Provided by The Guardian
Posted by Sarah Boseley Monday 17 March 2014 12.45 EDT
We must learn from the HIV epidemic and ensure that affordable prices are in place so that the millions with hepatitis C infection can get new drugs that appear to be a cure
Though the cure rate of the new breakthrough, sofosbuvir, seems close to 90%, the drug is very expensive. Photograph: Graham Turner for the Guardian
There are 185 million people in the world chronically infected with hepatitis C virus, which attacks the liver and can cause liver cancer and cirrhosis. Around 350,000 people die as a result every year. Hepatitis C is blood-borne, may show no symptoms for years and, until recently, its treatment has been far from ideal. Even if you can get interferon and ribavirin, which are not available everywhere, the combination does not work in everybody. Those who are infected have felt stigmatised and neglected.
The recent breakthrough in treatment is, therefore, really good news. Drugs called direct-acting antivirals are going through the approvals process after excellent trials results. The leader of the pack is Gilead's sofosbuvir, licensed in Europe in November and the following month in the US. Janssen and Bristol Myers-Squibb are hard on their heels.
The cure rate seems close to 90%, which is incredibly good news for people infected with hepatitis C. But with most of the sufferers in middle-income countries and prices being set at very high levels for these new drugs, those who watched the delay in getting HIV treatment to poor countries think it is time to start agitating for access to these medicines in countries that will not find them easily affordable.
Médecins du Monde, in a new report, says we must learn the lessons from HIV. "New Treatments for Hepatitis C virus: Strategies for Achieving Universal Access" looks at the need and what companies like Gilead say they will do about it. The authors are not, as yet, impressed.
Françoise Barré-Sinoussi, virologist, winner of the Nobel prize for her early work on the HIV virus and president of the International Aids Society, specifically makes the link with HIV in a quote in the report:
“We are witnessing a revolution in the treatment of hepatitis C virus with powerful molecules capable of curing the infection. There is no question that these treatments that can save millions of lives must be made universally available at an affordable price.”
Most of the companies, says the report, want to offer high prices in high-income countries and tiered pricing for middle-income countries. They are inclined to sign voluntary licences to allow generic manufacturers to supply the drugs to lower-income populations. This is a very expensive drug. Gilead's price in the US is over $80,000 (£48,000) for a 12-week course. That will cause problems for people with inadequate health insurance, even there.
In middle-income countries, Médecins du Monde says Gilead is planning to charge $2,000 for a course. It's a lot less, but far more unaffordable. To treat all those with hepatitis C in Egypt would cost 3,154 times the country's total health spending in 2011, says the report. In Indonesia, treatment for all would cost three-quarters of the total public and private spending on healthcare in 2011. This is clearly not possible without international help.
Gilead is negotiating voluntary licences. These would allow generic companies to make versions of its drug. But Médecins du Monde is concerned that signing those as planned in India, home of most of the generic companies that supplied Africa with HIV drugs at rock-bottom prices, will deter them from offering very cheap versions of hepatitis C medicines. "The generic companies that have a voluntary licence with Gilead will probably not be able to supply countries excluded from voluntary licences," says Pauline Londeix, author of the report.
Médecins du Monde says countries should begin thinking now about using the Trips (Trade-related aspects of intellectual property) flexibilities – agreed in the World Trade Organisation at the height of the debate over HIV drug prices – to bypass patents on these drugs in order to ensure access for those in need. Certainly, it is clear that the discussion over access to these important new medicines needs to start now.
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