The rollout of antiretroviral therapy in
resource-limited settings provides a model for efforts to increase access to
hepatitis C treatment and care in similar settings, investigators argue in the
online edition of Clinical Infectious
Diseases.
“Expanding access to hepatitis treatment in
resource-limited settings will require a dedicated effort to overcome practical
and political challenges,” comment the authors. “Perhaps the most important
lesson from the scaling up of ART [antiretroviral therapy] during the last decade
is that this will not happen without clear political commitment, and the
engagement of civil society to hold policy makers and drug manufacturers to
account.”
Globally, an estimated 170 million
individuals are infected with hepatitis C and 350,000 deaths annually are due
to hepatitis C-related liver disease.
Access to hepatitis C treatment and care in
sub-Saharan Africa, India and many other resource-limited settings is extremely
limited.
Challenges to increased access to hepatitis
C therapy include its costs, the perceived complexity of therapy, its side-effects
and the long duration of treatment. All of these were cited as obstacles to the
rollout of HIV therapy.
An international team of investigators identified
eight areas where the experience of scaling up access to antiretroviral therapy
can provide important lessons and models for improving access to treatment and
care for individuals with hepatitis C infection.
The
cost of treatment
Until mid-2000, antiretroviral therapy cost
US$10,000 per patient per year. However, lobbying from civil society, people
with HIV and some governments helped drive down the cost of treatment. In 2001
a manufacturer of generic medications announced that it could provide triple
antiretroviral therapy costing US$1 as day. The annual cost of HIV therapy in
resource-limited countries is now as little as US$60.
Hepatitis C therapy is currently expensive.
Generic forms of ribavirin are available in some low- and middle-income
countries. Nevertheless a 48-week course of therapy with pegylated interferon
and ribavirin still costs between US$12,000 and US$18,500.
Alternative sources of pegylated interferon
have been developed which could help lower the cost of therapy. In Egypt a
biosimilar of pegylated interferon has been produced meaning that a 48-week
course of therapy with pegylated interferon and ribavirin costs US$2000.
“Although comparative safety and efficacy
data are limited for pegylated interferon products, this nevertheless
demonstrates that substantial price reductions are possible,” write the
authors.
They add that the WHO prequalification
scheme played a crucial role in the availability of affordable antiretrovirals,
assuring the quality of generic products. “Quality assurance of antivirals for
HCV would give confidence to donors, patients and implementing organizations
and would allow developing countries to fast-track registration of generic or
biosimilar sources if antivirals for HCV.”
A number of new drugs which work directly
against hepatitis C have been approved or are in development and
interferon-free therapy for hepatitis C is a realistic future prospect. The
investigators believe that “concerted public and political mobilization to
pressure originator companies to reduce prices and stimulate generic
completion” will be needed to make these new drugs affordable for poorer
countries.
Simplifying
the model of care
HIV care in developed countries is highly
specialised, with treatment decisions guided by a battery of tests. Studies conducted
in resource-limited settings suggest that the monitoring of patients can be
achieved with a much simpler model of care.
In the context of hepatitis C this
simplified care could, for instance, include the use of blood tests rather than
biopsies to monitor liver fibrosis.
The investigators believe that “recommendations
for HCV management will need to strike a balance between what can be done today
and what should be done tomorrow.”
Task
shifting
Specialist HIV doctors provide most HIV
care in richer countries. In resource-limited settings many of these tasks have
been shifted to nurse-lead teams who provide care in community settings. A
similar model could help increase access to hepatitis C care.
Service
integration
HIV care has been integrated into wider
health systems. These include primary care, antenatal clinics, tuberculosis
programmes and clinics diagnosing and treating sexually transmitted infections.
Access to hepatitis C treatment and care
could be expanded by following a similar model.
Surveillance,
evaluation and research
Improvements in HIV disease surveillance
have helped inform the provision of therapy and helped identify new research
priorities. In contrast, the investigators argue that there is a “dearth” of
reliable hepatitis C epidemiological data. “This is particularly important
because the development of appropriate treatment strategies will require
accurate information regarding genotype prevalence in different countries.”
Patient
and community engagement
Lack of patient knowledge and stigma were
barriers to the scale-up of HIV treatment programmes.
This is also the case for hepatitis C,
which is a highly stigmatised disease. Many individuals are not aware of their
infection or lack information about the benefits of diagnosis and treatment.
Lessons can also be learnt from HIV
regarding the provision of patient information about adherence and the
management of side-effects.
The activism of patients with HIV helped
secure reductions in the price of therapies, increased funding, and the
acceleration of research and drug development. The authors note that “similar
activism is beginning to take shape for HCV and will be critical for making
treatment more widely available.”
Addressing
the needs of vulnerable groups
From the outset, antiretroviral treatment
programmes included a specific focus on vulnerable and marginalised groups. A
similar priority is needed for hepatitis C.
Financial
and political commitment
The dramatic reduction in the cost of HIV
therapy came largely because of political pressure. The provision of therapy to
over 6 million patients has been made possible by funding from several Western
governments, and major initiatives such as the Global Fund and PEPFAR.
The investigators argue that dedicated
funding “will be required to support expansion of access to diagnostics and
treatment” for hepatitis C.
They also emphasise the importance of
political commitment to act, especially given the stigmastised nature of the
hepatitis C epidemic and the marginalised populations it affects.
“Political commitment from national
governments in countries most affected by HIV/AIDS has been an essential driver
of the global response to HIV and will be critical in enabling the provision of
HCV treatment and care in institutions under the management of correctional
services.”