Netflix Model -Countries Use Novel Strategies to Tackle Price of HCV Drugs

Countries Use Novel Strategies to Tackle Price of HCV Drugs
Roxanne Nelson, RN, BSN
February 14, 2019

A recent study suggests that the WHO's goal of eliminating HCV infections worldwide by 2030 is potentially feasible but faces some daunting challenges, including the cost of DAAs.

To help overcome some of the barriers to treatment access, Australia and Brazil are each exploring innovative methods to circumvent the cost. Two perspective articles published February 14 in the New England Journal of Medicine outline how they hope to accomplish this goal.

The healthcare system in Australia is complex but is generally funded by the government. Drugs that are on the national formulary are usually paid for by the government. To help make DAAs more affordable to patients and the healthcare system, the Australian government has rolled out a strategy, nicknamed the "Netflix" plan because it is similar to the movie subscription service, in which payment is for bulk access.

Read more: https://www.medscape.com/viewarticle/909083 

New England Journal of Medicine

Perspective
Universal Medicine Access through Lump-Sum Remuneration — Australia’s Approach to Hepatitis C
Suerie Moon, M.P.A., Ph.D., and Elise Erickson, M.A.

References

High prices can restrict access to medicines in rich and poor countries alike. Australia’s approach to providing direct-acting antivirals (DAAs) for patients with hepatitis C virus (HCV) suggests that, under certain conditions, innovative approaches to payment can remove price as a barrier to access. In Australia, medicines on the national formulary are largely paid for by the government. In 2015, the authorities negotiated an agreement to spend approximately 1 billion Australian dollars (U.S.$766 million) over 5 years in exchange for an unlimited volume of DAAs for HCV from suppliers. This approach has been called the “subscription” or “Netflix” model, and the state of Louisiana announced in January 2019 that it was pursuing a similar approach for HCV. The Australian agreement is confidential, though the basic information above has been publicly reported..

Read more: https://www.nejm.org/doi/full/10.1056/NEJMp1813728?query=TOC 

New England Journal of Medicine

Brazil’s Fight against Hepatitis C — Universalism, Local Production, and Patents

Brazil’s strategy for addressing hepatitis C, which combines evidence-based treatment protocols and innovative initiatives for local production of generic direct-acting antiviral drugs, needs to be considered in light of ongoing conflicts over pharmaceutical patents.

Payment may be required to view article. 

HCV Special Conference - Worldwide HCV Epidemiology and Impact of Treatment

Website 

AASLD / EASL HCV Special Conference

February 1-2, 2019 

The goal of the conference is to promote global elimination of hepatitis C infection. World leaders in the related disciplines will assemble to establish the current state of the science and public health challenges. The experts will then formulate the most effective future steps toward elimination.

Coverage 

National AIDS Treatment Advocacy Project (NATAP)

Executive Director - Publisher, Editor, Reporter: Jules Levin

View slides and commentary from the HCV special conference over at (NATAP), here are a few presentations to get you started:

Baby Boomers; Is There a Need to Re-Focus our Efforts for Hepatitis C Screening Away from Baby Boomers? 23% HCV+ in Rural Drug Users Pennsylvania

Worldwide; HCV Epidemiology and Impact of Treatment 

What Is The Value Of HCV Treatment?
The Cost of HCV Elimination

Begin here: http://www.natap.org/2019/AASLDEASL/AASLDEASL.htm

NHS England’s plan to eliminate Hepatitis C decisively backed by High Court

NHS England’s plan to eliminate Hepatitis C in England by 2025 is on track after all aspects of a High Court challenge by pharmaceutical company AbbVie were dismissed.
18 January 2019
The NHS’s single largest medicines procurement, a deal worth almost £1 billion over five years, was launched in April last year but contract start dates had to be delayed by six months after legal action by AbbVie.

The High Court today handed down the judgment decisively backing NHS England’s plans to eliminate Hepatitis C.

In the ruling, the judge rejected all challenges brought by AbbVie against NHS England’s smart procurement for the supply of curative, direct acting antiviral treatments and industry backed projects to find and treat people with the virus as quickly as possible.

John Stewart, director of specialised commissioning at NHS England, said: “Court cases such as this are a waste of NHS resources and taxpayers’ money, in this case resulting in an unavoidable delay in our efforts to tackle the threat of Hepatitis C, which disproportionately affects some of the most vulnerable and marginalised people in society.

“We remain committed to driving best value to help eliminate Hepatitis C in England by 2025 or sooner, and with this court case behind us we can now get on with the job.”

Hepatitis C is a cancer-causing infectious disease, spread by contact with an infected person’s blood.

In recent years, Public Health England estimated that around 160,000 people are infected with Hepatitis C in England, although around half are unaware of their infection.

The disease, which can go undetected until the liver becomes damaged, can now be successfully cured in weeks using new oral tablets.

In 2015, NHS England established 22 Operational Delivery Networks (ODNs) to support treatment and testing efforts across the country and over 32,000 patients have been treated so far with around 95% being cured of the disease. NHS England plans to eliminate Hepatitis C in England by 2025, five years earlier than World Health Organisation goals.

The Hepatitis C procurement is the latest in a series of ‘smart deals’ the NHS has delivered to drive value for the taxpayer and benefits for patients.

These include a £300 million saving after negotiating deals with five manufacturers on low cost versions of the health service’s most costly drug, adalimumab; striking the first full access deal in Europe for CAR-T therapy which can potentially cure some children and adults with blood cancers where other treatments have failed; and reaching a deal to make the life-extending lung cancer drug pembrolizumab, available for routine use on the NHS.

https://www.england.nhs.uk/2019/01/nhs-englands-plan-to-eliminate-hepatitis-c-decisively-backed-by-high-court/

Low hepatitis C prevalence in Belgium: implications for treatment reimbursement and scale up

Low hepatitis C prevalence in Belgium: implications for treatment reimbursement and scale up Amber Litzroth Email author View ORCID ID profile , Vanessa Suin, Chloé Wyndham-Thomas, Sophie Quoilin, Gaëtan Muyldermans, Thomas Vanwolleghem, Benoît Kabamba-Mukadi, Vera Verburgh, Marjorie Jacques, Steven Van Gucht and Veronik Hutse

BMC Public Health 201919:39
https://doi.org/10.1186/s12889-018-6347-z
© The Author(s). 2019
Received: 21 September 2018
Accepted: 19 December 2018

Published: 8 January 2019

Abstract

Background
Prevalence data of chronic hepatitis C virus (HCV) infection are needed to estimate the budgetary impact of reimbursement of direct-acting antivirals (DAAs). In Belgium, the restricted reimbursement criteria are mainly guided by regional seroprevalence estimates of 0.87% from 1993 to 1994. In this first Belgian nationwide HCV prevalence study, we set out to update the seroprevalence and prevalence of chronic HCV infection estimates in the Belgian general population in order to guide decisions on DAA reimbursement.

Methods
Residual sera were collected through clinical laboratories. We collected data on age, sex and district. HCV antibody status was determined with ELISA and confirmed with a line-immunoassay (LIA). In specimens with undetermined or positive LIA result, HCV viral load was measured. Specimens were classified seronegative, seropositive with resolved infection, indicative of chronic infection and with undetermined HCV status according to the test outcomes. Results were standardized for age, sex and population per district, and adjusted for clustered sampling.

Results
In total 3209 specimens, collected by 28 laboratories, were tested. HCV seropositivity in the Belgian general population was estimated to be 0.22% (95% CI: 0.09–0.54%), and prevalence of chronic HCV infection 0.12% (95% CI: 0.03–0.41). In individuals of 20 years and older, these estimates were 0.26% (95% CI: 0.10–0.64%) and 0.13% (95% CI: 0.04–0.43), respectively. Of the total estimated number of HCV seropositive individuals in Belgium, 66% were between 50 and 69 years old.

Conclusions

Prevalence of HCV seropositivity and chronic infection in the Belgian general population were low and comparable to many surrounding countries. These adjusted prevalences can help estimate the cost of reimbursement of DAAs and invite Belgian policy makers to accelerate the scaling up of reimbursement, giving all chronically infected HCV patients a more timely access to treatment.

Full-text available online:

https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-018-6347-z

Progress and difficulties in the elimination of HCV infection: A population-based cohort study in Spain

Progress in the elimination of hepatitis C virus infection: A population-based cohort study in Spain 

Regina Juanbeltz, Alejandra Pérez-García, Aitziber Aguinaga, Iván Martínez-Baz, Itziar Casado, Cristina Burgui, Silvia Goñi-Esarte, Jesús Repáraz, José Manuel Zozaya, Ramón San Miguel, Carmen Ezpeleta, Jesús Castilla

Published: December 4, 2018
https://doi.org/10.1371/journal.pone.0208554 

Full-text article available online: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0208554

Abstract 

Background
The World Health Organization set targets to eliminate hepatitis C virus (HCV) infection through detection and treatment of all cases by 2030. This study aimed to describe the progress and difficulties in the elimination of HCV infection in Navarra, Spain.

Methods
Using electronic healthcare databases, we performed a population-based prospective cohort study to describe changes in the prevalence of diagnosed active HCV infection at the beginning of 2015 and the end of 2017, the rate of new diagnoses and the rate of post-treatment viral clearance (PTVC) during this period.

Results
At the beginning of 2015 there were 1503 patients diagnosed with positive HCV-RNA, 2.4 per 1000 inhabitants, and at the end of 2017 the prevalence had decreased by 47%. In the study period, 333 (18 per 100,000 person-years) new positive HCV-RNA cases were detected, but only 76 (23%; 4.2 per 100,000 person-years) did not have anti-HCV antibodies previously detected. Prevalent cases and new diagnoses of active infection were more frequent in men, people born in 1950–1979, HIV-infected patients and in those with lower income levels. Among patients with HCV-RNA, 984 achieved PTVC (22.7 per 100 person-years). PTVC was less frequent in patients born before 1940, in immigrants and in patients with lower income levels.

Conclusions
The prevalence of diagnosed active HCV infection has dropped by almost half over three years, because the number of patients with PTVC was much higher than the number of new diagnoses. Interventions specifically targeted at population groups with less favourable trends may be necessary.

On This Blog
Efforts to Eliminate Hepatitis C

Hepatitis C: is eradication possible?

Reviews
Hepatitis C: is eradication possible? 
Andrea Lombardi Mario U. Mondelli ESCMID Study Group for Viral Hepatitis (ESGVH)

First published: 25 November 2018
https://doi.org/10.1111/liv.14011 

This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. 

Please cite this article as doi: 10.1111/liv.14011

Abstract

Hepatitis C has a relevant global impact in terms of morbidity, mortality and economic costs, with more than 70 million people infected worldwide. In the resolution “Transforming our world: the 2030 Agenda for Sustainable Development” was included as a focus area in the health‐related goal with world leaders pledging to ‘combat’ it by 2030. In response, WHO drafted the Global Viral Hepatitis Strategy carrying the ambitious targets to reduce the number of deaths by two thirds and to increase treatment rates up to 80%. Despite the availability of highly effective therapeutic regimens based on direct acting antivirals many barriers to HCV eradication still remain. They are related to awareness of the infection, linkage to care, availability of the therapeutic drug regimens and reinfection. Overall, if an effective prophylactic vaccine will not be available, HCV eradication appears difficult to achieve in the future....

Key points:
DAA availability increased hope of HCV elimination and WHO defined that as a goal to be achieved by 2030. 

DAAs proved to efficiently eliminate HCV in specific settings/populations, but economical and logistic reasons make extremely difficult to apply this approach globally. 

A therapeutic vaccine is considered essential to reliably target HCV eradication.

Download Full Article: https://jumpshare.com/v/itrPCpIw4R33Hf1593sO

On Twitter

Article downloaded and  shared by Henry E. Chang via Twitter.

Australian experience shows high DAA uptake and rapid fall in rates of HCV viraemia among people who inject drugs

Australian experience shows high DAA uptake and rapid fall in rates of HCV viraemia among people who inject drugs

Michael Carter

Published: 28 November 2018

Providing hepatitis C virus (HCV) therapy with direct-acting antivirals (DAAs) to people who inject drugs can achieve rapid reductions in community prevalence of viraemia, according to Australian research published in the Journal of Hepatology. Uptake of HCV treatment increased from 10% to 41% after unrestricted access to DAAs was rolled out in March 2016, and the proportion of viraemic patients fell from 43% to 25%.

The authors believe their findings have significance for the World Health Organization (WHO) target of eliminating HCV as a public health threat by 2030.

Read More:

http://www.aidsmap.com/page/3394458/

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-

https://www.wjgnet.com/1007-9327/full/v24/i38/4330.htm

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.

View full-text article

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"

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. 

Read more: https://www.irishtimes.com/news/health/anti-virals-cure-up-to-98-of-hepatitis-c-patients-since-2014-1.3656345

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.

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

Full Text Online

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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.

Continue reading: https://www.wjgnet.com/1007-9327/full/v24/i27/3038.htm

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.

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

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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.

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

https://doi.org/10.1371/journal.pone.0193251

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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.

Read full article: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0193251

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:

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0193112

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.

Continue reading online: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0193112

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For Viral Hepatitis Elimination One Size Does Not Fit All

Health Is Global

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.

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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

Continue reading: https://www.healio.com/infectious-disease/hepatitis-c/news/online/%7B7ff1f624-9247-4f0b-aaf7-814ed4193ef0%7D/top-5-stories-about-hcv

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.”

https://www.england.nhs.uk/2018/01/hepatitis-c-2/

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.

Continue reading: http://www.medicalindependent.ie/101158/hse_urged_to_step_up_on_hep_c