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Saturday, November 04, 2006

Hep C, a more useful treatment

Hep C seems always to be in the news. It was discussed on US TV last night by Christopher Lawford, son of JFK's sister, author and actor.

This is another one of my "gee mainstream medicine, why aren't you thinking outside the box" moments.

Causes me a lot of frustration because so many people don't need to suffer as much with the side effects of the drugs that really do little to eradicate the dis-ease.

I say this with some lengthy background in the Hep C natural treatment approach. All I've seen is success and recovery. And it is well beyond the 'management' mentality.

Yes, more useful, safe and effective treatments are available! Let's get more of this information in the news. Same for HIV/AIDS.

I'm up for interviews...

Hepatitis epidemic hits Wales

Results of a research programme published today reveal a hepatitis epidemic in Wales.

About 14,700 people in Wales may have been infected with hepatitis C. Around one in five people naturally clear the virus leaving the remaining 12,000 people chronically infected. Three quarters of these may not know they have it.

It is estimated that one in 300 people in Wales have hepatitis B.

Hepatitis B and C are viruses carried in the blood that are both preventable and treatable.

If left untreated, hepatitis C can cause serious liver disease in some patients, including cirrhosis and liver cancer.

The major ways of getting hepatitis B in Wales include sexual intercourse with an infected person or injecting drug use, past or current. However, vaccination against hepatitis B is available and effective when given to those most at risk.

The reports, published by the National Public Health Service for Wales (NPHS), examine the extent of hepatitis B and hepatitis C, in people at most risk, and the services available for prevention and treatment. They include recommendations to prevent infection and improve services for people who are infected.

The risks for becoming infected with hepatitis C include receiving blood transfusions prior to 1991, the date when blood and blood products began being screened. Another risk is past or current injecting drug use. Other people may have become infected with hepatitis C through non-sterile medical or dental procedures, non-sterile tattooing or body-piercing or other forms of blood-to-blood contact. There is a small risk of a child being infected before or during birth if the mother has chronic hepatitis.

The research programme was designed to inform the development of the Blood Borne Viral Hepatitis Action Plan for Wales , which is due to be released in early 2007. It should also ensure that all providers of services have a clear understanding of the current prevalence of illness and the current services available to prevent or treat.

A national conference The Hepatitis Spectrum from Prevention to Treatment is to be held on 17th November 2006. All agencies with a responsibility or interest in blood borne viral hepatitis are invited.

Dr Marion Lyons , Programme Lead for Blood Borne Viral Hepatitis and Lead Consultant in Communicable Disease Control at the NPHS, said, "There are people who injected drugs years ago and who do not realise that they may be at risk from this disease. Any action in Wales must include a strategy for ensuring that all these people are made aware of that risk and the opportunities that now exist for testing for infection and for treatment if necessary.

"The research we have undertaken shows that one in four current injecting drug users in Wales are already infected with the hepatitis C virus, rising to 2 in 5 injectors in the major cities in Wales .

"The harm reduction services have worked hard with service users to encourage safe injecting. We know that there are people who are still sharing needles, spoons, water or other paraphernalia increasing the chance that they will pass the virus to others. Every year, one in 18 injectors will become infected."

The evidence from the research programme shows that there is inconsistency in the provision of preventative and treatment services across Wales . The expert guidance published in January 2005 from NICE (the National Institute for Health and Clinical Excellence) - has not been uniformly implemented for hepatitis C management. Sixty seven people completed treatment according to NICE guidance in 2005.

Dr Lyons said,"The future challenge will be to ensure that services are equitable across Wales in capacity and delivery and can meet the patients' needs.

"We recognise that there are a number of barriers to accessing and completing treatment. Individuals may not realise they are at risk or may fear the result of a test. In addition, many do not realise that there is effective treatment available. The pathway a patient follows from being diagnosed to treatment needs to be improved so that treatment and appropriate support is available to all. In addition, as part of Health Challenge Wales, all those who contribute to providing services should raise awareness, and encourage testing. They should also improve the knowledge and skill of their staff.

"Monitoring should be improved with the introduction of surveillance systems and evaluation of intervention programmes. Prevention should be strengthened through peer led intervention. There should be increased availability of harm reduction services including enhanced needle and syringe exchange services, substitute drug treatment and hepatitis B vaccination. Finally, levels of shared care provision within prisons, family doctors and Community Drug Teams should be increased..

"Services must continually review their service provision to ensure they are fit for purpose and that issues around access, shared care and supporting community and clinical staff networks are addressed."

The Conference details and the findings and recommendations of the blood borne viral hepatitis research programme will be available on line from Thursday 2 November 2006

The NPHS research on hepatitis was funded by the Welsh Assembly Government.

AASLD: Novel Drug Takes Toll on Hepatitis C

By Neil Osterweil, MedPage Today Staff Writer
Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of Pennsylvania School of Medicine.
November 01, 2006

MedPage Today Action Points

* Explain to interested patients that the investigational drug described here is an immune-system enhancer that works with standard therapy to control hepatitis C viral infections in patients with difficult-to-treat disease.

* This study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.

BOSTON, Nov. 1 -- An investigational immunomodulator -- a Toll-like receptor 9 (TLR9) agonist -- has shown early antiviral activity in patients with difficult-to-treat chronic hepatitis C infections.

The compound, called CPG 10101, or Actilon, appears to stimulate both innate immunity, in the form of antiviral cytokines such as native interferon α, and antigen-specific adaptive immunity, reported Ira Jacobson, M.D., of Weill Cornell Medical College in New York, and colleagues.

"The ancient but only recently recognized Toll-like receptor system is widely distributed in nature, and has evolved to allow for immunologic recognition of pathogen-associated molecular patterns," Dr. Jacobson said at the American Association for the Study of Liver Diseases meeting here.

The compound directly activates plasmacytoid dendritic cells, the largest sources of interferon α in the body, and B cells. It also indirectly activates natural killer and natural killer T cells, and appears to have synergistic antiviral activity with pegylated interferon and Rebetol (ribavirin), Dr. Jacobson said.

He and his colleagues investigated CPG 10101 in 74 patients who were infected with the treatment-refractory HCV genotype 1 and who had relapsed after a prior response to 24 or more weeks of treatment with Peg-IFN and Rebetol.

The patients were randomized and treated initially for 12 weeks with either Peg-IFN and Rebetol alone or with CPG 10101, and CPG 10101 alone or in combination with either Peg-IFN or Rebetol.

CPG 10101 was delivered in doses of 0.2 mg/kg subcutaneously weekly, Peg-IFN was given 1.5 μg/kg subcutaneously weekly, and Rebetol was given at 800 to 1,400 mg orally daily.

Patients in a treatment arm containing CPG 10101 who achieved ≥2 log10 reduction at week 12 were eligible to continue treatment for up to 48 weeks. All patients in the control (Peg-IFN and ribavirin) group were eligible to roll-over to the triple therapy after completing the initial 12 weeks of treatment, regardless of their viral level.

The authors found that the mean log10 HCV RNA reduction at week 12 was significantly greater among patients treated with CPG 10101 plus Peg-IFN and Rebetol (12 of 14 patients, or 86%) than with standard therapy alone (nine of 15 patients, or 60%).

In addition, 13% of patients receiving standard therapy alone or the CP10101-interferon combination had HCV RNA levels undetectable on an assay with a lower cutoff point of < 50 IU/mL, compared with 50% of patients on the triple-combination (P=0.05).

In all, 20 of 24 patients in treatment arms containing CPG 10101 elected to continue therapy, and of these, two on the triple combination and two on CPG 10101 and interferon head undetectable HCV RNA levels during the continuation phase.

On treatment responses, with HCV RNA < 50 IU/mL at week 24, occurred in seven of 14 patients (50%) on the triple therapy, three of 16 (19%) in the CPG 10101-interferon group, and none of the other groups.

Fourteen of the 15 patients who initially received standard therapy of Peg-IFN and Rebetol were rolled over to receive CPG 10101 after 12 weeks, and five of these patients also had HCV levels that fell off the radar screen.

CPG 10101 alone, however, had no effect on any of the clinical endpoints during the study.

Adverse events were predominantly mild to moderate, and consisted of headache, flu-like symptoms, fatigue and nausea. Injection-site reactions were more common among patients receiving CPG 10101, and there were two dropouts, one because of rash, and the other to injection-site cellulites and necrosis.

The investigators plan to follow patients for end of treatment response and sustained viral response out 48 or 72 weeks, Dr. Jacobson said.

Dr. Jacobson is a clinical investigator for Coley Pharmaceutical Group, maker of CPG 10101.
Primary source: American Association for the Study of Liver Diseases
Source reference: Jacobson IM et al. "Early Viral Response and On Treatment Response to CPG 10101 (ACTILONTM), in combination with pegylated interferon and/or ribavirin, in chronic HCV genotype 1 infected patients with prior relapse response." Presented Oct. 30.

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