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July 2014 Colleen Connell, Clinton Health Access Initiative

Implementing programs on diagnosis and treatment of hepatitis C in lower- and middle-income countries: What can we learn from the HIV experience?. July 2014 Colleen Connell, Clinton Health Access Initiative.

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July 2014 Colleen Connell, Clinton Health Access Initiative

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  1. Implementing programs on diagnosis and treatment of hepatitis C in lower- and middle-income countries: What can we learn from the HIV experience? July 2014 Colleen Connell, Clinton Health Access Initiative

  2. The opportunities and barriers faced by HCV are similar to those faced by HIV in early days of global response Current status Lack of HCV treatment programs in lower and middle-income countries is leading to high mortality, high costs to the public health system, and continued transmission Market shifts • Development of new HCV treatments that greatly increase chance of curing disease • Release of first WHO guidelines for HCV diagnosis and treatment • Push for greater global access to treatment by advocacy community Potential barriers • Prohibitive prices for necessary drugs and diagnostics • Perceived complexity of diagnostic algorithms and treatment regimens • Lack of country-level diagnostic and treatment guidelines and programs • Lack of infrastructure for treatment and diagnosis • Difficulties in case-finding due to perceived stigma of disease 2 Sources: WHO(1), UNITAID(1), TAG(1)

  3. However, there are important differences between HIV and HCV that must be considered when adapting HIV lessons HIV HCV implication Effect of drugs Drugs suppress virus Drugs cure patients Chronic disease management is not necessary for HCV Economic impact Affecting people in their prime, high direct economic loss Later stage mortality, less direct economic loss Strong evidence of potential impact in morbidity/mortality is needed to justify national programs Location of burden Over 80% in low/lower middle-income countries ~ 80% in middle-income countries Price reductions will be key as donor interest in middle-income markets may be limited Donor priority Donors open to large-scale treatment programs Donor support for large-scale programs unlikely Need to focus on highly cost-effective interventions from the beginning Lessons from HIV must be tailored to HCV – adapted rather than copied 3

  4. Seven key lessons from the HIV experience can guide future HCV program development and scale up Support operational technical assistance (TA) to accelerate guideline adoption, implementation and updating Ensure diagnostic programs and products develop in parallel with treatment Coordinate and align activities to leverage existing infrastructure Promote the rationaldeployment of diagnostic equipment Encourage the availability of a regulatory pathway for generic drugs and diagnostics Emphasize price reduction to drive greater access Build national, large-scale access programs early on 1 2 3 4 5 6 7

  5. Operational TA is key to adapting guidelines at the country level and ensuring that systems are in place to implement them • Normative guidelines from WHO were a key factor accelerating HIV treatment scale-up and impact • Operational barriers (particularly around planning, HR, and budgeting) often delayed the adoption, implementation, and updating of guidelines at the country level • Due to delays, impact of treatment innovations lagged in many countries • TA to MOHs was effective in mitigating operational barriers HIV: history and context Key lesson Support operational TA to accelerate guideline adoption, implementation, and updating 1 HCV: how to apply • Provide TA to adapt WHO guidelines to country context • Support program operational planning - including systems, HR, budgeting and training activities - to drive guidelines implementation • Establish process for rapidly updating local guidelines and programs (especially as new products come to market) Sources: NIH (1), WHO (1, 2), CHAI interviews, World Bank (1)

  6. Diagnostic programs require investment in systems strengthening and innovation • Guidance and TA for lab systems often lagged behind HIV treatment guidance • Delayed emphasis on laboratory system strengthening (e.g., training, QA/QC, and sample transport) was a bottleneck to treatment uptake • Similarly, innovation in diagnostic products (such as POC platforms) lagged treatment • Investment in diagnostic innovation is just now becoming a priority HIV: history and context Key lesson Ensure diagnostic programs and products develop in parallel with treatment 2 HCV: how to apply • Provide TA for lab system strengthening early on • Promote investment in diagnostic innovations (e.g., HCV antigen RDTs and DBS VL) as well as guidance where needed (e.g. target product profiles) in order to keep pace with advances in treatment Sources: NIH (1), Fearson (1), Chappel (1), CHAI interviews

  7. Strong coordination among partners can make programs more cost-effective and sustainable • International cooperation accelerated best practice sharing between countries • Eventual coordination of partner activitiesled to more efficient resource utilization (note coordination had to be learned over time) • Establishment of vertical HIV programs allowed for rapid scale-up of services, but these now must be integrated into the broader health system HIV: history and context Key lesson Coordinate and align activities to leverage existing infrastructure 3 HCV: how to apply • Share information between countries implementing HCV programs to encourage efficiency • Develop a global body similar to UNAIDS in the HCV space to lead partner activities • Integrate HCV programs into existing health systems where possible (carefully consider the downsides of siloing) Sources: Garrett (1), Howard (1), Berkman (1), Boyer (1), Rabkin (1), Ford (1)

  8. The efficient placement of diagnostic equipment can reduce program costs and improve effectiveness • Efficient placement of diagnostic equipment, particularly testing platforms, is a longstanding challenge for partners working in HIV • Equipment purchasing often preceded the establishment of national lab strategies in many countries • Lack of robust supply chain and maintenance schemes has led to significant equipment downtime and underutilization HIV: history and context Key lesson Promote the rationaldeployment of diagnostic equipment 4 HCV: how to apply • Survey existing infrastructure and identify potential synergies prior to purchasing/placing new diagnostic equipment • Define national strategic plans for diagnostic deployment and maintenance prior to program launch Sources: CHAI interviews, WHO(1), Olmsted(1), Parsons(1)

  9. Rapid regulatory pathways can accelerate the availability of necessary drugs and diagnostics • The WHO established prequalification in 2001, creating a validated pathway for generic ARVs to enter the market • A mechanism for non-US market ARVs to be approved by the FDA was established in 2004 for purchase by PEPFAR • For HIV diagnostics, an unclear regulatory pathway led to delays and duplication of efforts until a diagnostics PQ process was established in 2008 – note that even with PQ country registration a frequent bottleneck HIV: history and context Key lesson Encourage the availability of a regulatory pathway for generic drugs and diagnostics 5 HCV: how to apply • Establish a funded PQ process for fast and internationally accepted quality assurance of generic HCV treatments • Ensure that a clear venue for the rapid validation and regulatory approval of new diagnostic tools also exists in order to encourage investment and innovation Sources: Scielo (1), UNICEF (1), CHAI interviews

  10. Price reductions can catalyze patient access by removing price as a barrier • Community activists created pressure on ARV prices • ARV prices declined dramatically through a number of strategies: • New supplier entry and increased competition • Increased market transparency and pooled procurement • Cost-based negotiations based on reduced production costs HIV: history and context Key lesson Emphasize price reduction to drive greater access 6 HCV: how to apply • Encourage increased generic competition through greater transparency and reduced barriers to entry • Pursue cost-based negotiations, building on process chemistry and sourcing cost reductions • Use pooled procurement and other volume-based negotiation strategies Sources: CHAI interviews

  11. A focus on achieving large patient volumes early on can accelerate the development of access programs • A focus on national roll-outs built momentum and buy-in • Universal access, focusing on multiple entry points, accelerated uptake • Decentralized HIV care increased coverage and improved early access to care • Demand generation activities, such as community support in education and screening, were necessary to drive uptake HIV: history and context Key lesson Build national, large-scale access programs early on 7 HCV: how to apply • Prioritize establishing nation-wide programs with rapid scale-up • Provide access to HCV treatment through multiple, decentralized channels to accelerate uptake • Generate demand through community engagement to ensure that access programs reach scale Sources: Rueda (1), Howard (1), Berkman (1), Boyer (1) Ford (1)

  12. Practical operational research can support the application of HIV lessons to HCV • In order to maximize it’s contribution to increasing access in HCV, research should: • ..consider theoperational challenges that the roll out of new ideas will entail • ..build upon existing best practices • ..focus on regimen and dose optimization for the widest possible population to support volume optimization • ..take into account the minimum resources needed, rather than the optimal • ..concentrate on large operational programs as scale is often the limiting success factorin practice

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