Cost and access issues

The cost of new hepatitis C treatments continues to restrict access in Europe. This month the Irish government announced that it will fund new direct-acting antiviral treatment only for patients at imminent risk of liver failure, subject to a satisfactory agreement on pricing.

The French government has announced that it plans to tax any pharmaceutical company’s revenue from hepatitis C drugs if it exceeds 450 million euros in 2014 and 700 million euros in 2015. The tax is intended to contain the costs to the French healthcare system of new direct-acting antivirals. French newspapers have estimated that hepatitis C treatment in France could cost 1 billion euros in 2014 if everyone who is eligible receives treatment.

In Scotland, Janssen has proposed that NHS Scotland should pay for simeprevir (Olysio) only if a patient is cured of hepatitis C.

Harvoni approved in US

Harvoni is a once-daily fixed dose combination of the NS5B polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir. The combination has proved highly effective in clinical trials and in many cases does not require administration with ribavirin. Harvoni received marketing approval in the United States in October for the treatment of genotype 1 hepatitis C infection.

A pooled analysis of phase III clinical trials of sofosbuvir / ledipasvir showed that the combination was well tolerated and cured 97% of patients with HCV genotype 1. Trials evaluated regimens lasting 8, 12 or 24 weeks. There was no difference in cure rates between 12- and 24-week regimens but people with cirrhosis did somewhat less well in the 12-week compared with 24-week treatment arms of the phase III studies. In the 8-week arm of ION-3 (the only study to evaluate an 8-week treatment course), people with a viral load above 6 million IU/ml had a poorer response rate.

The findings regarding the duration of treatment that will be necessary for different groups of patients has led the Fair Pricing Coalition in the United States to call for a uniform price for a course of treatment with Harvoni, regardless of the length of treatment needed. They expressed concern that patients with more advanced disease will not be able to benefit from Harvoni owing to the very high price. Whereas Harvoni will cost up to $63,000 for an 8-week treatment course, 12 weeks of treatment will cost $94,500 and 24 weeks of treatment will cost $189,000.

Petition for improved HCV diagnosis and treatment for people in Europe who use drugs

The European Initiative on Hepatitis C and Drug Use has launched a petition to the European Parliament, calling for comprehensive national plans for hepatitis C diagnosis, treatment and care for people who inject drugs, accompanied by scale-up of harm reduction and decriminalisation of drug users. You can add your name to the petition here.

Egypt infection control

Egypt has the highest prevalence of hepatitis C infection in the world. Approximately 15% of the population is estimated to have hepatitis C virus (HCV). Research conducted in the 1990s suggested that the reason for high HCV prevalence was a national campaign to treat schistosomiasis, a waterborne parasite infection, during the 1960s and 1970s. Reuse of needles and syringes when giving anti-schistosomiasis treatment was blamed for spreading HCV.

New research based on the 2008 Demographic Health Survey now suggests that the vast majority of infections in Egypt are the consequence of poor standards of infection control in health care, in barbers and beauty salons or through household transmission, and that only 10% of infections are attributable to the schistosomiasis treatment campaign. The researchers found no substantial difference in HCV prevalence between areas where the campaigns had taken place and areas unaffected by schistosomiasis. But they did find a very strong association between clusters of people aged over 30 with HCV who had been exposed to the anti-schistosomiasis campaign and people under 30 with HCV who had never been exposed to the campaign. This relationship could be due to household transmission and transmission in local health facilities.

The findings indicate that infection control and improved safety of the blood supply are very high priorities in Egypt. In particular, education of nurses and others responsible for infection control is essential to reduce ongoing transmission.

The full text of the journal article in Hepatology is freely available online here.

Hepatitis C treatment factsheets

We have recently published a new factsheet on simeprevir (Olysio), an addition to the three other hepatitis C treatment factsheets published earlier this year.

Each factsheet focuses on one direct-acting antiviral drug and gives an overview of how it works, who can use it, how it is taken, what trial results tell us about how effective it is, known side-effects and drug interactions.

The factsheets are available to read online, and are also designed to be printed and shared.

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