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a quarterly training newsletter from the Hepatitis C Support Project
Welcome to HepSquads, a new newsletter published by the Hepatitis C Support Project. The goal of this newsletter is to provide HCSP trainers with the necessary tools to help support them in their outreach efforts with timely updates, personal stories and other pertinent information.
Regular features of “HepSquads” will include a quarterly news summary, personal success stories from HCSP trainers, training tips and more.
Help us make this newsletter as effective as possible by telling us what you would like to see in the newsletter to help in your efforts. You can mail us at HCSP, PO Box 427027, San Francisco, CA 94127 or email us at email@example.com with your suggestions.
To learn more about HCSP Trainings and the upcoming schedule, click here.
Vol 3: September, 2003
Table of Contents
Making Your Hep C Training Interactive
Most participants in HCV trainings are hungry for information and grateful for the opportunity to gain knowledge and learn from the trainer and other participants. Adult learning principles describe how people learn differently and how training modalities, or training activities, should reflect these differences. Some people learn best by observing or listening, while others learn more effectively by reading and other visual media. Most people retain more information when they are actively involved in the process of learning, instead of passively sitting and absorbing the information. Creating opportunities in your trainings for diverse learning styles will ensure your hepatitis information is reaching the majority of your participants in a meaningful way.
In general, training modalities are divided into three areas: didactic presentations, interactive activities and experiential activities. Didactic presentations are the classic way to convey information, using a PowerPoint presentation, overhead slides or easel pages. Typically, these presentations are given to participants with little involvement from the audience. There are several ways to create dialogue and interaction with participants during your didactic presentation. Asking open-ended questions such as “Why do you think the rates of HCV are so high in this community?” or “What have you heard about sexual transmission of HCV?” can build upon the existing expertise of your audience. Conducting brainstorms is another way to involve participants in a presentation. Asking the group to list how HCV is transmitted is a great way to start your section on transmission, and an opportunity to do a quick survey of how much hepatitis knowledge is in the room. You can also break up presentations by using questions or case studies to provoke conversations in pairs or small groups, as well as by taking questions during your presentation instead of waiting until the end. If time prohibits these activities, you can always use humor during your presentation to connect with your audience and to make your talk more interesting.
Interactive activities involve learners through small group work, case studies, games or other activities involving physical movement and/or sharing of knowledge. During a hepatitis C training, small groups can identify the most important information for people to know about transmission, testing and care and report back to the larger group. Small groups can also examine a case study of someone living with HCV, have a mock debate about HCV treatment in active IDUs, or identify the unique issues for special populations, such as those who are homeless or incarcerated. To teach about transmission, a human continuum can be utilized where each person represents a risk for getting HCV and people stand in order of highest to lowest risk for acquiring HCV. Interactive activities help keep the energy up, involve people in the learning process and create opportunities for people’s own expertise to be acknowledged and utilized.
Experiential activities are interactive activities that also include the exploration of people’s own feelings, values and/or experiences. For example, a values clarification exercise may help participants identify beliefs they hold in relation to hepatitis that may influence their work with clients. A guided visualization through an HCV counseling and testing session may provide insight into the anxiety and fear that accompanies many who decide to test for hepatitis C antibodies. An activity that focuses on identifying people’s hopes and fears about the hepatitis epidemic provides an opportunity for sharing feelings with each other and finding the commonalities we all share. There are many feelings related to working in and living with hepatitis, and experiential activities help participants connect with their feelings in relation to their work.
Creating and delivering interactive hepatitis trainings takes time, but making interaction a priority has many benefits. It includes teaching to a variety of learning styles, makes trainings fun, encompasses the vast knowledge and experience of participants and helps maintain energy throughout the day (especially needed after lunch). Be creative by modifying childhood games, stealing ideas from other trainers and changing them to meet your needs, or by asking participants if they have a quick energizer or joke to share with the group. You can still meet your training objectives while including activities that involve participants in the learning process – and perhaps have some fun as well.
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HEPSQUADS NEWS ROUNDUP
In the July 9 issue of the Journal of the American Medical Association, researchers from the Harvard School of Public Health published a report suggesting that HCV positive people who have minimal liver damage may be better off without treatment. Most people with chronic HCV never develop advanced liver disease, and for these people treatment may be neither helpful nor cost-effective. The report put the 30-year risk of developing cirrhosis at 13-46% for men and 1-29% for women. “For patients at low risk of progressing, the overall health gain from treatment may be minimal given the potential for toxic side effects,” said report co-author, Dr. Sue Goldie.
Results reported in the July 2003 issue of Gastroenterology provide another reason for waiting. In this study, 52% of patients with acute HCV infection spontaneous cleared the virus without treatment, usually within 12 weeks after the onset of symptoms. The study suggests that since a high percentage of acutely infected symptomatic people naturally clear HCV, therapy should be delayed until after 12 weeks to avoid unnecessary treatment. However, people with acute hepatitis C who do not experience symptoms are unlikely to clear HCV on their own, and should be treated as early as possible.
But for those who need it, interferon therapy provides long-term benefits. In the August issue of Hepatology, Japanese researchers reported that 9% of 355 HCV patients treated with interferon died during the follow-up period, compared with 14% of 104 untreated patients. And at the July meeting of the European Association for the Study of the Liver, researchers reported that 99% of HCV patients in their study who initially demonstrated a response to treatment with Pegasys remained virus-free up to four years later. “This information tells us that when a patient achieves a sustained virological response, they are indeed really ‘cured’,” said Dr. Mark Swain of the University of Calgary in Canada.
Pegasys vs. Peg-Intron
In the July 2003 issue of the Journal of Viral Hepatitis, E. Formann and colleagues from Austria suggested that Peg-Intron should be administered twice weekly to maintain adequate blood drug levels. In this study, by the end of the one-week dosing period, Peg-Intron was undetec-table in the blood of 9 out of 10 patients, and HCV viral load increased toward the end of the dosing period. When used twice weekly, Peg-Intron levels remained higher. “To achieve continuous drug exposure and to improve initial viral clearance, peginterferon-alpha-2b [Peg-Intron] has to be given at least two times weekly,” the authors concluded.
Schering Plough issued a warning this summer about lower than expected earnings and a dramatically reduced dividend. Market analysts blame part of Schering’s troubles on Roche’s entry into the pegylated interferon plus ribavirin market earlier this year—Roche now has 42% of the market share of HCV treatment medications. This increase in market share of Pegasys is believed to be due in part to lower cost and ease of administration of Pegasys compared with Peg-Intron.
Roche recently announced that it will soon begin a study of Pegasys in HCV patients who did not respond to their first attempt at treatment with Peg-Intron. The REPEAT trial, which expects to enroll 1,000 people in 12 countries, will test whether initial non-responders to Peg-Intron plus ribavirin will have better luck with Pegasys plus ribavirin. This will be the first trial to test Pegasys in Peg-Intron non-responders; previous studies have looked at the use of pegylated interferon in people who did not respond to the older standard interferon.
We know that in people with HCV, genotype 1 is more difficult to treat than genotypes 2 or 3. Mounting evidence suggests that genotype is also an important factor in people with HBV. In the August 15 issue of Clinical Infectious Diseases, Hong Kong researchers reported that patients with HBV genotype B have more severe liver disease, elevated ALT levels, a higher risk of developing decompensated cirrhosis, and a higher mortality rate than those with genotype C. Some studies have suggested that patients with HBV genotype B respond better to interferon therapy than those with genotype C. But in the July issue of Gastroenterology, researchers reported that treatment with adefovir (Hepsera) is equally effective regardless of HBV genotype.
In other HBV news, there is increasing evidence that pegylated interferon is better than standard interferon in treating chronic hepatitis B, as it is for HCV. In a study published in the July issue of the Journal of Viral Hepatitis, 28% of 194 patients who received Pegasys demonstrated a response after 24 weeks of therapy, compared with 12% who took standard interferon.
New data continues to confirm than coinfection with HIV accelerates progression of chronic hepatitis C. In a study of more than 4,700 U.S. veterans presented at the International AIDS Society (IAS) conference in July, T.P. Giordano and colleagues reported that HCV/HIV coinfected people are about ten times more likely to develop cirrhosis and about six times more likely to develop liver cancer than people with HIV alone. P. Braitstein and colleagues reported that HCV/HIV coinfected patients experience only modest CD4 cell increases after starting anti-HIV therapy (an average of 50 cells in coinfected patients vs. 190 cells in those with HIV alone). In the July issue of Gut, A.H. Mohson and colleagues estimated that the average time from HCV infection to the onset of cirrhosis was 23 years in coinfected people, compared with 32 years in people with HCV alone.
In terms of treatment, Martin Pols from the National Institutes of Health reported at the IAS meeting that HCV/HIV coinfected people appear to respond more slowly to HCV treatment, and that the usual 12-week cutoff for determining whether therapy is working may be too short for these patients. In terms of anti-HIV drugs, Canadian researchers reported that the protease inhibitor ritonavir (Norvir) and high cumulative exposure to stavudine (d4T or Zerit) were associated with a higher incidence of drug-related liver toxicity, while the protease inhibitor Nelfinavir (Viracept) was least likely to cause severe liver damage. But Italian researchers reported in the June issue of the Journal of Acquired Immune Deficiency Syndromes that taking anti-HCV therapy for six months prior to starting anti-HIV treatment reduced by more than half the rate of discontinuation of anti-HIV therapy due to drug-related liver toxicity.
Finally, in the realm of HBV/HIV coinfection, F. Raffi and colleagues reported results at the IAS conference showing that emtricitabine (FTC or Emtriva) was a safe and effective treatment for hepatitis B in HBV/HIV coinfected individuals. Emtrivitabine is structurally similar to lamuvudine (3TC or Epivir), but remains in the body longer and is less likely to promote drug resistance. After 48 weeks of treatment, 56% of coinfected patients receiving emtricitabine achieved undetectable HBV DNA. On July 2, the FDA approved emtricitabine as a treatment for HIV, but it is not yet approved for hepatitis B.
In other drug approval news, Schering Plough announced on July 31 that it had received FDA approval to market its Rebetol brand of ribavirin for use in HCV infected children ages 3 and older. Schering’s Intron A brand of standard interferon and Rebetol are currently the only drugs approved to treat HCV in children. But, as is the case with adults, pegylated interferon may prove superior to standard interferon for treating children with hepatitis C. At the May 2003 Digestive Disease Week conference, researchers reported that at weeks 24, 48, and 72 after beginning treatment with Pegasys, 57% (8 of 14), 43% (6 of 14) and 38% (5 of 13) of children, respectively, had undetectable HCV viral load, and most experienced only mild side effects.
Evidence continues to accumulate that alcohol can accelerate liver disease progression in people with chronic hepatitis. In the May issue of the Journal of Viral Hepatitis, researchers confirmed that alcohol sped up progression of fibrosis. According to results of a laboratory study published in the July 2003 edition of Hepatology, alcohol enhances HCV replication and reduces the effectiveness of interferon therapy. And in the same issue, researchers reported that even moderate alcohol consumption may accelerate liver disease progression by increasing oxidative stress.
Finally, researchers reported in the July issue of the Journal of Medical Virology that people who snort or sniff heroin in combination with cocaine have a higher risk of HCV infection. Sniffing drugs can cause the nasal passages to bleed, and HCV in the blood left on a straw can be passed to the next person who uses it. This study reinforces the recommendation that people who sniff or snort drugs should not share straws.
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The liver biopsy is considered by many experts to be the most specific diagnostic tool used to assess the nature and severity of liver diseases such as hepatitis C. Liver biopsies are important for many reasons, such as accurate diagnosis or ruling out any coexisting liver disease, staging and grading the severity of HCV disease, treatment decisions, patient reassurance and as a benchmark to gauge future disease progression.
A liver biopsy is usually performed in an office or hospital as an out-patient procedure. The most common type of biopsy is a percutaneous needle biopsy. Ultrasonography is sometimes performed before the biopsy both to identify lesions in the liver and to pinpoint the exact place where the needle will be inserted. Some people prefer light sedation before the procedure to alleviate the fear of possible discomfort. However, a person must be fully conscious during the procedure to avoid potential complications. There are three different types of needles (suction needle, cutting needle and spring-loaded). The area around where the needle is inserted is numbed with a local anesthetic before the actual insertion of the biopsy needle. The actual procedure is accomplished in a very short period of time—generally one-tenth of a second. The specimen can vary from between 1 and 3 centimeters in length and 1.2 and 2 millimeters in diameter, which represents 1/50,000 of the total mass of the liver. The patient is then asked to lie on the right site for 4-8 hours to control any possible bleeding from the liver. After several hours of observation the patient is discharged if there are no complications.
Side Effects and Complications of a Liver Biopsy
The most common side effect of the biopsy is pain—an estimated 20% of people biopsied experience mild to moderate pain during and after the procedure. More uncommon is the person that has severe pain as the result of the liver biopsy.
Complications for the procedure are another area of concern but are generally uncommon. It is estimated that 1 in 10,000 to 1 in 12,000 people die as a result of complications from a liver biopsy and that only approximately 2-3% of patients require hospitalization from the procedure.
Role of Liver Biopsy
Liver biopsies are performed for a variety of reasons from diagnosis to treatment issues. Diagnosis of other coexisting liver diseases is of prime importance in the management and treatment of hepatitis C. For instance, the diagnosis of hemo-chromatosis, occult hepatitis B and Nonalcoholic Steatosis can only be made by a liver biopsy and can have an important impact on the treatment and prognosis of hepatitis C.
There are other biochemical markers that are used to assess the severity of HCV liver disease, such as ALT’s (alanine aminotransferase); a combination of markers such as the ALT/AST (aspartate aminotransferase) ratio, platelet counts and PT (prothrombin time). However, in one recent study 20% of cirrhotics did not have these specific markers and the diagnosis of cirrhosis would have been missed if a liver biopsy had not been performed.
The most important role of the liver biopsy is the ability to stage the accurate extent of liver injury and fibrosis. Liver biopsy results are reported in terms of histological (liver tissue) stages. Stage 1 is liver inflammation without fibrosis. Stage II indicates inflammation with early fibrosis. Stage III indicates that the fibrosis is starting to bridge (connect) over adjacent areas. Stage IV is cirrhosis and loss of normal liver architecture. It should be noted that within each stage disease severity can vary widely; for example, Stage IV cirrhosis is classified into two different types: compensated cirrhosis and decompensated cirrhosis.
HCV Management Decisions
Properly staging the degree of damage to the liver is important in determining the rate of progression and the possible need for treatment. For example, many people can estimate when they were exposed to HCV by assessing risk factors such as blood transfusions or injection drug use. Duration of HCV and current disease severity can give you a good idea of the rate of future disease progression. For instance, someone who believes that he or she has been infected for 20 years and has been graded with stage 1 liver fibrosis may be fairly confident that the rate of progression is slow. This can be confirmed with serial biopsies every 3-5 years. On the other hand, if someone believes that he or she has only been infected with HCV for 2 years and the biopsy shows stage 3, then a more aggressive approach may be required. This information can be a comfort to the patient and physician and is another tool used to manage HCV.
Decisions about medical therapies should also be driven by information obtained from a liver biopsy. Medications used to treat hepatitis C have come a long way since the early days. Interferon monotherapy produced substandard treatment results with only up to 10-15% of patients achieving a sustained virological response, i.e., undetectable virus 6 months following the end of treatment. The introduction of ribavirin to be used in conjunction with interferon dramatically increased treatment response to up in the 40 percentile. Now, we have the combination of pegylated interferon plus ribavirin and the treatment response rates for genotype 1 are between 42-46% and 76-82% for genotypes 2 and 3 depending on the pegylated product used. But these treatments can have moderate to severe side effects and the liver biopsy can be a good tool in helping physicians and patients make intelligent and appropriate healthcare decisions.
Treatment for genotypes 2 and 3 yields up to an 80% sustained virological response (SVR) rate, so many physicians now routinely treat genotypes 2 and 3 even without a biopsy if it is clear that the patient does not have decompensated cirrhosis. However, SVR’s for genotype 1 are much lower and a liver biopsy can be a good tool for making a treatment decision. For instance, a person that has had HCV for 20 years, has minimal liver damage reported on a liver biopsy, and is HCV genotype 1 can probably postpone treatment until more effective and less toxic drugs are available. However, someone with HCV genotype 1 who acquired HCV 5 years ago with stage 3 fibrosis identified by a liver biopsy is a good candidate for treatment regardless of the potential to eradicate the virus since therapy has been shown to stop, reduce and even reverse fibrosis.
Currently, there is much research looking at various blood tests to actually measure the amount of inflammation and scarring of the liver. However, until these tests are perfected the percutaneous liver biopsy will be considered the standard of care in assessing liver damage caused by hepatitis C.
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Making a Difference in Your Community: Train the Trainer Program
HCSP Train the Trainer reached a milestone in 2003 as we began the process of recertification. One component of the recertification process is for the educators to list objectives accomplished as a result of the HCSP T-O-T workshops. We have included some comments below from the educators that we thought would be of interest to our readers and hopefully inspire other educators in their efforts to educate and support those affected by HCV.
“My favorite accomplishment is being able to share everything I have learned (including all the educational materials) with my group of inmate Peer Health Educators inside Central California Women’s Facility in Chowchilla. I also co-present HEP(A-E) for training and health workshops inside.”
Sheila Inke, Program Manager, Centerforce
“In the past two months I have tested and talked to many people about HCV. I’ve given positive results and most importantly I am now able to give information when someone tests HCV positive on what steps to take next and the important questions to ask.”
Bennie Balderama, Fresno, CA
“I have done presentations for county staff, health clinic staff, drug and alcohol treatment programs’ clients and staff, and at a large local commercial company for over 170 employees.”
Bob Brantley, Coordinator for the Fresno-Clovis Support Group
“I made sure that all of the staff in our medical department was vaccinated against hepatitis B.”
Jose Gutierrez, Fresno, CA
“My staff and I include Hep C information in the lecture series that is presented to the substance abuse treatment facilities at which we provide educational services. In addition, the staff at WestCare receive inservice trainings on Hepatitis C.”
Mica Ghimenti, Program Coordinator of the Health Education Dept, WestCare California.
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