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Welcome to the Christmas edition of the Hepatitis Scotland e-bulletin. There have been many exciting developments for people with Hepatitis C and B this year. The sensation of being on the threshold of momentous change is invigorating and we look forward to a new year where genuine access to new medications starts to make significant inroads into the numbers of those with chronic viral hepatitis. We hope that Santa is able to bring presents to all those who need them.
Hepatitis Scotland would like to wish everyone a merry Christmas and happy and healthy festive period. However, Christmas can be a time where we can sometimes over do things. We have produced a new blog post pulling together various pieces of research and advice on how you can live a healthy lifestyle with viral hepatitis, and which you might want to refer to beyond the holiday season.
Christmas can be an expensive time, between parties and trying to afford to give families the best Christmas you can. Sometimes this leads to overspending and debt worries in the new year.
National Debtline Scotland (0808 808 4000) has some very useful information and toolkits which may help with budgeting and debt management. Citizens Advice Scotland provides an impartial financial advice service. A video presentation by Vincent Chudy of Citizens Advice Scotland on this subject is available on the Hepatitis Scotland Youtube channel.
This checklist from Shelter Scotland provides some useful tips on preparing for winter; including staying warm while saving money on heating whether living in rented or bought accommodation.
At Christmas time some people may feel isolated, lonely, stressed or depressed. Christmas can put stress on families and relationships for all kinds of reasons. There are other health related strains for those coping with a chronic illness like hepatitis C.
Gilead has announced that their Hepatitis C combination treatment Harvoni has been granted an EU marketing licence, meaning that it can now be sold throughout the European Union. Gilead Sciences now begin the more complicated process of negotiating the price of this new highly effective but hugely expensive treatment with individual countries within the EU.
The treatment is a combination of 2 Gilead drugs (sofosbuvir and ledipasvir) and is taken once daily without the need for interferon or ribavirin, for Hepatitis C genotypes 1-4 without cirrhosis or with compensated cirrhosis.
In clinical trials and depending on factors such as genotype and cirrhosis, the treatment has reported SVR rates of 94-99%.. The US price of $95,000 per treatment course has caused some controversy in that country amid wider concerns about the cost of new Hepatitis C treatments across the world.
Harvoni plus ribavirin cure most people with Hepatitis C recurrence after liver transplantation
A study presented at the AASLD has shown that Gilead’s combination treatment for Hepatitis C, Harvoni (combination of sofosbuvir and ledipasvir), taken for 12 or 24 weeks plus ribavirin led to a cure in most genotype 1 patients with fibrosis or less advanced liver cirrhosis. Success rates fell for those with more severe cirrhosis or signs of decompensated cirrhosis but even then a majority were still cured.
In the past liver transplant patients were difficult to treat for Hepatitis C, which almost always infects the new liver after transplantation, because they do not respond as well to interferon and often can’t tolerate it’s side effects. Interferon also had reactions with immunosuppressant drugs.
The study included 223 liver transplant recipients with various degrees of fibrosis or cirrhosis, who were randomly assigned either 12 or 24 weeks treatment with Harvoni. At 12 weeks post treatment SVR12 rates for people with fibrosis scores of F0-F3 treated for 12 weeks were 96% and 98% for those treated for 24 weeks. Equally high rates were seen in those with CPT A cirrhosis (the mildest form of cirrhosis) at 96% for both 12 and 24 weeks.
However, cure rates fell markedly each cirrhosis level up, those with CPT B cirrhosis achieving SVR in 85% and 83% of cases (12 and 24 weeks respectively) and those with CPT C cirrhosis only managing cure rates of 60% and 67% (12 and 24 weeks respectively). As well as virological response participants also showed improvement in liver function.
The French government have negotiated a discounted price with Gilead Sciences for their blockbuster Hepatitis C treatment sofosbuvir. The Economic Health Products Committee has fixed the price of a box of sofosbuvir at 13,667 euros before tax, a reduction of 5,000 euros on the original price and now the cheapest price in Europe. This was after France threatened to impose a super tax on the very expensive treatment.
12 weeks of treatment will now cost 41,000 (£32, 165) euros rather than 56,000 euros (£43,933).
This compares with £36,000 for a 12 week course in the UK.
US Class Action Law Suit challenges Gilead’s sofosbuvir pricing
Gilead Sciences are being sued by the Philidelphia Transit Agency over the pricing of sofosbuvir, accusing the company of ‘price gouging’ (unfair or unreasonable pricing designed to take advantage of a surge in demand, and a crime in the US during civil emergencies).
The suit is on behalf of any person or entity in the US who has paid ‘excessive prices’ for sofosbuvir or who were unable to obtain the drug for that reason. The company says it has already spent $2.4million on staff with healthcare plans. The lawsuit says, “While rolling out its self-congratulatory marketing campaign about how the company is making this lifesaving drug available in third-world countries, Gilead has been simultaneously gouging its U.S.-based consumers and third-party payers of the drug.”
Critics point out that the high US price disproportionately hits the poorer hardest – as those from more deprived backgrounds are more likely to be affected by Hepatitis C.
Gilead is currently under investigation by a Federal Senate Committee in the US over their pricing of sofosbuvir. The company defends the price saying that it is justified due to the high efficacy and high long term savings to the health care system by averting cirrhosis or liver cancer.
The European Committee for Medicinal Products for Human Use (part of the European Medicines Agency) has granted a positive opinion for Abbvie’s combination therapy for Hepatitis C. The treatment Viekirax (combination of ombitasvir, paritaprevir and ritonavir) plus dasabuvir, with or without ribavirin is recommended for patients with genotype 1 or 4 Hepatitis C. In clinical trials the treatment saw cure rates of around 95%.
Abbvie’s triple Hep C treatment safe and effective in patients with history of depression
Analysis presented at the AASLD has shown that Abbvie’s new triple therapy for Hepatitis C (ABT-450, Ombitasvir and dasabuvir, with or without ribavirin) is both safe and effective in patients with a history of depression.
Adverse events including depression and mood changes were generally mild in patients with or without a history of depressive illnesses, although those who did have such a history were slightly more likely to experience adverse events.
Ian Duncan Smith has criticised the Advisory Council on the Misuse of Drugs, saying he believes they should look again at their findings on time limited opioid substitution therapy, ‘taking into account the harm done to individuals parked on methadone indefinitely, rather than providing cover for perpetuating drug addiction in the UK.’
In part 1 of our November e-bulletin we reported that the ACMD had advised against opioid substitution therapy (such as methadone prescription) for heroin users being time limited, noting that this would likely increase the risk of overdose, result in a majority relapsing into heroin use, increase drug driven crime and the spread of blood borne viruses including HIV and hepatitis.
In the same article we reported new research published in the JAMA network which showed recent OST was associated with lower incidence of Hepatitis C among young adult injection drug users, saying that maintenance treatment with methadone or buprenorphine may be an important strategy in preventing HCV infection among this group.
However, Mr Duncan Smith asserts that the opinion of the ACMD, and the research published in JAMA, as well as countless other pieces of peer reviewed research over 3 decades, including a recent government commissioned study on the efficacy of OST in Scotland – is only serving those with vested interests in maintaining a status quo, such as drug companies which produce methadone and treatment providers who profit from ‘parking’ people on methadone.
The Scottish Independent Expert Review of Opioid Replacement Therapy published in August 2013, concluded that ORT, in particular methadone, is supported by a strong evidence base, that local services are largely providing it in accordance with national guidance and its use should continue in Scotland. However, it also concluded that ORT must be one of a full range of treatment options across the country ranging from community to residential rehabilitation, and services should become more aspirational in relation to supporting individuals’ recovery.
In their submission to the Scottish Independent Expert Review of Opioid Replacement Therapy published in August 2013, the Scottish Drugs Forum called for an end to the ‘wasteful debate on methadone’ saying, "in the past, Scotland has found itself at the centre of an unnecessary and wasteful debate on ORT and particularly methadone, which has been a distraction from improving our response to problem drug use.
"Unhelpfully, controversialists have made this a frequent focus. While public scrutiny of the efficacy and efficiency of services is necessary and to be welcomed, much of this focus was ill-informed and based on poor understanding and misapprehensions.’’
Peg Interferon added to Tenofovir improves Hep B treatment response
A study presented has shown that adding pegylated interferon to Tenofovir in treatment for Hepatitis B improves treatment response – indicated by loss of Hepatitis B surface antigen. However, cure rates still fall short of 10%.
Tenofovir continues to suppress Hepatitis B virus for 8 years
Other research presented has shown that people treated with tenofovir for 8 years maintained viral suppression. Serological response rates continued to increase over time and kidney and bone related side effects continued to be uncommon.
Nucleoside analogues reduced HCC incidence in Hep B patients
A Canadian study has found that Hepatitis B patients treated with long term nucleoside analogue therapy had a decreased risk of developing Hepatitis B related liver cancer (hepatocellular carcinoma, or HCC). It was one of the largest North American cohort studies into the issue.
Healthcare workers may not need Hepatitis B vaccine booster
A study published in the journal of Clinical Infectious Diseases suggests that healthcare workers may not need to receive a Hepatitis B booster vaccination as the initial vaccine provides long term protection. Older age at vaccination was the only predictor of inadequate anti HBsAg level. Hepatitis B antibody levels normally start to decrease 10-31 years after initial vaccination.
A new report has been published in the Lancet Journal with ten key suggestions on how the UK can target its’ liver disease crisis. The report was co-written by the British Liver Trust, the Royal College of General Practitioners, the Children's Liver Disease Foundation, the Royal College of Physicians, the British Society of Gastroenterology, the Foundation for Liver Research, and the British Association for the Study of the Liver.
Key recommendations included:
Low vitamin D independently associated with risk of bacterial infection in cirrhotics
Low levels of vitamin D have been associated with higher levels of mortality (deaths) in cirrhotic patients. This study looked at levels of vitamin D in cirrhotic patients with and without bacterial infection.
The study found that a severe deficiency in vitamin D (specifically 25 hydroxy vitamin D) was a predictive factor for bacterial infection and a regression analysis found that presence of infection with significantly associated with mortality.
Low levels of vitamin D and increased cognitive decline
Another study has supported a link between low levels of vitamin D and increased risk of cognitive decline, prompting calls for clinical trials to investigate whether vitamin D supplementation may delay or prevent dementia.
A new report published on 11 December by Public Health England (PHE) warns that healthcare workers continue to be at risk of exposure to bloodborne viruses through occupational sharps injuries, despite the fact that safety-engineered devices to prevent these injuries are now available.
Glasgow Royal Infirmary criticised over cleanliness
Inspectors have told bosses at Glasgow Royal Infirmary to improve cleanliness and put in place policies and practises that will improve standards after seeing patient equipment spattered with blood and bodily fluids on 3 separate inspection visits, including in the A&E department.
Waverley Care Glasgow and Edinburgh Offices
Offices open as normal. Close on December 19th and reopen on Monday the 5th of January.
Positive Help Edinburgh
Closed on December 25th and 26th, and on January 1st and 2nd.
Close at 5pm on December 24th. Opens 9am 5th January.
Positive Support Lanarkshire
Closed from the 24th December to 5th January
Emergency contact on 29th, 30th and 31st December, Marc Simpson. Call 07435787431
Drugs Action Aberdeen
22nd, 23rd: Normal service
24th: Close at 5pm, No Northfield outreach
25th, 26th: Closed
27th, 28th: Normal service
29th: Normal service, no Northfield outreach
30th: Normal service No Mastrick outreach
31st: Close at 5pm, no Northfield outreach
1st, 2nd January: Closed
3rd, 4th: Normal service
5th: All services resume