Vertex warned over misleading hep C drug promotion

Boston Business Journal by Julie M. Donnelly Reporter

Date: Wednesday, May 30, 2012, 3:00pm EDT - Last Modified: Thursday, May 31, 2012, 9:17am EDT

The U.S. Food and Drug Administration has issued a letter to Vertex Pharmaceuticals (Nasdaq: VRTX) saying the company published a misleading “branded story” promoting its drug for hepatitis C, Incivek. The FDA is demanding that the Cambridge, Mass.-based company, which won FDA approval for the drug in May of 2011, stop disseminating the materials in question.

The letter reads in part, “The branded story is misleading because it overstates the efficacy, omits material facts and minimizes important risk information about the drug product.”

Vertex spokeswoman Erin Emlock said that the branded story had not yet been used as the basis for a patient presentation, which was its intent. "We are re-evaluating it," Emlock said. "we take the FDA's feedback seriously and will address the concerns raised."

The branded Incivek story described the experience of a patient named James, who had stage 3 cirrhosis due to hepatitis C and failed to have a response on another drug regimen. He found the drug combination including Incivek to be effective.

The story included statements such as:

“And six months after treatment ended, I found out I’d cleared the virus. That made me feel so good. I was so happy to know I’d be around a little longer to see my son grow up.” [page 5]

“. . .I’m cleared, I can take my son to the batting cage. We go sailing on my boat and take nice vacations. I even retired from the railroad and started a successful cab business, which I really enjoy. I’m loving life.” [page 5]

The FDA found that while these statements might reflect this patient’s experience, it is misleading because it implies that all such patients will successfully achieve a Sustained Virologic Response (SVR).

The FDA says that in fact, only 14 percent of patients like James, with cirrhosis who failed to respond on other drugs, achieved an SVR with the Incivek regimen.

The FDA asked Vertex to respond to the letter by June 11, detailing whether the company plans to comply with the agency’s request, listing all promotional materials that include violations, and providing a plan for discontinuing their use.

On Tuesday, Vertex revised data it had previously reported on the effects of another drug, Kalydeco, when used in combination with a potential treatment, VX-809, with cystic fibrosis (CF) patients. By Wednesday afternoon, the company's stock had substantially recovered from a drop of more than 20 percent, triggered by that news.

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Kadmon Launches 600 mg/day Ribasphere(R) RibaPak(R) to Provide Added Dosing Control for Triple Therapy Treatment of Chronic Hepatitis C

PRESS RELEASE

June 5, 2012, 8:02 a.m. EDT

NEW YORK, NY, Jun 05, 2012 (MARKETWIRE via COMTEX) -- Kadmon Pharmaceuticals, LLC, the commercial division of Kadmon Corporation, LLC, today announced that it has launched a new 600 mg/day dose pack of Ribasphere(R) RibaPak(R) (ribavirin, USP), Kadmon's proprietary ribavirin regimen, and the only ribavirin available in a daily, two-pill compliance package for enhanced therapy adherence. The new dose pack is designed to provide added dosing control to improve the management of hemolytic anemia in certain patients prescribed the triple therapy of a protease inhibitor, pegylated alpha interferon and ribavirin for the treatment of chronic hepatitis C virus infection.

"Anemia, particularly severe anemia, is an important concern with hepatitis C treatments, one which may be effectively controlled through ribavirin dose reduction," said John Ryan, Ph.D., M.D., Executive Vice President and Chief Medical Officer of Kadmon. "Anemia can also affect treatment adherence and a patient's ability to complete therapy. The new 600 mg/day Ribasphere(R) RibaPak(R) dose pack ensures that physicians can seamlessly reduce ribavirin dose without compromising the adherence advantages of RibaPak(R)."

Pooled data from studies of the protease inhibitors VICTRELIS(R) (boceprevir) and INCIVEK(TM) (telaprevir), approved in 2011 for the treatment of genotype 1 chronic hepatitis C virus, show that anemia was a frequently observed adverse event in both treatment-naive and treatment-experienced patients (Pearlman BL, et al. Journal Options Hepatitis. 2011;5:1), in some cases exhibiting a doubling of incidence over control (peginterferon/ribavirin). In clinical studies, anemia has been managed with ribavirin dose reduction and/or with off-label use of erythropoietin (Pearlman BL, et al. Journal Options Hepatitis. 2011; 5:1).

With the new 600 mg/day dose pack, Ribasphere(R) RibaPak(R) is now available in four dosing options: 600 mg/day, 800 mg/day, 1000 mg/day, and 1200 mg/day. Ribasphere(R) RibaPak(R) offers a unique packaging and dosage form designed to simplify treatment, reducing ribavirin pill burden by up to 66% over a 48 week course of treatment, and to make it easier for the patient to keep track of their treatment. Adherence to therapy is an important component in the successful treatment of hepatitis C. The risk of non-compliance includes treatment failure or relapse (Reddy KR, Shiffman ML, Morgan TR, et al. Clin Gastroenterol Hepatol. 2007;5:124-129) and, because of the direct antiviral mechanism of protease inhibitors, missed doses of a protease inhibitor could lead to viral resistance (Weiss, et al. Aliment Pharmacol Ther 2009; 30:14-27).

About Hepatitis C

Hepatitis C is a liver disease that results from infection with the hepatitis C virus ("HCV"). Hepatitis C virus can either be "acute" or "chronic." Acute hepatitis C virus infection is a short-term illness that occurs within the first six months after someone is exposed to the hepatitis C virus. Seventy five-85% of acute HCV infections become chronic HCV infections. Chronic hepatitis C virus is a serious disease than can result in long-term health problems, such as serious liver disease, including cirrhosis and liver cancer, or even death. An estimated 4 million Americans are infected with the hepatitis C virus.

About Ribasphere(R) RibaPak(R) (ribavirin, USP)

INDICATION

Ribasphere(R) (ribavirin, USP) in combination with peginterferon alfa-2a is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha.

IMPORTANT SAFETY INFORMATION

Ribasphere(R) (ribavirin, USP) monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication (see WARNINGS). The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may persist in non-plasma compartments for as long as 6 months. Ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6 month post treatment follow-up period.

CONTRAINDICATIONS

Ribasphere(R) (ribavirin, USP) is contraindicated in:

-- Patients with known hypersensitivity to Ribasphere(R) (ribavirin, USP) or to any component of the tablet.

-- Women who are pregnant.

-- Men whose female partners are pregnant, plan to become pregnant, or are not using contraception.

-- Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia).

-- In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials.

Ribasphere(R) (ribavirin, USP) and peginterferon alfa-2a combination therapy is contraindicated in patients with:

-- Autoimmune hepatitis.

-- Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment.

-- Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment.

WARNINGS AND PRECAUTIONS

Treatment with Ribasphere(R) (ribavirin, USP) and peginterferon alfa-2a should be administered under the guidance of a qualified physician and may lead to moderate to severe adverse experiences requiring dose reduction, temporary dose cessation or discontinuation of therapy.

Ribasphere(R) (ribavirin, USP) must not be used alone because ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection.

Ribasphere(R) (ribavirin, USP) and peginterferon alfa-2a should be discontinued in patients who develop evidence of hepatic decompensation during treatment.

There are significant adverse events caused by ribavirin/peginterferon alfa-2a therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, ophthalmologic disorders, cerebrovascular disorders, pulmonary dysfunction, colitis, pancreatitis, and diabetes. The peginterferon alfa-2a package insert and medication guide should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.

Pregnancy: Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.

Anemia: The primary toxicity of ribavirin is hemolytic anemia (hemoglobin < 10 g/dL), which was observed in approximately 13% of all ribavirin and peginterferon alfa-2a treated patients in clinical trials.

Hepatic Failure: Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including peginterferon alfa-2a. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART.

Hypersensitivity: Severe acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, and anaphylaxis) have been observed during alpha interferon and ribavirin therapy.

Renal Impairment: Ribasphere(R) (ribavirin, USP) should not be used in patients with creatinine clearance < 50 mL/min.

Pulmonary: Pulmonary symptoms, including dyspnea, pulmonary infiltrates, pneumonitis, pulmonary hypertension, pneumonia, and occasional cases of fatal pneumonia, have been reported during therapy with ribavirin and interferon. In addition, sarcoidosis or the exacerbation of sarcoidosis has been reported.

Bone Marrow Suppression: Pancytopenia (marked decreases in RBCs, neutrophils and platelets) and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the concomitant administration of pegylated interferon/ribavirin and azathioprine.

Pancreatitis: Ribasphere(R) (ribavirin, USP) and peginterferon alfa-2a therapy should be suspended in patients with signs and symptoms of pancreatitis, and discontinued in patients with confirmed pancreatitis.

Laboratory Tests: Before beginning peginterferon alfa-2a/Ribasphere(R) (ribavirin, USP) combination therapy, standard hematological and biochemical laboratory tests are recommended for all patients.

Drug Interactions: Nucleoside Analogues: NRTIs: In clinical trials, cases of hepatic decompensation (some fatal) were observed among the CHC/HIV coinfected cirrhotic patients receiving NRTIs. Patients receiving peginterferon alfa-2a/ribavirin and NRTIs should be closely monitored for treatment associated toxicities.

ADVERSE REACTIONS

Peginterferon alfa-2a in combination with ribavirin causes a broad variety of serious adverse reactions. The most common serious or life-threatening adverse reactions induced or aggravated by peginterferon alfa-2a and ribavirin include depression, suicide, relapse of drug abuse/overdose, and bacterial infections, each occurring at a frequency of < 1%. Hepatic decompensation occurred in 2% of CHC/HIV patients. Nearly all patients in clinical trials experienced one or more adverse events.

For more information please see the accompanying Ribasphere(R) RibaPak(R) (ribavirin, USP) Tablets Full Prescribing Information. The peginterferon alfa-2a Package Insert should be reviewed in its entirety for additional safety information prior to initiation of combination treatment.

C001.00059

About Kadmon Corporation

Kadmon Corporation, LLC is a global company built on a 21st-century paradigm for the translation of innovative science into treatment. The company currently offers products and services for the treatment and management of hepatitis C. Kadmon is pioneering medicines in oncology, infectious diseases, immunology and neurodegenerative diseases by using emerging concepts in molecular biology and genomics to develop therapies that target the metabolomics and signaling pathways associated with disease. For more information, visit www.kadmon.com .

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Hepatitis C 'switch' offers target for new drug research

May 31, 2012

Scientists have discovered a 'switch' in the Hepatitis C virus which could be used as a target for new kinds of drug treatment.

Hepatitis C affects more than 170 million people worldwide, but current combination treatment is only effective against a limited range of this naturally highly variable virus.

However, according to new research by the University of Warwick, the newly discovered SL9266 switch is very highly conserved and present in all Hepatitis C viruses, meaning this offers a good starting point for further research into an across-the-board treatment.

This region represents a vulnerable spot for attacking and clearing the virus from the body as it controls a critical event in the earliest stages of the virus lifecycle.

It seems the switch modulates the mutually incompatible translation and replication processes that must occur for the virus to spread inside the body.

University of Warwick scientists at the School of Life Sciences and their collaborators in the Roslin Institute at the University of Edinburgh are now working with chemists to develop custom-designed drugs that target the switch and lock it in the off position.

By locking the virus into a translation-only phase it cannot initiate replication, a process critical for infecting other cells in the liver.

The immune response to the initially infected cell would contribute to the clearance of the virus from the body.

Despite the variability of the virus, the mechanism and function of this switch is thought to be highly conserved, providing a means of targeting all Hepatitis C viruses.

Professor David Evans of the University of Warwick said: Hepatitis C is a growing concern worldwide and is set to place a massive demand on the organ transplant system.

We are already at the stage in many countries where the main need for liver transplants is due to liver damage caused by the Hepatitis C virus.

Current medication is not effective in all cases, thats why its vital that we continue to build on this early-stage research to focus drug development work on treatment which works across all Hepatitis C genotypes.

The research, funded by the UK Medical Research Council, is published in the journal Nucleic Acids Research.

The study is entitled A twist in the tail: SHAPE mapping of long-range interactions and structural rearrangements of RNA elements involved in HCV replication.

It is co-authored by Andrew Tuplin, Madeleine Struthers and David Evans of the University of Warwick and Peter Simmonds of the Roslin Institute, University of Edinburgh.

Source

One Year Post-Launch, The Protease Inhibitors, Incivek and Victrelis have Collectively Penetrated Over Three-Quarters of the US Genotype 1 HCV Market

PRESS RELEASE

June 6, 2012, 10:00 a.m. EDT

Incivek Accounts for a Significantly Larger Proportion of Market Share than Victrelis, According to New Research From BioTrends Research Group

EXTON, Pa., Jun 06, 2012 (BUSINESS WIRE) -- BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, finds that Vertex's Incivek (telaprevir) and Merck / Roche's Victrelis (boceprevir) have staked their claim as the standard of care in US genotype 1 hepatitis C virus (HCV) patients, with 96 percent of surveyed physicians reporting trial with at least one of the protease inhibitors (PIs). According to the recently released LaunchTrends(R): Incivek and Victrelis, Wave 4 report, since their launch one year ago, the PIs have penetrated over three-quarters of the genotype 1 HCV market. Though share for each PI has significantly increased since prior waves, current physician estimates have Incivek accounting for significantly more of the U.S. PI market than Victrelis.

After one year on the market, physician reports suggest Incivek has a slight advantage over Victrelis as the preferred PI in the genotype 1 HCV population. The 100 physicians (gastroenterologists, hepatologists and infectious disease specialists) included in this survey report significantly higher satisfaction with Incivek over Victrelis. Furthermore, physicians perceive that Incivek significantly outperforms Victrelis on the top four most important attributes of 'high SVR in genotype 1s,' 'high SVR in treatment naive patients,' 'high SVR in prior treatment failures' and 'supported by clinical data.' Although both PIs outperform dual therapy on the risk-benefit ratio, Incivek is ranked significantly better than Victrelis in terms of benefits of treatment outweighing the associated risks.

Physicians report that neither PI performs well on any of the associated side effects with triple therapy (anemia, rash, fatigue, etc.). Although Victrelis performs significantly better than Incivek on the side effects of rash, urticarial and pruritis, reported discontinuation rates, roughly 25 percent of all initiations, as well as the primary reasons for discontinuation, are very similar across the two products.

Though the majority of surveyed physicians agree that the PIs, Incivek and Victrelis, are important advances for the treatment of HCV and are a welcomed treatment option, they also highly agree that there remains a need for alternative therapies in the treatment and management of HCV. With regard to products in development, surveyed physicians report the greatest familiarity with Gilead's GS-7977, a significant increase over Wave 2, followed by Bristol-Myers Squibb's daclatasvir, Vertex's VX-222, Bristol-Myers Squibb's asunaprevir and Tibotec / Medivir's TMC-435.

LaunchTrends: Incivek and Victrelis, Wave 4 is a series of four post-launch syndicated reports designed to track the uptake of Vertex's Incivek and Merck / Roche's Victrelis at one month, three months, six months and one year post-launch. LaunchTrends assesses the trial and use of new products, barriers to use, reasons to use, typical patient types, line of therapy, product perceptions, promotional efforts/messages and product satisfaction

Analysis of Incivek (Incivo) and Victrelis in the EU is available via the TreatmentTrends(R): Hepatitis C in the EU report, which published in May 2012. Additional analysis of the U.S. hepatitis C market will be covered in TreatmentTrends: Hepatitis C in the U.S., a two-wave report series publishing in June and November 2012. Patient level audit analysis of hepatitis C patients is covered in ChartTrends(R): Hepatitis C in the U.S., publishing in July 2012. And finally the patient perspective and role of the patient in treatment selection is analyzed in PatientTrends(R): Hepatitis C, publishing in December 2012.

About BioTrends Research Group

BioTrends Research Group provides syndicated and custom market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at (610) 321-9400 begin_of_the_skype_highlighting (610) 321-9400 end_of_the_skype_highlighting or www.bio-trends.com .

About Decision Resources Group

Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com .

All company, brand, or product names contained in this document may be trademarks of their respective holders.

SOURCE: BioTrends Research Group

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International Patent Application Submitted Covering Vaccines for Influenza (Universal Vaccine), Hepatitis C, Cytomegalovirus and Human Papillomavirus

PRESS RELEASE

June 7, 2012, 7:01 a.m. EDT

OSLO, NORWAY, Jun 07, 2012 (MARKETWIRE via COMTEX) -- Bionor Pharma ASA (oslo:BIONOR)

News Summary

The new patent filed 6 June aims to strengthen the Company's general protection of its peptide based vaccine technology, including four specific product patents:

-- Vacc-Flu is a universal influenza vaccine that researchers believe could produce long lasting immunity, and be effective for all seasonal variations of influenza A.

-- Vacc-HCV is a vaccine that may be effective both as a therapy and for prevention of chronic liver infection. Hepatitis C (HCV) may lead to liver failure and liver cancer.

-- Vacc-CMV is a vaccine for treating cytomegalovirus (CMV) infection, which has been associated with inflammatory diseases as well as aggravating various cancer forms such as brain tumors and prostate cancer. -- Vacc-HPV is a vaccine for treating throat and vaginal cancer caused by Human papillomavirus (HPV).

Bionor Pharma ASA (oslo:BIONOR) announced today that it has initiated the international patent process for further protection of the Company's peptide vaccine technology platforms, and for the vaccine candidates Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV. This new peptide vaccine platform submission complements the two previously filed technology platform patents covering peptide vaccines designed for generation of antibody responses and peptide vaccines designed for generating T-cell responses.

All the vaccine candidates are developed from conserved parts (proteins) of the respective viruses. By applying the platform technology to modify the peptides, the vaccines are shown to have significantly improved immune response properties as compared to the corresponding unmodified (native) peptides.

The new platform patent is also covering protection of the various administration regimes connected to the vaccines. Preclinical research is ongoing for both the influenza and the HCV vaccines.

About Vacc-Flu Developing a "universal" influenza vaccine has been difficult because influenza viruses undergo constant genetic mutation. Vacc-Flu targets conserved regions, the "Achilles' Heels" that are common to all known Influenza A viruses. The vaccine is designed to provide long-term protection over several years, reducing deaths and related illnesses caused by all current influenza A subtypes, as well as future influenza viruses that may emerge and lead to an influenza pandemic. Vacc-Flu has shown in animal studies to reduce serious flu symptoms by 25 percent over the standard flu vaccine.

"The benefits of a universal vaccine far outweigh the current seasonal vaccine development approach," said Steen Kroyer, CEO, Bionor Pharma. "The goal is to eliminate the need for researchers to develop annual vaccines, a challenging process that requires manufacturers to operate on a tight schedule to meet WHO recommendations."

The global market for an influenza vaccine is approximately 250 million doses corresponding to annual sale of approximately $2 billion to $2.7 billion. Today's influenza vaccines are specific only for one season and new vaccines have to be developed each year.

About Vacc-HCV Bionor's therapeutic vaccine for hepatitis C, Vacc-HCV aims to treat chronic HCV infection that affects the liver and may lead to scarring and cirrhosis with liver failure or liver cancer in advanced disease.

An estimated 150 million people are living with chronic hepatitis C and between three and four million people become infected per year. Over 350,000 deaths annually are attributed to hepatitis C-related diseases.

Although new drugs are expected to enter the market, these treatments will not be without side effects and treatment failures. This opens the door to even better stand-alone therapy or combination therapies, including a therapeutic vaccine.

About Vacc-CMV Bionor's therapeutic CMV vaccine targets diseases associated with cytomegalovirus (CMV) infection. Researchers believe that CMV may not itself be the disease causing agent, but that it aggravates disease by changing the environment, resulting in a weakened immune system. Thus CMV may be a contributing factor to inflammatory diseases or tumor growth. In a number of inflammatory diseases such as rheumatoid arthritis, inflammatory bowel disease and psoriasis, active CMV infection can be detected. In various cancer forms such as prostate, colon, breast and brain cancer, CMV can be detected in the tumor but not in the nearby tissue.

Vacc-CMV will be developed as a therapeutic T-cell (killer cell) vaccine for treatment of CMV positive patients with inflammatory diseases or cancer.

About Vacc-HPV The Human papillomavirus is made up of a group of DNA viruses in the family Papillomaviridae that infect the skin and mucous membranes causing genital warts, cervical cancer and a growing number of throat cancer cases. Worldwide, cervical cancer remains the second most common malignancy in women, and is a leading cause of cancer related death for females in developing countries. Company researchers believe Vacc-HPV will be a therapeutic T-cell (killer cell) vaccine aiming to complement today's standard of care.

About Bionor Pharma ASA Bionor Pharma is a leading vaccine company, listed on the Oslo Stock Exchange. The Company's investments in developing therapeutic vaccines exceed US$70 million.

Bionor's vaccines are based on the proprietary technology platform developed following more than two decades of research on peptides. The vaccines are designed to safely activate each person's immune system to combat viral diseases. The Company's lead HIV vaccine, Vacc-4x, is being investigated as a therapeutic vaccine, and has completed a phase 2b randomized, multinational (USA and 4 European countries), double-blind, placebo-controlled trial. It produced a statistically significant reduction in viral load and viral load set point by killing of virus producing cells.

Bionor's second therapeutic HIV vaccine, Vacc-C5, is developed to induce antibodies to HIV that can reduce viral production (lowering the set point) and the harmful hyperactivation of the immune system that leads to AIDS. Recently, the clinical phase I/II study with Vacc-C5 was approved by the Norwegian Clinical Board. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, which could form the basis for both a therapeutic and a preventative HIV vaccine.

The Company's innovative technology platform is also well suited to develop vaccines for other viral diseases, including Influenza, HCV (Hepatitis C), CMV (Cytomegalovirus) and HPV (Human papillomavirus).

More information about Bionor Pharma, its research and products, is available at www.bionorpharma.com .

This information is subject of the disclosure requirements acc. to Section 5-12 vphl (Norwegian Securities Trading Act). Vacc-4x, Vacc-C5, Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV are investigational treatments that have not been approved for marketing by any regulatory authority.

Source

A quarter of L.A. homeless have hepatitis C; half don't know it

More than a quarter of L.A.'s homeless are infected with the hepatitis C virus. (Frederic J. Brown/AFP/Getty Images / June 12, 2012)

By Thomas H. Maugh II

June 12, 2012, 11:56 a.m.

More than a quarter of L.A.'s homeless adults are infected with the hepatitis C virus, and nearly half of them don't know it, UCLA researchers reported this week. Almost none of them have been treated for the infection, suggesting that the public health system could face a major financial burden as their infections progress to cirrhosis of the liver and end-stage liver disease.

The hepatitis C virus, known as HCV, represents a potentially lethal infection. It is transmitted through the blood, primarily by needles used for injecting drugs. It can also be transmitted through blood transfusion, tattooing with contaminated needles, kidney dialysis using contaminated machines, and sexual contact. As many as 170 million people worldwide are infected with the virus, including an estimated 2% of the American population. It can be held in check by regular treatment with the antiviral agents ribavirin and pegylated interferon, but the infection can never be cured. There is no vaccine against it. Left untreated, the infection gradually destroys the liver, first producing cirrhosis, then end-stage liver disease. The liver can be replaced by a transplant, but that new organ will eventually be damaged also. Recent government studies show that hepatitis C kills more Americans than AIDS.

Dr. Lillian Gelberg of UCLA's Geffen School of Medicine and her colleagues surveyed 534 homeless adults from 41 shelters and meal programs in the skid row area between June 2003 and February 2004. They questioned them about their HCV status, drug use and other behaviors, and took blood samples for analysis.

The team reported in the journal Public Health Reports that 26.7% of the homeless were infected with the virus. Of those, 46.1% were unaware that they were infected. Only 4% of the subjects were HIV-positive. Fewer than 3% of those who knew they were infected had ever been treated. HCV prevalence was significantly higher among the homeless who had used injection drugs, had been in prison, had less education, and who were at least 40 years old. Among those who had injected illegal drugs, 77.6% had HCV, compared to only 13.6% of those who had never injected drugs. Overall, sexual behaviors were not significantly related to HCV status.

"Homeless adults need interventions that include HCV education, counseling, voluntary testing and treatment services," the researchers concluded. "HCV prevention and treatment programs could be modeled after relevant successful interventions developed for U.S. homeless persons with HIV/AIDS."

LATimesScience@gmail.com

Twitter/@LATMaugh

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Many Livers 'Too Fat' For Transplant

By Kristina Fiore, Staff Writer, MedPage Today

Published: May 24, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

SAN DIEGO -- Increases in factors associated with fatty liver disease may be leading clinicians to discard more donated organs, researcher found.

In an analysis of data from the United Organ Sharing Network (UNOS), age, obesity, diabetes, and hypertension were associated with an increased risk of a liver being discarded, Eric Orman, MD, of the University of North Carolina at Chapel Hill, and colleagues reported during a press briefing at Digestive Disease Week here.

"We're actually throwing out livers that in the past may have been able to be used ... [because] of all these factors associated with fatty liver disease," Orman explained.

Orman said that over the past few years, there's been a decline in the number of liver transplants done, but that drop isn't explained by flat donation rates alone.

"Although donation rates have decreased overall, they haven't decreased to the same extent as the decline in the number of livers transplanted," he said, adding that one explanation may be an increase in discard rates due to poor quality of organs.

So he and colleagues conducted a retrospective study of data from UNOS between 1994 and 2010 totaling 93,232 organ donors. Living donors, split livers, and donors with a body mass index of less than 14 or more than 50 kg/m were excluded.

Among the nearly 94,000 donors, 75% of livers were transplanted and a quarter of livers were not used.

They found that the number of discarded organs was stable until 2003 (with a total of 1,058 organs discarded in that last year), and then rose to 1,828 by 2010.

In a bivariate analysis, they found that discarded livers more often came from donors who were older (median 49 versus 43 years), obese (35% verses 22% of non-obese donors), diabetic (35% versus 24% of nondiabetics), and hypertensive (31% versus 22% of normotensive patients).

Discard rates were also higher in donation after cardiac death, which is different from standard procurement. In the latter, a patient is declared brain dead but kept on a ventilator to keep the organs perfused (65% versus 22%). In donation after cardiac death, perfusion of blood to the organs is disrupted.

In multivariate analysis, the researchers found that all of the previous factors were associated with a liver being discarded:

• Age (OR 1.03 for each year increase, 95% CI 1.03­ to 1.04)
• Obesity (OR 1.92, 95% CI 1.82 to ­2.03)
• Diabetes (OR 1.42, 95% CI 1.32 to ­1.53)
• Hypertension (OR 1.15, 95% CI 1.08­ to 1.22)
• Donation after cardiac death (OR 12.3, 95% CI 11.3 to ­13.4)

The researchers also saw significant increases in median donor age (40 to 46) and the prevalence of obesity (13% to 31%) during the study period, along with significant increases in diabetes (3% to 13%), hypertension (22% to 39%), and donation after cardiac death (2% to 12%).

They estimated that in 2010, 44% of discards were due to increased age, 9% to obesity, 5% to diabetes, and 5% to hypertension. These proportions were stable over time, they said.

On the other hand, the proportion of livers discarded due to donation after cardiac death rose from 0.2% in 2000 to 26% in 2010, suggesting an increasing reluctance to use these grafts, they reported.

Orman said that, overall, the findings are important "because if these trends continue, we're going to see further declines in liver transplant."

Kenneth Andreoni, MD, a UNOS committee member, said the increasing prevalence of comorbidities in donors is a "double-edged sword" because it reflects the fact that public health messages about safety are getting through to younger people, even though that may mean fewer quality donors.

"We're seeing fewer young people dying in traumas, but we're getting less high-quality, excellent organs," Andreoni told MedPage Today. "The question is, how can we make the best use of more middle-age and older donors?"

When it comes to organs with fatty liver disease, some researchers have been trying to better quantify the type of fat in the liver so that surgeons can have a better idea of what's usable and what's not, said Andreoni, who is from Ohio State University in Columbus.

Improvements on the pathology side may also be needed, he said. For instance, pathologists may need to offer a more specific range in terms of the percentage of fat in the organ, so clinicians can more easily recognize if an organ needs to be discarded or not.

Other work has focused on whether there are better ways to protect a fatty liver so it has a better chance of working after it's transplanted. "Is there something you can put in during reperfusion, like an antioxidant, that will lead to better outcomes?" Andreoni said.

A co-author reported a relationship with Salix Pharmaceuticals.

Primary source: Digestive Disease Week
Source reference:
Orman ES, et al "The number of grafts available for liver transplantation is decreasing as a result of increasing age, metabolic syndrome, and donation after cardiac death" DDW 2012; Abstract 841.

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Statins Reduce Cirrhosis Deaths

By Kristina Fiore, Staff Writer, MedPage Today

Published: May 23, 2012

Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, BSN, RN, Nurse Planner

SAN DIEGO -- Giving statins to cirrhosis patients with heart disease appears to lower the risk of both hepatic decompensation and mortality, researchers said here.

In a small, retrospective study, significantly fewer cirrhosis patients on statins had decompensation compared with cirrhosis patients not on the cholesterol-lowering drugs (38.2% versus 50.62%, P=0.018), Sonal Kumar, MD, of Brigham & Women's Hospital in Boston, and colleagues reported at Digestive Disease Week here.

They also had significantly less mortality (P=0.043), she reported.

"Contrary to the prior belief that statins aren't safe in patients with cirrhosis, we found they actually may be beneficial in this population," Kumar said during a press briefing.

Clinicians have long been concerned that statins aren't safe in patients with severe liver disease, primarily because statins are metabolized in the liver and may put patients at greater risk of complications such as hepatic decompensation and liver failure.

Recent studies, however, have suggested that statins aren't harmful in these patients, and that they may even diminish morbidity and mortality for liver patients with heart disease, Kumar said.

So she and colleagues looked at data from the Partners Research Patient Data Registry on a total of 243 patients, 81 of whom were treated for dyslipidemia with statins for at least 3 months, and 162 who served as controls matched for age, gender, and liver disease severity.

The primary outcome was hepatic decompensation, defined as the development of ascites, jaundice, hepatic encephalopathy, or variceal hemorrhage.

The statin group was followed for a mean of 1,756 days and the control group for 1,503 days.

In each group, 70.4% of patients were Child-Pugh A and 29.6% were Child-Pugh B/C; factors such as MELD, albumin, presence of varices and beta-blocker use weren't significantly different between groups.

In multivariate analysis, statin therapy alone was significantly associated with a lower risk of decompensation, they reported (HR 0.44, 95% CI 0.27 to 0.71).

In addition, analyses showed an overall longer time to decompensation in patients on statins, they found (P=0.01), which was also present for patients with Child-Pugh A disease (P=0.04).

Kumar and colleagues also found that there was less all-cause mortality among cirrhotic patients on statins compared with those not on the drugs (37% versus 50.6%, P=0.043).

In multivariate analyses, statin use was significantly associated with lower mortality (OR 0.49, 95% CI 0.29 to 0.81). Coronary artery disease and non-alcoholic steatohepatitis, on the other hand, were associated with increased mortality, they reported (OR 2.62, 95% CI 1.78 to 3.86 and OR 1.61, 95% CI 1.03 to 2.52, respectively).

The researchers also saw a longer time to death in patients with Child-Pugh A disease who used statins (P=0.005).

Kumar said the beneficial effects on liver outcomes may be due to statins' ability to diminish portal pressure, which is associated with complications including jaundice and vomiting blood due to enlarged veins in the upper GI tract. That may be mediated via statins' known mechanism of increasing the production of nitric oxide, Kumar said.

She added that more prospective trials are needed, but Zobair Younossi, MD, of Inova Health System in Great Falls, Va., who attended the press briefing at which the data were presented, said evidence is amassing that statins are safe in liver disease patients.

"If you need to use them, you should use them, and not worry about the liver," Younossi said.

But Cam Patterson, MD, of the University of North Carolina at Chapel Hill, said in an email to MedPage Today that most physicians still have "second and third thoughts about using statins in patients with severe liver disease."

"This is a retrospective, nonrandomized study, so it would be a big mistake to use this study as a general advertisement that statins can be safely used in patients with severe liver disease or that patients with liver disease will do better and live longer if they receive statins," Patterson wrote.

"What this study does tell us," he added, "is that carefully selected patients with liver disease can be given statins and that they seem to tolerate them well."

Questions that still need to be answered before making broad recommendations for the use of statins in cirrhotic patients include assessing which patients will benefit most and finding out whether patients fare better with some statins more than others, Patterson said: "I hope that this small study provides an impetus for additional studies that will answer these questions."

Kumar reported no conflicts of interest.

Primary source: Digestive Disease Week
Source reference:
Kumar S, et al "Statin therapy decreases the risk of hepatic decompensation in cirrhosis" DDW 2012; Abstract 595.

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Herbal, Body Building, Diet Supplements Linked To Severe Liver Damage, Study

Even though supplements account for 18 percent of all liver injuries in the U.S. and their potential side effects and hepatotoxicity of supplements are still not well defined, nearly 4 out of 10 Americans take them. (David Gray/Reuters)

People taking body-building, weight-loss pills and other types of dietary and herbal supplements may be at risk for liver injury severe enough to warrant an organ transplant, experts warned.

By Christine Hsu | May 22, 2012

People taking body-building, weight-loss pills and other types of dietary and herbal supplements may be at risk for liver injury severe enough to warrant an organ transplant, experts warned at a press briefing at Digestive Disease Week in San Diego.

Even though supplements account for 18 percent of all liver injuries in the U.S. and their potential side effects and hepatotoxicity of supplements are still not well defined, nearly 4 out of 10 Americans take them.

"The number of cases in our network has increased over the years," Serrano said during the briefing. "There were no deaths, but 7% of patients needed a liver transplant. These are not trivial consequences," Dr. Jose Serrano of the National Institutes of Health said at the conference, according to Medpage Today.

According to the latest research from the U.S. Drug Induced Liver Injury Network, which evaluated patient information from eight locations across the U.S. from 2003 to 2011, dietary supplements used for body building and weight loss are the most common of any supplements to cause liver injury.

Serrano said that out of the 679 liver injury cases analyzed, 93 of the cases were caused by patients taking herbal or dietary supplements, adding that many of these patients were often younger than those who have similar liver injuries caused by other medications.

Among patients who had liver damage caused by supplements, 33 percent of them used them for body building, 26 percent for weight loss, and the remaining 31 percent used a variety of other supplements.

While the symptoms of liver injury caused by dietary or herbal supplements weren’t much different from injuries caused by other medications, researchers noted that one factor that distinguished liver injury from body building and supplements over drugs were itching, which occurred in more than 80 percent of the patients.

Around 66 percent of the patients in the study had to be hospitalized and 11 percent had developed abnormal liver function that lasted for more than 6 months.

While more than half of patients were only taking one type of supplement, 23 percent of patients used two or more supplements and 16 percent of patients look at least one supplement along with prescription drugs.

"There is so little regulation of the many products on the market," lead researcher Dr. Victor Navarro, professor at Thomas Jefferson University in Philadelphia, said in a meeting news release. "We couldn't possibly begin to figure out which products to target first without doing this research."

Dr. Donald Jensen of the University of Chicago warned that the biggest risk to patients that use supplements is not reporting it to a healthcare professional.

"Patients need to be label readers," Jensen told MedPage Today. "They can't just assume that everything out there is safe. There are things out there that can be potentially damaging."

He added that most patients may think that supplements "are food or that they're very safe. And there are some herbal medicines that probably are safe and may even do some benefit for people. I don't want to throw everything in the trash can. But, on the other hand, there are enough [supplements] that are damaging."

While not all people react negatively to supplements, Jensen said that there needs to be more research on potential patient interactions with herbal supplements.

"I don't think we're going to stop people from taking herbal medicines," he said. "I'd like to see the FDA regulate the toxic ones better, but otherwise I think the important next step is some scientific understanding of why some people get damaged and others don't."

Published by Medicaldaily.com

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Also See: Herbal, Dietary Supplements Take Toll on Liver

(RED)RUSH TO ZERO Campaign To Engage Gamers, Music Fans, Consumers And Celebrities In The Push For An AIDS Free Generation By 2015

PRESS RELEASE

May 24, 2012, 12:01 p.m. EDT

NEW YORK, May 24, 2012 /PRNewswire via COMTEX/ -- (RED) today announced the first-ever (RED)RUSH TO ZERO campaign, taking place June 1-10, 2012, to raise funding and awareness to help deliver an AIDS Free Generation by 2015, a critical milestone in the fight against AIDS. The virtual elimination of mother to child transmission of HIV is part of the eight Millennium Development Goals, which range from halving extreme poverty to halting the spread of HIV/AIDS by the target date of 2015.

(RED)RUSH TO ZERO, held in June, which is the 31st anniversary of the discovery of HIV, consists of a series of in-person and digital events and experiences involving brands, celebrities, gamers, music fans and consumers around the world. Since launching in 2006, (RED) has raised more than $190 million to fight AIDS. The recipient of these funds is the Global Fund to Fight AIDS, Tuberculosis and Malaria. (RED) helps finance Global Fund HIV/AIDS grants that have impacted the lives of more than 14 million people affected by AIDS in Africa.

(RED)RUSH TO ZERO will feature three major components: the (RED)RUSH Games, a global video game tournament; the (RED)Music program, allowing fans to buy (RED) tickets from major artists and iconic venues to turn their shows (RED); and the Cash & Rocket (RED)Tour, a fundraising road trip across Europe. "The world is at a historic moment in the fight against HIV/AIDS, with the opportunity to end mother-to-child transmission of HIV and take a critical step toward defeating this global pandemic," said Deborah Dugan, CEO of (RED). "We will only get over the finish line if we create new funding opportunities and new ways to keep people engaged and energized- (RED) will do its part by bringing business, culture, sport, and empowered women together to help empower other women and their children by ensuring that the next generation is born HIV free. (RED)RUSH is a unique effort to build momentum and ensure that the incredible progress that has been made over the last decade continues. We are, as always, grateful to our corporate partners for stepping up and creating exciting, new opportunities for engaging consumers and generating vital funding for the Global Fund."

"We've made so much progress in the fight against AIDS over the last decade. Now would be the worst time to slow down," said Gabriel Jaramillo, General Manager, the Global Fund to Fight AIDS, Tuberculosis and Malaria. "As the global economy threatens public sector funding, more than ever we need innovative fundraising models like (RED), which has done so much to align the private sector to our goals. We're excited about (RED)RUSH and its ability to tap into popular culture to help deliver a key milestone on our path to ending AIDS. We're very grateful for (RED)'s bold ideas to help us reach our goals."

The (RED)RUSH Games(RED)RUSH Games, which is being powered by STiKS GAMING, will launch on June 1st, and will partner with the world's largest gaming Conference, E3, in LA. Gamers will have the chance to compete globally against each other and their favorite celebrities on Xbox 360 and PlayStation 3 - for prizes and prestige - in video games including EA's FIFA 12, NHL 12, 2K Sports' NBA2K12, KINECT Sports Season 2 and Forza Motorsport 4. Gamers will donate-to-play, and proceeds will benefit the Global Fund. Each gamer's profile page will allow them to keep track of their scores, overall tournament results and, most importantly, see the impact of their donation.

Celebrities and brands signed up include Kate Upton, Converse, Michelle Rodriguez, Funny or Die, Samantha Ronson, Bugaboo, Michael B Jordan, Kris Allen, Mophie, Scott Porter, Ryan Cabrera, FEED, Wayne Brady, Aldis Hodge, Al Shearer, Kerli, Andrew Bowen, Ray Ford, Electric Touch.

(RED)MUSIC(RED)RUSH will engage music fans through (RED)ROWS, (RED) venues and the release of a single from the forthcoming album (RED) Hot + FELA. Artists are auctioning premium seats and exclusive packages to help fight AIDS in an initiative called (RED)ROWS. The first (RED)ROW auction will start on June 1st and end on June 10th and participating artists include Bryan Adams, The Black Keys, Leonard Cohen, Coldplay, Elvis Costello, Sheryl Crow, Death Cab for Cutie, The Killers, K'naan, Diana Krall, Maxwell, Tim McGraw, Metric, Tom Petty and the Heartbreakers, Phish, Pink Martini, Punch Brothers, The Tragically Hip and The xx. (RED) has partnered with white-label ticketing provider CrowdSurge to unveil (RED)ROWS, a unique technology solution that enables artists to turn their shows (RED) by auctioning concert tickets.

Popular live music venues across the U.S. will also participate in (RED)Music, with promotions to drive funds and awareness to the 2015 goal. Venues include Stubbs in Austin, Metro in Chicago, Brooklyn Bowl in New York and The Paramount, Neptune and Moore Theaters in Seattle.

Additionally, during (RED)RUSH the first single from the forthcoming album (RED) Hot + FELA will debut - a remake of Fela Kuti's "Lady" by Angelique Kidjo, tUnE-yArDs, Akua Naru and Ahmir Questlove Thompson which will be released on June 1.

Cash & Rocket (RED) TourA group of 70 women - entrepreneurs, lawyers, designers, doctors, CEOs, models, architects, fashion stylists - will take to the roads of Europe in (RED) branded vintage and classic cars on the Cash & Rocket (RED) Tour from London to Monte Carlo. The caravan of (RED) cars including (RED) CEO Deborah Dugan, Dr Patricia Asamoah from Ghana, LOVE editor Katie Grand, Charlotte Stockdale, trip organizer Julie Brangstrup, model Lily Becker, sisters Jemma and Jodie Kidd, entrepreneur Umberta Beretta leaves London's Berkeley Square on June 7 and ends in Monte Carlo on June 10, with stops in Paris and Milan. At the Paris stop, Bugaboo will unveil its latest design collaboration. (RED) has partnered with Crowdrise, the online fundraising tool, which will allow the women to fundraise before and during the trip. The trip will end with an auction in Monte Carlo with all proceeds going to the Global Fund.

During (RED)RUSH, (RED) corporate partners will offer consumers ways to fight AIDS and to build on the $190 million raised to date. The organization's first Central and South American partnership will see wireless providers Telcel and Claro introducing (RED) wireless products in 15 countries including Brazil, Mexico, Argentina, Colombia and Peru. (RED) will also launch two new partners - Tourneau will offer a (RED) collection of their Tourneau TNY watch and Bottletop will introduce (RED) versions of their iconic Luciana clutch bag and the unisex Kibe belt. (RED) partners include Apple, The Coca-Cola Company, Starbucks, Converse, Beats by Dr. Dre, Belvedere, Bugaboo, Nike, Penfolds, SAP and American Express, and they contribute up to 50% of the proceeds from the sale of (RED) products and services to help fight AIDS.

Beats by Dr. Dre will kick off the inaugural (RED)RUSH TO ZERO campaign with a party in their NYC store on June 2nd.

www.redrush.com

About (RED)(TM)(RED) engages business and consumer power in the fight against AIDS. To date, (RED) partners and events have generated over $190 million for the Global Fund to Fight AIDS, Tuberculosis and Malaria. This money supports Global Fund HIV/AIDS grants in Ghana, Lesotho, Rwanda, South Africa, Swaziland, and Zambia. So far more than 14 million people have been reached with prevention, treatment, counselling, and care services through these grants. (RED) dollars are used to support programs that have helped provide life-saving antiretroviral therapy for 220,000 HIV-positive people, put 130,000 HIV-positive pregnant women on preventative antiretroviral therapy to reduce the risk of mother-to-child transmission and reached 13 million people with HIV testing and counselling. Current (RED) Proud Partners include: American Express (UK only), Apple, Beats by Dr. Dre, Belvedere, Bugaboo, Claro, The Coca-Cola Company, Converse, Nike, Penfolds, SAP, Starbucks and Telcel and Special Edition partners include: FEED, Girl Skateboards, Mophie, Nanda Home, Shazam, Solange Azagury-Partridge and TOUS. (RED) is a division of The ONE Campaign. On World AIDS Day 2010, (RED) launched "The AIDS Free Generation is Due in 2015" campaign. (RED) has joined is joining the global health community in raising funds and awareness to help eliminate mother-to-child transmission of HIV by 2015 and helping to realize the first AIDS-free generation in nearly thirty years. Learn more at www.joinred.com .

About The Global Fund to Fight AIDS, Tuberculosis and MalariaThe Global Fund is a unique, public-private partnership and international financing institution dedicated to attracting and disbursing additional resources to prevent and treat HIV and AIDS, TB and malaria. This partnership between governments, civil society, the private sector and affected communities represents an innovative approach to international health financing. The Global Fund's model is based on the concepts of country ownership and performance-based funding, which means that people in countries implement their own programs based on their priorities and the Global Fund provides financing on the condition that verifiable results are achieved.

Since its creation in 2002, the Global Fund has become the main financier of programs to fight AIDS, TB and malaria, with approved funding of US$ 22.6 billion for more than 1,000 programs in 150 countries (as of 1 December 2011). To date, programs supported by the Global Fund are providing AIDS treatment for 3.3 million people, anti-tuberculosis treatment for 8.6 million people and 230 million insecticide-treated nets for the prevention of malaria. The Global Fund works in close collaboration with other bilateral and multilateral organizations to supplement existing efforts in dealing with the three diseases.

SOURCE (RED)

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Liver disease and recovery research at UF garners $1.3 million grant

Filed under Health, Research on Thursday, May 24, 2012.

GAINESVILLE, Fla. — University of Florida researchers have received nearly $1.3 million from the National Institute of Diabetes and Digestive and Kidney Diseases to uncover ways to lessen liver damage by studying the body’s natural process for breaking down and removing injured cells.

During surgery or transplantation, surgeons stop blood flow to the liver, temporarily cutting off oxygen and nutrients. When blood rushes back to the organ afterward it often causes serious damage called ischemia/reperfusion injury.

Finding a way to boost cells’ natural cleanup process, — and with it, older livers’ ability to recover from such stress-related injury — would help patients recover after liver surgery. It could also increase the number of livers available for people on the transplant waiting list by reducing damage to the organs of potential donors, and may lead to therapies for other diseases such as cancer and neurological disorders.

“All diseases, including liver disorders, are the consequence of multiple, complicated changes in the body,” said principal investigator Jae-Sung Kim, an assistant professor of surgery in the UF College of Medicine. “I think the way to cure diseases is to fully understand complicated mechanisms. We can take advantage of our natural defense mechanism that was evolutionally developed to fight against many causes of illness.”

More than 16,000 people in the United States await liver transplants, according to the U.S. Department of Health and Human Services’ Organ Procurement and Transplantation Network. Only 7 percent of all liver donations since 1988 have come from people older than 65, despite the fact that they die at higher rates than people in other age groups.

The multidisciplinary UF research team, which includes principal investigator Christiaan Leeuwenburgh, chief of the biology of aging division in the department of aging and geriatric research, seeks to confirm earlier findings that the liver’s ability to recover from ischemia/reperfusion injury is linked to the process by which cells remove structures called mitochondria when they are damaged. Mitochondria provide the cell with energy.

They also found that the older livers are, the slower they are at responding to stress-related damage, partly because of lowered levels of a protein responsible for directing the cell clean-up process. Injured cells resumed normal activity when inundated with the protein, called Atg4B.

The researchers will study older mice to examine age-related changes in the cell clean-up process. They also will explore ways to boost that process and examine the resulting effect on damaged livers.

“There are many studies that have investigated liver injury in younger animals and mechanisms there, but these studies are unique because they’re studying older animals,” said Leeuwenburgh a member of the UF Institute on Aging. “Most liver injuries occur and liver resection interventions are done in older individuals.”

Knowing more about how the cell clean-up process works could pave the way for new therapies, not just for liver disease, but also for a variety of other illnesses.

“Growing evidence indicates that dysfunctional or impaired autophagy, cells’ natural clean-up process, is directly associated with various diseases, including autoimmune diseases, cancer, neurological disorders and diabetes,” Kim said. “Through this study, we would like to better understand basic molecular mechanisms of autophagy.”

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Credits

Media Contact Laura Mize, lmize@ufl.edu, 352-273-5772

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CDC Invites Public Comment on Draft Recommendations for One-Time Hepatitis C Testing for Baby Boomers

Dr. John Ward

HIV Policy & ProgramsMay 24, 2012

By John W. Ward, M.D., Director, Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC

CDC has released draft recommendations proposing that all Americans born from 1945 through 1965 (“baby boomers”) get a one-time test for the hepatitis C virus. In the United States, hepatitis C is the leading cause of liver transplants and liver cancer, which is the fastest-rising cause of cancer-related deaths in the nation. More than 2 million U.S. baby boomers are infected with hepatitis C, accounting for more than 75 percent of all American adults living with the virus. Baby boomers are five times more likely to be infected than other adults. Most of them, though, do not know that they have the virus because hepatitis C can damage the liver for many years without noticeable symptoms. More than 15,000 Americans—mostly baby boomers—die each year from hepatitis C-related illness, such as cirrhosis and liver cancer, and deaths have been increasing steadily for over a decade.

CDC estimates one-time hepatitis C testing of baby boomers could identify more than 800,000 additional people with hepatitis C and save more than 120,000 lives. CDC believes the expanded screening efforts are needed to increase the proportion of persons with hepatitis C who are diagnosed, and referred to care to slow or halt progression of the disease and avoid transmission to others. New treatments are now available that can cure up to 75% of infections, and even more promising treatments are expected in the near future. CDC believes that expanded screening efforts can prevent thousands of unnecessary deaths from hepatitis C.

CDC’s new recommendations augment current hepatitis C testing guidelines that call for testing individuals with a known risk for the disease. Studies have found that most persons do not perceive themselves to be at risk and are not screened. CDC’s recommendations propose that a one-time blood test for hepatitis C should become a standard part of medical care for all persons born from 1945 through 1965.

In a May 22, 2012 Federal Register Notice, CDC formally invited public comment on this draft recommendation. We encourage you to review and comment on these important proposed recommendations which will be available for public comment through June 8 on www.regulations.gov, docket number CDC-2012-0005. Public comment will be used to inform the final recommendations, which will be finalized later this year.

For more information, see this factsheet (PDF 374KB) on the proposed testing recommendations.

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HealthWatch: Seale, Alabama man says his hepatitis C is gone; credits research group

 

May 24, 2012

 

Hepatitis C is the most common blood-borne infection in the United States. It?s estimated almost four million Americans are infected with this virus, but most of them don’t know it.

 

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A priceless journey: Friend’s birthday poem turned into a children’s storybook to help those dealing with cancer

Friend’s birthday poem turned into a children’s storybook to help those dealing with cancer.

By ROXIE HAMMILL

Special to The Star

It began as a birthday present—a poem written by Laura Myer for her good friend Lori Lober, who at one time had been given only a 2 to 3 percent chance of living five years.

But for much longer than that, Lober’s cancer has been kept at bay. So has the hepatitis C that Myer contracted. But the poem has blossomed into a self-published book, “Princess Elle and her Isle of Capri.” The illustrated storybook, which came out in February, is aimed at children and parents dealing with a cancer diagnosis.

It’s been a long journey for the two friends, much of it uphill.

Lober, of Kansas City, North, had late-stage breast cancer that metastasized to her liver. She still takes regular chemotherapy treatments, but there’s been no sign of cancer for more than 10 years.

Myer, a former surgical nurse who now lives in Overland Park, has been undergoing difficult treatment for hepatitis C, but she, too, has been free of symptoms for about 10 years.

The illustrator, Angie Prindle of Lee’s Summit, also could relate to the topic. Her mother, Barbara Brewer, is a cancer survivor.

The book is part celebration, part mission. Lober hopes the comforting cadence of the poem and the storybook imagery will speak to children and family members affected by cancer.

Originally, Lober said, the women had hoped to donate the proceeds to Touched by Cancer, but that organization has dissolved. Now Lober, a wellness coach, is more interested in using the book as a tool to help parents and children.

If there are profits after she recoups the $2,000 publishing fee, Lober said, the money will be divided among everyone who donated their work to make it happen. She said she’d happily donate her share to charity. The book is available for $16.99 through Amazon and Barnes & Noble and from the authors and illustrator themselves.

Lober and Myer met about 15 years ago through their husbands’ work with the Home Builders’ Association of Greater Kansas City. At the time, they were typical girlfriends who shared common interests and business.

Then, about a year later, Lober suspected something was wrong and began asking doctors to check her for breast cancer.

She had a type of pre-menopausal cancer that was difficult to detect without a biopsy, though, and she says it was two years before she got a cancer diagnosis. By then, the cancer had spread to her liver.

Myer gave her the birthday poem after Lober had undergone her surgeries but before she’d been declared symptom-free. “She was just really hard to buy for,” Myer laughed.

Myer, in the meantime, developed her own health problems. A year after Lober’s cancer was diagnosed, Myer said, she was found to have hepatitis C, which may have been contracted during her earlier years as a surgical nurse.

The two went from being regular girlfriends to “wellness buddies,” just like that, said Lober.

They learned how to eat nutritiously, went to spas and even investigated a Tibetan monk who touted herbal remedies for metastatic breast cancer.

“Having someone who understands what you’re going through helps. It’s priceless,” Lober said. “You know you’re not the lone wolf, going through it all on your own.”

Lober, 48, has self-published two other books, “Love to Live” and “Still Bigger than Pink” about her experiences with cancer. So after she read and re-read the birthday poem, an idea formed.

“It hit me. Oh, my God, this is so good! We need to turn it into a children’s book and have it illustrated.”

Myer immediately took the poem out to a quiet lake dock and started writing.

“When Lori Lober asks you to do something, you usually end up doing it,” she said with a laugh.

“Princess Elle” is an allegorical tale of a little girl on an island. One day she notices things are amiss, and soon she is in the clutches of a powerful dragon called C for carcinoma. However, she makes it through the confrontation and is helped back to wellness by her many bird friends.

“Feathers are important to me,” said Lober. “Whenever I needed hope or a sign, I would find a feather in an unusual place, as if it had been put there by an angel. I think of feathers when I need hope.”

After Myer, 51, and Lober were done tweaking the words, they set out to find an illustrator by sending out emails. Prindle learned about the project through a student’s parent.

By that time, tragedy had struck Lober. Her son, Colby James McLain, 19, died in a car crash in November 2005. After Prindle got the job, she commemorated Colby by working his features into one of the birds in the story. Since publication, Prindle has given away 60 copies and has held a fundraising event at a Lee’s Summit coffee shop.

Prindle, 44, says she had always wanted to illustrate a children’s book, and so was thrilled when her work was chosen. The book is done in watercolor, ink and Photoshop images of a little girl wandering through the island and fighting the dragon. Coincidentally, the girl in the photos is Prindle’s niece, Ellie, who was 5 at the time.

“It’s always everyone’s hope that you have a happy ending, that you conquered it and can move forward with life,” she said. “People can imagine, if this little girl did it, I can do it, too.”

Story books can be useful for children trying to understand cancer, said Amber Masso, national program director for the American Childhood Cancer Organization in Kensington, Md. In fact, one of the group’s functions is to distribute books and materials it’s commissioned for people with cancer. Those include story books.

“Talking about a journey and turning it into a fantasy is definitely more relatable to children,” Masso said. “It’s good to relate it in terms a child can understand, and it’s also a good tool for a parent to have.”

In fact, one of the group’s functions is to distribute books and materials it’s commissioned for people with cancer. Those include some story books, Masso said.

Myer was struggling with a course of treatment, and could not talk long about her book. But she remains upbeat.

“It’s so funny. I got (the book) the day I started treatment,” she says of her most recent round. “So I’ve had to read my own words and walk my own walk.”

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Patients May Receive Too Much Acetaminophen in Hospital

Use of drugs such as Tylenol, Percocet can exceed recommended daily dose, study finds

-- Mary Elizabeth Dallas

WEDNESDAY, May 23 (HealthDay News) -- Roughly 2.5 percent of admitted hospital patients may receive more than the safe daily cumulative dose of the pain-reliever acetaminophen, best known as Tylenol, on at least one day, according to a new U.S. study.

Patients on more than one drug containing acetaminophen often consume more than the recommended 4 grams per day of the drug, the researchers from Thomas Jefferson University Hospital in Philadelphia found.

Together, two tablets of extra-strength Tylenol contain 1 gram of acetaminophen, commonly used to relieve pain and reduce fever.

Over the course of two years, researchers led by Dr. Jesse Civan examined 46,000 hospital admissions and the medications those patients were given. They found that on at least one day of hospitalization, roughly 1,100 patients received more than 4 grams of acetaminophen in the form of Tylenol, Percocet and similar drugs.

The study authors also assessed the effects the acetaminophen had on the patients' livers and found only a small minority were given a blood test to check their liver function. The investigators noted that this test is typically used only when a doctor has a specific concern about possible problems with a patient's liver.

In the small number of patients who did have the blood test of liver function, the researchers noted that there were no serious liver injuries. They said there wasn't enough information to determine if abnormal test results were the result of excessive exposure to acetaminophen.

Civan and colleagues concluded that more research is needed to determine if new recommendations for the safe daily dosing of acetaminophen are necessary. They added that patients need better education on acetaminophen safety, particularly for use of the drug after they leave the hospital, when patients may try to duplicate the medications and doses they were given during their admission.

The study was presented Monday at the Digestive Disease Week meeting in San Diego. The data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

More information

The U.S. Food and Drug Administration has more about acetaminophen.

SOURCE: Digestive Disease Week, news release, May 22, 2012

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Herbal, Dietary Supplements Take Toll on Liver

    

By Cole Petrochko, Associate Staff Writer, MedPage Today

Published: May 22, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

SAN DIEGO -- Patients taking herbal and dietary supplements may be at risk for liver injury severe enough to warrant an organ transplant, researchers said here.

In a review of national data, supplements accounted for 18% of liver injuries in the U.S., Jose Serrano, MD, of the National Institutes of Health, reported during a press briefing at Digestive Disease Week.

"The number of cases in our network has increased over the years," Serrano said during the briefing. "There were no deaths, but 7% of patients needed a liver transplant. These are not trivial consequences."

It's estimated that as much as 40% of the U.S. population uses herbal or dietary supplements, but their potential side effects, including hepatotoxicity, are not well defined.

The researchers looked at data from the Drug Induced Liver Injury Network, which evaluated patient information from eight sites across the U.S. from 2003 to 2011.

Of 679 cases of liver injury, 93 were attributed to herbal or dietary supplements, Serrano said, adding that these patients tended to be younger than those who have similar liver injuries due to other medications. The majority of these patients were white.

Among patients that had used supplements, 33% used them for body building, 26% for weight loss, and the remaining 31% used a variety of other types of supplements.

Serrano said the symptoms of liver injury caused by supplements weren't different from those caused by other medications. But one factor that distinguished liver injury from body building supplements over the others was itching, which occurred in 86% of patients.

Those who had liver injury resulting from either body building or weight-loss supplements also tended to have a longer latency time between exposure and injury compared with liver injury from other medications or the miscellaneous category of dietary supplements.

Weight-loss products also appeared to be associated with a more hepatocellular pattern of injury, while body building supplements (usually anabolic steroids) had a more mixed pattern with increments on total bilirubin, Serrano said.

Most of the patients (66%) had to be hospitalized, and 11% developed alterations in liver function that persisted for at least 6 months, he added. The median serum alanine-aminotransferase (ALT) at presentation was 533 U/L, the alkaline phophatase was 166 U/L, and the total bilirubin was 7 mg/dL.

The R-value, which represents liver injury pattern, was in the hepatocellular range (>5%) in 65% of the patients with a median ALT of 1,275 U/L. The range for normal ALT is generally between 7 and 56 units U/L.

Symptoms included:

• Jaundice (78% of patients)
• Nausea (60%)
• Itching (58%)
• Abdominal pain (47%)

The majority of patients (60%) used only one type of supplement, while 23% used two or more supplements, and 16% used at least one supplement concurrently with prescription drugs.

While the most common injury pattern seen was hepatocellular, the distribution of overall causality scores was not significantly different across injury patterns (P=0.30), the authors stated.

The biggest risk to patients that use supplements is not reporting supplement use to a healthcare professional, noted Donald Jensen, MD, of the University of Chicago and DDW press conference moderator.

"Patients need to be label readers," Jensen told MedPage Today. "They can't just assume that everything out there is safe. There are things out there that can be potentially damaging."

He added that patients think supplements "are food or that they're very safe. And there are some herbal medicines that probably are safe and may even do some benefit for people. I don't want to throw everything in the trash can. But, on the other hand, there are enough [supplements] that are damaging."

He said that future research on supplements should focus on potential patient interactions with herbal supplements, noting that not all patients have negative interactions with them.

"I don't think we're going to stop people from taking herbal medicines," he said. "I'd like to see the FDA regulate the toxic ones better, but otherwise I think the important next step is some scientific understanding of why some people get damaged and others don't."

Navarro disclosed consultancy work for Merck.

Co-authors disclosed relationships with Boehringer-Ingelheim, Clinuvel, Novartis, American Porphyria Foundation, Iron Disorder Institute, Vertex, Lundbeck, Bristol-Meyers Squibb, GlaxoSmithKline, Siemens Medical Solutions, Roche, Gilead Sciences, Tibotec, and Catalent.

Primary source: Digestive Disease Week
Source reference:
Navarro VJ, et al "Herbal and dietary supplement induced hepatotoxicity in the U.S." DDW 2012; Abstract 167.

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HCV Patients May Be Able to Delay Therapy

By Kristina Fiore, Staff Writer, MedPage Today

Published: May 22, 2012

Take Posttest

SAN DIEGO -- Hepatitis C patients without significant fibrosis may be able to delay triple therapy and wait for simpler, shorter, and potentially all-oral regimens that are currently under investigation, researchers said here.

The addition of new protease inhibitors telaprevir (Incivek) and boceprevir (Victrelis) to previous standard therapy of interferon and ribavirin have significantly boosted sustained viral response for many patients, especially for blacks and Latinos, according to Maribel Rodriguez-Torres, MD, of the Fundacion de Investigation in Rio Piedras, Puerto Rico.

But patients with less severe disease may be able to hold off until a handful of newer agents -- offering less complex regimens that potentially cut the symptomatic interferon from the mix -- come to market, possibly within the next two years, Rodriguez-Torres said during a symposium at Digestive Disease Week (DDW) here.

"This is a slowly progressing disease and most of the time we have the time and opportunity to determine what's the best [treatment strategy] for our patients," she said. "Patients without significant fibrosis should wait. Those with more advanced disease should consider therapy today."

Triple Therapy Presents Challenges

Clinicians have cited a number of challenges with triple therapy. Both new agents are only indicated for patients with genotype 1 disease -- though this comprises the majority of patients -- and they add a significant cost to treatment, Rodriguez-Torres said.

The regimen is also complex and long-lasting, with both new agents adding multiple daily pills to ribavirin's four to six pills per day and weekly interferon injections, extending for 24 to 48 weeks.

There's also an increased risk of drug-drug interactions, as both new agents inhibit the common CYP34A metabolic pathway, potentially increasing levels of other drugs metabolized that way. That list includes some statins and ACE inhibitors, which "aren't unusual drugs," Rodriguez-Torres said.

Side effects include anemia, a concern because ribavirin already lowers blood hemoglobin levels, she said. Also, telaprevir appears to cause rash in more than 50% of patients.

Instead, a "dream regimen" is a simple one with fewer pills, contains only oral agents, spans all genotypes, and is highly effective with an excellent safety and tolerability profile -- though that possibility is not that far from reality, Rodriguez-Torres said.

Improvements Are on the Horizon

"We've never had such an explosion of drug development in the last 75 years compared to what we see now in chronic hepatitis C," she said. That robust pipeline includes not only a number of protease inhibitors and NS5A inhibitors -- which are typically genotype-specific -- but also nucleoside and cyclophilin inhibitors that are pan-genotypic.

Such robustness may help keep prices down as a result of increased competition, Rodriguez-Torres said. Also, the majority of drugs in development are dosed once or twice daily and some have a much shorter duration of therapy than the current standard of 24 to 48 weeks.

Early data also have shown that it's possible to drop interferon from the regimen. Last month at the European Association for the Study of the Liver meeting Barcelona, researchers reported that high proportions of patients has sustained virologic response rates with an all-oral regimen of ribavirin plus two investigational agents, ABT-450/r, a protease inhibitor, and ABT-072, a non-nucleoside NS5B polymerase inhibitor.

Also at that meeting, an early trial showed that a combination of daclatasvir, an NS5B inhibitor, plus GS-7977, a nucleotide NS5B inhibitor, led to rapid and sustained viral response in patients with genotypes 1-3, with or without ribavirin.

Treatment Issues Remain Complex

The pressing question facing clinicians, then, has been determining who to treat and when. Rodriguez-Torres said the simple answer is to treat those with severe fibrosis now, but hold off on treating those without significant fibrosis.

But Andrew Muir, MD, clinical director of hepatology at Duke University, told MedPage Today the decision should rest largely with the patient.

"I get concerned about us being too heavy handed deciding which patients should or should not get hepatitis C treatment," he said. "Our role should be to guide patients about potential options, and those discussions can take quite a bit of time."

He noted, however, that the side effects "will be much better for these patients with future therapies. But I have had patients elect to proceed with treatment even with early-stage disease. Some have felt it was the right time for them to proceed with treatment for a number of personal reasons. Some worried if they would have stable health insurance in the future."

On the other hand, Zobair Younossi, MD, of Inova Health System in Great Falls, Va., said some of his patients actually "warehouse themselves for regimens that do not include interferon."

Muir also noted that even some advanced fibrosis patients may be eligible for watchful waiting, since not all of them will progress quickly.

"If the patient has great risks to treatment, or if the patient does not think the chance of response is good enough to take on the side effects, then delaying therapy is the right thing for that individual [advanced fibrosis] patient as well," he told MedPage Today. "If they do not take treatment, they must get aggressive about liver wellness. That means no alcohol, get in shape and lose weight if needed, and get tight control of your blood sugars if you have diabetes."

Rodriguez-Torres reported relationships with Abbott Laboratories, Anadys, Bristol-Myers Squibb, Glaxo-SKB, Idera, Intarcia, Merck, Novartis, Pfizer, Pharmasset, Roche, Sanofi-Aventis, Valeant, Vertex Pharmaceuticals, ViroChem Pharma Inc, and Wyeth.

The other researchers reported no conflicts of interest.

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