-experienced. The aim of the study is to test the safety, pharmacokinetic properties, and measure the effect of the drug on HCV RNA (viral load). The study will be conducted at various European sites.
Source: Company press release
Brazil: HCV among Athletes
The risk of sharing injection equipment is the most common transmission route of hepatitis C. However, very little has been reported about the incidence of HCV in athletes who have used injectable vitamins or performance enhancing drugs. In Brazil, a study1 was conducted by Dr. Passos and colleagues in which 208 former professional and amateur soccer and basketball players from the region of Ribeirdao Preto, Brazil answered a questionnaire about their use of injectable stimulants and other risk factors when they were participating in sporting activities. Of the 208 who answered the questionnaires, 24.5% of all the participants had used injectable stimulants—50.8% among the participants who were professional athletes. All of the participants were tested for hepatitis C by the ELISA antibody test. Those who tested antibody positive were confirmed with a viral load test (PCR) and a genotype test. The overall prevalence of HCV in the entire group was 7.2% (11% of the professional athletes, and 5.5% of the amateur athletes). It is interesting that, when the HCV positive results were paired with the questionnaires about injection use, there was a high correlation between those who self-reported stimulant injection (36% of those who tested HCV positive self-reported injection use) and HCV infection compared to those who did not report injecting stimulants (0.8%).
1Mem Inst Oswaldo Cruz, Rio de Janeiro, Vol. 103(8): 809-812, December 2008.
Cost of Digestive Disease
A report sponsored by the National Institutes of Health was released in Gastroenterology in February. The lead author of the study, J. E. Everhart, MD, MPH reported that the costs of digestive disease in the United States was estimated at 100 million outpatient visits and 13 million hospitalizations every year at a cost of $141.8 billion. The annual deaths from combined digestive diseases was estimated at 230,000. The price tag for viral hepatitis (hepatitis A, B, & C) was $3.3 billion dollars (direct and indirect costs). The top ten digestive disease costs (by type of disease) for both direct and indirect costs were estimated at:
- Digestive cancer – $24.1 billion
- Liver disease – $13.1 billion
- Gastro esophageal reflux disease (GERD) – $12.6 billion
- Gallstones – $6.2 billion
- Abdominal wall hernia – $6.1 billion
- Diverticular disease – $4.0 billion
- Pancreatitis—$3.7 billion
- Viral hepatitis (A, B, C) – $3.3 billion
- Peptic ulcer disease – $3.1 billion
- Appendicitis – $2.6 billion
Source: American Gastroenterological Association – www.gastrojournal.org
Fatty Liver
A research paper in the journal Hepatology about weight loss and fatty liver is yielding a wealth of information on the role of weight in the management of fatty liver and liver health in general. The study was conducted by S.A. Harrison and colleagues to find out if treatment with orlistat (brand name – Alli – an inhibitor of fat absorption in the intestines) when combined with calorie restriction (1,400 Kcal/day) and vitamin E (800 IU) would improve fatty liver and general liver health in people who are overweight. There were 41 participants in the 9 month study and they were divided into two groups – group A received orlistat (120 mg three times a day), diet restriction and vitamin E (800 IU); group B received vitamin E (800 IU) and diet restriction (no orlistat).
The researchers reported that group A had an 8.3% reduction in body weight compared to 6.0% in group B which did not receive the orlistat – the results were not considered statistically significant. However, when the results of the two groups were combined it was found that, in those who decreased their weight by greater than or equal to 5%, there were improvements in insulin sensitivity, fatty liver, and liver inflammation compared to those who lost less than 5% of their body weight. In addition, those who lost greater than or equal to 9% of their body weight also improved liver histology (health). The take home message of this study is that moderate weight loss can lead to dramatic improvement in the overall health of the liver.
Source: Hepatology, Volume 49, Issue 1, Pages 80-86
Fibromyalgia
Fibromyalgia is believed to be an extrahepatic manifestation of HCV. There has long been a debate on the cause of and symptoms of fibromyalgia, but recent research has been pointing to a disorder that may be associated with the brain. Researchers at Louisiana State University conducted a study of 16 fibromyalgia patients to study the effect of stress on the brain by conducting brain imaging of the hippocampus region of the brain – the area that normalizes the effects of stress. What they found was that the hippocampus in the participants was not able to inhibit certain brain activity that helps to regulate the effects of stress.
The bottom line on this study is that it is important to control stress for everyone – especially those with fibromyalgia.
Source: www.ScienceDaily.com
Romark
Romark made a couple of announcments recently about nitazoxanide (NTZ) – the company’s drug that they are testing as an add-on drug to the current standard of therapy – pegylated interferon plus ribavirin. The data from a Phase II study of treatment-naïve genotype 4 patients taking a controlled release version of nitazoxanide in combination with pegylated interferon plus ribavirin was recently released at the Asian Pacific Association for the Study of Liver Disease (APASL). The aim of the study was to determine the safety and effectiveness of two doses of controlled release NTZ (675 or 1350 mg twice a day (bid)) as a 4 week lead-in, followed by triple therapy (NTZ, PegIFN alfa-2A (Pegasys), ribavirin). There were three treatment arms:
- Placebo - 4 weeks; Pegasys plus ribavirin - 48 weeks (8 patients)
- NTZ-675 mg bid for 4 weeks; NTZ 675 mg bid, Pegasys, ribavirin for 36 weeks (17 patients)
- NTZ-1350 mg bid for 4 weeks; NTZ 1350 mg bid, Pegasys, ribavirin for 36 weeks (16 patients)
The interim analysis found that the rapid virological response (less than 12 IU/mL after 4 weeks), complete early virological response (less than 12 IU/mL after 12 weeks) and early virological response (greater than or equal to 2 log10 after 12 weeks) was higher in all of the groups that included controlled release NTZ. In addition, 82% in the 675mg dose group and 100% in the 1350 mg dose group were HCV RNA undetectable after 12 weeks. The drugs were shown to be safe and well-tolerated without any type of serious adverse events or treatment discontinuations.
In related news Romark announced that it had entered into an agreement with Chugai Pharmaceutical Co. Ltd., a member of the Roche Group, to license the development and commercialization of nitazoxanide as a treatment for hepatitis C in Japan.
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