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Welcome to first Hepatitis Scotland e-Bulletin of 2015. This edition features more news on drug approvals and further developments on drug pricing; information on the Penrose Inquiry into infected blood products; the publication of two new Hepatitis Scotland videos; and a wider discussion on the implications for public health caused by widening inequality and changes to welfare and tax, both in the UK and internationally.
We also provide some updates on general research on both Hepatitis C and Hepatitis B.
Abbvie Pharmaceutical’s combination treatment for Hepatitis C, trade name Viekira Pak, has been granted an EU marketing license for treatment of Hepatitis C. The treatment combines 4 drugs, ombitasvir, paritaprevir, ritonavir and dasubuvir, administered with or without ribavirin.
The company reported cure rates of 95%-100% in phase 3 clinical trials. The treatment is taken for 12 weeks, or 24 for genotype 1a patients with cirrhosis. It was also approved for treatment of patients co-infected with HIV and for those who had had liver transplants. Pending approval by individual states the drug is now available for sale in the EU.
The treatment has also been approved by the Food and Drug Administration for use in the United States.
Gilead Sciences and Abbvie Pharmaceuticals have been engaging in a battle for dominance in the new Hepatitis C treatment landscape, with each company recently announcing exclusive prescription deals with US health management companies.
These moves are being viewed positively by some as signs that pressure is being brought to bear on the exorbitant price of these new Hep C treatments, with both companies likely to have had to reduce their marked price to win the deals.
NHS England has taken the unprecedented decision to delay prescribing sofosbuvir to Hepatitis C patients in England due to concerns over cost, despite NICE approving the drug as cost effective in its guidance. NHS England appears to be reluctant to introduce the treatment due to the £1billion cost of treating every 20,000 patients. With an estimated 160,000 people in England infected, the cost could reach £8billion. The drug will now not be available until July.
Charles Gore, Chief Executive of the Hepatitis C Trust expressed concern about the delay, questioning whether it could lead to further delays in the future if the NHS is basing decisions on immediate budgetary pressures rather than the standard cost effectiveness model usually applied. He said, ‘It feels like a whole new criterion has been invented by the back door.’
NHS England has already set aside over £18million to treat 500 patients with acute liver failure, many of whom are on transplant waiting lists. However, Professor of Hepatology Mark Thursz of Imperial College London and Chair of the Hep C Coalition said, “What worries me about it is that if you have got advanced liver disease with hepatitis C, you could progress at any stage to the point where it is very difficult or impossible to reverse the situation or have any improvement. Opportunities are being missed by any delay.”
The Indian patent office has rejected Gilead Sciences application for a patent for their Hepatitis C drug sofosbuvir, meaning that local manufacturers will potentially be able to produce cheaper generic versions of the drug. Indian patent law allows a third party to dispute patent applications and patient representative organisations did so on the basis that the drug was not sufficiently scientifically innovative. Gilead have appealed the decision.
Gilead had hoped to circumvent such an eventuality by licensing the drug at highly discounted rates to manufacturers in various developing countries, including 7 in India.
Research published in the Journal of Hepatitis has provided potential evidence of HIV negative gay men contracting Hepatitis C through sex. In a retrospective study carried out between January 2010 and May 2014, including 44 HIV negative MSM with Hep C, 93% of participants had reported unprotected intercourse in the previous 6 months, although other risk factors were also reported.
25% of respondents reported taking drugs during sex, with 16 men reporting snorting drugs and 9 reporting injecting drugs. With so few reporting injecting drug use and only a quarter reporting any drug use, this suggests that Hep C is being contracted sexually in this group.
For interest see also this discussion on the management of acute Hepatitis C in MSM in the era of all oral therapy.
Researchers in Philadelphia have documented large numbers of Hepatitis C patients not engaging in treatment beyond initial diagnosis. In research first published in the Journal of Hepatology in October, it is revealed that only 2% of patients in the city who are thought to be infected with Hepatitis C end up receiving treatment.
An estimated 47,000 people in Philadelphia, population 1.6 million, are infected with Hepatitis C, but due to lack of follow through, less than 1000 people a year are being treated, with patients falling away either after an initial test, confirmatory test or before they enter care.
The researchers said that there are ways to increase the number of people receiving care, including doctors testing the right people, ordering a specific test (RNA test) which only requires one blood sample to do the initial and confirmatory test and improving surveillance of the disease across the board.
A new report by the PhRMA has looked back over 25 years of developments in Hepatitis C treatment and highlighted that failed prospective treatments have actually led to eventual success in treating what was once thought to be an incurable illness.
According to the report there were 77 failed investigational medications between 1998 and 2014 but these led to the development of 12 successful treatments over the same period, bringing cure rates from around 6% up to over 90% with some of the new direct acting anti-virals that have become available since 2011. Not only are these medications more effective, they also come with significantly less negative side effects and shorter treatment durations.
After a series of delays the final report of the Penrose Inquiry into Hepatitis C/HIV acquired infection from NHS treatment in Scotland with blood products and blood products is to be published on March 25th 2015.
Meanwhile, 3 patients who contracted Hepatitis C from infected blood products in England are launching a legal challenge against the compensation scheme. The men claim that the scheme discriminates against them by paying them far less than those who contracted HIV.
The lawyer representing the 3 men said, "These viruses both sadly have serious implications for those who carry them and, in a proportion of cases, will lead to the death of the patient.We believe it is clearly unlawful that one group of sufferers of a serious virus, contracted through the same NHS disaster, are treated differently on account of their disability."
Recent research has questioned whether mass screening for Hepatitis C will ultimately lead to net clinical benefit in the screened populations. Key issues raised included:
• Interferon, ribavirin and older protease inhibitor based treatments for Hepatitis C can cause severe and sometimes fatal medical conditions – with new direct acting anti-virals long term effects not yet having been established due to small scale clinical trials and very short follow up
• Only a minority of patients with Hepatitis C will ever develop end stage liver disease and we cannot reliably identify those who will develop it
Canadian research has leant further weight to the US decision to screen for Hepatitis C using birth cohorts, with the Centers for Disease Control (CDC) recommending screening for all people born between 1945 and 1965 as cost effective. Whilst the results from Canada back up the cost effectiveness argument, some experts are questioning the wisdom of diagnosing large numbers of people who may not necessarily benefit from treatment.
Ronald L Koretz, emeritus professor of clinical medicine at David Geffen UCLA school of medicine in the US, previously questioned whether treatment of Hepatitis C is the best decision for everyone, and in a recent article published in the BMJ, has raised concerns that there has been no study to test as to whether this will lead to net clinical benefit or harm in screened populations.
Prof. Koretz points out that only a small minority of Hepatitis C infected patients will ever develop end stage liver disease, with most dying of other non hepatic conditions prior to the onset of severe liver disease. He also points out that older interferon, ribavirin and protease inhibitor treatments can have severe side effects and cause serious or sometimes fatal medical conditions – and that new direct acting anti-virals have not been sufficiently studied to understand any long term harms they may bring.
He questions the use of SVR as a marker of clinical benefit, saying that this does not constitute a cure and that the virus may resurface anyway. Finally he suggests longer term studies of the new direct acting anti viral therapies to properly establish clinical benefit.
Among the key messages in the article are:
Dr. Harry Burns, former Chief Medical Officer for Scotland and professor of global public health at Strathclyde University, has used an opinion piece published in New Scientist to say that social problems such as social cohesion, unemployment and poverty, particularly in early years, rather than lifestyle choice, explain Scotland's various ill health problems and a slowing rise in life expectancy.
He points to international research into the damaging effect that poverty and associated problems of deprivation in early childhood can have on long term health outcomes. The piece is published as a London School of Economics report into the Conservative/Liberal coalition government's social policy record says that families with children under the age of 5 have been worst hit by tax and benefit changes, with the poorest in the country hurt more than the better off.
See also a report by the Scottish Public Health Observatory concluding that changes to tax and benefits has bigger health implications than changes to health policy. The OECD has published a report saying that income inequaltiy harms growth, and Oxfam have released a report showing the vast gap between rich and poor worldwide, including in the UK. The Public Accounts Committee has also said that councils in the most deprived areas in England have been hardest hit by cuts.
New research published in the Journal of the American College of Surgeons demonstrates a new prediction model for the recurrence of hepatocellular carcinoma in liver transplant patients. Researchers say this model could be use to better select those who are likely to benefit from liver transplantation.
Hepatitis Scotland is pleased to release two new video webinars on around the subject of wider health issues when living with Hepatitis C. The first features an interview of Amy Solon, Waverley Care's Life Coaching worker, discussing their life coaching programme with some useful tips both for professionals working in the area and patients living with hepatitis on leading a healthy lifestyle with Hepatitis C.
The second video titled Alcohol and Viral Hepatitis features an interview with Dr. Peter Rice of Scottish Health Action on Alcohol discussing wider alcohol issues in Scotland, as well as alcohol and hepatitis and tips on how people might cut out or eliminate alcohol and how professionals can support people to achieve that.
Almost there with Point of Care HBV testing
A study published in the Journal of Viral Hepatitis has evaluated the Nanosign Point of Care test for Hepatitis B. The Nanosign test demonstrated sensitivity across several HBV genotypes and when serum samples were collected in local clinical settings was 73.7% sensitive and 97.8% specific. Despite this, researchers believe it offers advantages in limited resource settings due to low cost and immediately available results.
Further setback for Arrowhead Hep B drug
The US Food and Drug Administration has placed Arrowhead’s prospective Hepatitis B treatment ARC-520 – previously hailed as a ‘functional cure’ – on partial clinical hold and are seeking additional data from a mid stage study on the drug.
Entecavir better than lamivudine for Hep B patients receiving chemotherapy for lymphoma
A study published in JAMA has shown that in lymphoma patients the use of the anti-viral drug entecavir resulted in lower rates of Hepatitis B reactivation compared with anti viral drug lamivudine.