Showing posts with label HCV Worldwide. Show all posts
Showing posts with label HCV Worldwide. Show all posts

Wednesday, May 30, 2018

China Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir)

China Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir), Gilead's Pan-Genotypic Treatment for Chronic Hepatitis C Virus Infection

- Epclusa is the First Approved Pan-Genotypic Once Daily Single Table Regimen for Chronic Hepatitis C Virus Infection in China -

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 30, 2018-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Drug Administration (CDA) has approved Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. The CDA also approved Epclusa in combination with ribavirin (RBV) for adults with HCV and decompensated cirrhosis. Epclusa is the first pan-genotypic HCV single tablet regimen (STR) approved in China.

The approval of Epclusa in China is supported by five international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4 and ASTRAL-5. High overall rates of SVR12 (defined as undetectable HCV RNA 12 weeks after completing therapy), ranging from 92-100 percent, were achieved across difficult-to-cure patient populations including treatment-experienced patients and those with compensated or decompensated cirrhosis.

"The safety and efficacy profile of Epclusa are supported by large clinical and real-world global datasets," said Professor Lai Wei, Peking University People's Hospital and Institute of Hepatology, Peking University. "With high cure rates across all HCV genotypes, Epclusa could increase HCV treatment in China by potentially eliminating the need for genotype testing, which can be a barrier to treatment in many settings."

HCV is the fourth-most commonly reported infectious disease in China, with approximately 10 million people infected. HCV genotypes 1, 2, 3 and 6 account for more than 96 percent of all cases.

In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 treatment-naïve and treatment-experienced patients with genotype 1-6 HCV infection, without cirrhosis or with compensated cirrhosis, received 12 weeks of Epclusa. Ninety-eight percent (1,015/1,035) of patients achieved SVR12. In the ASTRAL-5 study, 106 treatment-naïve and treatment-experienced patients with genotype 1-6 HCV infection, without cirrhosis or with compensated cirrhosis, who were coinfected with HIV and on a stable antiretroviral therapy, received 12 weeks of Epclusa. Ninety-five percent (101/106) of patients achieved SVR12.

The ASTRAL-4 study assessed the safety and efficacy of 12 weeks of Epclusa with or without RBV or 24 weeks of Epclusa in 267 HCV-infected patients with genotypes 1-4 and 6 decompensated cirrhosis (Child-Pugh B). Patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved 94 percent (82/87) SVR12.

The most common adverse reactions (=10 percent) experienced by patients treated with Epclusa in ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-5 were headache and fatigue. The placebo-treated patients in the ASTRAL-1 experienced headache and fatigue at a similar frequency. The most common adverse reactions (=10 percent) experienced by HCV-infected patients with decompensated cirrhosis treated with Epclusa and RBV in ASTRAL-4 were fatigue, anemia, nausea, headache, diarrhea and insomnia. Four patients treated with Epclusa with RBV, discontinued treatment due to adverse events.

"As the first once-daily, interferon-free single tablet regimen for HCV patients regardless of genotype, Epclusa offers physicians in China an important new option for effectively treating their patients while potentially helping to reduce the significant burden of HCV at a population level," said John F. Milligan, PhD, Gilead's President and Chief Executive Officer. "Gilead has now launched two direct-acting antiviral treatments in China, and we are committed to supporting efforts to screen and link patients to treatment, to help address the country's HCV epidemic."

Epclusa received marketing approval from the U.S. Food and Drug Administration (FDA) and the European Commission in 2016 as the first pan-genotypic STR for HCV infection. It is also approved for use in 54 countries.

Sovaldi (sofosbuvir) as a single agent received marketing approval from the China Food and Drug Administration in 2017 for the treatment of adults infected with HCV genotype 1, 2, 3, 4, 5 or 6 and for adolescents (aged 12 to 18 years) with HCV genotype 2 or 3, as a component of a combination antiviral treatment regimen.

Wednesday, March 7, 2018

Hepatitis C: Key elements for successful European and national strategies to eliminate HCV in Europe

J Viral Hepat. 2018 Mar;25 Suppl 1:6-17. doi: 10.1111/jvh.12875.

Special Issue: Summit review: HCV Policy Summit Hepatitis C: The Beginning of the End - Key elements for successful European and national strategies to eliminate HCV in Europe

COMMISSIONED REVIEW
Hepatitis C: The beginning of the end—key elements for successful European and national strategies to eliminate HCV in Europe
Authors G. V. Papatheodoridis, A. Hatzakis, E. Cholongitas, R. Baptista-Leite, I. Baskozos, J. Chhatwal, M. Colombo, H. Cortez-Pinto, A. Craxi, D. Goldberg, C. Gore, A. Kautz, J. V. Lazarus, L. Mendão, M. Peck-Radosavljevic, H. Razavi, E. Schatz, N. Tözün, P. van Damme, H. Wedemeyer, Y. Yazdanpanah, F. Zuure, M. P. Manns

First published: 6 March 2018
Full publication history DOI: 10.1111/jvh.12875

Full Text
http://onlinelibrary.wiley.com/doi/10.1111/jvh.12875/full

Abstract
Hepatitis C virus (HCV) infection is a major public health problem in the European Union (EU). An estimated 5.6 million Europeans are chronically infected with a wide range of variation in prevalence across European Union countries. Although HCV continues to spread as a largely "silent pandemic," its elimination is made possible through the availability of the new antiviral drugs and the implementation of prevention practices. On 17 February 2016, the Hepatitis B & C Public Policy Association held the first EU HCV Policy Summit in Brussels. This summit was an historic event as it was the first high-level conference focusing on the elimination of HCV at the European Union level. The meeting brought together the main stakeholders in the field of HCV: clinicians, patient advocacy groups, representatives of key institutions and regional bodies from across European Union; it served as a platform for one of the most significant disease elimination campaigns in Europe and culminated in the presentation of the HCV Elimination Manifesto, calling for the elimination of HCV in Europe by 2030. The launch of the Elimination Manifesto provides a starting point for action in order to make HCV and its elimination in Europe an explicit public health priority, to ensure that patients, civil society groups and other relevant stakeholders will be directly involved in developing and implementing HCV elimination strategies, to pay particular attention to the links between hepatitis C and social marginalization and to introduce a European Hepatitis Awareness Week.

Thursday, February 22, 2018

The characteristics of residents with unawareness of hepatitis C virus infection in community

The characteristics of residents with unawareness of hepatitis C virus infection in community
Pin-Nan Cheng ,Yen-Cheng Chiu,Hung-Chih Chiu, Shih-Chieh Chien

Published: February 22, 2018

Full Text

Abstract
Background
Control of hepatitis C virus infection (HCV) is an increasingly important issue. Enhancing screening coverage is necessary to discover more HCV infected subjects in community. However, a substantial population is unaware of HCV infection that needs more attention.

Aim
The aims of this study were to evaluate the status of HCV infected residents in remote villages, to compare characteristics between already known and unaware HCV infection subjects, and to analyze the disease insights.

Patients and methods
Screening intervention for liver diseases was conducted in remote villages of Tainan City of southern Taiwan from August 2014 to July 2016. Items of screening examinations included questionnaire, blood sampling for liver tests and viral hepatitis markers (hepatitis B surface antigen and anti-HCV antibody), abdominal sonography survey, and liver stiffness measurement by transient elastography. Quantitation of HCV RNA was measured for residents with positive anti-HCV antibody.

Results
A total of 194 (13.5%) out of 1439 participants showed positive for anti-HCV antibody. HCV viremia was detected in 119 (61.3%) residents. Previously unaware HCV infection by questionnaire record was present in 68 (35.1%) of ant-HCV positive residents. By multivariate logistic analysis, unaware HCV infected residents exhibited significantly mild liver fibrosis (OR 0.876, 95% CI 0.782~0.981, p = 0.022), more prevalent of heart diseases (OR 6.082, 95% CI 1.963~18.839, p = 0.002), and less cluster of family history of liver diseases (OR 0.291, 95% CI 0.113~0.750, p = 0.011) when comparing with already known HCV infected residents. Among the 126 already know HCV infected residents, only 59 (46.8%) received antiviral treatment or regular follow-up. No concept or no willing to receive medical care was observed in 44 (34.9%) residents.

Conclusion
In HCV endemic villages of Taiwan, residents with unaware HCV infection comprised about one third of HCV infected residents and exhibited obscure characteristics to identify. Less than half of already known HCV infected residents received adequate medical care. To eliminate HCV infection, vigorous efforts on enhancing screening coverage, educating update knowledge of liver diseases, and linking to medical care are urgently needed.

Wednesday, February 21, 2018

Revisiting policy on HCV treatment under the Thai Universal Health Coverage: An economic evaluation and budget impact analysis

Revisiting policy on chronic HCV treatment under the Thai Universal Health Coverage: An economic evaluation and budget impact analysis
Waranya Rattanavipapong ,Thunyarat Anothaisintawee ,Yot Teerawattananon

Published: February 21, 2018
https://doi.org/10.1371/journal.pone.0193112

Full Text Article:

Abstract
Thailand is encountering challenges to introduce the high-cost sofosbuvir for chronic hepatitis C treatment as part of the Universal Health Care’s benefit package. This study was conducted in respond to policy demand from the Thai government to assess the value for money and budget impact of introducing sofosbuvir-based regimens in the tax-based health insurance scheme. The Markov model was constructed to assess costs and benefits of the four treatment options that include: (i) current practice–peginterferon alfa (PEG) and ribavirin (RBV) for 24 weeks in genotype 3 and 48 weeks for other genotypes; (ii) Sofosbuvir plus peginterferon alfa and ribavirin (SOF+PEG-RBV) for 12 weeks; (iii) Sofosbuvir and daclatasvir (SOF+DCV) for 12 weeks; (iv) Sofosbuvir and ledipasvir (SOF+LDV) for 12 weeks for non-3 genotypes and SOF+PEG-RBV for 12 weeks for genotype 3 infection. Given that policy options (ii) and (iii) are for pan-genotypic infection, the cost of genotype testing was applied only for policy options (i) and (iv). Results reveal that all sofosbuvir-based regimens had greater quality adjusted life years (QALY) gains compared with the current treatment, therefore associated with lower lifetime costs and more favourable health outcomes. Additionally, among the three regimens of sofosbuvir, SOF+PEG-RBV for genotype 3 and SOF+LDV for non-3 genotype are the most cost-effective treatment option with the threshold of 160,000 THB per QALY gained. The results of this study had been used in policy discussion which resulted in the recent inclusion of SOF+PEG-RBV for genotype 3 and SOF+LDV for non-3 genotype in the Thailand’s benefit package.

Monday, February 12, 2018

For Viral Hepatitis Elimination One Size Does Not Fit All

A blog about Global Health. An open space for discussing equitable access to health for everyone, everywhere.

For Viral Hepatitis Elimination One Size Does Not Fit All
Jeffrey Lazarus
12 February 2018

“For elimination, one size does not fit all” was a refrain repeated in a number of different ways throughout the presentations and discussions at the European Association for the Study of the Liver (EASL) Monothematic conference on “Striving towards the elimination of HCV infection” that has just come to a close in Berlin.

Whether in discussions about prevention, interventions in drug users, improving linkage to care, or treatment itself, attendees agreed that there is no golden ticket for hepatitis C elimination. However, there are a number of evidence-based strategies for impact that were presented very effectively by over 30 speakers in the six thematic panel sessions.


Links

Wednesday, January 31, 2018

Top 5 stories about HCV: Long-term effects of DAAs, AASLD critical of Cochrane review of HCV drugs & more

Top 5 stories about HCV
January 30, 2018

Report raises questions about long-term effects of DAAs for HCV
The changing HCV treatment cascade
Sharing injection paraphernalia does not lead to HCV transmission
Women injecting drugs at higher risk for HCV than men
IDSA, AASLD critical of Cochrane review of HCV drugs


Monday, January 29, 2018

England could become first country to eradicate Hepatitis C in 2025

England could become first country to eradicate Hepatitis C in 2025

England could be the first country in the world to eliminate Hepatitis C, under ambitious plans announced by the NHS today.

NHS leaders today called on the pharmaceutical industry to work with them to provide best value for money for treatments so that in its 70th year, the NHS can commit to eliminating Hepatitis C in England at least five years earlier than the World Health Organisation goal of 2030.

Hepatitis C is currently a significant public health issue globally, accounting for around 400,000 deaths per year. Most recent figures show that Hepatitis C is affecting 160,000 people in England.

The NHS has invested in Hepatitis C treatment each year as new treatments became available to improve outcomes for people with the virus but doctors, patient groups and NHS leaders believe it is possible to go further and is encouraging pharma companies to work with them to meet this more ambitious target.

The next round of procurement, which launches in February, is the single largest medicines procurement ever done by the NHS, and NHS England expects to see more new treatments curing even more patients by October. Over 25,000 patients have already been treated to date and this number is expected to rise to 30,000 later this year, prioritising the sickest patients first.

Part of the new agreements between NHS England and drug companies will involve collaboration to identify more people who are living with Hepatitis C who need to be treated. Experts have predicted that this approach, combined with the NHS sustaining the same level of investment and the best new treatments being used could undoubtedly lead to Hepatitis C being eradicated as a major public health concern in the very near future.

England is one of few countries in Europe where numbers of patients receiving new oral treatments for Hepatitis C are already increasing year on year, enabled by deals previously agreed with industry. The deals, including ‘pay per cure’ where the NHS only pays when a patient is cured and a focus on prioritising the sickest patients, have led to a 10% reduction in the number of deaths and the numbers of patients needing a liver transplant have reduced by 50%.

Further progress to date in the treatment of Hepatitis C includes:
The creation of 22 ‘operational delivery networks’ in each area in England – driving improvements in treatment in local areas, ensuring all patients can access the treatment they need, regardless of where they live. This will enable improvements in areas with historically low service provision.
In 2017 a National Hepatitis C patient registry was established – making it possible to record and monitor treatment uptake, outcomes and increased diagnosis rates in real time.

Professor Graham Foster, National Clinical Chair for Hepatitis C, NHS England, said:

“The progress made in the treatment of Hepatitis C has transformed the lives of many of my patients and has been made possible by NHS England working closely with industry to bring prices down and expand treatment options. Yet we have the opportunity to do so much more. Over the last seven decades, the NHS has been at the forefront of medical innovation – to be able to commit to a world first in the year of the NHS’ 70th anniversary would be another remarkable and truly historic achievement.”

Peter Huskinson, National Commercial Director, NHS England, said:

“The NHS has made major headway in the last three years in the treatment of Hepatitis C, which has enabled a once in a generation opportunity to eliminate a major disease. With the right response from pharma companies in the coming months, we can strike the most competitive deal possible – improving the future for patients with Hep C alongside securing the best value for money for taxpayers.”

Charles Gore, CEO of The Hepatitis C Trust, the national Hepatitis C charity, said:

“This is wonderful news. It is exactly what is needed. The proposed deal will galvanise the action we must take to find all those living with Hepatitis C who have not yet been diagnosed so that we can cure them. It will prevent the liver cancer that Hepatitis C causes. It will save lives. In the current environment we applaud NHS England’s ambition to be a world leader.”

Judi Rhys, Chief Executive of the British Liver Trust, said:

“We are delighted that NHS England are playing a leading role in tackling Hepatitis C and eliminating this deadly virus. A key challenge will be the fact that hep C often has no symptoms in the early stages and it is thought that less than half of those living with the virus have been diagnosed. It is therefore vital that anyone who is at risk asks to be tested.”

Thursday, January 25, 2018

HSE urged to step-up on hep C

News Features

HSE urged to step-up on hep C 
Catherine Reillyl | 25 Jan 2018 |

Resources are required to support increased testing and treatment of hepatitis C in the community as significant numbers of patients are not presenting for hospital-based care, heard a recent seminar in Dublin organized by the Hepatitis C Partnership. Catherine Reilly reports.

Since 2015, DAAs have been accorded an annual budget of €30 million under the HSE National Hepatitis C Treatment Programme (NHCTP). But clinicians and community stakeholders are fervently calling for better-resourced outreach and support, as well as testing and care in community settings. They strongly believe there are significant numbers of unidentified progressive cases among the populations primarily affected by hepatitis C, ie, former and current injecting drug-users, which are hard-to-reach groups.

Thursday, January 11, 2018

The Hepatitis C Trust launches 'Eliminating Hepatitis C in Scotland' report

The Hepatitis C Trust has today launched a new report, ‘Eliminating Hepatitis C in Scotland: A Call to Action’. The report follows an inquiry conducted by The Hepatitis C Trust and the cross-party Scottish Hepatitis C Parliamentary Champions group over the course of 2017, which involved oral evidence sessions and the submission of written evidence by individuals and organisations working across the hepatitis C patient pathway.
On the basis of this evidence, The Hepatitis C Trust produced the ‘Eliminating Hepatitis C in Scotland’ report, which looks in detail at Scotland’s approach to hepatitis C, including:
  • Elimination strategy
  • Awareness
  • Prevention
  • Testing and diagnosis
  • Linkage to care
  • Access to treatment
  • Funding
The report calls on the Scottish Government to produce a hepatitis C elimination strategy, with ambitious targets to decrease national incidence, mortality and overall prevalence. Additional recommendations on awareness-raising, prevention, testing and treatment are contained in the report, and include calls for:
  • An introduction of opt-out testing for hepatitis C in substance misuse services, with commissioning contracts stipulating clear mechanisms to hold services to account for failures to meet testing targets.
  • National guidance to be issued on effective implementation of opt-out testing in prisons.
  • Treatment cost reductions to be reinvested into additional treatments or services to ensure access to treatment is available to all who need it.
  • The Scottish Government to explore alternative treatment funding models offering the opportunity to rapidly increase the number of patients receiving treatment.
Charles Gore, Chief Executive of The Hepatitis C Trust said: “Without renewed efforts to find and treat the thousands of undiagnosed patients living with hepatitis C, Scotland may no longer be considered a world leader in tackling this deadly virus.
Eliminating a public health issue that disproportionately affects some of the poorest and most marginalised groups in our society is an extraordinary and eminently achievable opportunity which should be seized with both hands.”
The full report can be accessed here

Friday, January 5, 2018

How the elimination of HCV in England could become a reality

PharmaTimes
Dr Andrew Ustianowski

Hepatitis C virus (HCV) infection is a significant public health issue in England, but one which the World Health Organization (WHO) has announced can be eliminated within a generation. New direct-acting antiviral curative treatments have been available in the UK since 2015, which means that theoretically it is possible to meet the WHO target and eliminate a disease which currently is a heavy burden on patients, carers and the health system. However, although England has pledged support for the WHO initiative, without a formal elimination strategy in place it is going to be difficult to meet this aim.

Friday, October 27, 2017

Endocarditis - SPECIAL REPORT: London doctors’ simple strategy may stem a deadly toll

SPECIAL REPORT
London doctors’ simple strategy may stem a deadly toll
By Randy Richmond, The London Free Press
Friday, October 27, 2017 11:30:42 EDT AM

At University Hospital, Koivu started to notice more and more endocarditis deaths. When she asked her dying patients what they were using, almost all those who injected drugs said they were using HydromorphContin capsules.

To inject the drug, you first have to crush the capsules in a tiny container, usually a little pan called a cooker – the kind seen in movies and on television used to melt crack cocaine or crystal meth.

Cooking doesn’t dissolve the capsules, so you have to crush them as best as you can in a bit of water.

Then you place a tiny filter, sometimes called a sponge, over the hydro-laced mixture and draw liquid up with your needle.

Koivu theorized that when people drew up the crushed capsules in a syringe, even through a properly used filter, some particles were being drawn up as well.
Those particles scratch the heart valves...

Read the article here......

Of Interest
HIV and Hepatitis C Are No Longer the Most Serious Infectious Threats to People Who Inject Drugs
For whatever reason, endocarditis and other invasive bacterial infections are not nearly as feared as HIV and HCV, despite the fact that the former are far more immediately life threatening and way more difficult to treat.

Wednesday, October 11, 2017

Hepatitis C Cure 'Difficult to Implement'

Coverage from the
International Conference on Viral Hepatitis (ICVH) 2017

Hepatitis C Cure 'Difficult to Implement'

Tuesday, October 10, 2017

SMC accepts medicines for hepatitis C and multiple myeloma for use by NHS Scotland

October 2017 decisions news release

SMC accepts medicines for hepatitis C and multiple myeloma for use by NHS Scotland
The Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHS Scotland, has today published advice accepting two new medicines.

Daratumumab (Darzalex) was accepted for the treatment of multiple myeloma, a rare cancer of the white blood cells that may result in complications including severe bone pain, kidney damage and a depleted immune system with a consequent risk of serious infection. Following consideration through SMC’s Patient and Clinician Engagement (PACE) process for medicines used to treat end of life and very rare conditions, daratumumab was accepted for the treatment of patients who have received at least three prior treatment regimens. Through PACE, patient groups and clinicians highlighted that patients become resistant to treatments over time and that there are limited treatment options available at this stage. While there is currently no cure for multiple myeloma, daratumuab may provide an opportunity to improve control of the condition and disease associated symptoms.

Sofosbuvir/velpatasvir (Epclusa) was accepted for the treatment of specific sub-types of hepatitis C, a blood-borne virus that predominantly infects the cells of the liver, resulting in inflammation and significant damage. This affects the liver's ability to perform its essential functions, which include fighting infection and removing toxins from the body. Sofosbuvir/velpatasvir provides an opportunity to eradicate the Hepatitis C virus. Through a submission to SMC, patient groups highlighted that this medicine could enable patients to be treated with minimum disruption to their working and family lives.

SMC chairman Dr Alan MacDonald said:

“I am pleased the committee has been able to accept daratumumab and sofosbuvir/velpatasvir for use by NHS Scotland.

“Daratumumab offers a further treatment option for those patients with multiple myeloma who have already had a number of previous treatments. Through our PACE meeting, we know this decision will be welcomed by both patients and their families.

“Eradicating hepatitis C is considered a major health issue by both Scottish Government and the World Health Organisation, so being able to accept sofosbuvir/velpatasvir for certain types of hepatitis C may help meet this key public health aim.”

PharmaTime
Darzalex, Epclusa will be funded on NHS Scotland

Monday, September 25, 2017

Gilead's Sovaldi® (Sofosbuvir) Approved In China for Treatment of Chronic Hepatitis C

China Food and Drug Administration Approves Gilead's Sovaldi® (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection

- Sovaldi-based Regimens Demonstrated High Rates of Sustained Virologic Response or Cure for Chinese Hepatitis C Infected Patients -

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 25, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
  
The approval of Sovaldi is supported by a Phase 3 study conducted in China, presented earlier this year at the Asian Pacific Association for the Study of the Liver (APASL) meeting. SVR12 (HCV RNA undetectable 12 weeks after completing therapy) rates for Chinese HCV patients with genotype 1, 2, 3 or 6 ranged from 92-100 percent. The study evaluated Sovaldi in combination with ribavirin (RBV) or pegylated interferon+ribavirin (PegIFN+RBV) across a range of difficult-to-cure patient populations, including treatment-experienced patients and those with compensated cirrhosis. In this study, the safety profiles of the regimens were consistent with the known side effects of pegylated interferon and/or ribavirin. The most common adverse events were hematological abnormalities and pyrexia.
  
Professor Lai Wei, the principal investigator of Sovaldi’s Phase 3 study and former Chairman of the Chinese Society of Hepatology of the Chinese Medical Association said, “The approval of sofosbuvir in China provides more treatment options for Chinese HCV patients. The clinical trials in China and around the world provide evidence that the treatment is effective for multiple genotypes, which offers HCV patients in China a better chance at curing their disease.”
  
HCV is the fourth-most commonly reported infectious disease in China, with approximately 10 million people infected. HCV genotypes 1, 2, 3 and 6 account for more than 96 percent of all cases. Less than one percent of HCV patients are currently treated, using interferon-based regimens that have lower efficacy, longer treatment duration and less favorable safety profiles than more recent regimens that contain direct-acting antiviral medicines.
  
“With the approval of Sovaldi, there is now the potential opportunity to transform treatment for HCV patients in China,” said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “Medicines are one part of the solution but, as we have seen in other countries around the world, there are many other challenges that impact diagnosis, linkage to care and treatment. Gilead is committed to working with the government and other stakeholders with the goal to help reduce the significant burden of HCV disease in China.”
  
Sovaldi received marketing approval from the U.S. Food and Drug Administration (FDA) in 2013 and the European Commission in 2014. It is also approved for use in 79 countries including Australia, India, Indonesia, the Philippines, New Zealand, Canada, Egypt, Switzerland and Turkey.

Tuesday, September 12, 2017

NHS England New Report - HCV treatments saving thousands more lives

https://www.england.nhs.uk/wp-content/uploads/2017/09/spotlight-on-specialised-services.pdf
The head of NHS England, Simon Stevens, will today (Tuesday 12 September) set out an ambitious vision for the National Health Service as it approaches its landmark 70th anniversary – calling on health and care leaders to unleash the game changing potential of innovation for both patients and taxpayers.
Speaking at Expo conference in Manchester, Mr. Stevens will unveil new plans to free up funds for the latest world class treatments by slashing hundreds of millions from the nation’s drugs bill and announce that new and cutting edge treatments will be routinely available for the first time.

Innovations include:
  • Revolutionary new treatment for Hepatitis C is set to save NHS England more than £50 million as well as saving thousands more lives
  • New measures to slash up to another £300 million from the nation’s medicines bill
  • Trailblazing new treatment to restore sight using patients’ own teeth
  • Routine commissioning of the latest technology to help deaf children hear
  • An expansion of the test-bed programme testing the treatments and care models of tomorrow
Mr Stevens will reveal that investment in new oral treatments that can cure Hepatitis C more quickly and with fewer side effects has already led to a 10 per cent reduction in the number of deaths and an unprecedented reduction in liver transplants for Hepatitis C of around 50 per cent.

This is the latest in a series of innovative drug deals that has been made possible by NHS England working closely with industry to bring prices down, expand treatment options and make new treatments available rapidly – in one case within just four weeks of a treatment receiving its marketing authorization.

Health and care leaders will also hear how new rules on the use of biosimilar medicines – cheaper but equally clinically effective to original ‘biological’ treatments –giving doctors a choice of new treatments for thousands of patients with serious and painful conditions, such as cancer and rheumatoid arthritis, but at a significantly reduced cost.

Currently six of the top 10 drugs in the UK by cost are biological medicines – the most complex and therefore expensive used in the NHS. The plans to accelerate and widen the uptake of biosimilars will save hundreds of millions of pounds from the nation’s medicine bill, estimated to be up to £300m a year by 2021.

Simon Stevens, NHS England Chief Executive said: “The NHS has a proud history of innovation. As our 70th anniversary approaches it is important that we do not just celebrate these often unsung achievements but also unleash the full potential of innovation in treatment and commissioning to ensure we deliver high quality healthcare for future generations.”

Further detail on the Hep C announcement is in a new report that shines a light on specialised services, those which support people with a range of rare and complex conditions will also be published. It highlights recent standout investments across blood and infection, cancer, mental health, internal medicine, trauma and woman and children and how these will continue to be rolled out over the coming years.

One of those treatments to benefit from £700,000 of new investment is a medical technique called auditory brainstem implants which can help restore the sensation of hearing to some children born with profound deafness. The operation is performed by Central Manchester University Hospitals, and involves inserting a device directly against the brainstem, bypassing the cochlea and auditory nerve and could help around nine children a year.

Another innovative procedures outlined is a unique life-changing procedure known as osteo-odonto-keratoprosthesis (OOKP) or ‘tooth in-eye’ surgery, which restores vision to blind patients by using part of the patient’s own tooth root to support an optical cylinder.

The procedure takes place in several stages and is performed on blind patients with damaged corneas, for whom traditional transplants are not suitable. One patient who had the procedure was blind for twelve years before the surgery but after the bandages came off, he immediately saw faces and pictures on the hospital ward.

Mr Stevens has also signalled NHS England’s intent to continue to develop the successful Test Bed Programme as the NHS goes into its 70th year. Seven sites have been working with 40 innovators, 51 digital technology products, eight evaluation teams and five voluntary sector organisations to understand which products and processes can save and transform lives, at the same or lower cost than current practice.

Publication type: Report
Document first published:12 September

Blood and infection                                 

Rolling out new oral treatments for Hepatitis C
The largest single investment in new treatments for the NHS in 2016/17 was for new oral Hepatitis C treatments that can cure the disease.
NHS England has embarked on a sustainable roll-out strategy and we now have evidence that the investment in these game-changing treatments and the prioritisation by the Hepatitis C operational delivery networks of patients with greatest unmet clinical need, has significantly reduced deaths and liver transplants. By the end of August 2017, approximately 20,000 patients will have been treated, which amounts to more than 10 per cent of the total estimated infected population. Since we have followed NICE guidance to focus on those at greatest clinical need, this has led to a rapid reduction in mortality (by around 10 per cent) and an unprecedented reduction in liver transplants for Hepatitis C Virus of around 50 per cent.  
Through our work on drug pricing, the NHS is able to increase the number of patients treated within available resources. Industry has responded positively to our successive drug procurements and moved to an innovative ‘pay for cure’ approach for all hepatitis C treatments. This means the NHS only pays for the drug if patients are cured, which frees up funds and allows consideration of other access issues. For example, there are a small number of people with advanced disease for whom the first treatment was unsuccessful, and they need to be retreated urgently. Although NICE are set to review evidence for future guidance including retreatment, in the meantime NHS England has approved a policy to allow those with the most advanced disease to be retreated. As well as improving access for these patients, the number of people to be treated overall will increase by 25 percent this year (2017/18).
Read the full report:
Download PDF

For more information on the Test Bed Programme see our website here.
continue reading.. 

To keep up to date with all the latest specialised commissioning news, or to get directly involved with our work, please visit https://www.england.nhs.uk/commissioning/spec-services/ get-involved/

The Hepatitis C Trust responds to Simon Stevens speech highlighting NHS investment in hepatitis C treatment
In a speech at the Expo conference in Manchester today, NHS England head Simon Stevens emphasised a Health Service commitment to invest in revolutionary new treatments for hepatitis C.
The Hepatitis C Trust welcomes NHS England’s commitment to increasing the numbers of hepatitis C patients treated and cured with new highly effective oral treatments. The Trust is delighted to see initial evidence that mortality from hepatitis C is beginning to decrease in the United Kingdom. In order to sustain this decline in deaths, and to deliver the government’s commitment to the World Health Organisation target to eliminate hepatitis C by 2030, NHS England must ensure the curative treatments are available to all those infected.

Charles Gore, Chief Executive of The Hepatitis C Trust, said: “The new treatments offer a truly remarkable opportunity to eliminate hepatitis C as a global public health concern, making this deadly virus a thing of the past. The treatments have already transformed the lives of those with most advanced HCV-related disease. The government must now seize this possibility and take bold action in partnership with the pharmaceutical industry to make the availability of these treatments truly universal”.
http://www.hepctrust.org.uk/blog/sep-2017/hepatitis-c-trust-responds-simon-stevens-speech-highlighting-nhs-investment-hepatitis

Friday, August 25, 2017

HCV - Current treatment status and barriers in mainland China: A national multicenter cross-sectional survey in 56 hospitals

doi: 10.1097/MD.0000000000007885
Research Article: Observational Study

Current treatment status and barriers for patients with chronic HCV infection in mainland China: A national multicenter cross-sectional survey in 56 hospitals
Bian, Dan-Dan MDa; Zhou, Hai-Yang MDb; Liu, Shuang MD, PhDa; Liu, Mei MD, PhDa; Duan, Carol MDb; Zhang, Jin-Yan MDa; Jiang, Ying-Ying MDa; Wang, Ting MD, PhDa; Chen, Yu MD PhDa; Wang, Zhao MDb; Zheng, Su-Jun MD, PhDa,*; Duan, Zhong-Ping MD, PhDa,


Abstract 
Chronic hepatitis C virus (HCV) infection is a serious public health problem worldwide. China, as the country with the largest number of HCV infections in the world, plays a significant role in eliminating hepatitis C. Due to different financial situations and education background, hepatitis C patients take different actions for their disease treatment and management. Therefore, antiviral treatment status should be attached great importance to learn the medical demand of patients. A nationwide, multicenter survey was conducted from July 2015 to June 2016. Of 1798 inpatients and outpatients with chronic HCV from 56 hospitals participated in the survey. Each patient completed the questionnaire with questions about his/her antiviral therapy status, perception of treatment barriers, and expectations for future treatment. In total 1622 patients, including 1241 with chronic hepatitis C, 344 with cirrhosis, and 37 patients with hepatocellular carcinoma, fulfilled data collection requirements and finally were included in analysis. Overall, up to 30.7% of the patients had not or currently does not intend to receive antiviral therapy. The main reason was expecting more potent and well-tolerance medication (31.5%), followed by the fear of interferon related side effects (27.5%). Multiple regression analysis showed that the patient's annual income, the severity of HCV, and comorbidity were independent predictors of not receiving antiviral therapy. The whole patients were expecting more potent and well tolerance medication available soon. In summary, Peg-IFN/RBV treatment regimen cannot meet the need of patients well, and safe and efficient direct-acting antivirals are urgently needed in mainland China.

Source - Full Text

Lurking epidemic of hepatitis C virus infection in Iran: A call to action

World J Hepatol. Aug 28, 2017; 9(24): 1040-1042
Published online Aug 28, 2017. doi: 10.4254/wjh.v9.i24.1040

Letters To The Editor
Lurking epidemic of hepatitis C virus infection in Iran: A call to action 
Reza Taherkhani, Fatemeh Farshadpour

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Abstract
Despite having a relatively low prevalence in the Iranian general population, the burden of hepatitis C virus (HCV) infection is on the rise, and hepatitis C is predicted to be the most important leading cause of viral hepatitis-related mortality in the near future in Iran. The recent population-based epidemiological studies have revealed the predominant role of injecting drug use in increasing prevalence of HCV infection. Undoubtedly, new management paradigm is required to drive down the rising wave of hepatitis C in Iran. Priority should be given to young injecting drug users as the cornerstone of the lurking epidemic of HCV infection in Iran.

Key Words: General population, Injecting drug user, Epidemiology, Hepatitis C virus, Iran

Core tip: Iran is known as a low-endemic country for hepatitis C virus (HCV) infection, while the recent population-based epidemiological studies have revealed the increasing burden of HCV infection in the Iranian population. The asymptomatic nature of HCV infection and the undiagnosed HCV-infected injecting drug users have fueled this increase. Obviously, the current management paradigm is inadequate if control of HCV infection is aimed to be achieved.
Citation: Taherkhani R, Farshadpour F. Lurking epidemic of hepatitis C virus infection in Iran: A call to action. World J Hepatol 2017; 9(24): 1040-1042

TO THE EDITOR
Less than 0.5% of the population, as many as 186500 patients are infected with hepatitis C virus (HCV) in Iran[1]. The majority of HCV-positive patients have been infected by injecting drug use, equivalent to 75% of the HCV-infected population[2]. The burden of HCV infection shows a rising trend, and HCV infection is projected to be the most important leading cause of viral hepatitis-related mortality in the near future in Iran[1,3]. Obviously, the current management paradigm is inadequate if control of HCV infection is aimed to be achieved.

Mandatory screening of all blood donors for hepatitis C resulted in a remarkable decrease in the prevalence of HCV infection[1,2,4,5]. In view of the success in the Iranian Blood Transfusion Organisation, the talk of HCV elimination has been intensified. However, all hopes came to knot due to rising wave of HCV infection among injecting drug users (IDUs), those whom the control of HCV transmission among is the most difficult. The shared use of drug paraphernalia and lack of awareness among young IDUs regarding the risk of acquiring HCV infection via needle-sharing are the root cause of the increasing prevalence of HCV infection among IDUs community[1]. At the same time, the asymptomatic nature of HCV infection and the undiagnosed HCV-infected IDUs would accelerate this increase[1].

The recent changes in the genotype distribution of HCV have also fueled this epidemic[6]. High rates of mutation in HCV genome have resulted in the emergence of seven major genotypes and at least 67 subtypes[7]. Each geographic region has a distinct genotypic pattern, which depends on the predominant mode of transmission, risk factors, life style, the source of infection, disease transmission patterns and age distribution in that particular region[8,9]. These genotypic patterns are not constant, change overtime and influence the epidemiology of HCV infection in that region[10,11]. The most prevalent subtype in Iran is 1a, followed by 3a and 1b. Over the last decade, however, a gradual decrease in the frequency of subtypes 1a and 1b and an increase in subtype 3a have been reported due to changes in the routes of transmission of HCV from blood transfusion to injecting drug use[6,9-12]. These changes should be taken in to consideration to establish better strategies for managing the silent epidemic of hepatitis C in Iran.

Another challenge is treatment of HCV-infected population. Despite having poor tolerability, prolonged treatment course and frequent side effects, interferon (IFN)-based therapy is still recommended as the first-line therapy in Iran due to affordability and local availability[3,9]. Annually, 2.4% of the Iranian HCV-infected population is treated by pegylated IFN plus ribavirin, with approximately 58%-78% of patients showing a sustained virological response (SVR) depending on the HCV genotype[2]. Introduction of IFN-free direct-acting antivirals (DAAs) has revolutionized the treatment course of HCV infection due to superior rates of SVR, favorable tolerability, fewer side effects and shorter treatment period[13-15]. However, in reality, the restricted accessibility and high price of DAAs outweigh these benefits. Recently, the production of a domestic DAA, the combination of daclatasvir and sofosbuvir, with health insurance coverage has been announced in Iran, paving the way for low-cost access to DAAs and subsequently widespread use of these drugs in the near future[1,3]. This domestically produced DAA, Sovodak, has shown favorable SVR rates in Iranian patients infected with genotypes 1 or 3 HCV, the most predominant genotypes in Iran, providing an opportunity to improve the treatment rate and subsequently eliminate HCV infection in the future[1].

These challenges in the management of hepatitis C epidemic cannot be neglected any longer. Resent changes in the epidemiology of HCV would demand changes in health policies, prevention and management strategies. In view of the success of the transfusion-safety measures implemented in the Iranian Blood Transfusion Organization[4,9], screening of high-risk populations for hepatitis C, new therapeutic strategies with an emphasis on timely diagnosis and treatment, expansion of harm-reduction interventions, public education regarding the risk of HCV infection, as well as comprehensive cooperation and mobilization of health care providers are required to drive down the rising wave of HCV infection in Iran once again. Priority should be given to young IDUs as the cornerstone of this silent epidemic. Furthermore, national health policies should be prioritized in a way to curb the lurking epidemic of HCV infection once and for all.


Thursday, August 24, 2017

Asia-Pacific region - Cost-effectiveness prevention and management of gastrointestinal and liver disease

Review Article
COST-EFFECTIVE OPTIONS FOR THE PREVENTION AND MANAGEMENT OF GASTROINTESTINAL AND LIVER DISEASE IN THE ASIA-PACIFIC REGION
Authors Ian C Roberts-Thomson, Thomas Lung
Accepted manuscript online: 17 August 2017
Full publication history DOI: 10.1111/jgh.13925 

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Abstract
The Asia-Pacific region contains more than half of the world's population and is markedly heterogeneous in relation to income levels and the provision of public and private health services. For low-income countries, the major health priorities are child and maternal health. In contrast, priorities for high-income countries include vascular disease, cancer, diabetes, dementia and mental health disorders as well as chronic inflammatory disorders such as hepatitis B and hepatitis C. Cost-effectiveness analyses are methods for assessing the gains in health relative to the costs of different health interventions. Methods for measuring health outcomes include years of life saved [or lost], quality-adjusted life years [QALYs] and disability-adjusted life years [DALYs]. The incremental cost-effectiveness ratio [ICER] measures the cost [usually in US dollars] per life year saved, QALY gained or DALY averted of one intervention relative to another. In low-income countries, approximately 50% of infant deaths [<5years] are caused by gastroenteritis, the major pathogen being rotavirus infection. Rotavirus vaccines appear to be cost-effective but, thus far, have not been widely adopted. In contrast, infant vaccination for hepatitis B is promoted in most countries with a striking reduction in the prevalence of infection in vaccinated individuals. Cost-effectiveness analyses have also been applied to newer and more expensive drugs for hepatitis B and C and to government-sponsored programs for the early detection of hepatocellular, gastric and colorectal cancer. Most of these studies reveal that newer drugs and surveillance programs for cancer are only marginally cost-effective in the setting of a high-income country.

Source - Journal of Gastroenterology and Hepatology

Tuesday, August 1, 2017

Direct-acting antivirals successfully treating hepatitis C, says Public Health England

In Case You Missed It

Article Source
The Pharmaceutical Journal

Hepatitis C in the UK - 2017 report
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Direct-acting antivirals successfully treating hepatitis C, says Public Health England

A new report suggests early detection of the disease is key as treatment with direct-acting antiviral therapy in the initial stages has the best results.

Public Health England (PHE) is urging the public to get tested for hepatitis C after its latest figures revealed a fall in deaths from the disease, which it attributed to the introduction of direct-acting antiviral (DAA) therapy.

PHE’s annual report, published on 28 July 2017, estimated that around 200,000 people in the UK are unknowingly living with chronic hepatitis C, but it said that “revolutionary treatments” can successfully treat the disease in the vast majority of cases, with the best results in the earlier stages of the disease.

According to the report, Hepatitis C in the UK, people infected with the disease need to be found and treated as quickly as possible to sustain the recent nationwide drop in deaths from the condition.

The majority of cases in the UK are considered to be from marginalised and under-served groups in society, such as people who inject drugs.

Current data from PHE shows an estimated 10% reduction in mortality from hepatitis C-related end-stage liver disease and cancer in 2016, and the introduction of DAA drugs has resulted in a 50% reduction in need for liver transplantation for chronic hepatitis C infection.

Commenting on the report, Duncan Selbie, chief executive of PHE, said: “The recent fall in UK deaths looks likely to be the result of increased treatment with new direct-acting antiviral drugs, with an increase of nearly 50% over the past year, and of nearly 90% when compared with earlier years.
Sustaining increase in treatment

“Our ability to sustain this increase in treatment will ultimately be limited by our capacity to find and treat those who remain undiagnosed, and to help those who are diagnosed but untreated to engage with accessible treatment services.”

Helen Harris, clinical scientist at PHE’s Immunisation, Hepatitis and Blood Safety Department, said: “We strongly encourage anyone who may have been at risk of hepatitis C infection to get tested, whether or not they have any symptoms.

“We are hopeful that the increased access to improved treatments over recent years has contributed to the latest fall in deaths from severe hepatitis C-related liver disease. This, combined with interventions to prevent infection in the first place, can help us to achieve our vision of eliminating hepatitis C as a major public health threat in the UK.”

In June the Hepatitis C Trust criticised the results of a study carried out by the Cochrane Hepato-Biliary Group that cast doubt on the effectiveness of DAA drugs against hepatitis C.

Citation: The Pharmaceutical Journal, PJ July 2017 online, online | DOI: 10.1211/PJ.2017.20203312

Saturday, July 29, 2017

Hepatitis C: analysis of cures versus new infections in 91 countries

Review
The road to elimination of hepatitis C: analysis of cures versus new infections in 91 countries
Andrew M Hill, Sanjay Nath, Bryony Simmons 

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Published July, 2017

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Abstract
Background
Hepatitis C (HCV) can only be eradicated if annual rates of cure (SVR) are consistently and significantly higher than new HCV infections, across many countries. In 2016, the WHO called for a 90% reduction in new HCV infection by 2030. Direct-acting antivirals (DAA) can cure the majority of those treated, at around 90% in most populations, at potentially very low prices. We compared the net annual change in epidemic size across 91 countries using data on SVR, new HCV infections, and deaths. In a further 109 countries, we projected this figure using regional averages of epidemic size.

Methods
Epidemiological data for 2016 were extracted from national reports, publications and the Polaris Observatory. There were 91/210 countries with data on SVR, HCV-related deaths and new infections available for analysis; 109 countries had net change in epidemic size projected from the regional prevalence of HCV, extrapolated to their population size. ‘Net cure’ was defined as the number of people with SVR, minus new HCV infections, plus HCV-related deaths in 2016.

Results
For the 91 countries analysed, there were 57.3 million people with chronic HCV infection in 2016. In the remaining 109 countries, the projected epidemic size was 12.2 million, giving a global epidemic size of 69.6 million. Across the 91 countries, there was a fall from 57.3 to 56.9 million people in 2017, a 0.7% reduction. The projected global net change was from 69.6 to 69.3 million, a 0.4% reduction. Ten countries had at least five times more people reaching SVR than new HCV infections, including Egypt and USA. In 47/91 countries, there were more HCV infections than SVR in 2016.

Conclusion
Very few countries are on target to achieve elimination of HCV as a public health problem by 2030. While the North American, North African/Middle East and Western European regions have shown small declines in prevalence, the epidemic is growing in sub-Saharan Africa and Eastern Europe. Far higher rates of DAA treatment are required for worldwide elimination of HCV.