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

Friday, October 12, 2018

Egyptian experience, achievements and limitations towards HCV elimination

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In The Journals 
World J Gastroenterol. Oct 14, 2018; 24(38): 4330-4340
Published online Oct 14, 2018. doi: 10.3748/wjg.v24.i38.4330

Towards hepatitis C virus elimination: Egyptian experience, achievements and limitations
Dalia Omran, Mohamed Alboraie, Rania A Zayed, Mohamed-Naguib Wifi, Mervat Naguib, Mohamed Eltabbakh, Mohamed Abdellah, Ahmed Fouad Sherief, Sahar Maklad, Heba Hamdy Eldemellawy, Omar Khalid Saad, Doaa Mohamed Khamiss, Mohamed El Kassas

Worldwide, more than one million people die each year from hepatitis C virus (HCV) related diseases, and over 300 million people are chronically infected with hepatitis B or C. Egypt used to be on the top of the countries with heavy HCV burden. Some countries are making advances in elimination of HCV, yet multiple factors preventing progress; remain for the majority. These factors include lack of global funding sources for treatment, late diagnosis, poor data, and inadequate screening. Treatment of HCV in Egypt has become one of the top national priorities since 2007. Egypt started a national treatment program intending to provide cure for Egyptian HCV-infected patients. Mass HCV treatment program had started using Pegylated interferon and ribavirin between 2007 and 2014. Yet, with the development of highly-effective direct acting antivirals (DAAs) for HCV, elimination of viral hepatitis has become a real possibility. The Egyptian National Committee for the Control of Viral Hepatitis did its best to provide Egyptian HCV patients with DAAs. Egypt adopted a strategy that represents a model of care that could help other countries with high HCV prevalence rate in their battle against HCV. This review covers the effects of HCV management in Egyptian real life settings and the outcome of different treatment protocols. Also, it deals with the current and future strategies for HCV prevention and screening as well as the challenges facing HCV elimination and the prospect of future eradication of HCV.

Full-text article-

Wednesday, October 10, 2018

Pathways to ensure universal and affordable access to hepatitis C treatment

In Case You Missed It

Pathways to ensure universal and affordable access to hepatitis C treatment 
Caitlin H. Douglass, Alisa Pedrana, Jeffrey V. Lazarus, Ellen F. M. ‘t Hoen, Radi Hammad, Ricardo Baptista Leite, Andrew Hill and Margaret Hellard
BMC Medicine201816:175
https://doi.org/10.1186/s12916-018-1162-z
Received: 27 February 2018Accepted: 29 August 2018Published: 9 October 2018

History records very few opportunities to eliminate a chronic infection. In the DAA era, eliminating hepatitis C as a public health threat is possible, yet it can only be achieved with affordable access to DAAs worldwide. Case studies of Australia, Portugal and Egypt demonstrate that comprehensive public health-based viral hepatitis plans facilitate negotiations with pharmaceutical companies. Shifting from individual-focused hepatitis C treatment to elimination requires strong political will and advocacy. If price negotiations with pharmaceutical companies do not produce reasonable prices for DAAs, governments can utilise flexibilities in patent law to ensure access to low-priced generic sources.


Abstract
Direct-acting antivirals (DAAs) have dramatically changed the landscape of hepatitis C treatment and prevention. The World Health Organization has called for the elimination of hepatitis C as a public health threat by 2030. However, the discrepancy in DAA prices across low-, middle- and high-income countries is considerable, ranging from less than US$ 100 to approximately US$ 40,000 per course, thus representing a major barrier for the scale-up of treatment and elimination. This article describes DAA pricing and pathways to accessing affordable treatment, providing case studies from Australia, Egypt and Portugal. Pathways to accessing DAAs include developing comprehensive viral hepatitis plans to facilitate price negotiations, voluntary and compulsory licenses, patent opposition, joint procurement, and personal importation schemes. While multiple factors influence the price of DAAs, a key driver is a country’s capacity and willingness to negotiate with pharmaceutical companies. If negotiations do not lead to a reasonable price, governments have the option to utilise flexibilities outlined in the Agreement on Trade-Related Aspects of Intellectual Property Rights. Affordable access to DAAs is underpinned by collaboration between government, civil society, global organisations and pharmaceutical companies to ensure that all patients can access treatment. Promoting these pathways is critical for influencing policy, improving access to affordable DAAs and achieving hepatitis C elimination.

Continue to full-text article:
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1162-z

On This Blog

The controversy over expensive new drugs for hepatitis C
Link to a collection of research articles addressing the high cost of HCV medications, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries, or through online "buyers clubs"

Tuesday, October 9, 2018

Anti-virals cure up to 98% of hepatitis C patients since 2014

Anti-virals cure up to 98% of hepatitis C patients since 2014Paul Cullen 

Use of revolutionary drugs has led to ‘a triumph of science’, says hepatologist

Up to 98 per cent of patients with hepatitis C virus have been cured thanks to the use of revolutionary anti-viral drugs over the past four years, new figures show.

The figures from the national treatment registry for Irish hepatitis C patients represent “a triumph of science”, Dr Diarmuid Houlihan, a hepatologist at St Vincent’s University Hospital told a conference in Dublin on Monday.

Hepatitis C is a virus that infects and damages the liver. It can cause inflammation scarring of the liver, which in some people can progress to cause serious liver damage, such as cirrhosis. It is often referred to as a silent disease, as symptoms can take several years to develop and people do not realize they have the disease. 


Wednesday, August 8, 2018

Deaths from hepatitis C have fallen by 11 per cent in the last year

Deaths from hepatitis C have fallen by 11 per cent in the last year
New PHE data shows a decrease in deaths from hepatitis C but diagnoses of advanced liver disease and related cancers remain stable.

Published 8 August 2018
From: Public Health England

New data published by Public Health England (PHE) show that deaths from hepatitis C-related end-stage liver disease have fallen by 11% in 2017 compared to the previous year.

A fall has been sustained in 2017 after a continued rise in deaths over the last decade. This fall is most likely due to increased use of new antiviral medications now available on the NHS which have the potential to cure the condition in most cases and have fewer side effects than previously used medications.

More people are accessing treatment than ever before with an increase of 19% on the previous year and of 125% when compared to pre-2015 levels.

The new data also shows there was still an average of 1,974 new end-stage liver disease and cancer diagnoses per year, with the rate remaining stable between 2011 to 2015.

In the UK, around 200,000 people have a long-term infection with hepatitis C virus. People who have ever injected drugs are most at risk of infection, but around half of people living with hepatitis C are unaware of their infection.

PHE is urging anyone who has previously been diagnosed with hepatitis C or who has engaged in activities that may have put them at risk to get tested as they can benefit from this potentially curative treatment.

Two years ago, the UK government committed to a joint ambition with 193 other countries to eliminate the disease as a public health threat by 2030. As well as testing and treatment, prevention through needle and syringe exchange services and opiate substitution therapies need to be sustained to achieve and maintain elimination.

Dr Sema Mandal, Consultant Epidemiologist at PHE, said:

The fall in deaths from hepatitis C related advanced liver disease in the last year suggests that more people are accessing new, potentially curative treatments and shows we’re making positives steps towards reaching our overall goal of elimination of hepatitis C as a major public health threat.

However, more needs to be done. We are urging anyone who has ever injected drugs, even once or a long time ago, had a tattoo or medical treatment overseas where proper hygiene procedures may not have been followed, or has had a blood transfusion before hepatitis C screening was in place, to get tested at their GP, community drug services or sexual health clinic. It could save your life.

If untreated, infection with the hepatitis C virus can lead to liver damage, cancer and even death. It is normally spread through blood-to-blood contact by sharing needles, but even sharing razors or toothbrushes with an infected person could pass the virus on.

The disease often has no symptoms until it causes serious complications many years later. Urgent testing and prompt treatment is needed in order to ensure infected people don’t suffer from serious health complications in the future.

If people aren’t sure about whether they are at risk, they can take a short quiz on the Hepatitis C Trust website to find out if they should get tested. 

Background 
Hepatitis C can be treated with medicines that stop the virus multiplying inside the body. These usually need to be taken for several weeks. Until a few years ago, most people would have taken 2 main medications called pegylated interferon (a weekly injection) and ribavirin (a capsule or tablet). Tablet-only treatments known as direct acting antivirals which have a short duration and fewer side effects are now available. Using these latest medications, more than 90% of people with hepatitis C may be cured.

PHE’s hepatitis C Operational Delivery Network (ODN) profile tool provides estimates of hepatitis C prevalence, diagnoses, treatment and severe hepatitis C-related liver disease at local level to help with local planning and delivery of awareness-raising, testing and diagnosis and treatment services.

The introduction of widespread needle exchange programmes in the 1980s and 1990s, which provided sterile injecting equipment and opiate substitution therapies, helped to reduce the number of drug-related deaths and blood-borne virus infections. The sustained investment in these services since then has resulted in the UK having one of the lowest rates of hepatitis C among injecting drugs users in the world – but these services must continue for lower hepatitis C rates to be realised.

Thursday, July 19, 2018

Systematic overview of hepatitis C infection in the Middle East and North Africa

World J Gastroenterol. Jul 21, 2018; 24(27): 3038-3054
Published online Jul 21, 2018. doi: 10.3748/wjg.v24.i27.3038

Systematic overview of hepatitis C infection in the Middle East and North Africa
Karima Chaabna, Sohaila Cheema, Amit Abraham, Hekmat Alrouh, Albert B Lowenfels, Patrick Maisonneuve, Ravinder Mamtani 

Link

Core Tip: Targeting specific populations at higher risk of acquiring HCV infection and treatment programs require the development of evidence-based health policies. HCV infection epidemiology in the countries of the Middle East and North Africa was characterized in 37 systematic reviews (SR) during the last decade. Our systematic overview critically analyzes and synthesizes the findings of these SRs to map the evidence gaps in the region. Additionally, we assessed the quality of the reported outcomes and documented conflicts of interest of the SR authors who disclosed financial relationships with pharmaceuticals.

ABSTRACT 
AIM
To assess the quality of and to critically synthesize the available data on hepatitis C infections in the Middle East and North Africa (MENA) region to map evidence gaps.

METHODS
We conducted an overview of systematic reviews (SRs) following an a priori developed protocol (CRD42017076736). Our overview followed the preferred reporting items for systematic reviews and meta-analyses guidelines for reporting SRs and abstracts and did not receive any funding. Two independent reviewers systematically searched MEDLINE and conducted a multistage screening of the identified articles. Out of 5758 identified articles, 37 SRs of hepatitis C virus (HCV) infection in populations living in 20 countries in the MENA region published between 2008 and 2016 were included in our overview. The nine primary outcomes of interest were HCV antibody (anti-) prevalences and incidences in different at-risk populations; the HCV viremic (RNA positive) rate in HCV-positive individuals; HCV viremic prevalence in the general population (GP); the prevalence of HCV co-infection with the hepatitis B virus, human immunodeficiency virus, or schistosomiasis; the HCV genotype/subtype distribution; and the risk factors for HCV transmission. The conflicts of interest declared by the authors of the SRs were also extracted. Good quality outcomes reported by the SRs were defined as having the population, outcome, study time and setting defined as recommended by the PICOTS framework and a sample size > 100.

RESULTS
We included SRs reporting HCV outcomes with different levels of quality and precision. A substantial proportion of them synthesized data from mixed populations at differing levels of risk for acquiring HCV or at different HCV infection stages (recent and prior HCV transmissions). They also synthesized the data over long periods of time (e.g., two decades). Anti-HCV prevalence in the GP varied widely in the MENA region from 0.1% (study dates not reported) in the United Arab Emirates to 2.1%-13.5% (2003-2006) in Pakistan and 14.7% (2008) in Egypt. Data were not identified for Bahrain, Jordan, or Palestine. Good quality estimates of anti-HCV prevalence in the GP were reported for Algeria, Djibouti, Egypt, Iraq, Morocco, Pakistan, Syria, Sudan, Tunisia, and Yemen. Anti-HCV incidence estimates in the GP were reported only for Egypt (0.8-6.8 per 1000 person-year, 1997-2003). In Egypt, Morocco, and the United Arab Emirates, viremic rates in anti-HCV-positive individuals from the GP were approximately 70%. In the GP, the viremic prevalence varied from 0.7% (2011) in Saudi Arabia to 5.8% (2007-2008) in Pakistan and 10.0% (2008) in Egypt. Anti-HCV prevalence was lower in blood donors than in the GP, ranging from 0.2% (1992-1993) in Algeria to 1.7% (2005) in Yemen. The reporting quality of the outcomes in blood donors was good in the MENA countries, except in Qatar where no time framework was reported for the outcome. Some countries had anti-HCV prevalence estimates for children, transfused patients, contacts of HCV-infected patients, prisoners, sex workers, and men who have sex with men.

CONCLUSION
A substantial proportion of the reported outcomes may not help policymakers to develop micro-elimination strategies with precise HCV infection prevention and treatment programs in the region, as nowcasting HCV epidemiology using these data is potentially difficult. In addition to providing accurate information on HCV epidemiology, outcomes should also demonstrate practical and clinical significance and relevance. Based on the available data, most countries in the region have low to moderate anti-HCV prevalence. To achieve HCV elimination by 2030, up-to-date, good quality data on HCV epidemiology are required for the GP and key populations such as people who inject drugs and men who have sex with men.

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