The European Liver Patients Association (ELPA), in collaboration with a European research team, recently launched the Hep-CORE study to assess national responses to viral hepatitis in the region, collecting a preliminary dataset in advance of World Hepatitis Day (28 July 2016). The data, which were obtained by surveying ELPA member groups, suggest that some European countries are falling short in terms of the policies and practices that public health experts and the World Health Organization recommend as the basis for an effective response to the hepatitis B virus (HBV) and hepatitis C virus (HCV) epidemics.

The study has enrolled one ELPA member group or coalition of groups from each country to complete a comprehensive survey on key aspects of the response to HBV and HCV in their countries. Survey topics include viral hepatitis policies, disease monitoring, prevention, testing and treatment.

The preliminary data have indicated that only 14 of the 23 countries represented in the initial analysis currently have national hepatitis strategies. A viral hepatitis resolution approved by the World Health Assembly in 2014 called on all countries to develop and implement national strategies for preventing, diagnosing and treating viral hepatitis.

Additionally, there appear to be gaps in relation to harm reduction services for people who inject drugs, a population with high levels of chronic HBV infection and HCV infection in most European settings. While 18 of the 23 countries represented by survey respondents were said to have opioid substitution therapy available in all parts of their respective countries, only 7 of the 23 were reported to have needle and syringe programmes available in all parts of their respective countries. Needle and syringe programmes are proven to be a key viral hepatitis prevention tool.

The study also found that a high proportion of European countries place restrictions on access to direct-acting antiviral treatment for hepatitis C if people have a history of injecting drug use, or are active drug users.

Preliminary evidence of long waiting times for referral to liver specialists in some of Europe’s wealthiest countries, including Austria, Sweden and the United Kingdom, was also found during the study. In the United Kingdom the average waiting time for referral from primary care to a liver specialist is now estimated at over 12 weeks, the longest waiting time reported in Europe.

The fixed dose combination of elbasvir and grazoprevir (Zepatier) received marketing approval in the European Union at the end of July for treatment for genotype 1 or 4 hepatitis C infection, with or without ribavirin. Merck says that the European launch of Zepatier will begin in the fourth quarter of 2016 or the first quarter of 2017.

Zepatier consists of the NS5A inhibitor elbasvir and the NS3/4A protease inhibitor grazoprevir. It is dosed once daily.

Clinical trials have shown that Zepatier achieves a very high cure rate in people with genotypes 1 or 4, with or without cirrhosis.

The full prescribing indication recommends a 12-week course of treatment for all people with genotype 1 or 4 hepatitis C infection except for those with genotype 1 or genotype 4 infection and high viral load (> 800,00 IU/ml), for whom a 16-week course of treatment with added ribavirin is recommended, to minimise the risk of treatment failure. A 16-week course of treatment with added ribavirin is also recommended in people with genotype 1a with NS5A polymorphisms (natural variations in the NS5A region of the virus) which might reduce response to elbasvir at least fivefold.

Liver specialists consider the progression of liver fibrosis in hepatitis C infection difficult to predict. This is a problem when treatment for hepatitis C is rationed on the basis of fibrosis stage, for it is apparent that some people with early-stage fibrosis can experience faster progression of liver disease than people with more advanced fibrosis. It would be helpful to doctors and patients if more information was available to predict which patients might be at risk of faster progression of liver disease.

A large study which set out to examine the question of whether HIV affects the progression of fibrosis has now provided information that is relevant to everyone with hepatitis C infection. The study, conducted in people in the United States, looked at the progression of fibrosis in 378 individuals with at least two liver biopsy results. One third had HIV and hepatitis C virus (HCV) co-infection.

The study found that people with early-stage fibrosis were most likely to experience progression of liver fibrosis by one stage during an average follow-up period of seven years, and that the progression rate from stage 0 to stage 1 fibrosis was three times higher than the progression rate from stage 2 to stage 3 during this time. Progression of fibrosis was associated with early fibrosis stage, or with liver enzyme (ALT) flares. Surprisingly, people with HIV in this study did not experience faster progression of their liver disease; this contradicts previous studies which observed more rapid liver damage in people with HIV/HCV co-infection. Further research in other cohorts where multiple biopsy results are available ought to be carried out to confirm this finding.

When the investigators looked at the subset of people who progressed to cirrhosis, they found that genotype 3 infection or higher ALT level were the only factors significantly associated with progression.

The study findings call into question the idea that fibrosis progresses at a steady rate: on average the study found that people took two and a half years to go from stage 0 to stage 1, but 18 years to go from stage 2 to stage 3.

Treatment with statins decreases the risk of progression to liver cirrhosis in people with HIV and hepatitis C virus (HCV) co-infection, investigators from the United States report in the journal AIDS. The protective effect of statins was most evident in people with normal liver function. With each 30% increase in the amount of time taking statins, the risk of developing cirrhosis was reduced by approximately a third. The research also showed that several other metabolic risk factors were association with progression to cirrhosis, especially in people with poorer liver function.

Many people with chronic hepatitis B virus (HBV) infection have infrequent medical monitoring, according to US research published in the online edition of Clinical Infectious Diseases. Analysis of the records of over 2000 people followed for an average of six years showed that a quarter did not have an annual assessment of a key marker of liver function, only a third had yearly measurement of HBV DNA, and that 11% of people with cirrhosis had never had a liver ultrasound. Only 32% of people were prescribed HBV therapy and 44% of those with cirrhosis were not under treatment.

These disappointing findings come from the Chronic Hepatitis Cohort Study (CHeCS), a study conducted among people already diagnosed with hepatitis B. People receiving care through a specialist centre were more likely to be receiving regular monitoring, as were those aged 60 and over, those who were white and those with health insurance.

Further research underlying the importance of regular monitoring in people with hepatitis B was presented at the 21^st International AIDS Conference (AIDS 2016) in July, from a study of people in Cote d’Ivoire, West Africa, with HIV and HBV co-infection. The prevalence of co-infection with the two viruses is highest in sub-Saharan Africa. HIV treatment which contains tenofovir and either emtricitabine or lamivudine is recommended for all people with hepatitis B co-infection.

People with HIV/HBV co-infection have more than double the risk of death if they have ongoing high-level HBV replication, the Temprano clinical trial of early HIV treatment found, indicating a need for prompt treatment. The World Health Organization now recommends immediate HIV treatment for all people diagnosed with HIV; these findings from the Temprano study indicate the particular importance of early treatment for people with HBV co-infection, especially if it is impossible to monitor HBV DNA levels regularly due to lack of laboratory infrastructure.

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