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Welcome to the latest edition of the Hepatitis Scotland e-Bulletin.
The World Health Assembly has passed a resolution to improve prevention, diagnosis and treatment of viral hepatitis. The resolution highlighted the importance of expanding vaccination programmes for Hepatitis A and B and strengthening infection control measures in health care settings such as safer injecting strategies.
It also stressed the importance of protecting groups such as people who inject drugs from infection and improving their access to both diagnostics and treatment. The resolution also identified the need for improved screening given the a symptomatic nature of many hepatitis infections.
Delegates agreed on a range of measures to improve access to quality and affordable hepatitis diagnostics and medicines and to address intellectual property rights related to those products, including considering wherever necessary using existing administrative and legal means to ensure such access.
Medicines du Monde have also recently issued a report on HCV treatment access in which they strongly criticise Gilead's pricing structure as being likely to make universal access practically unattainable even in countries that are strongly committed to access to HCV care.
Indeed some countries are already engaged in using legal means and trade laws to bring about generic production of new Hepatitis C medicines to ensure that those in the poorest countries can access these life saving drugs.
Indian patent battle heats up as Big Pharma defend drug pricing
Gilead have said they expect to license their Hepatitis C drug sofosbuvir (Sovaldi) to 3 or 4 generic manufacturers in India to allow sales of the drug at lower prices in up to 60 developing companies. This is part of a tiered pricing strategy that could see sofosbuvir available in India at $2000 and has already seen them strike a deal with Egypt which will see it available for $300 for a 24 week course of treatment versus the $84,000 price in the United States.
However, while the company continue with negotiations to licence sofosbuvir to generic manufacturers, another Indian pharmaceutical company has formally asked the Indian Patent Office to deny Gilead a patent for sofosbuvir. Natco have made the request arguing that sofosbuvir is not innovative enough in scientific terms to merit a patent.
US Drug industry body defends Gilead pricing against backdrop of huge profits
Meanwhile John Castellani, President of Pharmaceutical Research and Manufacturers of America, has defended the cost of Gilead’s sofosbuvir. He said that the $84,000 cost could be justified because it would change people’s lives, and warned that researching and developing these drugs comes at a high cost to manufacturers . ‘The value to these patients, and to their loved ones and society – you can’t put a price tag on it......Policy makers need to value innovation and stop implying that it comes cheap.’
This comes as Gilead posted record sales of $2.27billion for the first 3 months of sales of sofosbuvir.
The World Health Organisation has been among those to call for cheaper drug pricing in their newly released guidelines on Hepatitis C.
EASL publishes Recommendations on Treatment of Hepatitis C 2014-04-15
The European Association for the Study of the Liver has issued new guidelines on the treatment of Hepatitis at the International Liver Congress 2014. The guidelines recommend that wherever possible, Hepatitis C patients should be treated with the newest direct acting antivirals.
View video presentations from the International Liver Congress 2014 here.
Abbvie presented the results of their TURQUOISE II study, which shows cure rates of between 92% and 96% for Hepatitis C genotype 1 patients with compensated cirrhosis, regardless of previous treatment history, within 12 to 24 weeks. A total of 191out of 208 patients who received 12 weeks of treatment had a sustained viral response 12 weeks after treatment completion, a rate of 92%. 165 out of 172 patients who received 24 weeks of treatment had a sustained viral response 12 weeks after treatment completion for a rate of 96%. The most common adverse events (side effects) were fatigue, headache and nausea. Only 2.1% of patients discontinued treatment due to adverse events meaning that the treatment was well tolerated.
A separate trial of the same treatment regimen (SAPPHIRE II) also showed up to 96% SVR rates in patients who had previously received treatment for Hepatitis C genotype 1, but who had either relapsed, had a partial response or been null responders.
The Scottish Medicines Consortium (SMC) advises on the use of new medicines in the NHS in Scotland.Before the SMC accepts a medicine for use by the NHS in Scotland, it needs to find out:
- how effective the medicine is
- which patients would benefit
- whether it is as good as or better than medicines the NHS already uses to treat the particular condition
- what it costs
- whether it is good value for money.
The SMC decision regarding Sofosbuvir will be announced on 9 June.
Other related news
Sofosubvir regimens high SVR rates reduces with multiple negative predictive factors
In another presentation at the International Liver Congress 2014, Professor Graham Foster highlighted how having 4 or more negative predictive factors raised the risk of post treatment relapse while using sofosbuvir.
The predictive factors significantly associated were high pre treatment viral load, male gender, older age, obesity or being overweight, IL28B gene status and high fibrosis score.
Ledipasvir and sofosbuvir for previously treated HCV genotype 1 patients
Another recent study published in the New England Journal of Medicine has also shown excellent SVR rates in Hepatitis C genotype 1 treatment experienced patients. 440 patients underwent randomisation and treatment, 20% had cirrhosis and 79% had genotype 1a infection. SVR rates were high in all treatment groups.
In the group that received 12 weeks ledipasvir and sofosbuvir there was an SVR rate of 94%; 96% SVR in the group that received 12 weeks of ledipasvir, sofosbuvir and ribavirin; 99% in the group which received 24 weeks of ledipasvir and sofosbuvir and 99% in those who received 24 weeks ledipasvir, sofosbuvir and ribavirin. All patients who achieved SVR at 12 weeks post treatment also had SVR at 24 weeks post treatment. No patient had a relapse after post treatment week 12. No patients discontinued treatment due to adverse side effects. Most common side effects included fatigue, headache and nausea.
Gilead Sciences announced on April 7th 2014 that the US FDA has granted Priority Review Designation to the Ledipasvir/sofosbuvir combination treatment and that a final decision is expected in October 2014. It is also currently under accelerated review by the European Medicines Agency.
Sofosbuvir and GS-5816 NS5A inhibitor effective against Genotypes 1-6
A recent phase 2 study of sofosbuvir and another Gilead Hep C candidate, the NS5A inhibitor GS-5816, has shown high SVR rates, especially in combination with ribavirin, across genotypes 1,2 and 3 and good SVR rates across genotypes 4-6 , although the studies were based on small numbers.
Sofosbuvir and Ribavirin, 3 is good, 2 is better
In a study published in the New England Journal of Medicine, SVR was achieved in 93% of patients with HCV genotype 2 who were treated for 12 weeks with sofosbuvir and ribavirin. Among patients with HCV genotype 3 infection, treated for 24 weeks, response rates were 91% and 68% among those without and those with cirrhosis, respectively.
NHS to pay for 500 people to be treated with sofobuvir before NICE issue guidance
The NHS in England has announced that it will spend £18.7million on treating 500 patients with sofosbuvir who are in danger of dying and who in many cases on liver transplant waiting lists, before the National Institute for Clinical Excellence (NICE) complete an assessment on the drug. NICE will assess the drug later this year but the government has been under pressure to act faster to prevent unnecessary deaths.
Read more on this here.
Simeprevir received marketing authorisation in the European Union for the treatment of adults with hepatitis C genotype 1 and 4 infection on May 16.
Interim results of a phase 3 trial with genotype 4 patients have shown promising efficacy of a once daily simeprevir pill with peginterferon and ribavirin for 12 weeks, followed by peg interferon and ribavirin for 12 or 36 weeks.
Having previously been granted Breakthrough Designation, Bristol Meyers Squibb have now submitted a New Drug application for their Daclatasvir/Asunaprevir treatment for Hepatitis C genotype 1b. They are also seeking approval for Daclatasvir in combination with other new Hepatitis C treatments across multiple genotypes. A BMS spokesman said, “We are excited to have achieved this milestone and, looking forward, will continue to innovate and invest in daclatasvir in a range of patient types and regimens.”
Daclatasvir has been shown to produce up to 99% SVR rates in previous clinical trials where it was combined with Gilead’s sofosbuvir. Gilead declined to go forward with this dual regimen but this does not mean clinicians cannot later mix and match different approved treatments.
The HCV Contaminated Blood Scoping Exercise is a Scottish Government initiative and the survey is restricted to infected and affected persons in Scotland. Those patients and families who were infected/affected by HCV (Hep C) via a different route than NHS blood or blood products are out with the scope of this particular exercise and should not complete the survey.
The Scottish Infected Blood Forum has been commissioned to manage the project on behalf of the Scottish Government Health and Wellbeing Directorates.
Glasgow North West Community Drama Group are looking for new members. They have worked closely with Hepatitis Scotland as well as putting on plays dealing with issues around Hepatitis C, drug use and welfare. They meet on Tuesday evenings between 5 and 7pm. View the poster here.
Berlin 23-24 October 2014
The Correlation Hepatitis C Initiative will stage the first European Conference on Hepatitis C and Drug Use in Berlin in October of this year. The conference will bring together key actors on Hepatitis C including drug user community representatives, harm reduction experts, healthcare professionals, pharmaceutical companies, researchers and policy makers to develop pathways for effective health responses and to open treatment to those who need it.
The conference is set against a background of 9million Hepatitis C infections in Europe. People who do or have previously injected drugs are the largest group, with prevalence rates as high as 90% among them in some European countries. Infection rates are also rising rapidly in other populations such as MSM (men who have sex with men). The Correlation say that the increasing burden of Hepatitis C in Europe is rarely reflected in attention or awareness. They say that the advent of new highly effective treatments mean this is about to change and that there is a need truly inclusive testing and treatment policies to be established now.
The first meeting of some of these Hep C actors took place in Amsterdam in February 2013, with our Lead Officer Leon Wylie in attendance along with almost 40 organisations including academics, service providers, drug user organisations and a couple of international networks discussed the work program for the next 2 years.
You can view the presentations here.
Waverley Care have opened a new Hepatitis C service in Argyll and Bute aimed at improving the lives of those with Hepatitis C and supporting people to start and maintain treatment as well as limiting the spread of the virus. Previously there were no specific Hep C support services in the area. The service is funded by the Argyll and Bute Community Health partnership.
Waverley Care Glasgow is recruiting new volunteers who are interested in helping to support people with HIV and/or Hepatitis C. You can find details including deadlines for applications on this flyer.
The charity is also seeking applications for a Hepatitis C Community Trainee position. This post offers the opportunity to complete an SVQ3 in Health and Social Care. Includes 30 hours per week of unpaid work/study.
For application details see here.
Waverley Care in Glasgow has issued it's summer peer group programme. The group meets every Monday from 12pm - 2pm.