Activists demand affordable access to new, life-saving hepatitis C virus medications

by Karyn Kaplan, Director, International Hepatitis/HIV Policy & Advocacy, Treatment Action Group (TAG), New York

“If the prices (of new HCV treatments) were to be unaffordable once more in history, it would be one more scandal around inequity of access to health care.”

-- Michel Kazatchkine, the United Nations Secretary General’s Special Envoy on HIV/AIDS in Eastern Europe and Central Asia

On 22-25 February 2014, treatment advocates from 22 countries came together in Bangkok, Thailand, for the “1st Hepatitis C Virus (HCV) World Community Advisory Board (CAB)” meeting to strategize for increased access to hepatitis C virus (HCV) diagnostics and treatment. Thirty-eight activists met with six originator pharmaceutical companies that produce pegylated interferon (PEG-IFN), the current standard of care (SOC) for treating HCV in most of the world, and/or HCV direct-acting antivirals (DAAs), which constitute the new SOC in the US and Western Europe. New DAAs are safer, less toxic, and more powerful, and are demonstrating cure rates of up to 100% in clinical trials. Pegylated interferon, on the other hand, on average 
cured only 50% of people with HCV.

 

Globally, about 185 million people are infected with HCV, or six times the number of people with HIV/AIDS, and 350,000 people die each year of HCV-related complications. Annually, three to four million are newly infected. Yet, only a small fraction of people with HCV is aware of their status. Due to the high price of PEG-IFN (up to US $20,000, even in lower middle-income countries (LMICs)), many countries have been unable to prioritize HCV testing, treatment and prevention programs, even where national prevalence is high.

Egypt, with the world’s highest HCV prevalence (15%), recently gained attention for its successful negotiation with PEG-IFN producers, Roche and Merck, for a price of US $2,000 per treatment course, a ten-fold price reduction. Egypt was able to achieve this price in part because a local company could produce a similar version of PEG-IFN cheaply. Roche and Merck wanted to maintain large shares of the Egyptian market, so they brought down their price.

“We want these new and coming HCV drugs as soon as people in rich countries can access them. Poor people’s lives count too, but obviously not in the eyes of these greedy pharmaceutical companies who care only about profit. None of the six companies we met with offered a plan that would help LMICs access affordable treatment,” said Jirasak Sripramong, an HCV educator and advocate with the Thai AIDS Treatment Action Group (TTAG) and participant at the HCV World CAB.

Eighty-five percent of people with HCV live in LMICs, but at current prices, there is no hope of treatment access for them --Gilead’s recently-approved sofosbuvir, which is expected to replace PEG-IFN as the new backbone of HCV treatment, for example, costs US $84,000 per treatment course in the U.S. and needs to be used in combination with other drugs. “Most people cannot afford HCV treatment—nor can their governments,” explains Paata Sabelashvili of the Georgian Harm Reduction Network. “My government, like others in the Eastern European region, is launching a national treatment program, but astronomically high prices will limit it. How can governments and donors effectively address HCV if Pharma refuses to drop drug prices?”

“All six companies claimed to have learned the lessons of the HIV/AIDS epidemic, but in fact refused to commit to price reductions or promote access to generic competition that will allow affordable access in LMICs. Abbvie, BMS, Gilead, Janssen, Roche, and Merck are holding people with HCV hostage to their corporate greed, and many will die waiting for treatment unless we fight back.” said Karyn Kaplan, an organizer of the meeting.

HepC activists continue to engage in numerous advocacy activities to increase access to affordable HCV treatment, including community education and mobilization, working with governments and pharmaceutical companies to negotiate lower drug prices, and lodging patent oppositions in courts to challenge the validity of new HCV drug patents where relevant (as in the recent I-MAK pre-grant patent opposition against sofosbuvir, in India – ruling still pending).

What can the general public do to support HepC activists?

The general public can participate in campaigns, such as our upcoming global advocacy campaign to get originator companies to bring down the price of new HCV DAAs, through signing onto petitions or joining solidarity actions in their cities. The price reduction campaigns are based on the right to health and recent studies that have shown true production costs of these new drugs are estimated at only a couple of hundred dollars per drug per treatment cost. We are questioning the methodology of how the companies decide on their final market price and their companies’ lack of a moral and ethical commitment to equitable access balanced with fair profit.

For further updates check out the Global HCV campaign website: www.hepcoalition.org

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The Road-Map Ahead: Treatment Action Group on Ending HIV in the US.

Treatment Action Group has been working on engaging decision makers to revitalize and catalyze real action towards realizing the goals of the US National HIV/AIDS strategy in order to end AIDS in the US.

Treatment Action Group (TAG) has been working on high-level advocacy efforts in order to push the government to revitalize action on NHAS goals. TAG has coordinated dialogue amongst HIV/AIDS policy makers, experts, researchers, service providers and community activists, synthesizing lessons into their ‘Revitalizing the U.S. National HIV/AIDS Strategy’ 2013 Report and Action Plan. Key recommendations were outlined, which include the need to scale up evidence-based strategies and practices, maximize engagement in care and treatment outcomes, and facilitate tighter collaboration between various federal agencies.

Thirty years into the HIV/AIDS epidemic, an artillery of scientific knowledge and medical strategies have been developed in which to mount a fight against the HIV epidemic. But an array of social, political, behavioral and cultural factors still pose significant barriers to making this potential a reality.

  

Approximately 1.2 million people are living with HIV in the U.S. Prevalence and new infection rates are disproportionately higher in communities facing extreme marginalization and discrimination, men who have sex with men (MSM), commercial sex workers (CSWs), and people who use drugs (PUDs). Entrenched inequities also remain and are divided along race and gender lines.  In the US, whereas black men and women represent approximately 14 percent of the population, they accounted for almost half of all new HIV infections in 2010.

Racism, homophobia, poverty, violence, trauma and criminalization are some of the structural factors that continue to drive the HIV epidemic and affect access to prevention, care and treatment services. In the US, one in five people are unaware of having been infected, and only 40 percent are engaged in continuous care. Moreover, only one in four people living with HIV is being successfully treated with antiretroviral medications and maintaining undetectable viral loads, meaning one’s health is potentially endangered and one can transmit the virus to others.  

In order to mount a worthy fight, political commitment, a supportive policy environment, adequate funding, multi-sectoral dialogues, effective service delivery mechanisms and empowered communities are vital.

The US National HIV/AIDS Strategy 2010 -2015, that has been fully supported by the White House, is a stated commitment towards reducing the number of HIV infections in key affected populations (KAPs), increasing access to care and improving health outcomes for PLHIV, and reducing HIV related health disparities through the use of community level approaches.

Vision for the National HIV/AIDS Strategy: The United States will become a place where new HIV infections are rare and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity or socio economic circumstances, will have unfettered access to high quality, life extending care, free from stigma and discrimination’

Many of the targets however are not likely to be met under the current pace.  

Gaps not addressed in the roadmap include a funding shortfall, estimated at 15.2 billion as well as a need for state level action.  TAG also recommends the need for priority allocation of resources, so that they can be directed to where they are most needed, demographically as well as geographically. HIV infection rates in the South continue to rise, particularly in states such as Mississippi and Florida where existing resources are stretched to breaking points.

There is also strong need to apply ‘implementation science’, which is a ‘bottom-up’ approach to research. It is primarily concerned with evaluating and translating interventions that have proven effective in clinical trials and other studies, taking into consideration the complex and shifting dynamics of real world settings.

Underlying these recommendations is the critical need for involvement of people and communities directly affected by HIV. Community mobilization and activism remains essential in the fight against HIV, both in terms of achieving and surpassing the goals of NHAS, and for ensuring that accurate data and information from the community are fed into decision-making bodies. The opinions, experiences and voices of PLHIV and KAPs need to be strengthened, validated and prioritized within HIV agenda setting, and in devising sustainable and local solutions that are impactful, realistic, and relevant.

Due to advocacy efforts, President Obama issued an Executive Order in July 2013, establishing the HIV Care Continuum Initiative which integrates many of the key recommendations outlined by TAG. A collaborative and cross-sectoral working group was established, with a mandate to focus on improving health care delivery, identify research gaps, and obtain input from affected communities.

To keep up to date with developments on the work of TAG sign up to their mailing list at www.treatmentactiongroup.org or follow them on Facebook and Twitter.

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