Access to hepatitis C treatment

Advocates are calling for pricing schemes for new hepatitis C drugs that would enable poorer countries to provide hepatitis C treatment.

Scientists and advocates claim that it may be possible to manufacture the new hepatitis C drug sofosbuvir for somewhere between $100 and $1400 for a 12-week course of treatment. The current US price of sofosbuvir is $84,000 for a 12-week course of treatment.

Manufacturer Gilead Sciences says that it is already in discussions with Indian pharmaceutical companies to grant voluntary licenses so that sofosbuvir can be manufactured at a lower cost for the Indian market. Gilead Sciences told an Indian newspaper that a 24-week course of sofosbuvir treatment might cost between $2000 and $2500 if enough companies seek voluntary licenses and compete against each other to offer the lowest price.

Advocates point to the success of voluntary licensing and tiered pricing in reducing the costs of drugs to treat HIV. The annual cost of HIV treatment for low-income countries has fallen from $10,000 a year for life in 2000 to $120 a year today. However, this reduction in cost has been possible only because very large amounts of funding have been made available by donors like the US government to treat HIV in low-income countries. This has created a large and predictable market, and has encouraged generic drug manufacturers to develop their own versions of recommended drug combinations. Until similar funding mechanisms are available to support hepatitis C treatment, it will be the responsibility of national governments to find the money. This may not drive down prices far enough for hepatitis C treatment to be affordable in the poorest countries.

Treat or wait?

New treatments for hepatitis C will become available gradually, from 2014, that do not require the use of interferon. Many patients are being advised to wait for these treatments to become available. But Professor Alfredo Alberti of the University of Padova, Italy, warns that physicians need to make sure that patients understand both the benefits and the risks of deferring treatment. Patients with potentially progressive liver disease ought to be made aware that there is a risk that new treatments might be delayed for regulatory or financial reasons. Careful monitoring by expert hepatologists is needed to ensure that the stage of liver disease is correctly diagnosed.

AbbVie completes interferon-free trials programme

AbbVie has completed six phase III studies of its interferon-free combination for treatment of hepatitis C, the company announced on 31 January. AbbVie expects that the combination will receive US approval before the end of 2014. The combination cured hepatitis C in 92 to 96% of patients with cirrhosis.

Gilead seeks approval for ledipasvir/sofosbuvir combination tablet

Gilead has filed for marketing approval of its first interferon-free combination in the United States. Gilead is seeking approval to market a fixed-dose combination of sofosbuvir and ledipasvir for treatment of genotype 1 hepatitis C infection. The European marketing application will be filed shortly.

Hepatitis C stroke risk

A review of studies covering 22,000 people with hepatitis C infection and 87,000 people not living with hepatitis C (non-infected controls) has found that people with hepatitis have an approximately 60% greater risk of suffering a stroke than people without hepatitis C.

Hepatitis B screening guidelines in US

The US Preventive Services Task Force has recommended that all Americans born in countries with a prevalence of hepatitis B greater than 2% should be screened for hepatitis B. Anyone not vaccinated in childhood, as well as people who inject drugs and men who have sex with men should be tested.

Is this your copy of the infohep news bulletin?

Is this your copy of the infohep news bulletin, or did you receive it from a friend or colleague, or find it online?

You can sign up to receive this monthly email bulletin, free of charge, on our website, where you can also find an archive of all the infohep news bulletins.