Ryan White Program Addressing Coinfection with Viral Hepatitis

May 2, 2013 • 0 comments • By Rupali K. Doshi, MD, MS, Medical Officer, HIV/AIDS Bureau, Health Resources and Services Administration, U.S. Department of Health and Human Services and Laura W. Cheever, MD, ScM, Acting Associate Administrator, HIV/AIDS Bureau, Health Resources and Services Administration, U.S. Department of Health and Human Services

For many years the Health Resources and Services Administration’s (HRSA) HIV/AIDS Bureau (HAB) has worked to increase access to hepatitis C treatment for HIV-infected patients in Ryan White-funded programs.

This attention is warranted given that, according to the Action Plan for the Prevention, Care and Treatment of Viral Hepatitis, an estimated 33% of persons living with HIV are coinfected with the hepatitis B virus (HBV) or hepatitis C virus (HCV). Further, the progression of viral hepatitis is accelerated among persons with HIV; therefore, persons who are coinfected with HIV and HCV experience greater liver-related health problems than non-HIV infected persons. The CDC also notes that while “antiretroviral therapy has extended the life expectancy of people living with HIV (PLWH), liver disease—much of which is related to hepatitis B and C infection—has become the leading cause of non-AIDS-related deaths among this population.”

Hepatitis C Treatment Expansion Initiative

One important initiative is the Hepatitis C Treatment Expansion Initiative. Funded by HRSA/HAB as a Special Project of National Significance (SPNS), this initiative supports two groups of Ryan White program grantees that have received $80,000 per year for two years to test a new model of integrating hepatitis C treatment into their clinical practice. The overall goal of the initiative is to enable sites to increase the number of co-infected patients treated for hepatitis C.

Among the presentations at the most recent Ryan White HIV/AIDS Program Grantee Meeting (November 27-29, 2012) were several by participants in this initiative, including AIDS Care Group [downloadable Powerpoint presentation] of Chester, Pennsylvania, and Siouxland Community Health Center [downloadable Powerpoint presentation] of Sioux City, Iowa. They shared their rationales for integrating HCV treatment into their practices, highlighted steps they took to develop and begin delivering these services, discussed clinical issues about HCV treatment, and shared lessons learned.

The University of South Florida, which has a cooperative agreement to serve as the training and evaluation center for this SPNS initiative, also presented at the grantee meeting. Their presentation, “Implementing HCV Treatment Programs in Comprehensive HIV Clinics,” [downloadable Powerpoint presentation] provided an overview of HCV and HIV coinfection, addressed elements of a successful HIV/HCV program, and highlighted four models of care delivery being used by the SPNS grantees:

• Primary care delivery with expert back-up
• Integrated care without a designated HCV clinic (expert consultation used for severe complications)
• Integrated care with a designated internal HCV clinic
• Co-located care with specialist who manages treatment at Ryan White clinical site

Outcomes to be measured across all sites include the number of HIV/HCV co-infected patients treated or not treated for hepatitis C, barriers to treatment, sustained virologic response, services utilization, and cost; grantees are also encouraged to conduct projects designed to investigate local issues that affect HCV treatment in their populations.

Project ECHO™ Adapted by Ryan White Grantees

Project ECHO™ (Extension for Community Healthcare Outcomes) is a telehealth program developed by the University of New Mexico to increase access to specialty care for individuals living with hepatitis C, HIV, addiction, chronic pain, complex diseases, rheumatologic disorders, and terminal illness, among others. Several Ryan White grantees are among the organizations around the country that have adopted Project ECHO™ to improve access to specialty medical care.

For example, Community Health Center, Inc., of Connecticut (CHCI) launched a telemedicine model in January 2012 to expand hepatitis C and HIV treatment throughout its entire network of health centers. Each remote site has a local champion who gets CME (continuing medical education) credits and training experience in hepatitis C and HIV by participating in weekly calls with the central expert team via videoconference technology. CHCI shared that some of the challenges in implementing this telehealth model have been primary care providers lacking sufficient time to invest in weekly calls, lack of expertise in hepatitis C or HIV care, high turnover rate of providers, and patient trust in the model. However, several mid-level providers (nurse practitioners and physician assistants) have become the “ECHO-ist” for their clinical site and have proven to be a committed group of providers, particularly around hepatitis C care and treatment.

In addition to clinical collaboration, Project ECHO™ and AIDS Education and Training Centers (AETCs) are working together to increase access to hepatitis C care and treatment. The Northwest AETC, managed out of the University of Washington, launched an ECHO™ program in 2009, which now supports expanded care for hepatitis C, HIV, addiction, pain, and complex diseases for individuals living in Washington, Alaska, Idaho, Oregon, and Montana. There are 20-25 active clinical sites that review 15-18 cases of hepatitis C on a weekly basis. Since its inception, about 400 hepatitis C patients have been reviewed by the expert team. Qualitative data suggests that participants enjoy project ECHO, and clinical outcomes have been similar to the existing literature.

One clinical site working with the Northwest AETC is Idaho State University’s (ISU) Department of Family Medicine, which is also a recipient of the SPNS Hepatitis C grant. ISU has expanded its provider education around hepatitis C and increased the numbers of patients treated. Of the 120 HIV+ patients at ISU, 20 are HCV antibody positive. Since beginning their treatment program, 6 patients have completed treatment (5 sustained virologic response, 1 relapse), and 4 others are currently on therapy. They are now planning to launch expanded hepatitis C screening based on the revised CDC recommendations, which call for a one-time HCV test for all “baby boomers.”

These are just a few of examples of approaches underway across the Ryan White HIV Program to address viral hepatitis. As we continue our efforts to deliver high quality HIV care to clients and collaborate with federal colleagues to implement the Viral Hepatitis Action Plan, we will continue to share information about successful approaches that can be adapted by others both in and beyond the Ryan White network.

HAB colleagues Adan Cajina, MPH; Diana Travieso Palow, MPH, MS, RN; Tracy Matthews, MHA, RN; Marlene Matosky, MPH, RN, and the Ryan White grantees mentioned in the article also contributed to this post.

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MSD recognizes UAE charities for their contributions to Hepatitis C patients

United Arab Emirates: 5 hours, 47 minutes ago

As part of their ongoing commitment to providing greater access to treatment and in their continued efforts to raise awareness of the growing prevalence of hepatitis C (HCV) in the UAE, MSD hosted an event to recognize the outstanding contributions of local charities in raising awareness and supporting UAE citizens with HCV in getting access to treatment.

The event which brought together over 25 representatives, from some of the UAE's largest charities, NGO's and support groups; focused on how to raise greater awareness of the risks of this virus and the best ways to manage and treat the disease.

Major charities who attended the event included, Red Crescent, Rahma Charity, Dar El Ber, Sharjah Charity Foundation, Dubai Charity Foundation, Sakr Bin Hamad El Qasimi, Fujirah Charity Foundation, RAK Charity, Al Ihsan Medical Centre, Patients' Friends' Committee, Human Appeal Association, Zakat Fund and Khalifa Bin Zayed Al Nahyan Charity.

As part of the event, MSD awarded several of these charities in recognition of their phenomenal contributions and achievements to supporting greater awareness of hepatitis C and providing new hope for the growing number of HCV citizens in the UAE.

Talking about their decision to host the event and commenting on the important role these charities play in the UAE, Mr. Mazen Altaruti, Managing Director of MSD in the Gulf, said, "Hepatitis C is one of the most serious and dangerous viruses affecting patients in the Middle East, with estimates that over 800,000 people in the Eastern Mediterranean Region are newly diagnosed with hepatitis C each year. In the UAE, the prevalence is particularly high, with studies suggesting that as many as 14 out of every 100,000 suffers from hepatitis C. In Abu Dhabi, where incidence rates are the highest, it is estimated that as much as 23 out of every 100,000 people may suffer from the virus. Hepatitis C places a severe financial and emotional burden on both the state and UAE citizens who face the disease. To be able to host an event such as this one where we can truly recognize the tireless efforts of local organizations, who support HCV patients, who continue to work on campaigns to raise awareness of the danger so of this disease, so that lives can be saved and UAE citizens can live long and healthy lives is truly an honor. So often these organizations work behind the scenes supporting UAE patients and their families through the most difficult times in their life without ever expecting anything in return. These people and charities are truly the unsung heroes of UAE society and recognizing them here today, is just a small way in which we can honor their outstanding contributions to our local community."

Adding to Altaruti's comments, Dr. Maryam El Khatry, who chaired the event, and is a Consultant Gastroenterologist at the Seif Hospital in Ras Khaima, as well as the Head of Emirates Gastroenterology Society, said, "One of the greatest dangers of hepatitis C, is that the disease is often very difficult to diagnose, particularly in the early stages when the virus is often symptomatic. It is for this reason that many UAE citizens are already suffering from chronic hepatitis C by the time they are diagnosed. In fact according to the latest research as many as 69,000 UAE citizens may suffer from chronic hepatitis already.¹ Raising awareness of this silent killer is crucial if we are to truly start addressing the growing prevalence of this disease and the inevitable complications, such as liver disease and in many cases liver failure, that the virus eventually causes."

"We are extremely pleased to be here today and have a chance to recognize both our colleagues and peers for the important work they continue to do, to raise awareness of the growing prevalence of hepatitis C in the UAE. Today is a great opportunity for us to all come together to discuss the ways in which we can create greater awareness of this virus and provide more support and access to treatment for these patients. It is important that we bring the needs of hepatitis C patients into focus if we are to prevent this virus from becoming an epidemic in the country. We hope that we will continue to receive support from the local community so we ensure that our charities and others like us are able to succeed in preventing the serious complications that hepatitis C can lead to if left untreated," said Mohamed Soliman Albloushy, Manager of Zakat Affairs Department.

Hepatitis C already places a substantial financial burden upon patients, local communities and the UAE economy at large, with estimates suggest that to treat just one UAE patient with current standard treatment of peginterferon alfa and ribavirin could cost as much as Dhs80,000 per year.

An additional Dhs100,000 is also spent to treat chronic liver disease and the complications it results in. The work of local charities and NGO's in the UAE who work to raise awareness of this disease and support access to treatment is crucial to reducing the prevalence of this disease and the financial burden that comes with it.

In Treatment-Naive Hepatitis C Virus, Thought Leaders' Opinions and Clinical Data Indicate That Sofosbuvir plus Ledipasvir plus Ribavirin Has Advantages Over Current Therapies

An All-Oral/Interferon-Free Regimen is One of the Great Unmet Needs in Treatment-Naive HCV, According to a New Report from Decision Resources

BURLINGTON, Mass., May 2, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed gastroenterologists in the United States and Europe agree that the percentage of genotype-1 hepatitis C virus (HCV) patients achieving a sustained virological response (SVR) is one of the attributes that most influences their prescribing decisions. Clinical data and interviewed thought leaders indicate that Gilead's interferon-free regimen of the nucleoside polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir plus ribavirin has advantages over the current sales-leading regimen on efficacy, safety and delivery attributes. For the treatment of HCV, the current sales-leading regimen is telaprevir (Vertex's Incivek, Johnson & Johnson's Incivo, Mitsubishi Tanabe Pharma's Telavic) in combination with peg-IFN-alpha (Roche's Pegasys or Roche/Merck's PegIntron) and ribavirin (Roche's Copegus, Merck's Rebetol, generics).

(Logo: http://photos.prnewswire.com/prnh/20130103/MM36784LOGO)

The Decision Base report entitled Substantial Opportunity and Fierce Competition Await Developers of Interferon-Free Therapies for Treatment-Naive Patients also finds that surveyed U.S. and European gastroenterologists and managed care organization (MCO) pharmacy directors consider an all-oral/interferon-free regimen is one of the greatest unmet needs in treatment-naive HCV. Clinical data and thought leader opinion indicate that several emerging regimens from developers such as Gilead (sofosbuvir plus lepidasvir plus ribavirin), AbbVie (ritonavir-boosted ABT450 plus ABT-333 plus ABT-267 plus ribavirin) and Boehringer-Ingelheim (faldaprevir plus BI-207127 plus ribavirin) have demonstrated the potential to fulfill this unmet need.

The report also finds that surveyed MCO pharmacy directors would reimburse a new HCV regimen that is ribavirin-free and interferon-free if it achieved a SVR rate that is up to 10 percent lower than a comparably priced regimen that is free of interferon but not of ribavirin. This finding suggests that emerging regimens that dispense with both ribavirin and interferon will face a somewhat less-stringent reimbursement review and/or receive more-favorable formulary status.

"Although U.S. gastroenterologists cited improved SVR in the absence of ribavirin as an area of high unmet need, they do not assign high weight to this attribute in making treatment decisions," said Decision Resources Analyst Seamus Levine-Wilkinson , Ph.D. "The low weight of this attribute is likely due to the current lack of highly efficacious ribavirin-free antiviral therapies for HCV infection. The high unmet need and lack of current treatment options indicates that this is an important area of differentiation that Bristol-Myers Squibb is seeking to capitalize on with their interferon- and ribavirin-free regimen of daclatasvir plus asunaprevir plus BMS-791325."

About Decision Resources
Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources 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 or registered trademarks of their respective holders.

SOURCE Decision Resources

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Also See: Gilead Reports Interim Data From Phase 2 LONESTAR Study

Gilead Reports Interim Data From Phase 2 LONESTAR Study

-- Company Plans to Initiate Phase 3 Study Evaluating Eight and 12 Weeks of Therapy with Sofosbuvir and Ledipasvir for the Treatment of Chronic Hepatitis C --

FOSTER CITY, Calif.--(BUSINESS WIRE)--May. 2, 2013-- Gilead Sciences (Nasdaq: GILD) today announced plans to initiate a third Phase 3 clinical trial of the company’s investigational fixed-dose combination tablet of sofosbuvir and ledipasvir for the treatment of chronic hepatitis C virus (HCV) infection. The study, called ION-3, will evaluate the once-daily fixed-dose combination of sofosbuvir and ledipasvir for eight weeks with and without ribavirin (RBV) and for 12 weeks without RBV in 600 non-cirrhotic, treatment-naïve genotype 1 HCV-infected patients.

The design of ION-3 was based on interim results from the Phase 2 LONESTAR study, which evaluated eight- and 12-week courses of therapy with the once-daily fixed-dose combination of sofosbuvir and ledipasvir with and without RBV in 60 treatment-naïve, non-cirrhotic patients.

In this study, 19/19 patients in the 12-week arm had a sustained virologic response four weeks after completing therapy (SVR4) and 40/41 in the eight-week arms had a sustained virologic response eight weeks after stopping therapy (SVR8), with one relapse occurring in the arm receiving sofosbuvir/ledipasvir without RBV.

Two additional cohorts in the LONESTAR study evaluated a 12-week course of the fixed-dose combination of sofosbuvir and ledipasvir with or without RBV in 40 patients who had previously failed therapy with an HCV-specific protease inhibitor-based regimen. Half of these treatment-experienced patients have documented, compensated cirrhosis. Ninety-five percent of patients in both arms achieved SVR4, one cirrhotic patient in the sofosbuvir and ledipasvir arm relapsed and one patient in the sofosbuvir and ledipasvir plus RBV arm was lost to follow-up.

Interim results from LONESTAR are summarized in the table below. Further details from this study will be presented at a future scientific meeting.

 

Treatment		Treatment Duration		Population		Results
Sofosbuvir + ledipasvir		8 weeks		GT 1 treatment-naïve		95% (19/20) SVR 8
Sofosbuvir + ledipasvir + RBV		8 weeks		GT 1 treatment-naïve		100% (21/21) SVR 8
Sofosbuvir + ledipasvir		12 weeks		GT 1 treatment-naïve		100% (19/19) SVR 4
Sofosbuvir + ledipasvir		12 weeks		GT 1 treatment-experienced		95% (18/19) SVR 4
Sofosbuvir + ledipasvir + RBV		12 weeks		GT 1 treatment-experienced		95% (20/21) SVR 4

“The LONESTAR results suggest that once-daily all-oral therapy with the nucleotide NS5B inhibitor sofosbuvir and the NS5A inhibitor ledipasvir may have the potential to cure most genotype 1 HCV infected patients with a remarkably short treatment duration,” said Eric Lawitz, MD, President and Medical Director, The Texas Liver Institute, University of Texas Health Science Center, San Antonio, and Principal Investigator for the LONESTAR study.

Both sofosbuvir in combination with ledipasvir, and sofosbuvir in combination with ledipasvir and RBV were well tolerated in the LONESTAR study.

“Based upon the encouraging data derived from LONESTAR, we are continuing to advance our research evaluating new drug combinations and shorter durations of all-oral therapy that have the potential to simplify treatment for those living with hepatitis C,” commented Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer at Gilead Sciences.

About ION-3

ION-3 is a randomized, open label Phase 3 clinical trial evaluating the efficacy and safety of sofosbuvir and ledipasvir for the treatment of chronic HCV in non-cirrhotic, treatment-naïve genotype 1 infected patients. Participants will be randomized to receive sofosbuvir and ledipasvir for eight weeks (n=200), sofosbuvir and ledipasvir plus RBV for eight weeks (n=200), or sofosbuvir and ledipasvir for 12 weeks (n=200). The primary endpoint of the study is SVR12, defined as maintaining undetectable HCV RNA 12 weeks post-treatment and considered a cure for HCV infection. The study is designed to assess non-inferiority of the eight-week treatment duration arms to the 12-week treatment duration arm.

Two other ongoing Phase 3 studies are examining all-oral HCV therapy with sofosbuvir and ledipasvir. ION-1 and ION-2 are testing 12- and 24-week courses of the fixed-dose combination with and without RBV among treatment-naïve and treatment-experienced genotype 1 HCV patients, including those with compensated cirrhosis. Based on the results of the LONESTAR trial, Gilead has amended ION-2 to shorten the duration of therapy in one of the two fixed-dose combination arms without RBV from 24 to 12 weeks.

Additional information about ION-1, ION-2, ION-3 and LONESTAR can be found at www.clinicaltrials.gov.

Sofosbuvir, ledipasvir and the fixed-dose combination tablet are investigational products and their safety and efficacy have not yet been established.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from the clinical studies evaluating sofosbuvir and the sofosbuvir and ledipasvir fixed-dose combination, including from the ION-1, ION-2 and ION-3 and LONESTAR studies. Gilead also faces risks related to its ability to enroll patients in the ION-3 study, the need to modify or delay the study and the risk of failing to obtain approval of sofosbuvir and/or the sofosbuvir and ledipasvir fixed-dose combination from regulatory authorities. As a result, sofosbuvir and the sofosbuvir and ledipasvir fixed-dose combination may never be successfully commercialized. In addition, Gilead may make a strategic decision to discontinue development of these products if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2012, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-80-GILEAD-5 or 1-650-574-3000.

Source: Gilead Sciences

Gilead Sciences
Patrick O’Brien, 650-522-1936 (Investors)
Amy Flood, 650-522-5643 (Media)

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Beta-blockers reduced bacterial translocation, improved intestinal permeability in cirrhotic patients

May 1, 2013

Patients with cirrhosis treated with beta-blockers experienced improved intestinal permeability and reduced bacterial translocation, reducing the risk for variceal bleeding, in a study presented at The International Liver Congress in Amsterdam.

In a study of 50 patients with cirrhosis, participants’ portal pressure, gastroduodenal and intestinal permeability and LPS-binding protein (LBP) and interleukin-6 (IL-6) levels were measured before and after treatment with nonselective beta-blockers (NSBB). Rates of bleeding and mortality were determined during follow-up.

Severe portal hypertension, defined as hepatic venous pressure gradient (HPVG) of 20 mmHg or greater, was observed in 35 cases. These patients had significantly higher urine sucrose levels (P=.049), sucrose/mannitol ratios (P=.007) and intestinal permeability indices (P=.002), as well as increased LBP (P=.002) and IL-6 levels (P=.025) compared with those with an HPVG less than 20 mmHg. Patients treated with NSBB experienced significant reductions to HVPG, LBP (–16%; P=.018) and IL-6 (–41%; P<.0001).

Those with abnormal gastroduodenal or intestinal permeability, as indicated by sucrose-lactulose-mannitol test results, trended toward increased incidence of variceal bleeding (P=.066 for gastroduodenal and P=.084 for intestinal permeability), as did those with elevated LBP (P=.18) and/or IL-6 (P=.038). Despite the increased incidence rate, none of these conditions was associated with increased mortality (P=.87 for gastroduodenal and P=.994 for intestinal permeability, P=.571 for elevated LBP and P=.594 for elevated IL-6).

“Beta-blockers have been successfully used … as a standard treatment to control blood pressure in other disease areas,” Mauro Bernardi, MD, treasurer of the EASL, said in a press release. “In cirrhosis, they have been used for decades for primary and secondary prophylaxis of bleeding from esophageal varices. The results of this study show that besides improving portal hypertension … their beneficial effects are also due to their ability to reduce bacterial translocation, which may widen the indication for the use of these drugs in this setting.”

For more information:

Reiberger T. #84: Improvement of Intestinal Permeability and Reducing Bacterial Translocation by Betablocker Treatment is Associated with a Lower Risk of Variceal Bleeding. Presented at: the International Liver Congress 2013; April 24-28, Amsterdam.

Source

Probiotics Cut Risk for Hepatic Encephalopathy in Half

Daniel M. Keller, PhD

May 01, 2013

AMSTERDAM, the Netherlands — Probiotics were effective in helping to prevent a first episode of overt hepatic encephalopathy in patients with cirrhosis, compared with patients not receiving probiotics, according to a new study.

"The patients in the control group had 2 times the chance of developing overt hepatic encephalopathy in the follow-up period," lead author Manish Lunia, MD, from the G.B. Pant Hospital in New Delhi, India, told delegates here at the International Liver Congress 2013.

It is estimated that hepatic encephalopathy occurs in 30% to 45% of patients with cirrhosis, and the mortality rate is 20% to 30%. Because bacterial overgrowth in the small intestine leads to endotoxemia, the researchers reasoned that probiotics could prevent the condition.

For their open-label, prospective, randomized trial, they enrolled patients 18 to 80 years of age with cirrhosis and no history of overt hepatic encephalopathy. A battery of psychometric tests, the critical flicker frequency test, and the psychometric hepatic encephalopathy score were used to diagnose encephalopathy. Glucose hydrogen breath tests were used to identify small intestinal bacterial overgrowth and lactulose hydrogen breath tests were used to identify orocecal transit time.

Study participants were randomly assigned to the probiotic group (n = 86) or the control group (n = 74). The researchers used the commercially available VSL#3, which is a mixture of nonurease-producing organisms: Streptococcus thermophilus and various species of Bifidobacterium and Lactobacillus (110 billion colony-forming units, 3 times daily).

There were no significant differences between the probiotic and control groups in terms of baseline age (about 44 to 47 years), sex, cause of cirrhosis, proportion of Child–Turcotte–Pugh classes, and model for end-stage liver disease (MELD) score. The groups also did not differ in various baseline laboratory parameters, such as small intestinal bacterial overgrowth (38.4% vs 35.1%) and the proportion of patients with minimal hepatic encephalopathy, defined as a psychometric hepatic encephalopathy score of 5 or lower (48.8% and 44.6%).

Patients were followed monthly for signs of overt hepatic encephalopathy or death (mean follow-up time, 38 to 40 weeks). Every 3 months, they underwent psychometric, arterial ammonia level, critical flicker frequency, glucose hydrogen, and lactulose hydrogen breath tests. Six probiotic patients and 5 control subjects were lost to follow-up.

More patients in the probiotic group than in the control group developed overt hepatic encephalopathy (8.8% vs 20.3%). Kaplan–Meier analysis revealed a hazard ratio for developing overt hepatic encephalopathy of 2.1 (95% confidence interval, 1.31 - 6.53; P < .05). There were fewer deaths in the probiotic group than in the control group (7.5% vs 11.5%).

A significantly greater proportion of patients with Child class B and C cirrhosis than with class A cirrhosis developed overt hepatic encephalopathy, but patients with Child class A and Child class B did not differ from each other (P = .36).

Table. Child Class Effect on Development of Hepatic Encephalopathy

Child Class of Cirrhosis	Proportion, %	P value (vs class A)
A	8.3	—
B	13.0	<.05
C	16.5	<.01

In the probiotic group, there were significant improvements from baseline to 3 months in arterial ammonia (P = .04), small intestinal bacterial overgrowth (P = .006), orocecal transit time (P = .05), psychometric hepatic encephalopathy score (P = .01), critical flicker frequency test (P = .02), and minimal hepatic encephalopathy (P = .001). In the control group, there were no significant differences from baseline in any of these parameters.

Factors significantly associated with the development of overt hepatic encephalopathy were minimal hepatic encephalopathy (adjust odds ratio [aOR], 3.1), Child–Turcotte–Pugh score (aOR, 1.6), small intestinal bacterial overgrowth (aOR, 2.1), and critical flicker frequency (aOR, 1.44).

Dr. Lunia reported that 5 patients with minimal hepatic encephalopathy or 31 patients without minimal hepatic encephalopathy would need to be treated to prevent 1 case of overt hepatic encephalopathy.

This study involved patients with a low level of hepatic encephalopathy at worst, and was therefore for prevention, not treatment, session moderator Isabelle Colle, MD, from Gent University in Belgium, who was not involved with the study, told Medscape Medical News. She explained that the use of probiotics is "certainly not" standard for such patients at this point.

She also questioned whether the use of probiotics in these patients is completely benign. "The gut permeability...is increased, so you can imagine that these bacteria can go through the intestine and cause bacterial translocation.... Do you see infections with this treatment?" she asked. It was a short study, and Dr. Lunia did not present any data on infections, Dr. Colle pointed out.

Dr. Lunia and Dr. Colle have disclosed no relevant financial relationships.

International Liver Congress 2013: 48th Annual Meeting of the European Association for the Study of the Liver (EASL). Abstract 78. Presented April 26, 2013.

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Combination Drugs are the Future of the European Hepatitis B and C Therapeutics Markets, Says Frost & Sullivan

Benefits include improved drug efficiency, reduced pill burden, and lower dosage frequency

LONDON, May 1, 2013 /PRNewswire/ -- The limited efficacy and negative side-effects associated with current therapeutics for Hepatitis B and C are highlighting the urgent need for new, improved alternatives. Combination therapies offering better clinical outcomes are coming to the fore and look set to transform the European market for Hepatitis B and C.

New analysis from Frost & Sullivan (http://www.lifesciences.frost.com), Analysis of European Hepatitis B and C Therapeutics Markets, finds that the Hepatitis B market earned revenues of $1.26 billion in 2012 and estimates this to reach $1.89 billion in 2019, while the Hepatitis C market is projected to expand from $2.40 billion to $3.66 billion over the same time period. The therapeutic segments covered include interferons and nucleoside analogues for Hepatitis B, and Standard of Care (Peginterferon alfa and Ribavirin) and protease inhibitors for Hepatitis C.

The side-effects associated with interferon-based therapeutics – such as fever, headache, fatigue, muscle and joint pain, shivering, and the ineffective response to Hepatitis C Virus (HCV) genotype 1 patients – are motivating the development of combination therapies.

"Improved drug efficiency, reduced pill burden and lower dosage frequency are among the common advantages related to the use of combination drugs," notes Frost & Sullivan Healthcare Research Analyst Deepika Pramod Chopda . "For instance, the combined use of interferon and interferon-free treatments is expected to yield positive results among infected patients; ribavirin-long acting interferons combination is estimated to boost the therapeutic success rate by over 50-60%."

The market is responding swiftly to the demand for improved therapeutic offerings. There has been an increase in new classes of compounds such as protease inhibitors, NS5a inhibitors, and nucleotide polymerase inhibitors for interferon-free treatment of HCV and Hepatitis B Virus (HBV).

At the same time, wider access to personalised medical treatment is encouraging the uptake of novel, improved therapeutics. The availability of drugs that target viral hepatitis infections according to distinct genetic strains is promoting market development.

HBV and HCV are prevalent among illegal drug users and migrant populations across Europe. However, low awareness means that many affected patients remain untreated.

"Wider access to national counselling programmes and enhancing awareness among high-risk populations such as drug users, infected mothers, and migrants is critical," concludes Chopda. "Such initiatives, together with free screening and reduced treatment costs, will help limit the incidence and impact of Hepatitis B and C."

If you are interested in more information on this research, please send an email to Anna Zanchi , Corporate Communications, at anna.zanchi@frost.com

Analysis of the European Hepatitis B and C Therapeutics Market is part of the Life Sciences Growth Partnership Service programme. Frost & Sullivan's related research services include: European HIV Drugs Market, European Hepatitis B and C Diagnostics Market, U.S. Hepatitis C Market, and U.S HIV/AIDS Therapies Market. All research included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants.

About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today's market participants.

Our "Growth Partnership" supports clients by addressing these opportunities and incorporating two key elements driving visionary innovation: The Integrated Value Proposition and The Partnership Infrastructure.

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Addition of simeprevir to peginterferon/ribavirin improves SVR rate among HCV patients

May 1, 2013

Simeprevir improves rates of sustained virologic response and may allow for a 24-week treatment duration when added to interferon-based therapy for chronic hepatitis C, according to data presented at the International Liver Congress in Amsterdam.

In the double blind, phase 3 QUEST-1 study, researchers randomly assigned 394 treatment-naive patients with HCV genotype 1 to either 150 mg oral HCV NS3/4A protease inhibitor simeprevir or placebo, for 12 weeks, plus 48 weeks of pegylated interferon alfa-2a with ribavirin (PR). Patients with HCV RNA below 25 IU/mL after 4 weeks of treatment and undetectable RNA at 12 weeks stopped treatment at 24 weeks. All placebo recipients received 48 weeks of PR therapy.

Rapid virologic response occurred in 80% of simeprevir recipients and 12% of the placebo group. Sustained virologic response at 12 weeks after treatment was achieved by 80% of the simeprevir group and 50% of placebo recipients (P<.001). Most simeprevir recipients (85%) stopped treatment at 24 weeks. Patients treated with simeprevir experienced less on-treatment failure (9% vs. 34% of cases) and less relapse (9% vs. 21%).

Similar results were observed in the QUEST-2 study, in which researchers randomly assigned 391 treatment-naive patients to simeprevir or placebo in addition to therapy with peginterferon alfa-2a or alfa-2b with ribavirin. In this trial, RVR occurred in 79% of simeprevir recipients and 13% of the placebo group, and SVR at 12 weeks occurred in 81% of the simeprevir group and 50% of placebo recipients (P<.001). Most patients in the simeprevir group (91%) were able to stop therapy after 24 weeks. Rates of on-treatment failure (7% vs. 32%) and relapse (13% vs. 24%) also were lower among simeprevir recipients.

In QUEST-1, commonly reported adverse events included headache, fatigue and pruritus, with 3% of simeprevir recipients discontinuing treatment due to adverse events. Common events in the QUEST-2 trial included headache, fatigue, pruritus and flu-like illness, with similar incidence rates of adverse events regardless of the type of peginterferon administered.

“Simeprevir 150 mg QD was well tolerated, leading to a high SVR 12 rate … when administered with either [peginterferon alfa-2a or -2b],” the researchers wrote. “The majority of patients receiving simeprevir [were] able to shorten therapy to 24 weeks.”

For more information:

Jacobson I. #1425: Simeprevir (TMC435) With Peginterferon/Ribavirin for Chronic HCV Genotype-1 Infection in Treatment-Naive Patients: Results from QUEST-1, a Phase III Trial. Presented at: The International Liver Congress 2013; April 24-28, Amsterdam.

Manns M. #1413: Simeprevir (TMC435) With Peginterferon/Ribavirin for Treatment of Chronic HCV Genotype-1 Infection in Treatment-Naive Patients: Results from QUEST-2, a Phase III Trial. Presented at: The International Liver Congress 2013; April 24-28, Amsterdam.

Source

Alicia Keys launching HIV campaign aimed at women

By Saundra Young, CNN

updated 12:03 PM EDT, Wed May 1, 2013

"We can't act like it's not happening," Alicia Keys says of HIV. "We have to make sure we know that we're all at risk."

(CNN) -- You know her best as a multi-platinum recording artist and a 14-time Grammy award-winning singer, songwriter and producer.

But Alicia Keys has also made quite a name for herself as a philanthropist and AIDS advocate.

It was in 2003, on her first trip to Africa, when Keys witnessed firsthand the disease's devastation.

When she returned to the United States, she co-founded "Keep a Child Alive," an organization that has raised millions to care for HIV/AIDS patients in Africa and India.

"So, as I've grown, you know, I think one of the things that I've realized is that there are not the headlines about the AIDS pandemic here in America that there should be, and it is shocking, and it is unacceptable," Keys told CNN last month.

CDC: Half of young people with HIV don't know it

"Yet we're not speaking about it, and so that's what's kind of brought me around to really becoming a part of what I like to say, 'bridging the conversation' so that there's not only an international conversation, there's not only a domestic conversation, there's a global conversation that we can all be a part of."

Keys brought that conversation to Washington, where she met with women being treated at the United Medical Center's Infectious Diseases Clinic. She also teamed up with Greater Than AIDS, a national public information group founded by the Kaiser Family Foundation and the Black AIDS Institute, to launch her latest initiative -- a campaign aimed at reaching out specifically to American women.

It's called "Empowered" and phase one features a video of Keys and five women who are HIV-positive from all walks of life.

They include Stephanie, a college graduate diagnosed at 19; and Kym, diagnosed three years ago after her new husband got sick and died of the disease (she did not know he'd been HIV-positive for a decade).

Also included are Cristina, a graduate student born with the virus; Jen, a wife and mother who was diagnosed at 18; and Eva, a wife, mother, grandmother and home health care professional who found out she was HIV-positive when she was just 17 -- and pregnant.

The women share their stories and their determination to change the course -- and the face -- of HIV/AIDS.

Keys said she wants all women to know the facts about HIV and its impact on women; to be able to speak openly about the disease with family and friends; to protect themselves and their loved ones; to get tested without shame; and to live rich, healthy lives by getting and staying on treatment.

Why youths aren't getting tested for HIV

"We can't act like it's not happening. We have to make sure we know that we're all at risk. This is all of our issues, you know. This doesn't make you bad. ... You shouldn't feel like you're ashamed. We have to make sure that we are demanding access to being tested. We have to demand access to treatment with dignity."

She found an ally in senior White House adviser Valerie Jarrett, whose passion about the epidemic inspired her. Part of that passion, Jarrett said, comes from losing her sister-in-law nearly 20 years ago to the disease.

"She was married with a young child and didn't really get the testing that she should have had early on in her illness because it never occurred to anyone that a married mom would actually ... be HIV positive," Jarrett told CNN.

"Losing her was just devastating for our family and so that's where I began to realize, of course, this could happen to anybody's family."

More than 1.1 million Americans are HIV positive, according to the Centers for Disease Control and Prevention. One in five don't know they're infected. One in four people living with HIV is a woman.

In Washington, one of the hardest-hit areas in the country, rates among African-American women have skyrocketed -- more than 92% of women living with HIV there are black. It was here, last year, that Keys and Jarrett came together and decided to support each other's efforts.

President Barack Obama is committed to the goal of an AIDS-free generation and will do everything in his power to eradicate the disease, according to Jarrett. That includes $23 billion for HIV in next year's proposed budget. But, said Jarrett, HIV still has to be brought out of the shadows.

Timeline: AIDS moments to remember

"We can't pretend it doesn't exist," Jarrett said. "When people share these stories, it de-stigmatizes it, it brings it out in to the light and when we do that, we improve the quality of life that all people will have."

For its part, Empowered will provide community-based grants of up to $25,000 for programs focused on women. That, Keys hopes, will help open up a meaningful dialogue in this country.

"For a woman and a black woman, you know, this is a conversation that we must have as all women. Again, as all human beings, we have to have this conversation," she said.

"I feel like this is an incredibly wonderful opportunity that we have to have a real dialogue, woman to woman, mother to mother, sister to sister, brother to sister ... father to daughter, daughter to mother, you know, friend to friend. This is what we have to start absolutely being open about."

Source

Targeted drugs to tackle hepatitis C

But experts debate US screening recommendations.

Beth Mole

01 May 2013

John strains to recall the gap between learning that he had hepatitis C and deciding to get treated: it was either four years or five. His thinking is clouded by the combination of three drugs that he is taking to clear the infection. After the treatments’ other side effects set in — severe flu-like symptoms, depression and exhaustion — he took leave from his job as a chef in New York. John, whose name has been changed to protect his privacy, was at high risk of catching the virus, having once been addicted to crystal methamphetamine. But as a 51-year-old, he is also a baby boomer — a member of the generation born between 1945 and 1965 — millions of whom will face the disease and its sometimes harrowing treatment.

Better drugs are on the way. But the possibility of improved treatment is intensifying a debate about whether to screen a broad swathe of the US population for hepatitis C.

Last month, the pharmaceutical company Gilead, based in Foster City, California, submitted its hepatitis-C drug sofosbuvir to the US Food and Drug Administration for approval, after phase II trials showed a 100% success rate in a few patient groups when it was used in combination with existing drugs. Last week, the first phase III results showed similarly promising results (E. Lawitz et al. N. Engl. J. Med. http://doi.org/mcc; 2013).

The drug is one of at least ten in phase III trials in the United States that promise to improve results or reduce side effects. The first of these drugs could reach the market as early as 2014, and a recommendation from the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, to screen an entire generation for the disease could create vast demand for them.

John is a part of a demographic time bomb. Up to 4 million Americans are infected with hepatitis C, which can irreparably damage the liver and lead to liver cancer, but because it inflicts injury slowly over decades, as many as 85% of carriers do not know that they have it. Baby boomers account for about 27% of the US population, but up to 75% of those infected with hepatitis C, possibly because injecting drugs — one infection route — was more common during their youth than in other eras. Last August, the CDC recommended screening the entire generation of people born between 1945 and 1965, as well as people in high-risk populations such as intravenous-drug users. The CDC predicts that generational screening would find an extra 800,000 cases and prevent at least 120,000 deaths. “We have an opportunity to make a real dent in the impact of the disease,” says Kimberly Page, an epidemiologist at the University of California, San Francisco.

Source: G. L. Davis et al. Gastroenterology 138, 513–521 (2010)

John’s doctor, infectious-disease specialist Kristen Marks of Weill Cornell Medical College in New York, says that screening is especially important for baby boomers because early symptoms of hepatitis C, such as fatigue and malaise, are difficult to distinguish from signs of ageing. People dismiss symptoms, says Marks, and some might not remember trying intravenous drugs in their youth. Even if they do, she adds, “they might not tell their doctor”. A peak in cases of liver scarring from untreated hepatitis C is expected in the next few years (see ‘An approaching burden’). But with the new drugs on the horizon, now is an optimistic time for treatment, says Marks. “Historically, not having good treatments was a disincentive for screening,” she says. “Now, I think there’s a renewed interest.”

But last November, the US Preventive Services Task Force (USPSTF), a panel of experts assembled by the US Department of Health and Human Services, released a draft statement giving the screening recommendation a ‘grade C’. That means that doctors should consider birth year when deciding whether to offer screening, but should take other factors into account. The mediocre grade could discourage many health-care providers — including Medicaid, the provider for people with low incomes — from pushing screenings.

As with its controversial recommendations in 2009 and 2012 to limit screening for breast and prostrate cancer, the USPSTF has tried to balance the benefits of screening against its costs and the risk of unnecessary treatment. The combination therapies used to combat hepatitis C can cost US$1,100 per week and last for up to a year, with severe side effects. Other treatments cost $4,100 per week. (Gilead declined to comment on the future price of sofosbuvir-based treatments.)

“We have an opportunity to make a real dent in the impact of the disease.”

Roger Chou, an internal-medicine specialist at Oregon Health and Science University in Portland and a scientific reviewer for the USPSTF, adds that in most patients, the disease is imperceptible: only 20% of people develop liver scarring in the first 20 years of infection, according to the CDC. Of the few baby boomers that might be caught through additional screening, says Chou, some will not need to be treated.

But new drugs, however expensive, could change the calculus for doctors and patients, says Mark Eckman, a physician at the University of Cincinnati in Ohio, who has calculated that even screening the entire US population would be cost effective given the financial and personal burdens of living with liver diseases (M. H. Eckman et al. Clin. Infect. Dis. 56, 1382–1393; 2013).

For example, sofosbuvir, which is one of a set of new antiviral drugs that specifically target hepatitis C rather than viruses in general, can achieve success rates above 90% in combination treatments of just three months. The drug inhibits the virus’s RNA polymerase, preventing viral replication. It is also being tested without the classic combination drug of pegylated interferon, which boosts the immune system but causes harsh side effects.

The USPSTF is still reviewing its draft recommendations, but it is likely to make a final decision in the next few months, well before approval of sofosbuvir or other new drugs could alter the calculations.

That is too bad, says David Thomas, a viral-hepatitis specialist at Johns Hopkins University in Baltimore, Maryland, who argues that the next generation of drugs helps to justify wide-scale screening. “It makes a pretty easy case for doing something different,” he says.

Nature 497, 18–19 (02 May 2013) doi:10.1038/497018a

Source

Sharecare Names Top 10 Social HealthMakers in Hepatitis C

PRESS RELEASE

May 1, 2013, 8:00 a.m. EDT

Today's 48- to 68-Year-Olds 5 Times More Likely Than Other Adults to Have Hep C

ATLANTA & SAN FRANCISCO, May 01, 2013 (BUSINESS WIRE) -- --May is Hepatitis Awareness Month--

According to the Centers for Disease Control and Prevention (CDC), people born between 1945 and 1965 are 5 times more likely than other adults to have hepatitis C--in fact, roughly 120,000 deaths could be prevented if all baby boomers were tested for hepatitis C. In light of these startling statistics, Sharecare, the health and wellness social network, has released its Top 10 Social HealthMakers in Hepatitis C. These informed individuals are leading online conversations about hepatitis C, providing invaluable insights on symptoms, treatment, support, and living with the virus.

Among them is a nurse who has treated and been treated for hepatitis C, a HepMag.com guest blogger who beat the virus with protease inhibitors, and an educator who has lived with the condition for 20 years. "Thanks to the latest treatments, four out of five HCV patients can spend the rest of their lives free of the disease," said Lucinda K. Porter, RN, #1 on the Sharecare Social HealthMakers list.

For Hepatitis Awareness Month in May, here are the Top 10 Social HealthMakers in Hepatitis C to follow:

1. Lucinda K. Porter, RN - LucindaPorterRN.com and HepMag.com

-- An RN, educator, consultant and author of Free from Hepatitis C who contracted hepatitis C in 1988, Porter served as clinical research nurse at Stanford's hepatology division and is active in hepatitis C support. Her second book Hepatitis C Treatment One Step at a Time: Inspiration and Practical Tips for Successful Treatment will be published September 2013.

2. John D. Carroll - FierceBiotech.com

-- FierceBiotech.com editor and a biotech analyst with 34 years prize-winning experience in journalism often covering hepatitis C drug releases and clinical trials, Carroll has written for Time magazine and The Dallas Morning News.

3. Margaret Dudley - Hepc-cured.com and HepMag.com

-- After contracting the virus via a tattoo needle and enduring the condition for six years before diagnosis, Dudley founded HCV Coalition for the Cure, petitioning to bring treatments to market.

4. Liz Highleyman - HIVandHepatitis.com

-- Freelance writer, editor and educator in public health, hepatitis B and C, HIV/AIDS, Highleyman is editor-in-chief of HIVandHepatitis.com and has written for HCV Advocate.

5. Adam Feuerstein - TheStreet.com

-- As senior columnist for The Street, Feuerstein reports on biotech stocks, including updates on hepatitis C drug releases and clinical trials.

6. Alan Franciscus - HCVadvocate.org

-- Franciscus is executive director of The Hepatitis C Support Project, which provides unbiased information, support and advocacy.

7. Karen Hoyt - iHelpC.com and HepMag.com

-- Founder of iHelpC.com, Hoyt beat the virus with protease inhibitors; she also guest blogs for HepMag.com.

8. Joseph S. Galati, MD - TexasLiver.com

-- A Houston-based liver disease specialist who has devoted his practice to the care of patients with acute and chronic liver disease, Dr. Galati also hosts a weekly health radio show, "Your Health First... with Dr. Galati."

9. Connie Welch - LifeBeyondHepatitisC.com

-- Blogger, sheep wrangler and educator who has lived with hepatitis C for 20 years.

10. Tom Horn - Treatment Action Group

-- Horn, a 20-year survivor of HIV, is the HIV Project Director for the Treatment Action Group (TAG) and writes for POZ.com and HepMag.com, addressing the importance of hepatitis C (HCV) testing, HIV/HCV co-infection and the staggering statistics around HCV infection.

Complete background information about all 10 Social HealthMakers in Hepatitis C can be found here: www.sharecare.com/static/top-ten-social-healthmakers.

Methodology

Sharecare Social HealthMakers (formerly SharecareNow) are among the most influential people in health and wellness on the Web, literally driving "conversations on the leading edge." They address a wide range of issues within specific topic areas while demonstrating consistent impact across multiple interactive channels--such as Twitter, Facebook, video and blogs. This impact is measured through a proprietary algorithm based on more than 100 individual metrics developed and powered by WCG, the marketing-leading digital communications agency, quantifying topic relevance, syndication, presence and reach. Prior Sharecare lists have identified Social HealthMakers in weight loss, infertility, heart disease, fitness, Alzheimer's disease and more.

About Sharecare

Sharecare is a health and wellness social network that connects people with experts, ranging from doctors and specialists to hospitals, healthcare companies and health-conscious consumers. The power behind the site's unique Q&A format is its collective wisdom, providing health-seeking consumers with answers reflecting multiple expert perspectives--greatly simplifying the search for quality information. Created by Jeff Arnold and Dr. Mehmet Oz in partnership with Harpo Productions, Sony Pictures Television and Discovery Communications, Sharecare allows people to ask, learn and act upon questions of health and wellness, creating an active community where knowledge is shared and put into practice--simply said, sharing care. Launched in 2010, Sharecare is based in Atlanta, GA.

-- Follow us on Twitter @SharecareNow

-- Like us on Facebook

-- Connect with us on LinkedIn

-- Read our Sharecare Blog

-- Watch us on YouTube

About WCG

Founded and led by chairman and CEO Jim Weiss, WCG is focused on integrated business solutions in the areas of innovation, change and growth for the world's leading companies and brands. WCG serves clients through a network of offices in San Francisco, New York, Chicago, Washington, D.C., Austin, Los Angeles and London. For more than a decade, WCG's seasoned professionals have specialized in providing analytics, content, engagement and strategy to a diverse set of clients across the consumer, technology, healthcare and pharmaceutical industries.

-- Follow us on Twitter: @wcgworld

-- Find us on Facebook

-- Read our CommonSense Blog

http://cts.businesswire.com/ct/CT?id=bwnews&sty=20130501005459r1&sid=cmtx4&distro=nx

SOURCE: Sharecare

Source

Hepatitis Outreach Network: A practical strategy for hepatitis screening with linkage to care in foreign-born communities

Journal of Hepatology
Volume 58, Issue 5 , Pages 890-897, May 2013

Ponni V. Perumalswami,  Stephanie H. Factor, Luciano Kapelusznik, Scott L. Friedman, Calvin Q. Pan, Charissa Chang, Frances Di Clemente, Douglas T. Dieterich

Division of Liver Diseases, The Mount Sinai Medical Center, Mount Sinai School of Medicine, NY, United States

Received 24 August 2012; received in revised form 26 December 2012; accepted 7 January 2013. published online 16 January 2013.

Abstract

Background & Aims

Many foreign-born persons in the US are at high risk of chronic hepatitis B (HBV) and C (HCV) infections, yet are not aware of their infection, and lack healthcare coverage or linkage to care.

Methods

A unique partnership, the Hepatitis Outreach Network, combines the expertise and resources of the Mount Sinai School of Medicine, the NYC Department of Health and Mental Hygiene, and community-based organizations, to provide education, screening and link to care in communities with high prevalence of chronic viral hepatitis. Comprehensive HBV and HCV screening identifies infected patients, who then receive further evaluation from either local or Mount Sinai physicians, combined with patient-navigators who organize follow-up visits.

Results

Of 1603 persons screened, 76 had HBV and 75 had HCV. Importantly, screening for HCV based on traditional risk factors would have missed 67% of those who tested positive. Of the 76 persons with HCV infection, 49 (64%) received a medical evaluation (26 with local providers and 23 at Mount Sinai). Of the 49 HCV-infected persons evaluated, treatment was recommended in 11 and begun in 8 (73%). Of the 76 persons with HBV infection, 43 (57%) received a medical evaluation (31 with local providers and 12 at Mount Sinai). Of the 43 HBV-infected persons evaluated, treatment was recommended and begun in 5 (100%).

Conclusions

Hepatitis Outreach Network has successfully established novel proof of concept for identifying HBV and HCV infections in foreign-born persons through use of several unique elements that effectively link them to care.

Keywords: Epidemiology, Patient navigators, Viral hepatitis, Testing, Treatment

PII: S0168-8278(13)00017-2

doi:10.1016/j.jhep.2013.01.004

© 2013 European Association for the Study of the Liver. Published by Elsevier Inc. All rights reserved

Source

HIV-Infected Men at Increased Risk for Cancer

Jim Kling

Apr 30, 2013

BERLIN, Germany — HIV-infected men are at twice the risk for non-AIDS defining cancers as the general population, but highly active antiretroviral therapy has a protective benefit, according to a new study.

Little is known about how HIV infection affects the risk for non-AIDS defining cancers that don't have an infectious component. "HIV patients are living longer, and they live with chronic diseases that can compromise the immune system. People with impaired immunologic status are at increased risk for lung cancer," Laura Albini, PhD, professor of infectious diseases at the University of Brescia, Italy, told Medscape Medical News.

She presented the study results here at the 23rd European Congress of Clinical Microbiology and Infectious Diseases.

Dr. Albini and her team conducted a retrospective analysis of 5090 HIV-infected patients registered in the Local Health Authority of Brescia in Northern Italy. The researchers linked their own clinical database to the Local Health Authority general database and the Local Health Authority population-based cancer registry to diagnose nonvirus-related non-AIDS defining cancers.

They used Poisson regression to compare the risk for cancer in people infected with HIV and those in the general population living in the same geographic region.

There were 138 cancers diagnosed in 131 patients over the course of the study (42.6 per 10,000 person-years; median age at diagnosis, 49 years). The most common cancers were nonmelanoma skin (29.7%), lung (16.7%), and breast (7.3%).

More Lung Cancer

Males were at higher risk for cancer (standardized incidence ratio [SIR], 1.86; 95% confidence interval [CI], 1.55 - 2.26) than people in the general population. They also had an increased risk for lung cancer (SIR, 3.59; 95% CI, 2.36 - 5.45) and testis cancer (SIR, 3.11; 95% CI, 1.48 - 6.52).

There were no differences in prostate and breast cancers in HIV-positive men (SIR, 1.10; 95% CI, 0.53 - 2.32) and women (SIR, 0.91; 95% CI, 0.47 - 1.74).

Predictors of nonvirus-related non-AIDS defining cancers included older age (incidence rate ratio [IRR], 1.10; 95% CI, 1.08 - 1.12 for each additional year) and a shorter duration or lack of exposure to highly active antiretroviral therapy (IRR, 2.31; 95% CI, 1.38 - 3.89; P = .002). Severe immunodeficiency (CD4+ count below 50 cells/mm³) was associated with malignancies, but only in the univariate model (IRR, 1.40; 95% CI, 0.99 - 1.98; P = .057).

The increased risk for lung cancer is likely due, in part, to the fact that smoking is a common habit, but immunodeficiency also likely plays a role, according to Dr. Albini.

The results of this study are similar to those from other studies of cancer incidence in HIV-infected individuals, "although there are some differences. Other studies have shown increases in breast cancer, but this one does not," session moderator José Miró, MD, PhD, professor of medicine at the University of Barcelona in Spain, told Medscape Medical News.

The results underscore the importance of lung cancer screening in HIV patients, Dr. Miró added. "Lung cancer is really epidemic in the HIV population. Physicians should use appropriate diagnostic tools if there are any symptoms suggesting lung cancer."

Dr. Albini and Dr. Miró have disclosed no relevant financial relationships.

23rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID): Abstract O155. Presented April 27, 2013.

Source

Embolizing Vascular Shunts Relieves Hepatic Encephalopathy

Daniel M. Keller, PhD

Apr 30, 2013

AMSTERDAM, the Netherlands ― Embolizing large spontaneous portosystemic shunts can relieve hepatic encephalopathy and can keep many patients free of it for as long as they have sufficient functional liver reserve, a new study has shown.

In the 100 days after embolization, 60% of patients were free of hepatic encephalopathy. During the overall follow-up of more than 2 years, that was reduced to still a very impressive 49%. Compared with the 2-year period before embolization, both reductions were significant (P < .001), reports Wim Laleman, MD, PhD, from the Department of Liver and Biliopancreatic Disorders at University Hospitals Leuven and the Catholic University of Leuven in Belgium.

Dr. Laleman presented the study results here at the International Liver Congress 2013.

The retrospective study involved men and women from a European multicenter cohort with cirrhosis, refractory encephalopathy, and large spontaneous portosystemic shunts that were amenable to angiographic embolization. Patients were excluded if they had a surgical shunt or transjugular intrahepatic portosystemic shunt graft, portal vein thrombosis, or hepatocellular carcinoma.

Most of the cirrhosis was caused by alcohol abuse or hepatitis C. Child–Pugh score before embolization was 7.9, and model for end-stage liver disease (MELD) score was 13.2 (range, 5 - 28).

In 37 of 38 patients, embolization was achieved with a percutaneous, transhepatic, or femoral vein approach using coils, Amplatzer plugs, or matrix. The most common spontaneous shunt was splenorenal (n = 20); the rest were mesentericocaval, periumbilical, or mesentericorenal.

In addition to the reduction in hepatic encephalopathy, embolization was associated with a reduction in the number of hospitalizations, from 3.8 in the preprocedure period to 1.3 in the follow-up period (P < .001). Hospital days were reduced from 41.0 to 17.8 (P >.001).

Quality of Life

Dr. Laleman explained that quality of life is very important in the context of hepatic encephalopathy. Before embolization, almost 73% of patients had limited quality of life and were in need of help with daily activities. After embolization, only 25% of patients had limited quality of life. Autonomy increased from 21.6% of patients to 64.9%, but there was no change in complete disability (about 10% before and after embolization), he reported.

Near-term safety was excellent. There was no mortality and 8 procedure-related complications, only 1 of which was serious (hypovolemic shock after a transhepatic approach that resolved after surgical hemostasis).

Dr. Laleman put to rest concerns about possible long-term complications of worsening liver function, thrombosis, and portal hypertensive complications. "There was no increase in the presence of gastroesophageal varices and no increase in gastropathy (2 patients developed de novo varices, but this was not considered statistically significant). With regard to ascites, we saw a similar evolution, so there was no apparent increase in portal hypertensive complications," he said.

There was no change in liver function (MELD score) from before to after the procedure (13.2 vs 15.2; P = .26). Although 4 patients had thrombotic problems, this was not statistically significant.

Patient Selection

On multivariate analysis, adjusted for time between diagnosis of hepatic encephalopathy and embolization, serum albumin, International Normalized Ratio, the presence of ascites, and preprocedure Child score, the only independent predictors of recurrence of hepatic encephalopathy were sex (odds ratio [OR], 0.06; 95% confidence interval [CI], .005 - 0.971; P = .048) and pre-embolization MELD score (OR, 1.52; 95% CI, 1.073 - 2.180; P = .019).

"Embolization of these shunts is feasible, effective, and safe, provided that sufficient functional liver reserve is guaranteed," Dr. Laleman concluded. According to the investigators, patients should have a MELD score of 11 or lower to be considered for the procedure.

This is important work because it is a large study, session chair Isabelle Colle, MD, PhD, professor of hepatology and gastroenterology and head of the gastroenterology clinic at Gent University in Belgium, told Medscape Medical News.

She explained that embolization of large spontaneous portosystemic shunts is "a good treatment for patients who have really important hepatic encephalopathy and have large shunts, because they are often Child A patients.... It's clinically important that we can offer treatment to those patients without offering transplantation."

Dr. Laleman and Dr. Colle have disclosed no relevant financial relationships.

International Liver Congress 2013: 48th Annual Meeting of the European Association for the Study of the Liver (EASL). Abstract 77. Presented April 26, 2013.

Source

Also See: Shunt Correction Eases Hepatic Encephalopathy

ViewPoints: Cost will limit uptake of off-label Gilead/Bristol-Myers Squibb Hep C combo, despite best-in-class data

(Ref: ViewPoints Desk)

April 30th, 2013

Once again, a combination of Gilead Sciences' sofosbuvir and Bristol-Myers Squibb's daclatasvir appears to offer the most efficacious way of treating patients with hepatitis C without the need for either interferon or ribavirin. However, Gilead has chosen not to pursue development of this combination – prompting speculation that off-label usage could prove a feasible alternative for physicians. Such an outcome is possible, say experts, although cost is likely to be a deciding – and ultimately limiting – factor.

Insight, Analysis & Opinion

Data unveiled last week showed that among a cohort of 41 patients treated with the sofosbuvir/daclatasvir combination, 40 patients were virus free (100 percent SVR) after 12 weeks of therapy. It is not the first time this combination has impressed; a year ago similarly robust data was released, providing a backdrop against which Gilead's decision to not pursue a combination therapy with Bristol-Myers Squibb was met with some consternation. See Spotlight On: Bristol-Myers Squibb and Gilead Sciences deliver stellar HCV results, decide to go separate ways?

Gilead claims that its decision to focus on internal developments, rather than partnering with Bristol-Myers Squibb has accelerated the development of its own efforts to bring a single tablet, interferon-sparing treatment to market. Gilead remains the leading player in this development race, albeit if its own impressive-looking combinations have yet to fully match the efficacy seen with sofosbuvir/daclastasvir, which are regarded as the best in class nucleotide NS5B inhibitor and NS5A inhibitor products, respectively.

With different assets in the HCV development space offering various mechanisms of action, mechanism diversity and potency, one suggestion is that once individual components become available, physicians will prescribe them together in an off-label capacity. In this respect, the HIV market – where combinations of best-in-class molecules are used despite different companies owning them – could prove to be a valid benchmark. Key opinion leaders (KOLs) suggest that such activity is likely to occur in the early period following the approval of new treatments, with off-label use also likely to be driven by independently-run clinical trials looking at cross-company regimens. See KOL Insight: Hepatitis C: the race for the first interferon-free regimen

Potential off-label use will have a direct impact on how companies price their own fixed-dose combinations, note KOLs, while the broader cost of treating an expanding HCV population will in turn limit the use of off-label prescribing, they add – particularly as Gilead, for example, has shown robust data for its own combination. One KOL told FirstWord that "there are just too many patients out there and the system could go bankrupt if screening and diagnosis rate of hepatitis C go up and everybody is just put on just a combination of the best drug classes. You may have people prescribing daclatasvir, simeprevir plus sofosbuvir, three drugs off label in a combination just because they feel that is really the best they can provide to their patients, but which from a healthcare perspective would be a disaster."

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Also See:

1. HCV Combo Impresses, but Use Unlikely (April 30, 2013)
2. Shunned Gilead/Bristol-Myers hep C combo may be too good for docs to ignore (April 28, 2013)
3. Gilead-Bristol Hepatitis C Drug Combo Cures All in Study (April 28, 2013)
4. Gilead-Bristol Hepatitis C Combo Cures 100% of Patients in Study (April 27, 2013)

FDA Rejects Two Gilead HIV Drugs as Standalone Products

Apr 29, 2013

By Toni Clarke

WASHINGTON (Reuters) Apr 29 - Gilead Sciences Inc said on Monday that U.S. health regulators rejected two of its HIV drugs as standalone therapies, citing deficiencies in documentation and validation of certain quality testing procedures.

The company is seeking approval for its integrase inhibitor elvitegravir for people with HIV who have already been treated with other products.

Gilead is also seeking approval of cobicistat, a drug that does not itself fight the virus but boosts the function of other HIV medicines.

Both drugs are already contained in Gilead's once-daily single-tablet HIV treatment Stribild, which combines four different medications and was approved in the United States last August.

Stribild contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.

Gilead said it is working with the U.S. Food and Drug Administration to address the questions raised in the rejection letter in order to move the application forward.

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Improving Engagement in HIV Care and Treatment Adherence: An Algorithmic Approach

Benjamin Young, MD, PhD

Apr 30, 2013

Advances in antiretroviral medications have revolutionized the care and prognosis of people living with HIV around the world. Where individuals have access to trained care providers and medications, HIV-related morbidity and mortality have decreased; in many highly affected regions, new infection rates are beginning to decrease.

Yet, as impressive as these gains seem, recent studies show that only a minority of people living with HIV in the United States are successfully engaged in care and achieve viral suppression.^[1,2] Central problems in HIV care are related to delays in testing, delays in care, and early dropout from medical care, and late access to HIV testing and treatment have been associated with increased immune system damage, risk for HIV transmission, and increased hospitalizations.^[3]

Unfortunately, these seemingly obvious barriers to successful implementation of therapeutics have only recently drawn systematic attention. Improving engagement in HIV medical care is hobbled by a relative dearth of scientific literature on the vast subject. In appreciating such challenges, our group, the International Association of Providers in AIDS Care (IAPAC), convened an international expert panel to identify best practices and evidence for engagement and adherence to HIV care and treatment. These first-ever evidence-based recommendations on improving entry into and retention in HIV care and treatment adherence were published in 2012.^[4]

In the current issue of JIAPAC, we describe a clinical management algorithm based on the evidence-based recommendations that charts simple operational interventions for engagement and care and treatment adherence. We believe that such tools can assist busy care programs in improving the delivery of important health interventions.

The algorithm recommends:

• Systematic monitoring of successful entry into and retention in HIV care; multiple data sources may need to be integrated to best achieve this monitoring goal. Intensive outreach is recommended for recently diagnosed individuals who do not enter care within 6 months of diagnosis. Peers or paraprofessionals may be considered to provide the needed human resources to achieve these goals.
• The use of once-daily treatment for persons initiating therapy. Among regimens of equal efficacy and safety, fixed-dose combinations should be used to decrease pill burden.
• Monitoring of adherence to treatment by routine self-reported adherence and pharmacy refill data. Reminder devices and the use of communications technologies with an interactive component and adherence-related educations and counseling are recommended.
• Education and counseling through one-on-one and group education; multidisciplinary education and counseling are recommended.
• It is important to note that although normative guidance is a necessary step in charting a pathway for improving care, recommendations frequently are not translated into operational improvements. Indeed, it is critical that agencies that author such documents take into consideration the operational and educational needs of implementation.

As a member-oriented organization, IAPAC strives to provide practical tools to assist front-line care providers in achieving the highest possible level of care in people living with HIV. In the past, efforts have focused primarily on the use of HIV treatment guidelines from the US Department of Health and Human Services and the World Health Organization. In constructing and publishing this algorithm, we extend this effort to improving engagement in care and treatment adherence.

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