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HEPSQUADS
Making a Difference in Your Community

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 sfhepcat@msn.com with your suggestions.

Alan Franciscus
Editor-in-Chief, HepSquads


To learn more about HCSP Trainings and the upcoming schedule, click here.

Vol 1:
Table of Contents

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Update on HCSP and the Train the Trainer Workshops
Alan Franciscus

The Hepatitis C Support Project continued to grow in 2002 with many new services including new web site features, educational materials and the launch of the HCSP Basic Train the Trainer Workshop.

The HCV Advocate Web site experienced phenomenal growth in 2002. The major accomplishments included launching the HCV Advocate Medical Writers' Circle that included some of the most prominent medical experts in the field of liver disease. In 2002, we were able to post two articles a month from various 'Circle' members. Last years web site traffic increased dramatically to an average of over 90,000 hits a week. Additionally, new features of the web site in 2002 included the Monthly News Review which summarizes the important news stories for HCV, HBV, HIV/HCV coinfection, a monthly HCV Benefits Column as well as a comprehensive HCV Glossary.

In 2003 the Medical Writers' Circle members expanded to include over 50 physician members that will allow for 3-4 postings of original articles on hepatitis per month. The HCV Advocate web site will be undergoing a new web site design that will make it easier to access and navigate our web site.

HCSP continues to produce high quality HCV educational materials. In 2002 we produced a Spanish brochure/poster, Understanding Research booklet, HCV Sexual Transmission brochure, Needle Exchange brochure and a series of HCV Fact sheets. HCSP distributed over 250,000 pieces of educational materials in 2002, which doesn't include the number of materials that are copied from our copy ready materials or that are down-loaded from our web site.

In 2003 HCSP is planning to expand our fact sheet series and produce new brochures that will include an updated HCV information booklet, an African American and HCV brochure, a depression booklet and HIV/HCV coinfection brochure/poster and various other brochures for special populations. Our expectation is that we will distribute over 500,000 pieces of educational materials in 2003.

In 2002 the Hepatitis C Support Project (HCSP) launched our Train the Trainer workshops in Northern California. To date HCSP has conducted 13 Basic two-day HCV Train the Trainer Workshops and various community forums throughout California and we now have certified over 400 individuals as Basic HCV Educators through the Hepatitis C Support Project.

In 2003 the HCSP trainings and educational outreach efforts are going to be greatly expanded and targeted towards partnerships with Hepatitis C Coordinators, public health officials and community based organizations. We are in the process of setting up 10 new training workshops in California, Nevada, Utah, Arizona, and Alaska. As we continue to grow we will be targeting areas in the Mid-West and East Coast later in 2003.

In 2003 we launched a new educational program in cooperation with Community Access targeted towards educating the African American community. We have targeted six cities nationwide and hope to expand this program in 2004.

As we expand and grow in 2003 our partnership with you will be our highest priority because I believe that HCV community educators have the potential to be the driving force behind more support and services for the HCV community.

To find out more about the Train the Trainer Programs and for an update on our new Community Access Program click here.

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Training Recertification Alert!

Hepatitis C Support Project HCV Basic Educator Recertification


Trainers originally certified in February, March, and April 2002 will be sent packets with instructions on how to apply for HCSP Basic HCV Educator recertification. All tests and information can be sent via email. If you would like to apply for recertification electronically, please send an email to sfhepcat@msn.com with "Recertification" in the subject line.

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Training in HCV: The Difference
Heather Lusk

Conducting trainings on hepatitis C is different than training on other health-related topics. Before exploring what makes training in hepatitis C unique, some basic terms should be defined: presenter, facilitator and trainer.

A presenter gives information to an audience in a didactic format, or lecture, with little interaction with participants. This modality is valuable when there is a lot of information that needs to be shared in a short amount of time. Research on adult learning has shown that most adults need to have participatory learning and interactive activities to support new knowledge being integrated into their existing frame of reference.

A facilitator involves the group in the training by building upon their experiences and by helping them share knowledge and skills with each other. Facilitators acknowledge that the group process is just as important as the content of the training and take care to engage everyone. If participants feel heard and their input validated, contribute to the group and get their needs met, the training will be more successful.

A trainer is a balance between an engaging presenter and mindful facilitator. He or she is able to give clear, accurate, concise and meaningful information while involving the participants in a group process that is interactive and inclusive of all experiences and viewpoints in the room. While giving a presentation on hepatitis C will always be a viable and essential way to learn the latest HCV information, trainings provide the unique opportunity to build upon the collective knowledge, experiences and feelings of those affected by hepatitis C.

There are four main areas which make training in the hepatitis C epidemic unique: the strong need for HCV information and the complex, changing knowledge base; the lack of federal, state and local resources to address HCV; the use of HCV training to promote activism; and the impact of strong feelings of participants on the training environment.

While HCV has been around for decades, only recently have hepatitis C specific trainings have been offered to the community. People are very hungry for information and are rushing to attend trainings to learn more. This has a positive impact on the learning environment because people want to attend (instead of being told to attend) and many have been waiting to ask their growing list of questions. This enthusiasm helps motivate the entire group. Some people attending may know very little about hepatitis C, and others will be very knowledgeable. For those who are newer to HCV, it is important to remember that the learning curve is bigger and their ability to integrate new information may slow the pace of the training. Balancing this with those who are knowledgeable and want updated and advanced information may be challenging. Interactive activities help those who are knowledgeable share information with those with less knowledge. Give a lot of time for questions and answers during your training as well as at the end of the day. If appropriate, a needs assessment or pre-training quiz may help tailor the content to your audience. It is also important to be clear about the origins of your information, whether or not there is consensus in the clinical and research community, and how to stay up-to-date. Much of the information in HCV is evolving and you want the participants to have the tools to access information after the training.

The lack of resources devoted to HCV affects the training environment in many ways. Participants often feel frustrated and pessimistic about how to use the information they have obtained when there is a lack of HCV-related services in their community. Sometimes, people use the lack of resources as rationale to not hold trainings in their community-why share information about hepatitis C when there are no monies available to offer testing or support services? While there are many reasons to train in underserved communities, it is important to acknowledge that not having many resources makes it challenging to do health education and bring awareness about hepatitis C. Yet this awareness may be the first step to securing funding in the future. During the training, brainstorm creative ways to provide HCV education. Sharing information is very low-cost and may create an awareness leading to a demand for allocation of resources-which highlights the importance of addressing politics in hepatitis C trainings.

Facilitating hepatitis C trainings creates an opportunity to give participants tools to become hepatitis C activists and advocates for those affected by the disease. Many public health movements have begun with a small committed group of activists who demonstrated the need for services and demanded funding. Once people have the facts on HCV, they are better poised to become active in their local HCV task force, write letters to their legislators or lobby their local health department. Taking time during an HCV training to explore how people can create awareness about hepatitis C and advocate for HCV-related services will help create a larger group committed to increasing the capacity of our communities in responding to the hepatitis C epidemic.

All of these issues have an emotional impact that affects the learning environment. Participants may feel scared, angry, sad or overwhelmed by their experiences. These feelings also arise during the training because of the lack of resources in their community, the lack of good epidemiological data, and from fears about themselves or someone they know living with hepatitis C. Creating a safe space for people to share their feelings is important because many people filter information through their feelings-and if they aren't addressed, it can have an impact on how someone hears the information. With the lack of venues for people to come together around hepatitis C, the training environment becomes an opportunity for people to feel connected with others and to see how their feelings may or may not impact their own work. Use an introductory exercise or icebreaker that allows people to share their feelings in relationship to HCV. During a heated discussion, take time to allow participants to talk in pairs about feelings that may come up. Most of all, create a space that acknowledges how emotional talking about HCV can be.

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Trainer's News Review
Liz Highleyman

Viral Hepatitis in Prisons

The growing epidemic of hepatitis C and B among prisoners was in the spotlight this past January. In the January 24 issue of Morbidity and Mortality Weekly Report the Centers for Disease Control and Prevention (CDC) published a report on "Prevention and Control of Infections with Hepatitis Viruses in Correctional Settings," which includes recommendations for the prevention, testing, and treatment of viral hepatitis (see www.cdc.gov/mmwr/preview/mmwrhtml/
rr5201a1.htm
). The following week the CDC held a conference in San Antonio, TX, on management of hepatitis C in prisons.

An estimated 16-41% of inmates show evidence of HCV infection (12-35% have chronic hepatitis C) and a similar 13-47% have evidence of HBV infection, although rates vary widely by state. The new guidelines recommend that all prisoners with a history of injection drug use or other risk factors should be tested for HCV and HBV. (The agency stopped short of recommending universal testing for all prisoners.) Prisoners showing signs of liver disease should be assessed by hepatitis specialists (including liver biopsies, if appropriate) to determine whether they need therapy. Those who do should receive standard-of-care therapy-in most cases, pegylated interferon plus ribavirin for HCV. The report also recommended that hepatitis prevention should be incorporated into prison health education programs, including information about transmission, risk reduction, hepatitis A and B vaccination, liver disease progression, and treatment options. Finally, because the prison epidemics can potentially have a major impact on the community when prisoners are released, the CDC recommends comprehensive release planning, including education about how to prevent transmission, counseling about how to reduce further liver damage, referrals to substance use programs if appropriate, and referrals to medical specialists for follow-up care.

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The National Harm Reduction Conference

Hepatitis and prison issues were also among the topics discussed at the National Harm Reduction Conference, held December 1-4 in Seattle. Prisoners are disproportionately infected with hepatitis C, and the majority of HCV in correctional institutions is attributable to injection drug use. Several researchers and activists discussed the situation of prisoners with HCV, who often have trouble getting appropriate care. Judy Greenspan, from the HIV/HCV in Prison Committee of California Prison Focus, reported that very few prisons offer any type of HCV education, and noted that she frequently hears from prisoners who learn they are HCV positive only after demanding to see their medical records. Brenda Goldhammer, from California STD/HIV Prevention Training, reported that good training programs can help prisoners improve their knowledge about hepatitis and their skills to prevent transmission. Conference attendees also heard from the CDC about programs that successfully integrate hepatitis and HIV education, and from Clean Needles Now about providing HCV prevention, treatment, and self-care information in the context of needle exchange programs. The overall message was the value of providing hepatitis C information within existing programs that meet prisoners and drug users "where they're at," and the importance of providing links and referrals to appropriate, accessible, and affordable follow-up medical care for those who are infected.

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Clinical Trials

African Americans have a higher rate of HCV infection than other U.S. populations, are more likely to develop chronic disease, and have lower treatment response rates-but may experience slower disease progression. Yet the reasons for these differences are not known, because this population has been underrepresented in the majority of HCV clinical trials conducted to date. To shed light on these issues, the National Institutes of Health (NIH) is conducting a large, multisited hepatitis C study-called VIRAHEP-C-that will include 200 African-Americans and 200 whites. All will receive pegylated interferon (Pegasys) plus ribavirin and will be followed for symptoms, side effects, ALT levels, and HCV viral load. For more details and contact information, see www.edc.gsph.pitt.edu/virahepc

In most trials of new treatments for hepatitis C, researchers look for undetectable HCV viral load-which many patients are unfortunately not able to achieve. But research increasingly suggests that even non-responders, partial responders, and relapsers may still benefit from interferon treatment, and that long-term interferon maintenance therapy may delay disease progression and liver damage. Although HCV maintenance therapy appears promising, it is not known whether the benefits of long-term interferon outweigh the difficult side effects. The HALT-C study, conducted by the NIH, is looking at whether long-term treatment with low-dose pegylated interferon (Pegasys) can help delay the development of fibrosis, slow the progression to decompensated cirrhosis, and reduce the chances of developing liver cancer. Ultimately, researchers want to know whether interferon maintenance therapy can reduce the need for liver transplants and keep people with chronic HCV alive longer-hopefully until more effective treatments become available. HALT-C will include more than 1,000 patients who have not achieved a sustained virological response after at least 12 weeks of treatment with any type of interferon or interferon plus ribavirin. For more details, study sites, and contact information, see www.haltctrial.org.

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Pegasys, Copegus, and Hepsera Approved

Good news for people with chronic hepatitis! Last fall the U.S. Food and Drug Administration (FDA) approved two new drugs for hepatitis C and one for hepatitis B.

In October the FDA approved Pegasys, Roche's brand of pegylated interferon-alpha-2a. Pegylated interferon, which is formulated to last longer in the body, can be injected just once per week (as opposed to three times weekly for standard interferon). Studies have shown that Pegasys in combination with ribavirin is more effective than standard interferon plus ribavirin, with sustained virological response rates of 46-51% for genotype 1 (41-46% for patients with high viral load, which is the majority of people with HCV in the U.S.) and 76-78% for genotypes 2 and 3. . Pegasys has been shown to work in several "hard to treat" patient groups, including people with compensated cirrhosis, transplant recipients, people with HCV/HIV coinfection, African-Americans, and patients who have relapsed or failed to respond to previous HCV treatment. Studies indicate that 48 weeks is an effective length of treatment for people with genotype 1, and 24 weeks for genotypes 2 or 3. Unlike Peg-Intron (Schering's brand of pegylated interferon-alpha-2b), Pegasys comes as a premixed solution that does not have to be reconstituted before use. Side effects reported for Pegasys include headache, fatigue, fever, muscle and joint aches, nausea, insomnia, irritability, depression, low blood cell counts, and irritation at the injection site. These symptoms are the same as those associated with standard interferon, but studies (and patient anecdotes) suggest that people taking Pegasys experience side effects less often. Pegasys costs about $300 per 180 µg vial, comparable to Peg-Intron. For a typical 48-week treatment course, this comes to about $14,000.

In December, the FDA voted to approve Copegus-Roche's brand of ribavirin-for use with Pegasys. Copegus costs about $5 per 200 mg tablet, about 40% lower than Schering's Rebetron brand of ribavirin. An even less expensive option may be available soon if the FDA approves a generic version of ribavirin produced by Three Rivers Pharmaceuticals. Generic ribavirin has been delayed by legal disputes over patents. In February, Schering settled a lawsuit by agreeing to grant Three Rivers a non-exclusive license to manufacture and sell generic ribavirin, which it will market under the name Ribasphere. Generic drugs have the same active ingredients and clinical effects as brand-name drugs but typically cost less than half as much.

Finally, last September the FDA approved adefovir (Hepsera) for the treatment of chronic hepatitis B. Research shows that adefovir is effective against "wild-type" and 3TC-resistant HBV, in both people with HBV alone and those with HBV/HIV coinfection.

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AASLD Updates

The annual meeting of the American Association for the Study of Liver Diseases (AASLD) took place last November 1-5 in Boston. AASLD is the major meeting of liver disease specialists.

Researchers reported on various factors that predict progression of liver fibrosis. A higher fibrosis score and older age at first biopsy were most strongly associated with progression of liver damage. Progression is not linear-that is, it does not progress at the same rate over time. Those who have higher fibrosis scores may progress more rapidly. The current recommendation is to perform a repeat liver biopsy every 4-5 years in untreated patients, but these new data suggest that people with higher fibrosis scores may need biopsies every 2-3 years. Another research team reported that heavy alcohol users were only half as likely to clear HCV, adding to the evidence that alcohol can worsen hepatitis progression.

On the treatment front, researchers have attempted to evaluate which brand of pegylated interferon-Pegasys or Peg-Intron-works best by looking at results from separate studies comparing the two drugs to standard interferon. One team found that while Peg-Intron did not seem to work as well as Pegasys, this may be because patients in the Peg-Intron study had worse liver fibrosis and were more likely to have genotype 1 HCV, which is harder to treat. Another group found that Pegasys seemed to produce better early treatment responses at 12 weeks. Also, new data suggests that Peg-Intron might work better if given twice instead of once per week. Until trials are conducted to directly compare the two types of pegylated interferon, decisions about which to use should be based on ease of use, tolerability, and cost.

In other treatment news, researchers reported that Peg-Intron and standard interferon may work about equally well for people with HCV genotypes 2 or 3, with sustained virological response rates of about 85% after 24 weeks of therapy. Also, results were presented showing that treatment response rates in people with HCV genotype 4 were about 78% for Pegasys, 75% for Peg-Intron, and 60% for standard interferon. Genotype 4 (most common in the Middle East and Northern Africa), has been considered "hard to treat," but this new data suggest it is easier to treat than genotype 1-although probably not as easy as genotypes 2 or 3. Preliminary (48 weeks) data were presented on treatment response rates in African-Americans. Several previous studies have shown that African-Americans do not seem to respond as well to HCV treatment. In this study, response rates were 32% for blacks and 52% for whites with genotype 1 taking Pegasys plus ribavirin. While the response rate for blacks was lower than that for whites, it was higher than those seen in earlier studies. Finally, in the area of advanced liver disease, researchers reported that treatment with interferon plus ribavirin can help patients with decompensated cirrhosis while they await a liver transplant. In this study, patients who achieved an undetectable HCV viral load before their transplants stayed negative after they received a new liver.

AASLD participants also heard about possible future treatments for hepatitis C. It remains uncertain how to treat HCV in people who do not respond or relapse after a first treatment attempt. Researchers presented results showing that two experimental therapies-amantadine and mycophenolate mofetil (CellCept)-do not improve treatment response rates in relapsers. Studies did show, however, that pegylated interferon (Pegasys) can successfully treat some patients who relapse after taking standard interferon, and that a 48-week course of treatment seems to work in some people who relapsed after a 24-week course. Two new forms of ribavirin-viramidine and levovirin-were shown to be less likely to cause hemolytic anemia, one of the most serious side effects of the drug. Researchers also discussed new approaches to hepatitis C treatment. Current HCV therapies stimulate the immune system (interferon) or kill a certain type of virus (ribavirin). Some newer treatments are tailored to work specifically against HCV by interfering with the action of enzymes it needs to multiply and infect new cells-the same way HIV treatments are targeted specifically at that virus. Some of the new HCV treatments under study include helicase inhibitors, polymerase inhibitors, and protease inhibitors. BILN 2061 (a protease inhibitor) appears most promising; in small, early human trials it dramatically reduced HCV viral load.

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Making a Difference in Your Community

Dear Hepatitis C Support Project,

I wanted to tell you how grateful we are that we came to the Hepatitis C Support Project's "Train the Trainer" training last year and how it has affected our work. It has helped us expand our outreach across the state of Montana. It has given us the credibility we needed to do the education part of our programs and has also allowed us to start two support groups in our area. Our funding resources have increased because of this training as well and we are looking at expanding even more this year. We are excited to also tell you that we have been given two state contracts for our groups to provide education to prisons and jails across the state. As you may remember we are an agency run by ex-cons for the purpose of helping prisoners re-enter society. Often times, because we are ex-cons, we aren't given much play within the system; however, because of the education and training we have gotten from your program, we are now allowed to educate the prisoners here in institutions across our state on HepC. This is huge because our prison population is 40% positive and that number is growing all the time. The health nurses who used to do the training say it is much more effective coming from us because we are ex-cons and know the behavior inside and outside of the walls. They tell us that the prisoners are much more responsive to our approach instead of their clinical approach. So again I would like to extend our deepest gratitude and thanks for the most informative training we have attended. We are looking forward to coming to the next training and being updated on this ever spreading disease. Please keep us informed of upcoming events and if we can be of any service to you or your organization please don't hesitate to ask.

Peace,

Casey Rudd
821 W. Mendenhall
Bozeman, MT. 59715
406-556-1139
caseyconnections@msn.com

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HCV Treatment Glossary

Common treatment and side effect related terms

ALOPECIA: hair loss

ANEMIA: reduced number of red blood cells or reduced ability of blood to carry oxygen. There are several types of anemia, all with different causes. Symptoms may include fatigue, weakness, pale skin, and difficulty breathing.

ARTHRALGIA: joint pain

AST: abbreviation for alanine aminotransferase. ALT is an enzyme produced inside liver cells. It is frequently elevated in people with chronic HCV infection because of a breakdown of the membranes of liver cells due to inflammation. Serum ALT levels are measured using a common blood test.

BID: taken twice a day

BIOCHEMICAL RESPONSE: how a person's serum ALT responds to treatment. When a patient's elevated serum ALT level becomes normal after HCV therapy has been initiated, this is considered a biochemical response.

BREAKTHROUGH: the return of detectable viral load in a person who had previously achieved a virological treatment response.

CYTOPENIA: low levels of blood cells.

EDEMA: swelling caused by the accumulation of fluid in body tissues.

EFFICACY: effectiveness; the ability to achieve a desired effect.

END OF TREATMENT (EOT) RESPONSE: the disappearance of detectable HCV RNA from the blood at the end of a course of treatment.

GENOTYPE: genetic variation in the structure of HCV. There are six major genotypes, designated by the numbers 1 through 6. There are also many subtypes, e.g., 1a, 2a, etc. In the U.S., genotype 1 is predominant (approximately 70-75% of patients).

HCV RNA: the genetic material of the hepatitis C virus. HCV is a single-stranded ribonucleic acid (RNA) virus.

INTERFERON: a naturally occurring protein in the human body produced by the immune system. Interferon interferes with viral replication. Genetically engineered products based on the natural protein have been developed by several pharmaceutical companies, and are approved for the treatment of chronic HCV infection.

MALAISE: a generalized feeling of illness and discomfort; a flu-like feeling.

MYALGIA: muscle pain.

NEUTROPENIA: an abnormally low number of neutrophils, resulting in increased susceptibility to infection.

NEUTROPHIL: the most common type of immune system white blood cell. Neutrophils are phagocytes that engulf and destroy invading organisms such as bacterial and fungi.

NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI): an antiviral drug that suppresses viral replication by interfering with the action of the reverse transcriptase enzyme. Ribavirin is an NNRTI.

NONRESPONDER: a person who does not show sufficient improvement while undergoing treatment. In HCV, a nonresponder is a person who does not experience a disappearance of HCV RNA.

PEGYLATED INTEERFERON (PEG-INTRON, PEGASYS): a form of interferon that has a long half-life in the body and can be injected less often (typically once per week). Pegylated interferon is approved for the treatment of HCV.

PERCANTANEOUS: through the skin.

PLATELET: see thrombocyte.

QUALITATIVE: relating to, or expressed in terms of, quality. A qualitative viral load test measures the presence of a virus.

QUANTITATIVE: relating to, or expressed in terms of, quantity. A quantitative viral load tests measures the amount of viral genetic material.

RELAPSE: recurrence of disease symptoms following a period of improvement. In HCV, relapse can refer to an increase in viral load after it has been suppressed by antiviral treatment.

RESPONSE TO TREATMENT: how a disease responds to drug therapy. The term can refer to a biological, histological, or virological response.

RESPONDER-RELAPSER (or RELAPSER): a person who initially responds well to a treatment but then experiences a relapse. In chronic HCV infection, this is someone who initially has a positive response to treatment (normal ALT and loss of HCV RNA), but does not sustain that response when therapy is stopped.

RIBAVIRIN (REBETOL, COPEGUS): an antiviral medication that is used in combination with interferon for treatment of chronic HCV infection.

SUBCUTANEOUS (SQ): underneath the skin; usually refers to a drug injected under the skin.

SUSTAINED RESPONSER (SVR): a person who maintains a long-term response to treatment. In HCV, a sustained responder has a long-term beneficial result of HCV treatment (usual endpoints are normal ALT and negative HCV RNA) that persists after treatment has been stopped (six months is the generally accepted time interval).

THROMBOCYTE (PLATELET): a type of blood cell responsible for normal blood clotting.

THROMBOCYTOPENIA: an abnormally low number of platelets, which may result in abnormal bleeding and bruising.

TREATMENT-NAÏVE: a person who has not had prior treatment for a particular condition.

VIRAL LOAD: the amount of virus (i.e., the HCV RNA level) that can be measured, usually in the blood.

VIROLOGICAL RESPONSE: how a person's viral load responds to treatment. In HCV, when a patient's HCV RNA becomes undetectable after HCV therapy has been initiated, this is considered virological response. If the HCV RNA remains negative beyond six months, the term sustained virological response is used.


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