World Hepatitis Summit news

The World Hepatitis Summit took place in early November in São Paolo, Brazil.

Nine countries – Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands and Qatar – are on course to eliminate hepatitis C by 2030, according to data released at the summit.

The World Health Organization’s elimination target challenges countries to aim for a 90% reduction of new hepatitis B and C infections and a 65% reduction in hepatitis B and C related mortality by 2030.

Approximately 250 million people worldwide have hepatitis B and 68 million have hepatitis C. Ahead of the summit, the World Health Organization announced that 3 million people have been treated for hepatitis C and 2.8 million have begun treatment for hepatitis B in the past 2 years.

Major obstacles to elimination include:

  • low rates of diagnosis in many countries
  • high cost of treatment
  • lack of funding for treatment.

You can download the presentations from the World Hepatitis Summit at: www.worldhepatitissummit.org/2017/resources/presentations

Low rates of diagnosis

Charles Gore presenting at the 2017 World Hepatitis Summit. Image credit: www.worldhepatitissummit.org

The Hepatitis C Trust drew attention to the low rates of hepatitis C diagnosis in the United Kingdom. "We have at least 100,000 people to find," said Charles Gore, chief executive of the Hepatitis C Trust. "If we don’t find them, not only will we never reach the goal of elimination, but significant numbers will die. To be honest, with these new drugs available, if anyone dies of hepatitis C, it should be viewed as an appalling failure of the system."

According to Dr Homie Razavi of the Polaris Observatory, "To make the 2030 elimination target [in the United Kingdom], at least 10,000 patients need to be treated each year, and there are already signs that it is becoming harder to find diagnosed patients to treat. Although in 2016 some 10,000 people were treated and in 2017 this could reach 12,500, the projections suggest the annual total will drop to an estimated 5,000 patients treated per year by 2020 without better diagnosis and linkage to care."

Diagnosis of hepatitis C is also low in many parts of the United States.

The Polaris Observatory estimates that just over half of people with hepatitis C in the United States are aware of their infection. Although rates of diagnosis are high in New York state (81%) and California (71%), other states are doing less well, and the United States is also experiencing a sharp increase in new hepatitis C infections in young adults and adolescents as a result of sharing of injecting equipment.

Research presented at the AASLD Liver Meeting in Washington, DC in October shows that worldwide, for every person cured of hepatitis C, another becomes infected. Central and Eastern Europe and sub-Saharan Africa saw net increases in the number of people infected with hepatitis C, whereas Australia (-13%), Egypt (-11%), the US (-9%) and Spain (-9%) saw substantial reductions as a result of large-scale treatment.

High cost of treatment and measures to reduce drug costs

Médecins Sans Frontières (MSF) announced at the summit that it has secured a deal to buy sofosbuvir and daclatasvir from generic manufacturers for $120 for a 12-week course of treatment.

Based on prices paid for raw materials used in the manufacturing of direct-acting antivirals (DAAs), Dr Andrew Hill of Liverpool University has estimated that it could be possible to cure hepatitis C for $50 per person. At $50 per treatment course, it would cost $3.5 billion to treat all 70 million people living with hepatitis C virus (HCV) worldwide – around the same as two months' worth of commercial DAA sales.

"The pharmaceutical companies have already profited enormously from their investments in research and development. Now it is time to lower HCV drug prices worldwide," Hill told infohep. "We need to lower HCV drug prices to levels which allow universal access in a wide range of countries."

As a guide, he suggested that low-income countries should pay from $50 to $150 per cure, middle-income countries should pay from $150 to $500 and high-income countries should pay up to $3000.

New financing mechanisms needed

The World Health Organization estimates that $6 billion a year will be needed between now and 2030 to fund hepatitis C elimination activities. Although integration of viral hepatitis diagnosis and treatment into the wider health system will meet some of the costs, the large up-fronts costs of diagnosis and treatment may require new funds. Possible mechanisms for mobilising new funding include:

Nivolumab improves outcomes in liver cancer

Bruno Sangro presenting at The Liver Meeting 2017. Photo by Liz Highleyman, hivandhepatitis.com

Nivolumab (Opdivo), a PD-1 checkpoint inhibitor that helps the immune system fight cancer, was associated with a decrease in tumour size or disease stabilisation in people with hepatocellular carcinoma (HCC) in the CheckMate 040 study, according to a report at the 2017 AASLD Liver Meeting last month in Washington, DC.

The kinase inhibitor sorafenib (Nexavar) is the only approved first-line therapy for HCC that cannot be removed by surgery, but it typically extends survival by only a few months. The US Food and Drug Administration recently approved nivolumab for second-line therapy after sorafenib. Nivolumab is currently approved in Europe for advanced lung, kidney, bladder and head and neck cancers and Hodgkin lymphoma. Bristol-Myers Squibb has decided to delay seeking a European Union licence for the use of Opdivo for HCC until it has data from further clinical trials. A licensing application was withdrawn in July 2017 after the scientific committee of the European Medicines Agency (EMA) concluded that the lack of data from studies comparing nivolumab to other therapies made it impossible to determine whether the benefits of treatment with the drug outweighed the risks.

The primary study endpoints were safety and objective response, meaning either complete or partial tumour shrinkage.

Approximately one in five of those treated experienced an objective response but complete tumour regression was uncommon. People who had not been treated previously with sorafenib were somewhat more likely to experience an objective response. Liver cancer stabilised in around one-third of people, meaning that 54% of people who had never used sorafenib and 55% of those who had done so did not experience disease progression. Treatment with nivolumab was generally safe and well tolerated.

Cost-effectiveness of HCV treatment in Japan

Zobair Younossi presenting at The Liver Meeting 2017. Photo by Liz Highleyman, hivandhepatitis.com

Direct-acting antiviral treatment is likely to be more cost-effective in older populations who have had hepatitis C for longer and are more likely to develop liver disease.

In Japan, the prevalence of hepatitis C is highest among older people who were exposed to hepatitis C virus (HCV) as a result of re-use of medical equipment or needles. It is estimated that between 1.2 million and 2 million people may have hepatitis C infection in Japan.

Treatment of chronic hepatitis C with direct-acting antivirals will lead to substantial savings by preventing the development of liver failure and liver cancer in Japan, according to a mathematical modelling study presented at the AASLD Liver Meeting last month in Washington, DC.

The study found that in a hypothetical cohort of 10,000 Japanese people with hepatitis C, selected to match the demographics of the Japanese patient population, curing the infection in 95% of people would result in a total economic saving that ranged from ¥11,879,592.6 to ¥17,219,592 (about £115,718, €129,381 or US$154,373 at the high end). Much of the savings resulted from prevention of liver cancer and decompensated cirrhosis.

New hepatitis B vaccine

The US Food and Drug Administration has approved the first new hepatitis B vaccine in 25 years. The Heplisav-B vaccine, developed by Dynavax, produced a significantly higher rate of protection than a currently available vaccine in adults, especially in those groups of people who have responded poorly to hepatitis B vaccines in the past. People with diabetes, the elderly and the obese who received the Heplisav-B vaccine all showed higher rates of protection in phase 3 trials.

Heplisav-B is given in two doses whereas vaccines in current use require three doses to achieve the highest levels of protection. Hepatitis B vaccination courses have a low rate of completion as a result of three-dose vaccination, reducing the proportion of people who are fully protected by vaccination. Public health doctors hope that a two-dose vaccination will improve completion rates.

New vaccination guidelines issued in November by the American College of Physicians and the US Centers for Disease Control and Prevention recommend that more people should be tested for hepatitis B and that a wider range of people at risk of infection should be vaccinated against hepatitis B.

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