Recent developments on Hep-C treatment and access

Recently, there have been two key developments in the area of Hep-C treatment– firstly the release of the first ever WHO guidelines for screening, care and treatment of persons infected with HCV and secondly the specific discussion on generic production and use of TRIPS flexibilities to address access barriers. A parallel to the situation with treatment for HIV/AIDS in 2000 is being drawn when HIV drug prices in the absence of competition were dramatically high.

The full text of the guidelines is available here

Read the articles on new oral regimens and pricing below –

WSJ says U.S. Spending on Hepatitis C Medications to Skyrocket 1,800 Percent by 2016, read full article here

WSJ blogUnsustainable for Our Country: Express Scripts Calls Out Pricey Meds

Reuters: Global response to hepatitis C hangs on access to new oral drugs, MSF warns of countries’ inability to scale up treatment in wake of first-ever WHO guidelines, unless medicines are more affordable. Access the full article here

WHO Guidelines May Help With Price Reductions For Hepatitis C Drugs, Published on 9 April 2014, Intellectual Property Watch

Excerpts of the IP watch article are produced below……

“Guidelines for the treatment of hepatitis C released by the World Health Organization today recommend revolutionary new drugs for the virus. However, the exorbitant price of these drugs means they will remain out of reach for most of the millions infected. The WHO guidelines themselvesoffer limited recommendation for reducing prices, but may help in creating the conditions for price reduction by accruing demand and giving countries official backing in price negotiations.

“WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection” were presented at a press conference at the United Nations in Geneva on 8 April.”

Some 130-150 million people are infected globally with the hepatitis C virus (HCV), which often causes related liver diseases including liver cancer and cirrhosis, from which 350,000 to 500,00 people die every year. The guidelines provide recommendations on screening for HCV infection, mitigating liver damage, care of people infected with the virus, treatment and prevention. “They are intended for policy-makers, government officials, and others working in low- and middle-income countries who are developing programmes for the screening, care and treatment of persons with HCV infection,” it says.

The virus can be cured with antiviral treatment with a success rate ranging from 50 percent of persons treated with older treatments, to 90% treated using the newest drugs on the market.

“The recent registration of new, safer and more effective oral hepatitis medicines is a game-changer in hepatitis C treatment,” said the WHO. “Much needs to be done to ensure that these advances lead to greater access to treatment globally.” Older treatments involved a 48-week programme ofinjections with toxic side effects. This has now been reduced to a 12-week programme, some without the need for injections, and is much safer.

Only about 2-3 percent of people who need to be treated get treatment in high-income countries. France has the highest level of treatment at only 6 percent due to a national programme. The data is not known for lower- and middle-income countries, but he said it is “much lower… it’s nothing.”

According to a statement released by Médecins Sans Frontières (MSF, Doctors without Borders) today, “a study by researchers at Liverpool University however has found that a twelve-week course of sofosbuvir could cost as low as $68-$136.”

“Hepatitis C treatment is currently unaffordable to most patients in need. The challenge now is to ensure that everyone who needs these drugs can access them,” said Beyer.

The WHO will look at putting drugs such as sofosbuvir on the essential medicines list…… The guidelines will also help in increasing demand as “unless guidelines are out there, countries won’t take up very expensive treatments.”

Leena Menghaney, India manager for MSF’s Access Campaign said in a statement, “Already, civil society groups have filed patent oppositions in India to ensure affordability and generic production; with 12 million people estimated to be infected with chronic hepatitis C in India, there’s a lot at stake.”

The official launch of the guidelines is taking place at the International Liver Congress in London, tomorrow, 10 April.

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