How Activists Are Driving Down the Cost of Hepatitis C Treatment in Asia

Published September 15, 2015

 
Indonesian protestors demand access to affordable sofosbuvir.

By Lucile Scott

In December 2013, the U.S. FDA approved the revolutionary new hepatitis C virus (HCV) treatment Sovaldi® (sofosbuvir), immediately sparking global headlines and controversy. The treatment, part of a class of drugs known as direct-acting antivirals (DAAs), was associated with cure rates of over 90% in clinical trials, nearly double the rate of previous treatments. However, Sovaldi’s initial price tag of $1,000 a pill, or $84,000 for a 12-week course of treatment, put it far beyond the reach of nearly all of the approximately 170 million people chronically infected with HCV globally—including approximately five million people living with HIV (PLHIV). Even in the U.S., the price was too much for public and private insurance providers, causing them to limit coverage to patients with advanced disease. Worldwide, advocates began campaigning to bring prices down and facilitate greater treatment access.

Then in September 2014, Gilead, the manufacturer of Sovaldi, signed a voluntary license agreement allowing seven (and later eleven) Indian generic companies to sell a less expensive generic version of sofosbuvir in 91 lower-income countries, which was expanded to 101 in August 2015. However, this list excludes many of the world’s hardest hit middle-income countries, such as China. With 29 million people living with HCV, it carries the world’s largest national burden of HCV infections. And even in the included countries, a course of treatment would cost at least $900, which is still far above what many low-income countries can afford on a large scale. It is also much higher than the estimated $120 British researchers have concluded it could cost to manufacture a 12-week course of therapy.  

“While the introduction of sofosbuvir by generic Indian companies has been a very positive development, access to the medicine still remains a key challenge in many countries,” says Giten Khwairakpam, TREAT Asia’s project manager for community and policy. “Advocates are working hard to improve that access.”

The Toll of HIV and HCV Co-Infection

The Asia-Pacific region bears the highest burden of the world’s hepatitis infections, but few governments there or in other low- and middle-income countries have national HCV screening and treatment plans, and international access to any of the available HCV treatments is extremely low. The most common older regimen, a combination of pegylated interferon and ribavirin, costs at least $10,000 in most developing countries, making it unaffordable in most parts of the world.

Without access to treatment, between 350,000 and 500,000 people die of liver disease caused by HCV each year. The infection progresses more rapidly in those who are co-infected with HIV, and these patients are six times more likely to develop end-stage liver disease than those infected with HCV alone. Ironically, as access to antiretroviral treatment (ART) across the world continues to improve, more and more people living with HIV are dying as a result of HCV infection.  

“Right now many of our community members are surviving HIV, but dying from hepatitis C,” says Aditya Wardhana, executive director of the Indonesia AIDS Coalition. “So we are demanding that our government pay more attention to access.”

“Right now many of our community members are surviving HIV, but dying from hepatitis C,” says Aditya Wardhana, executive director of the Indonesia AIDS Coalition.Uniting Globally for Hepatitis C Treatment Access

In an effort to bolster Wardhana’s and other advocates’ efforts, TREAT Asia began hosting regional HCV consultations in 2013 that provide national and international advocates an opportunity to brainstorm on best strategies and streamline their efforts into a more concentrated and united advocacy front. “The first regional consultation emerged from the idea that many advocates were doing something on their own for hepatitis C treatment access, but were not focused on how we can work together,” says Khwairakpam.

Regional stakeholders wanting to capitalize on the advent of DAAs as a motivating force for change have increasingly focused on the need to implement national screening and treatment programs as a key step towards bringing the HCV epidemic under control. As part of that effort, they have advocated for high-level partners like the World Health Organization (WHO) to use their influence to encourage national health programs to better address the HCV pandemic. A number of key decisions and reports have begun to demonstrate that this advocacy is working.

• April 2014:  The WHO released its first international treatment guidelines for HCV, bringing greater attention to the need to aggressively and collectively confront the disease.
• March 2015:  Motivated primarily by concern over the growing impact of HIV-HCV co-infection, the board of The Global Fund to Fight AIDS, Tuberculosis and Malaria voted to include treating HCV as part of their public health and disease control strategy.
• May 2015:  The WHO added sofosbuvir and four even newer DAAs to the WHO Model List of Essential Medicines—a document that many governments use to determine which medicines to provide under their own health programs.

Both the Global Fund and the WHO have stressed the need to further reduce the cost of DAAs, and have begun to undertake their own advocacy work to address this issue. According to the Global Fund, if strategies similar to those employed to drive down the cost of HIV treatment were used for DAAs, the cost of a course of generic treatment could be reduced to as little as $150–250.

Despite this progress, as of July, nearly a year since the Gilead voluntary license was first negotiated, sofosbuvir had been approved and registered for use in only eight developing countries, with applications pending in 13 more.

Advocacy on the Ground in the Asia-Pacific

The successful reductions in the cost of HIV treatment a decade ago were the result of both robust generic competition and the massive treatment demand, and intense advocacy, from people living with the disease. At the latest TREAT Asia regional HCV consultation this August, the group agreed that creating similar demand by educating individuals with HCV about the new DAAs was among their top priorities for the coming year.

“For many people living with HCV, treatment has always been a distant and impossible dream, so our first goal is to make sure people understand the very real possibility of accessing effective, affordable treatment with the new generation of DAAs,” says Odilon Couzin, coordinator of the AIDS Care China HCV Treatment Access project, who attended the consultation.

In addition, regional partners are working with national governments to employ another tool that proved key to reducing the cost of HIV meds: national and international intellectual property law. “We have intellectual property specialists on our team and are working with countries to help them use all the methods they have to overcome intellectual property barriers and access these drugs at an affordable price,” says Marc Lallemant, head of the Pediatric Disease Program at DNDi, which participated in the TREAT Asia consultation.

The situation on the ground and current advocacy approaches vary widely across the region. The activities of three TREAT Asia partners from China, Indonesia, and Thailand provide a snapshot of their ongoing campaigns.

TREAT Asia Director of Research Dr. Nicolas Durier discusses a TREAT Asia’s study aiming to develop a model for treating HIV-HCV co-infected patients in the region.

Thailand

Between 500,000 and three million people are living with HCV in Thailand. The country is not included in Gilead’s voluntary license agreement, but the government approved Gilead’s application to register sofosbuvir in the country in early September 2015. According to Charlermsak Kittitrkaul, coordinator for the AIDS ACCESS Foundation’s Access to Medicines Campaign, the Thai government is currently evaluating the cost-effectiveness of covering sofosbuvir under its national plan.

Gilead’s tiered sofosbuvir pricing plan is based on country income for those not included in the voluntary license. The cost of a full course of therapy in Thailand, an upper-middle-income country, could be up to $15,000, and advocates are hoping to negotiate that down to $1,000. If Gilead refuses to offer a price that would make coverage cost-effective, advocates may push the government to issue a compulsory license—a provision included in the World Trade Organization’s international intellectual property framework that allows for the generic production of a patented product without the patent owner’s consent. However, this move would likely subject Thailand to extensive legal action by Gilead, and could cause potential harm to Thailand’s other trade relationships. It is consequently considered a “last resort” option.  

China

As mentioned above, China claims the world’s largest number of people living with HCV. It is not included in Gilead’s voluntary license agreement, and the company has not filed an application to register sofosbuvir there. AIDS Care China’s Couzin says he expects it to take years for DAAs to be registered in China, due to the government’s slow regulatory approval process. “However, I think that it is possible that a sincere offer from Gilead to lower the price or to license local generic production might inspire leaders to introduce fast-track mechanisms for approval,” he says.  

China could also choose to use a legal bargaining chip through the patent process. In June 2015, the country rejected one of Gilead’s patent requests for sofosbuvir. Gilead does hold one existing patent on sofosbuvir in the country, but under current Chinese law, it could be challenged and overturned. Such a step could allow Chinese generic drug companies to produce sofosbuvir without paying Gilead royalties—an approach with unknown potential consequences for the country and Gilead.

Indonesia

An estimated two million people in Indonesia are infected with HCV, and the country is included in Gilead’s voluntary license agreement. The company has filed an application to register sofosbuvir; however, according to the Indonesian AIDS Coalition’s Wardhana, Gilead has yet to file the necessary papers for approval, and the application remains on hold.

Indonesian advocates are working to insert a new provision in the country’s patent law modeled after Section 3(d) of India’s Patents Act, which would allow the country to reject patents on medicines similar to existing drugs. In India, a case using Section 3(d) to challenge Gilead’s sofosbuvir patent application is ongoing. “We hope to send the message to Gilead that if they are not fast enough, we will use our legal work to abolish their patent,” Wardhana says.

They also have built a national protest movement to advocate for better HCV treatment access. According to Wardhana, during a recent meeting, governmental representatives informed advocates that improving HCV treatment access was not a national priority. The advocates promptly organized a large protest and press conference—and two weeks later the government issued a decree that it would cover sofosbuvir under the national health plan.

“We realize it will take more effort from us to ensure the government keeps its promise,” says Wardhana. “So we plan to continue our efforts to show people in Indonesia that this medication can really save lives.”