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e-Bulletin September 2014

Welcome to the latest edition of the Hepatitis Scotland e-Bulletin.

 

Welfare Reform in Scotland: The impact on people living with HIV and viral Hepatitis


Hepatitis Scotland have collaborated with HIV Scotland on producing a new report on the effect of welfare reform on people living with HIV, Hepatitis B and Hepatitis C. Data was gathered using a patient survey and service provider survey to record the views and experiences of both since welfare reforms have begun to take effect.

This research was carried out in follow up to the 2012 report ‘People living with Hepatitis C and HIV: their views on welfare reform’ which looked at the potential impact of welfare reform in Scotland on this group. This report gives an insight into how the changes have actually affected patients and services in Scotland.

The results show beyond doubt that the welfare reforms and not at all suitable for people with blood borne viruses.  They  are causing significant uncertainty and anxiety, worsening the mental and physical health of people in grave need, and adding to the burden carried by specialist services that are already stretched and oversubscribed.

In our e-bulletins, we have repeatedly questioned how welfare reforms can be reconciled with the outcomes of the Sexual Health and Blood Borne Virus Framework, specifically that people affected by blood borne viruses lead longer healthier lives. 2 years after the publication of our first joint report on this topic, our recommendations have not been implemented and patients are suffering as a result, with services struggling to cope with increased demands.

The report sets out a list of recommendations for the NHS, DWP and Job Centre, local authorities and the Scottish Government which could mitigate these problems.

 

Sanctions hit most vulnerable hardest independent report says

An independent report written for the DWP has said benefit sanctions hit the most vulnerable people the hardest, with claimants not being told about hardship funds and people having sanctions imposed when they were not at fault.

 

The report was written by respected welfare expert Matthew Oakley, who has previously worked as an economic advisor to the Treasury and for the centre right think tank Policy Exchange.

The report said that the way the DWP communicated with claimants was confusing, unclear and legalistic. It said that actual and sample letters seen by the review team were hard to understand even for people working in the field. It also said that the most vulnerable claimants often didn’t understand why their benefits had been stopped and were frequently not informed about hardship payments they were entitled to.

These criticisms are supported by our own recent report, where respondent comments where people were unfairly sanctioned where they were unable (rather than unwilling) to comply with conditions e.g. due to a lack of understanding of the sanction process or practical and personal barriers to ensure compliance.

 

Penrose Inquiry costs rise to £12million


A report in the Scotsman highlights that the cost of the Penrose Inquiry into Scottish NHS contaminated blood products has almost quadrupled from its’ original £3million budget, having cost £11.3million up to May of this year. The inquiry has been investigating how hundreds of people in Scotland, including haemophilia patients were given contaminated blood products in the 1970’s and 80’s.


The inquiry has already been beset by numerous delays due to various issues, including warning letters being sent out to those criticised in the report taking longer than anticipated, and the death of Lord Penrose’ wife.

Dan Farthing, senior executive officer of Haemophilia Scotland said, “It would have been inexcusable if Lord Penrose had cut corners to keep costs down. An inquiry on the cheap which answered none of the big questions would have been worse than no inquiry at all.”

Scottish Labour’s Health spokesman Neil Findlay said that victims and their families needed to know the final conclusions of the report as soon as possible.

 

 

Scotland: Rapid decline in HCV incidence seen among PWID associated with national scale up of harm reduction

Scotland: Rapid decline in HCV incidence seen among PWID associated with national scale up of harm reduction

 

The implementation of a range of harm reduction measures in Scotland has seen a rapid reduction in new infections among people who inject drugs (PWID), according to research published in the PLOS ONE journal. The Hepatitis C Action plan and subsequent Sexual Health and Blood Borne Virus Framework saw increasingly high coverage of needle and syringe exchange programmes and opiate substitution therapy (OST). Individual level evidence demonstrated that these measures were associated with a reduced risk of recent HCV exposure and the researchers estimate that in combination they may have averted 1,400 new Hepatitis C infections in Scotland between 2008 and 2012.

 

Impact of methadone maintenance therapy on HCV incidence among IDU

 

A recent study from Canada has added further weight to significant benefits of opiate substitution therapy on reducing Hepatitis C transmission. The study also found that there appeared to be a dose responsive effect of increasing methadone exposure on Hepatitis C transmission rates. That is to say that those on higher doses of methadone were less likely to acquire Hepatitis C.


 

HCV infection epidemiology among people who inject drugs in Europe


This European study, published online in the PLOSone Journal, was based on 12 countries who reported on HCV chronicity and 22 on HIV prevalence among HCV infected PWID. The study concluded that key data suggested high levels of undiagnosed infections and poor treatment uptake and that greater efforts are required by many European countries to improve data availability in order to guide an increase in Hepatitis C treatment among PWID.

 

Treatment options are improving and may enhance prevention; however access for PWID may be poor. The review found that 9 of the 27 member states had data on HCV incidence among PWID, which was often high (2.7-66/100 person years). The most common genotypes were genotypes 1 and 3, but genotype 4 may be increasing while the proportion of traditionally difficult to treat genotypes (1 and 4) showed large variation.

 

Undiagnosed infection was assessed in 5 countries and was found to be high (median 49%), while the proportion of those diagnosed entering treatment was low (median 9.5%). Where it was assessed, burden of disease was high and is anticipated to rise in the next decade.

 

Gilead TRIPS, International pricing debate rages on

Gilead are still bearing the brunt of the international debate due to its’ exorbitant pricing of Sovaldi. In the US Gilead have been asked to furnish a variety of financial information, including documents about Sofosbuvir’s original research and development costs to Pharmasset. These documents appear to show Sofosbuvir’s R&D costs to that company, prior to the companies purchase by Gilead, of just under US$70 million. In just the second quarter of 2014 Sofosbuvir’s sales were US 3.48 BILLION!

 

Several EU countries, led by France, have joined forces to lobby Gilead to reduce their price for Sovaldi. The French Health Minister, Marisol Touraine, said, “If we accept such a high price, firstly, we won’t be able to treat everyone and we will also be creating a risk for our social security system.”

Due to the costs and the very high likelihood there will be many people unable to easily access the new treatments, a number of civil society organisations are pressuring governments to explore the compulsory acquisition of drug patents under World Trade Organisation (WTO) legislation, first used to bring HIV medicines to poorer countries.

 

The WTO DOHA provision of 2001 states each Member State has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. Each Member State has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that epidemics are one such circumstance.

 

Apart from the ethics of such high prices Hepatitis Scotland are concerned that any subsequent medications will be priced with these prices in mind, driving up the overall price points.


 

USA


In the US, 2 senators, including Senator Ron Wyden who chairs the Senate Finance Committee, have written to Gilead asking for detailed financial information about the $11billion acquisition of original developer Pharmasset, R&D costs and subsequent pricing forecasts. In their letter, they said ‘the pricing ($84,000 per course in the US) has raised serious questions about the extent to which the market for this drug is operating efficiently and rationally.’

 

Also in the US, 2 doctors from CVS Caremark Corp, the biggest healthcare related company on the Fortune 500 list by sales, have said that whilst Gilead’s pricing of Sovaldi is in line with previous treatments for Hepatitis C, the healthcare system will not likely be able to handle that kind of ‘sticker shock’ and that competition will probably bring down the price tag in the coming months and years.

They point out that if all 3 million Hepatitis C patients in the US were treated with Sovaldi, Gilead would make $250billion on the $11billion investment they made to buy Pharmasset, who developed the drug. Dr. Troyen Brennan of CVS said, ‘When you look at the overall cost (of the drug) to society, it’s unsustainable.’

 

Europe


Several EU countries, led by France, have joined forces to lobby Gilead to reduce their price for Sovaldi.

ACT UP Basel , a coalition of activists for access to Hepatitis C treatments based in Switzerland, has said that the French Government must issue a compulsory licence for Sovaldi and seek the use of generic drugs for Hepatitis C treatment. In a press release the group said,

 

‘... access to HCV new treatments in France will only be possible through an out-of-reach spending from the national health insurance. To treat 55% of people infected with chronic HCV in France (133,000 patients, with an advanced stage of infection – stage 2-4 fibrosis or “F2″ to “F4″), the national health insurance must pay the equivalent of the annual budget of all Parisian hospitals and health centres to cover the cost of sofosbuvir (Sovaldi) alone, or 7 billion Euros.’

 

They point out that the price for treating individuals may well increase markedly when Sovaldi is combined with other new treatments currently pending approval. They say that with a new DAA like Daclatasvir (Daklinza) it would cost between 100,000 and 150,000 Euros per 12 week course of treatment combined with Sovaldi, while the production costs of both drugs together is estimated at 57 and 122 Euros. They say the profit that will be garnered by these companies is huge, exceeding the margins of all other industries by far.

 

Asia and Africa


In India, companies and activists have been engaged in a patent battle with Gilead Sciences, claiming that Sovaldi is not innovative enough to be granted a patent. Forbes magazine contributor John LaMattina, has speculated that the likely $900 per treatment price Gilead will offer may still be unpalatable to India, with government officials pointing out that 80% of the population don’t have health insurance and many will not be able to afford this reduced price.

 

India has the mechanisms and track record of granting compulsory licences of the nature sought by ACT UP Basel in France for life saving drugs deemed too expensive, and so the company may have to reduce their price offer still further to avoid the granting of a compulsory licence to allow generic companies to produce the drug.

 

In Eygpt, the country which has the highest prevalence of Hepatitis C in the world, with around 12 million people chronically infected, the government has concluded a deal with Gilead to supply Sovaldi for $300 per 12 week course, as Gilead works to supply Sovaldi at more affordable prices in poor countries with high prevalence.

 

In response to criticism of the sometimes vast price differentials set by Gilead in different countries, Gregg Alton, executive vice president of corporate and medical affairs at Gilead, said, ‘Gilead’s global pricing model is based on a country’s ability to pay.’

 

Couples based intervention has impact on HCV incidence and risky sexual behaviour among drug involved couples


A couples-based risk reduction intervention in Kazakhstan has shown a reduction in Hepatitis C incidence and levels of sexual risk taking among drug involved couples. Kazakhstan has one of the fastest growing HIV epidemics in the world and a high prevalence of injecting drug use.


The Renaissance study hypothesised that couples assigned to the risk reduction programme would have lower incidence of HIV, HCV, STIs, unprotected sex and unsafe injection over the 12 month follow up period than those in the control group. 300 couples were recruited and randomly assigned to either a 5 session HIV/HCV/STI prevention risk reduction group or to a 5 session general wellness group.

 

Over the 12 month follow up period, those assigned to the risk reduction group saw significantly reduced incidence of HCV infection (69%). This group also saw a 51% reduction in HIV and STI incidence than the wellness group, though these differences were not statistically significant. However, the risk reduction group did report significantly fewer cases of unprotected vaginal sex and more consistent condom use over the entire follow up period compared with the wellness group.

 

The study did note that reductions in sexual risk were mainly seen in the first 3 months of follow up, leading authors to suggest that this demonstrated the strength of risk reduction intervention in reducing risky sexual behaviours early on. They suggested booster sessions may help cement this behaviour change over time.

 

Participants in both groups reported substantial reductions in rates of needle sharing and unsafe injecting over the follow up period with no significant difference between the groups. The authors suggested that this was likely due to the overdose prevention and health related content in both study programs.

 

They conclude that these findings draw attention to an HIV/HCV/STI prevention intervention strategy that can be scaled up for drug involved couples in harm reduction programs, drug treatment and criminal justice settings.

 

Hepatitis C Correlation Network update

Hepatitis C and Drug Use Conference update
23rd - 24th October, Berlin


The 1st European conference will bring together key actors on HCV, including drug user community representatives, harm reduction experts, health care professionals, pharmaceutical companies, researchers and policy makers to develop pathways for effective health responses and to open treatment for those who need it.

 

The conference will address:

- the policy of pricing 
- first results of the new treatment regimes
- HCV in prison
- treatment as prevention - what does it mean for drug users
- barriers to testing
- a demonstration of screening with FibroScan®

 

Join or register here.

World Hepatitis Alliance Quest Patient Survey

The World Hepatitis Alliance has launched a global patient survey which will reveal how HCV is treated around the world and how living with HCV impacts your day-to-day life.

 

The information gathered will be used to inform policy makers, doctors and pharmaceutical companies so the more responses they receive the better.


 

Upcoming training dates

Hepatitis Scotland have several upcoming blood borne virus training sessions which are open for booking and are free of charge. Dates and locations listed. For more info and booking contact view them on our events calendar.

 

Grampian


8th October - Aberdeen
12th November - Aberdeen
13th November - Elgin

 

Lanarkshire


6th November - venue tbc
6th February 2015 - venue tbc

 

Fife


27th November - Kirkcaldy
4th February 2015 - Kirkcaldy

 

Highland


8th October - Inverness

 

Western Isles


10th October - venue tbc

Contact

Hepatitis Scotland
91 Mitchell Street
Glasgow
G1 3LN

Telephone: 0141 225 0419
Fax: 0141 248 6414

 

Email:

enquiries@hepatitisscotland.org.uk 

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