May 13, 2013

Obesity Trumps Alcohol in Liver Damage

Daniel M. Keller, PhD

May 13, 2013

AMSTERDAM, the Netherlands — In terms of liver-related morbidity and mortality, obesity is even more dangerous than alcohol consumption, a study of more than 100,000 women has shown.

"For both overweight and obese women in this study, heavy drinking increased the absolute risk of liver events." The effect was additive if the women were overweight and super additive if they were obese, said lead author Paul Trembling, BM, MRCP, clinical research fellow at the Institute for Liver and Digestive Health, University College London, the United Kingdom.

Dr. Trembling presented the results here at the International Liver Congress 2013.

Dr. Trembling and his team examined the effect of the interaction between body mass index and alcohol consumption on liver-related events in the general population of women middle-aged and older.

The researchers obtained data on 107,742 women who participated in the UK Collaborative Trial of Ovarian Cancer Screening. They obtained follow-up data from routine healthcare databases and death certificates.

BMIs were calculated from self-reported height and weight at recruitment, and subjects reported their alcohol consumption 3.5 years after recruitment.

Median age at baseline was 61 years, 35% of the participants were smokers, 32% had hypertension, 24% had hypercholesterolemia, 6% had heart disease, and 5% had diabetes.

For alcohol intake, 62% of participants consumed 0 to 3 units per week (23% drank 0), 3% drank 16 to 20 units per week, and 2% drank more than 20 units per week.

For BMI, 44% of participants were in the normal range (18.50 - 24.99 kg/m²), 37% were overweight (25.00 - 29.99 kg/m²), and 19% were obese (≥30.00 kg/m²).

Investigators used hospital inpatient data and death certificates with any mention of alcoholic liver disease or fatty liver to determine the outcome measure of the incidence of a first event related to chronic liver disease, cirrhosis, or decompensation of cirrhosis.

During follow-up, there were 616 first events, including 110 deaths, 74 of which were from a liver-related cause. The standardized event rate was 0.06 per 100 participant-years.

For women who drank 20 units per week or less, being overweight was a risk-factor equivalent to drinking more than 21 units of alcohol per week, Dr. Trembling reported (adjusted hazard ratio, 1.7 vs 1.8). "For those who drink heavily, the risk of an event increases whether or not you are overweight and whether or not you are obese."

Table. Influence of Weight and Alcohol on Risk for Liver Outcomes

BMI (kg/m²) Alcohol (Units/Week) Adjusted Hazard Ratio (95% Confidence Interval)*
<30 <21 1.0
≥30 <21 1.7 (1.4–2.0)
<30 ≥21 1.8 (1.0–3.4)
≥30 ≥21 2.4 (0.8–7.6)

*After adjustment for metabolic factors.

Dr. Trembling reported that the event rate was higher in heavy drinkers who are overweight than in heavy drinkers who are not. It was also higher in people who are overweight but do not drink heavily. "The combined risk here is additive," he pointed out.

The risk is even higher in those who drink heavily and are obese. "The combined risk here is super additive," he said. The risk for an event is higher in those who are overweight than in those who drink heavily, and higher in those who are obese than those who drink heavily, he noted.

After adjustment for factors other than metabolic risk, the hazard ratios increase, indicating that features of metabolic syndrome contribute to the risk associated with weight.

Dr. Trembling concluded that the absolute risk for liver events increases with increasing alcohol consumption and weight gain, but BMI appears to be the greater risk. The absolute risk for events attributable to high alcohol intake is similar to that attributable to being overweight, and obesity results in a higher risk than heavy alcohol consumption.

"If you're obese, the damage that you do to yourself by drinking is much greater than if you're just overweight, explained senior researcher William Rosenberg, MBBS, DPhil, professor of hepatology at University College London.

"This is the first study really to demonstrate this in a large population of women," he said. "People are not aware that they are putting themselves at this risk."

During a news conference, moderator Daniele Prati, MD, from the Ospedale Alessandro Manzoni in Lecco, Italy, pointed out that Europe has the heaviest alcohol consumption in the world, and that alcohol consumption is the third leading cause of early death and illness, after tobacco and hypertension.

"From the early 1970s to 2000 in England, there was a 10-fold increase in women aged 35 to 44 dying from liver cirrhosis," he said.

He praised the study for its large size and for its assessment of the influence of alcohol and weight on liver-related morbidity and mortality. "There is a need to better set the proper thresholds, alone and in combination, to be able to prevent liver disease," Dr. Prati explained.

Solutions do not lie with hepatologists, he told Medscape Medical News. "Most of the work should be done with education and by the government in terms of...sensitizing the population to the risk. That's probably the only way, because both obesity and alcohol, despite the relevance for public health (not only in terms of liver disease), are conditions for which we have no really effective treatments," he concluded.

Dr. Trembling and Dr. Rosenberg have disclosed no relevant financial relationships. Dr. Prati reports consulting for Roche, Bristol-Myers Squibb, Novartis, and AbbVie.

International Liver Congress 2013: 48th Annual Meeting of the European Association for the Study of the Liver (EASL). Abstract 115. Presented April 27, 2013.


OraSure Technologies, Walgreens and Chronic Liver Disease Foundation to Launch Rapid Hepatitis C Testing Initiative in Support of National Hepatitis Testing Day

Select Walgreens Locations to Offer Rapid HCV Testing With OraQuick(R) HCV Rapid Test

WAG | 5/13/2013 10:00:30 AM

BETHLEHEM, Pa., May 13, 2013 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR), Walgreens (NYSE:WAG), and the Chronic Liver Disease Foundation announced today that they have joined with local health organizations to offer hepatitis C (HCV) testing with the OraQuick® HCV Rapid Test to individuals who may be at risk for HCV infection. The testing will be available in select Walgreens locations across 11 states in observance of National Hepatitis Testing Day, May 19. The on-site testing, patient education and linkage to care will be conducted by local health organizations. National Hepatitis Testing Day was established by the Centers for Disease Control and Prevention (CDC) as an opportunity to remind healthcare providers and those individuals at risk that they should be tested for viral hepatitis.

"Today, approximately 4 million Americans are infected with hepatitis C and the vast majority does not know it," said Dr. Willis C. Maddrey, President of the Chronic Liver Disease Foundation. "However, new therapies are now available that can effectively treat and in some cases eliminate the virus from the body, making testing for HCV – particularly among baby boomers – a critical step in fighting this epidemic."

"Hepatitis C is a silent epidemic and these testing events can help make a meaningful impact on prevention, treatment and awareness," said Glen Pietrandoni, Walgreens senior manager of virology. "By working collaboratively, we can help educate communities on the risk factors and link people to appropriate care."

OraQuick® HCV is the first and only FDA-approved and CLIA-waived point of care test for detection of HCV infection in at-risk individuals. The simple platform enables healthcare providers to deliver a diagnosis based on lab-accurate test results in 20 minutes, using venipuncture or fingerstick blood.

"Using traditional laboratory testing, individuals typically wait days or weeks before receiving their hepatitis C test results," said Douglas A. Michels, President and CEO of OraSure Technologies. "The OraQuick® HCV Rapid Test is ideal for use at the point of care – it's easy, accessible and provides lab-accurate results in 20 minutes – enabling individuals presumed to be infected to be referred immediately for follow-up care."

In addition to this initiative with Walgreens and CLDF, OraSure's OraQuick HCV Rapid Test is being deployed at public testing events in Washington, D.C., Los Angeles, New York City, Chicago, Pittsburgh, and other cities across the U.S. in recognition of National Hepatitis Testing Day.

For more information, including Walgreens testing locations and hours, please visit:

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In July 2012, the Company received approval from the U.S. Food and Drug Administration for the Company's OraQuick® In-Home HIV Test for sale directly to consumers in the over-the-counter (OTC) market - making it the first and only rapid OTC HIV test approved in the U.S. In addition, the Company is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, and commercial and industrial entities. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health.

For more information on OraSure Technologies, please visit

About Walgreens

As the nation's largest drugstore chain with fiscal 2012 sales of $72 billion, Walgreens ( vision is to become America's first choice for health and daily living. Each day, Walgreens provides more than 6 million customers the most convenient, multichannel access to consumer goods and services and trusted, cost-effective pharmacy, health and wellness services and advice in communities across America. Walgreens scope of pharmacy services includes retail, specialty, infusion, medical facility and mail service, along with respiratory services. These services help improve health outcomes and lower costs for payers including employers, managed care organizations, health systems, pharmacy benefit managers and the public sector. The company operates 8,086 drugstores in all 50 states, the District of Columbia and Puerto Rico. Take Care Health Systems is a Walgreens subsidiary that is the largest and most comprehensive manager of worksite health and wellness centers and in-store convenient care clinics, with more than 700 locations throughout the country.

About the Chronic Liver Disease Foundation

Established in 2001, the Chronic Liver Disease Foundation is a nonprofit 501(c)(3) educational organization dedicated to providing hepatology related continuing medical education, news and information to healthcare professionals across the US. The CLDF is led by a Board of Trustees comprised of nationally renowned liver disease specialists. Furthermore, the CLDF believes that educational programs should be developed by the specialists who are actively involved in the research, treatment and management of a disease. As such the CLDF has developed a network of 75 Centers of Educational Expertise and multiple Advisory Boards who are actively involved in program creation related to specific disease topics which include; hemochromatosis, hepatic encephalopathy, hepatitis B, hepatitis C, hepatocellular carcinoma, HIV co-infection, liver transplantation and NASH/NAFLD. The CLDF's educational opportunities are offered in a variety of formats including an interactive web site, live meetings, teleconferences, print pieces, webcasts and other electronic mediums. For more information, please visit


Toward Improved Outcomes in HCV Mono- and Coinfection

Valerie Martel-Laferriere, MD, Douglas Dieterich, MD

May 13, 2013

The International Conference on Viral Hepatitis (ICVH), organized in collaboration with the International Association of Providers of AIDS Care and the Icahn School of Medicine at Mount Sinai in New York and held March 25-26, 2013, focused on the use of new agents in the treatment of hepatitis C (HCV), and particularly on the rapid progress made in the treatment of HIV/HCV-coinfected patients.

Management of HCV Monoinfection: The Promise of Novel Agents

New data on 2 novel agents in development were presented during ICVH. SOUND-C2 is a phase 2b open-label randomized trial in treatment-naive patients with HCV genotype 1; it is evaluating the combination of faldaprevir, a NS3/4A protease inhibitor, and BI 207127, a nonnucleoside NS5B inhibitor.[1] This was a 5-arm study: faldaprevir 120 mg daily, BI 207127 600 mg 3 times daily, and ribavirin for 16 weeks, 28 weeks, or 40 weeks; faldaprevir 120 mg daily, BI 207127 600 mg twice daily, and ribavirin for 28 weeks; or faldaprevir 120 mg daily and BI 207127 600 mg 3 times daily, without ribavirin, for 28 weeks. A total of 362 patients were enrolled, approximately two thirds of whom were HCV genotype 1b. Around 25% were IL28B CC, and 10% were cirrhotic. The primary endpoint was achievement of sustained virologic response 12 weeks after treatment (SVR12).

The arm in which BI 207127 was administered twice daily had the best response, with an SVR12 of 69%. The arm without ribavirin did the worst, with an SVR12 of only 39%. Subgroup analysis showed that genotype had a very important effect on results: SVR12 ranged from 11% to 47% for patients with genotype 1a to 56% to 85% for patients with genotype 1b. IL28B had less of an effect, with a difference of 10%-25% between IL28B non-CC vs CC. In multivariate analysis, sex, HCV subtype, IL28B genotype, and baseline gamma-glutamyltransferase level significantly affectedSVR12.

No patients had relapse between week 12 and 24 post-treatment, but not all patients reached this time point. There was 1 late relapse that occurred between 24 and 48 weeks post-treatment.

Side effects were tolerable: Grade 3 hemoglobin levels were reported in 8 patients, 1 patient had a grade 4 anemia, and 7 patients developed severe rashes. As expected, depending on study arm, 13%-46% of patients developed grade 3/4 elevated total bilirubin levels. Phase 3 studies combining faldaprevir 120 mg daily, BI 207127 600 mg twice daily, and ribavirin are under way.

Finally, 2 presentations discussed the resistance profile of the novel protease inhibitor MK-5172.[2,3] In vitro studies identified mutations associated with resistance in genotype 1a (Q41R, D168A/E/G/V), genotype 1b (F43S, A156S/T, D168A/G/V), genotype 2a (Y56H, V71A, A156T, D168E), and genotype 3a (Q168R).[2] After treatment with MK-5172 monotherapy for 14 days, D168A/E/V was found in genotype 1a, A156S/T and D168A/V were found in genotype 1b, and Q168R was found in genotype 3a.

Of note, MK-5172 maintained good antiviral activity when tested against virus with mutations associated with failure of first-generation protease inhibitor treatment.[3] MK-8742, an NS5A inhibitor, demonstrated fewer resistant replicons than did daclatasvir or ledipasvir (GS-5885) when tested alone or in combination with MK-5172.[3] The barrier to resistance of the combination of MK-5172 and MK-8742 is thought to be high because combined mutations conferring resistance to NS3 and NS5A were rare in the replicons.

HIV/HCV Coinfected Patients: Focus on Acute Infections and Reinfections

HCV is now recognized as a sexually transmitted disease in HIV-infected men who have sex with men (MSM). Over the 5-year period from 2008 to 2012, Sanchez and colleagues[4] recorded an increase in the rate of syphilis in Madrid, Spain, from 3.1% to 10.4%, whereas the rate of HCV increased from 0.05% to 0.3%. These results are concordant with those seen in the CASCADE Collaboration study,[5] which showed a slowly but steadily increase of HCV in HIV-infected MSM between 1990 and 2007, increasing from 0.09-0.22 per 100 person-years in 1990 to 2.34-5.11 per 100 person-years in 2007.

The close relationship with viruses seen in intravenous drug users in Spain and the concomitant diagnosis of syphilis and HCV seen in 7 patients underscores the importance of preventive measures and periodic HCV screening among MSM to maximize treatment benefit during the acute phase of HCV infection.

Treatment of acute HCV infection in HIV infected patients is associated with significantly better outcomes than is treatment of chronic infection: SVR rates range from 53% to 82% for acute HCV infection vs 14% to 38% for chronic HCV genotype 1 and 44% to 72% for HCV genotype 2 or 3.[6-17] Dr. Daniel Fierer of Mount Sinai Hospital[18] presented results of a study of 20 consecutive HIV-infected MSM with newly diagnosed HCV treated with 12 weeks of telaprevir, pegylated interferon, and ribavirin. The study is still ongoing, but preliminary data show SVR at 4 weeks of 85% (17 of 20 patients). A limitation of the study is that the favorable IL28B polymorphism CC was overrepresented (65%) compared with what is usually seen in the US population, and this may partially account for the high response rate.

Despite the effectiveness of treatment for acute HCV infection, reinfection remains a concern. In 2011, Lambers and colleagues[19] showed that among 51 HIV-infected MSM treated successfully for an acute HCV infection at 2 clinics in Amsterdam, The Netherlands, 11 became reinfected shortly after, resulting in a reinfection rate of 15.2 over 100 person-years. At ICVH, Dr. Emma Page of the Chelsea and Westminster Hospital in the United Kingdom[20] reported data from a similar evaluation conducted at her hospital, where the incidence rate of reinfection was 8.1 per 100 person-years among a cohort of 145 MSM followed from January 2004 to April 2012. Of note, reinfection occurred within 4 years of documented negative HCV antibody testing.

Treating Chronic HCV Infection: Real-Life Experiences

The addition of telaprevir and boceprevir to treatment regimens for HCV genotype 1 has greatly changed the outcome of chronic HCV treatment. However, these drugs have significant side effects and drug interactions, little is known so far about their effectiveness in real life, and their use in HCV/HIV-coinfected patients is off-label.

Ahmed and colleagues[21] presented the experience at Chelsea and Westminster Hospital with using boceprevir and telaprevir in 5 coinfected patients with previous treatment failure and who had bridging fibrosis or cirrhosis on liver biopsy. All patients achieved early virologic response, and 4 patients achieved SVR at 24 weeks. The remaining patient had an undetectable viral load at the end of treatment but died during follow-up.

Adverse events, including anemia, were common, and 80% of patients received erythropoietin. No patient had a detectable HIV load during treatment. Evaluation of 7 coinfected patients who started a telaprevir-based regimen is ongoing.

The use of telaprevir at the Icahn School of Medicine at Mount Sinai and John Hopkins University[22] in 33 coinfected and 117 monoinfected patients also showed good results and no statistically significant difference between groups in the SVR12 rate (61% vs 43%; P = .07), even though the coinfected group consisted of a more difficult-to-treat population (more African Americans and more prior nonresponders or patients who were intolerant of therapy). Discontinuation because of adverse events and severe anemia was common, but the proportions did not differ between the groups.

Drug/Drug Interactions

A recurrent theme during ICVH was the issue of drug/drug interactions with the use of the new direct-acting antivirals, especially in coinfected patients.[23] Boceprevir and telaprevir are both CYP3A inhibitors, although telaprevir is a little more permissive than boceprevir when it comes to drug/drug interactions. For example, efavirenz can be used at an increased dose (1125 mg 3 times daily) with telaprevir, but cannot be used with boceprevir.[24,25] Atazanavir boosted with ritonavir is also an acceptable option in patients taking telaprevir, but the US Food and Drug Administration does not recommend its use with boceprevir because of the potential for HIV escape.[25,26] Because data on drug/drug interactions in clinical settings are not always available, clinicians should be cautious when they select a treatment regimen for coinfected patients.

Liver Transplantation in Coinfected Patients: Facing the Challenges

For many years, HIV-infected patients were not considered potential liver transplant candidates. Now, well-selected HIV-positive patients can benefit from liver transplant, but the outcomes vary widely. Thus, given the shortage of available donor livers, the debate is still open about whether HIV-positive patients should undergo transplant.

In a series of 22 patients with hepatitis B coinfection, the difference in the 5-year survival rate did not statistically differ between coinfected and monoinfected patients (86% vs 100%; P = .09).[27] No patients died of HIV or hepatitis B virus infection during follow-up. Of note, around one half of the patients had low viremia, which may support the long-term use of hepatitis B immunoglobulins plus antivirals.

The benefits of transplantation in HIV/HCV coinfection are more difficult to assess: Studies have shown higher rates of wait-list mortality, higher rates of post-transplant mortality, and more severe recurrent HCV disease.[28] Indeed, data from a prospective multicenter trial showed significantly higher 3-year survival and graft survival in HCV-monoinfected transplant recipients vs coinfected transplant recipients (overall survival, 60% vs 79% [P < .001]; graft survival, 53% vs 74% [P < .001]).[29] However, contrary to what was expected, acute rejection was more common in coinfected patients than it was in monoinfected patients (35% vs 18%). The challenges of managing immunosuppressive drugs in already immunosuppressed patients, as well as a potential drug/drug interactions, may explain this phenomenon. As a precaution, some have advised that HIV protease inhibitors be avoided in this population to reduce the risk for interactions.[28]


Hepatitis C research is a rapidly moving field. Over the past year, the epidemiology of the disease has started to change with the appearance of more sexually transmitted cases among HIV-infected patients. Understanding of the timing of treatment in acute infection has been refined, and new treatments are available and in development for chronic infection. Although HIV is still a barrier to liver transplantation in coinfected patients, it is no longer an absolute contraindication.


Addressing Psychosocial Issues in Patients With Hepatitis C

Jeffrey Weiss, PhD, MS

May 13, 2013

Editor's Note: The International Conference on Viral Hepatitis (ICVH) 2013 -- held in New York on March 25-26, 2013, and jointly sponsored by the International Association of Providers of AIDS Care and the Icahn School of Medicine at Mount Sinai -- was designed to update practitioners and scientists on the most recent advances in the management of hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV/hepatitis coinfection.

Jeffrey Weiss, PhD, MS, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, moderated a panel at ICVH 2013 featuring patients discussing barriers to care in hepatitis[1] and comoderated another panel on optimizing outcomes in patients with liver disease.[2] Here, he shares his thoughts on some of the key issues raised during these panel discussions regarding psychosocial issues in patients with HCV.

Two issues raised during ICVH 2013 highlight some of the challenges facing clinicians in managing patients with hepatitis. The Institute of Medicine recommendations for the prevention and control of HBV and HCV noted the need for improved knowledge and awareness about hepatitis among healthcare and social-service providers and the public, especially in at-risk people, as well as the need for improved access to available services.[3] One method raised by the panelists to improve engagement in care was to increase deployment of the peer influence model, which has been used as part of HCV and HIV prevention strategies.[4] Adapting this model to focus on access to and engagement in hepatitis care, peers would go into targeted, hard-to-reach communities to provide education and to connect individuals with testing and treatment opportunities.

Creating tools for primary care physicians to readily educate patients about the importance of effective treatment for hepatitis was also discussed as a potential method for increasing education about and engagement in care. This type of coordinated care has been identified as critical to increasing screening and prevention strategies and may play a key role in improving outcomes in patients with chronic disease.[5]

Yet, engaging patients in care is only a first step toward maximizing treatment benefit in patients with HCV infection. A wide variety of psychosocial factors can influence adherence and treatment effectiveness, particularly among injection drug users, which is a key at-risk population.[6] A structured, integrated approach to ensuring medication adherence in patients with HCV infection is currently lacking at most sites of care,[7] but patients who are given the necessary pretreatment preparation and on-treatment support are more likely to be retained in care and adhere to medication regimens, thus increasing the likelihood for improved outcomes.



Facing the Challenges in Managing HCV/HIV Coinfection

Mark R. Nelson, MD

DisclosuresMay 13, 2013

Editor's Note: The International Conference on Viral Hepatitis (ICVH) 2013 -- held in New York on March 25-26, 2013, and jointly sponsored by the International Association of Providers of AIDS Care and the Icahn School of Medicine at Mount Sinai -- was designed to update practitioners and scientists on the most recent advances in the management of hepatitis B virus, hepatitis C virus (HCV), and HIV/hepatitis coinfection.

Mark R. Nelson, MD, Physician and Clinical Lead for In-Patient Services at the Chelsea and Westminster Hospital in London, United Kingdom, and Co-chair of ICVH 2013, shared his thoughts on some of the key issues discussed at the conference.

We are continually learning about the management of patients with HCV infection and are exploring new ways to improve treatment outcomes in both monoinfected and HCV/HIV-coinfected patients.

With the wide array of new drugs and new treatment approaches on the horizon,[1] we need to take a step back and consider the personal and public health implications of immediate treatment, given the unknown drug/drug interactions and toxicities -- especially in coinfected patients.[2-4]

But we know that we cannot hold off on treatment for too long. Among coinfected patients in particular, survival in those with end-stage liver disease is poor, and the value of transplantation in this population is still being debated.[5]

Another critical issue that needs to be addressed is the growing epidemic of acute hepatitis C among patients with HIV -- first described at our hospital -- that is rapidly replacing those with chronic HCV infection who were successfully treated.[6] The reinfection rate in these patients can be high, and treatment can be costly. How will that affect patients who need repeated treatments over the long term?

This is a very exciting time for clinicians and researchers involved in the management of patients with HCV infection. But it is also a time in which we need to consider how to obtain the data we need to develop strategies that can offer the best opportunity for improved outcomes.



FDA is announcing a Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research

June 14, 2013
9:30 a.m. to 5:30 p.m
FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Room 1503A (Great Room)
Silver Spring, MD 20993

On June 14, 2013, as part of the Patient-Focused Drug Development initiative intended to enhance patient input, FDA will be hosting a public meeting on human immunodeficiency virus (HIV) Patient-Focused Drug Development and HIV Cure Research. FDA is interested in obtaining patient input on the impact of HIV on daily life and currently available therapies to treat the condition (topic 1), and patients’ views on issues related to HIV cure research (topic 2).

Topic 1 is expected to be discussed from approximately 9:30 AM to noon, and Topic 2 approximately 1:30 - 5:30 PM.

Questions intended to frame discussion on these topics are provided below.

For each topic, a panel of patients and patient representatives/advocates will present comments to begin the dialogue which will be followed by a facilitated discussion inviting comments from other patients and patient representatives in the White Oak audience.

If you are interested in providing comments as part of one of the initial panel discussions, please indicate so during the registration process. Participants selected for the panel discussions will be confirmed prior to the meeting.

There will also be an opportunity for patients, patient representatives and others to provide comments on issues other than topics 1 and 2 during an Open Public Comment session. Sign up for Open Public Comment will take place the day of the meeting. For more information, refer to the FDA Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research website (

There is no cost for registration, but please register (below) by June 5, 2013.

The meeting will be webcast, however, remote viewers will not be able to directly participate in the discussions.
Questions for Discussion

Topic 1: Patients’ perspective on current approaches to managing HIV and on symptoms experienced because of HIV or its treatment

1) What are you currently doing to help manage your HIV and any symptoms you experience because of your condition or other therapies? (Examples may include prescription medicines, over-the-counter products, and non-drug therapies such as diet modification.)

a) What specific symptoms do your therapies or treatments address?

b) How long have you been on treatment and how has your treatment regimen changed over time?

2) How well does your current treatment regimen treat any significant symptoms of your condition?

a) How well have these treatments worked for you as your condition has changed over time?

b) Are there symptoms that your current regimen does not address at all, or does not treat as well as you would like?

3) What are the most significant downsides to your current therapies or treatments, and how do they affect your daily life? (Examples of downsides could include bothersome side effects, physical change to your body because of treatment, going to the hospital for treatment, etc.)

4) Of all the symptoms that you experience because of your condition, or because of your therapy or treatment, which 1-3 symptoms have the most significant impact on your life? (Examples could include diarrhea, insomnia, difficulty concentrating, etc.)

a) Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include sleeping through the night, daily hygiene, driving, etc.)

5) Assuming there is currently no complete cure for your condition, what specific things would you look for in an ideal therapy or treatment to manage your condition?

Topic 2: Patients’ perspectives on HIV Cure Research

1) What do you believe are the benefits of participating in an HIV cure research study?

2) What would motivate you to participate or to not participate in an HIV cure research study?

3) What risks would you find unacceptable for participating in an HIV cure research study, and why? (Examples of risks that may be associated with participation in an HIV cure research study include common side effects such as nausea and fatigue, and less common but serious adverse events such as blood clots, infection, seizures and cancer.)

4) In certain HIV cure research studies, you would be asked to stop any other HIV medications that you are currently taking. How would this affect your decision whether to participate in an HIV cure research study?

5) The process of informed consent is an important way for the researchers to communicate the purpose of an HIV research study, as well as its expected benefits and potential risks, so that people can make an informed decision whether to participate in the study.

a) How should the informed consent clearly communicate to you the purpose of an HIV cure research study, particularly when a study is designed only to provide scientific information that could guide future research and development of treatments?

b) How should the informed consent clearly communicate to you the potential benefits of an HIV cure research study? In particular, how should the informed consent describe benefit when we do not think that participants in the study may gain any direct health benefits?

c) How should informed consent communicate clearly to you the potential risks of participating in an HIV cure research study? In particular, how should the informed consent describe a study if there is very limited understanding about how the medications or interventions may affect participants or what are the potential risks of those interventions or medications?

d) Is there any other information that you would find helpful when deciding whether to enter an HIV cure research study?

6) What else do you want FDA to know about HIV Cure Research from your perspective?

To register for this meeting, visit
Registration will close on June 5, 2013.

The registration website contains links to background materials, and will be updated as additional meeting materials are developed, including a background document intended to help, along with the questions above, to frame discussion on the day of the meeting. That backgrounder will also be provided via this list serve prior to the meeting.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

If you are interested in receiving information about a broader range of FDA topics, consider subscribing to the FDA Patient Network News, a twice monthly newsletter containing FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.

Received as Email Alert from FDA May 13, 2013

U.S. FDA grants priority review to Simeprevir for combination treatment of genotype 1 chronic hepatitis C


13-May-13 Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) by Janssen for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease.

“This is a very important step bringing simeprevir closer to the market, making this therapy available to hepatitis C patients” comments Charlotte Edenius, EVP Development of Medivir.

The FDA grants priority review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. FDA review will begin approximately 60 days after receipt of the application and will aim to be complete within six months from when the review period begins.

The regulatory submission by Janssen for simeprevir is supported in part by data from three pivotal phase III studies: QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment. Janssen also recently submitted simeprevir for marketing authorization to regulatory authorities in Japan and Europe.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Mobile: +46 708 537 292

About Simeprevir
Simeprevir is a new generation NS3/4A protease inhibitor jointly developed by Medivir and Janssen for the treatment of chronic hepatitis C in adult patients with compensated liver disease.

For additional information about simeprevir clinical trials, please visit

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease and liver transplants, is a rapidly evolving treatment area with a clear need for innovative treatments. Approximately 150 million people are infected with hepatitis C worldwide, and about 350,000 people per year die from the disease.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases.

Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor in late phase III clinical development for hepatitis C that is being developed in collaboration with Janssen R&D Ireland. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir AB, please visit the Company’s website:

Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people’s lives.


Top 6 natural remedies to keep your liver healthy


Provided by

Anusuya Suresh, Last Updated: May 13, 2013 at 12:49 PM

The liver is one of our body’s busiest organs, with a role to play in most of the biochemical processes that sustain life. It produces bile that is vital to digestion, produces plasma proteins, stores iron, regulates the clotting of blood, synthesizes cholesterol, stores glucose as glycogen, regulates the levels of amino acids in blood, is involved with clotting of blood, removes toxins from the body and produces immune factors that help prevent infections. With our modern-day food and lifestyles (think greater junk food, alcohol, smoking, stress and medication) we put a greater pressure on our liver and this can cause several health problems right from allergies and migraines to obesity and indigestion. Here are a few herbal remedies that can help your liver stay healthy.

Amla or Gooseberry

The Indian gooseberry or amla is known as one of the richest sources of vitamin C. What is less well-known is its ability to keep the liver functioning at optimal levels. This herb has been used extensively in Ayurveda for treatment of a sluggish liver; now researchers are finding in laboratory studies that extracts from amla have liver-protective function. However, there is no clear indication of whether it is useful to treat hepatitis B infection. Amla is one of the important components in Chyawanpraash that has immunity boosting, digestive and liver-protective action. The best way to consume it is raw as small pieces in your salad or by making a raitha with grated amla and curd.

Jethimad or Licorice

People with non- alcoholic fatty liver disease show increased levels of the transaminase enzymes called ALT and AST. Studies have found that the use of licorice (Jethimad or Mulhati in Hindi) extracts led to reduced concentrations of these enzymes indicating that licorice has beneficial effects on the liver. Although licorice is more well-known for its sweet taste and anti-ulcer action, it has been used in Ayurvedic remedies to cure liver ailments. Licorice is available at stores selling Indian medicinal herbs; get the root, powder it at home and make a tea by pouring boiling water into the powder, steeping for a few minutes and then straining the liquid.

Amrith or Guduchi

Yet another herb that Ayurveda considers to have rejuvenating properties, Amrith is commonly grown in many kitchen gardens. It is said to have the ability to clear toxins from the liver as well as strengthen its functioning; more importantly, it does not cause any significant complications even on using long-term. However, Ayurvedic physicians warn that using this herb can precipitate a liver crisis if the patient has a large amount of toxins in the liver; therefore, it is best to use this only under an Ayurvedic practitioner’s guidance.

Haldi or Turmeric

Full of valuable antioxidants, turmeric is an important herb that improves liver health. No wonder then that people in Asian countries use it so extensively in their cooking. Now, it is being recognized even in western countries for its liver-protective value. Some studies have also found that the antiviral action of turmeric is effective in preventing the multiplication of the viruses causing hepatitis B and C. The easiest way to take turmeric is to include it in your cooking; you can also make it a practice to drink a little turmeric-flavoured milk on a regular basis to get its benefits.


Certain receptor sites normally bind hormones and keep them circulating in the blood. This puts a strain on the liver which has to filter out these excess hormones. Studies have found that the phytoconstituents in flaxseeds have the capacity to bind with such receptor sites and this prevents hormonal binding, and this means less work for the liver. Just sprinkling a few crushed or whole flaxseeds on your toast, salad or cereals can help you make use of their liver-protective effect.


Certain vegetables contain ingredients that help the liver secrete greater concentrations of important enzymes; in turn, these enzymes help to excrete potential carcinogens (cancer-causing substances) from the body. Beet, cabbage, carrot, broccoli, onion and garlic are important vegetables with such an action. Broccoli, onion and garlic are believed to provide sulfur to the body; this helps in the detoxification reactions the liver carries out and prevents damage to the liver.

Along with the use of these natural remedies, it is also important to avoid foods that cause damage to the liver. If you eat foods that are highly processed with a large number of additives, or if you take too many medications, your liver has to work overtime to tackle this greater chemical load and this can cause damage. Food that is rich in hydrogenated oil, high fructose corn syrup, artificial sweetening agents and alcohol are some of the other substances that can put a greater load on your liver. Along with consuming of liver-protective herbs, it is also important to make sure you avoid the foods that cause it harm.

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First Published: May 13, 2013 at 12:29 PM


Hepatitis C education important

Provided by Cape Breton Post

Published on May 13, 2013

By Judy Kelley (Your Health, Your Community)

One of the most challenging yet exciting aspects of my job as a public health nurse is having the opportunity to educate the community about hepatitis C.

I have come to learn that there are some common misconceptions about hepatitis C.

An estimated 250,000 Canadians have hepatitis C, but many don't know it. Hepatitis C can be silent in your body and you can have it for decades without having any symptoms. Approximately one in five people who are infected with hepatitis C is not aware they are infected and may unknowingly spread the disease to others.

The hepatitis C virus lives in the blood and can survive on surfaces for three days or longer. The majority of people contract the virus through injection drug use by sharing needles, spoons/cookers, rinse water and other gear that has been contaminated with hepatitis C infected blood. People will usually become infected within the first three years of drug use.

It can also be spread from sharing other items that may have microscopic amounts of blood on them, such as straws for snorting drugs, crack pipes, toothbrushes, razors, needles, nail clippers, tattoo guns and ink.

Prior to 1990, the Canadian blood system did not test blood for hepatitis C and some people were infected through blood transfusion. Blood transfusions are now screened and considered safe from hepatitis C.

It should be stressed that hepatitis C is spread through blood-to-blood contact and it cannot be spread through casual contact like handshakes, hugs and sharing eating utensils (used for eating, not injection drug use).

Many people get mixed up about the three most common types of viral hepatitis (hepatitis A, B and C). They may think they are protected from all hepatitis viruses by getting a Twinrix vaccine (hepatitis A and B vaccine). While the Twinrix vaccine is safe and effective in preventing hepatitis A and B, it does not offer any protection against hepatitis C.

The hepatitis C virus is like the common cold in that it replicates and changes so much that the body can never be immune to it. That being said, there is hope that a hepatitis C vaccine will someday be available.

Tattoos and multiple piercings are risk factors for hepatitis C. As a result, public health has partnered with HepNS to deliver safer tattooing and piercing messages (Hip not Hep) to the Grade 9 students within the Cape Breton-Victoria Regional School Board. Students are given information of the associated risks of tattoos and piercings and are encouraged to make informed decisions about their health.

Getting tested is the only way to find out if you have hepatitis C or not. It is a leading cause of cirrhosis, liver cancer and can lead to liver transplant. New treatments are available that can cure hepatitis C, prevent further liver damage and improve health outcomes for people infected.

Cape Breton has higher rates of hepatitis C than other parts of the province. This is due to many variables which are compounded by poverty, food and housing issues.

The most important thing to remember is if you have ever engaged in a high risk activity, even if it was only once and a longtime ago, consider getting tested for hepatitis C.

Judy Kelley is a public health nurse with the Cape Breton District Health Authority. This column is part of a locally written series on population health, which looks at factors like income, education, social support, housing etc., that influence the health of a community.


In Brazil, Mexico and Argentina, Dual Combination Therapy With Peg-IFN-alpha and Ribavirin Remains the Most Commonly Prescribed Treatment for all Hepatitis C Virus-Infected Patients



May 13, 2013, 9:00 a.m. EDT

However, Recent Changes in Brazil and Argentina are Expected to Drive a Shift in Treatment of HCV Genotype 1 Infections, According to a New Report From Decision Resources

BURLINGTON, Mass., May 13, 2013 /PRNewswire via COMTEX/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the majority of hepatitis C virus (HCV) patients in Brazil, Mexico and Argentina rely entirely on government-sponsored medical programs to cover their treatment costs. However, in Mexico, approximately half of the population remains uncovered for HCV therapies, while the remaining population has access to only dual therapy through Social Security (SS). Surveyed clinicians in this country point to out-of-pocket costs and government/hospital-imposed budget restrictions as barriers to prescription drug treatment. Moreover, although Brazilian clinicians report higher rates of prescription drug treatment in all segments of diagnosed, viremic HCV public patients compared with physicians in Mexico and Argentina, treatment rates of nonresponders among surveyed clinicians are usually less than 40 percent in all countries.

The Emerging Markets Physician & Payer Forum report entitled Positioning of Current and Emerging Agents for Hepatitis C Virus: Physician and Payer Perspectives on the Prescribing and Patient Access Landscape in Brazil, Mexico, and Argentina also finds that peg-IFN-alpha (Roche's Pegasys and Merck's PegIntron) enjoys full government sponsorship in all three countries, but current access to protease inhibitors (Johnson & Johnson's Incivo and Merck's Victrelis) is still very limited in some of the markets; therefore, peg-IFN/ribavirin is the treatment that surveyed clinicians most frequently prescribe to treatment-naive and nonresponder public patients. In Brazil, for example, triplet regimens are used in the treatment of only 20 percent of nonresponder HCV1 public patients and in only 5 percent of those who are treatment-naive.

The report also finds that in a scenario where all treatments for HCV are reimbursed by the government, surveyed clinicians clearly indicate their willingness to prescribe triple therapy to their HCV patients, including those with HCV genotype 2/3, despite the lack of evidence for clinical benefit in this subpopulation.

"Initiatives to include protease inhibitors in public programs in all three countries are currently gaining momentum," said Decision Resources Analyst Andreia Ribeiro, Ph.D. "In Brazil, Incivo and Victrelis are now being incorporated in public reference hospitals and state HCV programs, after a positive recommendation by CONITEC (the national HTA body) for the inclusion of protease inhibitors in the National Health System in July, 2012. In Argentina, the Superintendencia de Servicios de Salud recently included protease inhibitors in the coverage of the Single Refund System. Therefore, the different SS funds (Obras Sociales) can now be reimbursed for the provision of triple therapy treatment to HCV1 patients. Additionally, in Mexico, the fact that Victrelis was recently included in the national formularies may lead to the incorporation of this drug in the SS sector soon."

About Decision ResourcesDecision Resources ( 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 GroupDecision 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

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SOURCE Decision Resources


May is Hepatitis Awareness Month

May is Hepatitis Awareness Month

National Hepatitis Testing Day on May 19th

May is dedicated to highlighting the silent epidemic of chronic hepatitis B and hepatitis C infections that affects more than 5 million Americans. Most, however, are unaware of their infection. To boost screening rates, the Centers for Disease Control and Prevention (CDC) has designated May 19 as National Hepatitis Testing Day. Find an event near you to support during May at Hep B United, a national hepatitis B campaign spearheaded by the HBF and AAPCHO, and the Centers for Disease Control. Read more.

May is National Hepatitis Awareness Month and the goal is to highlight the silent epidemic of more than 5 million Americans suffering from chronic hepatitis B and hepatitis C infections. With most Americans unaware that they are infected with these serious liver infections, it is essential to improve screening and testing rates to reduce the burden of illness and death from these diseases.

May 19 is National Hepatitis Testing Day, an educational initiative of the Center for Disease Control (CDC) Division of Viral Hepatitis and the U.S. Department of Health & Human Services, to boost screening rates in the U.S.

For more information about May Hepatitis Awareness Month and to find an event near you for May 19 Hepatitis Testing Day, visit the following websites:

Hep B United – A national hepatitis B campaign to support and leverage local coalitions around the country addressing hepatitis B and liver cancer. Includes links to Hepatitis B Testing events in different states.

CDC Hepatitis Awareness Month - Check back over the course of the month as exciting new resources and tools are added to this page maintained by the CDC.

CDC NPIN – Find events across the country on this CDC webpage that includes an interactive map of the U.S.