FDA Requests Additional Safety Data for Idenix Hepatitis C Drug

By Nathalie Tadena

June 20, 2013, 5 p.m. ET

Idenix Pharmaceuticals Inc. (IDIX) said the U.S. Food and Drug Administration has requested additional preclinical safety data for one of the biopharmaceutical company's hepatitis C treatments, which will delay the start of clinical trials.

Shares, which had been halted ahead of the news, slumped 25% to $3.87 after hours when trading resumed. The stock has fallen 52% over the past 12 months, through the close.

The company said it must provide a satisfactory response to the FDA before clinical trials can begin in the U.S. for its IDX20963 lead uridine nucleotide prodrug candidate. Idenix said it recently submitted an investigational new drug application for IDX20963 to the FDA that included preclinical data demonstrating potent, pan-genotypic activity.

Hepatitis C is a blood-borne virus that afflicts an estimated four million Americans and 170 million people world-wide. The disease often is contracted during sex or by sharing needles. Current treatment of the drug requires long courses of painful injections and often doesn't work. Drug makers have been racing to find pills that are both more potent and easier to take.

In February, the company said it would discontinue its clinical development program for two of its investigational treatments for hepatitis C, after the FDA said the treatments would remain on clinical hold.

Write to Nathalie Tadena at nathalie.tadena@dowjones.com

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State Legislature passes bill requiring doctors to offer hepatitis C tests to baby boomers

By James T. Mulder | jmulder@syracuse.com The Post-Standard
on June 20, 2013 at 4:21 PM, updated June 20, 2013 at 4:29 PM

Syracuse, N.Y. -- Baby boomers in New York will be offered screening tests for hepatitis C when they visit a doctor or hospital under a bill passed by the state Legislature today.

The bill requires screening tests to be offered to people born between 1945 and 1965.

Many baby boomers may have hepatitis C and not know it. An estimated 3.2 million Americans -- including about 20,000 New Yorkers -- are infected with hepatitis C, most of them baby boomers.

Hepatitis C is a serious virus infection that over time can cause liver damage and even liver cancer. Early treatment can prevent this damage. Many people with hepatitis C do not get the care they need because they don't know they are infected. It can take many years before someone who is infected exhibits symptoms.

Hepatitis C is mostly spread through contact with an infected person's blood. Some people could have gotten infected before widespread screening of blood began in 1992. People who have injected drugs, even if only once in the past, could have been infected by sharing a needle or drug equipment with someone who had hepatitis C.

The bill passed the Senate today 63-0. It passed the Assembly by a vote of 138-1 June 10. AARP, which backed the bill, is calling on Gov. Andrew Cuomo to sign the measure into law.

The Medical Society of the State of New York, which represents doctors, opposed the bill because the U.S Preventive Services Task Force has recommended against routine screening of adults who do not have symptoms and are not considered to be at high risk of having hepatitis C.

The influential task force is at odds with the federal Centers for Disease Control and Prevention which has called for hepatitis C screening of baby boomers.

The bill was sponsored by Sen. Kemp Hannon, R-Long Island, and Assemblyman Kenneth Zebrowski, D-New York City.

Zebrowski's father died in 2006 at age 61 of liver failure and cirrhosis caused by hepatitis C. He contracted the disease from a 1973 blood transfusion, according to his son.

Source

Also See:

• NY Baby Boomers Could Avoid Serious Disease With New Hep C Test Requirement
• Bill would provide Hep-C testing for more NY'ers
• NBLCA Supports Proposed New York State Legislation That Would Expand Testing for Hepatitis C Virus in Baby Boomers

NY Baby Boomers Could Avoid Serious Disease With New Hep C Test Requirement

June 20, 2013

Bill Passed by Legislature Requires Offer of Screening Test for Boomers Visiting Doctor or Hospital; Follows Recommendation by Centers for Disease Control

(ALBANY, N. Y.)Baby boomers across New York, many of whom may have hepatitis C without knowing it, will be offered a screening test when visiting health care providers under an AARP-backed bill passed by the state Legislature today.

The bill (S2750A/A1286), sponsored by Senate Health Committee Chairman Kemp Hannon (R-Nassau) and Assemblyman Kenneth Zebrowski (D-New City), requires people born between 1945 and 1965 to be offered a screening test for hepatitis C – a potentially fatal illness - when seeing their primary care doctor and receiving hospital inpatient and outpatient care.

The federal Centers for Disease Control and Prevention (CDC) called for such testing last August after finding people born between 1945 and 1965 are at risk for Hepatitis C infection. Those baby boomers accounted for 75 percent of the estimated 3.2 million Americans infected with hepatitis C, the CDC found.

An estimated 200,000 New Yorkers are living with Hepatitis C, and it’s an increasing cause of illness and death. But 45 percent to 85 percent of people living with the disease are unaware they have it, since it often shows no symptoms, according to a CDC report.

Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver and can lead to cirrhosis (scarring of the liver) or fatal liver cancer.

“This is truly a life and death matter, and AARP is so pleased that Senator Hannon and Assemblyman Zebrowski won such an important victory for baby boomers,” said Beth Finkel, AARP New York State Director. “Offering a screening test to the thousands of New Yorkers whose lives could be saved or improved is just plain common sense.”

The bill passed the Senate today 63-0. It passed the Assembly 138-1 on June 10.

There have been great advances over the past few years in treatments for hepatitis C and many carrying the disease can be cured.

By increasing testing opportunities, the bill will make more people living with hepatitis C aware of their infection status, get available treatment, and take steps to prevent transmission.

Empowering individuals to know their hepatitis C infection status is an important step toward meeting the public health challenges presented by a disease which is contagious and communicable. Given that many people infected with this disease show no symptoms, testing is a crucial factor in disease prevention.

New York City Mayor Michael Bloomberg’s health commissioner, Dr. Thomas Farley, urged colleagues this spring to test all baby boomers for hepatitis C.

AARP New York, which advocates on behalf of New Yorkers 50 and older, is calling on Governor Andrew Cuomo to sign the bill into law.

Follow us on Twitter: @AARPNY and Facebook: AARP New York

AARP is a nonprofit, nonpartisan organization, with a membership of more than 37 million, that helps people turn their goals and dreams into real possibilities, strengthens communities and fights for the issues that matter most to families such as healthcare, employment and income security, retirement planning, affordable utilities and protection from financial abuse. We advocate for individuals in the marketplace by selecting products and services of high quality and value to carry the AARP name as well as help our members obtain discounts on a wide range of products, travel, and services. A trusted source for lifestyle tips, news and educational information, AARP produces AARP The Magazine, the world’s largest circulation magazine; AARP Bulletin; www.aarp.org; AARP TV & Radio; AARP Books; and AARP en Español, a Spanish-language website addressing the interests and needs of Hispanics. AARP does not endorse candidates for public office or make contributions to political campaigns or candidates. AARP Foundation is an affiliated charity of AARP that is working to win back opportunity for struggling Americans 50+ by being a force for change on the most serious issues they face today: housing, hunger, income and isolation. AARP has staffed offices in all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Learn more at www.aarp.org.

Source

Also See:

• Bill would provide Hep-C testing for more NY'ers
• NBLCA Supports Proposed New York State Legislation That Would Expand Testing for Hepatitis C Virus in Baby Boomers

The State Of The Hepatitis C Pill Race: Gilead Vs. AbbVie

Jun 20 2013, 15:59

Peter Geschek

Gilead Sciencies (GILD) is believed to be leading the hepatitis C pill race, but AbbVie (ABBV) is not far behind. According to Scott Brun, AbbVie's head of pharmaceutical development, AbbVie may even win the race.

In June, at the Goldman Sachs Annual Global Healthcare Conference, he said:

"I'll say that it is a very tight race and like I said we're executing extremely well and I think we've got a very good shot at being first, but it's close."

Gilead

In a Phase II trial, Gilead's all-oral hepatitis C treatments sofosbuvir and ledipasvir, an NS5A inhibitor, cured 95 percent of patients after eight weeks of the therapy.

Sofosbuvir, which Gilead acquired in 2012 in the famous $11 billion acquisition of Pharmasset, has proved itself in four completed Phase III studies.

In May, following the encouraging interim results from a Phase II trial of sofosbuvir and ledipasvir, Gilead Sciences announced plans for a Phase III trial of a fixed dose of the two drugs. Called ION-3, the study will test a once-daily fixed-dose combination therapy of the two drugs both with and without ribavirin for eight weeks, as well as without ribavirin for 12 weeks. Six hundred non-cirrhotic, new-to-treatment patients with genotype 1 of the virus will participate in the trial.

In June, Gilead received a priority review designation from the FDA, a step that can save about four months in the approval process.

Confident in approval, Gilead is getting ready for the launch of sofosbuvir in the first quarter of 2014 in the U.S. and the second quarter in Europe by preparing sales teams and arranging training opportunities for physicians.

AbbVie

According to Brun, Gilead's advantage is overstated.

AbbVie is running 6 Phase III trials in 30 countries around the world with over 2200 patients.

It is running a dedicated study in cirrhotic patients, who are the hardest to treat of all. Cirrhosis means the liver is scarred, and it functions poorly. Cirrhosis is considered the final stage of chronic liver disease. AbbVie's treatment represents a possible cure, even for these hard-to-treat patients.

AbbVie's HCV portfolio includes experimental medicines with three different mechanisms of action. The compounds in the studies are ABT-450/r (protease inhibitor and ritonavir), ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor).

AbbVie's treatment will require three pills in the morning and one at night, according to Brun. In a Phase II trial with the drugs, 90 percent of patients who completed the eight-week regimen had the virus cleared from their body.

Some analysts consider AbbVie's treatment cumbersome compared to Gilead's because it requires four pills a day. But according to Brun, this is a very manageable regimen when you consider the situation of the HIV infected patients who receive Ritonavir (AbbVie's drug for HIV) boosted regimens for a lifetime on a much more complicated schedule. It is a matter of patient education.

AbbVie also is working on next generation programs already: ABT-493 is a protease inhibitor and ABT-530 is an NS5A inhibitor, both with very favorable pharmacologic characteristics, and neither will need Ritonavir boosting.

AbbVie also testing a regimen in Japan for genotype 1b patients requiring two pills once a day for 12 weeks with no Ribavirin. It is using the co-formulation of the ABT-450 and ABT-267 with Ritonavir. This combination is also being prepared for western markets.

Continue reading full article ….

Older Liver Cancer Patients Respond to Radioembolisation Using Sir-Spheres Equally as Well as Younger Patients, New Study in Journal of Hepatology Says

Provided by Canada Newswire

June 20, 2013 11:37 AM

Based on New Data from Multi-Centre ENRY Evaluation of 325 Patients, Authors Suggest that Radioembolisation May Be a Well-Tolerated and Effective Option for an Increasing Population of Older Patients

BOLOGNA, Italy, June 20, 2013 /CNW/ - Results of a new analysis by members of the multi-centre European Network on Radioembolisation with Yttrium-90 Resin Microspheres (ENRY), published on-line in the Journal of Hepatology, the peer-reviewed official journal of the European Association for the Study of the Liver^[1], may have important implications for older patients with inoperable primary liver cancer (hepatocellular carcinoma, or HCC).

(Logo: http://photos.prnewswire.com/prnh/20130620/622581 )

The analysis found essentially identical long-term treatment outcomes following radioembolisation using SIR-Spheres in 128 elderly (age 70 years or older) compared to 197 younger (less than 70 years of age) patients with otherwise similar demographics.  "Our findings suggest that age alone should not be a discriminating factor for the management of HCC patients.  This is important because there is a trend towards increased age in patients diagnosed with HCC, particularly in developed countries," said the article's lead author, Rita Golfieri, MD, Professor of Radiology in the Department of Digestive Diseases and Internal Medicine of The University of Bologna.

Prof. Golfieri also stated that "While age should not be a barrier to the management of older patients with HCC, physicians should definitely take age and frailty into account when deciding which treatments to use.

"For example, the relative mildness of procedure-related events after radioembolisation with SIR-Spheres compared with transarterial chemoembolisation, or TACE, suggests that an effective single radioembolisation procedure may be more acceptable to elderly patients than the multiple courses of treatment required with TACE.

"In addition, while the tyrosine kinase inhibitor, sorafenib, represents a good treatment option for many elderly patients with HCC, the increased frequency of adverse events associated with its use in patients over 75 years old may require dose-modification," Prof. Golfieri said.

The new study is the most recent report based on an extensive evaluation of 325 HCC patients treated by teams of liver specialists, oncologists, interventional radiologists and nuclear medicine physicians at eight centres in Germany, Italy and Spain, and coordinated by Bruno Sangro, MD, PhD, Director of the Liver Unit at Clinica Universidad de Navarra, Pamplona, Spain, and chair of the ENRY group.

About Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) occurs in people whose livers have become severely damaged or cirrhotic, due to conditions such as hepatitis and alcoholism.  It is one of the ten most-common cancers in the world, with nearly 750,000 cases diagnosed annually, and the third-leading cause of cancer deaths.^[2]  It occurs with greatest frequency in regions where hepatitis is most often diagnosed, such as in Asia Pacific and Southern Europe.

Hepatocellular cancer can be cured only by surgery, either by resecting the diseased parts of the liver, or by transplantation with a liver from a healthy donor.  These interventions, however, are inappropriate for the great majority of patients, whose survival may range from a few months to two or more years depending largely on the state of their liver at the time of their diagnosis and the extent of tumour invasion.

Key Findings of the Age-based ENRY Evaluation

The new analysis compared HCC treatment outcomes among 128 patients age 70 or older (mean age 74) with those for 197 younger patients (median age 58).  The authors also performed an additional sub-analysis of 49 very elderly patients ranging from 75-87 years (median age 78).

The elderly and younger age groups had similar baseline characteristics, with many having multi-nodular, advanced-stage HCC which was present in both lobes of the liver and had reasonably-well compensated (Child-Pugh class A) underlying cirrhosis.  Elderly patients had a significantly lower tumour burden, smaller liver volume - both overall and the amount targeted by radioembolisation - and were less likely to have had hepatitis B viral infection.

Overall survival of patients in the study was not statistically significant between elderly (median 14.5 months) and younger (12.8 months) patients.  There was also no significant difference in survival between very elderly patients (75 years or older) and those under that age (median 14.9 vs. 12.8 months).

Radioembolisation with SIR-Spheres was equally well-tolerated in both age groups.  Common procedure-related events, such as fatigue, nausea and/or vomiting, abdominal pain, fever and raised bilirubin, were predominantly mild-to-moderate in severity and short in duration.  Almost none of these events were rated at grade 3 or above, the exceptions being one reported case of grade 3 fatigue and two grade 4 elevations in bilirubin.  Gastrointestinal (GI) ulceration (caused by the inadvertent deposition of microspheres in the GI tract) was similarly infrequent and of mild-to-moderate intensity in the two age groups.  Severe GI ulcers (grade 3 and above) were actually almost three times less common among older patients (0.8% vs. 2.7%).

When the consolidated ENRY data were first published in 2011,^[3] Professor Sangro noted that: "As ENRY was not a prospective study, our findings must be interpreted conservatively.  What we can say, based on our evaluation of a broad range of patients with HCC treated in routine clinical practice, is that radioembolisation using SIR-Spheres directly targets tumours and spares viable liver tissue, which enables us to reduce the burden of disease and potentially increase both the patient's survival and quality of life.  The greatest survival benefit can be expected in those patients with better performance status, fewer tumour nodules and no occlusion of the portal vein.

"What we can now also say based on Prof. Golfieri's analyses, is that the benefits we observed apply as much to older patients as to younger ones, with some potential added value for radioembolisation based on its relatively mild side-effect profile compared to other treatments for this very serious disease.  These patients have few other treatment options," Prof. Sangro explained.

Other treatment options that have been demonstrated to extend survival for patients with inoperable HCC include TACE, which requires repeated interventional procedures and hospitalisation due to the resulting post-embolisation syndrome; and sorafenib, an oral medication taken twice daily which can give side effects leading to discontinuation of the drug in more than a third of patients (38%).^[4]

"Radioembolisation may also be a synergistic option when combined with newer pharmaceutical treatments, such as sorafenib," Prof. Sangro said.

Physicians and patients interested in participating in one of three on-going randomised controlled trials of radioembolisation using SIR-Spheres may learn more at:

• the SORAMIC trial is being conducted in Europe on SIR-Spheres combined with sorafenib compared to sorafenib alone in patients with HCC (http://www.soramic.de and http://clinicaltrials.gov/ct2/show/NCT01126645);
• the SIRveNIB trial is being conducted in Asia Pacific and is comparing SIR-Spheres to sorafenib in patients with HCC (http://www.sirvenib.com and http://clinicaltrials.gov/ct2/show/NCT01135056);
• the SARAH trial is being conducted in France and is comparing SIR-Spheres to sorafenib in patients with HCC (http://clinicaltrials.gov/ct2/show/NCT01482442).

References:

1. Golfieri R, Bilbao JI, Carpanese L, et al on behalf of European Network on Radioembolization with Yttrium-90 resin microspheres (ENRY).  Comparison of the survival and tolerability of radioembolization in elderly versus younger patients with unresectable hepatocellular carcinoma.  Journal of Hepatology 2013; ePub doi: http//dx.doi.org/10.1016/j.jhep.2013.05.025.
2. GLOBOCAN.  Liver Cancer Incidence and Mortality Worldwide in 2008.  http://globocan.iarc.fr/factsheets/cancers/liver.asp accessed 28 June 2011.
3. Sangro B, Carpanese L, Cianni R et al on behalf of European Network on Radioembolization with yttrium-90 resin microspheres (ENRY).  Survival after ⁹⁰Y resin microsphere radioembolization of hepatocellular carcinoma across BCLC stages: A European evaluation.  Hepatology 2011;54:868-878.
4. Llovet J, Ricci S, Mazzaferro V et al for the SHARP Investigators Study Group.  Sorafenib in advanced hepatocellular carcinoma.  New England Journal of Medicine 2008;359:378-390.

708-EUA-0613

Photo: http://photos.prnewswire.com/prnh/20130620/622581

SOURCE: ENRY Trialists

For further information:

Contact: Gill Dunn, email: gill@auroracomms.com, office: +44-207-148-4175, mobile: +44-7713-112600 
Further materials can be found at http://www.sirtpressroom.com

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Hepatitis C Virus Survival: Syringe Specifics

June 20, 2013

Proving the virus can survive in a syringe for up to 63 days, research demonstrates three different characteristics that make Hepatitis C transmission viable from a needle.

By Nicole Cutler L.Ac.

Hepatitis C is known to be transmitted via blood to blood contact; however, there is still some grey area regarding how long the virus can persist out of the body. Putting a time limit on Hepatitis C’s viability on inanimate surfaces helps quantify how long a contaminated object can transmit this infection. In an attempt to gain clarity on the survivability of Hepatitis C long after the contaminated blood is no longer fresh, a study delves into the virus’s longevity in its most likely vehicle.

Before 1992, when widespread screening of the blood supply began in the United States, Hepatitis C was commonly spread through blood transfusions and organ transplants. Today, most new Hepatitis C infections are a result of the sharing of needles or other drug-injecting equipment. To learn more about Hepatitis C’s ability to survive in the environment most implicated in its spread, Yale researchers investigated whether or not the virus remains viable for long periods in contaminated syringes. What they found cements our regard for Hepatitis C as being a hardy virus – and it provides an explanation for a good percentage of Hepatitis C transmissions.

Continue reading this entire article:

Liver biopsy, mental health did not affect HCV treatment

Provided by Healio

Kluck J. Hepat Res Treat. 2013;doi:10.1155/2013/653976.

June 20, 2013

Having a pretreatment liver biopsy did not predict whether patients completed a full treatment course for hepatitis C, researchers reported. In subsequent analyses, the presence of a psychiatric disorder also did not affect treatment completion.

Using a computerized patient record system, researchers examined the effect of having liver biopsy and the presence of psychiatric disorders on the the treatment response and completion rates among 375 HCV-infected veterans who were being treated at the VA Philadelphia Medical Center. Treatment, which began within 1 year of the biopsy, included combination pegylated interferon plus ribavirin for 24 weeks for HCV genotypes 2 and 3, or 48 weeks for HCV genotypes 1 and 4.

Sustained virological response was achieved in 31% of patients, and 45% completed the full treatment course.

The researchers hypothesized that having an invasive procedure such as a liver biopsy would make patients more aware of their disease and “psychologically” motivate them to complete the extensive HCV treatment. Additionally, HCV treatment has been associated with psychiatric adverse effects — including anxiety, depression and posttraumatic stress disorder — which also may lead to treatment discontinuation.

However, of the patients who received a liver biopsy, 44% completed treatment vs. 46% of those with no biopsy.

Although biopsy status had no effect on treatment completion, the researchers said having a biopsy may be associated with treatment uptake. For example, the biopsy rate among the cohort was 23% vs. the biopsy rate among those at the VA center who were untreated (3.8%).

Psychiatric disorders, which were based on ICD-9 codes, progress notes and prescription records, were common in the cohort (59.7% having at least one disorder), but did not significantly alter the treatment course.

The most common reasons for discontinuation among those with psychiatric disorders were medication-related adverse effects, virological failure and loss to follow-up.

“Interestingly, our study showed that the rates of HCV therapy discontinuation due to psychiatric-related adverse drug effects were similar between patients with a mental health disorder at baseline and with no mental health disorder at baseline,” the researchers wrote.

Disclosure: The researchers report no relevant financial disclosures.

Source

FDA Approves First Genotyping Test for Patients with Hepatitis C Virus

FDA NEWS RELEASE

For Immediate Release: June 20, 2013
Media Inquiries: Susan Laine 301-796-5349, susan.laine@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves first genotyping test for patients with hepatitis C virus

The U.S. Food and Drug Administration today approved a test that identifies the genotypeof hepatitis C virus (HCV) that apatientis carrying. The Abbott RealTime HCV Genotype II, which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5,using a sample of an infected patient’s blood plasma or serum, will aid health care professionals in determining the appropriate approach to treatment.   Because the various HCV genotypes respond differently to available drug therapies, knowing the type of HCV a person is infected with can result in better patient outcomes.

“Tests such as this one can help physicians gain an understanding of a patient’s HCV status,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “Along with other clinical factors, the particular type of HCV is an important consideration in aiding health care professionals in determining if and when to initiate treatment and the appropriate type of treatment.”

According to the Centers for Disease Control and Prevention, HCV is the most common chronic blood-borne infection in the United States and the leading cause of liver transplants. About 3.2 million people in the United States have a chronic HCV infection and approximately 15,000 people die from the effects of the virus each year. Seventy-five to 85 percent of people infected with HCV are not able to fight off the virus on their own and develop a chronic HCV infection that requires treatment. Untreated chronic HCV infections may lead to liver cancer, severe liver damage and liver failure.

HCV is transmitted through blood and other bodily fluids. Injection drug users who share needles are at the highest risk for HCV infection. Health care workers stuck by needles that have been used on HCV-infected patients and children born to HCV-infected mothers are also at risk.

The Abbott RealTime HCV Genotype II is approved for individuals known to be chronically infected with HCV. It is not approved for use as a diagnostic test or as a screening test for the presence of HCV genetic material in blood, blood products or tissue donors. It has not been evaluated in newborns or pediatric patients, or in patients with compromised immune systems, such as people with AIDS.

The FDA based its approval of the Abbott RealTime HCV Genotype II, in part, on the assessment of the test's accuracy in differentiating specific HCV viral genotypes compared to a validated genesequencing method.  The FDA also reviewed data from investigators demonstrating the relationship between HCV genotype and effectiveness of drug therapy.

The Abbott RealTime HCV Genotype II test is manufactured by Abbott Molecular Inc.,
in Des Plaines, Ill.

For more information:

• FDA: Medical Devices¹
• FDA: Office of In Vitro Diagnostic Device Evaluation and Safety²:
• CDC: Hepatitis C Information for Health Professionals
  ³
• Testing Recommendations for Chronic Hepatitis C Virus Infection Among Persons Born During 1945-1965⁴
• VA: National Hepatitis C Program⁵
• NIH: What I need to know about Hepatitis C (simple text)  ⁶
• NIH: Chronic Hepatitis C: Current Disease Management⁷
• NLM: Hepatitis C - Interactive Tutorial  ⁸

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Page Last Updated: 06/20/2013
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SVR after triple therapy maintained long-term durability in HCV patients

Provided by Healio

Rutter K. Aliment Pharmacol Ther. 2013;38:118-123.

June 20, 2013

Nearly all patients with chronic hepatitis C who achieved sustained virologic response to therapy with pegylated interferon, ribavirin and direct-acting antivirals continued to have undetectable HCV RNA over long-term follow-up in a recent study.

Researchers followed 103 white patients with chronic HCV who had participated in randomized, controlled trials or an extended access program in which they achieved sustained virologic response (SVR) at 24 weeks after completing combination therapy with peginterferon alfa-2a and ribavirin and a direct-acting antiviral (DAA). Evaluated DAAs included protease inhibitors (90.3% of cases), NS5B polymerase inhibitors (6.8%) and both in combination (2.9%). Patients were followed for a median of 21 months after achieving SVR (range 7 to 64 months).

The cohort included 80 treatment-naive patients, 17 who had been nonresponsive and six who had relapsed during prior therapy. Nearly all patients were infected with HCV genotype 1, including 34 with genotype 1a and 67 with 1b, while two patients had genotype 4.

Relapse occurred in two patients who had genotype 1b and had been treated with faldaprevir. Both patients achieved undetectable HCV RNA levels at 4 weeks, and cloning sequencing after relapse indicated identical sequences to those observed at baseline. Viral resistance was unseen in either case.

One treatment-naive, noncirrhotic woman who relapsed had detectable HCV RNA 8 months after therapy cessation, which increased to pretreatment levels in subsequent months. Retreatment with 24 weeks of peginterferon, ribavirin and telaprevir resulted in undetectable RNA levels. The second relapser, a treatment-naive cirrhotic man, had detectable HCV RNA 12 months after therapy ended that returned to pretreatment levels shortly after detection.

“To the best of our knowledge, this is the first study reporting long-term virological outcomes in patients with hepatitis C after successful antiviral triple therapy,” the researchers wrote. “Our study shows that HCV eradication by triple therapy remains durable and confirms an excellent long-term prognosis of HCV patients with SVR. To assess the long-term clinical benefit of triple therapy, studies with a longer follow-up and larger patient numbers are needed.”

Disclosure: See the study for a full list of relevant disclosures.

---

Perspective

William Carey

Sustained virological response, historically, has been tantamount to a cure in patients who are treated for hepatitis C. The problem, of course, is that with every change in therapy, it's necessary to validate that the concept of SVR - no virus detectable in the blood 6 months after stopping treatment - actually applies. It applies for pegylated interferon and ribavirin, and now we're seeing evidence that it also applies when we're using direct-acting antiviral agents in addition.

[This is] an important study to do. I think the strength of it is that it has at least a moderate number of patients, over 100, and they found, not surprisingly, that SVR 24 weeks after stopping treatment seems to be associated with permanent eradication of detectable virus. Again, this is not surprising, but still an important detail that needs to be hammered out, and the study goes a long way toward doing that.

The limitations of the study are that they looked at many different direct-acting agents, and so the number of patients treated with any particular direct-acting agent is somewhat limited. This really comes into focus when we look at the two breakthrough patients: They were both treated with the same drug. So [the study] raises, but doesn't answer the question: "Is faldaprevir different than the other agents that were tested?" It's really impossible to say, because the numbers are too small, but it raises the question of whether this agent is going to be associated with a higher rate of breakthrough than the other agents tested here.

Instead of 100 patients, I'd like to see 1,000, and certainly there are many many hundreds of patients who have been in randomized trials, and this data is or will soon become available. So I think that this is a good beginning, but we just need to see larger numbers, and we need to see numbers that are specific to each and every direct-acting antiviral drug.

William Carey, MD

Professor of medicine, Cleveland Clinic Liver College of Medicine
Founding member, Cleveland Clinic Hepatology section

Disclosures: Dr. Carey reported no relevant financial disclosures.

Source

Perceptions of drug users regarding Hepatitis C screening and care: a qualitative study

Published on: 2013-06-20

Illicit drug users have a high prevalence of HCV and represent the majority of newly infected persons in the U.S. Despite the availability of effective HCV treatment, few drug users have been evaluated or treated for HCV.

Racial and ethnic minorities have a higher incidence and prevalence of HCV and higher HCV-related mortality. Factors contributing to poor engagement in care are incompletely understood.

Methods: Fourteen mixed-gender focus groups of either African American or Latino/a drug users (N = 95) discussed barriers to HCV testing and treatment.

Themes were identified through content analysis of focus group discussions.

Results: Many drug users were tested for HCV in settings where they were receiving care. Outside of these settings, most were unaware of voluntary test sites.

After testing HCV positive, drug users reported not receiving clear messages regarding the meaning of a positive HCV test, the impact of HCV infection, or appropriate next steps including HCV clinical evaluations. Many drug users perceived treatment as unimportant because they lacked symptoms, healthcare providers minimized the severity of the diagnosis, or providers did not recommend treatment.

Mistrust of the motivations of healthcare providers was cited as a barrier to pursuing treatment. Social networks or social interactions were a source of HCV-related information and were influential in shaping drug users perceptions of treatment and its utility.

Conclusion: Drug users perceived a paucity of settings for self-initiated HCV testing and poor provider-patient communication at test sites and during medical encounters.

Notably, drug users reported having an unclear understanding about the meaning of a positive HCV test, the health implications of HCV infection, the importance of clinical evaluations and monitoring, and of treatment options for HCV. Efforts to improve the delivery of clinical messages about HCV infection for drug users at test settings and clinical encounters are needed.

Author: Ashly E JordanCarmen L MassonPedro Mateu-GelabertCourtney McKnightNicole PepperKatie BoucheLaura GuzmanEvan KletterRandy M SeewaldDon C Des-JarlaisJames L SorensenDavid C Perlman

Credits/Source: Harm Reduction Journal 2013, 10:10

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