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November 2006 HCV Advocate

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Coinfection News from XVI International AIDS Conference and ICAAC
Liz Highleyman

Healthwise: Living with Stress and HCV
Lucinda K. Porter, RN

Update: HCV Drug Pipeline
Alan Franciscus, Editor-in-Chief

The Most Common Questions about Access to Treatment
Alan Franciscus, Editor-in-Chief

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Coinfection News from XVI International AIDS Conference and ICAAC
Liz Highleyman

Two recent conferences – the XVI International AIDS Conference held in Toronto in August and the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in September – featured several presentations on HIV/HCV coinfection.

More Data from APRICOT
Three research teams presented further data from APRICOT, a pivotal trial in which 860 HIV/HCV coinfected participants were treated with conventional interferon plus ribavirin, pegylated interferon-alfa-2a (Pegasys) monotherapy, or pegylated interferon plus ribavirin for 48 weeks. Most were on combination anti-HIV therapy (HAART) and had stable HIV disease. As reported in the July 29, 2004 New England Journal of Medicine, 29% of genotype 1 patients treated with Pegasys/ribavirin achieved sustained virological response (SVR), compared with 14% in the Pegasys monotherapy arm and 7% in the conventional interferon/ribavirin arm. For patients with genotypes 2/3, the corresponding rates were 62%, 36%, and 20%.

As reported at the AIDS Conference, J. Sasadeusz and colleagues (abstract WEPE0040) analyzed data from 257 participants who received Pegasys/ribavirin and had baseline fibrosis assessments. Treatment was equally effective in patients with various stages of mild-to-moderate (stage F0-F4) fibrosis (SVR rates ranging from 40%-50%), but those with advanced fibrosis(stage F5-F6) had lower sustained response rates (28%). Safety and need for dose adjustment did not differ significantly according to fibrosis stage. These data indicate that even coinfected patients with advanced liver disease can tolerate and benefit from anti-HCV therapy.

At ICAAC, M. Rodriguez-Torres and colleagues (abstract H-1887) presented an analysis of the relationship between baseline HCV RNA and sustained response in 271 participants in the pegylated interferon/ribavirin arm of APRICOT. The HCV RNA cutoff-point that most effectively identified patients likely to achieve SVR was 400,000 IU/mL. Among patients with HCV RNA below this level, SVR rates were high regardless of genotype. Among participants with genotype 1, the SVR rate was “markedly lower” in those with baseline HCV RNA levels of 400,000 IU/mL or higher (20% vs 71%); among patients with genotype 2 or 3, the difference was “slight.” The researchers emphasized, however, that the outcome of treatment for any specific individual cannot be predicted in advance based on HCV viral load.

In another APRICOT analysis, D. Dieterich and colleagues (ICAAC abstract H-1888) looked at CD4 percentage and response to hepatitis C treatment. It was previously shown that coinfected patients with higher baseline CD4 cell counts had slightly better response rates. CD4 cell percentage – the proportion of all lymphocytes that carry the CD4 surface marker – is another measure of immune function. They found that among genotype 1 patients, the lowest virological response rates were seen in patients with the lowest CD4 percentages; this relationship was not seen in genotype 2 or 3 patients. Although analysis by CD4 percentage “did not reveal any strong influence on virological response rates,” the researchers concluded, “a slight trend toward an earlier and possibly a slightly more sustained response was seen in those with higher baseline CD4 percentage.”

Latest PRESCO Results
Also at ICAAC, M. Nunez and colleagues (abstract V-1910) presented the latest data from the Spanish PRESCO trial, which treated 389 HIV/HCV coinfected individuals with Pegasys plus 1000-1200 mg/day weight-based ribavirin – higher than the 800 mg/day used in APRICOT. Patients who experienced early virological response at Week 12 continued therapy for 48 or 72 weeks if they had genotype 1 or 4, and 24 or 48 weeks if they had genotype 2 or 3. Here, too, most subjects were on HAART and had well-controlled HIV. End-of-treatment response was seen in 55% of patients with genotype 1, 90% with genotype 2 or 3, and 41% with genotype 4. SVR rates were 36%, 70%, and 33%, respectively. The researchers concluded that “[t]he use of ribavirin 1000-1200 mg/day along with [Pegasys] provides higher SVR than previously reported in HCV/HIV coinfected patients treated with fixed low ribavirin dose.” Prolonged treatment, however, did not improve response rates.

Retreatment of Coinfected Patients
P. Labarga and colleagues (ICAAC abstract H-1061) also presented data suggesting the superiority of higher-dose ribavirin. The Spanish PILOT study included 51 coinfected participants (72% with genotype 1 or 4) who were non-responders (74%) or relapsers (26%) to previous suboptimal hepatitis C therapy with conventional interferon monotherapy, conventional interferon plus ribavirin, or pegylated interferon plus 800 mg/day ribavirin. All were retreated with Pegasys plus 1000-1200 mg/day weight-based ribavirin. After 12 weeks, early virological response rates were 98% among genotype 2/3 prior relapsers, 93% among genotype 1/4 prior relapsers, 75% among genotype 2/3 prior non-responders, and 52% among genotype 1/4 prior non-responders. At 24 weeks, proportions with undetectable HCV in these four groups were 69%, 65%, 75%, and 48% respectively (the study is still underway). Plasma ribavirin concentration was the strongest predictor of retreatment response at 24 weeks.

Treatment of Acute HCV
At ICAAC, M. Vogel and colleagues (abstract H-1060) with the German Hepatitis Group reported on a trial in which HIV positive gay/bisexual men with acute, apparently sexually transmitted HCV were offered treatment with pegylated interferon for 24 weeks; partway through the study, genotype 1 patients added weight-based ribavirin. Out of 47 participants, 11 remained untreated and only three experienced spontaneous HCV clearance. Among 36 treated patients, 72% had an end-of-treatment response and 61% achieved SVR. Spontaneous clearance and treatment response rates did not differ based on HCV or HIV viral load, CD4 count, use of HAART, or ALT level.

Coinfection in Children
D. Micheloud and colleagues (ICAAC abstract H-1890) conducted a retrospective study of children infected with both HIV and HCV through vertical (mother-to-child) transmission. Coinfected children had 25% lower CD4 cell counts and more than 4-log higher HIV viral loads during the first two years of life compared with the HIV monoinfected patients. By their third birthday, however, CD4 counts reached levels similar to those of HCV negative patients. The coinfected children had higher liver enzyme levels, leading the researchers to conclude that vertically coinfected children had “acceptable immunologic evolution” and HIV viral loads by the third year of life, but showed signs of liver disease progression.

Hyperlipidemia in Coinfected Patients
Hyperlipidemia, or elevated blood fat levels, is a side effect of some anti-HIV drugs, particularly protease inhibitors. At ICAAC, C. Cooper and colleagues (abstract H-1902) reported on an analysis of lipid elevations in 217 coinfected and 561 HCV negative individuals starting HAART. After 12 months, the mean increases in cholesterol level from baseline were 1.43 mmol/L in the HIV monoinfected patients and 0.01 mmol/L in the coinfected patients; the difference remained statistically significant through 30 months, even though the coinfected patients were less likely to be taking protease inhibitors. Metabolic complications led to HAART interruption in 7% of HIV monoinfected subjects, compared with less than 1% of coinfected patients; 8% of HIV monoinfected subjects started lipid-lowering medications versus none in the coinfected group. The researchers concluded that “HCV coinfection confers a degree of protection from HAART-related lipid complications.”

Liver Fibrosis and Liver Failure
Several past studies have indicated that liver disease progresses more rapidly in coinfected patients compared to those with HCV alone. P. Barreiro and colleagues (ICAAC abstract V-1912) retrospectively analyzed liver disease progression in two cohorts of untreated chronic hepatitis C patients in France and Spain, 184 of them HIV positive and 359 HIV negative; 94% were on HAART and most had well-controlled HIV. The researchers used the non-invasive FibroScan method to estimate fibrosis. More HCV monoinfected than coinfected patients had absent or minimal (stage F0-F1) fibrosis (56% vs 30%). And at more advanced fibrosis stages, the coinfected patients had higher rates than those with HCV alone (14% vs 9% for F3; 35% vs 15% for F4). HIV positive patients with CD4 counts greater than 350 cells/mm3 were less likely to have advanced fibrosis than those with lower CD4 counts. The researchers concluded that HIV/HCV coinfected patients “show more advanced liver fibrosis, which seems to be related with the degree of immunosuppression.”

At the AIDS conference, F. Bani-Sadr (abstract TUAB0301) presented a study of progression to advanced liver disease among 248 coinfected patients in the French RIBAVIC trial, who received pegylated or conventional interferon plus ribavirin for 48 weeks; about one-third (29%) achieved SVR. After a mean follow-up period of 30 months, nine patients (4%) developed end-stage liver disease (ESLD); six died of liver-related causes and two of non-liver-related causes. All ESLD events occurred in patients without SVR, and all but one occurred in patients with stage F3-F4 fibrosis at baseline. After three years, 93% of non-responders and 100% of sustained responders remained free of ESLD. Independent risk factors for ESLD were baseline stage F3-F4 fibrosis, CD4 cell count below 350 cells/mm3, and lack of sustained response. No ESLD occurred in coinfected patients who achieved SVR, even if they started treatment with advanced fibrosis.

For complete conference abstracts, see:
• XVI International AIDS Conference: www.aids2006.org/PAG/PAG.aspx
• 46th ICAAC: www.icaac.org (click on online program planner)

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HealthWise: Living with Stress and HCV
Lucinda K. Porter, RN

I moved recently and it was stressful. Halfway through the move, I decided to make stress the topic for this month’s Healthwise. I wanted something good to come from the teeth clenching, heart racing, and sleepless existence I endured. I also needed better coping skills. However, I feel a bit hypocritical about writing a stress management article, since I did it so poorly. Sort of like Attila the Hun writing about diplomacy.

There are many types of stress. Lily Tomlin said, “Reality is the leading cause of stress for those in touch with it.” Work, children, money and traffic are common stressors. Having a chronic illness, such as hepatitis C (HCV), is stressful. Stress is any physical, chemical, or emotional factor that places tension on the body, mind or spirit. This tension may disrupt the balance of health and the body’s ability to maintain wellness.

Not all stress is harmful. Eustress is a positive form. Moderate exercise is a good example of eustress. Marriage, birth of a child or job promotions are other examples. However, these same factors may lead to harmful stress or distress. For instance, the birth of a baby may bring joy, but it may also bring less sleep and the disruption of lives. This type of stress is unlikely to cause health problems if coped with adequately.

The body is designed to respond to stress. If under pressure to finish a work-related project, then your body may help you by producing stress chemicals to keep you alert and active. If you have to take a test, your body will provide a little boost that may help you to do well on the exam. We want this stress response.

Stress becomes a potential problem when it is ongoing or intense. If you are constantly under deadlines or have too much to handle, your body is not going to be happy. If multiple stress factors visit you all at once, this may be distressful.

Research shows that stress interacts with the immune system. Eustress may boost immunity while distress may reduce it. Chronic stress may cause immune cells to age prematurely. In its early stages, stress may cause stomach problems, headaches, weight gain or loss, insomnia and other conditions. Chronic stress may contribute to more serious conditions, such as high blood pressure, heart disease or substance abuse.

For me, managing stress is an integral part of managing HCV. Although no research states unequivocally that stress has a negative impact on HCV, if stress affects the immune system, then it stands to reason that chronic stress probably does not help HCV patients.

I am not waiting for research to tell me if and how stress affects HCV. I prefer avoiding stress whenever possible. I do not like the way stress feels. I like feeling calm. Realistically speaking, stress is a part of life. So in order to stay calm, I need stress management tools.

Recognizing the effects of stress is an important part of stress management. In its early stages, it is common to feel irritable, anxious or angry. Muscles may feel tight, particularly the jaw, neck, and shoulders. It is easy to get upset at the slightest provocation and have sleeping problems. Headaches and stomach problems are more frequent. Heart rate and blood pressure may increase. Smoking, drinking or excessive eating occur with stress. In short, one feels overwhelmed and tense.

If the effects of stress are severe, you may need professional help. If you have thoughts of suicide or hurting yourself or others, seek immediate professional help. If you have chest pain or any symptoms of a stroke or heart attack, call 911. Do not drive yourself to the emergency room.

Fortunately, most of us never have to face severe consequences of stress. Ours is more garden-variety. However, don’t let this fool you. Even mild stress may have long-term harmful effects if it is a constant companion. Imagine holding a one-pound rock at arm’s length. Then imagine holding the same rock at arm’s length for days, weeks or months. It would be very painful and damaging. This is much like the effects of chronic stress.

Learning how to manage stress is the best way to avoid these potentially harmful effects.

The following are some stress management tips. Note: If you do not think you can spare the time to try any of these activities, consider this – you may be more efficient if you manage stress. Also, ask yourself if you can risk getting a stress-related illness.

• Do not aggravate the situation by turning to smoking, overeating, skipping meals, drinking, or drug use that is not medically supervised.

• Find a physical outlet. Try walking, running, dancing, biking, golfing, swimming, gardening, playing with kids, or yoga. Do this for at least 15 minutes daily. Even better, do this twice a day or increase your activity to 30 or 45 minutes.

• Maintain good nutrition. Try to eat a low fat, high fiber diet. If you are short on time, fast food restaurants now offer healthy alternatives to the usual fried fare.

• Find ways to relax and turn your mind off. Spend time with friends and family. Go to the movies, play some music, watch a sporting event, play cards, read a magazine, take a hot bath, go to a favorite restaurant, get a massage, light a candle, do a crossword puzzle, read the comics.

• Attend a stress-management class. Some employers, HMOs, health insurance and adult education services offer stress management classes.

• Talk about it. Sometimes others can see ways to improve our situations.

• Put a positive spin on things. Don’t turn little things into big things. Try saying to yourself, “This too shall pass.”

• Help others. Sometimes the best way to get out of our head is to help someone else.

• Let others help you. Perhaps you can off-load some of your responsibilities.

• Set limits. Remember that the word “no” is a complete sentence.

• Take issues one task at a time, one minute at a time. Don’t overwhelm yourself by thinking about everything you have to do. Make a list and focus on what you can accomplish. Be realistic. Prioritize. Put your health at the top of the list.

• Prune your “to do” list. My favorite way to shrink my “to do” list is to cross something off without doing it. This is very liberating.

• Waiting in long lines can be uncomfortable when we are stressed. Prepare for this by bringing along a puzzle or something to read. Try finding the longest line rather than the shortest one. This can be surprisingly therapeutic.

• Avoid others who increase our stress.

• Practice acceptance. Let go of what is unchangeable.

• Find ways to laugh. When we laugh, the body produces helpful stress hormones. “He who laughs, lasts.”

I was going to add, “don’t move” to the list. Moving is stressful. However, now that it is over, I am enjoying a lovely home, steeped in peace. One thing I did was let others help me pack. I did the sorting and they did the packing. It was a bittersweet way to be together and a memory I will always cherish. What I would have done differently is this – written this article before I moved and taken my own advice.

• The American Institute of Stress
• Mayo Clinic www.mayoclinic.com/health/stress

• Medline www.nlm.nih.gov/medlineplus/

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Update: HCV Drug Pipeline
Alan Franciscus, Editor-in-Chief

There has been much news lately about various investigational drugs to treat hepatitis C. At the end of this month there will be even more information released from the American Association for the Study of Liver Disease conference. This article will discuss the current news items pertaining to new drugs in pre-clinical development and drugs entering into or currently in human clinical studies as well as two new major clinical trials announced by Human Genome Sciences and Roche Pharmaceuticals.

Human Genome Sciences announced the Phase III development program for Albuferon (albumin-interferon alpha 2b by injection) for the treatment of hepatitis C. Albuferon is a long acting type of interferon produced by genetic fusion with human albumin and interferon alpha 2b. HGS expects to initiate the phase III trial by the end of 2006.

• ACHIEVE 1 – 1278 HCV genotype 1 treatment naïve patients will be enrolled into 3 treatment arms – 2 groups will receive Albuferon once every 2 weeks at either 900 mcg or 1200 mcg and one group will receive Pegasys at 180 mcg weekly. All trial participants will receive ribavirin and will be treated for 48 weeks with a 24 week follow-up period. The primary end point of the study is undetectable HCV RNA (viral load) less than 10 IU/mL at week 72 (sustained virological response).

• ACHIEVE 2/3 – 918 HCV genotype 2 or 3 treatment naïve patients will be enrolled into 3 treatment arms – 2 groups will receive Albuferon once every 2 weeks at doses of 900 mcg or 1200 mcg and 1 group will receive Pegasys at 180 mcg weekly. All participants will receive ribavirin and will be treated for 24 weeks, with a 24 week follow-up period. The primary end point of the study is undetectable HCV RNA (viral load) at Week 48 (sustained virological response).

AVI-4065 is an antisense compound that is being developed by AVI BioPharma and is currently in clinical trials on patients with hepatitis C. Phase I study data was released earlier this year which found that AVI-4065 showed a favorable safety and tolerability profile with no serious drug-related adverse events (side effects). However the second phase of the study was recently released and it was reported that AVI-4065 did not show efficacy at the treatment dose and treatment duration used in the study protocol. Based on the data from this study, AVI BioPharma announced that it will be revising the study protocol for new additional studies with higher doses and longer duration of treatment.

Nautilus Biotech announced that an Investigational New Drug application (IND) has been filed with the U.S. Food and Drug Administration for Belerofon – a protease resistant long-acting (once a week by injection) form of interferon to treat hepatitis C. According to a company press release, Belerofon’s biological activity is the same as alfa-interferon, but the half-life is comparable to pegylated interferon. It is theorized that since lower doses of Belerofon can be used to treat HCV there should be better safety and a lower side effect profile than with current pegylated interferons. Nautilus expects to initiate Phase I trials in the United States in the first quarter of 2007.

ITMN-191, an oral HCV protease inhibitor, recently completed pre-clinical studies, and InterMune announced that an application has been filed (an electronic Clinical Trial Authorization [CTA]) with the French Medicinal and Biological Products Evaluation Directorate (AFSSAPS). If approved, InterMune expects to initiate a phase I clinical trial by the end of 2006. On another note, it was announced that InterMune and Roche have entered into an agreement to develop and commercialize products from InterMune’s pipeline of HCV protease inhibitors including ITMN-191.

R1626 and R1479
Roche announced that their HCV polymerase inhibitor R1626 will be advancing into a phase II study. In previous studies R1626 showed strong antiviral effect against the hepatitis C virus in genotype 1 patients. Based on the data in the phase I study, a new clinical trial will be initiated. In this study, patients will be randomized into 4 treatment groups:

a) R1626 1500 mg twice a day plus Pegasys 180 mcg every week for 4 weeks

b) R1626 3000 mg twice a day plus Pegasys 180 mcg every week for 4 weeks

c) R1626 1500 mg twice a day plus Pegasys 180 mcg every week plus ribavirin 1000-1200 mg daily for 4 weeks

d) Pegasys 180mcg every week plus ribavirin 1000-1200 mg daily for 4 weeks (current standard of care)

After the 4 week treatment period, all patients will receive Pegasys 180 mcg every week plus ribavirin 1000-1200 mg daily for another 44 weeks.

The objective of the study is to evaluate the 4 week safety profile and antiviral effect of combining R1626 with Pegasys alone or R1626 with Pegasys plus ribavirin.

It was also announced that R1626 received Fast Track status by the U.S. Food and Drug Administration.

R1479 is another HCV polymerase inhibitor that is being developed by Roche. Data from a preclinical study on the resistance profile and antiviral effect of R1479 was released at ICAAC last month. Two studies found that R1479 exhibited strong antiviral action against HCV and that there was no apparent cross-resistance between R1479 and NM283, interferon, or ribavirin.

Information about HCV disease progression, current HCV therapies and new experimental drugs will be released at AASLD and will be covered by the HCV Advocate Web site and in next month’s HCV Advocate newsletter.

Antisense Compounds: Compounds that target gene sequences associated with diseases to interfere with the disease process.

Glucosidase Inhibitors: Inhibitors of endoplasmic reticulum (ER), α-glucosidase has been shown to inhibit viral replication and secretion.

Immuomodulator: an agent that influences the body’s immune response.

Interferon (IFN): a cytokine (messenger protein) that plays a role in immune response. The three major classes of interferon are alpha, beta, and gamma.

Polymerase Inhibitor: an agent that inhibits viral replication by interfering with the polymerase enzyme.

Prodrug: a compound that is converted to an active drug within the body.

Protease Inhibitor: an agent that inhibits viral replication by interfering with the virus’ protease enzyme.

Vaccine: a preparation administered to stimulate an immune response to protect a person from illness. A vaccine typically includes a small amount of a killed or inactivated microorganism, or genetically engineered pieces. A therapeutic (treatment) vaccine is given after infection and is intended to reduce or stop disease progression. A preventive (prophylactic) vaccine is intended to prevent initial infection.

Source: HCV Advocate Web site Medical Glossary

Experimental Drugs Currently in Phase II and Phase III Studies for Treatment of Hepatitis C.

• Antisense Compound:
AVI-4065 – Phase II

• Glucosidase Inhibitors:
MX-3253 (celgosivir) – Phase II

• Immunomodulators:
CPG 10101 (Actilon) – Phase II

• Interferons:
Albuferon – Phase III
Medusa – Phase II
Omega – Phase II

• Polymerase Inhibitors:
NM 283 (Valopicitabine) – Phase II
R1626 – Phase II

• Protease Inhibitors:
SCH 503034 – Phase II
VX – 950 (Telaprevir) – Phase II

• Ribavirin Prodrug:
Viramidine (Taribavirin) – Phase III

• Therapeutic Vaccines:
E-1 – Phase II
GV1001 (Heptovax) – Phase II
IC41 – Phase II

Source: HCV Advocate Web site HCV Drug Pipeline

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The Most Common Questions about Access to Treatment
Alan Franciscus, Editor-in-Chief

Access to Treatment
The most common question our organization receives is about access to medical care and HCV medications from people who are uninsured or underinsured. Unfortunately, there are no programs that will provide free medical care and HCV medications like there are for HIV. Still there are some ways that people can receive medical care and receive free or low cost drugs if they qualify for assistance from the pharmaceutical companies who sell HCV medications and/or through many clinical trials.

Patient Assistance Programs
There are various patient assistance programs for people to receive free HCV medications. The various drug manufacturers (Roche, Schering, Valeant, MedMark Solutions Pharmacy) will provide free medications for people who meet their requirements. For more information about these programs see the resource section at the end of this article.

Unfortunately, in order to apply for these programs you have to have an attending physician who must apply for the assistance and oversee your medical care. But, what about those people who do not have an attending physician? Clinical trials may be an option.

Clinical Trials
One way that people can receive medical care and treatment for hepatitis C is by enrolling in a clinical trial. Within the last year there have been many new experimental drugs to treat hepatitis C such as protease inhibitors, polymerase inhibitors and other agents advancing through clinical development.

Clinical trials can be an excellent way to obtain medical care and free medication – some clinical trials may also pick up some or all of the costs of the physician visits and lab tests.

Clinical trials are tightly regulated to protect the trial participant or consumer. It is important to read and understand the terms and conditions of the study. Every participant of a clinical trial must be informed in writing about the potential benefits and risks, as well as their rights, should they decide to take part in the study. In addition, there is a study coordinator who is assigned to the study to make sure that participants are well-informed and monitored throughout the trial.

There are some drawbacks to participating in a clinical trial:

• You may not receive the experimental medication
• You may not receive a dose that is effective
• Some of the new medications are direct antiviral medications so there is a possibility that by taking the experimental drug the participant may develop drug resistance.
• There may be unknown side effects from the medications.

Finding a Clinical Trial
The job of finding a clinical trial in your area does require a bit of work. Check with your medical provider, support groups, on-line support groups, on-line listserves, and on the internet. Local medical centers and medical universities may also conduct clinical trials.

The best place to start is on the internet at www.clinicaltrials.gov Once the main page loads, type in hepatitis C, and a list of current clinical trials will load. To find out more information about a particular clinical trial listed, click on the title and you will be directed to another page that lists the trial information, including the inclusion and exclusion criteria. Clinicaltrials.gov also includes resources and information to help learn about and understand clinical trials. I recently went to clinicaltrials.gov and found over 150 different clinical trials for hepatitis C.

If you don’t have access to the internet, ask your family and/or friends if you can use their computer. Also, many public libraries have free or low cost internet access.

For more detailed information about clinical trials and medical research see HCSP’s A Guide to Understanding Clinical Trials and Medical Research in Hepatitis C.

Patient Assistance Programs

See: www.hcvadvocate.org/hepatitis

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