Daclatasvir (Daklinza) approved in the EU

The European Commission has approved Daklinza (daclatasvir), a pan-genotypic NS5A inhibitor for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Daclatasvir is approved for use in combination with either sofosbuvir (with or without ribavirin) or with pegylated interferon and ribavirin.

Further details regarding the use of daclatasvir are available from the European Medicines Agency website.

Universal access to hepatitis C treatment in the EU

Pan-European patient advocacy organisations have written to European Union (EU) ministers of health urging the use of compulsory licensing if price negotiations with pharmaceutical companies fail to result in universal access to new hepatitis C drugs within the EU. Compulsory licensing allows a government to issue a licence to produce a drug to manufacturers other than the originator. The letter also urges that the community should be involved in these negotiations, and that EU health ministers should consider using new pooled procurement mechanisms to reduce the price of hepatitis C treatment.

Activists staged a sit-in to publicise these demands at an informal meeting of EU health ministers in Milan on 22 September.

Access to hepatitis C treatment outside the EU and US

Gilead Sciences has announced details of voluntary licensing arrangements that will permit access to sofosbuvir in up to 91 lower-income countries. The agreements allow six pharmaceutical companies in India to manufacture their own versions of sofosbuvir and export those products to specified countries in the developing world. Prices will be set by generic manufacturers. The deal covers India, Egypt, Vietnam and much of sub-Saharan Africa. Many of the countries in Africa have a low prevalence of hepatitis.

Critics of the licensing arrangements say that the proposals do not go far enough to make sofosbuvir affordable for countries with a high burden of hepatitis C or very low incomes.  Middle-income countries such as Brazil, China, Thailand and Turkey are not eligible despite their high burdens of hepatitis C. The agreements also prohibit generic manufacturers from supplying countries that issue a compulsory licence which overrides Gilead’s sofosbuvir patents.

US insurance restrictions and barriers to treatment

The US National Viral Hepatitis Roundtable and a coalition representing 700 organisations working in the viral hepatitis field have written to the US Secretary of Health and Human Services to call for swift action to remove barriers to hepatitis C diagnosis and treatment in the United States. In particular, they express concern about restrictions placed on who can receive hepatitis C treatment by state Medicaid programmes. Medicaid funds drug costs for people on lower incomes without full insurance coverage. Each state decides which drugs it will pay for through its Medicaid programme.

Directors of Medicaid programmes have been critical of the quality of evidence supporting the use of sofosbuvir (Sovaldi) and highlighted "multiple and significant conflicts of interest" among the authors of recent American Association for the Study of Liver Disease guidance on the use of new direct-acting antivirals. They say that studies of sofosbuvir conducted by Gilead Sciences do not show whether sofosbuvir is more effective or safer than regimens containing telaprevir or boceprevir, the previous standard of care.

Two US organisations representing physicians who specialise in treating HIV infection have asked insurance companies to drop restrictions on who may provide hepatitis C treatment. They say the restrictions are preventing HIV specialists in some parts of the US from providing new treatments for people with HIV and hepatitis C co-infection.

Pricing of sofosbuvir / ledipasvir

A new combination pill containing sofosbuvir and the NS5A inhibitor ledipasvir is likely to receive approval in the United States before the end of 2014. Early indications suggest that the combination pill will be priced even higher than sofosbuvir. A Gilead spokesman has hinted at a price equivalent or higher than the cost of sofosbuvir plus pegylated interferon and ribavirin (USD 95,000). However, the cost of treatment may be 33% lower for previously untreated patients with less advanced disease who stand a good chance of being cured in 8 weeks rather than 12 weeks.

A survey of US prescribing patterns suggests that early demand for sofosbuvir may be falling as the sickest patients receive treatment. The survey detected an 8% discontinuation rate in everyday practice compared to a 2% discontinuation rate in clinical trials, but the study covers only 1965 patients. One commentator suggested that demand is falling due to the imminent arrival of other interferon-free regimens such as sofosbuvir / ledipasvir.

First European Conference on hepatitis C and harm reduction

The 1st European Conference on hepatitis C and harm reduction will bring together key actors on hepatitis C, including drug user community representatives, harm reduction experts, healthcare professionals, pharmaceutical companies, researchers and policy makers to develop pathways for effective health responses and to open treatment for those who need it.

The conference takes place on 23-24 October 2014 in Berlin.

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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