World Hepatitis Summit 2015

The World Hepatitis Summit took place in Glasgow, Scotland, 2-4 September. The Summit was designed to bring together policymakers, public health specialists and community advocates to build momentum towards the development of comprehensive national plans for control of viral hepatitis. The Summit was organised by the World Hepatitis Alliance and the World Health Organization in partnership with the Scottish government.

The World Health Organization (WHO) is calling for ambitious new global targets for diagnosis, treatment and cure of viral hepatitis, signalling a major increase in momentum towards elimination of viral hepatitis by 2030:

  • 90% reduction in new cases of chronic hepatitis B and C by 2030.
  • 65% reduction in hepatitis B and C deaths by 2030.

Modelling carried out by WHO shows that the targets could be achieved by:

  • Increasing childhood hepatitis B vaccine coverage from 81% to 90% by 2020, and increasing coverage of birth-dose hepatitis B vaccine or other interventions to prevent vertical (mother-to-child) transmission of hepatitis B from 38% to 50% in 2020 and to 90% in 2030.
  • Increasing the proportion of injections carried out safely worldwide from 5% today to 50% in 2020 and to 90% in 2030.
  • Treating 5 million people with hepatitis B by 2020 and providing treatment for 80% by 2030.
  • Treating 3 million people with hepatitis C by 2020 and providing treatment for 80% by 2030.

The modelling exercise also calculated the possible cost of achieving these targets, assuming that the cost of hepatitis C treatment can be brought down to US$200 per course of treatment in lower-income countries, $500 per course in middle-income countries and $10,000 per course in higher-income countries.

According to the preliminary model, the cost of viral hepatitis control would rise from $2 billion in 2016 and $8 billion in 2020, to just over $11 billion in 2025. Thereafter total costs would decline, to $9 billion in 2030, as harm reduction and hepatitis B treatment costs begin to go down.

The Summit also heard that the Medicines Patent Pool is interested in working to reduce the price of hepatitis C drugs through negotiating voluntary licences with pharmaceutical companies that would allow generic versions of hepatitis C drugs in lower- and lower-middle income countries. The developers of new drugs can agree a single voluntary licence with the Medicines Patent Pool covering a large number of lower-income countries. Generic manufacturers can then apply to use the patents in the Medicine Patents Pool to produce quality-assured versions of drugs, and to produce combinations of drugs in one pill. All companies which market antiretroviral drugs for HIV treatment have licensed at least some of their products to the Medicines Patent Pool. The organisation’s executive director said that if the Medicines Patent Pool began work on hepatitis C, its priority would be to negotiate deals that would allow generic manufacturers to develop a direct-acting antiviral combination that could be used to treat any genotype.

Daclatasvir, manufactured by Bristol-Myers Squibb, is active against hepatitis C genotypes 1-4. The Medicines Patent Pool says that its first priority in hepatitis C would be to negotiate a voluntary licensing agreement for daclatasvir that would allow generic manufacturers to produce the first pan-genotypic combination by combining it with sofosbuvir.

Gilead releases preliminary results on new pan-genotypic combination

Gilead Sciences has issued preliminary results from four trials testing a new direct-acting antiviral combination of sofosbuvir and velpatasvir, a new NS5A inhibitor. The trials tested whether the combination was effective against all genotypes of hepatitis C.

A 12-week course of treatment with the combination cured hepatitis C in 99% of people with genotypes 1, 2, 4, 5 and 6. In a separate study in people with genotype 3 infection, the combination cured 95% of people without the addition of ribavirin. In people with genotypes 1-6 and decompensated cirrhosis (Child-Pugh B class) the combination cured 94% of people when dosed for 12 weeks with ribavirin, or 86% when dosed for 24 weeks without ribavirin.

Fuller results from these studies will be presented at scientific conferences, and Gilead Sciences plans to submit marketing applications for the new combination in the United States and European Union by the end of 2015.

Hepatitis C and heart disease

Chronic hepatitis C virus (HCV) infection is associated with an important early warning sign of cardiovascular disease, investigators from the Multicenter AIDS Cohort Study (MACS) report in the online edition of the Journal of Infectious Diseases. Both HIV and HCV infections were independently associated with hardening of the coronary artery, but there was no evidence that HIV and HCV co-infection worsened atherosclerosis. After controlling for HIV infection and other factors associated with heart disease, a consistent relationship was present between chronic HCV infection and coronary artery plaque formation.

Daklinza approval for genotype 3 in European Union

The European Commission has approved a new shorter-course regimen of daclatasvir with sofosbuvir for use in the treatment of genotype 3 hepatitis C in people without cirrhosis. Previously, daclatasvir was licensed for use in combination with sofosbuvir in genotype 3 only when used with ribavirin for 24 weeks.

Interferon-free treatment for people with HIV and HCV co-infection

Three different interferon-free regimens – sofosbuvir/ledipasvir, AbbVie's 3D regimen and grazoprevir/elbasvir – were well-tolerated and cured hepatitis C in more than 90% of participants with HIV and HCV co-infection in three clinical trials, confirming that HIV-positive people can respond as well as HIV-negative people to modern hepatitis C treatment, according to a set of reports presented at the Eighth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2015) in July, in Vancouver, Canada.

Findings from the French compassionate access programme presented at the same conference showed that interferon-free treatment using daclatasvir (Daklinza) and sofosbuvir (Sovaldi), with or without ribavirin, was well-tolerated and produced sustained virological response (SVR) rates of 95 to 100% for people with HIV and HCV co-infection and advanced liver disease.

The 24th International Harm Reduction Conference

The 24th International Harm Reduction Conference takes place in Kuala Lumpur, Malaysia, next month.

We'll be publishing relevant news reports from the conference on infohep.org and including them in the next infohep bulletin.

NAM (aidsmap.com) is the official scientific reporter from the conference. You can sign up for a free conference summary bulletin in English, French, Malay, Portuguese, Russian or Spanish at www.aidsmap.com/ihrc2015

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