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July 2008 HCV Advocate

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The Future – miRNA’s?
Alan Franciscus, Editor-in-Chief

Durability of SVR
Alan Franciscus, Editor-in-Chief

Hepatocellular Carcinoma
Liz Highleyman

HealthWise: Hepatitis Seeing
Lucinda Porter, RN


PROVE 3-Interim Results
Alan Franciscus, Editor-in-Chief


HCV Advocate Eblast
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The Future – miRNA’s ?
Alan Franciscus, Editor-in-Chief

There has been a lot of news about a new class of drugs that can potentially treat a wide variety of conditions and diseases.  Surprisingly, one of the biggest news stories about this new class of drugs has hardly made a splash.  That news is that the first microRNA or miRNA compound went into human testing and it is being studied to treat hepatitis C.  The compound, SPC369, is being developed by Santaris in collaboration with GlaxoSmithKline.  The clinical trial will enroll a maximum of 48 healthy male volunteers to test the safety, tolerability, and pharmacokinetics of SPC369.  The company reported that one group of the study participants has already completed treatment satisfactorily. 

SPC369 specifically targets microRNA-122 – a chemical that has been shown to assist in the replication of the hepatitis C virus in liver cells.  Inhibiting microRNA-122 could potentially stop the replication of HCV.

The discovery of  microRNAs and their potential as therapeutic agents for a wide variety of conditions has a long and interesting history that started back when the Human Genome Project was launched in 1990 by the U.S. Department of Energy and National Institutes of Health.  The goal of the Human Genome Project was to identify all of the genes in human DNA and to determine the sequence of approximately 3 billion chemical base pairs that make up human DNA.  The original goal was to identify all human DNA genes in 15 years, but because of rapid technological advances over the years, the project was able to meet the goals and to identify all the human DNA genes in 13 years. 

The Human Genome Project was able to map approximately 25,000 protein-coding genes, but this is only 1.9% of human DNA.  The remaining DNA was labeled as “dark” or “junk” DNA and was thought to be of no particular importance.  However, scientists at Rosetta Genomics believed differently and were able discover and patent some 35 viral microRNAs.

MicroRNAs are short naturally occurring, single-stranded RNA molecules that do not code for protein, but instead attach to messenger RNAs to suppress their function.  Inhibition of microRNAs could potentially interfere with the viral replication and/or the disease process. 

In addition to being tested to treat hepatitis C, microRNAs also are being looked at to treat  many other diseases and conditions including HIV, cardiovascular disease, muscle  disorders, and liver cancer.  These new drugs, however, are only in the initial stages in the development cycle so we don’t know yet how effective they will be or what type of side effects might result after taking these medications.  Still, the potential of these new drugs is so exciting because they could be used to treat so many diseases and conditions. 


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Durability of SVR
Alan Franciscus, Editor-in-Chief

At the recent 2008 Digestive Disease Week (DDW) conference two posters were presented on the long term clearance of HCV and disease progression in people who had achieved a sustained virological response (SVR) – defined as HCV RNA negative 24 weeks post antiviral therapy.

The two studies compiled data from previous studies of PegIntron with or without ribavirin in adults and children.  The aim of the studies was to find out if the people who achieved an SVR were still HCV RNA negative (after more than 5 years) and the effect an SVR had on the histology or health of the liver.

Durability in Adults
In the first poster K.L. Lindsay and colleagues studied the durability issue as well as the ability of an SVR to halt or slow disease progression.

The study participants were taken from 2 large, international clinical trials of patients who had received either PegIntron monotherapy or the combination of PegIntron plus ribavirin.  In order to be eligible for the study, trial participants had to have completed 24 weeks of follow-up in one of the 2 initial studies and were also required to enroll in the current study anytime between 1.5 to 5.5 years after treatment.  In addition participants were not allowed to receive any HCV medications while enrolled in the current study.  Participants were also evaluated for clinical evidence of liver disease progression.  The viral load tests were able to detect low levels of HCV RNA: <125 IU/mL (PCR-TaqMan) and <50 IU/mL (COBAS TaqMan).

In all, 33% (567 of 1695 patients) of eligible participants were enrolled in the long-term follow-up study.  Of these, 366 patients were considered sustained responders and 201 were considered non-responders (control group).  This article will only report on the study participants who had been followed for at least 5 years.  Sixty-two percent (227 of 366 patients) who achieved an SVR were followed and it was found that only 4 participants (1%) in this study relapsed (became HCV RNA positive) during the 5-year follow-up period.   It was also found that there was no clinical progression of liver disease during the long-term follow-up period.  Only 1 person in the non-responder group was found to have clinical progression (bleeding varices) of HCV.  The authors concluded that “Attainment of SVR after treatment with PEG-IFN alfa-2b, with or without ribavirin, predicts long-term clearance of HCV.”

Durability in Children
In the other poster, K. Kelly and colleagues reported on the durability of SVR in children.   Sustained virological response was defined as above and the trial included children between the ages of 3 to 16 years who were treated with PegIntron/ribavirin (dosed by body weight).  The study design, and criteria for the detection of HCV RNA were the same as in the study above.  The children were also evaluated for clinical evidence of liver disease progression.

In total 58% (97 of 166 patients) were included in the study and 75% of the sustained responders completed 5 years of follow-up.  In the children who achieved an SVR, 98% remained HCV RNA negative 5 years after the completion of therapy – only one child relapsed during this period.  In addition there was no evidence of clinical progression of liver disease in the children who achieved an SVR. 

The authors concluded that “Attainment of SVR after treatment with IFN alfa-2b and RIBA [ribavirin] predicts long-term clearance of HCV in pediatric patients.” 

Bottom Line
The current studies and previous studies conducted by Roche also support data from other studies that have found that up to 99% of people who achieve an SVR remain HCV RNA negative for at least 5 years after the completion of therapy.  Hopefully, the studies conducted by Roche and Schering will continue to follow the people in their trials over time to confirm these findings and to improve our understanding of the durability of an SVR.


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Hepatocellular Carcinoma
Liz Highleyman

Over the course of years or decades, people with chronic hepatitis C or B virus (HCV or HBV) may develop advanced liver disease, including hepatocellular carcinoma (HCC).  HCC is the most common type of primary liver cancer, meaning it originates in the liver, rather than metastasizing (spreading) from elsewhere in the body. 

Epidemiology
With an estimated 21,000 new cases in the United States in 2008, HCC accounts for less than 2% of all cancers.  But its incidence has risen sharply over the past two decades as people infected with HCV many years ago began to reach advanced stages of disease; experts estimate that as many as half of U.S.  primary liver cancer cases are now associated with hepatitis C.

HCC is much more common in other parts of the world, such as Asia and Africa, due to endemic hepatitis B infection and environmental exposures; worldwide, nearly 600,000 new cases are diagnosed annually.

Who Is at Risk?
Only a small minority of people with chronic viral hepatitis will develop HCC over a lifetime, and it is difficult to predict in advance who these will be.  The disease is significantly more common in men compared with women, and usually occurs after age 50.

About one-quarter of people with chronic hepatitis C or B progress to liver cirrhosis (scarring), and an estimated 5% of these develop HCC.  Researchers think this happens as long-term liver injury leads to tissue regeneration, eventually resulting in uncontrolled proliferation of hepatocytes (liver cells).

HCC is most likely to occur in people with active HCV or HBV replication, as indicated by detectable HCV RNA or HBV DNA viral load.  Its connection with specific viral genotypes is unknown. 

Liver cancer seldom occurs in hepatitis C or B patients without cirrhosis.  HCC typically develops 20 to 30 years after HCV or HBV infection, though it may occur as soon as five years after exposure.  People with both HCV and HBV, and those with HIV coinfection, tend to experience more rapid liver disease progression.

HCC can also be caused by other forms of liver damage, including alcoholic liver disease, hemochromatosis (iron overload), and inherited metabolic disorders.  There is growing evidence linking obesity, insulin resistance, and diabetes – which are associated with liver steatosis (fat accumulation) – to liver cancer.  Exposure to aflatoxin, a substance produced by mold on poorly stored nuts and grains, is also a risk factor.

HCC Prevention
Since people with chronic hepatitis C or B who do not have cirrhosis usually do not develop HCC, antiviral therapies that slow or halt fibrosis progression can reduce the risk of liver cancer. 

Several studies have shown that chronic hepatitis C patients who achieve sustained virological response (SVR) to interferon-based therapy are significantly less likely to develop HCC – three-fold less likely over five years in one recent study.  Though data are inconsistent, some research suggests that even people who do not achieve complete HCV eradication may still benefit.  But in the recent HALT-C trial, prior nonresponders to pegylated interferon (Pegasys or PegIntron) plus ribavirin who received low-dose Pegasys maintenance therapy for three years were no less likely to develop HCC than those who received no further treatment (about 3% in both groups).

Symptoms
Detection of HCC is difficult because most people have no symptoms during the early stages.  As the cancer progresses, people may experience malaise, loss of appetite, fever, and fatigue, but these are signs of liver disease in general, not specifically HCC.  Liver cancer patients commonly present with symptoms of cirrhosis, including jaundice, ascites (abdominal swelling), and portal hypertension.  Some people experience pain in the upper right part of the abdomen, and sometimes the liver is enlarged or a tumor can be felt from outside the body. 

Screening
Since HCC is most easily treated when it is detected early, people at high risk should receive regular monitoring.  The most frequently used biomarker screening test for HCC measures the alpha-fetoprotein (AFP) enzyme.  The test is inexpensive and easy to perform, but has a high rate of false-negative and false-positive results.  Many people with early-stage liver cancer have normal AFP levels, and elevated levels can signal conditions besides HCC, including hepatitis flare-ups, testicular cancer, and pregnancy.  Other blood biomarkers for HCC are currently under study.

Imaging scans are also used for HCC monitoring.  Abdominal ultrasound is relatively simple and inexpensive, but not very accurate.  Computed tomography (CT) and magnetic resonance imaging (MRI) are used to detect liver tumors, and some techniques can determine blood flow in major liver arteries and veins.  Angiograms, which show patterns of blood vessel growth, can also reveal tumors.  All these methods, however, may fail to detect small tumors.

Liver biopsy remains the “gold standard” for definitely diagnosing HCC, since microscopic examination can distinguish malignant tumors from benign growths.  In practice, a diagnosis of HCC is often made without a biopsy if a patient with cirrhosis has a high AFP level and a growing mass on consecutive imaging tests.

Most experts recommend that people with cirrhosis should be screened for HCC every six months to one year.  Less frequent monitoring is considered sufficient for non-cirrhotic people with HCV or HBV.  But since it can be difficult to determine the exact extent of liver damage without repeated biopsies, some clinicians favor screening people with significant fibrosis.  Studies have shown that a combination of AFP and imaging can detect smaller tumors and improve survival in high-risk patients, but the cost effectiveness of HCC screening remains unclear.

Staging
Once cancer is detected, it is staged to determine the size, number, and location of tumors, the extent of metastasis beyond the liver, and involvement of blood vessels.  HCC is usually classified as localized resectable (a single tumor that can be completely removed), localized unresectable (localized cancer that cannot be completely removed due to its location or the medical condition of the patients), or advanced (cancer that has spread to both lobes of the liver, nearby lymph nodes, or other parts of the body).  Several different staging systems are used, including the “TNM” and the “CLIP” methods.

Treatment
Although therapies for HCC have improved in recent decades, it remains among the most difficult cancers to treat.  Choice of treatment depends on characteristics of the tumors, whether the cancer has spread outside the liver, and the overall health of the patient; prognosis may depend more on a person’s liver function than on features of the cancer itself.  Since it is usually detected late, survival is typically measured in months, but individuals who are diagnosed early have better outcomes. 

Resection
If tumors are small (less than 5 cm), few, and confined to a limited area of the liver, the cancer may be completely removed by surgery, known as hepatic resection.  The surgeon may remove a wedge of liver tissue, an entire lobe, or even more, since the liver can regenerate itself.  This method is highly effective when appropriate, but only 10% to 20% of HCC patients have completely removable tumors.  In addition, some malignant cells may be left behind, leading to recurrence.

Transplantation
Liver transplantation may be another option if the cancer has not spread elsewhere in the body.  This approach also offers a potential cure, but the supply of donor livers is extremely limited and patients must be in good enough health to withstand surgery.  Outcomes are best for individuals with small tumors, and therapies to shrink tumors may be used while a person is on the waiting list. 

Ablative Therapies
If the cancer cannot be completely removed, various “ablative” therapies may be used to destroy or shrink tumors in place.  Radiofrequency ablation (RFA), for example, uses an electrode probe to deliver a current that heats the tumor; newer thermal methods use microwaves or lasers.

Other ablation methods include percutaneous ethanol or acetic acid injection (substances are injected into the tumor to poison the cells), cryosurgery (freezing the tumor with liquid nitrogen), and radiation.  Typically, this involves injecting tiny beads containing radioactive material (TheraSphere) into the liver; another method, the CyberKnife, delivers a focused beam of radiation to the tumor.

Transarterial chemoembolization (TACE) involves blocking the hepatic artery and injecting chemotherapy drugs directly into the tumor’s blood supply – a method that causes fewer side effects than systemic chemotherapy. 

Combinations of therapies tend to produce better results.  Chinese researchers recently reported, for example, that patients who underwent both TACE and RFA lived longer than those treated with either method alone (37 vs. 22-24 months). 

Systemic Chemotherapy
If cancer has spread beyond the liver, systemic chemotherapy may be tried, but outcomes are generally poor because HCC is relatively resistant to drugs, and patients with advanced liver disease may be unable to tolerate side effects.  However, investigators with the SHARP trial recently reported that sorafenib (Nexavar), a drug newly approved to treat unresectable HCC, improved survival compared with placebo in patients with advanced liver cancer.

Hope for the Future
With all these approaches, outcomes are best in younger patients with better preserved liver function whose HCC is less advanced.  While response rates may approach those of resection surgery – up to 80% under ideal circumstances – ablation and chemotherapy are considered palliative rather than curative.

HCC remains difficult to treat, but regular screening can detect the disease at an earlier stage.  Treatment approaches have improved considerably in recent decades, and patients who participate in clinical trials have the first chance to benefit from experimental therapies.

Ultimately, the best “cure” for HCC is prevention of underlying liver disease, and there is good reason to hope that more widespread hepatitis B vaccination and improved treatments for hepatitis C and B will reverse the recent upward trend in liver cancer.

References
 Cheng, B-Q. et al. Chemoembolization combined with radiofrequency ablation for patients with hepatocellular carcinoma larger than 3 cm. JAMA 299(14): 1669-1677. April 9, 2008.

 Di Bisceglie, A.M. et al. Prolonged antiviral therapy with peginterferon to prevent complications of advanced liver disease associated with hepatitis C: Results of the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial. 58th Annual Meeting of the American Association for the Study of Liver Diseases. Boston, MA. November 2-6, 2007. Abstract LB1.

 Galle, P. et al. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma and prior anti-tumor therapy: a subanalysis from the SHARP trial. 43rd annual meeting of the European Association for the Study of the Liver. Milan, Italy. April 23-27, 2008.

 Hung, C.H. et al. Long-term effect of interferon alpha-2b plus ribavirin therapy on incidence of hepatocellular carcinoma in patients with hepatitis C virus-related cirrhosis. J Viral Hepatitis 13(6): 409-414. June 2006.

 Taura, N. et al. The impact of newer treatment modalities on survival in patients with hepatocellular carcinoma. Clin Gastroenterol Hepatol. 4(9): 1177-83. September 2006.


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HealthWise: Hepatitis Seeing
Lucinda Porter, RN

No organ is more important than any other, but try to convince us of that when it comes to our eyes.  This point was demonstrated recently when a patient I was working with developed vision problems.  Six months earlier he had completed hepatitis C (HCV) treatment.  Naturally he wondered if there was a correlation between his eye condition and the treatment.

His liver specialist and other experts in the field did not believe there was a correlation in this particular case.  Eye diseases are common, particularly as we age.  According to the National Eye Institute (NEI), in the 2000 U.S. census there were more than 119 million adults over age 40 with age-related eye diseases.  This number is expected to double in the next three decades. 
Some eye conditions are associated with HCV.  The most common of these is dry eye syndrome.  HCV treatment may cause or worsen some eye problems.  Corneal ulcers are associated with HCV and its treatment.  Prescription information for peginterferon-alpha with ribavirin warns of ophthalmologic (eye) disorders such as decreased, blurred or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema.  Let’s discuss these and other terms.

Diagram of the eye, showing the location of the iris, pupil, cornea, lens, vitreous, macula, sclera, optic nerve, and retina.

Courtesy of the National Eye Institutewww.nei.nih.gov

The outer most layer of the eye is the cornea.  Ulcerations on the cornea may be caused by a variety of factors, HCV being one of them.  One example, Mooren’s ulcer is discussed in the HCV Advocate’s Medical Writers’ Circle’s Extrahepatic Manifestations of Chronic Hepatitis C, by Remoroza and Bonkovsky.

Retinopathy refers to retina problems.  The retina is a nerve-rich area in the back of the eye.  It receives light and transmits images to the brain.  Many factors cause retinopathy.  People with high blood pressure or diabetes have a higher risk for retinal problems.  White puffy spots on the retina are called cotton wool spots and may indicate nerve damage.  A retinal thrombosis is a blockage in one of the retinal vessels.  A retinal hemorrhage is a bleeding vessel.  Treatment-related retinopathy usually ceases after medication is stopped.

The macula lies near the center of the retina.  It is responsible for clarity of sight.  Macular edema means that there is swelling caused by fluid accumulation.

Optic neuritis is swelling of the optic nerve.  This nerve transmits information from the retina to the brain.  The head of the optic nerve is the optic disc.  If the disc swells due to an increase in pressure from the brain or spinal fluid, the result is known as papilledema.

When undergoing HCV treatment, report eye problems immediately.  Many of these problems turn out to be minor, often caused by dry eyes or even fatigue.  However, since some eye problems can contribute to permanent vision impairment, let your doctor evaluate the situation.

Dry eye syndrome or keratoconjunctivitis sicca is common, more so in people with HCV.  It can be caused by insufficient or improper tear production or when tears evaporate too quickly.  Inflammation may accompany dry eyes.  This condition may be uncomfortable or painful.  Ulcers, scars, and even vision loss may occur if dry eye syndrome is not treated.

Certain factors may intensify dryness, such as air travel, dry climates, menopause, and some medications.  Antihistamines, decongestants, antidepressants, tranquilizers, estrogen and interferon may cause eye dryness.  Some people develop dry eyes after vision surgery, such as the Lasik procedure.

Eye dryness is associated with other diseases, particularly autoimmune disorders.  Those with HCV have an increased risk of autoimmune disease, so your medical provider may want to rule out other causes before assuming that dry eyes are related solely to HCV.

Treatment of dry eyes begins with understanding the cause of the problem.  Over-the-counter tear replacement drops or ointment may be suggested.  Choose preservative-free artificial tears if you use them more than 4 times daily.  Avoid sun and glare.  Use sunglasses that wrap around your head and block out UVA and UVB rays.  Your specialist may suggest a dietary supplement, such as omega-3 fatty acids.  Since too much or too little of certain vitamins may contribute to dryness or other problems, do not take a supplement without first discussing it with your medical provider.  Your eye specialist may prescribe medication or recommend plugging your eyes’ tear drainage holes.

Your HCV medical provider may know something about eye diseases, but you should see an eye specialist to manage these.  Unless you have a severe problem or need surgery, you will likely see a doctor of optometry (O.D.). Optometrists have 4 years of advanced training in their field.  Although they are not physicians, optometrists can prescribe medication and handle most eye problems except surgery.  If the problem is more complicated, you may be referred to an ophthalmologist (M.D.).  This specialist has attended medical school and can perform surgery.  If you need glasses, you may see an optician.  This professional dispenses glasses and in some states, contact lenses, but does not treat eye diseases.

Patients should have a baseline eye exam prior to beginning HCV treatment.  Those with diabetes or hypertension should consult with an ophthalmologist before treatment.  Patients with multiple health conditions, such as HIV and diabetes, need close monitoring during HCV treatment.

HCV patients who need a liver transplant are at risk for post-operative eye infections that may occur in all post-transplant situations.  Post-transplant patients with vision or eye problems are encouraged to report these immediately.

Eye problems are a concern for those living with HCV, but can occur in anyone.  In spite of the numbers, many of us are tempted to blame every ache and pain on hepatitis C.  It is a natural response to living with a chronic disease.  Others operate in the opposite extreme and deny having any aches or pains of any cause.  Learning to live somewhere in between is sensible.  It takes knowledge and practice to navigate illness.  While you are practicing, keep your eyes wide open.

 

Vote Health
A very exciting election is taking place in the midst of these rocky times.  Rock the Vote is a campaign to get out the youth vote. This is good, but Baby Boomers are the original Rock generation and are facing Medicare shortfalls. Baby Boomers need to rock the vote too – for the country’s health as well as their own. www.rockthevote.com/home.html


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PROVE 3-Interim Results
Alan Franciscus, Editor-in-Chief

On June 9th, Vertex released very promising data from their PROVE3 clinical trial. PROVE3 is a phase II clinical trial using telaprevir combination therapy to treat people with HCV genotype 1 who had been previously treated with pegylated interferon plus ribavirin, but who did not achieve a sustained virological response (SVR).

In this phase II study, the patient population included treatment non-responders, treatment relapsers and people who had a viral breakthrough while on therapy. The trial participants received 12 weeks of telaprevir in combination with Pegasys plus ribavirin followed by an additional 12 weeks of therapy with Pegasys plus ribavirin (without telaprevir). The total treatment duration in the telaprevir arm was 24 weeks.

The control arm also consisted of HCV genotype 1 patients previously treated with pegylated interferon plus ribavirin who were deemed treatment nonresponders, relapsers, and breakthoughs. The patients in the control arms were treated with Pegasys plus ribavirin (without telaprevir) for a treatment duration of 48 weeks. Since the treatment duration of the control arm is 48 weeks the SVR12 and other SVR rates are not available.

The patient population of the group that received the telaprevir combination therapy comprised prior non-responders (66 patients), relapsers (40 patients) and breakthroughs (9 patients). The SVR 12 (undetectable HCV RNA twelve weeks after therapy ends) results for the arms that received telaprevir are given in the table.

  Week 12
(end
SVR 12)
Week 24 12 weeks post-treatment (Week 36 of treatment)
Non-responders (n=66) 71% 65% 41%
Relapsers (n=40) 88% 83% 73%
Breakthroughs (n=9) 44% 44% 44%
Total (n=115) 75% 70% 52%

It was noted that the side effects reported in this study were similar to the side effects seen in previous studies of pegylated interferon, ribavirin, and telaprevir.

Successful treatment results from HCV therapy is usually defined as sustained virological response or SVR – that is undetectable HCV RNA 24 weeks following the completion of therapy. The preliminary results reported in the press release are SVR12 results – undetectable HCV RNA 12 weeks following the completion of therapy. In previous studies of telaprevir, the SVR12 results have been in line with the regular results reported 24 weeks following the completion of therapy.

In addition to the study arms listed above, there were two additional arms, one of which included a 24-week arm of telaprevir without ribavirin, and the other a 48 week treatment arm that included 24 weeks of telaprevir in combination with pegylated interferon and ribavirin. Vertex reported that the interim results from these two arms support the use of ribavirin and that the use of telaprevir beyond 12 weeks does not provide additional treatment benefit. It was also noted that the dosing for all the patients in PROVE3 has been completed.

The final results for all arms of the study are expected to be released at the AASLD 2008 Conference.

Vertex in collaboration with Tibotec also announced that a phase III study is planned for the third quarter of 2008 to examine the use of telaprevir in combination with pegylated interferon plus ribavirin in HCV genotype 1 patients who failed to achieve an SVR with pegylated interferon plus ribavirin. According to the press release, treatment duration will be 48 weeks – 12 weeks of telaprevir, pegylated interferon, and ribavirin followed by 36 weeks of pegylated interferon plus ribavirin, but without telaprevir (total treatment duration of 48 weeks). Visit www.clinicaltrials.gov for information about HCV clinical trials that are actively recruiting patients.

Bottom Line
These results are the highest yet seen for the re-treatment of people who have not been able to achieve an SVR with pegylated interferon plus ribavirin therapy. It goes without saying that these results are very encouraging and brings hope to people who are in need of treatment.

Hopefully, the new phase III study will yield even more good news and perhaps even higher response rates.


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