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.”
Ford N et al. Expanding access to treatment for hepatitis C in resource-limited settings: lessons from HIV/AIDS. Clin Infect Dis, online edition. DOI: 10.1093/cid/cis277, 2012.