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 deliver health care solutions that support people living with HCV worldwide.
The World Health Organization (WHO) estimates that 3 percent of the world’s population may be infected with HCV and that as many as 170 million people may be chronically infected and at risk of developing liver cirrhosis and/or liver cancer. One of the challenges of managing hepatitis C is that people with HCV often have no symptoms—and can live with an infection for decades without feeling sick.
Our scientists have been engaged in research to address HCV infection since the discovery of the virus in the late 1980s.
- 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. ZEPATIER has also been approved in the European Union, Switzerland, Israel and Saudi Arabia. Regulatory applications are under review in numerous other markets, including Japan.
- 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 co-morbidities and health complications such as severe renal impairment, compensated cirrhosis, and HIV co-infection, as well as those on opioid agonist therapy
Ongoing clinical research efforts are underway to develop new oral therapies to bring continued innovation to viral hepatitis treatment; including studies on regimens targeting additional HCV genotypes.
“We decided to have studies that would encompass the breadth and depth of HCV, with many different types of HCV patients, including HIV-co-infected patients, patients with chronic kidney disease (CKD), and HCV-infected people who inject drugs and are receiving opiate agonist therapy (OAT). These people have traditionally been excluded from clinical trials. When we designed our Phase III Zepatier trials, we wanted to bring new treatment options not only to the ‘big middle,’ but also to underserved patients.”
Dr. Eliav Barr
Vice President, Infectious Disease, MRL
Access to Medicines 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.
Elevate awareness of HCV through:
- Educational programming for patients and providers to better identify and address unmet needs
- Academic research initiatives addressing the burden of HCV in areas most impacted by the disease
Enhance access to our medicines through:
- Developing an Access pricing program for our pegylated interferon α2b medicine for low-income countries to help facilitate the initiation of treatment programs
- Differential pricing frameworks based on disease burden and country income in middle-income countries
Engage in local partnerships through:
- Collaborations with governments to initiate awareness and screening programs
- Support for international programming through civil society groups, including regional HCV research initiatives
Our company recognizes 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.
Several of the collaborations that we have undertaken are highlighted in the tabs above.
|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.
Pricing Designed to Enable Broad Patient Access
Innovations in chronic-HCV treatment that have become available over the past three years, now including ZEPATIER, provide the U.S. with an unprecedented opportunity to significantly reduce the burden of HCV. The scientific community believes that control of HCV infection may be possible, and is actively working to achieve that goal by 2030. A significant medical need remains: it is estimated that less than one in five patients with chronic HCV infection are currently treated, with thousands of new cases each year.
However, the majority of patients with chronic HCV have not yet been treated, in some cases because of to cost constraints. After considering these factors, our company established a list price in the United States 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.
“Our company’s decades-long commitment in chronic hepatitis C—and infectious diseases overall—has been to both scientific innovation and access. We are embracing this opportunity to partner with payers and physicians to enable as many appropriate patients to be treated as possible, as quickly as possible.”
President, U.S. Market, Global Human Health
Financial Assistance Programs
Our company also offers assistance through our Patient Assistance Program (PAP) to patients who cannot afford ZEPATIER. The PAP for ZEPATIER is designed primarily for the uninsured who, without our assistance, could not afford their medication. Additionally, for those patients whose insurance plan covers ZEPATIER, but who still cannot afford their medication, a request for an exception may be made if they meet certain financial, medical, and/or insurance criteria. Click here for more information about the PAP.
In India, the highest prevalence of Hepatitis C is in the northwestern provinces of Haryana and Punjab, and the low-income, rural population is disproportionately affected.
Recognizing the high prevalence, high cost burden and challenges of treatment adherence of HCV, MSD in India initiated Project Sambhav (“making it possible”), a program aimed at educating patients and their families about HCV and help, manage the cost of treatment. Through Project Sambhav, MSD in India provides subsidies for financing treatment to eligible patients and counseling to help educate about treatment, adherence and transmission prevention.
HCV treatment in India is currently not provided by government health programs. To access treatment, patients must generally pay for treatment out of pocket. Unfortunately, with no public funding for hepatitis C treatment, these low-income patients have had very limited access to treatment.
In 2012, we began two efforts to increase access to treatment in Haryana and Punjab.
In 2012, we started engagement with the government of Haryana seeking to increase awareness of the public health burden of HCV and to co-create a comprehensive HCV disease management program.
In December 2013, Haryana announced Jeevan-Rekha (meaning “Lifeline”), India’s first public program hepatitis C with free access to treatment for patients below the poverty line. The government of Haryana issued a tender for manufacturers that included provisions on “pay-for-performance” and deferment of payment as tender conditions, a first-of-its-kind tender in public procurement in India. These provisions ensured that the government paid only for patients who successfully completed treatment and allowed the government to extend payment. Our company was awarded this two-year performance-based contract in January 2014.
The Jeevan-Rekha comprehensive free-treatment program was initiated with the following elements:
- Free medication (ViraferonPeg® therapy) for eligible patients
- An independently run integrated disease management program consisting of:
- On-therapy diagnostics to monitor prognosis of all enrolled patients
- A treatment counselor to help patients complete their therapy
- An online disease management application where patients’ progress is monitored on a real-time basis for prognosis and adherence
- Performance evaluation as part of the pay-for-performance requirement, our company would provide free doses to the government for patients who had adhered to therapy but did not achieve SVR
More than 1,200 low-income patients who had previously not had access to treatment have been treated under this program since it began. Of these, 96 percent have achieved a sustained virologic response (SVR).
In order to help facilitate access to treatment for patients paying out of pocket, in 2012, MSD in India launched Project Sambhav, a microfinance pilot program in the state of Punjab.
MSD partnered with a third-party disease management program coordinator, a leading local finance company, and local health care clinics to develop and implement the program.
The program consisted of two components relating to financing and disease management:
- Enrolled patients were offered interest-free loans subsidized by MSD to access HCV treatment
- Physicians referred patients and their families to a trained health counselor to encourage adherence and improved disease management strategies
Patients diagnosed with HCV and identified as having an issue affording treatment were referred to a counselor who provided disease treatment and transmission-prevention information, and information on the loan option. Low-interest loans were offered to eligible patients to cover the cost of treatment. Patients got vouchers to be redeemed for MSD’s ViraferonPeg® at authorized pharmacies. Patients repay the loan in small monthly installments over a period of two to three years and continue to receive counseling and drug administration support during the course of treatment.
MSD’s subsidy of the loan includes covering the cost of waiving the repayment of loans for any patients who have experienced treatment failure.
After seeing success with this model in Punjab, MSD in India expanded the program to several states in India where hepatitis C prevalence is very high. More than 200 treatment centers have actively participated in this program and nearly 1,000 patients (nearly 40 percent of treated patients in these states) have received treatment through this financing program. Moreover, the loan repayment rates have been very high, enabling this program to sustain itself.
Sambhav has received external recognition as an innovative approach to increasing access to treatment.
Our company’s Foundation has awarded a multiyear grant to Population Services International (PSI), a leading global health organization, to conduct educational outreach targeting at-risk populations and health care providers.
Additionally, service providers from high-prevalence areas were trained to promote an understanding of HCV and facilitate referrals for diagnosis and prevention counseling.
In 2013, our company’s Foundation awarded a three-year, $650,000 grant to Population Services International (PSI) to build awareness, motivation and capacity to help prevent HCV among the most at-risk groups in Vietnam:
- PSI conducted research throughout 2013 to identify factors facilitating HCV transmission in Vietnam. Results found that a low perceived risk of HCV, limited access to information and limited access to HCV prevention methods were major drivers of transmission among the most at-risk groups.
- In response to this research, PSI initiated activities to improve access to and create demand for information on HCV behaviors among the most at-risk individuals, including people who inject drugs (PWID), who are at risk of both HCV and HIV
- In addition, PSI worked with the ministry of health to develop a national HCV prevention training package to build capacity and commitment in order to integrate routine HCV prevention and referral for diagnosis and treatment into HIV service provision at sites offering other services, including voluntary counseling for HIV and methadone treatment
- HCV prevention communication materials including non-stigmatizing messages designed to motivate the practice of HCV prevention behaviors, including the use of sterile low-dead-space syringes, which reduce the risk of HCV, and increased knowledge of HCV status. Messages are conveyed via highly cost-efficient channels including outdoor billboards, leaflets and interactive events in locations accessible to people at greatest risk.
- PSI improves access to HCV prevention products and materials at outlets accessible to key at-risk groups, including tea stalls and truck stops as well as pharmacies and health service delivery points
PSI’s programming has had a measurable impact on individuals at risk for HCV in Vietnam, As evidence by the following results achieved in January–September 2014:
- More than 15,000 years of healthy life have been saved as a result of more than 2 million low-dead-space syringes distributed
- More than 9,200 individuals at risk of HCV have been reached with messages to motivate HCV prevention behaviors
- The perceived risk of HCV increased by 86 percent among individuals reached by PSI’s HCV communications
- 106 health care providers were trained using the HCV training package
PSI’s programs supported by the Foundation grant are still progressing, with ambitious goals for future programming that include:
- Scale-up of activities initiated in 2013 for greater coverage and impact
- Increased national and provincial support for expanded HCV prevention programming, including face-to-face events and promotional materials
- Development of practical training tools to facilitate routine integration of HCV services into HIV care
MSD supported the development of the National Treatment Program, a public awareness program that has greatly increased the level of discussion and awareness of HCV in Ukraine.
Over the past five years, we have collaborated with local governments, advocacy groups and scientific leaders to raise awareness and understanding of chronic HCV among both patients and health care providers. MSD continues to collaborate with these partners on ways to improve HCV treatment.
Beginning in 2009, MSD in Ukraine initiated a wide range of programming to increase discussion about HCV and engagement with civil society and government on HCV, including:
Expert Forums and Patient Roundtables: Through coordination with civil organizations such as Patients of Ukraine and Stop Hepatitis, MSD in Ukraine collaborated with HCV experts and patient organizations to elevate the conversation about HCV in Ukraine and best practices to fight the disease.
White Paper on Hepatitis: MSD in Ukraine, along with Stop Hepatitis, supported the development of an epidemiological and economic assessment of HCV in Ukraine, which helped inform discussions during patient/expert roundtables and helped communicate to the government of Ukraine the urgency of the HCV problem.
Treatment Access: In 2013, MSD in Ukraine, through engagement with civil society and the Ministry of Health, agreed to lower the price of treatment of HCV to facilitate pilot treatment programs for patients co-infected with HCV and HIV through the ministry of health and the AIDS Alliance, a Global Fund grant recipient. MSD also supported training of 30 doctors to properly administer care through the AIDS Alliance program.
Hepatoschools: In Ukraine, “hepatology” is not a formal medical specialty. In order to build capacity to treat HCV, MSD in Ukraine initiated a medical education program to train young gastroenterologists and infectious disease specialists on hepatitis C. More than 120 doctors were educated through three training stages to better equip them to recognize and treat HCV.
- MSD in Ukraine has worked to help facilitate the conversation about HCV through collaboration with patients, government and advocates to improve the situation in Ukraine. Ukraine’s first National Treatment Program (NTP) for HCV was developed and approved in 2013. For the first time, patients were registered to receive state funding for HCV medicines.
- To date, 44,000 patients have been diagnosed with HCV. From the moment the NTP was approved until today, about 4,500 patients have been covered with our HCV treatment.
- In 2012, we undertook a number of initiatives to improve patients’ access to our treatment. We localized PEGINTRON® (peginterferon alfa-2b) and lowered the price by 100 percent for the state and Global Fund tenders for the next years.
- In 2015, to support co-infected patients with combination therapy using a new HCV treatment (Sovaldi), we donated 600 units of PEGINTRON to the AIDS Alliance.
- More than 120 doctors were trained throughout Ukraine to increase their knowledge of how to treat HCV, as well as developments and innovation in medicines for the virus. An additional 30 doctors were trained to combat HCV through the AIDS Alliance program.
MSD initiated several programs, including the Liver Evaluation and Disease Awareness (LEAD) program, to help address low diagnosis and awareness of HCV in Thailand.
As part of the LEAD program, health care providers are trained to be aware of and recognize at-risk populations to help ensure interventions prior to disease manifestations or complications.
Since 2012, MSD in Thailand has developed and rolled out three programs to address health care provider (HCP) HCV education, low HCV diagnosis rates, and HCV awareness and education among the general public:
Building Provincial Capacity to Treat HCV Program: MSD in Thailand partnered with the Thai Red Cross AIDS Research Center and HIV Netherlands, Australia, Thailand Research Collaboration (HIVNAT) to improve the quality of care for HCV patients by educating HCPs across health care sectors. Over a period of six months, HIV and HCV experts delivered seminars and workshops at five hospitals in different provinces in Thailand. In addition to building general education and awareness, the program sought to inform future educational programming by surveying trainees and participants about the effectiveness of the program.
An Integrated Program for Education and Management of Viral Hepatitis in the National Blood Center: MSD in Thailand awarded a $70,000 grant to the Department of Medicine of Chulalongkorn University (CU) to support the National Blood Bank in Thailand. With the collaboration of CU and the Thai Red Cross Society, we targeted HCPs working at the National Blood Bank to improve knowledge and awareness of viral hepatitis among the professional staff and blood donors. The goal of the program is to increase identification of infected people, who can then receive appropriate medical management and education on viral hepatitis. In addition, the program provided similar guidance and appropriate management of viral hepatitis for blood donors who are chronically infected with HBV or HCV.
Liver Evaluation and Disease Awareness (LEAD): The LEAD program was a two-pronged approach to improving hepatitis disease awareness and patient diagnosis of viral hepatitis through a collaboration of several local hospitals to conduct educational programs and hepatitis screening event, among lay people. MSD in Thailand also partnered with a laboratory-test company to implement a patient support program to facilitate diagnostic testing of patients who are chronically infected with HBV or HCV but who cannot afford diagnostic testing to monitor disease progression and the need for treatment.
The LEAD program is continuing in Thailand, and its results to date include:
- Nearly 1,100 HCPs, primarily physicians, nurses and pharmacists, were educated as a result of the collaboration with HIVNAT
- In the Integrated Program for Education and Management of Viral Hepatitis in the National Blood Center, 80,000 new blood donors and approximately 2,000 infected donors to the National Blood Bank were educated and provided with appropriate management of viral hepatitis.
- The LEAD program is continuing in Thailand, and its results to date include more than 15,000 people from all over the country having been screened and educated.
Recognizing the urgent need for action in Egypt, we collaborated with the ministry of health (MOH) and advocacy and industry partners to develop targeted programming to fight HCV.
The initiation of communications campaigns, screening programs and treatment subsidies across the country has helped increase awareness and understanding of chronic HCV in Egypt. In 2013, our company launched the first Middle East School of Hepatology (MESH), which provided numerous medical professionals from across the region with advanced medical education targeting hepatic disease in the Middle East.
Egypt has the greatest prevalence of HCV of any country globally, with 10–13 percent of the population infected.
Recognizing the high disease burden in Egypt, MSD has taken an active role in fighting the HCV epidemic in Egypt for many years, including a number of programs initiated since 2006:
Ministry of health (MOH) collaborations: MSD in Egypt has worked closely with the MOH to develop programming and lower pricing for its HCV medicines. Notably, MSD agreed to offer PEGINTRON, its pegylated-interferon medicine, to the Egyptian government at its lowest price globally, recognizing the high burden of disease in Egypt and the Egyptian government’s commitment to expanding HCV treatment.
Egyptian Education, Access, Screening and Treatment (EEAST) program: The EEAST program was a multifaceted campaign to increase education for both patients and health care providers. Through collaborations with several hospitals, the campaign sought to educate HCPs about safe injection practices and proper screening procedures. At the same time, the campaign featured screening programs for patients in which they too were educated about prevention methods for HCV.
Virus C Free Children Initiative: MSD recognized the high rate of pediatric HCV patients, and collaborated with the Egyptian Society for Treatment of Liver Disease and the MOH to help remedy the epidemic. MSD supported the use of noninvasive screenings for pediatric patients at risk of HCV and supplied discounted treatment for these patients.
Middle East School of Hepatology (MESH): A significant cause of the spread of HCV in Egypt is poor knowledge of prevention methods among HCPs. MSD invested $640,000 and collaborated with the Misr El Kheir Foundation to launch the region’s first Middle East School of Hepatology. The program focused on educating doctors on hepatology to increase quality of care for HCV and to stop the spread of unsafe practices. The program, while based in Egypt, sought to educate doctors from countries throughout the Middle East.
Through its wide scope of programming, MSD has engaged with the advocacy, industry and governmental community in Egypt to address the country’s HCV epidemic. Results of some of this programming include:
- Discounted medicines for patients across 26 treatment centers in Egypt
- More than 350,000 patients treated in the national program since 2006 prior to the introduction of all-oral treatments in 2014
- Screening through the EEAST program in three major sites of HCV prevalence
- More than 100,000 individuals introduced into the National Database Project for HCV
- More than 850 children screened and treated through the Virus C Free Children Initiative
- 50 HCPs educated as hepatologists over two years across 16 countries in the Middle East, who graduated on October 10, 2015