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
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
• Development of new HCV treatments that greatly increase chance of
curing disease
Market shifts
• Release of first WHO guidelines for HCV diagnosis and treatment
• Push for greater global access to treatment by advocacy community
• Prohibitive prices for necessary drugs and diagnostics
• Perceived complexity of diagnostic algorithms and treatment regimens
Potential
barriers
• 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)
However, there are important differences between HIV and
HCV that must be considered when adapting HIV lessons
Effect of
drugs
Economic
impact
Location of
burden
Donor
priority
HIV
HCV
IMPLICATION
Drugs suppress
virus
Drugs cure
patients
Chronic disease management is
not necessary for HCV
Affecting people
in their prime,
high direct
economic loss
Over 80% in
low/lower
middle-income
countries
Donors open to
large-scale
treatment
programs
Later stage
mortality, less
direct economic
loss
Strong evidence of potential
impact in morbidity/mortality is
needed to justify national
programs
~ 80% in middleincome
countries
Price reductions will be key as
donor interest in middle-income
markets may be limited
Donor support for
large-scale
programs
unlikely
Need to focus on highly costeffective interventions from the
beginning
Lessons from HIV must be tailored to HCV – adapted
rather than copied
3
Seven key lessons from the HIV experience can guide future
HCV program development and scale up
1
Support operational technical assistance (TA) to accelerate guideline adoption,
implementation and updating
2
Ensure diagnostic programs and products develop in parallel with treatment
3
Coordinate and align activities to leverage existing infrastructure
4
Promote the rational deployment of diagnostic equipment
5
Encourage the availability of a regulatory pathway for generic drugs and
diagnostics
6
Emphasize price reduction to drive greater access
7
Build national, large-scale access programs early on
4
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
HIV: history
and context
• 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
Key lesson
1
Support operational TA to accelerate guideline adoption,
implementation, and updating
• Provide TA to adapt WHO guidelines to country context
HCV: how to
apply
• 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)
5
Diagnostic programs require investment in systems
strengthening and innovation
• Guidance and TA for lab systems often lagged behind HIV treatment
guidance
HIV: history
and context
• 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
Key lesson
2
Ensure diagnostic programs and products develop in parallel with
treatment
• Provide TA for lab system strengthening early on
HCV: how to
apply
• 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
6
Sources: NIH (1), Fearson (1), Chappel (1), CHAI interviews
Strong coordination among partners can make programs more
cost-effective and sustainable
• International cooperation accelerated best practice sharing between
countries
HIV: history
and context
Key lesson
• Eventual coordination of partner activities led 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
3
Coordinate and align activities to leverage existing infrastructure
• Share information between countries implementing HCV programs to
encourage efficiency
HCV: how to
apply
• 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)
7
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
HIV: history
and context
Key lesson
• 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
4
Promote the rational deployment of diagnostic equipment
• Survey existing infrastructure and identify potential synergies prior to
purchasing/placing new diagnostic equipment
HCV: how to
apply
• Define national strategic plans for diagnostic deployment and
maintenance prior to program launch
8
Sources: CHAI interviews, WHO(1), Olmsted(1), Parsons(1)
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
HIV: history
and context
Key lesson
HCV: how to
apply
• 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
5
Encourage the availability of a regulatory pathway for generic drugs
and diagnostics
• 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
9
Sources: Scielo (1), UNICEF (1), CHAI interviews
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
HIV: history
and context
• Increased market transparency and pooled procurement
• Cost-based negotiations based on reduced production costs
Key lesson
6
Emphasize price reduction to drive greater access
• Encourage increased generic competition through greater transparency
and reduced barriers to entry
HCV: how to
apply
• Pursue cost-based negotiations, building on process chemistry and
sourcing cost reductions
• Use pooled procurement and other volume-based negotiation strategies
10
Sources: CHAI interviews
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
HIV: history
and context
• 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
Key lesson
7
Build national, large-scale access programs early on
• Prioritize establishing nation-wide programs with rapid scale-up
HCV: how to
apply
• 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)
11
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 the operational 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
factor in practice
12