The Big Tent

CTSI 2016 NIH Renewal Proposal Launchpad

The Global HCV Treatment Revolution: A Response Model for Future Challenges and Opportunities

Scale and significance of the problem

New pathogens and developments in diagnostics and therapeutics are transforming healthcare.  Comprehensive planning for paradigm-changing advances, when possible, can mobilize the full range of expertise available in a complex institution like UCSF and in our community partners. Systematic planning can identify new research opportunities, reduce institutional costs and improve patient care.

One healthcare challenge that can serve as exemplary for other implementation opportunities is the treatment of hepatitis C virus (HCV) infection. HCV is a large epidemic-more than 200 million cases worldwide- causing substantial morbidity and mortality. Current treatments have serious limitations but new drug development has been remarkable with soon-to-be-approved drugs achieving close to 100% cure rates after only 12 weeks of use with low toxicity. These drugs will cause an explosive increase in treatment volume over the next 1-2 years despite a high cost (est. $70,000).

Lessons learned in this demonstration project will apply to pending breakthroughs including the discovery of effective drugs to prevent or treat Alzheimer’s disease and the identification of genetic causes of common diseases with resulting targeted interventions.

Current approaches (nationally)

No comprehensive model of HCV treatment exists and no other attempts have been presented that approach this proposal in establishing a comparison for implementing efficient systems for other diseases and new challenges. HCV care is currently fragmented, delivered by hepatologists, infectious disease specialists of general internists with limited collaboration or involvement by teams as proposed here.

Proposed approach and why it is innovative

We will design optimized systems of care and research organization to monitor, evaluate and adjust the screening of patient populations, to stage underlying liver disease and to initiate therapy when indicated. As each of the three primary UCSF-related medical centers; Parnassus, San Francisco General Hospital and the VA Medical Center have large but demographically distinctive patient populations and payment systems, comparing experience through data sharing will enrich the development of the HCV response model and increase its generalizability. Linking the information collected across UCSF with data from the network of the five University of California medical centers through the UC BRAID system of CTSI with 12 million covered lives will further strengthen the lessons learned from this project, representing an innovative use of “big data” in healthcare.

The HCV model project will be dynamic. As drugs are approved and as demand for care increases, the team will monitor data from each medical center to compare population screening rates and success in each step of the treatment “cascade” familiar from the HIV experience.

The project will be innovative and outward looking in working from the start with community members and with experts at UCSF expert in engaging the very different communities most affected by the HCV epidemic.

The HCV project will continually attend to how the systems found effective might be similarly deployed against other health care imperatives, particularly as the entire structure of American healthcare adjusts to the rollout of the Affordable Care Act.

Potential partners

The project will build from an existing cross-campus planning group of clinicians, basic scientists and epidemiologists, adding information technology to created data linkages across the three UCSF medical centers and with UC BRAID and economists and pharmacists to model cost and policy implications. Community members and community engagement experts will increase project impact and broad participation. Implementation scientists will develop models which can inform other healthcare challenges an d global health experts will consider applications in resource-limited settings.

Projected impact (estimate resources needed)

HCV infects 200 million worldwide. Designing a coordinated and effective response to new curative treatments would have an immediate benefit to those affected, decrease further transmission and provide a crucial model for other emerging healthcare priorities.


Supporting Documents: 


Addressing the treatment of HCV in the era of upcoming newer and more effective but costly agents has a significant public health impact. A multidisciplinary approach proposed to address this issue and its impact not only  locally but also globally is of outmost importance and is certain to lead to further research and education opportunities. This is a very important and timely proposal.

The proposed project is very timely because, as a new era of treatment dawns and screening identifies more infected individuals, we have the opportunity to create large prospective treatment cohorts.  Such cohorts are needed to provide sufficient data on the earliest immunologic events needed for treatment-mediated clearance.  Knowledge gained from such data may in turn stimulate progress toward a prophylactic vaccine.

Very exciting.  The big issue here though is how to turn this on its head, describing it more as a model for integrating research at various levels (including implementation science) with policy and care to measurably improve health.  The model will be tested with HCV.... (something like that is more likely to be aligned with a CTSA submission - since the CTSA award is supposed to enable infrastructure, not directly fund the response to any specific disease)

I was just reading about a CTSA project - HCV Target 

Are there any synergies or intersections that can be leveraged or built upon here?



Summarize the problem being addressed. Please make sure this is NOT disease-specific.

  • Emerging healthcare imperatives demand a coordinated, effective response; and new tools may offset the challenge of resource constraints
  • HCV provides a model of large disease burden and demographically variable epidemiology and natural history; where dramatic treatment advances will cause predictable explosive increase in service demand 


Summarize the solution being proposed.  Please make sure this is NOT disease-specific, although you can provide examples of specific test cases

  • Design a multisite and multidisciplinary team to address new demands using new HCV treatment advances as a model
  • Enhance scalability by data integration across sites with differing demographics (Parnassus, SFGH, VA), and Statewide through BRAID
  • Define implementation strategies though upfront inclusion of healthcare economics and community engagement


What partners are involved in the solution?

  • Existing planning group of clinician investigators, basic scientists and epidemiologists
  • Informatics (data sharing) and economists and pharmacists (payment strategies for expensive but curative new treatment regimens)
  • Implementation scientists, medical center, community engagement specialists (model adjustments, scalability), global health scientists


What is the potential impact?

  • HCV infects 200 million worldwide. Designing a coordinated and effective response to new curative treatments would have an immediate benefit to those affected, decrease further transmission and provide a crucial model for other emerging healthcare priorities
  • Success would further UCSF reputation in innovating comprehensive responses to most important emerging challenges locally, Statewide and abroad

Submitted on behalf of the retreat discussion team.

History: UCSF has history of epidemics and associated UCSF, e.g. HIV.  HCV treatment effective, toxic, curable and many new drugs now being produced/marketed. New therapies are coming that are less toxic, more effective. Need to bring together a “big tent” of people, including global health practitioners and policy makers, economists, health care practitioners. Identify community engagement.  If starting point is UCSF focus, then need to optimize the use of IT to identify patients in the UCSF system (UCSF, VA, SFGH) and statewide. Potential for immediate response to the release of these new, very expensive ($70K/yr) drugs. Currently is a very siloed therapy in the UCSF system (GI, ID). Goal of this proposal would be a national model for other emerging health care crises, over and above HCV. Adaptability to multiple emerging disease states would increase fundability of proposal.

Experience with HIV, both past successes and failures, including access to health care, expense, patient adherence. Community engagement key toward success of the proposal.

  1. How to maximize impact?

Proactive designed approach with a feasible economic model. Ideally engage with other countries with significant numbers of infected patients, i.e. not the U.S. (versus working within the UCSF system). Early interaction with policy makers, CMS, politicians all will maximize impact.

    2. What UCSF infrastructure already exists?

Heath economists (IHP), clinicians, CAPS, Kaiser, community engagement with CTSI, IT sharing agreements exist, implementation science. Good connections with pharma and biotech exist, but need strengthen.

    3. What creative/innovative partnerships?

Increased strengthening of relationships with pharma, increased community engagement (including infected patients in these early stages) with DPH, others. UC systemwide (UC BRAID) could potentially be a partner.  An early partnership with MediCal is needed to determine State of Calif accessibility, funding of new agents. Important to collaborate with employers, e.g.the Safeway model for its employees. ACOs important partnership as well….who pays for these agents?

Everyone agrees that this is an important infection and that emerging DAA treatments present a rare opportunity to develop/test new models for health care delivery.  A great start!  Leslie points to a well-established project (HCV-Target) and Maininder points out that the CTSA is intended to enable infrastructure rather than respond to a specific disease.  With each point in mind, it seems that focusing on modernizing models of health care delivery, using HCV as an example, could be an appropriate framework.  HCV-Target appears to focus on benefits and risks specific to HCV treatment, not models of care, so it would not overlap.  Moreover, there is potential to ask how new models could help health care delivery as well as health outcomes research (like HCV Target).  Perhaps new health care delivery models that (1) focus on responding to challenges through technology-based infrastructure, (2) are developed/tested by multidisciplinary teams, and (3) result in open-source programs that would benefit groups worldwide are worth considering.  I have not read the "Big Tent" technology posts, but maybe there are opportunities for overlap and/or synergy.

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