e-Bulletin June

Welcome to the next edition of our e-Bulletin. It has been a busy few months with lots of developments and news.


Are we there yet?


As the era of inteferon-free Hepatitis C treatment regimens comes closer, Sovaldi, the first of a number of exciting new drugs looking to take the cure rate for Hepatitis C into the 90 per cent range, has been accepted for restricted Scottish NHS use, across a number of Hepatitis C genotypes, by the Scottish Medical Consortium. Sovaldi will currently still be mainly used in conjunction with interferon and ribavirin.



At a UK list price of £35000 for a 12 week course Sovaldi is a very expensive medication that will have major impacts on budgeting decisions for health systems in many countries. It is hoped that these prices do not delay treatment to people who need it.

Back to top^

Patient-important benefits of clearing hepatitis



This simulation study, involving key Scottish researchers, looks at benefits gained from current treatments by a large group of patients ranging from low levels of fibrosis to cirrhosis and across a range of ages. A key finding was that for older patients with less advanced liver fibrosis, an SVR gained using current treatment therapies, is less likely to confer benefit in terms of averting liver failure and reducing mortality.

Back to top^

Medicaid director's report questions use of sofosbuvir

report, compiled by the U.S. Center for Evidence-based Policy and released in late May by the U.S-based National Association of Medicaid Directors, has suggested that there is not yet clear evidence that sofosbuvir (Sovaldi) should be used routinely to treat patients. It suggests that while initial, uncontrolled, response rates appear to be relatively high among carefully selected populations, response rates in “real world” populations are likely to be lower and there is evidence that relapse rates may be substantial, ranging from 5% to 28%.

Medicaid is a U.S. government insurance program for those whose income and resources are insufficient to pay for health care. A variety of different types of health providers are contracted to deliver Medicaid through state-run programs at an agreed cost, including for-profit and not-for-profit organisations.


Alcohol poses increased risk for advanced liver disease in HIV/HCV co-infected



study published in Clinical Infectious Diseases has shown all alcohol use categories were strongly associated with advanced hepatic fibrosis in HIV/HCV-coinfected patients.


A previous e-bulletin also highlighted a study from the United States which showed that for people with Hepatitis C infection, having as little as 1 or 2 glasses of wine per day could significantly increase risk of liver related death and led the authors to suggest that the results should inform clinicians to advocate complete alcohol abstinence in patients with Hepatitis C.


Public Health England modelling study looks at cost and benefits of increasing treatment rates.

A new study has looked at the cost of increasing hepatitis C treatment uptake in England, and the impact this would have on disease burden.



Updated NICE guidance seeks to tackle BBVs among IPED

The National Institute for Clinical Excellence has issued updated guidance on Needle and Syringe Programmes, which includes recommendations for tackling the spread of blood borne viruses in the increasing number of people using image and performance enhancing drugs.


Recommendation 10 in the public health guidance says that it should be ensured that ‘needle and syringe programmes are provided at times and in places that meet the needs of people who inject image and performance enhancing drugs. (For example, offer services outside normal working hours, or provide outreach or detached services in gyms.)


NICE say that conservative estimates suggest almost 60,000 people aged between 16 and 59 used anabolic steroids in the last year. Whilst needle and syringe services have traditionally been geared towards hard drug users, many have reported an increase in the number people, particularly male 18-25 year olds, presenting in the last few years.


Dr. Fortune Ncube of Public Health England said, “Anyone who injects drugs is at risk of HIV and other blood-borne viruses, regardless of the substance they inject. Our recent research suggests that levels of HIV and hepatitis infection among men using image and performance enhancing drugs have increased since the 1990s.”


We must maintain and strengthen public health interventions focused on reducing injection-related risk behaviours to prevent HIV and hepatitis infections in this group. This includes ensuring easy access for those who inject image and performance enhancing drugs to voluntary confidential testing services for HIV and hepatitis and vaccination against hepatitis B, as well as to appropriate sterile injecting equipment through needle and syringe programmes.”


The guidance also recommends high coverage of needle and syringe exchange to combat the HIV and Hepatitis C epidemic, including 24 hour needle exchange where necessary – with the aim being that every injector should have even more sterile injecting equipment than they need for every injection.


Single injection cure for HCV?

Australian company Benitec Biopharma has initiated patient dosing with its’ gene silencing Hepatitis C treatment TT-034, a ddRNAI-based therapeutic, designed to treat and potentially cure Hepatitis C with a single injection.

The main objective of this phase I/IIa clinical trial is to demonstrate that it can be used safely in patients with Hepatitis C. Pre clinical trials in non human primates showed very low toxicity at therapeutically relevant doses and the company hopes to see the same results in humans. Biotec’s CEO Peter French added, “...we will be able to assess the impact of TT&034 treatment on HCV viral load in these patients, and this important efficacy marker constitutes one of the secondary endpoints of this study.”

14 genotype 1 HCV patients have been enrolled in the study and initial cohorts will be treated with a sub-therapeutic dose to ensure there are no safety concerns before progressing onto higher potentially therapeutic doses.


Importance of HCV genotype 1 subtypes for drug resistance and response to therapy

This article looks in some detail at the issue of viral resistance in direct acting antivirals against Hepatitis C, including the new drugs which have either been approved or are awaiting approval, particularly in the context of the traditionally more difficult to treat genotype 1 infection.

It concludes that response rates and resistance patterns for approved and investigational direct acting anti virals are different for genotype 1a and genotype 1b. It points out that these differences have also been observed in second wave protease inhibitors as well as NS5A inhibitors and non nucleoside NS5B inhibitors.

It says the differences can be mitigated with very potent, high resistance barrier combinations. The article finishes that as more treatment options become available, differences in resistance to Hep C genotype 1 subtypes may have implications for clinical practise and that simplified dosing regimens may increase treatment adherence – another crucial factor in avoiding viral resistance.


Alcohol poses increased risk for advanced liver disease in HIV/HCV co-infected

study published in Clinical Infectious Diseases has shown that patients co-infected with both HIV and Hep C are at high risk of advanced hepatic fibrosis across all drinking categories. This means that even low levels of alcohol consumption or non hazardous consumption are associated with advanced liver disease in co-infected patients. 

Advanced hepatic fibrosis was also present at low levels of alcohol consumption and increased with higher use across all participants but was more prevalent among HIV or Hepatitis C mono-infected individuals vs those not infected. 

A previous e-bulletin also highlighted a study from the United States, published in Alimentary Pharmacology and Therapeutics, which showed that for people with Hepatitis C infection, having as little as 1 or 2 glasses of wine per day could increase risk of liver related death by 74 times.


Viral Hepatitis more deadly than HIV in Europe

Analysis of the Global Burden of Disease Study 2010, presented for the first time at the International Liver Congress 2014, showed that  during 2010 in the EU, Hepatitis C is estimated to have caused nearly 57,000 deaths with 31,000 deaths from Hepatitis B and just over 8,000 from HIV infection – meaning approximately 10 times more people died due to viral hepatitis infection than HIV.

The analysis concludes ‘while HIV/AIDS undeniably remains a key global health priority, mortality from viral hepatitis is higher than that of HIV/AIDS in the EU though this is not the case in other areas of Europe. The release of the GBD 2010 results provides a unique opportunity to set global and local priorities for health, and address previous imbalances in addressing the major preventable causes of human death, among which hepatitis B and C must clearly now be counted.’


New Chinese herbal medicine has significant potential for Hep C treatment

An abstract presented at the International Liver Congress identifies early research on a new compound, SBEL1, which can inhibit HCV at different points in the virus’ life cycle. SBEL1 was isolated from Chinese herbal medicines and has been found to inhibit Hepatitis C viral activity by significant amounts. It is extracted from a traditional herb used for sore throats and inflammations.

In the study, scientists pre-treated human liver cells in vitro with SBEL1 before infecting the cells with Hep C and found that the pre-treated cells had 23% less Hep C virus protein than those untreated, suggesting that the compound blocks virus entry. Hepatitis C RNA levels were also significantly reduced by 78% in cells treated with SBEL1 and also inhibited IRES – mediated translation, a vital process for viral protein production.


Hepatitis B latest

Financial incentives increase uptake of HBV vaccine in IDU

Research published in the Lancet have shown that small financial incentives of as little as £30 dramatically increased the uptake and completion of the Hepatitis B vaccination course in injecting drug users. UK researchers found that people undergoing treatment for heroin addiction who received up to £30 in supermarket vouchers in equal or graduated instalments were 12 times more likely to complete the full vaccination course within 28 days compared with those who did not receive a financial incentive. However, even with these incentives only around half completed the full vaccination course leading researchers to say that refinements were needed to the reward system in order to further increase uptake.


Financial incentive schemes are common in the USA in recent times but are less common in the UK. Hepatitis B affects about 22% of injecting drug users in the UK and it is estimated that around 15 – 25% of people with untreated chronic Hepatitis B die of liver disease.


GPs in England and Wales asked to take on Hep B Vaccination for at risk babies

GPs in England and Wales are being tasked with vaccinating newborn babies who may be at high risk of contracting Hepatitis B under a new service starting this year. Practises will now be responsible for checking that at risk babies on their register have received the first dose of Hepatitis B vaccine, ideally given in hospital immediately after birth, before ensuring that they complete the vaccination course. Practises will be paid £7.64 for each of the 3 or 4 doses of the vaccine they deliver. 


The General Practitioners Council said that hospitals would usually provide the first vaccination to at risk babies, including those whose mothers are Hepatitis B positive, before informing the mother’s practise.

However, their new co lead on immunisations and vaccinations has said that GPs need to bear in mind that some mothers may not have registered with a GP or informed the hospital who their GP would be.


High Hep B surface antigen risk factor for recurrence of hepatocellular carcinoma

A new study published in the JAMA surgery has shown that high Hepatitis B surface antigen (HBsAg) levels are an independent risk factor for recurrence of hepatocellular carcinoma (liver cancer) in patients who have undergone surgery to remove part of their liver – one of the effective treatments for liver cancer.

In patients with low viral loads, high levels of Hepatitis B surface antigen had been shown to predict development of hepatocellular carcinoma, but it was not previously known whether it increased the risk of recurrence after hepatic resection (removal of all or part of the liver).

The study found that preoperative levels of Hep B surface antigen of 1000 IU/mL or greater is an independent risk factor for recurrence of hepatocellular carcinoma.

Hepatitis B a growing problem in UK prisons


Increasing coffee consumption protects against type 2 diabetes

A new observational study of 3 large US cohorts has shown that people who increased their intake by about 1 and a half cups of regular coffee a day on average, had an 11% lower risk for type 2 diabetes over the next 4 years compared with those who did not change their intake. Conversely those who decreased their coffee consumption by a median of 2 cups a day had a 17% higher chance of developing type 2 diabetes over the next 4 years.


Seperate research has also suggested that eating a handful of pistachio nuts and almonds may help protect against type 2 diabetes in individuals who are already at risk. 

In previous bulletins we have reported on research that suggests coffee can reduce the risk of liver disease and can even increase likelihood of SVR in Hepatitis C patients. 


Among other extra hepatic manifestations of Hepatitis C infection is increased risk of type 2 diabetes. As such this provides more evidence that drinking up to 6 cups of coffee a day may be beneficial to Hepatitis C patients general health as well as their liver health. Other evidence has shown that coffee consumption can decrease the risk of cardiovascular disease.


Researchers said that regular coffee consumption should be seen as part of a healthy diet.


Research identifies mechanism explaining Hep C persistence

A new study by the University of San Diego, published in the Proceedings of the National Academy of Sciences, has uncovered a mechanism that explains why people with Hepatitis C get liver disease and why the virus is able to persist in the body for so long.

The virus attacks the livers energy centres – the mitochondria – dismantling the cells ability to fight infection by altering cells mitochondrial dynamics. The study suggests that mitochondrial operations could be a therapeutic target against Hep C.


Non-invasive diagnosis of liver fibrosis in chronic hepatitis C

 This review discusses the different noninvasive methods that are currently available for the evaluation of liver fibrosis in chronic hepatitis C, their advantages, limitations and application in clinical practice.


Hepatitis Scotland
91 Mitchell Street
G1 3LN

Telephone: 0141 225 0419
Fax: 0141 248 6414