PROBLEM
Hepatitis kills approximately 1,400,000 people every year, more than HIV/AIDS. Every 22 seconds, someone dies of hepatitis; and globally, 4,100 lives are lost per day due to Hepatitis B (HBV) and Hepatitis C (HCV). With the availability of affordable vaccines, diagnostics and medicines, these deaths are entirely preventable.
CDAF’s Polaris Observatory has conducted Hepatitis disease burden analyses in over 100 countries/territories and has conducted economic impact analyses in 30 countries/territories. They all show that hepatitis elimination strategies are not only cost-effective, but cost-saving with a positive return on investment (ROI) within 25 years. Yet little action is being taken.
Except for a few countries/territories (Egypt, Mongolia, Pakistan and India), most programs in LMIC are small in scale, focused on special populations or they provide testing and treatment for free, making them neither sustainable nor scalable. The WHO 2030 elimination targets can only be achieved with programs targeting large populations and focusing on both HCV and HBV.
The majority of hepatitis burden is in LMIC (96% of HBV and 89% of all HCV infections). Most of these countries/territories lack the resources to fund the upfront investment needed to support an elimination program. And it is widely recognized that, unlike with HIV programs, large donors are not going to step forward with grants to fund hepatitis elimination programs.
SOLUTION
CDA Foundation has developed a scalable, sustainable catalytic funding mechanism that allows countries/territories to start their hepatitis elimination programs without a large upfront investment.
- The program relies on the premise that, even in LMIC, a majority of the population can afford to pay for treatment if drug prices and program costs are kept low.
- A modest markup on treatment pricing to those who can afford to pay can fund treatments for the smaller segment who cannot afford to pay. The mark-up can also fund all screening and laboratory tests.
- A small catalytic investment is needed to cover up-front costs/ working capital. Subsequent costs are paid for by the small markup on medicines.
- The program is based on a sustainable business model, not a donation-based model.
- Political-will is easier to achieve when governments are not required to support the full program with funding.
- National, rather than global focus opens investment opportunities to the broader community of local investors seeking local social impact.
- This approach represents a paradigm shift in funding global health programs.
UZBEKISTAN HEPATITIS ELIMINATION PILOT (UHEP) PROGRAM
To validate this concept at a large scale, CDAF has funded and is leading a pilot program in Tashkent, Uzbekistan in partnership with the Research Institute of Virology (RIV), the Uzbekistan Ministry of Health and a network of 13 Polyclinics serving the Tashkent region.
UHEP is NOT micro-elimination; it is a general population elimination program, which is essential to achieving WHO 2030 elimination targets.
Over a 12-month period, starting on July 28th, 2019 – World Hepatitis Day – UHEP will screen 250,000 people for HBV and HCV and provide treatment to an estimated 20,000 people. Approximately 1,000 people per day will be screened at community polyclinics. Patients will be treated by general practitioners at the Polyclinics and liver specialists at the RIV.
INNOVATIONS
Although scalable and sustainable funding of hepatitis elimination is the primary objective of the UHEP project, we are introducing numerous other innovations to reduce or eliminate barriers across the entire continuum of care. The innovations will simplify testing and treatment, make services more accessible and convenient, reduce elimination costs and improve linkage and adherence rates.
UHEP innovations include:
- Use of catalytic funding to reduce the amount of upfront capital required for an elimination program and use of patient payments to cover all program costs including repayment of the initial catalytic investment.
- Use of a pooled procurement mechanism (GPRO) to source affordable, quality-assured diagnostics and medicines at prices affordable to LMIC patients.
- Effectiveness of awareness programs and digital dissemination methods to drive broad participation in screening programs.
- Simplified “test & treat” strategies for HCV and HBV that will substantially reduce losses in the Cascade of Care.
- Task-sharing and training of healthcare workers to deliver testing and treatment within the community.
- Development of operational and logistical processes to efficiently test and treat high volumes of patients, reduce wait times, increase patient satisfaction, and optimize supply chain activities.
- Motivational Interview programs to motivate patients to participate in screening campaigns, seek treatment, get linked to care, and follow up with the healthcare providers.
- Supportive electronic systems (hardware and software) for managing patient data and patient follow up in remote and resource limited settings.
Combined with the funding mechanism, these innovations will comprise a simplified, adaptable, and scalable hepatitis elimination “franchise” that provides both a step-by-step road map and a tool-kit to cover all aspects of achieving hepatitis elimination at the national level.
UHEP OUTCOMES
KPIs and Minimum [Expected] Success Criteria
- Large scale general population hepatitis screening is feasible with rapid HBV and HCV diagnostic tests.
Minimum and [Expected] success criteria: Screen 125,000 [250,000] adults with HCV & HBV RDT in the general population for HCV and HBV over 1 year.
- A streamlined blood collection program will result in a high percentage of confirmed HCV testing rates among those found to be HCV antibody positive.
Minimum and [Expected] success criteria: 80% [95%] of all who are anti-HCV+ will agree to give blood to be tested for HCV core antigen.
- With a low-cost treatment option and motivational interviewing, a high percentage of chronic HCV and HBV patients will choose to be treated as part of this program.
Minimum and [Expected] success criteria: 55% [80%] of all diagnosed chronic HCV and HBV patients go on treatment.
- With patient education, HBV patients will stay on chronic treatment.
Minimum and [Expected] success criteria: 75% [95%] of patients starting HBV treatment will remain on treatment after 1 year.
- With patient education and reminders, patients will have a high refill ratio.
Minimum and [Expected] success criteria: 75% [90%] of all HCV & HBV patients will refill their Rx within 10 days.
- With patient education and reminders, HCV patients will come back for their SVR12, and HBV patients will come back for their annual tests.
Minimum and [Expected] success criteria: 70% [85%] of all HCV & HBV patients on treatment.
- A catalytic funding mechanism can be used to finance hepatitis elimination programs without need for massive donations or grants.
Minimum and [Expected] success criteria: 80% [100%] of the initial catalytic investment is paid back at the end of the pilot program.
UHEP PARTNERS
As shown below, the pilot will encompass an international group of experts, in the form of Key Partners and an Advisory Board, who will work closely to develop a program that can be replicated in other low-income settings. Their expertise from working on other hepatitis elimination program will be used to develop an optimized hepatitis elimination program that could be used as a template in other countries/territories.
Key Partners:
UHEP Advisory Board
An international advisory board has been formed to oversee the implementation of the pilot program. They are shown below.
| Advisory Board Members | |
| Chulanov, Vladimir | Central Research Institute of Epidemiology |
| Cloherty, Gavin | Abbott |
| Dunn, Rick | CDA Foundation |
| Favorov, Michael | Task Force |
| Feld, Jordan | Toronto General Hospital |
| Katz, Zach | FIND |
| Kottilil, Shyam | University of Maryland |
| Musabaev, Erkin | Institute of Virology |
| Ninburg, Michael | World Hepatitis Alliance |
| Razavi, Homie | CDA Foundation |
| Observers | |
| Abutaleb, Ameer | University of Maryland |
| Ahmed, Nabil | Integral Global Health |
| Anstiss, Tim | Academy for Health Coaching |
| Averhoff, Francisco | US CDC |
| Chiang, Betty | Gilead Sciences |
| Gore, Charles | Medicine Patent Pool |
| Kamarck, Ben | Gilead Sciences |
| Kamili, Saleem | US CDC |
| Karamatova, Shakhinya | US CDC |
| Karpievich, Maria | Algimed |
| Korns, Kristians | Cepheid Europe |
| Lou, Lily | John Martin Foundation |
| Marathe, Madhura | Hetero Pharmaceuticals |
| Mathur, Poonam | University of Maryland |
| Mirzoeva, Farangiz | Cepheid Europe |
| Mozalevskis, Antons | WHO Euro |
| Osmanov, Saladin | Abbott |
| Samuel, Clifford | Gilead Sciences |
| Shearer, Tina | CDA Foundation |
| Wang-Lu, Sean | Intech Diagnostics |
SPECIAL THANKS
CDA Foundation would like to extend a special thank you to the following organizations and people for their generous assistance in coordinating the logistics of the UHEP program:
Minister Shadmanov Alisher Kayumovich, Ministry of Health, Uzbekistan
First Deputy Minister Yusupaliyev Baxodir Kaxramonovich, Ministry of Health, Uzbekistan
Dr. Erkin Musabaev, Director, Uzbekistan Research Institute of Virology, Uzbekistan
Mr. Javlon Vakhabov, Ambassador, Embassy of Uzbekistan to the US
Mr. Akhror Burkhanov, Cultural Attaché, Embassy of Uzbekistan to the US
Mr. Eldor Mannopov, Managing Partner, Dentons
Ms. Anna Snejkova, Legal Counsel, Dentons
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