Hepatitis C drugs now effective for most genotypes

Hepatitis C drugs now effective for most genotypes
Irish Medical Times
October 5, 2016 by Gary Culliton

Access to hepatitis C treatment remains an important issue, Gary Culliton reports in his latest Clinical Update. There is currently a significant number of patients who are not eligible for direct-acting antivirals

There are two or three options for the treatment of genotypes one and four. Currently, one treatment is preferred for genotype 3 (sofosbuvir and daclatasvir are used — with or without ribavirin depending on whether the patient has cirrhosis). Newer agents held out the prospect of further options, said Dr Feeney.

Currently all treatments — depending on the genotype — are combinations of two or three antivirals

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Hepatitis C - The era of first direct-acting antiviral agents: What did we learn?

Clinical Liver Disease
Special Issue: Biomarkers in Liver Disease, In My Opinion, Emerging Liver Scholars & Implications of Translational Research

Clinical Liver Disease (CLD) is a digital educational resource published on behalf of the American Association for the Study of Liver Diseases (AASLD).

View recently published articles in the latest issue of Clinical Liver Disease
Volume 8, Issue 3 Pages 59 - 82, September 2016

Article Of Interest
The era of first direct-acting antiviral agents: What did we learn?
Omar Y. Mousa, Surakit Pungpapong and Victor Ankoma-Sey
Version of Record online: 2 OCT 2016 | DOI: 10.1002/cld.574

The introduction of oral direct-acting antiviral agents (DAAs) revolutionized the treatment of patients infected with hepatitis C virus (HCV). The first class of DAAs to be approved by the US Food and Drug Administration were the protease inhibitors (PIs), telaprevir (TVR) and boceprevir (BOC). Because of their low potency and low genetic barrier to develop resistance-associated variants (RAVs), these drugs were approved to be used in combination with pegylated interferon-α and ribavirin (PR). Even though both PIs had significant issues related to safety and efficacy, they heralded a new era in therapy for chronic HCV infection.[1, 2] Like shooting stars in the night sky, they shone brightly yet briefly, illuminating the path for future advances in the treatment of HCV. Within 3 years of their approval to be available in the United States, both TVR and BOC were discontinued from that market. They are no longer recommended by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases for the treatment of HCV because they have been superseded by more effective and safer second-generation PIs and/or other classes of DAAs. So what did we learn from those shooting stars, TVR and BOC?
Continue reading Full Text Article

Watch a video presentation of this article
Watch the interview with the author

View additional articles, here. ​

FDA MedWatch/Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating

FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C

The U.S. Food and Drug Administration (FDA) is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death.

As a result, we are requiring a Boxed Warning, our most prominent warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines.
Direct-acting antiviral medicines are used to treat chronic hepatitis C virus (HCV) infection, an infection that can last a lifetime. These medicines reduce the amount of HCV in the body by preventing HCV from multiplying, and in most cases, they cure HCV. Without treatment, HCV can lead to serious liver problems including cirrhosis, liver cancer, and death (see List of Direct-Acting Antivirals).

Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up. It is currently unknown why the reactivation occurs.

Patients should tell your health care professional if you have a history of hepatitis B infection or other liver problems before being treated for hepatitis C. Do not stop taking your DAA medicine without first talking to your health care professional. Stopping treatment early could result in your virus becoming less responsive to certain hepatitis C medicines. Read the patient information leaflet or Medication Guide that comes with each new prescription because the information may have changed. Contact your health care professional immediately if you develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of serious liver problems.

We identified 24 cases of HBV reactivation reported to FDA¹ and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18, 2016.^2-7 This number includes only cases submitted to FDA, so there are likely additional cases about which we are unaware. Of the cases reported, two patients died and one required a liver transplant. HBV reactivation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV co-infection were excluded from the trials. The trials excluded these patients in order to specifically evaluate the safety of DAAs, including their effects on the liver, in patients infected with only HCV and without the presence of another virus which affects the liver (see Data Summary).

We urge health care professionals and patients to report side effects involving DAAs and other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

List of Direct-Acting Antivirals (DAAs)*

Brand name	Active ingredient(s)	Drug Manufacturer
Daklinza	daclatasvir	Bristol-Myers Squibb
Epclusa	sofosbuvir and velpatasvir	Gilead Sciences
Harvoni	ledipasvir and sofosbuvir	Gilead Sciences
Olysio	simeprevir	Janssen
Sovaldi	sofosbuvir	Gilead Sciences
Technivie	ombitasvir and paritaprevir and ritonavir	Abbvie
Viekira Pak	dasabuvir and ombitasvir and paritaprevir and ritonavir	Abbvie
Viekira Pak XR	dasabuvir and ombitasvir and paritaprevir and ritonavir	Abbvie
Zepatier	elbasvir and grazoprevir	Merck Sharp Dohme

*DAA regimens not requiring use in combination with interferon. The DAA medicines, Victrelis (boceprevir) and Incivek (telaprevir), are not included in the list as they are used in combination with interferon and are no longer available in the United States.

Read more here...

Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating

AUDIENCE: Infectious Disease, Gastroenterology, Patient

ISSUE: The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks.

As a result, FDA is requiring a Boxed Warning, our most prominent warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines.

BACKGROUND: Direct-acting antiviral medicines are used to treat chronic hepatitis C virus (HCV) infection, an infection that can last a lifetime. These medicines reduce the amount of HCV in the body by preventing HCV from multiplying, and in most cases, they cure HCV. Without treatment, HCV can lead to serious liver problems including cirrhosis, liver cancer, and death (see List of Direct-Acting Antivirals in the FDA Drug Safety Communication).

FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18, 2016. This number includes only cases submitted to FDA, so there are likely additional cases about which FDA is unaware. Of the cases reported, two patients died and one required a liver transplant. HBV reactivation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV co-infection were excluded from the trials. See the data summary section in the Drug Safety Communication for more detailed information.

RECOMMENDATION: Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up.

Patients should tell your health care professional if you have a history of hepatitis B infection or other liver problems before being treated for hepatitis C. Do not stop taking your DAA medicine without first talking to your health care professional. Stopping treatment early could result in your virus becoming less responsive to certain hepatitis C medicines. Read the patient information leaflet or Medication Guide that comes with each new prescription because the information may have changed. Contact your health care professional immediately if you develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of serious liver problems.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov

Related;

HCV Guideline Update
People with HCV Should Be Tested for HBV Before Starting Antiviral Therapies
The updated information can be found in the Monitoring Patients Who Are Starting Hepatitis C Treatment, Are On Treatment, or Have Completed Therapy section of the Guidance.

More from Medscape - If you have a patient with hepatitis C virus (HCV), it is important to screen them for hepatitis B virus (HBV) before you start direct-acting antiviral treatment. Guidelines were recently updated after case reports described reactivation of HBV in patients with both HBV and HCV who were only treated for HCV. The thought is that the reactivation may have to do with an increase in hepatitis B viral replication after the HCV is cleared. It does not seem to be due to toxicity from any specific drug.

To ensure successful therapy for patients with HCV, it is important that the HBV treatment start before or at the same time as treatment for HCV. If your patient does not meet criteria for HBV treatment because their viral load is low or undetectable, they will still need to be followed closely for reactivation, which can be very serious.

Treatment of HCV infection should be considered for everyone in Australia who has a chronic infection

A practical overview of the treatment of chronic hepatitis C virus infection
Khoo A, et al. Aust Fam Physician. 2016.

Authors
Khoo A, Tse E.
Citation Aust Fam Physician. 2016 Oct;45(10):718-720.

Full Text Article
Download PDF or  View Online

Abstract
BACKGROUND: Although hepatitis C virus (HCV) infection is associated with significant morbidity and mortality, OBJECTIVE: This article provides an overview for GPs on the principles involved in assessing and treating patients with chronic hepatitis C within a community setting.

DISCUSSION: Treatment with DAA medications listed on the PBS should be considered for all patients with chronic HCV infection. These regimens are well tolerated, highly efficacious and have all-oral administration. A thorough pre-treatment evaluation should be undertaken, and patients with cirrhosis, significant comorbidities or potential drug-drug interactions should be referred to a specialist. Successful eradication of HCV is characterised by undetectable HCV ribonucleic acid viral load on polymerase chain reaction testing 12 weeks after treatment completion, although antibodies to HCV may remain positive for the rest of the patient's life.

Affecting more than 230,000 individuals in Australia, hepatitis C virus (HCV) infection is a common cause of chronic liver disease, leading in many cases to cirrhosis, decompensated disease, liver cancer and death.^1,2 Despite significant morbidity and mortality, it is estimated that <2% of people with chronic HCV infection receive treatment.^3,4 A key contributor to this low treatment uptake has been a lack of infrastructure available to administer therapy, which was previously undertaken only through specialist liver disease clinics or via specially trained and accredited GPs.⁵

As of March 2016, new oral direct-acting antiviral (DAA) treatments for HCV became available on the Pharmaceutical Benefits Scheme (PBS) for patients >18 years of age in Australia. These treatments can be prescribed by GPs in consultation with a gastroenterologist, hepatologist or infectious diseases physician experienced in the treatment of chronic HCV infection.⁶
Logistically, the nature of this consultation varies in different states and territories; however, most patients with uncomplicated HCV infection can be treated in the community without being seen by a specialist. The nationally standardised Remote consultation request for initiation of hepatitis C treatment form from the Gastroenterological Society of Australia (available at www.gesa.org.au/professional.asp?cid=77&id=454) is an easily accessible document that can be submitted to many treatment centres in Australia for sighting and approval by an appropriate physician.

Implementation of the new treatment paradigm has far-reaching implications, as the vast majority of patients with chronic HCV infection have not been referred to specialty services or considered for treatment.⁷ Empowering primary care physicians to facilitate rapid work-up and treatment of the disease allows treatment to be offered in the community to individuals who are unable to readily access specialty services.
The purpose of this article is to provide a practical overview of the approach to and treatment of HCV infection within the community setting for primary care physicians.

Pre-treatment evaluation
The new DAA medications are associated with average cure rates of >90%. They are better tolerated, are orally administered and are more effective than previous therapies for HCV infection.⁸ As such, everyone living with chronic HCV infection should be considered for antiviral treatment, even if they have tried and failed interferon-based therapy in the past.
Prior to commencing DAA therapy, patients should undergo a thorough pre-treatment evaluation (Box 1). This should include identifying the genotype of hepatitis C involved, whether there is evidence of cirrhosis, and if treatment had been previously attempted. These factors directly influence the choice and duration of therapy. As compliance is a key component of treatment success, comorbid physical or psychological conditions should also be optimised before commencing therapy.

Box 1. Core concepts in the pre-treatment evaluation of patients with HCV infection

Is the patient infected with HCV? If so, what is the genotype? HCV antibody positive indicates exposure HCV viral load (PCR) indicates current infection Hepatitis C genotype Is there evidence of cirrhosis? Physical examination: spider naevi, palmar erythema, gynaecomastia, splenomegaly Biochemical tests: thrombocytopenia, low albumin, prolonged PT/ INR, aspartate aminotransferase-to-platelet ratio index >1.0 Imaging: ultrasonography or elastography (FibroScan) Is the patient treatment naive or treatment experienced? Do other medical conditions need optimisation first? Patient has significant comorbidities or concurrent infections Patient has prominent psychiatric issues that may interfere with medication compliance Patient will soon be undergoing surgery that may make administration of medications more challenging Do medication interactions need to be addressed? Some antiepileptics, such as carbamazepine and phenytoin, are contraindicated, whereas others, such as sodium valproate and levetiracetam, are safe Patient has prominent psychiatric issues that may interfere with medication compliance Proton pump inhibitors may need to be taken at reduced doses and with the same administration time as certain antivirals (eg ledipasvir + sofosbuvir) Does the patient need to be referred to a specialist for treatment? Patients with cirrhosis, significant comorbidities or challenging drug–drug interactions should be referred

HCV, hepatitis C virus; INR, international normalised ratio; PCR, polymerase chain reaction; PT, prothrombin time

Table 1. Examples* of approved regimens for HCV under the Pharmaceutical Benefits Scheme⁶

		Genotype 1	Genotype 2	Genotype 3	Genotypes 4–6
Non-cirrhotic	Treatment-naive	Ledipasvir + sofosbuvir   (8 or 12 weeks†)	Sofosbuvir + ribavirin (12 weeks)	Daclatasvir + sofosbuvir   (12 weeks)	Sofosbuvir +  PEG-IFN + ribavirin (12 weeks)
	Treatment-experienced	Ledipasvir + sofosbuvir (12 weeks)	Sofosbuvir + ribavirin (12 weeks)	Daclatasvir + sofosbuvir   (12 weeks)	Sofosbuvir +  PEG-IFN + ribavirin (12 weeks)
Cirrhotic	Treatment-naive	Ledipasvir + sofosbuvir (12 weeks)	Sofosbuvir + ribavirin (12 weeks)	Daclatasvir + sofosbuvir (24 weeks)	Sofosbuvir +  PEG-IFN + ribavirin (12 weeks)
	Treatment-experienced	Ledipasvir + sofosbuvir (24 weeks)	Sofosbuvir + ribavirin (12 weeks)	Daclatasvir + sofosbuvir (24 weeks)	Sofosbuvir +  PEG-IFN + ribavirin (12 weeks)
*A full list of approved regimens is available at www.pbs.gov.au/info/healthpro/explanatory-notes/general-statement-hep-c †Treatment for 8 weeks can be considered if pre-treatment HCV viral load is <6 million IU/mL HCV, hepatitis C virus; PEG-IFN, peginterferon alfa-2a

Several groups of patients will require referral to a specialist for treatment, particularly those with current or prior evidence of decompensated cirrhosis, such as encephalopathy, previous variceal bleeding or refractory ascites.⁴ Regardless of the degree of compensation, individuals with cirrhosis will benefit from specialist review to assess readiness to commence therapy and assist with other aspects of care (eg variceal surveillance, hepatocellular carcinoma screening).

In cases where a diagnosis of cirrhosis is uncertain, referral for elastography (FibroScan) is the authors’ preferred method for establishing the degree of fibrosis. Thrombocytopenia, prolonged prothrombin time (PT)/international normalised ratio (INR) and hypoalbuminaemia are biochemical features that suggest the presence of cirrhosis. In the absence of elastography, a variety of other non-invasive tools, such as the aspartate aminotransferase-to-platelet ratio index (APRI) or Hepascore, can assist in establishing a diagnosis.⁹

Other patient groups that warrant closer specialist input are those in whom multiple comorbidities or concomitant medications make choosing the right regimen challenging. Many DAAs and their metabolites are renally cleared, and as such, their dosing in those with severe renal impairment (creatinine clearance <30 mL/min/1.73 m2) can be challenging. Other key considerations before commencing therapy are potential drug–drug interactions. Discontinuation of, or alternatives to, certain medications such as macrolide antibiotics, St John’s wort and certain antiepileptics, such as carbamazepine or phenytoin, is critical. The University of Liverpool drug–drug interaction checker (available online at www.hep-druginteractions.org) is a useful tool for ensuring there are no relevant drug–drug interactions.

Treatment
Six genotypes of hepatitis C have been identified, although genotypes 1 and 3 comprise 90% of all cases in Australia.¹⁰ An example of an approved treatment regimen for each genotype is listed in Table 1. Most of these regimens consist of once daily dosing; side effects of fatigue, headache, nausea and insomnia are uncommon and typically mild, and rarely necessitated cessation of the drug in clinical trials.¹¹ In contrast to traditional interferon-based treatment regimes, intensive monitoring during therapy with DAAs is therefore seldom required. Nonetheless, it should be emphasised to patients that poor adherence to the daily dosing regimen can significantly affect response to therapy.
Treatment response is assessed 12 weeks after completion of therapy, with an assessment of hepatitis C viral load by polymerase chain reaction (PCR). Successful treatment is characterised by an undetectable level indicative of sustained virologic response (SVR). Although patients will remain positive for HCV antibodies, those who achieve SVR at 12 weeks should no longer be considered as being infected with the virus.^12,13 However, it should be noted that positive serology is not a marker of protection, and repeat exposure may lead to reinfection.
Treatment of HCV is also an effective therapy for extrahepatic manifestations of hepatitis C such as cryoglobulinaemia and glomerulonephritis, and these should also demonstrate lasting improvement following treatment.¹¹

Patients with normal liver function tests after SVR can be managed as if they had never been infected with HCV; however, high-risk behaviours should be addressed if present. Individuals with ongoing liver function test derangement, or those who have failed to achieve SVR, maintain a requirement for entry into surveillance programs and specialist involvement to pursue further therapeutic options.

Conclusion
Treatment of HCV infection should be considered for everyone in Australia who has a chronic infection. The relative scarcity of specialist services, compared with the prevalence of the disease, clearly suggests that treatment cannot be managed by specialists alone. Australia’s new model of care provides primary care physicians with streamlined access to highly effective and well-tolerated oral DAA therapy in consultation with experienced specialists. Furthermore, non-cirrhotic individuals with no significant comorbidities, concurrent infections or relevant drug–drug interactions rarely need to see these specialists in person to complete treatment.

Cure of chronic HCV infection has the potential to significantly improve the health of 230,000 Australians, decrease mortality from complications of chronic infection and reduce the burden of liver disease in Australia’s healthcare system.

Authors
Anthony Khoo MBBS, Basic Physician Trainee, Department of Medicine, Royal Adelaide Hospital, Adelaide, SA. anthony.khoo@sa.gov.au
Edmund Tse MBBS, PhD, FRACP, Head of Clinical Hepatology, Department of Hepatology, Royal Adelaide Hospital, Adelaide, SA

Competing interests: Edmund Tse has received a grant from BMS for research into models of care and honoraria as an independent consultant on advisory boards for BMS/MSD/Gilead. He has been a speaker at a product launch presentation for BMS/Abbvie/Gilead.
Provenance and peer review: Not commissioned, externally peer reviewed.

References

1. Hepatitis Australia. A guide to current and emerging hepatitis C treatments in Australia. Woden, ACT: Hepatitis Australia, 2012.] Search PubMed
2. Sievert W, Razavi H, Estes C, et al. Enhanced antiviral treatment efficacy and uptake in preventing the rising burden of hepatitis C related liver disease and costs in Australia. J Gastroenterol Hepatol 2014;29(Suppl 1):1–9. Search PubMed
3. Dore GJ, Law M, MacDonald M, Kaldor JM. Epidemiology of hepatitis C virus infection in Australia. J Clin Virol 2003;26(2):171–84. Search PubMed
4. Hepatitis C Virus Infection Consensus Statement Working Group. Australian recommendations for the management of hepatitis C virus infection: A consensus statement 2016. Melbourne: Gastroenterological Society of Australia, 2016. Search PubMed
5. NPS MedicineWise. Direct acting antivirals for hepatitis C: New developments. Surry Hills, NSW: NPS MedicineWise, 2015. Available at www.nps.org.au/publications/health-professional/health-news-evidence/2015/new-therapies-hepatitis-c [Accessed 17 May 2016]. Search PubMed
6. Pharmaceutical Benefits Scheme. General statement for drugs for the treatment of hepatitis C. Canberra: PBS, 2016. Available at www.pbs.gov.au/info/healthpro/explanatory-notes/general-statement-hep-c [Accessed 1 May 2016]. Search PubMed
7. Holmes J, Thompson A, Bell S. Hepatitis C – An update. Aust Fam Physician 2013;42(7):452–56. Search PubMed
8. Thompson AJ. Australian recommendations for the management of hepatitis C virus infection: A consensus statement. Med J Aust 2016;204(7):268–72. Search PubMed
9. European Association for Study of Liver, Asociacion Latinoamericana para el Estudio del Higado. EASLALEH clinical practice guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis. J Hepatol 2015;63(1):237–64. Search PubMed
10. McCaw R, Moaven L, Locarnini SA, Bowden DS. Hepatitis C virus genotypes in Australia. J Viral Hepat 1997;4(5):351–57. Search PubMed
11. American Association of the Study of Liver Diseases, Infectious Diseases Society of America. HCV guidance: Recommendations for testing, managing, and treating hepatitis C. Virginia, VA: AASLD, IDSA, 2014. Available at www.hcvguidelines.org [Accessed 1 May 2016]. Search PubMed
12. Yoshida EM, Sulkowski MS, Gane EJ. Concordance of sustained virological response 4, 12, and 24 weeks post-treatment with sofosbuvir containing regimens for hepatitis C virus. Hepatology 2015;61(1):41–45.    Search PubMed
13. Swain MG, Lai MY, Shiffman ML, et al. A sustained virologic response is durable in patients with chronic hepatitis C treated with peginterferon alfa-2a and ribavirin. Gastroenterology 2010;139(5):1593 Search PubMed

UNITAID and FIND launch initiative to improve diagnostics and treatment for hepatitis C

UNITAID and FIND launch initiative to improve diagnostics and treatment for hepatitis C

4 October 2016

GENEVA - UNITAID today announced a partnership with FIND to improve diagnostics and treatments for hepatitis C virus (HCV) and make them more affordable and widely available to those in need.

The US $38.3 million project will support the development of better, simpler, diagnostic tools for HCV where people seek care, and will introduce HCV testing and treatment over three and a half years in HIV programmes in seven countries: Cameroon, Georgia, India, Malaysia, Myanmar, Thailand and Vietnam.

Until recently, treatment of HCV was complex, lengthy and of limited efficacy. In addition, severe side effects made it difficult for some to complete the full course of treatment, which could take a year or more.

New medicines for the treatment of HCV, in the form of direct acting antivirals (DAAs), have revolutionized HCV treatment in recent years. Combinations of these new medicines, which are generally well tolerated and highly effective, can cure HCV in as little as 12 weeks, compared with the older, year-long regimens.

However, a lack of appropriate diagnostic tools for HCV infection remains a challenge; it is estimated that fewer than 5 percent of HCV-infected people are diagnosed. Existing HCV screening and diagnostic tools are relatively expensive and not suited for the clinical contexts of low- and middle-income countries or for all infections, particularly where patients are co-infected with HIV and HCV. This makes it hard to identify and diagnose – and thus to treat – HCV infection in people living with HIV.

“This is a classic example of a bottleneck where UNITAID can help to unlock markets with the potential to make HCV diagnostics and treatment more affordable and therefore available for millions of people,” said Lelio Marmora, Executive Director of UNITAID.

“The treatment breakthrough offers a tremendous opportunity to address HCV, particularly among HIV/HCV co-infected people, who progress faster to serious disease than HCV mono-infected people,” said Catharina Boehme, Chief Executive Officer at FIND. “Testing and treatment must go hand in hand, and the main obstacle now is the lack of appropriate diagnostic tests. This makes those co-infected with HIV/HCV a priority group for diagnosis and treatment”.

In May 2016, the World Health Assembly adopted, for the first time ever, a strategy on viral hepatitis calling for: 90 percent reduction in new cases, 65 percent reduction in mortality, 90 percent of HCV infections diagnosed, and 80 percent of eligible people with chronic HCV infection treated by 2030.

Today’s new project aims to: make new HCV point-of-care products ready for purchase; make HCV diagnostic tests and treatments available in the health systems of the project countries; lower the prices of HCV testing and treatment; and use findings from the FIND project to drive global and regional policy towards scaling up HCV management. Project implementation will be supported by WHO, which issued ground-breaking policy guidance for countries to scale up access to hepatitis C medicines and diagnostics earlier this year.

http://unitaid.org/en/press-releases/1608-unitaid-and-find-launch-initiative-to-improve-diagnostics-and-treatment-for-hepatitis-c

International data shows injecting drug use (IDU) is a major contributor to the global burden of HCV, HBV and HIV

Oct 3, 2016

Estimating the burden of disease attributable to injecting drug use as a risk factor for HIV, hepatitis C, and hepatitis B: findings from the Global Burden of Disease Study 2013

A new analysis of international data shows injecting drug use (IDU) is a major contributor to the global burden of HCV, HBV and HIV.

Previous estimates of the burden of these diseases among people who inject drugs have not included estimates of the burden attributable to the consequences of past injecting. Therefore, a team of researchers from Australia, the UK and the USA used the Global Burden of Disease Study and United Nations data to study this risk factor.

They estimated 10million disability-adjusted life-years (DALYs) were attributable to previous exposure to HIV, HBV, and HCV via IDU, a four-times increase since 1990.

In total, in 2013, IDU was estimated to cause 4% of DALYs due to HIV, 1.1% of DALYs due to HBV, and 39.1% of DALYs due to HCV. The IDU-attributable HIV burden was highest in low-to-middle-income countries, and the IDU-attributable HCV burden was highest in high-income countries.

The researchers suggest that effective interventions to prevent and treat these important causes of health burden need to be scaled up.

Summary Source - https://www.basl.org.uk/

Reference
Estimating the burden of disease attributable to injecting drug use as a risk factor for HIV, hepatitis C, and hepatitis B: findings from the Global Burden of Disease Study 2013. Degenhardt L, Charlson F, Stanaway J et al. Lancet Infect Dis. 2016 Sep 21 [Epub ahead of print]

Elimination viral hepatitis by 2030: What's needed and how do we get there?

Elimination viral hepatitis by 2030: What's needed and how do we get there?

ECDC comment on the adoption of regional hepatitis action plan by WHO Regional Committee European Centre for Disease Prevention and Control (ECDC)

During the annual session of the WHO Regional Committee for Europe in September 2016, the Member States adopted the European action plan for the health sector response to viral hepatitis. This is the first Action Plan for the Region and aims at guiding countries to achieve the set goal of eliminating viral hepatitis as a public health threat by 2030.

The Action Plan, as presented to the Regional Committee, provides regional milestones and targets across the continuum of viral hepatitis services and proposes priority actions for Member States.

Viral hepatitis in Europe
Currently, the countries of the European Union and European Economic Area report around 57 000 newly diagnosed acute and chronic cases of hepatitis B and C each year. And these figures most likely represent an underestimate of the true situation. Instead, it is believed that an estimated 10 million Europeans have chronic hepatitis B and C infection, most of them without knowing it as hepatitis is largely asymptomatic.

Data indicate a greater disease burden for hepatitis C compared with hepatitis B across Europe: numbers and notification rates for hepatitis C infection are nearly twice as high as those reported for hepatitis B. Read about recent data and trends here.

A systematic review on Hepatitis A virus (HAV) seroprevalence and Hepatitis A incidence in EU/EEA countries shows that although HAV circulation has been decreasing steadily over the past four decades, an increasing proportion of the EU/EEA population has become susceptible to HAV infection.

What's important to achieve elimination
This first European Action Plan provides an important driver to aid countries in their fight against viral hepatitis, to which ECDC had the opportunity to contribute directly. Currently, the available surveillance data show on-going transmission of hepatitis in Europe and in order to interrupt this chain and to prevent further infections, European countries need to strengthen local prevention and control practices as outlined in the plan.

To achieve elimination of viral hepatitis by 2030, European countries need to ensure that:

• those who might be unknowingly infected with viral hepatitis need to be identified through more effective testing and screening programmes;
• treatment programmes and coverage of local prevention and control practices (e.g. harm reduction, vaccination, prevention of mother-to-child transmission) are scaled up to interrupt existing transmission chains and to reduce morbidity and mortality;
• national surveillance systems need to be improved to better reflect the local burden of viral hepatitis.

It is especially important that those most at-risk for hepatitis have easier access to testing, for example, people who inject drugs, men who have sex with men or migrants from countries where the prevalence viral hepatitis is high. As reaching and testing those at risk of infection is still a public health challenge across Europe, ECDC also backs the efforts of the European HIV-Hepatitis testing week.

In order to help countries assess the hepatitis disease burden, evaluate existing prevention and control strategies and to define epidemiological trends or transmission patterns, ECDC coordinates efforts to improve the EU-wide surveillance data for hepatitis A, B and C.

Read more on viral hepatitis on the ECDC website.

October; HCV Blogs, Newsletters, and Flu Updates

October Updates

Autumn kicks off with a beautiful day here in Michigan, I hope the sun is shinning in your part of the world as well.

Here is a look at October updates from around the web.

*Make sure to download; Oral combination therapies for HCV infection: Successes, challenges, and unmet needs. Published online at the end of September, found on this page under - In Case You Missed It.  

The Flu And You

Have you been reading all about this years flu season? If so you may be wondering how early is too early to get vaccinated; so many opinions in the news this year. Bottom line? Last week Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention addressed the subject - urging us to get that flu shot as soon as possible. To learn more about this topic or access other updates view, Baby Boomers - Get Your Flu Shot. In addition read more on the benefit of vaccination for people living with chronic liver disease and those over the age of 50. Finally watch a few videos that discuss changes to this years CDC recommendations, start here.

Creating a World Free of Hepatitis C

by LUCINDA PORTER.
Welcome to my website and blog. My name is Lucinda Porter and I am a nurse committed to raising awareness about hepatitis C. I believe that we can create a world free of hepatitis C. We do this together, one step at a time.

Latest Entry
By Lucinda Porter

Can I Get a Flu Shot?
I had the flu three times in my life, and it taught me one thing—I get a flu shot every year. Last year, despite having a flu shot in October, I got the flu anyway. It happens. Flu shots only protect us from the most common strains that are predicted for that year, and the predicted strains are included in the vaccine. Some years, the vaccines have better coverage than other years.

NEJM

The Now@NEJM blog, produced by the NEJM publishing communications team, is about new and innovative content in the New England Journal of Medicine (NEJM.org). Our goal is to inform you about what’s new and provide some additional context to complement the content published in NEJM.

Latest Entry

Influenza Vaccination
Posted by Carla Rothaus

At what time of the year are decisions made regarding the composition of each annual influenza vaccine?
The specific influenza viruses that will be included in the vaccine each year are determined by worldwide surveillance and antigenic characterization of human viral isolates by the Global Influenza Surveillance and Response System of the World Health Organization. Currently, the production process requires that these decisions be made in February to allow for the production of vaccines to be distributed in the Northern Hemisphere in the following fall.

In The News
Certain Parents More Likely to Skip Kids’ Flu Shot
October 03, 2016.
By Amy Norton
HealthDay Reporter
Children who see "alternative" health providers, such as acupuncturists or massage therapists, are less likely than other kids to get their annual flu shot, a new study suggests.

Hepatitis C Blogs

HEPATITISC.NET
Stay up to date on Hepatitis C news, hear from our patient advocates and physician experts. The HepatitisC.net Headlines will provide tips and tools for living with and managing Hepatitis C.

Latest Entries
Hepatitis C Virus Treatment Side Effects
By Jenelle Marie Davis
What treatment options are there? The treatment options available for hepatitis C include different types of pills and, in rare cases, injections. Many treatment plans also include dietary changes, which are not...

List of Signs You Might Have Ascites
By Karen Hoyt
Once the belly swells out and you look like you’re pregnant, you have probably figured out that it’s ascites. I remember the first time my whole tummy felt jiggly. It was just before...

Take the Cost of Healthcare Survey
By Editorial Team
Cost is a major factor in managing a chronic condition such as hepatitis C. There are many things people do to save money and cut costs, however not all patients are aware...

Read other recent HepatitisC.net headlines

HEP
Your Guide To Hepatitis
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and Hep Magazine are the go-to source for educational and social support for people living with hepatitis.

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The Italian Story
By Greg Jefferys

Over the next few days I'm going to spend a little time talking about Italy because that is where I think the next big breakthrough on Hep C generics is going to happen.

A look at Epclusa versus sofosbuvir plu daclatasvir
By Greg Jefferys
As most people now know Gilead has launched its pan-genotype combination Epclusa, which is the combination of Sofosbuvir + Velpatasvir. With its usual eye on the market place Gilead launched Epclusa with plenty of promotions and advertising however the reality of Epclusa is that it is just another expensive and overpriced medicine that Gilead will use to squeeze more money out of the global health care system.

Read more blog updates @ HEP.

Hepatitis B

AGA Journals Blog

Dr. Kristine Novak is the science editor for Gastroenterology and Clinical Gastroenterology and Hepatology. She has worked as an editor at biomedical research journals and as a science writer for 15 years, covering advances in gastroenterology, hepatology, cancer, immunology, biotechnology, molecular genetics, and clinical trials. She has a PhD in cell biology and an interest in all areas of medical research.

Latest Entry
Dr. Kristine Novak
What is the Best Way to Predict Disease Progression in Patients With Inactive HBV?
In patients with chronic hepatitis B virus (HBV) infection who are negative for HBe antigen (HBeAg), monitoring levels of HB surface antigen (HBsAg) can predict disease progression, researchers report in the October issue of Clinical Gastroenterology and Hepatology. Most persons chronically infected with HBV clear HBeAg and enter an inactive carrier phase, characterized by low or undetectable
Read more

Publications Updates

Lets start with HCV Advocate and their October newsletter, here are the highlights;

HCV Drugs by Alan Franciscus – I reviewed two studies: The first study is about the final results of the treatment of Odalasvir plus AL-335 with and without simeprevir to treat HCV genotype 1 treatment naïve patients for 6 or 8 weeks. The second review is the mind-boggling outcomes of a study that used a 2-day response guided protocol to treat people for 3 weeks that produced 100% cure rates.

Snapshots by Alan Franciscus—I reviewed two studies: The first one is a study conducted in the Veterans Affairs National Health Care System that evaluated all of the current (at that time) direct-acting antivirals (DAAs) medications to understand the cure rates and the ‘real-world’ results vs. results from the clinical trials.

HealthWise – How I Nearly Outed Someone’s Hepatitis C Status: A Cautionary Tale by Lucinda K. Porter, RN—Lucinda discusses privacy issues that we are all concerned about in the age of Facebook, Twitter, and the other social media/internet and how to combat privacy issues and stigma.

Under the Umbrella—No Man is an Island: Part 2, Hepatitis C in Rural Southern Indiana—Matthew continues his saga about HCV with an emphasis on jails and prisons including what can be done to provide education and support to improve the health outcomes of inmates living with hepatitis C and therefore the entire community of hepatitis C.

Monthly Drug Pipeline has been updated with a link to the article about the Janssen story in this month’s HCV Advocate.

What’s Up!
We have reviewed and updated our entire HBV Treatment Fact Sheet Series!

Don’t forget to check out our HCV Advocate Clinical Trials Reference Guide – we only include clinical trials that are actively recruiting patients and we are constantly adding content.
Vote.USA.gov provides information by state on the requirements to register to vote and how to apply to vote.

Read the Weekly Bull

For over a decade HepCBC a Canadian non-profit organization has published an incredible monthly newsletter offering awareness, personal stories and basic information about HCV. Recently the highly successful newsletter has been retired, however without fail a new publication "The Weekly.Bull" will continue to serve us well, here is the latest issue.

The Week in Review: Sep 23 – 30, 2016
Friday, September-30-16

This month the eViralHepatitis Review from Johns Hopkins University devoted a whole issue to Extrahepatic Manifestations of Hepatitis C: Screening and Management, which you can read about and access via our Weekly.Bull. As well lawyers representing some of the more than 500 victims in the pre-1986/post-1990 Hepatitis-C settlement group filed a submission last week in Vancouver requesting that the courts of Ontario, Québec and British Columbia address a $65 million shortfall in their settlement fund.

Read more…http://hepcbc.ca/2016/09/30/week-review-sep-23-30-2016/

The National Viral Hepatitis Roundtable 

The National Viral Hepatitis Roundtable is a broad coalition working to fight, and ultimately end, the hepatitis B and hepatitis C epidemics. We seek an aggressive response from policymakers, public health officials, medical and health care providers, the media, and the general public through our advocacy, education, and technical assistance.

Recap of NVHR's September Webinars
Hepatitis C Treatment Access: State-Level Advocacy Successes
NVHR's webinar on Friday, September 9, 2016 featured three panelists from New York and Pennsylvania who shared how coalition-building and advocacy led to successful expansion of hepatitis C treatment in their states. Click here to view the slides and webinar recording.

Hepatitis C Screening in Emergency Departments
NVHR's webinar on Monday, September 26, 2016 included four panelists who discussed their work implementing hepatitis C screening initiatives in emergency departments, targeted versus universal screening, and the challenges of program sustainability. Click here to view the slides and webinar recording.

In Case You Missed It

Review in Advance first posted online on September 23, 2016. (Changes may still occur before final publication  online and in print.)
Oral combination therapies for HCV infection: Successes, challenges, and unmet needs
The current standard of care for the treatment of hepatitis C virus (HCV) consists of interferon-free direct-acting antiviral(DAA) regimens, including combinations of DAAs and fixed-dose combination pills. DAAs for HCV are likely to be heralded as one of medicine’s greatest advancements. Viral eradication rates are pushing 100% for many HCV infected populations, including patients with HIV/HCV coinfection, decompensated cirrhosis, liver and kidney transplants, and end stage liver disease. We highlight the greatest successes of combination DAA therapies, discuss the ongoing challenges, and identify the remaining patient subgroups with unmet medical needs.

Conference News
In September we had the EASL-AASLD Special Conference in Paris, and in Gold Coast, Australia the 10th Australasian Viral Hepatitis 2016 Conference took place. In Australia The Kirby Institute’s Hepatitis B and C Annual Surveillance Report Supplement was released, view the report here; "The Supplement was produced to coincide with the 2016 Australasian Viral Hepatitis Conference to provide a timely update on the roll out of hepatitis C direct acting antiviral treatments in Australia. With the World Health Organization calling for the elimination of hepatitis B and C by 2030, this report provides vital information on progress and gaps in the Australian response."

At the EASL-AASLD conference new recommendations on the treatment of hepatitis C were released which added Epclusa (sofosbuvir/velpatasvir) and Zepatier (grazoprevir/elbasvir) to the arsenal of treatments. Download the new HCV EASL recommendations or watch a video of the livestreamed updates with a follow-up Q&A session, here. All conference news with updates can be viewed, here.

Journal Updates

Gastroenterology
October 2016 - Volume 151, Issue 4
High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis 
In cirrhotic HCV GT1- or GT3-infected patients, ABT-493 plus ABT-530 with or without RBV achieved SVR12 rates of 96%–100% and was well tolerated.

Hepatitis C Virus RNA Persists in Liver Explants of Most Patients Awaiting Liver Transplantation Treated With an Interferon-Free Regimen 
The main goal of antiviral treatment in patients awaiting a liver transplant is to prevent hepatitis C virus (HCV) graft infection by eradicating the virus in serum and live.

Alimentary Pharmacology & Therapeutics
Published ahead of print
Implementation of a ‘care bundle’ improves the management of patients admitted to hospital with decompensated cirrhosis
Since 1970, there has been a 400% increase in liver-related deaths due to the increasing prevalence of chronic liver disease in UK. The 2013 UK National Confidential Enquiry into Patient Outcome and Death report found that only 47% of patients who died from alcohol-related liver disease received ‘good care’ during their hospital stay. Dr Stuart McPherson and colleagues from the United Kingdom developed a ‘care bundle’ for patients with decompensated cirrhosis, aiming to ensure that evidence-based treatments are delivered within the first 24 hours of hospital admission.

Journal Of Hepatology
October issue of the Journal of Hepatology
Selection of the month - HCV eradication and the risk of HCC: Issues with direct acting antiviral (DAA) therapy? and Treating HCV improves portal hypertension, HCV recurrence after OLT – not a concern anymore!

Journal of Hepatology Supplement​ - New Perspectives in HCV Infection
Topics - Management of the patient with SVR and Second generation direct-acting antivirals – Do we expect major improvements?

HCV Guideline Update
People with HCV Should Be Tested for HBV Before Starting Antiviral Therapies
The updated information can be found in the Monitoring Patients Who Are Starting Hepatitis C Treatment, Are On Treatment, or Have Completed Therapy section of the Guidance.

More from Medscape - If you have a patient with hepatitis C virus (HCV), it is important to screen them for hepatitis B virus (HBV) before you start direct-acting antiviral treatment. Guidelines were recently updated after case reports described reactivation of HBV in patients with both HBV and HCV who were only treated for HCV. The thought is that the reactivation may have to do with an increase in hepatitis B viral replication after the HCV is cleared. It does not seem to be due to toxicity from any specific drug.

To ensure successful therapy for patients with HCV, it is important that the HBV treatment start before or at the same time as treatment for HCV. If your patient does not meet criteria for HBV treatment because their viral load is low or undetectable, they will still need to be followed closely for reactivation, which can be very serious.

In The News
Insider Q&A: A front-row seat for the drug pricing battle
Dr. Steve Miller, the chief medical officer of Express Scripts, sits at the center of the storm over rising drug prices.

Miller has watched super-sized drug prices infuriate patients and strain the health care system with growing frequency, starting when a new hepatitis C drug hit the market at $84,000 for a course of treatment and continuing through the recent revelation that the price of Mylan's EpiPen rose more than 500 percent since 2007.

AbbVie's HCV Regimen glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) Receives FDA Breakthrough Therapy Designation
Sept. 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.​

Autumn is over so quickly, I hope you get out and take advantage of fall before its gone. Stay healthy this flu season.

Tina