World Hepatitis Day: the launch of the NOhep movement

Supporters at the die-in in central London. Image from the World Hepatitis Alliance

On World Hepatitis Day, the world turned green for the launch of NOhep, a global movement to eliminate viral hepatitis by 2030. Supporters from across the world took action to create awareness of viral hepatitis – from lighting up Niagara Falls in green to staging a ‘die-in’ in central London. The Hepatitis C Trust and the World Hepatitis Alliance organised the first hepatitis die-in to send a powerful message to world leaders that there is no excuse not to eliminate viral hepatitis and there is no excuse for needless deaths. Over 100 activists attended the die-in and joined in solidarity to launch NOhep. The World Hepatitis Alliance also released a video which looked “back” at 2030's achievements and called for people to take action today to eliminate viral hepatitis by 2030.

Sofosbuvir/velpatasvir (Epclusa) approval in European Union and United States

Gilead Sciences has received marketing approval in the European Union and the United States for its sofosbuvir/velpatasvir combination pill Epclusa in the past month.

Epclusa contains 400mg of the nucleotide hepatitis C virus (HCV) polymerase inhibitor sofosbuvir (marketed separately as Sovaldi) and 100mg of the novel NS5A inhibitor velpatasvir.

Epclusa is the first direct-acting antiviral product to be approved for treatment of all hepatitis C genotypes.

Epclusa is recommended for use without ribavirin for all people apart from those with decompensated cirrhosis. Physicians may also consider adding ribavirin for people with genotype 3 with compensated cirrhosis.

Epclusa was approved based on clinical trials showing that it produces high rates of sustained virological response (SVR), considered to be a cure. In the phase 3 ASTRAL trials, sofosbuvir/velpatasvir cured 99% of people with chronic hepatitis C with genotypes 1, 2, 4, 5 and 6, and 95% of those with harder-to-treat genotype 3. SVR rates were similar regardless of prior treatment experience or the presence of compensated cirrhosis.

For people with decompensated cirrhosis, 94% achieved SVR with sofosbuvir/velpatasvir plus ribavirin in ASTRAL-4. ASTRAL-5 showed a cure rate of 95% for people with HIV/HCV co-infection. Treatment was safe and generally well tolerated, with few serious drug-related adverse events or drug discontinuations. The most commonly reported side-effects include headache, fatigue or diarrhoea.

Viekirax treatment course for genotype 4 reduced in European Union

AbbVie announced this week that the European Medicines Agency has granted a positive opinion for the use of 12 weeks of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) with ribavirin in adults with chronic genotype 4 hepatitis C virus with compensated cirrhosis (Child-Pugh A). The current EU indication in this patient group is for a 24-week course of treatment with Viekirax and ribavirin.

US treatment guidelines updated

The American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America and International Antiviral Society-USA have updated their hepatitis C guidelines to add newly approved direct-acting antiviral regimens, offering more options for people with hepatitis C virus (HCV) genotypes other than 1 or 4. The full guidance is available online at

The biggest change was the addition of Gilead Science's newly approved sofosbuvir/velpatasvir co-formulation (Epclusa). The previous guidelines revision in February added Merck's recently approved grazoprevir/elbasvir (Zepatier) combination.

The European Association for the Study of the Liver (EASL) announced at the International Liver Congress in April that it will release an update to its hepatitis C guidelines at a special meeting in September.

Sofosbuvir/velpatasvir is now a recommended regimen for previously untreated and treatment-experienced people with HCV genotypes 1, 2, 3, 4, 5 and 6.

Viral hepatitis worldwide

Viral hepatitis is a leading cause of death and disability worldwide, data from the Global Burden of Disease Study published in The Lancet shows. Between 1990 and 2013, the number of deaths attributable to viral hepatitis increased by almost two-thirds. Hepatitis B virus and hepatitis C virus accounted for 96% of viral hepatitis-related mortality in 2013.

Between 1990 and 2013, deaths due to viral hepatitis increased from 890,000 to 1.45 million, a 63% increase. The number of life-years lost due to viral hepatitis C mortality increased by 34% and there was a similar increase in the number of years lived with disability because of hepatitis.

Viral hepatitis (acute and chronic) was the tenth most important cause of death globally in 1990 but the seventh most important in 2013. Over the same period, other communicable diseases, including malaria and tuberculosis, declined in importance.

Diabetes, cirrhosis and liver cancer

Diabetes is a strong risk factor for hepatocellular carcinoma (HCC) in people with hepatitis C virus infection and cirrhosis who have received successful treatment for the infection, Swedish investigators report in Clinical Infectious Diseases. The risk of HCC, or liver cancer, was especially high for people with cirrhosis in the first two years after therapy achieved a sustained virological response (SVR), or cure. The risk then diminished. This observation was only made in people who already had cirrhosis at the time when their infection was cleared. In contrast, people with advanced fibrosis at the time of SVR had a very low risk of liver cancer, and the investigators question whether they need advanced surveillance for this complication.

Portal hypertension

Direct-acting antiviral therapy for hepatitis C that produces a sustained virological response can lead to reductions in portal vein pressure, which causes some of the most serious complications of cirrhosis, according to a report in the 26 May online edition of the Journal of Hepatology. However, the researchers cautioned, reversal of portal hypertension is less likely if liver damage is too advanced, providing an argument for earlier treatment.

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