Daklinza label expanded in Europe

The hepatitis C direct-acting antiviral daclatasvir (Daklinza) has received European Union marketing approval for use in three new populations of people with genotype 1, 3 or 4 hepatitis C infection. Daclatasvir has been approved for use in combination with sofosbuvir in people with HIV and hepatitis C co-infection (genotypes 1, 3 or 4). Daclatasvir has been approved for treatment of hepatitis C in combination with sofosbuvir in people with decompensated cirrhosis (Child Pugh Class C), for use with or without ribavirin, for a recommended duration of 24 weeks. Daclatasvir has also been approved for the treatment of post-transplant recurrence of hepatitis C in genotypes 1, 3 and 4.

Cholesterol and liver damage in women with hepatitis C

A diet high in cholesterol appears more harmful to the liver, and is more strongly linked to liver-related death and liver transplantation, in women with hepatitis C and advanced fibrosis but not in men, according to an analysis of a large hepatitis C treatment trial published in the British Journal of Nutrition.

When comparing cholesterol intake above and below US dietary guidelines, women with a cholesterol intake above the recommended level of 300mg a day had a fourfold increased risk of liver-related death or transplantation compared to those women who had a lower cholesterol intake. There was no significant difference in either of these outcomes when cholesterol intake was assessed in men.

The authors speculate that the underlying mechanism for any sex-related effect is hormonal, but say that more work is needed to establish how cholesterol intake might affect women with hepatitis C differently from men.

The researchers say these findings are important for women who have not yet started treatment and for those who are waiting for treatment due to rationing or the high cost of treatment, and also for women who have been cured of hepatitis C but who remain at risk of developing hepatocellular carcinoma (liver cancer) due to advanced fibrosis.

Cryoglobulinemia and direct-acting antivirals

Treatment with direct-acting antivirals not only cures people of hepatitis C, but can also rapidly reduce the severity of one of the most troublesome extrahepatic manifestations of the disease, a study published this month shows.

Although studies of direct-acting antivirals show that newly-licensed combinations can cure hepatitis C in 90 to 95% of people, there is less information about the extent to which curing hepatitis C leads to improvements in the health of the liver or resolution of symptoms such as cryoglobulinemia.

Cryoglobulinemia is the presence of complexes of abnormal antibodies and proteins, which cluster in the blood vessels, in the kidneys or joints (vasculitis) causing skin lesions (purpura), pain in the joints of the hands and legs and damage to peripheral nerves (peripheral neuropathy). The presence of mixed cryoglobulins in the kidneys can lead to inflammation and kidney damage (glomerular nephritis) and the loss of kidney function over time.

The study, which reported on 12 patients with symptomatic cryoglobulinemia, found that direct-acting antiviral treatment cured 83% of patients of hepatitis C infection. This resulted in a reduction in cryoglobulins, as well as the reduction in symptoms in most patients and an improvement in kidney function in all those with impaired kidney function.

CDC warning on dialysis

The US Centers for Disease Control and Prevention (CDC) has received an increased number of reports of newly acquired hepatitis C virus (HCV) infection among patients undergoing haemodialysis. Infection control lapses in dialysis care could expose patients to HCV.

The CDC is urging health care providers to:

  • Assess current infection control practices and environmental cleaning and disinfection practices within the facility to ensure adherence to infection control standards
  • Address any gaps identified by the assessments
  • Screen patients for HCV, following CDC guidelines, to detect infections, determine treatment potential, and halt secondary transmission
  • Promptly report all acute HCV infections to the state or local health department.

The lapses highlight the importance of infection control policies and training in infection control practices for staff in haemodialysis centres, the importance of HCV screening for people receiving haemodialysis and the value of surveillance reporting for acute infection.

Drug pricing controversy builds in the United States

Merck’s decision to price its combination hepatitis C treatment Zepatier (grazoprevir/elbasvir) at least 30% below the wholesale price for a 12-week course of Harvoni (sofosbuvir/ledipasvir) in the United States has inflamed an already heated debate about the cost of hepatitis C treatment.

Merck will sell Zepatier at $54,600 for a 12-week course of treatment, although the manager of one of the largest US pharmacy benefits companies told Bloomberg that he expects to see further negotiation between Merck and pharmacy benefits schemes on price as Merck tries to capture market share from Gilead.

However, Merck’s decision to price the drug at $54,600 needs to be considered in the context of the widespread use of an 8-week course of Harvoni in easier-to-treat genotype 1 patients. After discounts, it is possible that Merck’s price is matching the price charged for an 8-week course of Harvoni, rather than undercutting it.

The Fair Pricing Coalition welcomed Merck’s pricing decision and called for other companies to follow its example, but also called on Merck to negotiate lower prices for Medicare and Medicaid in order to improve access to hepatitis C treatment for lower-income patients.

Hepatitis C drug prices are placing US state finances under enormous pressure. In Massachusetts the state attorney has opened an enquiry into whether Gilead has violated the state’s consumer protection law by pricing its hepatitis C drugs at very high levels.

When states can’t pay, they face legal actions from people denied treatment. Lawsuits are currently underway in Indiana, Massachusetts, Minnesota and Pennsylvania to determine whether states are breaking the law if they refuse “medically necessary treatment”. The American Civil Liberties Union is suing the state government of Indiana on behalf of Medicaid recipients denied hepatitis C treatment, for example. Dr Lynn Taylor, author of a study on state Medicaid restrictions on access to hepatitis C drugs, told Kaiser Health News that state restrictions on hepatitis C drugs are discriminatory. “We don’t withhold cancer treatment to only those with the most advanced stages of the disease,” she said. “We don’t deny smokers treatment for lung cancer.”

A lawsuit in Washington state is pursuing a similar challenge against private insurers, arguing that two insurers in the state are denying treatment on the grounds of cost, by restricting access to those patients with advanced liver disease. The American Association for the Study of Liver Diseases (AASLD) recommends treatment for everyone with hepatitis C, regardless of liver damage.

In California the state government has had to pay $387 million to managed care providers who treat people on low incomes and retired people to cover the cost of hepatitis C treatment up to November 2015. In November California citizens will vote on a proposal to restrict the amount that the state pays for prescription drugs to the lowest price paid by the US Department of Veterans Affairs. The VA has achieved a 50% discount on the wholesale price of sofosbuvir (Sovaldi) and state governments are beginning to ask why these deals should be restricted to one health care system.

However, even the prices paid by the VA system are being questioned by lawmakers in Washington. The US Federal Government ultimately foots the bill for the care of military veterans, and lawmakers are unhappy at the cost of hepatitis C treatment. An investigation by the House Committee on Veterans Affairs has questioned whether the inventor of sofosbuvir, Dr Raymond Schinazi, used VA resources to develop the drug in his spare time through a private company, Pharmasset.

Online treatment access data collection

mapCrowd, a new online crowdsourcing platform created by Médecins du Monde (MdM) and Treatment Action Group (TAG), is designed to help collect and share up-to-date hepatitis C virus (HCV) information.

It includes data uploaded by HCV advocates across the globe, as well as current scientific and institutional information. Initially covering 23 countries, mapCrowd presents national epidemiological, diagnostic, treatment and policy data, and contact information for local HCV organisations.

mapCrowd data is available at mapCrowd.org for free; users can access interactive charts, graphs, and maps, and download the full mapCrowd dataset.

A preliminary analysis of data reflecting data gathered to January 2016 shows:

  • A high relative burden of HCV among people who inject drugs.
  • Limited access to HCV diagnostics, especially in low- and middle-income countries, where the diagnostic package is priced at up to five times the monthly gross national income (GNI) per capita.
  • Access to hepatitis C treatment is restricted by high prices and by a registration gap – lack of drug registration in many low- and middle-income countries.
  • Lack of national HCV policy plans worldwide.
  • Low treatment uptake.

Improving referral from primary care

Ensuring that people with hepatitis C benefit from recent improvements in treatment requires more than access to drugs. Diagnosing people, retaining them in care and ensuring that people undergo monitoring tests for liver disease, in order to identify people in most urgent need of treatment, are all part of the care pathway or `treatment cascade` that ultimately determines who gets cured of hepatitis C.

Improving referral to hepatitis specialists and assessment by specialists resulted in almost four times as many people beginning hepatitis C treatment in one year at hospitals in Nottingham, the findings of a study published in Open Forum Infectious Diseases show.

Provision of specialist hepatitis care through drug treatment services and primary health clinics for people who inject drugs also greatly improved treatment uptake, the study found.

Anti-microRNAs: a new experimental treatment for hepatitis C

A new type of treatment for hepatitis C using an experimental technology called microRNA inhibition in the form of two injections has the potential to reduce the duration of hepatitis C virus (HCV) treatment to one month when combined with a direct-acting antiviral, according to results of a phase II study released this week.

MicroRNAs are small sequences of viral RNA which switch on or switch off the activity of genes in human cells. Anti-microRNAs bind to these sequences and stop their activity. RG-101 is being developed by Regulus Therapeutics as a component of hepatitis C treatment to target inhibitor miR-122, a liver-specific microRNA that regulates cholesterol and fatty acid synthesis. It also plays a crucial role in the HCV lifecycle by binding to the viral genome and protecting it from degradation by cellular enzymes. Drugs that interfere with the action of miR-122 could therefore inhibit HCV replication, acting earlier in the viral lifecycle than currently approved HCV protease, polymerase or NS5A inhibitors.

Research presented at the AASLD Liver Meeting in 2015 showed that a single dose of RG-101 was safe and resulted in viral suppression throughout 28 weeks of follow-up in 6 of 32 study participants. Interim findings from a phase II study in which 38 people received two injections of RG-101 at the beginning and end of a four-week course of treatment with either sofosbuvir/ledipasvir, simeprevir or daclatasvir, showed that 97% had an undetectable viral load after eight weeks of follow-up. Regulus Therapeutics will report full follow-up on 79 patients followed for at least 12 weeks after completing treatment in a few months’ time.

World Hepatitis Alliance Webinars

The World Hepatitis Alliance is hosting a series of webinars on patient group advocacy over the next few months. The webinars are free to join.

Whether your focus is on hepatitis, HIV, or another health issue, patient group advocacy is an important tool. Although the webinars are being held for hepatitis patient groups, it is likely that some of the information will be useful to people working in other areas too. The information below has been supplied by the World Hepatitis Alliance.

Harnessing patient power to effect change

The ability to engage policymakers and make change is heavily reliant on identifying the right opportunities and making best use of a range of tactics and materials to call on governments to develop strategies, adopt policies, commit to increased funding etc.

From February to April 2016, the World Hepatitis Alliance will host the ‘Tools for Change’ webinar series which will include three webinars aimed at educating and up-skilling viewers on various aspects of advocacy and the tools needed. A number of panellists, including representatives from the World Health Organization, national governments and member organisations will convene to discuss key topics and how viewers can use them in their national activities.

The webinars will be hosted twice on each respective date to accommodate attendees from different time zones.

Webinar 2: ‘How to interpret and leverage results for effective advocacy: HCV Quest Global Patient Survey’, will be held on 10 March at 10.00 am GMT / 19.00 pm GMT. It will discuss how useful surveys are for lobbying and campaigning. It will also provide an introduction to the HCV Quest toolkit, which includes documents and resources on how to organise a survey and utilise the results for advocacy activities.


  • Click here to register for 10.00am GMT webinar
  • Click here to register for 19.00pm GMT webinar

Webinar 3: ‘Awareness as a policy lever’, will be held on 4 April at 10.00 am GMT / 19.00 pm GMT. This webinar will review how media is used to influence policymakers. It will also provide information on how to build a global movement and an overview of World Hepatitis Alliance’s plans to launch a global hepatitis elimination movement this year.


  • Click here to register for 10.00am GMT webinar
  • Click here to register for 19.00pm GMT webinar

This is a great opportunity to hear from leading experts and to get first-hand examples of advocacy initiatives happening across the world. The webinar series is free and open to all of the public.

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