HCV Research and News: 09/24/13

September 24, 2013

The Burden of HIV

Insights From the Global Burden of Disease Study 2010

Katrina F. Ortblad, Rafael Lozano, Christopher J.L. Murray

AIDS. 2013;27(13):2003-2017.

Abstract and Introduction

Abstract

Objectives: To evaluate the global and country-level burden of HIV/AIDS relative to 291 other causes of disease burden from 1980 to 2010 using the Global Burden of Disease Study 2010 (GBD 2010) as the vehicle for exploration.

Methods: HIV/AIDS burden estimates were derived elsewhere as a part of GBD 2010, a comprehensive assessment of the magnitude of 291 diseases and injuries from 1990 to 2010 for 187 countries. In GBD 2010, disability-adjusted life years (DALYs) are used as the measurement of disease burden. DALY estimates for HIV/AIDS come from UNAIDS' 2012 prevalence and mortality estimates, GBD 2010 disability weights and mortality estimates derived from quality vital registration data.

Results: Despite recent declines in global HIV/AIDS mortality, HIV/AIDS was still the fifth leading cause of global DALYs in 2010. The distribution of HIV/AIDS burden is not equal across demographics and regions. In 2010, HIV/AIDS was ranked as the leading DALY cause for ages 30–44 years in both sexes and for 21 countries that fall into four distinctive blocks: Eastern and Southern Africa, Central Africa, the Caribbean and Thailand. Although a majority of the DALYs caused by HIV/AIDS are in high-burden countries, 20% of the global HIV/AIDS burden in 2010 was in countries where HIV/AIDS did not make the top 10 leading causes of burden.

Conclusion: In the midst of a global economic recession, tracking the magnitude of the HIV/AIDS epidemic and its importance relative to other diseases and injuries is critical to effectively allocating limited resources and maintaining funding for effective HIV/AIDS interventions and treatments.

Introduction

In the last 30 years, the HIV/AIDS epidemic has emerged as one of the major challenges for the world, going from a relatively small problem in the 1980s to one of the leading causes of mortality and burden over the last decade.^[1–3] The global trend is towards a larger and larger share of disease burden coming from noncommunicable diseases and injuries; however, HIV/AIDS is a dramatic exception.^[2–4] Mortality and burden from HIV/AIDS increased steadily until around 2004, against the general trend of declining infectious disease burden. The HIV/AIDS epidemic has been truly global with 186 countries reporting HIV cases or deaths in 2012.^[5,6]

Substantial concerted global action has emerged around the HIV/AIDS epidemic. New institutions have been formed: UNAIDS in 1996^[7] and the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) as well as the US President's Emergency Plan for AIDS Relief (PEPFAR) in 2002.^[8,9] These new global actors with substantial commitments to HIV/AIDS have been, along with many other nongovernmental programmes, key in raising national policy awareness in many affected countries and in scaling up access to antiretroviral therapies (ARTs).^[10,11] In 2011, eight million HIV-positive people received ARTs (a 20-fold increase since 2003), translating into 54% of all eligible people in low and middle-income countries.^[5] Expansion of ART coverage is likely to have contributed to the reversal of the global trend in HIV/AIDS mortality. Successful scale-up of ARTs and the progress in reducing HIV/AIDS mortality have sparked excitement in the global community, and ambitious goals have followed.^[12] In 2011, UNAIDS released its 'Getting to Zero' campaign with a vision that entails a future generation with 'zero new HIV infections, zero discrimination and zero AIDS-related deaths'.^[13,14]

Many factors have contributed to the achievements of the global response to the epidemic; new financial resources are likely to have been critical. Between 2002 and 2010, development assistance for health (DAH) targeted for HIV/AIDS increased from US$1.4 billion to US$6.8 billion (385.7%);^[15] and this does not include the substantial funds spent by low- and middle-income countries themselves.^[13] Since 2010, however, levels of DAH have stagnated, as the long-run effects of the global financial crisis become apparent in the budgets of high-income countries. Because of the success of ART programmes and the continued evolution of the epidemic, the numbers of individuals who need ARTs will continue to rise steadily.^[5] Increasing need for resources for HIV/AIDS programmes in the context of flat-line budgets is also happening in parallel with renewed attention to other health problems such as child mortality, maternal mortality and more recently noncommunicable diseases.^[15]

Maintaining and expanding the response to the HIV/AIDS epidemic will require continued emphasis on quantifying the magnitude of the impact of the epidemic in each country. UNAIDS and the WHO provide bi-annual assessments of the epidemic in terms of incidence of new infections, the prevalence of people living with HIV and deaths from HIV/AIDS for the vast majority of countries.^[5,16–18] These analyses have been invaluable in garnering policy attention and response. The financial needs of HIV/AIDS programmes during a period of stagnant DAH levels highlight the importance of tracking the HIV/AIDS epidemic in the context of other health problems. At the national level, understanding the importance of the HIV/AIDS epidemic and its trends is facilitated by measuring the burden of disease in units that allow comparison with other major conditions. Comparable metrics of disease burden provide much-needed information on where the epidemic remains one of the dominant causes of health loss and where the burden is still rising despite progress in many countries.^[19]

The Global Burden of Disease Study 2010 (GBD 2010)^{[1–3,20–25]} provides a comprehensive coherent view of the magnitude of 291 diseases and injuries from 1990 to 2010 for 187 countries. GBD 2010 uses a consistent set of definitions, approaches to data and methods to quantify health loss from all these diseases and injuries.^[21] Multiple metrics are used to compare conditions, including death numbers, age-specific mortality rates, years of life lost due to premature mortality (YLLs), years lived with disability (YLDs) and disability-adjusted life years (DALYs). DALYs are a summation of YLLs and YLDs and serve as an overall metric of disease burden. In this study, we use GBD 2010 to understand the magnitude of the HIV/AIDS epidemic at the national level, in the context of all other major health problems, and how it has been changing over the last two decades.

Continue reading full article here …..

Expanded Hepatitis C Virus Screening Recommendations Promote Opportunities for Care and Cure

Annals of Internal Medicine 3 September 2013, Vol 159, No. 5

Editorials | 3 September 2013

Quyen Ngo-Metzger, MD, MPH; John W. Ward, MD; and Ronald O. Valdiserri, MD, MPH

[+-] Article and Author Information

Drexel Researchers Create Molecule That Can Trick HIV Into Destroying Itself

Provided by Infection Control Today

Pinning down an effective way to combat the spread of the human immunodeficiency virus, the viral precursor to AIDS, has long been challenge task for scientists and physicians, because the virus is an elusive one that mutates frequently and, as a result, quickly becomes immune to medication. A team of Drexel University researchers is trying to get one step ahead of the virus with a microbicide they’ve created that can trick HIV into “popping” itself into oblivion.

Its name is DAVEI, which stands for “Dual Action Virolytic Entry Inhibitor," and it can pull a fast one on HIV. DAVEI was invented and tested by scientists from Drexel’s College of Engineering; School of Biomedical Engineering, Science and Health Systems; and College of Medicine, and is the latest in a new generation of HIV treatments that function by specifically destroying the virus without harming healthy cells.

“While several molecules that destroy HIV have recently been announced, DAVEI is unique among them by virtue of its design, specificity and high potency,” says Dr. Cameron Abrams, a professor in Drexel’s College of Engineering and a primary investigator of the project.

A team co-led by Abrams and Dr. Irwin Chaiken in the Department of Biochemistry and Molecular Biology in Drexel’s College of Medicine, and including Dr. Mark Contarino and doctoral students Arangassery Rosemary Bastian and R. V. Kalyana Sundaram, developed the chimeric recombinantly engineered protein – that is, a molecule assembled from pieces of other molecules and engineered for a specific purpose, in this case to fight HIV. Their research will be published in the October edition of the American Society for Microbiology’s Antimicrobial Agents and Chemotherapy.

The idea behind DAVEI was to design a molecule that hijacks the virus’s fusion machinery, the tools it uses to attach to and attack a healthy cell, and trick the virus into destroying itself. HIV invades a healthy cell by first attaching via protein “spikes” that then collapse to pull viral and cell membranes together, fusing them and allowing the genetic contents of the virus to enter the healthy cell. The cell is rewired by the viral genetic material into producing more viruses instead of performing its normal function, which, in the case of cells infected by HIV, involves normal immunity. AIDS is the result.

“We hypothesized that an important role of the fusion machinery is to open the viral membrane when triggered, and it follows that a trigger didn’t necessarily have to be a doomed cell,” Abrams says. “So we envisioned particular ways the components of the viral fusion machinery work and designed a molecule that would trigger it prematurely,” Abrams adds.

They designed DAVEI from two main ingredients. One piece, called the Membrane Proximal External Region (MPER), is itself a small piece of the fusion machinery and interacts strongly with viral membranes. The other piece, called cyanovirin, binds to the sugar coating of the protein spike. Working together, the MPER and cyanovirin in DAVEI “tweak” the fusion machinery in a way that mimics the forces it feels when attached to a cell.

“For lack of a better term, DAVEI ‘tricks’ the virus into ‘thinking’ it is about to infect a healthy cell, when, in fact, there is nothing there for it to infect,” Abrams says. “Instead, it releases its genetic payload harmlessly and dies.”

Chaiken’s lab has extensively investigated the molecular mechanisms of HIV-1 envelope protein interactions and structure-based design of agents that fight HIV. The researchers produced DAVEI by recombinant protein engineering and used HIV-1 pseudoviruses to demonstrate that it can physically rupture and irreversibly inactivate the virus particles.

“DAVEI and other new-generation virolytic inactivators open up an important opportunity to develop a topical microbicide to block the transmission of HIV, and at the same time provide lead ideas to discover treatment strategies for people who are already infected,” Chaiken says. “Our hope is that determining the structural driving forces of both inhibitors and viral entry machinery that enable spike inactivation will help to advance molecular designs with increased power, specificity and clinical potential for both prevention and treatment.”

Source: Drexel University

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'Traffic light' test could prevent hundreds of people developing alcohol-related cirrhosis

Provided by MedicalXpress

September 24, 2013

A simple 'traffic light' test that detects hidden liver fibrosis and cirrhosis in high risk populations could reduce harmful drinking rates and potentially prevent hundreds of alcohol-related deaths a year.

Devised by Dr Nick Sheron and colleagues at University of Southampton and Southampton General Hospital, the Southampton Traffic Light (STL) test, which costs about £50, could be used by GPs in the community.

Published in the October 2013 issue of the British Journal of General Practice (BJGP), the STL appeared to help reduce drinking rates in people with the highest risk of liver disease.

Liver disease develops silently without symptoms, and many people have no idea they have liver failure until it is too late – one third of people admitted to hospital with end-stage liver disease die within the first few months. However, a simple test available in primary care could diagnose disease much earlier, enabling those at risk to change their behaviour and save lives.

The STL test combines several different tests and clinical markers which are given a score that indicates the patient's likelihood of developing liver fibrosis and liver cirrhosis.*

The result comes in three colours: red means that the patient probably has liver scarring (fibrosis) and may even have cirrhosis, green means that there is no cirrhosis and the patient is highly unlikely to die from liver disease over the next five years. Amber means there is at least a 50:50 chance of scarring and patients are advised to reduce or avoid drinking to avert further disease progression.

During the study, funded by the National Institute for Health Research (NIHR) Research for Patient Benefit Programme, the STL test was used on 393 heavy drinkers identified through a questionnaire administered by their GP surgery. Results from the test showed there were 45 (12 per cent) red patients, 157 (40 per cent) amber and 191 (49 per cent) green. In the vast majority of patients (75 per cent) with a red test, the usual panel of liver blood tests were entirely normal, so there was no way that GPs would have been able to pick up the hidden liver disease and warn their patients of the impending problem.

Follow up questionnaires were sent to participants a year later to assess their drinking habits. Results showed that 65 per cent of the harmful/dependent drinkers with a red and amber STL results reduced drinking to a non-harmful amount, nearly twice as many as those with green STL (35 per cent) results.

Dr Nick Sheron, lead author and Head of Clinical Hepatology at the University of Southampton, and consultant hepatologist at Southampton General Hospital, said: "Patients are developing alcohol-related liver disease in the community but it is not being picked up until they are admitted to hospital, by which time it is too late for many of them. Since 1996 there have been about 4,000 admissions to Southampton General Hospital with cirrhosis and 75 per cent of them won't have known they had it.

"It is possible that hundreds of lives could be saved by having a simple test, like the STL test, available in the community, not to mention NHS resources. Our results show that overall, of those attending the STL test, 42 per cent reduced their drinking rate. But what is even better is that the really high risk group of harmful drinkers, 65 per cent reduced their alcohol intake to a non-harmful level."

Study co-author and GP Dr Michael Moore said: "Liver death rates in the UK have doubled over the last 15 years mostly attributed to consumption of alcohol. Liver disease is a silent killer. In primary care, minor abnormalities of existing liver tests are quite common but we struggle to know how best to investigate these further and who warrants specialist intervention. The traffic light test has the advantage of highlighting those at highest risk who should be investigated further and those in whom the risk is much lower where a watchful approach is more appropriate. Alcohol has harmful effects other than on the liver and of course we recommend to all those drinking at hazardous levels to cut down. Using this test appears to provide additional motivation to those at greatest risk of liver disease."

Explore further: High alcohol relapse rate blamed for poor survival in liver-disease patients

Journal reference: British Journal of General Practice

Provided by University of Southampton

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OSAP offers hepatitis C prevention information toolkit

In light of last week’s announcement of the first documented patient-to-patient transmission of hepatitis C virus (HCV) in a dental practice, the Organization for Safety, Asepsis and Prevention (OSAP) is offering some members-only resources to the broader dental community to help support compliance efforts for safe infection prevention practices.

The HCV case stems from the public health investigation of a Tulsa, Oklahoma oral surgical clinic in which current and former patients of the practice may have been exposed to bloodborne viruses. The Oklahoma State Department of Health and Tulsa Health Department released an interim status report on September 18 on the results of their public health investigation.

“This is the first documented report of patient-to-patient transmission of hepatitis C virus associated with a dental setting in the United States,” said Dr. Kristy Bradley, Oklahoma State Epidemiologist. Dr. Bradley spoke at OSAP’s 2013 Infection Prevention Symposium in June. “While dental procedures are generally safe, this reinforces the importance of adhering to strict infection control procedures in dental settings.”

With the amount of media coverage this case is receiving, OSAP believes the time is right for the dental team to have a conversation about infection control and bloodborne pathogens, especially hepatitis C. OSAP has developed a free downloadable hepatitis C toolkit featuring relevant regulations and guidelines, best practices, instructional resources and patient resources available to its members. It can now be accessed by every dental professional here.

Also available are videos in English and Spanish, fact sheets, online training and many other resources.

A summary of Dr. Bradley’s June lecture describing the investigative process in this case that includes key takeaways, implementation steps and hyperlinked resources can be found on pages 2-3 of the 2013 OSAP Symposium Proceedings, available here.

The Oklahoma State Department of Health’s announcement can be found here.

Additional resources are available through OSAP’s website, the Centers for Disease Control and Prevention (CDC), and the American Dental Association (ADA).

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Real-world SVR rate about 33% with hepatitis C triple therapy

09/24/13

AT ICAAC 2013

By: M. ALEXANDER OTTO, Family Practice News Digital Network

DENVER – Only one-third of a group of patients with hepatitis C achieved a sustained virologic response when a protease inhibitor was added to standard ribavirin and interferon dual therapy, a real-world finding that flies in the face of reported response rates closer to 90%, according to Dr. Arpita Sheth who presented a poster at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

Of 42 patients at the Veterans Affairs hospital in East Orange, N.J., who started on triple therapy with the protease inhibitor boceprevir, 9 had to drop out because of previously recognized adverse events, including thrombocytopenia, neutropenia, anemia, and depression. Five other patients did not comply with treatment, and treatment failed in 10. About half of the patients were new to therapy and the rest either non- responders to dual-therapy or triple-therapy relapsers.

Of the 18 who completed treatment, 9 achieved SVR [sustained virological response] at 3 months and 5 at 6 months. The four remaining patients relapsed.

"The incremental gain of adding protease inhibitors to the traditional regimen of ribavirin and interferon has a potential SVR rate of 33% (14/42) among retreaters and naive-to-treatment patients. Treatment should be evaluated at a more realistic number of 33% success [rather] than the 80%-90% SVR rate so frequently quoted from the FDA registration trials," concluded Dr. Sheth, a fellow at Rutgers New Jersey Medical School in Newark, in her presentation.

The real-world rate is lower, at least in Newark’s VA population. To avoid disappointment, "we should always make our patients aware of that; we’ve seen a lot of patients get upset that they didn’t really get cured" with triple therapy, she said at the meeting. The findings from the study conducted by Dr. Sheth and her associates was published earlier (N. Engl. J. Med. 2011;364:1207-17).

The results probably had something to do with "the patient population we had. They do have some underlying history that includes depression, alcohol use, drug use, and a lot of other things. Even though [most] said they were compliant, I don’t think [compliance was] what they reported," Dr. Sheth said.

About a third of patients in the study required erythropoietin to maintain their hemoglobin at 10 g/dL or higher while on triple therapy.

Dr. Sheth and her team reported that they have no disclosures.

aotto@frontlinemedcom.com

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The impact of chronic hepatitis C on resource utilisation and in-patient mortality for Medicare beneficiaries between 2005 and 2010

Alimentary Pharmacology & Therapeutics

Early View (Online Version of Record published before inclusion in an issue)

Original Article

Z. M. Younossi^1,2,*, M. Stepanova², A. Mishra¹, C. Venkatesan¹, L. Henry², S. Hunt^1,2

Article first published online: 12 SEP 2013

DOI: 10.1111/apt.12485

Summary

Background

As baby boomers age, chronic hepatitis C (CHC) will become increasingly important in Medicare eligible group.

Aim

To evaluate trends in Medicare resource utilisation for CHC.

Methods

We analysed the Medicare in-patient and out-patient data from 2005 to 2010. For each patient, all claims with CHC as a principal diagnosis were added up and yearly CHC-related spending was calculated.

Results

A total of 48 880 out-patient claims for 21 655 CHC patients and 4884 hospital admission claims for 3092 patients were included. The number of in-patient (1.5–1.6/year) or out-patient (2.2–2.3/year) visits per patient did not change over time, nor did the demographic characteristics of the CHC population. The majority of this population was eligible for Medicare based on disability and the average number of diagnoses per in-patient claim (from 8.11 in 2005 to 8.60 in 2010) and per out-patient claim (from 2.18 in 2005 to 2.71 in 2010) increased (both P < 0.0001). The average total yearly spending per patient increased in the out-patient setting from $488 in 2005 to $584 in 2010 (P = 0.0132) and did not change in the in-patient setting (from $22 245 in 2005 to $23 383 in 2010, P = 0.14). In the multivariate analysis, the number of diagnoses and conditions per claim and the number of in-patient or out-patient procedures per year were the important independent predictors of increased resource utilisation.

Conclusions

Most Medicare beneficiaries with chronic hepatitis C who sought in-patient or out-patient care in 2005–2010 had received Medicare for disability. Although the total resource utilisation did not change, the proportion of patient's responsibility increased.

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Combining Drugs Cures Some With Hepatitis C

Provided by Voice of America

Carol Pearson

September 24, 2013

At least 150 million people in the world have a chronic liver disease called hepatitis C, according to the World Health Organization. Hepatitis C runs the gamut from a mild disease to a deadly one. While there's no vaccine to prevent it, researchers have found a combination of drugs that cures many difficult cases.

Researchers have been looking for ways to cure or prevent hepatitis C infections. Hepatitis C is contagious, and it can cause liver failure, liver cancer and death.

“Chronic hepatitis C infection is the leading reason why we have liver transplantation in the United States," said Dr. Anthony Fauci from the National Institutes of Health.

Fauci headed a study that focused on patients who lived in poor, urban areas, mostly African-American who already had liver disease. These patients were given a new drug, sofosbuvir, which has not yet been approved by the Food and Drug Administration.

“Sofosbuvir is an agent that acts directly against the hepatitis C virus itself. It interferes with one of the enzymes that’s important for this virus to replicate itself," Fauci said.

The patients also received rivavirin, an older drug that fights hepatitis C. After receiving both drugs for a period of time, between 50 and 70 percent of the patients were cured. They did not have the hepatitis C virus in their blood.

The treatment excluded interferon - a drug frequently given by injection to combat the disease.
Interferon can cause serious effects that make it difficult to take, but the combination of drugs given in the trial had minimal side effects, and none of the patients dropped out.

Hepatitis C is considered a silent killer because most people don't know they have it until the disease is advanced. Catching it early prevents liver cancer and liver failure, and improves the odds of a cure, which is why Fauci says aggressive screening is as important as finding drugs that are easy to take.

“The idea of getting these people diagnosed and, if they need it, to get them into a treatment regimen is a very important public health imperative," he said.

The study appeared in the Journal of the American Medical Association.

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CME: Future Therapies: Understanding Emerging IFN-free Options

Provided by Healio

CME

Earn CME Credit »

Author(s)/Faculty: Michael W. Fried, MD

Source: Healio - Gastroenterology Education Lab

Type:
Articles/Items: 2

Release Date: 9/13/2013
Expiration Date: 9/12/2014

Credit Type: CME
Number of Credit(s): 0.25

Cost: Free

Provider:

Chronic hepatitis C virus (HCV) infection is a leading cause of cirrhosis, end-stage liver disease, hepatocellular carcinoma, and death from liver disease in the United States. The discovery, development, and availability of direct-acting antiviral agents (DAAs) offers new treatment options and the possibility of improved outcomes for newly diagnosed patients as well as those who have experienced a relapse or failed to respond to previous treatment. However, use of the first generation protease inhibitors introduced new challenges and added to the complexity of HCV treatment and care. With rapid advancements in the field and new agents offering potential improvements in outcomes, shorter treatment durations, use without interferon, and unique adverse event profiles, clinicians must stay informed of the evolving data in order to counsel patients appropriately—in particular, those who may wish to discuss the benefits and risks of initiating therapy now vs. waiting for therapies in the near-term vs, delaying treatment for interferon-free options.

Effective management of HCV continues to pose a challenge for health care practitioners. This activity is a pre-study module corresponding with the topics offered as part of the for the HCV VOICE Meeting Series. The purpose of the unique HCV VOICE initiative is to provide specific, targeted educational opportunities for clinicians who are involved in the management of patients with HCV.

This activity is supported by educational grants from abbvie and Genentech.

Pretest

Interview

Posttest

Sponsorship Statement: This continuing medical education activity is co-sponsored by and .

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AIDS nonprofit group faces union campaign

Medical staff members at the AIDS Healthcare Foundation are seeking representation by the National Union of Healthcare Workers, charging that care is suffering.

By Abby Sewell

September 24, 2013

A group of medical providers at clinics run by an influential but controversial AIDS-focused nonprofit group have launched a bid to unionize, saying that the organization's leadership has lost sight of its mission and patient care is suffering.

Doctors, nurses and physicians assistants in the AIDS Healthcare Foundation's Los Angeles and Bay Area clinics have been engaged in a behind-the-scenes struggle with the organization's leadership for the last two months.

On July 31, medical staff members submitted a petition to the National Labor Relations Board, announcing their desire to organize under the National Union of Healthcare Workers.

The foundation's leadership has contested the validity of the petition, saying that some of the employees involved in the union drive are supervisors not allowed to take part in union organizing.

The organization, with a budget of $750 million, runs a network of HIV and AIDS testing and treatment facilities around the world, as well as its own pharmacies. Its 10 clinics in the Los Angeles area serve more than 7,000 patients, many of them through contracts with the county.

Local providers say that those clinics are understaffed, that there is a lack of Spanish interpreters and that there has been a push to pack more patients into the schedule each day at the expense of quality care. They say their complaints have been disregarded and that the organization is focusing too much energy on political advocacy. Those include fights with the county and with the adult film industry over attempts to mandate condom use on set as a way to reduce exposure to social diseases.

"We support AHF's mission — that's why we're all here in the first place, but we feel like they're not really carrying out their mission," said Felipe Findley, a physician's assistant at the foundation's downtown clinic.

Kim Sommers, medical director at the organization's Hollywood center, recalled that one day the clinic was so over capacity that a patient suffering from chest pains was sent home by the lone over-stressed medical assistant on duty because no one was available to give him the electrocardiogram Sommers had ordered.

"He came back two days later and he ended up being OK," Sommers said. "But the point is, we don't want to wait for something horrible to happen."

AIDS Healthcare Foundation founder and President Michael Weinstein said the union process had been "tainted" by the involvement of middle managers.

"They've got an absolute right to form a union, but right now it's been organized by people in management, and they've put a lot of pressure on rank-and-file employees," he said. For their part, employees have filed complaints alleging that the executive leadership retaliated against them for their union activities.

Weinstein said the organization is indeed focused on patient care and that changes in scheduling policies were made because the organization had lost patients when they were unable to get follow-up appointments scheduled in a timely manner. He defended the organization's political activities as a core part of its mission.

"The advocacy is who we are, and I would argue that the advocacy we do has very much helped us to improve the care in our patient centers," he said.

The workers went public with their complaints as the foundation's leadership is heading into another political fight with Los Angeles County. The foundation says that the county's Department of Public Health is sprawling and inefficient and is campaigning for a measure for the June ballot that would create an independent health department in the city of Los Angeles.

The county Board of Supervisors voted 3 to 2 last week to go to court in an attempt to stop the measure from getting to the ballot. The board is scheduled to discuss the potential effects of the proposal Tuesday.

abby.sewell@latimes.com

Times staff writer Seema Mehta contributed to this report.

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Ligand Partner GSK Receives Marketing Authorization from the European Commission for Additional Revolade(TM) (Eltrombopag) Indication as the First Approved Treatment for Chronic Hepatitis C-Associated Thrombocytopenia

PRESS RELEASE

SAN DIEGO--(BUSINESS WIRE)--September 24, 2013--

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner GlaxoSmithKline plc (LSE:GSK) (NYSE:GSK) announced today that the European Commission has granted an additional indication for Revolade(TM) (eltrombopag) as a treatment for low platelet counts (thrombocytopenia) in adult patients with chronic hepatitis C infection, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon (IFN)-based therapy.(1)

Thrombocytopenia may prevent the initiation(2) and maintenance of peginterferon (pIFN)-based treatment, thereby reducing a patient's chances of achieving a sustained virologic response (SVR)*(3) - the primary goal of hepatitis C treatment.

"We are extremely pleased with the decision of the European Commission, and eagerly await the launch of Revolade in the European Union for this indication. This is an important achievement, as otherwise very sick patients suffering with chronic hepatitis C infection with few therapeutic options will now have the opportunity to potentially receive needed treatment," commented John Higgins, President and Chief Executive Officer of Ligand. "Ligand commends GSK's global Revolade and Promacta team for their commitment to this program and for leading it to continued regulatory success."

About Eltrombopag

Eltrombopag, marketed under the brand name Revolade(TM) in Europe and most ex-US countries, and Promacta(R) in the U.S., is an oral thrombopoietin receptor agonist licensed in over 90 countries around the world as a treatment for thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Eltrombopag, indicated in adult patients as a once-daily oral therapy, was approved for chronic hepatitis C-associated thrombocytopenia by the European Commission on September 23, 2013. Promacta(R)/Revolade(TM) is approved for chronic hepatitis C associated thrombocytopenia in Argentina, Australia, Bangladesh, Pakistan, Philippines and the US.

About GlaxoSmithKline

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company that develops and acquires assets it believes will generate royalty revenues and, under its lean corporate cost structure, produce sustainable profitability. Ligand has a diverse asset portfolio addressing the unmet medical needs of patients for a broad spectrum of diseases including thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia, anemia and osteoporosis. Ligand's Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances with the world's leading pharmaceutical companies including GlaxoSmithKline, Onyx Pharmaceuticals, Merck, Pfizer, Baxter International, Bristol-Myers Squibb, Lundbeck Inc., Eli Lilly & Co. and Spectrum Pharmaceuticals. Please visit www.captisol.com for more information on Captisol and www.ligand.com for more information on Ligand.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains certain forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These statements include those related to the importance of the approval of additional indications for Revolade (eltrombopag) or any potential launch or marketing effort associated therewith. Actual events or results may differ from Ligand's expectations. There can be no assurance GlaxoSmithKline will continue clinical development of eltrombopag, or any additional indications thereof, that the product will be commercially successful, provide new options or be successfully marketed; that any future milestone or royalty payments will be received, or that if any future milestones or royalties are received that they will not be subject to sharing obligations with any third party. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand's business can be found in prior press releases available via www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

(1) REVOLADE(TM) Summary of Product Characteristics.

(2) Giannini EG et al. Liver Int 2012;32(6):1113-1119.

(3) Everson GT et al. Hepatol 2006;44:1675-1684.

* where the hepatitis C virus remains undetectable for six months -- following completion of antiviral therapy

SOURCE: Ligand Pharmaceuticals Incorporated

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'Needle risk' over beauty treatments

Botox paralyses muscles to give the face a smoother look

23 September 2013 Last updated at 20:58 ET

By Michelle Roberts Health editor, BBC News online

A health watchdog is concerned that people having beauty treatments like Botox could be at risk of infection from dirty needles.

The National Institute for Health and Care Excellence says growing numbers of people are injecting tanning agents, dermal fillers and Botox at home and in salons, and some are lax about hygiene.

Sharing needles can spread blood-borne diseases like HIV and hepatitis C.

Nice is updating its advice for England and Wales accordingly.

The guidelines, which are out for public consultation, aim to encourage people to use sterile needle and syringe programmes to stem the spread of infections.

Sharps bins

Most blood-borne diseases occur among people who inject drugs like heroin and anabolic steroids.

But NICE says people seeking out cosmetic fixes are also at risk.

A spokeswoman said: "We are seeing an increasing issue with drugs that are used for vanity purposes."

This includes the anti-wrinkle treatment Botox, dermal fillers and tanning agents.

Prof Mike Kelly, Director of the NICE Centre for Public Health Excellence, said: "Since we last published our guidance on needle and syringe programmes in 2009, we've seen an increase in the use of performance-and-image-enhancing drugs such as anabolic steroids, Botox, tanning agents and the use of dermal fillers like collagen.

"We've also heard anecdotal evidence that more teenagers are injecting these performance-and-image-enhancing drugs too.

"We're updating our guidance - and our public consultation on the draft update is an important part of this process - to make sure all of these groups of people are considered in the planning and delivery of needle and syringe programmes."

One of the recommendations proposed in the new guidelines is that local councils consider providing sharps boxes for people to dispose of used needles and syringes.

Rajiv Grover, consultant plastic surgeon and president of the British Association of Aesthetic Plastic Surgeons (BAAPS), said: "Due to the lack of regulation in the cosmetic sector it is impossible to know how many patients could be at risk of blood borne diseases from needle sharing with either Botox or fillers.

"These should be considered medical procedures and BAAPS has campaigned for over a decade to have this field of non-surgical cosmetic treatments tightly regulated. The dangers of sharing needles in cosmetic injectables are so great that any practitioner who does this should be considered guilty of a criminal offence and nothing less."

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