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Welcome to the latest Hepatitis Scotland e-Bulletin.
Janssen, in cooperation with the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) would like to inform you of the following:
To read the Janssen communication in full please click here.
Gilead Sciences has announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, the first of an expected number of drugs targeting hepatitis C. Janssen has also announced it has submitted an NDA seeking approval for simeprevir, a new protease inhibitor. Gilead said that it planned to file for regulatory approval of the drug in the European Union, in the second quarter of 2013.
The company added that the data submitted in the NDA supported the use of Sofosbuvir and Ribavirin, as an oral therapy for patients with genotype 2, 3 HCV infection. It can also be used in combination with interferon in genotype 1 patients.
Janssen’s Simeprevir application is based on genotype 1 patient studies conducted in combination with Interferon and Ribavirin.
After the US FDA recently approved Gilead’s new four-in-one AIDS treatment combination Stribild, the company priced it at $28,500 (WAC), 37% higher than the price of their previous best selling 3-in-1 AIDS treatment Atrilpa – making it the most expensive HIV/AIDS combination drug on the market. Gilead also raised the price of its other HIV/AIDS medications by an average of 6% in January.
Gilead also indicated earlier this year that they would be discontinuing trials using their drug Sofosbuvir and Bristol Myers Squibb’s Daclatasvir, which had reported 100% cure rates across all Hepatitis C genotypes with no requirement for interferon or ribavirin, in favour of a combination with one of their own drugs and continued to require use of either interferon or ribavirin.
Various online petitions are encouraging Gilead Sciences to cooperate with Bristol Myers Squibb to bring forward this ‘game changing’ cure for Hepatitis C – and live up to their own mission to advance the care of patients suffering from life-threatening diseases worldwide. Dr. Douglas J. Manion, a senior vice president for Bristol Myers Squibb, said his company was keen to work with Gilead but that “thus far they have been unwilling to engage in that collaboration.
AIDS Healthcare Foundation Director of US Domestic Policy said, “Gilead has generated record profits - and over $54 million in annual pay for its CEO - at the expense of state ADAP and Medicaid programs, the largest purchasers of Gilead's products, and the people living with HIV/AIDS that rely on these programs but cannot access them due to funding constraints."
Secretary General of the European Association for the Study of the Liver was quoted as saying "The combination of daclatasvir and GS-7977 has shown positive results at Phase II. EASL is disappointed that development of this combination has been halted as daclatasvir and GS-7977 promised to deliver a highly effective oral regimen that we hoped would be available to HCV patients soon.”
Gilead Sciences have now applied to the US FDA for approval for Sofosbuvir.
The issue of the wider responsibility to society of drug companies was also raised by the Chief Medical Officer for England. Professor Dame Sally Davies described the danger posed by growing resistance to current antibiotics as being as big a threat to the nation as terrorism, warning that routine operations could become deadly in as little as 20 years if we lose the ability to fight infection.
She highlighted that pharmaceutical companies needed to be encouraged to invest in development of new antibiotics, with their manufacture not currently being viewed as profitable.
"We haven't as a society globally incentivised making antibiotics. It's quite simple - if they make something to treat high blood pressure or diabetes and it works, we will use it on our patients every day. Whereas antibiotics will only be used for a week or two when they're needed, and then they have a limited life span because of resistance developing anyway."
She described this situation as a ‘market failure’ which needed to be corrected through international cooperation between governments, the medical profession, pharmaceutical companies and individuals.
A third way?
Andrew Witty, the Chief Executive of GlaxoSmithKline, has suggested that in the future pharmaceutical companies should be able to freeze or even reduce costs of new drugs by passing on savings made from more efficient research and development to customers.
He highlighted that this practise is normal in many other industries. The high cost of new drugs to treat the likes of cancer, HIV and Hepatitis C is a growing challenge for healthcare providers, particularly in times of austerity. Drug companies often argue that they must charge high prices because the average cost of bringing a new drug to market is $1billion. However, Mr Witty said this was a myth of the industry, with that figure including money spent on failed drugs. He went on to say that due to a revamp of research and development practises at GSK, return on investment has increased roughly 30% over the last 3 or 4 years.
"If you stop failing so often you massively reduce the cost of drug development ... it's why we are beginning to be able to price lower," Witty said.
He also said improvements in research, increased global demand and particularly an explosion in demand from developing countries should contribute to lower unit costs, all of which should mean that savings can be passed on to customers.
Santaris Pharma has announced the publication of study results (published in the New England Journal of Medicine) into the MicroRNA drug miravirsen. These kinds of drugs may become an important new class of drugs in treatment for Hepatitis C. Miravirsen can be used against all genotypes and was found to be safe, well tolerated, provided prolonged antiviral activity and had few adverse events. Where adverse events were recorded they were mild and did not lead to treatment discontinuation. The study also reported no signs of viral resistance.
RNA's are a type of biological molecule present in the body's cells. The Hepatitis C virus uses a MicroRNA specifically found in the liver to replicate. These kinds of drugs seek to block the replication of the virus.
Another potential benefit mentioned by the study authors was that due it's tolerability and long lasting anti-viral effects Miravirsen could be particularly useful in treating 'hard to treat' patients, including those who have previously failed treatment.
Hepatitis Scotland has co-signed an open letter to the UK Government by Kevin Stewart MSP stating opposition to the so-called bedroom tax. In previous e-bulletins, which can be accessed below, we have compiled various research pieces and evidence – including the governments own Impact Assessments – which demonstrate that these changes are likely to make it more difficult to achieve the outcomes of the Sexual Health and Blood Borne Virus Framework.
This decision was also taken in light of research we conducted with HIV Scotland in 2012, looking at patients concerns over Welfare Reform. The findings of the report we published in June, 2012, were that patients were extremely concerned about the negative impact that Welfare Reform would have on their lives. Nobody who participated in our road-show events and research felt that they would be better off as a result of the Welfare reforms.
Hepatitis Scotland National Advisory Group member and Evening Times Scotswoman of the Year 2012, Dr. Mary Hepburn, has been featured in a Herald article citing class differences to explain the exclusion of vulnerable women from antenatal care.
She was quoted as saying, "Services were all designed for middle-class women".
Dr. Hepburn leads Glasgow's Special Needs in Pregnancy Service (Snips), a service for pregnant women with complex life situations such as a history of alcohol and drug use. In the article she discusses what for some has been the contentious issue of treating heroin addicted pregnant women with methadone.
She says, "We want the mothers on methadone. Heroin is harmful to the baby and can cause death, prematurity and low birth weight. Methadone doesn't. It can and will cause withdrawal symptoms, but they are short term and we treat them"
Notwithstanding research highlighted in past e-Bulletins, a Medscape review of recent vitamin D research shows many areas which could impact on people affected by the symptoms of Hepatitis C or its treatment.
A study presented at the Society for Endocrinology has linked Vitamin D levels and skeletal muscular health and potentially explains physical fatigue suffered by patients with vitamin D deficiency.
These findings could have implications from those affected by viral hepatitis given that symptoms of the illness and side effects of the treatment can include fatigue as well as muscular and joint pain.
A multicentre genetic study published in PLOS online has shown that obesity is a causal factor in vitamin D deficiency. This has particular relevance to those with viral hepatitis with obesity shown to lead to faster progression of serious liver disease and recent scientific conjecture that insulin resistance can have significant impact on treatment outcomes. (evidence).
Brighton council are giving 'serious consideration' to opening drug consumption rooms to deal with the city's drug death problem. There were 104 drug related deaths between 2009 and 2011 and it is estimated that around 2,000 people in the city have a serious drug problem. Brighton's health and wellbeing board are to discuss this at their next meeting in June. The board's chair, Rob Jarrett said,
"I think from our perspective we see the health benefits of accepting drug use is going to happen and it might as well be happening in a place that can be monitored.
"Our primary concern is the health of the people to make sure they don't kill themselves. I believe in Switzerland, where it has been tried, it has worked. Up until now we have had policies that have been based on emotional knee-jerk reactions that haven't solved the problem at all."
Read more on this story here.
You can also read a situational assessment of public drug consumption rooms in Germany in the publications section of our website.
The Norwegian Government has announced recently that it is considering decriminalising heroin inhalation in order to cut down on the number of overdoses in the country. Of the 285 drug related deaths reported in the country in 2009, 137 were linked to heroin use. Norwegian Health Minister Jonas Gahr Store said "The numbers of deaths from drug overdoses is too high, I would say it’s a shame for Norway. The means by which addicts take their drugs is important in preventing overdose. My opinion is that we should allow them to smoke heroin. Injecting it is worse and more dangerous.”
The potential change in policy follows recommendations made in the 2011 study of fatal overdoses in Oslo which was conducted by the Norwegian Centre for Addiction Research. That study concluded the following:
"The high prevalence of fatal overdoses in Oslo can be explained by the high number of persons who inject heroin in combination with other substances. Thus, a reduction in the number of fatal overdoses will be possible if the number of persons who inject is reduced. This can be achieved by facilitating smoking instead of injecting through the distribution of smoking equipment and allocated areas (‘user rooms’) where the substances can be smoked."
Reducing the frequency of injecting is of course one of the main aims and benefits of opiate substitution therapy (OST) such as methadone prescription. Decriminalising heroin inhalation may provide another string to the bow in efforts to reduce injecting episodes and therefore lowering the risk of overdose, whilst also reducing the risk of exposure to blood borne viruses.
However, at a recent respiratory health conference in Darwin, New Zealand, the benefits of smoking rather than injecting drugs were called into question by a leading doctor. Dr. Alistair Story said that Australian data indicated that drug users were following the overseas trends of the 'respiratory route' rather than injecting.
He commented that '"In the United Kingdom, there is a trend among health care providers to describe smoking rather than injecting drugs as a harm reduction measure. However, I prefer to call this harm diversion. We know that injecting drugs is extremely damaging to health, but so is smoking drugs. We need drug users who choose to smoke the drug to understand the health consequences in terms of chronic lung diseases. The lung is a non-regenerative organ and declining lung health is a one way ticket."
A research report has looked at the decline of HIV and Hepatitis C prevalence (HIV prevalence has nearly halved) in Amsterdam since 1990 along with incidence of both dropping to almost zero. It examined some possible explanations for these trends, including the implementation of harm reduction measures aimed at reducing the risk behaviour of injecting drug users.
Whilst the report cited other factors including changes to the IDU population, and viral progression/death of those infected before effective treatments became available,, it said that 'a strong decrease in risk behaviour due to intervention was in line with the data. Indeed, a full incidence decline of HIV and HCV and a decline in HCV prevalence were difficult to reproduce in a model without harm reduction.'
It concluded by saying that 'future research aimed at quantifying the benefits of the interventions should not neglect the influence of natural epidemic progression and demographic changes. Gaining more insight into the impact of these factors on the transmission dynamics of HIV and HCV could also help to target future intervention measures more effectively.'
Key Scottish experts, including Hepatitis Scotland National Advisory Group members have contributed to a research paper that explores the potential impact new medications could have on HCV prevalence amongst people who inject drugs (PWID). The study looks at a number areas across the world, including Edinburgh.
Interferon-free DAAs could enable increased HCV treatment uptake among PWID, which could have a major preventative impact. However, treatment costs may limit scale-up, and need to be addressed.
More (requires athens access)
A new study from the United States, published in Alimentary Pharmacology and Therapeutics, has shown that for people with Hepatitis C infection, having as little as 1 or 2 glasses of wine per day could make you 74 times more likely to die of a liver related death than a similar person without HCV.
Those with Hepatitis C who are heavy drinkers (3 or more drinks a day), were 5 times more likely to die of a liver related disease than heavy drinkers who were not infected.
The author of the study, Dr. Zobair Younossi, said that this showed that if you have Hepatitis C you really shouldn't be drinking alcohol. She also said that given that those diagnosed with HCV are already accessing healthcare services, this was an ideal time to talk to them about their drinking habits.
Effect of motivational interviewing on reduction of alcohol use
A study published on Drug and Alcohol findings looked at Californian methadone clinics and their use of nurse led group education sessions focussing on the risks of aggravating hepatitis infection through alcohol use. They found that they worked just as well as one to one motivational interviewing in significantly reducing alcohol intake, and were thus a cost effective way of achieving this.
UK Cabinet concern for living standards
The Prime Minister’s policy on minimum pricing of 45p a unit on alcohol looks set to be defeated after a cabinet revolt headed by Home Secretary Theresa May, former Health Secretary Andrew Lansley and Education Secretary Michael Gove. They cited an unacceptable impact on living standards and called it a ‘regressive tax’. Problem drinking and alcoholism has been correlated strongly with poverty and deprivation. Minimum pricing moves have received almost exclusive support from medical professionals, with the original minimum pricing plans being estimated to cut drinking by 4.3%, potentially saving 2,000 lives within a decade.
Meanwhile the government is pressing ahead with the Welfare Benefits Upratings Bill, the so called ‘bedroom’ tax and recently Ian Duncan Smith suggested that parental drug use is the most important factor determining child poverty and that giving people more in benefits would actually increase alcohol or drug dependence.
The National Forum on Drug Related Deaths in Scotland has published their latest annual report for the year 2011-12. There were a record 584 recorded drug deaths in Scotland over that period. Methadone was either implicated in or contributed to almost half of the deaths. This sparked intense debate around harm reduction/opiate substitution therapy and saw the Scottish Government set up an independent panel to review methadone prescription.
The report also highlighted that 'despite previous recommendations, health care workers in primary care, secondary care and community pharmacies may still offer a service to drug users which is less sympathetic and supportive than that to other patient groups. This is based on an inappropriate stigma associated with addiction and sometimes erroneous beliefs of the efficacy of treatment.'
Harm reduction and opiate substitution therapy
There has been a significant amount of media attention given to harm reduction therapies and particularly methadone prescription since the latest Scottish drug related death figures became available. Many press articles have criticised the amount of money being spent on methadone in Scotland and questioning it's validity as a treatment for heroin addiction - particularly given it's implication in almost half of drug related deaths over the reporting period.
The Drug Related Death report points out that these figures have various possible interpretations. It noted that 'when considering the impact of methadone, it is important to note there were few deaths where methadone was the only drug present (14 of 584) and could confidently be said to have been the single cause of death.' Alcohol was also present in a significant number of cases which the report said indicated an important, and perhaps increasingly important risk co-factor - acting dually as a depressant on the brain and stopping the liver from breaking down other drugs taken. This lengthens the period of risk during which overdose can occur.
In many of the cases in which methadone was implicated the pathologist felt that death was likely caused by an unfortunate combination of drugs which affect the respiratory centre of the brain. The report also pointed out the reality that drug dependent patients and individuals use multiple drugs and even when they are considered to be stable on a substitution therapy are at risk from death from life event crises which may cause them to relapse into using illegal drugs or supplement their prescribed medication.
The report also provided insights from Scotland's Drug-Related Deaths Database into deaths recorded in 2010. Of the 365 deaths analysed 79% were male and around half lived in the most deprived areas. There was a high prevalence of co-occuring psychiatric conditions and problem alcohol use. Physical comorbidities were also common such as liver problems, including Hepatitis C and B.
Indeed in a previous e-bulletin we highlighted a study showing that drug overdose and suicide were common causes of death among people with chronic Hepatitis C - often due to comorbidities and issues detailed in the Scottish Forum on Drug Related Deaths.
Impact of Stigma
The Forum on Drug Related Deaths specifically highlighted 'inappropriate stigma associated with addiction' among health care works in primary care, secondary care and community pharmacies - leading to less sympathy or support compared with other patients groups.
Indeed the related stigma around injecting drug use can act as a further barrier to testing and treatment for Hepatitis C for people who inject drugs. These issues were looked at in depth in a qualitative WHO study published in June 2012. Amongst it's key findings were that social structural issues, such as those relating to HCV stigma, unstable housing, social support availability, caring demands, benefit access, gender, culture and criminalisation; the hospital based setting of treatment, and also stigma and discrimination from healthcare workers many participants reported receiving - all acted as barriers to current injecting drug users accessing Hepatitis C testing and treatment.
Literature Review - (Athens login required)
A recently published narrative literature review (published by the Department of Health Sciences, The University of York) has looked in detail at the stigmatisation of problem drug users. Among many detailed insights into the subject they quote from one piece that 'there is a sizeable and growing body of research on the potentially stigmatising attitudes of health professionals towards PDUs'. They also quote from a UK study which interviewed 18 district nurses who worked with clients who misuse substances, describing how nurses accounts were 'heavily interwoven with notions of "prejudice" and "stigma".
The review considers generally how stigma comes about and discusses stigma as a concept, considering the potential damage it can do to good public health outcomes.
Two studies carried out by infectious disease experts at John Hopkins Medicine have advanced our knowledge on the impact of HIV on hepatitis C infection, while also discovering two genetic mutations that make it more likely that patients' immune systems can rid the body of hepatitis C.
Their first study showed that HIV might promote aging and faster progression of liver disease in HIV co-infected patients. Acceleration of the onset of the aging process may also increase risk of cancer, cardiovascular and liver disease.
The studies are due for publication on the 3rd of April 2013 in the Annals of Internal Medicine.
Other Co-infection updates
Further research published in the Journal of Clinical Infectious Diseases followed a cohort of HIV infected men with primary HCV infection in New York. It indicated a more rapid progression to decompensated cirrhosis, liver transplant and death in HIV infected men after primary HCV infection.
Gilead Sciences seek FDA approval for 'game changing' Hepatitis C drug Sofosbuvir - read here.
Interferon free Abbott drug scores 95% success in treatment naive patients
Two studies of a direct acting antiviral combination drug ABT-450 (combined with ribavirin and another drug) produced by Abbott pharmaceuticals have delivered up to 95% cure rates in clinical trials, but only 47% in a group who had previously failed therapy.
Coffee consumption linked to decreased risk of liver cancer - read here.
Vertex Pharmaceuticals and Bristol Myers Squibb sign deal for Hepatitis C treatment studies - read here.
Hepatitis C Vaccines in the era of new Direct Acting Anti-virals
A review of where current Hepatitis C treatments stand, areas of new development and the continued research into an Hepatitis C vaccine.
Innovio reveal interim results of a collaborative phase II clinical study of Hepatitis C vaccine candidate
Innovio pharmaceuticals have revealed the results of collaborative study with ChronTech into a Hepatitis C vaccine. The results were not promising with there being no statistically significant difference between the vaccinated and non vaccinated group. The study sample size has also been criticised as too small to allow for any 'rigorous parametric analysis'.
High maternal viral load linked to vertical transmission of HBV
Children born to mothers with a high hepatitis B viral load are more likely to infected with the virus.
Effect of Immunosuppressive Therapy on Patients With Inflammatory Bowel Diseases and Hepatitis B or C Virus Infection - Read here.
Dynavax hepatitis B vaccine rejected by FDA for adult use
A new hepatitis B vaccine which had shown promising results in trials, requiring fewer doses to take effect, has been rejected for use in adults by the US FDA. The company will now seek approval for use in a smaller patient group.
Chronic Hepatitis B in children
An article published in the Journal of Viral Hepatitis and available on Medscape which looks back on 25 years of research in this area.
Tenofovir and 3TC protect against new HBV infections in gay men with HIV - read here.