Investigational Device Prolongs Survival Of Livers for Transplantation

General Surgery News

ISSUE: JUNE 2013 | VOLUME:

May Increase Availability of Donor Livers

By Victoria Stern

Patients who need a new liver to survive must hope that they are one of the approximately 13,000 liver transplant recipients in the United States and Europe each year. But with 30,000 people on waiting lists, and with only ice keeping livers for transplantation viable for up to 14 hours, the odds are not always in the patients’ favor. Each year, more than 2,000 livers don’t survive the journey to their new home.

A liver 30 seconds after connection to the OrganOx Metra device. Parts of the organ are still cold, while other parts are warm and perfused with red cell solution.

“Preserving organs by cooling them down is far from perfect,” said Peter J. Friend, MD, director of transplantation surgery, Nuffield Department of Surgical Sciences, Oxford Transplant Centre, U.K. “Although cooling the organ on ice slows its metabolism by a factor of 10, the liver continues to metabolize slowly and deteriorates as a result. It’s hard to tell which organs will work and which ones won’t.”

Now, however, Dr. Friend and his colleague Constantin Coussios, PhD, professor of biomedical engineering at the University of Oxford, have devised a novel technology that may be a game changer: A machine that allows the liver to function for up to 24 hours, as though it were still inside a human body.

On March 15, the team of engineers and physicians announced the preliminary success of this machine, which has safely transported livers to two transplant recipients at King’s College Hospital in London.

“The first two cases went very well,” said Dr. Friend. “They weren’t exceptionally high risk, but the machine did what it was supposed to do.”

Long Time in the Making

In 1994, Drs. Friend and Coussios devised the idea for the technology, but faced several engineering challenges while developing it. The co-inventors needed to create an artificial environment, that could simulate the key functions of the human body, including pumping blood and providing nutrition to the organ. These functions not only had to be automated to make it possible for transplant surgeons around the globe to use the technology, but also small enough for easy transportability.

The liver 5 minutes after connection to the OrganOx Metra, now fully perfused and at physiologic temperature.

After 15 years of developing and tweaking the design, Drs. Friend and Coussios have created a technology that appears to meet these requirements. The liver’s main blood vessels are connected to tubes on the machine, which automatically regulate the environment around the liver. The device maintains the liver at body temperature and infuses it with oxygenated red blood cells, nutrition such as glucose and amino acids, and other chemicals to create a physiologic environment that mimics the human body. The liver is not only kept alive, but it continues to produce bile as well.

Additionally, the machine is compact.

“It’s about the size of a supermarket trolley [shopping cart], which means it can go in back of ambulance, small plane or helicopter,” Dr. Friend said. “Size was very important because we knew there was no point in making a machine if it couldn’t fit in the back of a vehicle.”

Notably, the machine also may allow the liver to recover from injuries it sustained during or before removal, Dr. Friend pointed out. This function of the device is particularly important because it could expand the number of viable livers for transplantation. In recent years, the demand for livers has grown, as liver disease has become more common, whereas the quality of donor livers has diminished.

The King’s College Hospital, Oxford University and OrganOx team successfully connects the first human liver for transplantation to the OrganOx Metra device.

More and more, donors tend to be older, and have a high body mass index or coexisting major health problems,” Dr. Friend noted. “Because of the increasing demand for livers, we are having to use organs we would have once said no to.”

Now with the machine, transplant surgeons can test how well the liver is working during preservation.

“If the liver works on the pump, then we can assume it will work in the recipient,” said Maria B. Majella Doyle, MD, MBA, associate professor of surgery at Washington University School of Medicine, St. Louis, who specializes in liver transplantation. Dr. Doyle was not involved in developing this pump, but she is performing research to develop a different liver pump system, one that also keeps the liver at physiologic temperature.

In April 2008, Drs. Friend and Coussios cofounded a company called OrganOx Ltd., to continue their University of Oxford research. With financial support from the Royal Society and several venture capital funds in the United Kingdom, the company has been working to bring the technology to patients.

Although promising, the device still needs more testing. The U.K. team has begun a pilot trial at King’s College Hospital to test the ability of the machine to transport livers to 20 transplant patients. If the trial is successful, OrganOx then could apply for marketing authority, which would make the device commercially available in Europe.

“If the machine is as good as we believe, we would expect a significant increase in patients who get liver transplants,” Dr. Friend said.

According to Dr. Doyle, the group is “ahead of the game.” To her knowledge, two other teams are developing physiologic-temperature liver pump systems—Dr. Doyle and her colleagues William Chapman, MD, and Vijay Subramanian, MD, at Washington University, and Constantino Fondevila, MD, PhD, at the University of Barcelona—but both are at more preliminary stages.

“The U.K. team is the first to produce human data with the pump and show it’s safe and viable as a liver transplantation device. Now, it’s important to make sure the technology is foolproof and cost-effective,” Dr. Doyle said.

“The U.K. team needs to be highly commended. The pump is a great achievement.”

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Telaprevir-based triple-drug therapy benefits CHC patients with ESRD

By: SHARON WORCESTER, Internal Medicine News Digital Network

06/10/13

ORLANDO – Triple-drug therapy with the protease inhibitor telaprevir plus ribavirin and peg-interferon alpha 2a provides higher sustained virologic response than traditional dual-drug therapy in chronic hepatitis C patients on hemodialysis, according to findings from the randomized, placebo-controlled Target C Trial.

Sustained virologic response after 24 months was 63% in 12 patients treated with telaprevir for weeks 0-12 plus ribavirin and peg-IFN alpha 2a for weeks 0-24 (group A) and 50% in 12 patients treated with telaprevir for weeks 0-12 plus ribavirin for weeks 13-36 and peg-IFN alpha 2a for weeks 0-36 (group B), compared with 25% in 12 patients treated with placebo plus standard dual therapy with ribavirin and peg-IFN alpha 2a for weeks 0-24 and weeks 37-48 (group C, reference arm), Dr. Patrick Basu reported at the annual Digestive Disease Week.

Telaprevir in groups A and B was given as two 750-mg tablets three times daily for 4 days and three 750-mg tablets given twice daily for 3 days after dialysis. The ribavirin dose in group A was 200 mg for weeks 0-12 and 400 mg for weeks 13-24; for group B it was 400 mg for weeks 13-36 (with placebo given for weeks 0-12). All ribavirin doses in group C were 400 mg, and peg-IFN alpha 2a doses in all three groups were 135 mcg, said Dr. Basu of Columbia University College of Physicians and Surgeons, New York.

Patients in the study included 26 men and 10 women with a mean age of 58 years, a mean body mass index of 26.6 kg/m², and a mean viral load of 869,000 IU/mL who were treated between May 2011 and November 2012. All had end-stage renal disease and were on hemodialysis for a mean of 6 years. The groups were well balanced with respect to BMI, race, viral load, and disease genotype.

Adverse events that occurred more often in the telaprevir groups (A and/or B), compared with group C, included anemia, neutropenia less than 750 ANA, thrombocytopenia, skin rash, anorectal dysfunction, dysgeusia, depression, and constipation. Neuropathy was more common in group C.

Protease inhibitors are now part of the standard of care for treatment of chronic hepatitis C, genotype 1. Telaprevir was approved in May 2011 for this purpose.

Since the drug is primarily metabolized in the liver and excreted in the feces, thus limiting renal toxicity, it was considered a promising treatment option for the 3% of chronic hepatitis C patients with end-stage renal disease on hemodialysis – a population with progressive fibrosis and high mortality, Dr. Basu said.

The findings of this pilot study suggest that truncated triple therapy that includes telaprevir does indeed have an advantage over the standard of care for this special population, he concluded, noting that the telaprevir regimen requires further evaluation in a large prospective trial.

Dr. Basu disclosed financial relationships with Gilead Science, BMS, ROMAX, Genentech, Vertex, Otsuka, Takeda, Three Rivers, GI Pathology, and Salix.

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Fatty Liver Diet | “Chinese Secrets to Fatty Liver” Instructs People How to Reverse Their Fatty Live Disease – V-kool

Chinese Secrets to Fatty Liver created by Abe Hsieh is a new fatty liver treatment book that reveals to people a fatty liver diet plan, and step-by-step strategies on how to reverse their fatty live disease and obesity naturally. A full Chinese Secrets to Fatty Liver review on the site Vkool.com indicates if this book is worth buying.

Seattle, WA (PRWEB) June 12, 2013

Chinese Secrets to Fatty Liver created by Abe Hsieh is a new fatty liver treatment book that reveals to people a fatty liver diet plan, and step-by-step strategies on how to cure this disease naturally. This book also introduces to people advanced methods, natural remedies, and meal plans that help them cure their fatty live disease and obesity quickly without using drugs or pills. In addition, the book provides people with a list of healthy foods and vegetables, and simple exercises that they can use for reducing the risk of getting some diseases such as lung cancer, liver cancer, pharynx cancer, larynx cancer, colon cancer, pancreas cancer, and stomach cancer. Furthermore, in this fatty liver treatment book, people will discover all necessary information about fatty live disease such as fatty liver symptoms, causes, and ways to treat this disease naturally and quickly. After Abe Hsieh launched the “Chinese Secrets to Fatty Liver” book, a lot of customers have used it for treating their fatty live disease, and preventing it from coming back again. They said that this book helped them reverse this disease, and improve their liver health. Consequently, the website Vkool.com gathered customers’ opinions and completed a full review about this book.

A full review of Chinese Secrets to Fatty Liver on the site Vkool.com points out that in this book, people will find out advanced methods, natural remedies, and step-by-step techniques that help them treat their fatty liver disease fast, lower the risk of cancer, and reclaim their life from the deadly grip of fatty liver. In addition, the book reveals to people safe recipes that they can use for clearing their skin naturally. Furthermore, the book gives people simple exercises, easy-to-follow techniques that help them reduce stress and anxiety, normalize their sleep patterns, and gain back control of their life. Moreover, in this book, people will discover easy ways to get rid of night sweats and hot flashes forever.

Aaron Danker from the site Vkool.com says that: “the “Chinese Secrets to Fatty Liver” book covers an exclusive fatty liver treatment plan, and step-by-step instruction on how to cure this disease permanently. In addition, when ordering this book, people will get 3 special gifts from Abe Hsieh such as the “100 Succulent Chinese Recipes” book, the “Attract Wealth And Live” book, and the “Chinese Herbs: The Modern Counteractant” book. Furthermore, the book gets a policy of money back if it does not work for users.”

If people wish to view pros and cons from a full Chinese Secrets to Fatty Liver review, they could visit the website: http://vkool.com/fatty-liver-treatment-chinese-secrets-fatty-liver-obesity-reversal/

To get a direct access to Chinese Secrets to Fatty Liver, visit the official site
______________

About the website: Vkool.com is the site built by Tony Nguyen. The site supplies people with tips, ways, programs, methods and e-books about many topics including business, health, entertainment, and lifestyle. People could send their feedback to Tony Nguyen on any digital products via email.

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Calls to help support local filmmaker raising awareness

Calls to help support local filmmaker raising awareness

SamanthaJ33169 12th Jun 2013 3:16 PM

Young local filmmaker, Lee Philipson, is currently making a name for himself in local and regional film festivals, having recently graduated from a Bachelor of Media through Southern Cross University. Despite a shortage of opportunities on a regional scale, Lee has been frivolously shooting and entering competitions as a pathway to the industry.

He recently entered a short film competition where entrants were asked to shoot a public service announcement raising awareness for Hepatitis-C, to de-stigmatise the illness. With a bounty of entries from all around the nation, Lee's short film "Hep C: See the person behind the illness" was selected by a panel of judges for the top six finalists. Now, Lee is busily promoting the film online to gain the many public votes, crucial to win the competition.

"It's amazing the amount of support you can get in a very short amount of time on social media sites like Facebook," the budding director claims, "but we're still looking to broaden the reach of our message".

Lee wants to encourage Coffs Harbour locals to rally behind him in support of regional film talent, to help get the word out that Coffs Harbour is fully committed to it's vibrant film community.

"It's not just about winning," says the filmmaker, "It's also really important that our film is able to reach out to people and let them know that Hepatitis C doesn't have to be a life sentence."
Lee encourages locals to head to the See The Real Thing competition website and vote for the film.

www.seetherealthing.com.au
Head to the video gallery page and look for "Hep C- See the person behind the illness" By Lee Philipson.

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Hep C poorly managed in haemophiliacs

Gastroenterology Update 11 JUNE 2013

Hugo Wilcken

People with inherited bleeding disorders are not being adequately monitored for hepatitis C, despite high levels found in those screened, say Australian experts.

Only 61% had been tested for hepatitis C, the researchers found in a study of 700 patients with bleeding disorders born after 1992.

Of those who had been tested, over half were hepatitis C antibody positive, with prevalence approaching 100% in patients with severe bleeding disorders.

But of those found to be positive, only a third had actually been treated, with a response rate of 45%.

Around 30% of patients with hepatitis C had had no follow-up with a clinician in the previous two years, the authors from the Alfred Hospital in Melbourne found.

A fifth of the 220 patients with hepatitis had died, including four from hepatocellular carcinoma and four from other liver-related complications. Over a fifth of patients with hepatitis C had never seen a specialist for their viral infection, the authors found.

Reporting in Haemophilia, the authors said high rates of disease in this population were largely due to exposure through blood transfusion before 1992, when blood products were first screened for the virus.

The authors said without testing, many of these patients would remain asymptomatic for years until irreversible complications set in.

But there was no comprehensive database to determine which patients might have received infected blood products, they noted, and patient self-reporting was a poor alternative as the blood may have been given to them as small children.

“Given the substantial morbidity and mortality associated with hepatitis C and new therapeutic options becoming available, it seems important to reengage patients to diagnose, offer treatment and monitor this infection,” they concluded.

Haemophilia 2013; online

%2012/06/2013%209:40:13%20AM&utm_content=" target=_blank>Source

Hep C knowledge gap endangering children

Gastroenterology Update 11 JUNE 2013

Hugo Wilcken

People at high risk of hepatitis C infection have a poor knowledge of the disease which is putting their children in danger, an Australian survey has found.

Less than half of those attending NSW methadone clinics admitted to being positive for the hepatitis C virus (HCV), a survey of 330 people found, although actual exposure rates in high-risk populations are generally double that.

Around half said their children had been tested for HCV but almost all believed their children’s status was negative, the authors from the University of Sydney said.

This clearly reflected a lack of understanding of the risk of vertical transmission from mother to child, as well as poor compliance with current guidelines which recommend the children of all high-risk people be tested, the authors said.

But when offered free testing for themselves and their children, only one participant accepted.

Writing in the Journal of Paediatrics and Child Health the authors said children of high-risk populations “remain an unrecognised cohort of HCV carriers and are particularly at risk of spreading and developing the infection in later life”.

The findings suggested “a striking non-adherence to best practice, a lack of awareness of HCV...and that many children in this high-risk population are lost to follow-up,” the authors said.

They underlined the need to screen children born to HCVpositive mothers and also to screen high-risk populations at least every one to two years.

The authors recommended active case monitoring through a HCV registry for high-risk people and their children, as well as further initiatives to raise awareness in the general population.

Journal of Paediatrics and Child Health 2013; online

%2012/06/2013%209:40:13%20AM&utm_content=" target=_blank>Source

Hepatitis C virus and human immunodeficiency virus transmission routes: Differences and similarities

World J Hepatol. 2013 May 27; 5(5): 234-236.

Published online 2013 May 27. doi: 10.4254/wjh.v5.i5.234.

©2013 Baishideng Publishing Group Co., Limited. All rights reserved.

Francesca Cainelli.

Francesca Cainelli, Department of Internal Medicine, School of Medicine, Faculty of Health Sciences, University of Botswana, Private Bag 00713, Gaborone, Botswana

Author contributions: Cainelli F wrote the paper.

Correspondence to: Dr. Francesca Cainelli, MD, Department of Internal Medicine, School of Medicine, Faculty of Health Sciences, University of Botswana, 4775 Notwane Rd, Private Bag 00713, Gaborone, Botswana. francescacainelli@yahoo.it

Telephone: +267-35-54563 Fax: +267-31-05979

Received March 24, 2013; Revised April 21, 2013; Accepted May 7, 2013;

Abstract

Bouare et al found that hepatitis C virus (HCV) infection in Malian women is mainly transmitted through medical procedures with contaminated supplies, and that human immunodeficiency virus (HIV) transmission is predominantly sexual. The results of this study confirm those of a recent case-control study in New York and Oregon which demonstrated that healthcare exposures represent an important source of new HCV infections in United States. HCV seroprevalence was only 0.2% in pregnant, young Malian women, indicating that hygiene improved in healthcare facilities over time. Heterosexual transmission of HCV is exceptional, and can occur, from males to females, in extremely rare occasions in case of vaginal mucosal damage or less rarely through anal intercourse. The Malian study did not show an association between HIV infection and hospitalization, transfusion, tattoo, dental care. Transmission by needle-stick injury occurs in 0.9%-2.2% of exposures from HCV-infected subjects and in 0.1%-0.3% of exposures from HIV-infected individuals. HCV is therefore more transmissible through percutaneous exposure.

Keywords: Hepatitis C virus, Human immunodeficiency virus, Transmission, Sub-Saharan Africa, Pregnant women

Core tip: The results of a number of studies have shown that hepatitis C virus (HCV) infection is mainly transmitted through medical procedures with contaminated supplies, whereas human immunodeficiency virus (HIV) transmission is predominantly sexual. Heterosexual transmission of HCV is exceptional and can occur, from males to females, in extremely rare occasions in case of vaginal mucosal damage or less rarely through anal intercourse. Transmission by needle-stick injury occurs in 0.9%-2.2% of exposures from HCV-infected subjects and in 0.1%-0.3% of exposures from HIV-infected individuals; therefore HCV is more transmissible through percutaneous exposure.

COMMENTARY ON HOT TOPICS

Bouare et al[¹], studying 1000 pregnant women in six reference health centers, and 231 older women who attended general practice in two hospitals in Mali, found that hepatitis C virus (HCV) infection is mainly transmitted through medical procedures with contaminated supplies rather than through blood transfusion, whereas human immunodeficiency virus (HIV) transmission is predominantly sexual.

The results of this study confirm those of a very recent case-control study done in three health departments that performed enhanced viral hepatitis surveillance in New York and Oregon and included reported cases of symptomatic acute hepatitis B and hepatitis C occurring in persons ≥ 55 years of age from 2006 to 2008; healthcare exposures were found to represent an important source of new HBV and HCV infections in United States[²]. Many other studies also found the same in different countries[^3-6]. It is reassuring that HCV seroprevalence was only 0.2% in pregnant (young) Malian women[¹], possibly indicating that hygiene improved in healthcare facilities over time. The results also confirm that heterosexual transmission of HCV is exceptional[^7-10]. Indeed heterosexual transmission of HCV from males to females can occur in extremely rare occasions in case of vaginal mucosal damage[¹¹] or less rarely through anal intercourse[^12,13].

What about HIV? The Malian study did not show an association between HIV infection and hospitalization, transfusion, tattoo, dental care. A significant decrease of HIV seroprevalence was detected in young women who used condoms for contraception more than for other purposes, whereas surprisingly HIV seroprevalence was significantly increased in young women using condoms mainly to prevent sexual infections[¹]. The authors interpreted these findings as suggestive of awareness of transmission and prevention of HIV infection only after contagion. However knowledge of vaginal sex as an HIV transmission risk and condom use as an HIV prevention strategy were associated with a higher likelihood of HIV infection in Mozambique and elsewhere in sub-Saharan Africa[¹⁴], inconsistent condom use was not related to the probability of HIV transmission per coital act in a study of Ugandan HIV discordant couples[¹⁵], and condom use was not negatively associated with incident HIV infection in a large study conducted in Benin, Ghana, India, Nigeria, and South Africa[¹⁶]. At least the latter of these surprising findings are likely to derive from the inaccuracy of self-reported data[¹⁷].

Transmission by needle-stick injury occurs in 0.9%-2.2% of exposures from HCV-infected subjects[^18,19] and in 0.1%-0.3% of exposures from HIV-infected individuals[²⁰]; therefore HCV is more transmissible through percutaneous exposure. It has not been definitively established why HCV is much less transmissible than HIV by heterosexual contact, and more infectious through parenteral exposure. Although low infectivity of HCV by vaginal intercourse has been related to low titres in genital secretions, titres of free HIV are also low. It may be that as infection of tissue dendritic DC-SIGN(+)-DC cells and localised replication in cervico-vaginal tissues are of fundamental importance for HIV infection of exposed individuals[²¹], the lack of target cells in the genital tract may prevent infection by HCV through vaginal intercourse.

Footnotes

P- Reviewers Hou WH, Kagawa T, Quer J, Sira MM S- Editor Gou SX L- Editor A E- Editor Li JY

References

1. Bouare N, Gothot A, Delwaide J, Bontems S, Vaira D, Seidel L, Gerard P, Gerard C. Epidemiological profiles of human immunodeficiency virus and hepatitis C virus infections in Malian women: Risk factors and relevance of disparities. World J Hepatol. 2013;5:196-205. [DOI]

2. Perz JF, Grytdal S, Beck S, Fireteanu AM, Poissant T, Rizzo E, Bornschlegel K, Thomas A, Balter S, Miller J. Case-control study of hepatitis B and hepatitis C in older adults: Do healthcare exposures contribute to burden of new infections?. Hepatology. 2013;57:917-924.[PubMed] [DOI]

3. Baha W, Foullous A, Dersi N, They-They TP, Alaoui KE, Nourichafi N, Oukkache B, Lazar F, Benjelloun S, Ennaji MM. Prevalence and risk factors of hepatitis B and C virus infections among the general population and blood donors in Morocco. BMC Public Health. 2013;13:50.[PubMed] [DOI]

4. Spada E, Mele A, Mariano A, Zuccaro O, Tosti ME. Risk factors for and incidence of acute hepatitis C after the achievement of blood supply safety in Italy: results from the national surveillance system. J Med Virol. 2013;85:433-440.[PubMed] [DOI]

5. Flisiak R, Halota W, Horban A, Juszczyk J, Pawlowska M, Simon K. Prevalence and risk factors of HCV infection in Poland. Eur J Gastroenterol Hepatol. 2011;23:1213-1217.[PubMed] [DOI]

6. Kim JY, Won JE, Jeong SH, Park SJ, Hwang SG, Kang SK, Bae SH, Kim YS, Lee HC. Acute hepatitis C in Korea: different modes of infection, high rate of spontaneous recovery, and low rate of seroconversion. J Med Virol. 2011;83:1195-1202.[PubMed] [DOI]

7. Terrault NA, Dodge JL, Murphy EL, Tavis JE, Kiss A, Levin TR, Gish RG, Busch MP, Reingold AL, Alter MJ. Sexual transmission of hepatitis C virus among monogamous heterosexual couples: the HCV partners study. Hepatology. 2013;57:881-889.[PubMed] [DOI]

8. Ndong-Atome GR, Njouom R, Padilla C, Bisvigou U, Makuwa M, Kazanji M. Absence of intrafamilial transmission of hepatitis C virus and low risk for sexual transmission in rural central Africa indicate a cohort effect. J Clin Virol. 2009;45:349-353.[PubMed] [DOI]

9. Hajiani E, Masjedizadeh R, Hashemi J, Azmi M, Rajabi T. Hepatis C virus transmission and its risk factors within families of patients infected with hepatitis C virus in southern Iran: Khuzestan. World J Gastroenterol. 2006;12:7025-7028.[PubMed]

10. Vandelli C, Renzo F, Romanò L, Tisminetzky S, De Palma M, Stroffolini T, Ventura E, Zanetti A. Lack of evidence of sexual transmission of hepatitis C among monogamous couples: results of a 10-year prospective follow-up study. Am J Gastroenterol. 2004;99:855-859.[PubMed] [DOI]

11. Quer J, Murillo P, Esteban JI, Martell M, Esteban R, Guardia J. Sexual transmission of hepatitis C virus from a patient with chronic disease to his sex partner after removal of an intrauterine device. Sex Transm Dis. 2003;30:470-471.[PubMed]

12. Healey CJ, Smith DB, Walker JL, Holmes EC, Fleming KA, Chapman RW, Simmonds P. Acute hepatitis C infection after sexual exposure. Gut. 1995;36:148-150.[PubMed] [DOI]

13. Halfon P, Riflet H, Renou C, Quentin Y, Cacoub P. Molecular evidence of male-to-female sexual transmission of hepatitis C virus after vaginal and anal intercourse. J Clin Microbiol. 2001;39:1204-1206.[PubMed] [DOI]

14. Brewer DD. Knowledge of blood-borne transmission risk is inversely associated with HIV infection in sub-Saharan Africa. J Infect Dev Ctries. 2011;5:182-198.[PubMed] [DOI]

15. Wawer MJ, Gray RH, Sewankambo NK, Serwadda D, Li X, Laeyendecker O, Kiwanuka N, Kigozi G, Kiddugavu M, Lutalo T. Rates of HIV-1 transmission per coital act, by stage of HIV-1 infection, in Rakai, Uganda. J Infect Dis. 2005;191:1403-1409.[PubMed] [DOI]

16. Feldblum PJ, Lie CC, Weaver MA, Van Damme L, Halpern V, Adeiga A, Bakare R, Schwartz J, Becker M, Solomon S. Baseline factors associated with incident HIV and STI in four microbicide trials. Sex Transm Dis. 2010;37:594-601.[PubMed] [DOI]

17. Turner AN, De Kock AE, Meehan-Ritter A, Blanchard K, Sebola MH, Hoosen AA, Coetzee N, Ellertson C. Many vaginal microbicide trial participants acknowledged they had misreported sensitive sexual behavior in face-to-face interviews. J Clin Epidemiol. 2009;62:759-765.[PubMed]

18. Ryoo SM, Kim WY, Kim W, Lim KS, Lee CC, Woo JH. Transmission of hepatitis C virus by occupational percutaneous injuries in South Korea. J Formos Med Assoc. 2012;111:113-117.[PubMed] [DOI]

19. Tomkins SE, Elford J, Nichols T, Aston J, Cliffe SJ, Roy K, Grime P, Ncube FM. Occupational transmission of hepatitis C in healthcare workers and factors associated with seroconversion: UK surveillance data. J Viral Hepat. 2012;19:199-204.[PubMed] [DOI]

20. Ippolito G, Puro V, De Carli G. The risk of occupational human immunodeficiency virus infection in health care workers. Italian Multicenter Study. The Italian Study Group on Occupational Risk of HIV infection. Arch Intern Med. 1993;153:1451-1458.[PubMed] [DOI]

21. van den Berg LM, Geijtenbeek TB. Antiviral immune responses by human langerhans cells and dendritic cells in HIV-1 infection. Adv Exp Med Biol. 2013;762:45-70.[PubMed] [DOI]

Source

Bill would provide Hep-C testing for more NY'ers

Photo by Cassandra Hamdan.

By RICHARD MOODY

June 11, 2013

A group of about 50 advocates dressed in black and white T-shirts with "Vocal New York" printed across their fronts crowded the Million Dollar Staircase in the Capitol; signs, that said, "Hep C Testing = Saved Lives," and "Fight Hep C," waved in the air; chants of, "No justice, no peace," and "End Hep-C" reverberated up and down the staircase.

"You are all making history here," Assemblyman Zebrowski said to the group of advocates from Vocal New York, a grassroots advocacy group that speaks on the behalf of low-income people, and concerned individuals as they rallied behind a bill (A.1286/S.2750) — the first piece of legislation of its kind nationally — to add a new section to the public health law requiring certain health service providers to offer Hepatitis-C tests to people born between 1945 and 1965. And if the test should come out positive the provider must offer follow-up health care ¬— or refer the infected individual to a provider who can — including a Hepatitis-C diagnostic test.

The bill also requires the state health commissioner to evaluate the impact of the legislation and report the findings to the governor and Legislature.

The bill passed in the Assembly on Monday and advanced into its third reading in the Senate on the same day. The bill was sponsored in the Assembly by Assemblyman Kenneth Zebrowski, D-New City, whose father, also an assemblyman, died in 2007 of Hepatitis-C. "Three to five million people have Hep-C and most of them don't even know," Zebrowski said. He seemed optimistic about the possibility of the bill passing in the Senate saying that all it needs is a "little push."

"We will get this all signed into law."

Assemblywoman Joan Millman, D-Brooklyn, who co-sponsored the bill, said her message was simple, "We need to pass this bill."

The rally was emceed by Bobby Tolbert, a board member of Vocal New York, who tried to buy time for Sen. Kemp Hannon, R-Garden City, sponsor of the bill in the Senate, to arrive to the press event by opening the floor to personal testimonies. One such testimony was given by a Diane Nunez who was diagnosed with Hepatitis-C in 1998 and went for treatment in 2003. "This is a pandemic in our communities," said Nunez, "We have to end Hep-C."

Hadiyah Charles, a longtime advocate HIV/AIDES prevention associated with the Lower East Side Harm Reduction Coalition, praised New York for taking a big step in national history and said that with this legislation "New York should cause a domino effect" of other states passing similar legislation.

Sammy Santiago, a concerned individual who was tested in 1996 for Hepatitis-C and was declared "undetectable" and earlier this year found out he had cirrhosis of the liver, has been getting treatment for Hepatitis-C for four months. "In the first four weeks I was declared undetectable again," Santiago said. Santiago stressed the importance of getting tested for Hepatitis-C, "That's what's important: we all need to be educated."

George Santana of the CitiWide Harm Reduction Coalition spoke about his experience after being diagnosed with Hepatitis-C. "I've done the treatment. It sucks, anyone who has done it knows what I'm saying, but it was worth it," Santana said. "We must continue to fight, because I know deep in my heart this bill will pass."

Source

Also See: NBLCA Supports Proposed New York State Legislation That Would Expand Testing for Hepatitis C Virus in Baby Boomers

Global Commission on Drug Policy: Hepatitis C an epidemic

Hepatitis C kills about 350,000 people worldwide every year and the World Health Organization (WHO) estimates that about 150 million people are chronically infected. In the Americas, between seven million and nine million are infected with the disease, according to the Pan American Health Organization (PAHO). (Francois Nascimbeni/AFP)

Between seven million and nine million people in the Americas are infected with the disease.

By Ezra Fieser for Infosurhoy.com – 11/06/2013

SANTO DOMINGO, Dominican Republic – The counter-narcotics fight is fueling an international hepatitis C epidemic, according to a new report, leading prominent world and Latin American figures to call on countries to decriminalize drug use and focus on treatment.

“The Negative Impact of the War on Drugs on Public Health: the Hidden Hepatitis C Epidemic,” produced by Global Commission on Drug Policy, stated that about five of every eight intravenous drug users are living with the disease.

The World Health Organization (WHO) estimates that about 150 million people are chronically infected with hepatitis C, which kills about 350,000 people a year – most of whom develop cirrhosis or cancer.

In the Americas, between seven and nine million are infected with the disease, according to the Pan American Health Organization (PAHO). The organization doesn’t estimate the number of deaths specifically caused by the disease, but according to PAHO statistics about 16,500 people die of related disease – such as cirrhosis – annually.

About 10 million people living with the disease are intravenous drug users. But the Global Commission on Drug Policy said the disease is needlessly spread due to outdated laws and policies that target drug users.

Hepatitis C, one of the five types of viral hepatitis diseases that affect the liver, is contracted through contact with the blood of infected persons, meaning intravenous drug users run a high risk of contracting the disease. It is a leading cause of liver transplants.

Infection rates are highest in countries in Central Asia and Eastern Europe, where as many as 90% of intravenous drug users are infected.

The commission carries the weight of several prominent figures. Former United Nations Secretary-General Kofi Annan, seven former presidents and Virgin Group founder Richard Branson are among the commission’s members.

Former Brazilian President Fernando Henrique Cardoso, the commission’s chairman, said hepatitis C is “both preventable and curable when public health is at the core of drug response.”

With the report, “we are exposing the links between repressive drug policies and the spread of hepatitis C, another massive and deadly global epidemic,” Cardoso said in a video message introducing the study. “This is another concrete example of the failure and negative impacts of repressive drug policies around the world.”

The commission previously had warned of the link between criminalized drug use and the spread of HIV/AIDS. By linking drug use to hepatitis C, the commission hopes to provide another example in the argument that drug use should be decriminalized.

Cardoso also said it’s a human rights issue.

“Though human rights abuses are widespread in most parts of the world, they come about in different ways,” he said. “In Latin America, the main issue is mass incarceration, violence and corruption and the strengthening of organized crime.”

Specifically, the commission is recommending governments:

• End criminalization and mass incarceration of drug users;
• Redirect money currently dedicated to the counter-narcotics fight toward public health projects aimed at drug users;
• Make sterile syringes available and offer treatment programs, such as opioid substitution therapy for heroin users;
• Better report hepatitis C cases by improving surveillance systems and other measures;
• Reduce the cost of medicines that can treat hepatitis C by negotiating with pharmaceutical companies and making the drugs more widely available.

The report was released in advance of the International Harm Reduction Conference in Lithuania, which began June 9.

Meantime, last week’s 43rd General Assembly of the OAS ended with foreign ministers’ creating a roadmap they hope leads to long-term renewal of their regional drug policy in 2016.

Officials at the General Assembly, which was held in the Guatemalan city of Antigua, said they will convene a special meeting during the first half of 2014 to outline the counter-narcotics strategy that will be discussed when the OAS holds its 44th General Assembly in June 2014 in Paraguay.

“We have already reached a consensus and agreed that our final declaration will include changes to the current anti-drug model,” Guatemalan Foreign Minister Fernando Carrera told reporters. “We already have some ideas on how to change drug-fighting policies.”

Source

Ukraine Injects Addicts With Hope

Tuesday, June 11, 2013 - 16:46 Inter Press Service

VILNIUS, Lithuania, Jun 11 (IPS) - As former presidents, senior diplomats and experts meet in the Lithuanian capital to discuss a litany of rights abuses, lethal epidemics and social destruction caused by repressive drug policies in Eastern Europe and Central Asia, pockets of hope for drug reform are emerging across the region.

Eastern Europe and Central Asia (EECA) is home to over 3.7 million people who inject drugs - almost a quarter of people who inject worldwide. Injecting drug use is fuelling HIV and hepatitis C epidemics in most EECA countries - almost a third of injecting drug users in the region are thought to be living with HIV while even more are infected with hepatitis C.

Many EECA countries also have some of the world’s strictest legislation on drugs. Lengthy jail sentences are routinely imposed for even the most minor drugs offences, and government approaches to harm reduction – including needle exchanges, opioid substitution treatment and social support systems - range from apathetic to actively obstructive.

However, as the enormous scale of the HIV/AIDS and hepatitis C epidemics has emerged and authorities have begun to realise the massive public health implications of drug use, some governments are softening their drugs policies, albeit mildly.

Michel Kazatchine, the UN Secretary General’s special envoy on HIV/AIDS for East Europe and Central Asia, told IPS: “Countries across the Eurasian region, from the Ukraine to Belarus and all the way to Central Asia are showing signs of moving in a more positive direction on harm reduction.”

Delegates at the International Harm Reduction Conference in Vilnius Jun. 9-12 – which brought together more than 800 scientists, politicians, researchers, health workers, doctors and drug user activists from across the world – repeatedly heard how state drug policy across the region remains widely rooted in repression and criminalisation, compounding public health problems and having no effect on reducing drug use.

Drug addicts who spoke to IPS at the conference told stories of police waiting outside harm reduction service centres to arrest addicts for having dirty needles on them, and using the residue in their needles as proof of possession.

But what also emerged from the conference was the success of harm reduction efforts in some countries and surprising reform plans in others.

Georgia’s justice minister, Tea Tsulukiani, outlined plans for sweeping reforms of the former Soviet state’s drug policy. At present harm reduction services are not legalised, there is no treatment for drug users in prisons, and possession of even the smallest amounts of drugs can end in an 11-year jail sentence.

The ministry wants to decriminalise possession of small amounts of both soft and hard drugs, overhaul healthcare services for drug users, and legalise harm reduction.

Tsulukiani told IPS: “At the moment Georgia has a repressive machine to deal with drugs. This needs to be changed to a system that is fair and human.”

In Kazakhstan, meanwhile, the health ministry at the end of last year expanded opioid substitution therapy programmes, and there has been a significant upgrade of funding for harm reduction programmes. It has also introduced a large programme to tackle hepatitis C.

But arguably the greatest changes have been seen in Ukraine, which is already being hailed as a shining example for the rest of the region of how to implement harm reduction programmes and to successfully engage authorities on drug policy reforms.

Ukraine has struggled for the last decade with one of the fastest growing HIV/AIDS epidemics in the world, driven by injection drug use. There are an estimated 290,000 injecting drug users in Ukraine.

But last year, for the first time, the rate of new HIV infections in Ukraine dropped. This has been put down to the widespread implementation of harm reduction programmes.

The Ukrainian harm reduction group International HIV/AIDS Alliance Ukraine implements the largest HIV prevention programme in the EECA, supporting 170,000 drug users in more than 300 cities. The government also recently approved the country’s first hepatitis C programme to combat the epidemic in the country.

The programme was approved largely after sustained pressure from civil society groups who led dialogue with authorities, persuading them of the public health risk of the epidemic.

Andrij Klepikov, executive director of International HIV/AIDS Alliance Ukraine, said other countries in the region should try to follow their lead.

He told IPS: “We need to get the message out about our success. Our programmes have been a success and there is so much we can easily share with other countries in the region - there is no language barrier because Russian is widely spoken around the region and there are similar situations in many countries with regard to the drug problem and related health problems.

“Our experience could be really useful for them.”

Tsulukiani told IPS that Ukraine’s implementation of harm reduction services was one example which her ministry was looking at as it formulates a body of evidence to present to other ministries “to persuade them that by implementing reforms the situation with drug use will not get worse in Georgia.”

But as delegates at the conference heard, for all the progress in these countries, drug users continue to face human rights abuses, a chronic lack of access to harm reduction services and criminalisation which does nothing to combat addiction. Prisons remain flooded with illicit drugs and are breeding grounds for diseases such as HIV and hepatitis.

Tsulukiani told IPS that one of the “pillars” of the reforms she wants to push through in Georgia are changes in healthcare services for drug users and particularly for incarcerated drug users.

“Drug users are seen as criminals and put in prison. All they get there is detox, no treatment, and they come out psychologically destroyed,” she said.

However, some people are hopeful that the situation in the region can be changed for the better, as the example of Ukraine has shown.

Alexander Kwasniewksi, former president of Poland and member of the Global Commission on Drug Policy, told IPS: “It’s not all bad news in the EECA, there are positive things happening, such as law changes and the scaling-up of services in some countries.

“And while much, much more still needs to be done, we can look at the example of the Ukraine and see that with enough pressure and work from NGOs, change can definitely be effected.”

Source

Novel Liver Stem Cell Model Could Speed Up Process for Developing New Drugs

In the latest issue of STEM CELLS Translational Medicine, a research team reports a new method which involves the creation of a highly stable and sensitive liver stem cell model.

Durham, NC (PRWEB) June 11, 2013

The path to bringing a new drug to market is, simply put, a rocky one. Not only is it estimated to take over 12 years at an average price tag running anywhere between US $800 million and US $2 billion, but more often than not the new drug never makes it through the process.

But now a research team reports that it has developed a way to speed up the process. Their work, which involves the creation of a highly stable and sensitive liver stem cell model, is reported in the latest issue of STEM CELLS Translational Medicine.

“Liver toxicity is the second most common cause of human drug failure,” explained David Hay, Ph.D., of the University of Edinburgh’s MRC Centre for Regenerative Medicine, who led the team made up of university colleagues and scientists from Bristol-Myers Squibb, Princeton, N.J. “But one major bottleneck in safety testing new drugs has been finding a routine supply of good quality primary human hepatocytes from the desired genetic background.”

Scientists have long believed that finding an efficient way to force pluripotent stem cells (PSCs) to develop into hepatocytes — liver cells — could be the way around the problem. “But faithfully recapitulating human physiology in a dish from a renewable source remains a holy grail for medicine and the pharmaceutical industry,” Dr. Hay noted.

“Many procedures have been described that, to a limited extent, exhibit human-tissue-specific function in vitro but incomplete cellular differentiation and/or the loss of cell phenotype after they differentiate. Using our knowledge in pharmacology, stem cell biology and materials chemistry, we developed a highly stable and sensitive model.”

Their method involved expanding PSCs and driving their differentiation to hepatocytes, then replating them onto a synthetic surface. The results yielded active cell populations that displayed stable function for over two weeks in vitro.

“The scalable nature of our model combined with the interchangeable genetic element demonstrates clear advantages over the erratic supply of highly variable human hepatocytes from deceased specimens,” Dr. Hay added. “We believe our approach is important and will likely contribute to improvements in drug safety testing.”

“This model was compared to human liver cells from deceased donors and found to be equivalent, suggesting that stem cell-derived hepatocyles have potential to improve the preclinical assessment of human liver toxicity,” said Anthony Atala, M.D., Editor of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. “

The full article, “Developing high fidelity hepatotoxicity models from pluripotent stem cells,” can be accessed at http://www.stemcellstm.com.

About STEM CELLS Translational Medicine: STEM CELLS TRANSLATIONAL MEDICINE (SCTM), published by AlphaMed Press, is a monthly peer-reviewed publication dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices.

About AlphaMed Press: Established in 1983, AlphaMed Press with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes two other internationally renowned peer-reviewed journals: STEM CELLS® (http://www.StemCells.com), celebrating its 31st anniversary in 2013, is the world's first journal devoted to this fast paced field of research. The Oncologist® (http://www.TheOncologist.com), also a monthly peer-reviewed publication, entering its 18th year, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. All three journals are premier periodicals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines.

Source

Organ transplants - to donate or not

By Liu Zhihua
China Daily/Asia News Network
Tuesday, Jun 11, 2013

Serious health problems, such as heart or kidney or liver failure, cancer, blindness, or Parkinson's disease affect millions of people around the world, altering the quality of life and putting a major burden on family members and society.

In some cases, an organ transplant may be the only treatment or lifeline available - for those who have access to the procedure. But, even then, there is such high demand for organs that many people can die before they qualify for a suitable organ.

According to the Red Cross Society of China, which runs a State-sanctioned organ donor programme, China has about 1.5 million people in need of an organ transplant every year, but only about 10,000 can undergo the procedure.

The reason for this are age-old but can be illustrated by a recent incident in April. When the family of a trucker, in Wuhan, Hubei province who had died donated his organs and helped five people on the transplant list, the news spread like wildfire on the Internet. The man, Chen Gang, 35, had suddenly lost consciousness on April 21, at work, and by the second day when there appeared to be no hope of saving him, his family told the doctors they wanted to let someone else benefit from his organs.

For Yin Shumin, a 45-year-old farmer in Henan, and four other men, that one decision was a major turning-point. Yin underwent a life-saving heart transplant at Wuhan's Union Hospital, on April 23, something he had been waiting for since January.

Yin's wife, who didn't give her name, had this to say, "No one could possibly understand how worried I was while we were waiting for the results. He was getting weaker every day and the doctors explained that if he couldn't get a proper heart, he would die in a few months."

The same day that Yin was operated on, a patient he had met in the hospital, who had been waiting for a heart transplant a long time, died.

Where are the donors?

Yin was lucky getting a perfect match, out of several dozen people with heart problems who were still waiting.

Dong Nianguo, the chief surgeon working on Yin and a major specialist in that field, noted regretfully, "A lot of people die waiting for a heart."

But, with so few organ donors and the huge difference between the need and the supply, things can look rather grim. In contrast, the surgical procedures for many organ transplants in China are mature enough to ensure a high rate of success, but unfortunately for those in need of a heart, kidney, liver, lung, or a cornea, even with the expert service, prospects can be quite dim.

So, "When something unusual happens, it makes the news, and people notice what Chen and his family did, because so few people do the same", Dong said.

In this regard, there was a national pilot programme that started in 2010, to solicit organ donations, in 19 provinces, including Hubei. Red Cross branches have set up offices to make people more aware of the importance of organ donations and to connect with area hospitals to look for potential donors.

Personnel from these offices talk with dying patients or their family members to try to get their permission to donate. And, a computerized system tracks the needs of waiting patients in relation to the state of the disease and the distance from a potential donor, then identifies the most likely recipient.

Chen and his family who were willing to donate his organs became a part of this system. But statistics show, by the end of February, only 659 people had donated organs, a total of only 1,804, via this system.

Xiu Dianrong, a liver transplant surgeon at Peking University's No 3 Hospital, said, "There are a lot of potential donors, but few become donors."

At Xiu's hospital, one of the earliest to undertake liver transplants in China, the lack of organs is the biggest major obstacle to saving lives. It is certainly not the technical difficulties.

The Chinese have little exposure to a philosophical approach to death, which is an unpleasant cultural topic, and few can accept the idea of donating organs of a loved one who is dying, or even talk about the possibility, Xiu commented.

But, Xiu continues, death, as well as illness and aging, need to be perceived as a natural part of life, and people should not be afraid.

Alternatives

Dong, the cardiac surgeon, also expresses the hope that more people will change their attitude toward donating organs and understand the meaning of such behaviour and its impact on others.

Meanwhile, not every organ for a transplant necessarily needs to come from a human, some people are already looking to animals for the solution.

Historically, doctors have made attempts to replace failing human organs with those of animals such as pigs or monkeys, but these xenotransplants, or inter-species transplants, have failed for unknown or unresolved reasons.

In recent years, there have been some breakthroughs. In the mid 1990s, scientists in the US were pioneers with a procedure that used pigs as the most likely organ choice among animals.

Now, with the development of genetic technology, researchers have been looking for ways to genetically modify donor animals to prevent organ rejection, and more genetically modified pigs have become available, with human genes, to avoid a human immune system reaction.

On May 8, 2013 , doctors at the Xijing Hospital in Xi'an, Shaanxi, announced that they had planted part of a liver from a genetically altered pig to a monkey.

Source

Italy leads Europe in hepatitis C cases

Milan

11/06/2013

Some 3% of population infected, over half with the worst kind

Milan, June 11 - Italy leads Europe in cases of hepatitis C with 3% of the population infected, more than half of whom suffer from the most difficult variety to treat, leading experts said Tuesday. Some 1.6 million people carry the liver infection in Italy and 55% of them are afflicted with genotype 1, a particularly infectious strain of the disease, said doctors at the Premio Giornalistico Riccardo Tomassetti conference on virology in Milan. "At least one million Italians are chronic carriers of the infection," said Massimo Colombo, director of special treatments and organ transplants at Milan's Maggiore hospital. "One third of these people have developed or are developing serious liver infections". The majority of patients contracted the virus in the 1970s and 80s, Colombo said, with infected blood transfusions, or from health instruments such as hypodermic needles that were not sterilized. "But another 200-300,000 contracted the disease due to risky behaviour such as unprotected sex, piercings and tattoos. "In addition we should include a substantial number of migrants who come from areas with high levels of hepatitis C".

Source

Despite the Numerous Agents in Development for the Treatment of Chronic HCV Infections, a Notable Share of Physicians in Europe Lack Awareness of the HCV Pipeline

One Third of Surveyed Specialists in the EU5 were Unable to Cite Any New Therapy in Development for HCV, According to a New Report from BioTrends Research Group

EXTON, Pa., June 11, 2013 /PRNewswire/ -- BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, finds in their TreatmentTrends^®: Hepatitis C Virus (EU) report, that surveyed gastroenterologists and hepatologists in Spain and France are more likely to be aware of emerging HCV drugs than their counterparts in the United Kingdom, Italy and Germany.  Among physicians with unaided awareness of HCV therapies in development, 42 percent specifically recalled Gilead's sofosbuvir, while only 13 percent cited Janssen/Medivir's simeprevir – two products expected to launch in Europe in the first half of 2014. When asked about the most desired attributes in new HCV therapies, surveyed EU5 physicians pointed to high SVR rates in both genotype 1 patients and in patients who have experienced previous treatment failure.

(Logo: http://photos.prnewswire.com/prnh/20130103/MM36805LOGO )

"EU5 physicians expect sofosbuvir and simeprevir to improve cure rates in genotype 1 and treatment-experienced patients. However, our analyses reveals that there are several additional attributes, including pan-genotypic activity, simplified regimens and ribavirin-sparing efficacy, where follow-on therapies can differentiate themselves from currently available treatments and future regimens," said Director of Infectious Diseases Brenda Perez-Cheeks, Ph.D. "Looking ahead, these opportunities will likely become important as the HCV space becomes increasingly competitive with highly efficacious direct-acting antivirals and regimens. Consequently, novel agents will have to carve out niche opportunities for market penetration."

Surveyed EU5 physicians also noted the uptake of the protease inhibitors (PIs) as the focus of treatment shifts in the past six months. However, trending analysis of physician-reported prescribing between 2012 and 2013 indicates that PI triple therapy uptake is stabilizing in France and Germany, while PI-based therapy has seen gains in on-treatment patient shares in both the UK and Spain. Further, Janssen/Vertex's Incivo continues to outpace its competitor Merck/Roche's Victrelis on usage, brand perception and physician satisfaction. 

The TreatmentTrends^®: Hepatitis C Virus (EU) report covers the use of agents for the treatment of HCV infections in the EU5 based on primary market research with 258 gastroenterologists and hepatologists. This annual study focuses on current and future use of HCV treatment regimens, patient market share, perceived strengths and weaknesses of the key brands, barriers to broader usage and sales force performance. The report also explores the potential impact of regimens in development, including ABT-267, ABT-333, ABT-450, BI-207127, asunaprevir, daclatasvir, faldaprevir, ledipasvir simeprevir and sofosbuvir. The biannual study entitled TreatmentTrends^®: Hepatitis C Virus (US), Wave 1, which provides insight into the treatment of chronic HCV infections in the U.S. from the perspective of gastroenterologists, hepatologists and infectious diseases specialists, is also now available.

About BioTrends Research Group
BioTrends Research Group provides syndicated and custom primary market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please visit www.bio-trends.com. BioTrends is a Decision Resources Group company.

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.

For more information, contact:

Decision Resources Group
Christopher Comfort
781-993-2597
ccomfort@dresources.com

SOURCE BioTrends Research Group

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Widespread Ignorance of Medication That Prevents HIV

Fran Lowry

Jun 10, 2013

Many teens and young adults at high risk for HIV in Washington, DC, would be willing to take pre-exposure prophylaxis every day to prevent infection, if only they were aware that such a thing existed.

In a study conducted to ascertain knowledge, acceptability, and willingness to use prophylaxis in sexually active at-risk people, only 10% said they had ever heard of it.

And when they learned that medication could protect them from HIV infection, most said they would take it, if offered by their healthcare provider.

The findings were presented at the 8th International Conference on HIV Treatment and Prevention Adherence in Miami, Florida. The meeting was jointly sponsored by the International Association of Physicians in AIDS Care, the National Institute of Mental Health, and the Post Graduate Institute for Medicine.

"As our study showed, there is very limited knowledge of pre-exposure prophylaxis overall," lead investigator Amanda Castel, MD, MPH, from George Washington University in DC, told Medscape Medical News. "There is a definite and urgent need for a lot of education and social marketing if pre-exposure prophylaxis is going to be an effective HIV prevention intervention."

In the past 18 months, several studies have shown that the option is an effective method of reducing HIV incidence in a variety of populations, including men who have sex with men, heterosexuals, and serodiscordant couples, where one person is negative for HIV and the other is positive.

Some ongoing trials are focusing on adolescents and young adults, but not many are looking at whether youth are even interested in pre-exposure prophylaxis or willing to take it, Dr. Castel said.

To find out, she and her colleagues surveyed 293 patients attending a clinic for sexually transmitted infections, a community-based general clinic for gay men, and a general adolescent health clinic at Children's National Medical Center in Washington, DC.

“The prevalence of HIV in Washington is higher than anywhere in Russia.”

All participants were HIV-negative and had had sex in the previous 6 months. Participants 13 to 24 years of age accounted for 45% of the cohort and those 25 years and older accounted for 55%.

"We were able to get waivers of parental consent so that we could include participants younger than 18," Dr. Castel noted.

The participants completed their surveys using iPads. "It takes away some of the interviewer bias because we were asking sensitive questions about sexual behaviors, condom use, that kind of thing," she said.

Just 31 participants had previously heard of pre-exposure prophylaxis, 9 of whom were in the younger age group.

Significantly more people in the older group than in the younger group reported that they were more likely to use the medication if it had few or no adverse effects (78% vs 62%; P = .02).

In addition, more older than younger participants reported that they would take medication if it were offered by their healthcare provider (70.6% vs 62.4%; P = .02) and would be able to follow a provider's instructions (76.9% vs 67.7%; P = .03).

Also, significantly more of the older group would prefer to take it after sex than as a daily medication (32% vs 20%; P = .004).

Finally, 64.7% of youth reported they would consider participating in future studies.

"Overall, there is very limited knowledge about pre-exposure prophylaxis and potentially poor adherence. Those things may pose pretty distinct barriers to implementation in this population," Dr. Castel said.

She conceded that taking medication every day for a condition that you don't have is difficult and requires strong motivation and organizational skills.

"A provider might have a patient who fits the high-risk-for-HIV profile, but that person might be terrible at adherence, so may not be a good candidate for pre-exposure prophylaxis, which requires taking it on a daily basis. In that situation, perhaps another prevention intervention, like encouraging condom use, could be tried," she said.

Injections of a long-acting antiretroviral might also be particularly useful for teens and young adults, she suggested.

Medscape Medical News asked Benjamin Young, MD, vice-president and chief medical officer of the International Association of Providers of AIDS Care in Washington, DC, to comment on the study. "This is a really interesting paper because we know from a number of large studies that pre-exposure prophylaxis can work in people who are at risk and who can be adherent to medication."

The study is particularly relevant in a place like Washington, DC, which has the highest prevalence of HIV in the United States, if not the world, Dr. Young added.

"I used to work part time in Russia, and the Russian Ministry of Health used to point out that the prevalence of HIV in Washington is higher than anywhere in Russia and approaches the prevalence in certain capital cities in East Africa. The United States takes on enormous efforts and spends all this money around the world, yet here in Washington, rates are super high, especially among young gay men and young gay men of color."

"I thought it was a travesty that Barrack Obama didn't walk the 3 or 4 blocks from the White House to the convention center during the AIDS conference last summer. It wasn't that he was tied up doing important state business or was out of the country. He was in the White House at the time and the flag was flying during the conference. That was particularly poignant if not outrageous to me, and I'm a supporter," Dr. Young said.

The failure on the part of President Obama to attend the AIDS conference highlights the problems that lead to such a high HIV prevalence in the nation's capital, he added.

"State-level programs work on prevention, but Washington, DC, because it doesn't have a state government but a somewhat dysfunctional city government and doesn't have adequate representation in congress, is forgotten," he said. "The AIDS epidemic is probably just one symptom of this. The study by Dr. Castel's team speaks to this problem. That is why it is important."

Dr. Young said he agrees that much more awareness about pre-exposure prophylaxis is needed.

"The amazing thing is that 90% of at-risk people didn't even know that it exists. It's probably the same nationwide; I don't think this is unique to Washington. But the study shows that people would use pre-exposure prophylaxis if they knew about it and could get it," he noted.

Dr. Castel reports no relevant financial relationships. Dr. Young is an employee of the International Association of Providers of AIDS Care and reports financial relationships with Bristol-Myers Squibb, GlaxoSmithKline, Merck & Co, ViiV Healthcare.

8th International Conference on HIV Treatment and Prevention Adherence. Presented June 3, 2013.

Source

HCV transmission rate higher among MSM with HIV

Provided by Healio

Witt M. Clin Infect Dis. 2013;57:77-84.

June 10, 2013

Transmission of hepatitis C virus among men who have sex with men has been occurring since early in the HIV epidemic, and the rates of infection are higher among those with HIV, according to data published in Clinical Infectious Diseases.

“HCV transmission among MSM has been ongoing for at least 3 decades in both HIV-infected and HIV-uninfected men,” Chloe Thio, MD, associate professor of medicine at Johns Hopkins University, told Infectious Disease News. “Recent reports of HCV in MSM suggest that this is an emerging problem, so it was unexpected to find that transmission has been occurring at relatively high rates for several decades.”

From 1984 to 2011, the researchers prospectively followed 5,310 MSM who were enrolled in the Multicenter AIDS Cohort Study. The cohort included men with HIV and men at risk for HIV. All of the men tested negative for HCV antibody within 2 years of enrollment and at one or more follow-up visits through Sept. 30, 2011. Incident HCV infection was defined as a positive HCV antibody test at two or more follow-up visits.

The cohort was followed for a median of 7.1 years and had 55,343 person-years of follow-up. During this time, there were 115 incident HCV infections, with an incidence rate of 2.08 per 1,000 person-years (95% CI, 1.73-2.49). Among men with HIV, the incidence rate was 4.22, nearly 8.5-fold higher than the 0.5 incident rate for men without HIV.

In a multivariable analysis, factors associated with an increased risk for HCV included older age, HIV infection, being positive for hepatitis B surface antigen, history of injection drug use, drinking more than 13 drinks a week, syphilis and having unprotected receptive anal intercourse with multiple partners in the prior 6 months. Among men with HIV, the risk for HCV decreased as CD4+ counts increased from 0 cells/mm³ to 500 cells/mm³.

“These data emphasize the importance of checking for HCV in all MSM regardless of whether they are still sexually active, since they could have been infected decades ago,” Thio said. “In addition, counseling patients about the increased risk for receptive partners should also occur.”

Thio said that future research questions should address whether outcomes of the incident infections have changed over time. In addition, based on the finding that lower CD4+ counts are associated with increased risk for HCV, it is important to understand how immunosuppression from HIV affects acquisition of HCV.

For more information:

Chloe Thio, MD, can be reached at: Department of Medicine, Johns Hopkins University, 855 N. Wolfe St., Baltimore, MD, 21205.

Disclosure: Thio reports no relevant financial disclosures.

Source

Hepatitis B Viral Levels May Soar When Vitamin D Drops

Medscape Medical News

Diedtra Henderson

Jun 10, 2013

Insufficient serum levels of vitamin D, which ebb and flow with sun exposure, are associated with high levels of hepatitis B virus (HBV) replication in treatment-naive people who suffer from chronic infection.

Harald Farnik, from the Medizinische Klinik 1, Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Germany, and colleagues report the results of their study in an article published online May 22 in Hepatology.

HBV infection remains one of the most significant infectious diseases worldwide. According to the World Health Organization, 2 billion people worldwide have been infected with HBV, and roughly 600,000 die each year. Without antiviral therapy, the virus can attack the liver, and chronic infections progress to liver disease and cirrhosis. An emerging body of evidence has shown that vitamin D plays a role in inflammatory and metabolic liver diseases and that vitamin D can have a therapeutic effect for patients with tuberculosis. Although previous research has failed to demonstrate a correlation between hepatitis C viral load and circulating vitamin D levels, Dr. Farnik and colleagues sought to characterize the relationship between vitamin D metabolism and chronic hepatitis B.

They analyzed serum samples from treatment-naive patients with chronic hepatitis who visited the outpatient liver clinic of the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany from January 2009 to December 2012. Two hundred and three patients were enrolled in the study. Every 3 HBV-infected patients enrolled in the study were randomly matched, according to age and sex, with 2 HCV-infected patients. Sixty-nine of the patients had severe vitamin D deficiency (25(OH)D3 levels < 10 ng/mL), 95 had vitamin D insufficiency (25(OH)D3 ≥ 10 ng/mL and < 20 ng/mL), and 39 had normal vitamin D levels (25(OH)D3 ≥ 20 ng/mL), Dr. Farnik and colleagues write.

"25(OH)D₃ and HBV DNA serum levels showed a significant, inverse correlation (P=0.0003)," the authors write. "In both uni- and multivariate analyses, HBV DNA was the strongest determinant of low 25(OH)D₃ serum concentration in our cohort (P=0.0007 and P=0.000048), respectively.

Additional studies will be needed to establish a causal relationship between vitamin D metabolism and HBV replication, the researchers write, as well as to explore the effect of adding supplemental vitamin D to existing therapies to improve the durability of treatment.

"In conclusion, we demonstrate a significant association between low 25(OH)D3 serum levels and high levels of HBV replication in chronically infected patients," they authors write. "Future studies to evaluate a therapeutic value of vitamin D and its analogs in HBV infection may be justified."

The authors have disclosed no relevant financial relationships.

Hepatology. Published online May 22, 2013. Abstract

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New Loyola Study on Hepatitis C Virus Entry Factor

Public release date: 10-Jun-2013
Contact: Stasia Thompson
thoms@lumc.edu
708-417-5036
Loyola University Health System

Loyola researchers identify disruption of iron uptake receptor

Hepatitis C virus (HCV) infects more than 170 million people worldwide. Approximately 80 percent of infections lead to chronic illness including fibrosis, cirrhosis, cancer and also hepatic iron overload. A new study completed by researchers at Loyola University Chicago Stritch School of Medicine reveals that HCV not only alters expression of the iron-uptake receptor known as transferrin receptor 1 (TfR1) but that TfR1 also mediates HCV entry.

"We have not yet discovered a cure for Hepatitis C, however discovering the relationship between HCV and TfR1 sheds more light on the complex, multistep process required for the virus to get into liver cells," said senior author Susan L. Uprichard, PhD, virologist and Director of Hepatology Research, Loyola. "This new knowledge reveals important insight into how the virus interacts with and changes our liver cells for its own benefit. As such, it may facilitate the development of entry inhibitors or treatments for HCV-associated iron overload." The research findings could also potentially be used in the clinical setting for the care of patients not only for those with chronic liver disease but also for post liver transplant where it might help prevent infection of a new liver or at least slow disease progression. Uprichard says her HCV research lays important groundwork. "This research is like finding one of the four corners of a puzzle," she said. "It creates a key building block toward finding a medical solution to Hepatitis C."

The new study is part of a project initially directed at understanding how HCV may disrupt cellular iron homeostasis. "TfR1 plays a role in HCV infection at the level of glycoprotein-mediated entry, acts after CD81 and is possibly involved in HCV particle internalization," said Danyelle Martin, the first author of the study who performed this research as part of her Ph.D work at University of Illinois at Chicago (UIC) and is now manager of the newly established Clinical Research Office Biobank at Loyola University Medical Center. "More studies will need to be done to determine if and how the interaction between TfR1 and HCV leads to the hepatic iron overload seen in HCV infected patients."

Results of the HCV study are published in the Proceedings of the National Academy of Sciences (PNAS) the week of June 10, 2013.

"The Hepatitis C Virus is fascinating and complex; we are still learning about the biology of the virus including the liver cell factors the virus needs to replicate and how these interactions cause the specific liver dysfunction observed in patients," said Uprichard, who also began the research while at UIC.

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Uprichard and Martin are members of the Division of Hepatology at Loyola University headed by Scott Cotler, MD and the Clinical Research Office led by Thomas Layden, MD.

Together with Harel Dahari, Ph.D, a mathematical modeler and another member of the Division of Hepatology, Dr. Uprichard co-directs a new Program for Experimental and Translational Modeling currently being established at Loyola to promote interdisciplinary research.

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FDA Grants Priority Review To Oral Hepatitis C Drug Sofosbuvir, Approval Set For December

Gilead's drug will be the first to hit the market in a new generation of targeted hepatitis C treatments with high cure rates.

By Jonathan Weiss, Ph.D. | Jun 10, 2013 10:05 AM EDT

Following successful late stage Phase III clinical trials of sofosbuvir, the FDA has granted a priority review designation for Gilead's new hepatitis C drug. If successful during the abbreviated approval process, Gilead expects the drug to be approved by December 8 of this year, making it one of the first in a new generation of drugs that target the virus itself to hit the market.

Sofosbuvir is a small molecule pharmaceutical compound, which acts on the hepatitis C polymerase and blocks the virus' ability to replicate its RNA.  The drug is meant to be used in combination with pegylated interferon (a longer lasting version of interferon alpha) and ribavirin (an antiviral currently used to treat hepatitis C). The drug can also be used with ribavirin alone or with other direct-acting antiviral (DAA) treatments.

Clinical trials from the drug showed great promise in curing patients of hepatitis C infection. A study published recently in the New England Journal of Medicine that we have previously covered showed that when combined with another antiviral drug, ribavirin, sofosbuvir was able to give a patient response rate of 93 percent for subtype 2, and 61 percent for subtype 3 of the hepatitis C virus. These two subtypes make up 25 percent of all hepatitis C cases in the United States. There are approximately four million Americans living with hepatitis C infections, many of whom are unaware of their infections.

Another clinical study called ELECTRON showed that interferon-free treatment with the drug and ribavirin caused a 100 percent response rate at 24 weeks post-treatment.  The study was conducted in patients who had hepatitis C with genotypes 2 and 3.

The oral pill will be prescribed for those with genotype 2 and 3 of the virus in combination with ribavirin. In patients who have never received treatment for hepatitis C, or naïve patients, and have genotypes 1, 4, 5 and 6, the oral drug would be used in combination with peg-interferon and ribavirin.

Hepatitis C treatments are coming out of the woodworks with almost every major pharmaceutical and biotechnology company set to be submitting drugs for approval within the next year. This comes as good news to those suffering from chronic hepatitis C virus infection. The virus can slowly cause liver failure because of scarring and can also result in liver cirrhosis. An estimated 130 to 200 million people worldwide are infected with the hepatitis C virus. Of people initially infected with the virus, 85 percent have the virus persist chronically.

The majority of liver transplants are performed because of hepatitis C infection. And sadly, even with a transplant, the virus can reassert itself. Currently, there is no vaccine for the virus.

Another drug, simeprevir, made by Medivir and Janssen, a division of Johnson & Johnson, was submitted last month to the FDA and also had promising late stage Phase III clinical trial results. Simeprevir targets a different pathway in the virus life cycle than Gilead's sofosbuvir does.

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Ending Mother-to-Child HIV Transmission

Huffington Post

Deborah Dugan CEO, (RED)

Posted: 06/10/2013 10:02 am

Imagine a world where no mother living with HIV will have to transmit the virus to her baby while giving birth. Just 10 years ago, this would have been considered an impossible goal. But, thankfully, with the incredible advances in HIV/AIDS treatment, prevention of mother-to-child transmission is real today and is helping the world take giant steps towards achieving an AIDS Free Generation. But still, 900 babies are born every day with HIV.

(RED) and the Global Fund envision a world in which no baby is born with HIV, and every mother has the opportunity to help her child thrive. To achieve this, ending mother-to-child transmission has become a cornerstone of (RED)'s commitment to the fight. But there is so much more to do before we get to our target, and we need the world to rally around making this a reality.

As a mother of three and CEO of (RED), the focus on safeguarding mothers and their babies from HIV couldn't hit closer to home. Our mission is to bring people and companies into the fight, to generate heat around the crisis and, through the Global Fund, enable some of the world's best-known companies to fund HIV/AIDS programs on the ground in Africa. Thanks to the incredible support of our partners (including Apple, Starbucks, Coca Cola and Belvedere), I am thrilled to announce that we have expanded our number of recipient countries to include Tanzania and Kenya - two countries with a high HIV/AIDS prevalence in which Global Fund programs funded by (RED) can make a real impact.

But real impact requires action. And money. Starting today, a new partnership with Johnson & Johnson means every time someone 'Likes', 'Tweets' or 'Pins' a (RED) infographic, Johnson & Johnson will donate $1 to the Global Fund, up to $100,000. Every cent from that donation will help ensure that HIV+ mothers in Africa have the tools they need to deliver healthy babies.

We are at a crucial point in the fight against HIV/AIDS. By acting now, and by acting collectively, our chances of helping deliver an AIDS Free Generation are infinitely greater.

This blog post was produced by The Huffington Post and (RED) as part of a series to support the CHOOSE (RED), SAVE LIVES campaign this June. To see other posts in the series and to see content from "The Big Push" (the initiative by the Global Fund, the recipient of (RED) monies, to fight AIDS, Tuberculosis and Malaria), click here. For more information about how you can join the fight against AIDS, please go to www.joinred.com/CHOOSERED.

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