Doctors Without Borders Secure Generics for Hepatitis C

Médecins Sans Frontières (MSF) says it has reached deals to purchase a 12-week treatment course of generic hepatitis C (HCV) drugs sofosbuvir (Sovaldi) and daclatasvir for as little as $120 — or $1.40 per day.

The international humanitarian aid group, known in the US as Doctors Without Borders, will get the generics from companies in Egypt and India, Christa Cepuch, pharmacist coordinator at MSF's Access Campaign, told MD Magazine.

Gilead Sciences Inc. charged $1,000 a pill when it unveiled Sovaldi in 2013. Bristol-Myers Squibb’s daclatasvir (Daklinza) initially cost $750 per pill in 2015, according to MSF. This brought the original price tag for a person’s 12-week combination treatment to $147,000, the Geneva-based non-profit said.

“Lower prices mean more patients can be treated,” Cepuch said. “This removes one of the most significant barriers to treatment.”

Direct-acting antiviral (DAA) drugs such as Sovaldi and Daklinza have been hailed as breakthroughs in fighting the liver-attacking virus. The medicines produce cure rates of more than 90% with fewer side effects than previous therapies based largely on interferon.

However, high DAA prices have limited access. Many countries reserve the drugs only for people with the most advanced stages of the disease.

MSF is already working with people living with HCV in 11 countries: Belarus, Ukraine, Pakistan, Uzbekistan, India, Myanmar, Cambodia, Uganda, Kenya, Mozambique, and South Africa.

Since 2015, the organization has provided DAAs to almost 5,000 individuals. Those who have completed the treatment have achieved an overall 94.9% rate of sustained virologic response, MSF said. Untreated, chronic HCV can lead to liver cancer, cirrhosis and death.

“People are dying; they cannot afford the medicines out of pocket,” Cepuch said. “Governments can now better afford to scale up treatment programs for HCV.”

Globally, an estimated 71 million people have chronic HCV infection. Of these, 72% live in low- and middle-income countries.

By the end of 2016, 3 years after Sovaldi was launched, only an estimated 2.1 million individuals had been treated with the medicines. About 69 million people lack access, MSF says.

MSF has been in the vanguard of advocating for lowered DAA prices and increased distribution.

In 2015, the group started procuring Sovaldi and Daklinza from Gilead and Bristol-Myers Squibb through special access programs at $1,400 to $1,800 per 12-week treatment.

In March 2017, MSF was among 30 humanitarian organizations across Europe who opposed Gilead’s patent for Sovaldi. Groups from 17 countries filed a challenge with the European Patent Office (EPO) to increase access.

Currently, MSF can use the DAAs in any nation where it can use generics in its projects, which is most of them, Cepuch said.

“However, any country where generics could be procured for HCV can also negotiate this price,” she said about the $1.40 price.

In addition, governments in nations where DAAs are patented have the opportunity to grant compulsory or government-use licenses to access generic DAAs, Cepuch said.

MSF’s push for wider access to generic DAAs is reminiscent of its effort to procure drugs to fight human immunodeficiency virus (HIV).

“Almost two decades ago, MSF and others worked hard to get access to generics and bring down prices for HIV medicines,” said Mickael Le Paih of MSF in Cambodia, where the group treats people living with HCV.

“History is repeating itself with hepatitis C,” he said. “The medicines we need are again too expensive, but we are finding ways to make treatment affordable so that our patients can be cured.”

A press release regarding the purchase can be read here.

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