DISCLAIMER: Neither HeCSC nor the hepc.bull can endorse any physician, product or treatment. Any guests invited to our groups to speak, do so to add to our information only. What they say should not necessarily be considered medical advice, unless they are medical doctors. The information you receive may help you make an informed decision. Please consult with your health practitioner before considering any therapy or therapy protocol. The opinions expressed in this newsletter are not necessarily those of the organisation.

WESTPORT, Jan 13 - Early-stage cirrhosis and hepatic fibrosis may be reversible in some hepatitis C patients who respond to long-term interferon therapy, according to investigators from the New England Medical Center in Boston.

Dr. Marshall M. Kaplan and others at the Massachusetts-based medical center report on two such patients in the December issue of Digestive Diseases and Sciences.

Both patients had early-stage (class A) cirrhosis and/or extensive fibrosis. "Neither patient had any signs of portal hypertension or of liver

failure," according to the report.

After 23 and 30 months of treatment with interferon-alpha, liver biopsies in both patients revealed no evidence of cirrhosis or liver fibrosis, Dr. Kaplan and colleagues say. Both patients also demonstrated complete responses to interferon therapy, with "...normalisation of all liver function tests and disappearance of hepatitis C viral RNA."

This is not the first report of cirrhosis or fibrosis regression after appropriate therapy, the authors note. Based on their experience and that of other investigators, Dr. Kaplan and his team conclude that "...the presence of cirrhosis on a liver biopsy in a patient with chronic hepatitis C and conserved hepatic synthetic function should not be a contraindication for treatment with [interferon-alpha]."

Dr. Kaplan stressed in an interview with Reuters Health that the contraindication applies only to patients who are Child-Pugh class C and that those who are class A or B are potentially curable.

"A dogma in medicine has been that cirrhosis is not reversible and, by analogy, is therefore not treatable," he commented. "This paper is to say that this is not true."

Dig Dis Sci 1998;43:2573-2576.

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If you have cirrhosis, you may want to think twice about popping an aspirin or other NSAID. It is universally accepted that NSAIDs can have severe gastrointestinal effects and cause peptic ulcers to bleed. They may cause oesophageal bleeds, as well. According to an article (Anti-inflammatory drugs and variceal bleeding: a case-control study) in the February 1999 issue of GUT magazine, interviews were conducted at the University Hospital in Poitiers, France, with 200 patients with cirrhosis. Of these patients, 125 had been admitted for a first bleeding episode mainly related to oesophageal varices, and 75 patients had never had a bleed.

Twenty five percent of the patients who were admitted for bleeding had used NSAIDs during the week before the bleed. In contrast, only 8 of the 75 who had not had a bleed had used NSAIDs. Use of aspirin alone or combined with other NSAIDs was also more prevalent in the cases with bleeds (17%) than in the cases with no bleeds (4%). Analysis showed that NSAID and the size of the varices were the only variables independently associated with the risk of bleeding.

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VX-497 is a potent inhibitor of inosine monophosphate dehydrogenase (IMPDH), a human enzyme that is essential for production of nucleotides—the building blocks of RNA and DNA. Blocking IMPDH may be an effective strategy for blocking the growth of certain cell types, such as lymphocytes, and the growth of viruses, because both lymphocytes and viruses depend on nucleotide synthesis for growth.

"VX-497 is a drug candidate with potential in a variety of autoimmune diseases, because of its selective activity on the proliferation of lymphocytes that orchestrate the immune response," said Vicki Sato, Senior Vice President and Chief Scientific Officer of Vertex. "In vitro experiments conducted in the past year with VX-497 have shown that blocking IMPDH also inhibits the growth of a wide variety of RNA and DNA viruses, including viruses that are closely related to the hepatitis C virus. This antiviral activity, together with the demonstrated effects of VX-497 on lymphocyte migration and proliferation, suggest that this compound has the potential to contribute to the treatment of HCV infection, a disease of both viral proliferation and liver inflammation."

The Phase II clinical trial announced today is a dose range finding study designed to measure the safety and pharmacokinetics of VX-497 as a single agent in HCV-infected patients unresponsive to prior treatment with interferon alpha, a standard HCV therapy. The study will also make a preliminary assessment of VX-497's efficacy in reducing levels of serum alanine aminotransferase (ALT) and HCV viral RNA in plasma. Decreases in serum ALT would indicate an improvement in overall liver function and reduction in liver inflammation, and decreases in viral RNA would provide direct evidence of an antiviral effect of VX-497. Both measures are considered key endpoints in measuring anti-HCV activity. The trial involves 30 preselected patients, who will be treated initially for a period of four weeks. If the compound is well-tolerated, patients may be treated with VX-497 for an additional three months. Future studies with VX-497 may evaluate the compound as monotherapy or in combination with other agents for the treatment of HCV.

In addition to the current trial involving VX-497, Vertex is actively working to discover inhibitors of the HCV protease and helicase enzymes, which are critical for viral replication.

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According to Sobesky and Mathurin, (GASTROENTEROLOGY 116:378-386, 1999), regression of fibrosis may not be limited to responders:

"These investigators found that overall, interferon treatment changed the natural fibrosis progression rate in patients with chronic disease independently of genotype and early response. As Sobesky and colleagues suggest, treatment with interferon in chronic active hepatitis C should be a priority for patients with a high likelihood of progressive disease even if they have no response, especially at 3 months. The importance of this concept should be even more useful for the future evaluation of combination interferon and ribavirin in non-responders."

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DISCLAIMER: Neither HeCSC nor the hepc.bull can endorse any physician, product or treatment. Any guests invited to our groups to speak, do so to add to our information only. What they say should not necessarily be considered medical advice, unless they are medical doctors. The information you receive may help you make an informed decision. Please consult with your health practitioner before considering any therapy or therapy protocol. The opinions expressed in this newsletter are not necessarily those of the organisation.

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Castlegar/Grand Forks/Trail Contact: Robin, 365-6137.

Chilliwack Contact: David, 792-3467.

Nanaimo HeCSC Meetings: Second Thursday of each month, 7 PM, Health Unit-Central Vancouver Island, 1665 Grant St. NEXT MEETING: Apr. 8^th. Contact: Helen, 245-8759.

New Westminster Support Group Meetings: Second Monday of each month, 7:00-8:30 PM, First Nation's Urban Community Society, Suite 301-668 Carnarvon Street, New Westminster. NEXT MEETING: Apr. 12^th. Contact Dianne Morrissettie 525-3790.

Prince Rupert Contact: April, 627-7083.

Quesnel Contact: Elaine, 92-3640.

Richmond Meetings: Fourth Tuesday of each month, 7 to 9 PM, Westminster Health Unit, 7000 Westminster Hwy., main floor, room 3. NEXT MEETING: Apr. 27^th. Contact: Carmel at Richmond Health Unit, 279-4069.

White Rock Support Group: Meeting Room #2, Peace Arch Hospital. Contact Lisa Peterson at 538-8704.

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1. Transfusions since the 1970's—the incidence following transfusion has been variable—approximately 3%. In a Canadian study 9.2% post transfusion were positive for hepatitis C (570 participants in this study).

2. Transplantation is another effective way of transmitting the disease.

3. The most efficient method of transmission is by IVDU. Hepatitis C is much more efficient than HBV or HIV. There is a 90 percent prevalence over 5 years in IVDU. And the probability of succeeding here with prevention is very low.

4. There is poor practice used in body piercing in general. And body piercing has been around in one way or another since at least the time of Caesar.

5. Occupational transmission is through needlesticks, cuts, etc. The probabilities of acquiring infection this way is approximately 1.8%. The range is between 0 and 7 percent. A total of 200 - 300 of these infections have been looked at in a variety of studies and found that the hollow needle is associated with a much greater risk.

6. Sexual transmission is certainly a risk. Male to female transmission is 4 to 1.

7. Household contacts—a very small proportion of unrecognized HCV. Perinatal transmission does occur, but it is HIV dependent. It is between 14-23% from mother to child. This increased vertical transmission has been shown to be lower in a few small studies where birth was by Caesarian section.

I would say that the transmission of HCV is 60% from IVDU, 20% from sexual, 10% from occupational, and 10% unknown. (We seriously question the sexual transmission statistics given here and which Health Canada and the CDC in the USA but much much lower—ed.)

British Columbia

• renografts - 3.3%
• prisons including both male and female - 25%
• male prisoners - only 40%

Alberta

• prisons including both male and female-25.6%
• homosexual population- 6.4%

Worldwide

The highest incidence is in Egypt with 25 percent. However all studies are based on blood donors and are not representative of the general population.

Canada

• Three-quarters of the HCV population comes from Ontario, British Columbia, Alberta, and Quebec.
• The range is from 2.4% to 8.7%.
• The rate outside the city of Montreal is much higher than in the city core.
• IV drug use is much more prevalent within the city and we have no explanation for this observation.

1998 was the first time we have seen a drop in the number of hepatitis C cases identified in the CRD. In 1995, there were 427 cases, in 1996, 528 cases, in 1997, 624 cases, and in 1998, 572 cases were reported.

Capital Health Region's Street Outreach nurses can be accessed 7:30 to 9:30 PM at the Needle Exchange for free hepatitis A and hepatitis B vaccines for hepatitis C infected persons who are street entrenched only. Their office phone number is 384-1372, where you can leave messages. (These nurses can also help if you are taking interferon, and because of prior IV drug abuse, you do not wish to inject yourself.)

All other HCV positive persons who are Hep B or Hep A negative can access the vaccine free of charge through their family physician or probably walk-in medical centres who can order the vaccine for them. Because of sheer numbers, EDC is not administering vaccines to HCV positive persons at this time, and folks are encouraged to go through their doctors. Please note, the CRD does not hand out vaccines to people to take back to their doctors. The doctor’s office must pick up the vaccine with their regular vaccine orders on behalf of patients.

Title: The Shifting Epidemic: HIV and Hepatitis C Co-infection

Speakers: Jenny Heathcote, James Kreppner, Martin Schechter

Moderator: Michael O'Shaughnessy

Co-sponsored by the NHRDP and the CTN.

Date: May 4th

Time: 10:30 am- 12:30 pm

Place: Victoria Conference Centre.

Mike O'Shaughnessy, of the Canadian HIV Trials Network, has agreed to provide passes for our members to attend the workshop at this conference. They are devoting one morning to Hep C and HIV co-infection. James Kreppner is a co-infected person. Dr. Heathcote is a Hep C specialist, and Dr. Schechter will be talking about the epidemiology.

If you would like tickets, you may sign up by calling the HeCSC Victoria office at 388-4311. You may leave a detailed message.

(Please contact the following nurses at 604-876-5122)

1. Phase III Open—label randomized, multi-center parallel dose efficacy and safety study comparing PEG interferon alpha 2a (IFN) to an induction regimen of Roferon A in the treatment of HCV. Please contact Susan for more info.
2. A study of viral load in HCV measured at 12 hour intervals for 5 intervals before and after the start of treatment with interferon alpha 2a. Please contact Natalie for more info.
3. A study of induction consensus interferon in HCV patients with failed response to interferon alpha 2a and ribavirin. Please contact Susan for more info.
4. Treatment of chronic HCV in patients with coagulation disorder. Please contact Susan for more info.
5. Study comparison of PEG IFN alpha 2b plus ribavirin versus IFN alpha 2b plus ribavirin for the treatment of chronic HCV in previously untreated adult patients. Please contact Natalie for more info.
6. Ribavirin plus Intron A combo in non-responding or relapsing chronic HCV patients following IFN therapy. Please contact Natalie for more info.
7. A study of maintenance IFN alpha in HCV patients with an inadequate response to IFN and ribavirin. Please contact Natalie for more info.

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If you are interested in volunteering to visit our sick members who are home-bound or hospitalised, please call Trish at 479-5369, or email her at plunkett@islandnet.com

We need items and books for our GARAGE SALE, which will take place in July. Please contact Jean Day, 370-1587.

Volunteers are needed for our Run For Life on July 18^th. Please contact 388-4311.

URGENT: We need 20 to 30 volunteers for Ribbon Day, Sunday, May 23^rd, to hand out ribbons and information at the malls. Please contact 388-4311.

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This column is a response to requests for a personal classified section in our news bulletin. Here is how it works:

To place an ad: Write it up! Max. 50 words. Deadline is the 15^th of each month and the ad will run for two months. We'd like a $10 donation, if you can afford it. Send checks payable to HeCSC Victoria Chapter, and mail to HeCSC, Attn. Squeeky, 1611 Quadra St., Victoria, BC V8W 2L5. Give us your name, tel. no., and address.

To respond to an ad: Place your written response in a separate, sealed envelope with nothing on it but the number from the top left corner of the ad to which you are responding. Put that envelope inside a second one, along with your check for a donation of $2, if you can afford it. Mail to the same address as above.

Ad No. 10

Respectful, respectable man (49) but looks younger who is very active and loves life. I'm 6' tall, 210 lbs. and considered nice looking, emotionally and financially secure and non-symptomatic. I won't let Hep C rule my life and am looking for a positive female to share a long-term happy life together. Vancouver area.

Ad No. 11

Would like very much to begin a new friendship via letters, or in person, with an HCV positive man. I am an upbeat, kind-hearted, enthusiastic female, late 40's who delights in seaside walks and derives great pleasure in nature's endless array of offerings! A good sense of humour a definite plus. BC please.

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