Hepatitis C

Hepatitis C

For nearly three decades, our company has been at the forefront of the response to the hepatitis C virus (HCV) epidemic. We are dedicated to applying our scientific expertise, resources and global reach to the development and delivery of health care solutions that support people living with HCV worldwide.

The World Health Organization (WHO) estimates that, in 2015, 71 million people globally were chronically infected with HCV, and at risk of developing liver cirrhosis and/or liver cancer, with 1.75 million new infections occurring each year. In 2015, WHO and its 194 Member States committed to eliminating viral hepatitis as a public health threat by 2030.

Our scientists have been engaged in research to address HCV infection since the discovery of the virus in the late 1980s, and we continue to work to advance scientific understanding of this significant global public health epidemic.

  • Company researchers developed the first approved therapy for chronic HCV, interferon α2b, in 1991.
  • In 1998, the first combination therapy developed by our scientists for chronic HCV, interferon α-2b+ribavirin, was approved. We also launched boceprevir, one of the first direct-acting antiviral medicines against HCV, in 2011.
  • In January 2016, ZEPATIER™ (elbasvir and grazoprevir)—a once-daily, fixed-dose combination tablet for the treatment of adult patients with chronic HCV—received regulatory approval from the U.S. Food and Drug Administration (FDA) and Health Canada for specified HCV genotypes. Since that time, ZEPATIER has been approved in the 28 European Union member countries and in more than a dozen additional countries around the world.

We believe it is in the best interests of public health to broaden and accelerate patient access to HCV treatment, including underserved or difficult-to-treat chronic HCV–infected populations.

The clinical development program for ZEPATIER enrolled diverse groups of patients with chronic HCV infection, including patients who had failed certain prior therapies and patients with significant comorbidities and health complications such as severe renal impairment, compensated cirrhosis, and HIV co-infection.

Notably, the clinical development program also included a trial of patients with a history of injection drug use who were receiving opioid agonist therapy.

According to WHO, in addition to unsafe health care practices, injection drug use is one of the most common modes of transmission of HCV. In the United States, 75 percent of new infections with hepatitis C result from injection drug use. Patients who inject drugs are and will be an important population to address in achieving the WHO’s goal of eliminating viral hepatitis as a public health threat by 2030.

PRICING DESIGNED TO ENABLE BROAD PATIENT ACCESS

Innovations in chronic-HCV treatment that have become available over the past several years, now including ZEPATIER, provide the world with an unprecedented opportunity to significantly reduce the burden of HCV by 2030. However, a significant medical need remains: it is estimated that fewer than one in five patients with chronic HCV infection are currently treated, with thousands of new cases occurring each year.

Innovation without access limits meaningful benefit to patients. The majority of patients with chronic HCV have not yet been treated. While restricted access continues to be a barrier to chronic HCV treatment worldwide, our company is taking steps to address these barriers. We have worked closely with key stakeholders in the countries where we have launched ZEPATIER to increase the affordability of treatment, reduce barriers, and expand eligibility criteria to broaden and accelerate access to treatment for more patients.

In the United States, our company established a list price and a comprehensive commercial- and public-segment access strategy that we anticipate will help broaden and accelerate patient access to treatment and move us closer to our shared goal of reducing the burden of chronic HCV in the U.S.

Hepatitis C IN EMERGING MARKETS

In many developing countries, the spread of HCV is facilitated by unsafe medical practices, such as the reuse of needles and syringes by medical practitioners. The use and misuse of intravenous drugs is also a major route for HCV  transmission.1 Health systems in many of the countries most impacted by HCV are poorly equipped to widely diagnose HCV and to deliver care and treatment for those with the virus.2

Together, these factors are contributing to the heightened HCV disease burden in these regions. We are committed to developing sustainable solutions to improve awareness, diagnosis, and access to care and treatment in areas where the HCV disease burden is greatest.

We recognize that global elimination of HCV will require the combined efforts of all stakeholders—governments, donor organizations, policy makers, advocacy groups, nongovernmental organizations (NGOs) and the private sector—to build a framework for promoting awareness, prevention and treatment of viral hepatitis, especially among the populations most at risk for chronic HCV. We remain committed to strengthening new and existing partnerships to achieve greater access to health care.

Our company has had a particular focus on addressing these issues in two key countries in the developing world: India and Vietnam.

Project Echo®

To help build health care capacity and expand access to specialty care for complex or chronic conditions among underserved populations in Asia, our company’s Foundation launched a new partnership in December 2016 with Project ECHO (Extension for Community Healthcare Outcomes) through a $7 million commitment over five years (2017–2021) to expand the replication of Project ECHO in India and Vietnam. Learn more.

1. European Association for the Study of the Liver. "Therapy of Hepatitis C: Clinical Application and Drug Development." http://www.who.int/mediacentre/factsheets/fs164/en/.
2. Ewen Callaway. “Hepatitis C drugs not reaching poor.” Nature 508:295–296.17 April 2014.