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."

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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.”

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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.”

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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.

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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.

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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".

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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

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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.

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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

Source

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.

Source

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.

Source

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.

Source

Hepatitis C 101: Protecting High-Risk Baby Boomers and Vulnerable Communities From the Silent Epidemic

Huffington Post

C. Virginia Fields President & CEO, National Black Leadership Commission on AIDS

Posted: 06/10/2013 2:36 pm

I talk and write a lot about the disproportionate impact of HIV/AIDS and other health disparities on communities of color and other vulnerable populations. During Hepatitis C Awareness Month this past May, the National Black Leadership Commission on AIDS, Inc. (NBLCA) joined with other groups and organizations to educate and inform our communities about this often-invisible virus that has become a silent epidemic in the United States.

Left untreated, the Hepatitis C virus (HCV) causes potentially life-threatening liver damage. African Americans are twice as likely to be infected with HCV than non-Hispanic whites and are also twice as likely to have chronic (lifelong) rather than acute (non-recurring) Hepatitis C. Four times as many African Americans and Latinos have Hepatitis C than have HIV.

At highest risk for HCV infection are baby boomers -- people born between 1945 and 1964. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 75 percent of the 3.2 million adults with HCV in the U.S. are baby boomers. Most don't even know they are infected, and without treatment, their risk of developing serious and even fatal liver diseases, such as cirrhosis and liver cancer, greatly increases.

On the June 5 premiere of Health Action Radio, the weekly, hour-long radio series presented by NBLCA on WWRL1600 AM in New York City, I moderated a discussion about Hepatitis C with Gloria Searson, president and founder of the Coalition on Positive Health Empowerment (COPE), and Hadiyah Charles, Hepatitis C Advocacy Manager at the Harm Reduction Coalition.

According to Ms. Searson, the majority of available information indicates that the lifestyles lived by many people in the 1970s, many of them baby boomers, exposed them in large numbers to the blood-borne Hepatitis C virus. (Many people were also infected during medical procedures before 1992, when the U.S. introduced universal blood product screening.) In fact, Ms. Searson indicated that many baby boomers have been living unknowingly with the virus for as long as 30 years. This is so because there are often no telltale signs of infection. She said baby boomers should be tested and screened not only for HCV but also for all seven types of hepatitis that exist.

Ms. Searson also noted that the co-infection rates for Hepatitis C and other diseases in communities of color are high. African Americans often fall through the cracks of the health care system because many access medical care only through emergency room visits. And, because instances of Hepatitis C are now based mostly on self-reporting, detection is difficult.

There are currently two ways to get tested: Ask for a blood test from your physician or go to an organization such as COPE for a rapid finger stick test, and within 20 minutes you will receive the results. If you don't have the virus, you will receive counseling and information that will help you prevent future infection. If you do test positive, you will be referred to appropriate and affordable care and treatment.

HCV is an epidemic and silent killer in the U.S. today, and we must be proactive about measures that will prevent its spread and help those at risk gain access to treatment. NBLCA fully supports New York State legislation A1286/S2750, which would require health care providers and hospitals to offer those born between 1945 and 1964, with their consent, screening for the Hepatitis C virus (HCV).

As Ms. Charles of the Harm Reduction Coalition pointed out, this legislation, if passed, may be a first-in-the-nation law that could be the "first domino" to fall that will prompt other states with a high HCV prevalence to follow suit.

Policy prompts action and influences budgets. It is imperative to get this legislation passed and signed into law. Since our legislators are working on behalf of us, their constituents, we want them to know that we support this ground-breaking, farsighted proposed legislation.

Please take action and call your state senator to encourage him or her to support A1286/S2750. There is information on the Harm Reduction Coalition's website to assist you in contacting your representatives. You can also help us show our state legislators that we have mobilized broad support for the measure by attending a rally in Albany on Tuesday, June 11.

Advocates, academics, medical professionals, legislators, policy experts, citizens, non-profit organizations, faith-based institutions, and others must work together to highlight and remedy the dire health consequences of Hepatitis C in our communities. We must have, as President Barack Obama has said so many times, all hands on deck.

Source

The Majority of Physicians that Treat Hepatitis C Virus (HCV) Have Begun “Warehousing” and Preparing Their HCV Patients for the Next Generation of HCV Treatments

Sixty Percent of Surveyed Physicians Agree That They Are Beginning To Warehouse HCV Patients Until New Interferon-Free Regimens Are Available, According to a Recently Published BioTrends Report

May 23, 2013 - Exton, Penn. – BioTrends Research Group, one of the world’s leading research and advisory firms for specialized biopharmaceutical issues, finds that, unaided, one in five surveyed gastroenterologists, hepatologists, and infectious disease specialists reported that in the past six months, they have begun warehousing patients (e.g., intentionally delaying treatment) in anticipation of the next generation of HCV treatments—notably more physicians than six months ago, when only 6 percent reported that they had begun warehousing patients.

Furthermore, only one in five physicians agrees that they are satisfied with currently available treatment options, underscoring the high unmet need for alternatives to treat chronic HCV infections. The trending analyses of physician-reported anticipated prescribing in TreatmentTrends®: Hepatitis C Virus (US), Wave 1 also finds that, for the first time in a year, surveyed physicians are expecting to treat a greater proportion of their genotype 1 (3 percent) and 2/3 (3 percent) patients in the next six months with regimens that are not currently available. Unaided responses from most physicians who expect to be using other treatments suggest they are expecting products in development, potentially interferon-free regimens, to be available for use in the next six months.

In aided physician responses, Gilead’s sofosbuvir and Janssen/Medivir’s simeprevir garnered the highest degree of familiarity for use in HCV treatment, followed closely by Bristol-Myers Squibb’s daclatasvir and asunaprevir. Additionally, 20 percent of the surveyed physicians believe that Gilead’s sofosbuvir is the most promising product in development, primarily due to its favorable tolerability, oral dosing, pan-genotypic activity, and its possibility to be utilized as an interferon-free regimen.

“The protease inhibitors, Vertex’s Incivek and Merck’s Victrelis, were very important advances in the management of HCV infections,” said BioTrends Research Group Associate Director, Lynn Price. “However, there is still a clear unmet need for alternative HCV therapies and the recent NDA filings for simeprevir and sofosbuvir have physicians hopeful for new treatment options that are highly efficacious and more tolerable than the currently available protease inhibitors.”

TreatmentTrends®: Hepatitis C Virus (US), Wave 1 is a report that covers the use of agents for the treatment of HCV infections. This bi-annual study focuses on current and future use of leading HCV treatment regimens, patient market share, perceived strengths and weaknesses of the key brands, barriers to broader usage, sales force performance, and perceived value of manufacturers’ patient assistance programs. In addition, this report assesses potential impact of regimens in development, including Abbott’s ABT-267, ABT-333, and ABT-450, Boehringer Ingelheim’s BI-207127 and faldaprevir, Bristol-Myers Squibb’s asunaprevir and daclatasvir, Janssen’s simeprevir, and Gilead’s sofosbuvir and ledipasvir. In the current wave of research, BioTrends surveyed 101 U.S. gastroenterologists, hepatologists, and infectious disease specialists in March 2013.

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 contact us at (610) 321-9400 or 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:

Lisa Osgood
Decision Resources Group
781-993-2606
losgood@dresourcesgroup.com

Source

Testing for HCV Infection

Morbidity & Mortality Weekly Report

Jane P. Getchell, DrPH, Kelly E. Wroblewski, MPH, Alfred DeMaria Jr, MD, Christine L. Bean, PhD, Monica M. Parker, PhD, Mark Pandori, PhD, D. Robert Dufour, MD, Michael P. Busch, MD, PhD, Mark E. Brecher, MD, William A. Meyer, PhD, Rick L. Pesano, MD, PhD, Chong-Gee Teo, MD, PhD, Geoffrey A. Beckett, MPH, Aufra C. Araujo, PhD, Bernard M. Branson, MD, Jan Drobeniuc, MD, PhD, Rikita Hatia, MPH, Scott D. Holmberg, MD, MPH, Saleem Kamili, PhD, John W. Ward, MD

Morbidity & Mortality Weekly Report. 2013;62(18):362-365.

Introduction

In the United States, an estimated 4.1 million persons have been infected with hepatitis C virus (HCV), of whom an estimated 3.2 (95% confidence interval [CI] = 2.7–3.9) million are living with the infection.^[1] New infections continue to be reported particularly among persons who inject drugs and persons exposed to HCV-contaminated blood in health-care settings with inadequate infection control.^[2]

Since 1998, CDC has recommended HCV testing for persons with risks for HCV infection.^[3] In 2003, CDC published guidelines for the laboratory testing and result reporting of antibody to HCV.^[4] In 2012, CDC amended testing recommendations to include one-time HCV testing for all persons born during 1945–1965 regardless of other risk factors.^[1]

CDC is issuing this update in guidance because of 1) changes in the availability of certain commercial HCV antibody tests, 2) evidence that many persons who are identified as reactive by an HCV antibody test might not subsequently be evaluated to determine if they have current HCV,^[5] and 3) significant advances in the development of antiviral agents with improved efficacy against HCV.^[6] Although previous guidance has focused on strategies to detect and confirm HCV antibody,^[3,4] reactive results from HCV antibody testing cannot distinguish between persons whose past HCV infection has resolved and those who are currently HCV infected. Persons with current infection who are not identified as currently infected will not receive appropriate preventive services, clinical evaluation, and medical treatment. Testing strategies must ensure the identification of those persons with current HCV infection.

This guidance was written by a workgroup convened by CDC and the Association of Public Health Laboratories (APHL), comprising experts from CDC, APHL, state and local public health departments, and academic and independent diagnostic testing laboratories, in consultation with experts from the Veterans Health Administration and the Food and Drug Administration (FDA). The workgroup reviewed laboratory capacities and practices relating to HCV testing, data presented at the CDC 2011 symposium on identification, screening and surveillance of HCV infection,^[7] and data from published scientific literature on HCV testing. Unpublished data from the American Red Cross on validation of HCV antibody testing also were reviewed.

Changes in HCV Testing Technologies

Since the 2003 guidance was published,^[4] there have been two developments with important implications for HCV testing:

1. Availability of a rapid test for HCV antibody. The OraQuick HCV Rapid Antibody Test (OraSure Technologies) is a rapid assay for the presumptive detection of HCV antibody in fingerstick capillary blood and venipuncture whole blood. Its sensitivity and specificity are similar to those of FDA–approved, laboratory-conducted HCV antibody assays.^[8] In 2011, a Clinical Laboratory Improvements Amendments waiver was granted to the test by FDA. The waiver provides wider testing access to persons at risk for HCV infection, permitting use of the assay in nontraditional settings such as physician offices, hospital emergency departments, health department clinics, and other freestanding counseling and testing sites.

2. Discontinuation of RIBA HCV. The Chiron RIBA HCV 3.0 Strip Immunoblot Assay (Novartis Vaccines and Diagnostics) that was recommended^[4] for supplemental testing of blood samples after initial HCV antibody testing is no longer available. As a result, the only other FDA-approved supplemental tests for HCV infection are those that detect HCV viremia.

Identifying Current HCV Infections

In 2011, FDA approved boceprevir (Victrelis, Merck & Co.) and telaprevir (Incivek, Vertex Pharmaceuticals) for treatment of chronic hepatitis C genotype 1 infection, in combination with pegylated interferon and ribavirin, in adult patients with compensated liver disease. Boceprevir and telaprevir interfere directly with HCV replication. Persons who complete treatment using either of these drugs combined with pegylated interferon and ribavirin are more likely to clear virus (i.e., have virologic cure), compared to those given standard therapy based on pegylated interferon and ribavirin.^[9] Viral clearance, when sustained, stops further spread of HCV and is associated with reduced risk for hepatocellular carcinoma^[10] and all-cause mortality.^[11] Other compounds under study in clinical trials hold promise for even more effective therapies.^[6]

Because antiviral treatment is intended for persons with current HCV infection, these persons need to be distinguished from persons whose infection has resolved. HCV RNA in blood, by nucleic acid testing (NAT), is a marker for HCV viremia and is detected only in persons who are currently infected. Persons with reactive results after HCV antibody testing should be evaluated for the presence of HCV RNA in their blood.

Benefits of Testing for Current HCV Infection

Accurate testing to identify current infection is important to 1) help clinicians and other providers correctly identify persons infected with HCV, so that preventive services, care and treatment can be offered; 2) notify tested persons of their infection status, enabling them to make informed decisions about medical care and options for HCV treatment, take measures to limit HCV-associated disease progression (e.g., avoidance or reduction of alcohol intake, and vaccination against hepatitis A and B), and minimize risk for transmitting HCV to others; and 3) inform persons who are not currently infected of their status and the fact that they are not infectious.

Recommended Testing Sequence

The testing sequence in this guidance is intended for use by primary care and public health providers seeking to implement CDC recommendations for HCV testing.^[1,3,4] In most cases, persons identified with HCV viremia have chronic HCV infection. This testing sequence is not intended for diagnosis of acute hepatitis C or clinical evaluation of persons receiving specialist medical care, for which specific guidance is available.^[12]

Testing for HCV infection begins with either a rapid or a laboratory-conducted assay for HCV antibody in blood (Figure). A nonreactive HCV antibody result indicates no HCV antibody detected. A reactive result indicates one of the following: 1) current HCV infection, 2) past HCV infection that has resolved, or 3) false positivity. A reactive result should be followed by NAT for HCV RNA. If HCV RNA is detected, that indicates current HCV infection. If HCV RNA is not detected, that indicates either past, resolved HCV infection, or false HCV antibody positivity.

Recommended testing sequence for identifying current hepatitis C virus (HCV) infection

* For persons who might have been exposed to HCV within the past 6 months, testing for HCV RNA or follow-up testing for HCV antibody is recommended. For persons who are immunocompromised, testing for HCV RNA can be considered.
^†To differentiate past, resolved HCV infection from biologic false positivity for HCV antibody, testing with another HCV antibody assay can be considered. Repeat HCV RNA testing if the person tested is suspected to have had HCV exposure within the past 6 months or has clinical evidence of HCV disease, or if there is concern regarding the handling or storage of the test specimen.

Initial Testing for HCV Antibody

An FDA-approved test for HCV antibody should be used. If the OraQuick HCV Rapid Antibody Test is used, the outcome is reported as reactive or nonreactive. If a laboratory-based assay is used, the outcome is reported as reactive or nonreactive without necessarily specifying signal-to-cutoff ratios.

Testing for HCV RNA

An FDA-approved NAT assay intended for detection of HCV RNA in serum or plasma from blood of at-risk patients who test reactive for HCV antibody should be used. There are several possible operational steps toward NAT after initial testing for HCV antibody:

1. Blood from a subsequent venipuncture is submitted for HCV NAT if the blood sample collected is reactive for HCV antibody during initial testing.

2. From a single venipuncture, two specimens are collected in separate tubes: one tube for initial HCV antibody testing; and a second tube for HCV NAT if the HCV antibody test is reactive.

3. The same sample of venipuncture blood used for initial HCV antibody testing, if reactive, is reflexed to HCV NAT without another blood draw for NAT.^[13]

4. A separate venipuncture blood sample is submitted for HCV NAT if the OraQuick HCV Rapid Antibody Test for initial testing of HCV antibody has used fingerstick blood.

Supplemental Testing for HCV Antibody

If testing is desired to distinguish between true positivity and biologic false positivity for HCV antibody, then, testing may be done with a second HCV antibody assay approved by FDA for diagnosis of HCV infection that is different from the assay used for initial antibody testing. HCV antibody assays vary according to their antigens, test platforms, and performance characteristics, so biologic false positivity is unlikely to be exhibited by more than one test when multiple tests are used on a single specimen.^[14]

Test Interpretation and Further Action

Table.  Interpretation of results of tests for hepatitis C virus (HCV) infection and further actions

Test outcome	Interpretation	Further action
HCV antibody nonreactive	No HCV antibody detected	Sample can be reported as nonreactive for HCV antibody. No further action required. If recent HCV exposure in person tested is suspected, test for HCV RNA.*
HCV antibody reactive	Presumptive HCV infection	A repeatedly reactive result is consistent with current HCV infection, or past HCV infection that has resolved, or biologic false positivity for HCV antibody. Test for HCV RNA to identify current infection.
HCV antibody reactive, HCV RNA detected	Current HCV infection	Provide person tested with appropriate counseling and link person tested to medical care and treatment.†
HCV antibody reactive, HCV RNA not detected	No current HCV infection	No further action required in most cases. If distinction between true positivity and biologic false positivity for HCV antibody is desired, and if sample is repeatedly reactive in the initial test, test with another HCV antibody assay. In certain situations§ follow up with HCV RNA testing and appropriate counseling.

* If HCV RNA testing is not feasible and person tested is not immunocompromised, do follow-up testing for HCV antibody to demonstrate seroconversion. If the person tested is immunocompromised, consider testing for HCV RNA.
^†It is recommended before initiating antiviral therapy to retest for HCV RNA in a subsequent blood sample to confirm HCV RNA positivity.
^§If the person tested is suspected of having HCV exposure within the past 6 months, or has clinical evidence of HCV disease, or if there is concern regarding the handling or storage of the test specimen.

Laboratory Reporting

"Acute hepatitis C" and "hepatitis C (past or present)" are nationally notifiable conditions, and are subject to mandated reporting to health departments by clinicians and laboratorians, as determined by local, state or territorial law and regulation. Surveillance case definitions are developed by the Council of State and Territorial Epidemiologists in collaboration with CDC.^[15] In all but a few jurisdictions, positive results from HCV antibody and HCV RNA testing that are indicative of acute, or past or present HCV infection, are reportable. Specific policies for laboratory reporting are found at health department websites.^[16]

Future Studies

Research, development, validation, and cost-effectiveness studies are ongoing to inform the best practices for detecting HCV viremia and for distinguishing between resolved HCV infection and biologic false positivity for HCV antibody in persons in whom HCV RNA is not detected. Outcomes of these studies will provide comprehensive guidance on testing, reporting, and clinical management, and will improve case definitions for disease notification and surveillance.

References

1. CDC. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945–1965. MMWR 2012;61(No. RR-4).

2. CDC. Viral hepatitis surveillance, United States, 2009–2011. Atlanta, GA: US Department of Health and Human Services, CDC; 2012. Available at http://www.cdc.gov/hepatitis/statistics/2010surveillance/index.htm.

3. CDC. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR 1998;47(No. RR–19).

4. CDC. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. MMWR 2003;52(No. RR–3).

5. CDC. Vital signs: evaluation of hepatitis C virus infection testing and reporting—eight U.S. sites, 2005–2011. MMWR 2013;62(18).

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

PRESS RELEASE

June 10, 2013, 9:30 a.m. EDT

NEW YORK, June 10, 2013 /PRNewswire via COMTEX/ -- The National Black Leadership Commission on AIDS, Inc. (NBLCA) is working in partnership with allied organizations to advocate for the passage of New York State Senate (S2750) and Assembly (A1286) bills to expand access to testing for the Hepatitis C virus (HCV), which has reached epidemic proportions in New York and the United States. The proposed legislation would require hospitals and health care practitioners to offer Hepatitis C screenings to all people born between 1945 and 1964--the "Baby Boomer" generation, which has been disproportionately affected by HCV. Advocates are organizing a rally in Albany on Tuesday, June 11, to urge passage of the bill.

According to the U.S. Centers for Disease Control and Prevention (CDC), more than 75 percent of the 3.2 million adults with HCV in the United States are Baby Boomers. Because there are often no noticeable symptoms, most of them don't know they are infected with the virus, and without treatment, they face a greatly increased risk of developing potentially life-threatening liver diseases, such as cirrhosis and liver cancer.

In New York State, Boomers have the highest HCV infection rate of any group. The NYS Department of Health estimates that more than 200,000 New Yorkers have the virus--60 percent of them in New York City--but 75 percent of them don't know their status. African Americans are two times as likely as non-Hispanic white people to be infected and are less likely to be tested and to receive treatment.

The Hepatitis C virus is transmitted by blood-to-blood contact. Since no vaccine for HCV is available, testing is crucial to prevent new infections. "By getting tested and determining their status, those at risk can get life-saving treatment and learn how to protect themselves against future infection," said NBLCA President and CEO C. Virginia Fields. "We need to educate and inform as many people as possible about this often invisible virus that has become a silent epidemic in the United States. We urge New Yorkers to contact their local and state elected officials to support passage of this critical state legislation that will expand access to testing and set an example for other communities throughout the nation."

For information about the June 11 Albany rally, call 212-614-0023 or email rarichards@nblca.org. For more about HCV or the proposed legislation, visit www.nblca.org and listen to the premiere of Health Action Radio, hosted by NBLCA on WWRL-AM 1600, featuring C. Virginia Fields and experts on medical issues and policies related to HCV.

Media Contact:

Teri Wade, 212-595-4047, teri@missionandmessage.com 

SOURCE National Black Leadership Commission on AIDS, Inc.

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Partial Livers from Deceased Donors Saving the Lives of Infants

Press Release

June 10, 2013

New research reveals that transplantation of partial livers from deceased adult and teen donors has become less risky for infants and young children, helping to save these young lives. Findings published online in Liver Transplantation, a journal of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, indicate that risk of organ failure and mortality from partial or split liver transplant was comparable to whole organ transplant in this pediatric population.

Available livers for transplantation are in short supply, particularly size-matched organs for the youngest patient on the waitlist. While there is evidence that partial organs donated from living donors are superior to those from deceased donors, they accounted for less than 11% of pediatric liver transplants in 2010. Since 2002, studies show an eight-fold increase in the use of partial grafts from deceased donors, accounting for up to 32% of liver transplants in children.

“Infants and young children have the highest waitlist mortality rates among all candidates for liver transplant,” explains senior author Dr. Heung Bae Kim, Director of the Pediatric Transplant Center at Boston Children’s Hospital in Massachusetts. “Extended time on the liver transplant waitlist also places children at greater risk for long-term health issues and growth delays, which is why it is so important to look for methods that shorten the waitlist time to reduce mortality and improve quality of life for pediatric patients.”

To further understand outcomes of using deceased donor partial livers in infants, the team identified 2,679 liver transplant recipients under the age of two in the United Network of Organ Sharing (UNOS) database from 1995-2010. There were 1,114 partial livers and 1,565 whole organs from deceased donors that were used in the transplants analyzed. They examined mortality and graft survival over time.

Graft survival between partial and whole grafts were significantly different in 1995-2000, but comparable in 2001-2005 and 2006-2010, suggesting that transplants using partial livers became less risky over time. Adjusted risk of graft failure and mortality was similar for partial and whole organs in 2006-2010.

“Infants continue to have twice the mortality rate of adult candidates on the waitlist,” concludes Dr. Kim. “Our study confirms that organ failure and mortality risk in the very young was similar for partial and whole organs from deceased donors. The transplant community must continue to look for ways to reduce mortality rates in pediatric patients and using partial livers from deceased, as well as living donors, may hold the key.”

Full citation: “Deceased Donor Liver Transplantation in Infants and Small Children: Are Partial Grafts Riskier Than Whole Organs?” Ryan P. Cauley, Khashayar Vakili, Kristina Potanos, Nora Fullington, Dionne A. Graham, Jonathan A. Finkelstein and Heung Bae Kim. Liver Transplantation; (DOI: 10.1002/lt.23667) Online Publication: May 21, 2013.
URL: http://doi.wiley.com/10.1022/lt.23667

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