Spotlight on hepatitis research
Hepatitis research hit the headlines in 2014 when a clinical study known as the “Turquoise-II trial” revealed that a new treatment cured more than 90% of patients with hepatitis C with 12 weeks of tablets (find out more). This breakthrough does indeed mark a turning point in treatment of the hepatitis C virus – or HCV as it is often called. It’s for that reason that we’ve decided to shine a spotlight on hepatitis C research on World Hepatitis Day 2014.
It’s only by doing research that we will make progress in treating diseases. And that’s what’s happening right now with hepatitis C – we’re making rapid progress. Previously, treatment focused on boosting the immune system with interferon injections over six or 12 months. But this approach came with difficult side effects and failed to cure three people in every ten treated.
Thanks to research we now have a revolutionary treatment approach. A new generation of oral drugs are being used to block the virus and stop it from replicating – leading to successful results in nine out of ten cases. This leap forward in treatment not only brings great benefits for HCV patients, it also means that we now have a real prospect of eradicating hepatitis C from the population – without using a vaccine.
Of course we must be mindful that there are many variations of viral hepatitis. Each requires completely different treatments. But hepatitis C is one of the two biggest killers, hepatitis B being the other. World Hepatitis Day provides us with an opportunity to raise awareness about the new generation of treatments in development, whilst highlighting the important role that UK research plays in combating worldwide diseases. We are now seeing patients being cured where previous treatments failed – the impact that has on people’s lives is phenomenal.
The Turquoise-II trial is just one of many clinical research studies looking at these new drugs. On these webpages you’ll find out more about how we’re working together to beat hepatitis C.
Dr Stephen Ryder, National Clinical Specialty Lead for Hepatology, November 2014
*Please note that patient names used are not real names
Hepatitis research is on the up
- In the 2009/2010 financial year the Clinical Research Network supported just 7 clinical research studies looking at viral hepatitis. By 2013/2014 that figure had grown to 58 studies – an increase of 729%.
- In the 2009/2010 the Network recruited 118 patients into viral hepatitis studies. By 2013/14 that figure had risen to 5916 – a 49-fold increase.
- The patient's perspective
- Researcher's perspective
- Life-sciences industry perspective
- Charities and associations
The patient's perspective
When John found out that he had hepatitis C he was told that he’d probably had the hepatitis C virus for about 12 to 14 years. He was completely unaware of the disease and had no idea how he caught it. It wasn’t until he started suffering from exhaustion that John went to see his GP and was diagnosed with the virus straight away.
In 2004 he took part in a clinical research study at King’s College Hospital which aimed to remove the virus from his body with a treatment programme involving interferon. John experienced some nasty side effects and then, halfway through, the treatment was abandoned as John was deemed a “non-responder”. Statistically, there was only ever a 70% chance of success.
John was willing to give anything a try but with no other treatment available at the time it was a matter of waiting and hoping. Then, in early 2013 his consultant at Kings College Hospital invited him to take part in a second study looking at an innovative new drug therapy – one that has since changed his life.
After taking part in the Turquoise-II study John was clear of the virus. Almost one year on, and he is still clear. His next set of tests in August 2014 will determine if John is cured for good.
*Update* John received his last set of results on 19 August 2014. He’s officially clear of the Hepatits C virus.
“I was essentially clear of the virus from week eight. And since I’ve finished the treatment I’ve had a series of tests and remained clear.”
Amelia found out that she had hepatitis C in 2004 after donating blood. Until that point she had no idea. She suspects that she acquired the virus from a navel piercing, although she can’t be sure.
Shortly after being diagnosed, in 2004, Amelia took part in a clinical research study and received a combined treatment of interferon and ribavirin for six months. Post treatment she was initially found to be clear of the virus. But one month into the follow up period the virus was detected again. The treatment had failed.
Amelia has been lucky so far as she’s suffered very little damage to her liver. But with no other treatment available, and a family to think about, Amelia is understandably concerned about her health in the long term. So when she was offered the opportunity to take part in a second clinical research study looking at a new type of drug she jumped at the chance.
At the end of the trial Amelia was clear of the virus. She’s hopeful that this time she’ll stay clear.
“…taking part in this study is my opportunity to seize the moment and hopefully stop this disease in it’s tracks, once and for all.”
Theo is 50. He found out in 2012 that he has probably had the hepatitis C virus for over 30 years. It wasn’t until he began to experience a series of health problems that he was diagnosed. Until that point he was completely unaware of the disease.
In 2013 Theo commenced treatment to try and eradicate the virus from his body. His therapy combined interferon with Ribovirin and, like many, Theo experienced some nasty side effects. But half way through the treatment it was abandoned by the medical professionals as it was deemed ineffective. Only seven in every 10 patients respond well to this type of treatment and, unfortunately, Theo wasn’t one of those seven.
With no other treatment available on the NHS, Theo was left worrying about his future and wondering how long it might be before a new type of treatment might be offered. Later that year he received a phone call from his clinician inviting him to take part in a clinical research study looking at one such therapy – one that is proving to be up to 95% effective.
Theo tolerated the new treatment well and immediately after taking part in the BOSON study he was clear of the virus, and then again one month after finishing the treatment programme. It’s early days and there are more tests to do at three and six months, but Theo is optimistic about his future.
“When you are told that you have a serious condition, and that there is no treatment, a trial like this is a lifeline.”
Dr Ellie Barnes
Dr Ellie Barnes is a key researcher in the hepatitis C field and a member of the Network’s Hepatology Specialty. For her, working in this area is extremely exciting because the advent of new all oral drugs and the development of vaccines against HCV mean that there is now a real prospect of achieving global eradication of the hepatitis C virus (HCV).
She currently heads-up a collaborative project called STOP HCV which brings together clinicians, academics, scientists, and the life-sciences industry. It aims to optimise treatments for HCV patients by working out who is going to respond to which of the new therapies best and by giving drugs for just the right amount of time – which is crucial to ensure that these drugs are affordable to the NHS in the future. This approach is called stratified (or personalised) medicine and marks a further step-change in HCV treatment.
Ellie describes how Gilead’s BOSON study fits into this picture and how this new, novel way of working is helping to beat hepatitis C. She’s a champion for true collaboration in every sense of the word.
“…having this kind of genuine collaboration between research and industry means that patients are getting access to revolutionary drugs sooner.”
Life-sciences industry perspective
Gilead is the life-sciences company that has developed sofosbuvir; a new medication licensed for the treatment of hepatitis C. Sofosbuvir can be combined with ribavirin, or ribavirin and interferon over different periods of time to treat the disease. The BOSON study is trying to find out which is the best treatment regime for patients who are infected with the genotype 3 variation of the hepatitis C virus.
For the development and delivery of the BOSON study, Gilead collaborated closely with the STOP-HCV consortium. This collaboration helped to ensure a successful outcome, as did using the Clinical Research Network’s study support mechanisms.
In this interview you’ll find out exactly why the UK’s performance on the BOSON study was head and shoulders above that of other countries involved in the trial across the globe.
“We had one fully executed site contract within 25 days which is a company record for a UK site.”
Charities and associations
The Hepatitis C Trust
The Hepatitis C Trust is the national UK charity for hepatitis C. The Trust’s mission is to reverse the rapidly increasing death toll caused by hepatitis C in the UK until no one dies from this preventable and treatable disease and, ultimately, it is all but eradicated in this country.
The Network’s Hepatology Specialty is linking with The Hepatitis C Trust to harness the power of patient groups to help people access new drugs in clinical trials, as well as learning about what types of new research studies HCV patients want to access, and how they want to access them.
Find out more about the Hepatitis C Trust.
The Hepatitis C Trust provides the secretariat for the hepatitis C professional network: HCVAction. Standards and practices of hepatitis C care and treatment vary greatly across the country so a crucial part of this group’s remit is to help professionals share and promote good practice in hepatitis C prevention, testing and treatment.
Find out more about HCV Action.
The British Liver Trust
The British Liver Trust is a UK-wide registered charity which supports patients and campaigns to improve awareness of liver disease, and its causes. The charity is also involved in lobbying for better services for liver patients. Importantly, The British Liver Trust funds research looking at both the causes and the treatments of liver disease.
Find out more about the British Liver Trust.
British Society of Gastroenterology
Find out more about the British Society of Gastroenterology
British Association for the Study of the Liver
The British Association for the Study of the Liver is dedicated to the knowledge and understanding of the biology and pathology of the liver for the optimal care of patients. BASL members are composed of both scientists and clinicians, including GPs, and members from the pharmaceutical industry interested in liver physiology and pathophysiology.
Find out more about the British Association for the Study of the liver
Core is a UK charity that is focussed on diseases of the gut, liver and pancreas. Its work falls into three areas: funding research; patient information; and raising awareness. CORE aims to fund significant research across a diverse field of activities from the lab to patient services, supporting scientific breakthroughs and advances in patient care.
Find out more about CORE
Hepatology research isn’t just about hepatitis; it covers all diseases of the liver, biliary tree and pancreas. The Hepatology Specialty supports research across all of these areas. You can find out more by visiting the other Hepatology Specialty webpages and you can learn about how we support clinical research studies in the NHS by visiting the Clinical Research Network webpages.
The Hepatology Specialty members have helped deliver a number of initiatives over recent years to help boost hepatology research so that more studies happen and more patients can take part:
- Patient centred There is a real appetite for research amongst hepatitis C patients. We want to harness the power of patient groups in helping people access new drugs in clinical trials – over one third of patients participating in a recent primary biliary cirrhosis study (a form of autoimmune liver disease) were recruited via patient groups. In response, the Hepatology Specialty is linking with The Hepatitis C Trust to discover what types of research studies HCV patients want to access and how they want to access them.
- Focus on delivery Nine out of the last ten commercial viral hepatitis studies that we have supported have been delivered 100% to time and target. This is above the Clinical Research Network’s average (last financial year 73% of all commercial contract studies were delivered 100% to time and target). This combined with the Network’s community of well-connected and research-active clinicians makes the UK an attractive destination for commercial hepatitis research. And with more commercial contract studies, comes better access to cutting edge treatments for NHS patients. THESE FUGURES WERE PUBLISHE DIN 2014.
- Wider reach Before the Network moved to its new structure (in April 2014) a new sites initiative aimed to make sure that each Local Research Network area had at least one hospital site that was active in hepatology research – that equated to 25 sites across England. Those sites continue to deliver hepatology studies within the new Clinical Research Network structure which means that more patients can access hepatology research closer to home.
- Working collaboratively Gastroenterology (digestive disorders) and Hepatology (liver disorders) are two areas of medicine that overlap. The Hepatology Specialty is working together with the Gastroenterology Specialty and the British Society of Gastroenterology to help identify priority areas for new research. This led to hepatology and gastroenterology featuring strongly in a recent NIHR funding call. Hepatology Specialty member, Dr Ellie Barnes, (see researcher’s perspective section above) describes how the Clinical Research Network is contributing to STOP HCV and HCV Research UK which are both national research initiatives targeting hepatitis C.
*The data referenced on these pages relates to viral hepatitis and was extracted from the NIHR CRN Open Data Platform on 27 June 2014. (Search terms: “Hepatitis, HCV, HBV, HEV”. Alcoholic Hepatitis has been excluded.)