For nearly three decades, our company has been engaged in the response to the hepatitis C virus (HCV) epidemic.
We have worked to apply 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.
IN THE PAST DECADE, MSD’S CLINICAL DEVELOPMENT PROGRAMS IN CHRONIC HCV INFECTION HAVE:
Enrolled Approximately 10,000 Participants
Included more than 135 Clinical Trials in Approximately 40 Countries
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 with the scientific community to advance understanding of this significant global public health epidemic.
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 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 today. Patients who inject drugs are and will be an important population to address in achieving 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, when our company launched ZEPATIER, we established a list price and a comprehensive commercial- and public-segment access strategy that we anticipated would 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. Since that time, we have continued to implement commercial strategies and public policy efforts in both the United States and in other countries to accelerate access to treatment.
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.
|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.