November 10, 2013

Transplant Proc. 2013 Nov;45(9):3325-8. doi: 10.1016/j.transproceed.2013.04.011.

Kelly MA, Kaplan M, Nydam T, Wachs M, Bak T, Kam I, Zimmerman MA.

Division of Transplant Surgery, University of Colorado Health Sciences Center, Aurora, Colorado, USA. Electronic address: Mara.Kelly@ucdenver.edu.

Abstract

INTRODUCTION: Hepatitis C virus (HCV) recurrence following orthotopic liver transplantation is an expected outcome in all patients transplanted for a primary diagnosis of HCV. HCV recurrence has been shown to be associated with graft fibrosis and graft loss. Recent studies suggest that sirolimus (SRL) therapy may slow or inhibit hepatic fibrosis following liver transplant in patients positive for HCV at the time of transplant.

METHODS: Among 313 patients who underwent orthotopic liver transplantation for HCV between 2000 and 2009, 251 qualified for inclusion in the study. Per protocol liver biopsies were performed on all patients at 1 year following liver transplantation and/or at the time of a clinical diagnosis of HCV recurrence. Biopsies were scored for fibrosis using the Batts-Ludwig staging system (0-4); significant fibrosis was defined as fibrosis ≥ stage 2.

RESULTS: Overall, there was no difference in overall survival or graft loss in the SRL compared with the control group. Multivariate analysis revealed SRL therapy to be associated with decreased odds of significant hepatic fibrosis at year 1 postoperatively and over the study duration.

CONCLUSIONS: This retrospective, single-center study showed sirolimus-based immunosuppression to be associated with a lower risk of significant graft fibrosis, both at year 1 and throughout the study period, following liver transplantation in HCV-infected recipients.

Copyright © 2013. Published by Elsevier Inc.

PMID: 24182811 [PubMed - in process]

Source

Journal of Viral Hepatitis

Early View (Online Version of Record published before inclusion in an issue)

Original Article

J. P. Colagreco1,*,D. E. Bailey2,J. J. Fitzpatrick3,C. M. Musil3,N. H. Afdhal1,M. Lai1

Article first published online: 7 NOV 2013

DOI: 10.1111/jvh.12207

© 2013 John Wiley & Sons Ltd

\Article first published online: 7 NOV 2013
Manuscript Accepted: 11 SEP 2013
Manuscript Received: 10 MAY 2013

Keywords: depression; fibrosis; hepatitis C; uncertainty; watchful waiting

Summary

Background and Aims: New therapies for HCV are rapidly emerging and providers are advising select patients to defer treatment and elect ‘watchful waiting’. During the watchful waiting period, patients have been shown to have high rates of illness uncertainty and depression. We sought to answer the question of whether reassuring histological data (showing minimal fibrosis or no fibrosis progression over time) is associated with less illness uncertainty and depressive symptoms.

Methods: This was a single-centre outpatient prospective cohort study to determine whether stage of fibrosis, fibrosis progression and reasons for treatment deferral were related to illness uncertainty and depressive symptoms in patients following watchful waiting.

Results: Illness uncertainty was significantly related to depressive symptoms (r = 0.49, P < 0.01). More than half of the participants (54%) had moderate levels of uncertainty. About 40% of the participants were at risk for clinical depression (21.7% at mild to moderate risk and 18.5% at high risk). Treatment naïve subjects had lower mean scores on both the CES-D (depressive symptoms measure) and the MUIS-A (illness uncertainty measure) total score, MUIS-A Ambiguity subscale and MUIS-A Inconsistency subscale than subjects who failed treatment or were interferon intolerant or ineligible. Surprisingly, liver fibrosis stage and progression were not significantly associated with overall illness uncertainty or depressive symptoms.

Conclusion: Patients with chronic hepatitis C on watchful waiting are at high risk for significant illness uncertainty and depressive symptoms. Reassuring histological data does not seem to correlate with less uncertainty or depressive symptoms.

Source

Clin Infect Dis. 2013 Nov 5. [Epub ahead of print]

Ly KN, Xing J, Klevens RM, Jiles RB, Holmberg SD.

Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia.

Abstract

Background. Previous research indicates that the mortality burden from viral hepatitis is growing, particularly among middle-aged persons. To monitor progress toward prevention goals, it is important to continue to document characteristics and comortalities of these deaths. This study sought to examine demographic characteristics and the most frequent causes of death among decedents with a viral hepatitis-related death. Methods. A cross-sectional study was performed on approximately 2.4 million death records from 2010. We calculated mortality rates for decedents with and without hepatitis A, B, and C virus (HAV, HBV, and HCV) and relative risks for the most frequently cited conditions in decedents with and without HBV and HCV. Results. In 2010, there were 18 473 (0.7%) deaths with HAV, HBV, and HCV listed among causes of death, disproportionately in those aged 45-64 years. Among the 10 frequent causes of death, decedents listing HBV or HCV died, on average, 22-23 years earlier than decedents not listing these infections. HBV- and HCV-infected decedents aged 45-64 years had an increased risk of having the following conditions reported than decedents without these infections: cancer of liver and intrahepatic bile duct; fibrosis, cirrhosis, and other liver diseases; alcohol-related liver disease; gastrointestinal hemorrhage; human immunodeficiency infection; acute and unspecified renal failure; and septicemia (HCV only). Conclusions. Decedents with other causes of death that include HBV or HCV died 22-23 years earlier than decedents not listing these infections. These data suggest and support the need for prevention, early identification, and treatment of HBV and HCV.

KEYWORDS: causes of death, death certificates, mortality, viral hepatitis

PMID: 24065331 [PubMed - as supplied by publisher]

Source

Journal of Viral Hepatitis

Volume 20, Issue 12, pages 829–837, December 2013

Original Article

J. L. Casado*,C. Quereda,A. Moreno,M. J. Pérez-Elías,P. Martí-Belda,S. Moreno

Article first published online: 25 APR 2013

DOI: 10.1111/jvh.12108

© 2013 John Wiley & Sons Ltd

Keywords: fibrosis; hepatitis C; histological; interferon therapy; regression; transient elastography

Summary

There are few data about the long-term histological outcome of HIV-/HCV-coinfected patients after therapy with interferon and ribavirin. We performed an observational study of 216 patients who received therapy against HCV and who had at least three successive transient elastographies (TE) during the follow-up. The primary endpoint was confirmed fibrosis regression, defined as a reduction of at least 1 point in Metavir fibrosis score, confirmed and without worsening in successive TE. At baseline, 23% had fibrosis stage 4 or cirrhosis. Overall, 82 (38%) achieved sustained virological response (SVR), without differences in baseline fibrosis or time of follow-up. Confirmed fibrosis regression was observed in 55% of patients, higher for SVR (71% vs 44%; P < 0.01), and the likelihood of achieving fibrosis regression at 3, 5 and 7 years was 0.17, 0.51 and 0.67, respectively, for SVR patients, in comparison with 0.02, 0.23 and 0.41 for no SVR patients (P < 0.01, log-rank test at any time point). Progressive regression, defined as continuous improvement in successive TE, was observed in 62% of patients with advanced liver fibrosis or cirrhosis who achieved SVR. In a Cox regression model, only SVR (HR, 4.01; 95% CI, 2.33–7.57; P < 0.01) and a younger age (HR, 1.14; 95% CI, 1.05–1.25; P < 0.01; per year) were associated with fibrosis regression. This study confirms that the rate of liver fibrosis regression increases during the follow-up after SVR to interferon therapy in HIV-/HCV-coinfected patients.

Source

Journal of Viral Hepatitis

Volume 20, Issue 12, pages 847–857, December 2013

Original Article

L. M. Hagan1,2,3,*,Z. Yang2,M. Ehteshami1,3,R. F. Schinazi1,3

Article first published online: 10 JUN 2013

DOI: 10.1111/jvh.12111

Published 2013. This article is a U.S. Government work and is in the public domain in the USA

Keywords: antiviral agents; combination therapy; HCV ; ribavirin; sustained virologic response; triple therapy

Summary

Interferon-based standard of care treatments (SOC) for chronic hepatitis C are unable to provide high cure rates in certain subgroups of the infected population and can cause debilitating side effects. Clinical trials evaluating all-oral, interferon-free treatments have demonstrated high rates of sustained virologic response with no resistance or major adverse events in most populations. As these drug regimens move towards FDA approval, it will be important to assess their cost-effectiveness in addition to their clinical efficacy. A decision-analytic Markov model with a lifetime, societal perspective was used to evaluate the cost-effectiveness of a generalized all-oral drug regimen compared to SOC by modelling the progression of a 50-year-old, HCV-positive cohort through disease natural history and treatment. In base case analysis, all-oral treatment dominated SOC across a range of willingness-to-pay (WTP) thresholds with an incremental cost-effectiveness ratio (ICER) of US$44 514/quality-adjusted life year (QALY). In sensitivity analyses, the model was sensitive to all-oral drug costs as well as rates of SVR and treatment uptake among noncirrhotic subjects, but robust to variations in all other parameters. All-oral treatment was most cost-effective among genotype 1 subjects but remained cost-effective for genotypes 2 and 3 at WTP thresholds ≥$80 000/QALY. Quality-adjusted life years gained per dollar spent were maximized in younger treatment cohorts. Using this model, the degree of cost-effectiveness depended on the WTP threshold and the final cost set for approved drug combinations.

Source

Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

Liver Injury and Regeneration

Sam Lattimore1,*,Will Irving2,Sarah Collins1,Celia Penman1,Mary Ramsay1, On behalf of the collaboration for the sentinel surveillance of blood-borne virus testing

DOI: 10.1002/hep.26926

Copyright © 2013 American Association for the Study of Liver Diseases

Accepted manuscript online: 9 NOV 2013 04:08AM EST
Manuscript Accepted: 5 NOV 2013
Manuscript Revised: 21 OCT 2013
Manuscript Received: 31 JUL 2013

Keywords: Hepatitis C; epidemiology; surveillance; treatment; England

ABSTRACT

Background & Aims: To develop and validate an algorithm to monitor rates of, and response to, treatment of patients infected with hepatitis C virus (HCV) across England using routine laboratory HCV RNA testing data.

Methods: Hepatitis C testing activity between January 2002 and December011 was extracted from the local laboratory information systems of a sentinel network of 23 laboratories across England. An algorithm based on frequency of HCV RNA testing within a defined time period was designed to identify treated patients. Validation of the algorithm was undertaken for one centre by comparison with treatment data recorded in a clinical database managed by the Trent HCV study group.

Results: In total, 267,887 HCV-RNA test results from 100,640 individuals were extracted. Of these, 78.9% (79,360) tested positive for viral RNA, indicating an active infection, 20.8% (16,538) of whom had a repeat pattern of HCV-RNA testing suggestive of treatment-monitoring. Annual numbers of individuals treated increased rapidly from 468 in 2002, to 3,295 in 2009, but decreased to 3,110 in 2010. Approximately two thirds (63.3; 10,468) of those treated had results consistent with a sustained virological response, including 55.3% and 67.1% of those with a genotype-one and non-one virus, respectively. Validation against the Trent clinical database demonstrated that the algorithm was 95% sensitive and 93% specific in detecting treatment, and 100% sensitive and 93% specific for detecting treatment outcome.

Conclusions: Laboratory testing activity, collected through a sentinel surveillance programme has enabled the first country-wide analysis of treatment and response among HCV-infected individuals. Our approach provides a sensitive, robust, and sustainable method for monitoring service provision across England. (Hepatology 2013;)

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Don’t Marginalize Your HCV-Infected PWID—Treat Them

Provided by Clinical Care Options

Jason Grebely, BSc, PhD - 9/16/2013 More from this author

In many ways, people who inject drugs (PWID) represent a “forgotten” group of patients eligible for hepatitis C virus (HCV) treatment. Generally, they have been excluded from clinical trials and HCV treatment guidelines. When they have approached clinicians for treatment, they have been told that once they stop using drugs for more than 6 months, they can think about treatment. Preconceptions about low rates of adherence, inability to attend appointments, increased susceptibility to adverse effects, and the potential for high rates of reinfection have limited providers’ willingness to reach out to and treat this at-risk population. Concerns about HIV coinfection, interactions between drugs—both prescribed and illicit—and liver damage due to heroin or methadone have further limited interest in treating PWID.

Recently published international recommendations from the International Network on Hepatitis in Substance Users, of which I am a coauthor, are intended to supplement existing guidelines and address many of these issues. To implement these recommendations, we have to address obstacles that may interfere with the initiation of treatment.

Breaking Down the Barriers
PWID continue to experience high rates of HCV infection in developed countries. The damage associated with HCV infection is known to be accelerated by factors such as age, ongoing moderate or heavy alcohol use, HIV coinfection, obesity, and insulin resistance. However, there is no evidence that fibrosis is accelerated by methadone or heroin use and little is known about the effect of methamphetamine. Similarly, whereas active PWID were excluded from the pivotal trials of the currently available direct-acting antivirals, results from separate trials indicate that methadone/buprenorphine can be coadministered with direct-acting antivirals. Finally, treatment for HCV should not significantly affect treatment for drug dependency nor lead to an increase in drug use.

If the decision is made to treat PWID for HCV, will they adhere to therapy or will they fail to complete their course of treatment? The few studies addressing HCV treatment in a setting of active drug use indicate that PWID can be treated successfully. My experience is similar to that described by Graham Foster: When PWID are carefully identified and counseled, they stay with therapy almost as readily as any other population.

What about reinfection? Many providers believe that PWID actively using drugs, even intermittent users, are just going to get reinfected, negating previously successful treatment efforts. As it happens, this does not appear to be the case. Actively using PWID certainly should be counseled about the risks associated with certain behaviors and the potential for reinfection, but the reinfection rates associated with active drug use may actually be quite low based on a recent review of available studies. These data suggest that there is no need to avoid treating HCV in PWID for fear that it will be necessary to repeat the process.

Some providers have raised concerns about the possibility of poor adherence among this patient population. Taking into consideration the high costs of HCV therapy and the potential for transmitted resistance by nonadherent patients, many providers may be reluctant to initiate therapy in this population. However, this perception is not borne out by the evidence that indicates PWID are no less likely to adhere to therapy than other patients. Furthermore, in the era of direct-acting antivirals, resistance may be a less of a concern due to their higher barrier to resistance.

Overcoming Our Own Preconceptions
There are numerous strategies we can employ to improve outcomes for PWID. First, we have to decide to treat these patients, and to make that decision, we need to recognize that what appear to be barriers are not necessarily so. There is no denying that there are challenges to the treatment of HCV in this population. However, when barriers are systematically identified and addressed within a supportive, multidisciplinary environment, PWID can be successfully treated for HCV infection. Also, reinfection is lower than one might expect. This is not to deny that challenges do exist, but they are not insurmountable. We can begin by overcoming our own preconceptions, which will allow us to implement appropriate strategies and successfully treat these patients.

Your Thoughts?
I am keen to hear your thoughts and experiences in treating HCV in PWID. Do you treat actively using PWID or ask them to cease drug use? How have you approached the treatment of PWID? Is there a particular strategy that has been successful for you in treating PWID?

Topics: HCV – Treatment

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Provided by Clinical Car5e Options

Gregory Dore, - 9/24/2013 More from this author

Need and the greater good should drive healthcare decision making. As a consequence, we must never forget that behind a needle and spoon, there is a human being in need. Human frailty, personal choices, and politics aside, people who inject drugs (PWID) represent a segment of the population that, with understanding and the will to act, can be successfully treated for hepatitis C. However, to achieve the goal of successful treatment, healthcare providers must first create a nonjudgmental environment to overcome the reluctance of PWID to report their drug use. By allowing them to open up to us as providers, we establish a foundation of trust and support that will enable them to begin and then remain on treatment.

Engage With Education
Once we know where we stand, both sides of the treatment equation can meet the inevitable challenges together. It is this partnership between provider and patient that creates the foundation of a successful treatment team, especially when those patients are PWID. Once patients have taken the first step to reach out, it is incumbent upon providers to identify and address their needs in order to keep them coming back.

In my experience, developing a program that successfully treats PWID begins with early and ongoing education of providers and staff across the spectrum of specialties. Although the number of studies is limited, the data they present argue in favor of treating PWID for hepatitis C. A recent systematic analysis revealed that PWID—even those who actively use drugs during treatment—have demonstrated acceptable sustained virologic response (SVR) rates of 37% for genotype 1/4 and 67% for genotype 2/3 after peg-IFN/RBV treatment for chronic HCV infection. Another analysis of pooled data found that PWID experience low reinfection rates (1% to 5% per year) following successful treatment. Additional pooled study results have found that PWID demonstrate 80/80/80 adherence rates of 82% (95% CI: 74% to 89%) and discontinuation rates of 22% (95% CI: 16% to 27%), both rates that approximate those for people who do not use drugs. Finally, the Enhancing Treatment for Hepatitis C in Opioid Substitution Settings (ETHOS) study demonstrated that a multidisciplinary team integrating nursing and specialist support into existing community health clinics and opioid substitution treatment centers can successfully assess and engage PWID in HCV treatment. We have promoted these data as widely as possible to bring attention to the possibility of treating PWID successfully. Ongoing initiatives will evaluate strategies to improve HCV treatment uptake among PWID and enhance treatment outcomes, particularly in the context of new direct-acting antiviral (DAA) regimens.

To enhance hepatitis C treatment and care for PWID, there is a need to expand points of assessment. One provider group we should aggressively recruit is addiction specialists. Using their access to and intimate knowledge of these patients enables us to reach these patients on a more personal and immediate level. Reaching this group of providers is especially important when we recognize that many PWID are reluctant to engage in care at large, tertiary care centers. They are often more easily engaged at smaller community clinics and methadone treatment centers. Once engaged in an environment they are comfortable in and by providers they are familiar with, PWID could be either treated within drug and alcohol or community-based settings or referred to more specialized providers at larger secondary or tertiary care centers. The advent of IFN-free all-oral DAA regimens should enhance feasibility of hepatitis C treatment delivery within a broader range of settings.

By reaching out to specialists other than the “usual suspects” of hepatologists and gastroenterologists, we are following the very successful HIV care model. This outreach allows us to create care partners who recognize the real possibility of treating PWID successfully, if not by the individual provider, then by a readily available specialist. Furthermore, in keeping with the HIV model, a multidisciplinary team will enable us to maximize the possibility of successfully treating not only their hepatitis C, but also their common comorbid psychiatric difficulties, social isolation, and other medical issues.

Impacting Care and Treatment
We can affect both the health of our community and PWID by recognizing that they can be treated successfully with careful patient selection. Getting information into the hands of providers who may be more familiar with and trusted by PWID is an important first step. PWID should not be dismissed as “untreatable” but receive individualized assessment for treatment as undertaken for other patients with hepatitis C. A range of disease-based, social, and family factors require evaluation in relation to treatment readiness and potential impact on outcomes.

Rightfully, society at-large has concerns about the enormous expense associated with hepatitis C therapy and the potential for transmitted resistance due to suboptimal adherence in any patient with hepatitis C including PWID. Individualized hepatitis C treatment assessment thus provides the opportunity to optimize uptake and outcomes.

Educate yourself, educate others, and make a positive impact in everyone.

Recently published international recommendations from the International Network on Hepatitis in Substance Users, of which I am a co-author, supplement existing guidelines and address many issues associated with successfully treating HCV in PWID.

Your Thoughts?
I am interested in hearing your thoughts on treating HCV in PWID. Is there an outreach program in your community to engage these patients? What has your experience been in treating PWID for any medical condition? How have you overcome obstacles to treatment in this patient population?

Topics: HCV – Treatment

Follow Discussion

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Friday, November 08, 2013 by Proactive Investors

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Immuron Limited (ASX: IMC) is set to trade higher after receiving investigational new drug clearance from the US Food and Drug Administration to commence a clinical trial of its bovine colostrum-derived therapeutic for the treatment of a liver disease, alcoholic steatohepatitis, or ASH.

Immuron is also in preparation for Phase IIb clinical trials of non-alcoholic steatohepatitis, or NASH.
Notably, the principal investigator for its NASH trial has been awarded a National Institutes of Health grant to conduct a clinical trial for ASH.\

This trial will be conducted by the TREAT consortium, one of the world’s leading collaborations for clinical research into fatty liver diseases.

TREAT consortium's ASH trial is expected to provide Immuron with additional guidance for its NASH trials commencing next year.

NASH and ASH arise from different causes; both result in liver damage potentially leading to liver fibrosis, liver cirrhosis hepatic carcinoma.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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New drug combo causes cancer cells to 'eat themselves'

PTI Nov 6, 2013, 03.59PM IST

WASHINGTON: A new drug combination therapy could effectively kill colon, liver, lung, kidney, breast and brain cancer cells without affecting the healthy cells, scientists say.

The results from a recent preclinical study at Virginia Commonwealth University Massey Cancer Center lays the foundation to plan a future phase 1 clinical trial to test the safety of the therapy in a small group of patients.

"It is still too premature to estimate when a clinical trial will open to further test this drug combination therapy, but we are now in the planning phase and encouraged by the results of these laboratory experiments," said Andrew Poklepovic, assistant professor in the Division of Hematology, Oncology and Palliative Care at VCU School of Medicine.

The study led by Paul Dent demonstrated that the drugs sorafenib and regorafenib synergise with a class of drugs known as PI3K/AKT inhibitors to kill a variety of cancers.

Sorafenib and regorafenib work by blocking the production of enzymes called kinases, which are vital to the growth and survival of cancer cells.

Sorafenib is currently approved by the FDA to treat kidney and liver cancers, and regorafenib is currently approved for the treatment of colorectal cancer.

However, sorafenib and regorafenib do not directly affect PI3K and AKT kinases, which are also very active in promoting cancer cell survival.

The addition of a PI3K/AKT inhibitor to the combination of sorafenib and regorafenib dramatically increased cell death and was even effective against cells with certain mutations that make one or the other drug less effective.

"We know that there are certain cellular processes that are frequently dysregulated in cancers and important to cell proliferation and survival, but if you shut down one, then cells can often compensate by relying on another," said Dent.

"We are blocking several of these survival pathways, and the cancer cells are literally digesting themselves in an effort to stay alive," Dent said.

Results showed that the combination therapy killed the cells by physically interacting with molecules to block the survival pathways and induce a toxic effect known as autophagy.

Autophagy is a protective process where cells metabolise themselves when starved of the resources needed to survive.

The study was published in the journal Molecular Pharmacology.

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AUDIENCE: Consumers, Healthcare Professionals

ISSUE: The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated.

In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to  becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants. For a list of products affected please see the FDA News Release.

BACKGROUND: By letter dated Nov. 6, 2013, the FDA notified USPlabs about findings indicating a link between the use of OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.

In a warning letter issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient (i.e., an ingredient not marketed in the United States before Oct. 15, 1994) that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.

In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.

RECOMMENDATION: Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner. If consumers think they have suffered a serious harmful effect or illness from a dietary supplement, healthcare professionals and patients are encouraged to report adverse events or  side effects related to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For Complete MedWatch Safety Alert with links to FDA News Release and Previously Posted MedWatch Safety Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm374398.htm


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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Also See: Supplements Blamed for Liver Toxicity

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New Hepatitis C Treatments Effective, But Expensive

Posted by Toi Williams on Nov 10th, 2013 // No Comments

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Turning the tide against the rise of hepatitis C has been a primary goal of the medical community for many years. Being able to eliminate the virus from the body with a simple, effective treatment would be an enormous public health achievement. Hepatitis C kills more Americans annually than AIDS. The virus is also the leading cause of liver transplants.

After being diagnosed with an hepatitis C infection that was slowly destroying his liver, Dr. Arthur Rubens, a professor of management at Florida Gulf Coast University, tried several experimental treatments. Many of the treatments subjected him to unpleasant side effects, like fever, insomnia, depression, anemia and a rash that “felt like your skin was on fire.” This year, Dr. Rubens joined a clinical trial testing a new pill designed to eliminate hepatitis C infections from the body. After three months of treatment, the virus was cleared from his body.

New drugs are expected to come to market that will cure most patients with the virus beginning near the end of 2013 and continuing over the next three years. If the new medications are proven to be successful with a wider range of patients, it would mark the first time that a viral epidemic has been controlled without the use of a vaccine. Dr. Mitchell L. Shiffman, the director of the Bon Secours Liver Institute of Virginia said, “There is no doubt we are on the verge of wiping out hepatitis C.”

One of the new drugs is a once-a-day pill taken for as few as eight weeks. The medication in the pill has shown few side effects so far. Current therapies for hepatitis C require six to 12 months of injections that often have terrible side effects. These therapies cure about 70 percent of newly treated patients.

However, the cost of the new drugs may limit their usage. Some of the new drugs are expected to cost from $60,000 to more than $100,000 for a course of treatment. This would put the drugs out of reach for the uninsured and infected patients in developing countries.

Not everyone diagnosed with a hepatitis C would be helped by the new drugs. Many people infected with hepatitis C never suffer serious liver problems. Dr. Ronald Koretz, emeritus professor of clinical medicine at the University of California, Los Angele, said, “The vast majority of patients who are infected with this virus never have any trouble.”

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