Scaling up access to treatment for people infected with HCV in low- and middle-income countries requires careful consideration of resource availability in individual settings. A high-income model of specialist care with a high physician-to-patient ratio and availability of advanced laboratory monitoring is not feasible in many countries and therefore service delivery plans need to be adapted accordingly. A public health care-based approach to improve access to health care for people infected with TB and HIV has been promoted by WHO and has resulted in improved health care in many resource-limited settings.219 The roll-out of screening, care and treatment for HCV in low- and middle-income countries will require an assessment of many of the same issues already addressed by TB and HIV treatment programmes, and similar approaches are likely to be effective.
10.1. Service planning
Service planning requires an estimation of the local burden of disease, and an assessment of the availability of resources and infrastructure for rolling out treatment. National programmes are required to plan screening and treatment strategies. At present, many countries have poor documentation of the prevalence of infection; this is particularly the case in low-income countries. The Global policy report on the prevention and control of viral hepatitis, 2013 provides country-specific information on policies and structures already in place to combat viral hepatitis.107 Building on these policies and structures will be necessary to increase the availability of treatment for those infected. Estimates of how many people are likely to be affected may be made by assessing populations at high risk as well as previously documented prevalence and incidence rates. Regular sentinel screening of targeted populations using serology and NAT is therefore required to facilitate service planning and is the first step in increasing access to care and treatment for HCV. Improvements in molecular tools for rapid screening, including dried blood spot and oral fluid testing, as well as polyvalent PCR platforms, would increase the numbers of infected patients identified. They would also allow the expansion of screening services into the field as well as among difficult-to-access populations such as PWID. Integration of HCV screening with HIV, HBV and TB screening services may be suitable in many settings as the routes of transmission are common.
A central barrier to treatment roll-out is cost – this includes the cost of medicines, taxes, import charges, appropriate medical facilities and staff, as well as diagnostic and monitoring facilities. Negotiation on drug costs is required and prioritization of particular groups, for example, patients with advanced liver disease (≥F2 disease or, in more constrained settings, F4) may be required. Integration of services, for example, diagnostic and treatment facilities, may help to minimize costs and is likely to facilitate treatment delivery. Task-shifting is the process of sharing clinical management responsibilities with trained personnel such as nurses, clinical officers and pharmacists. Such personnel should have access to consultations with specialized team members as necessary and are likely to require training in order to facilitate adequate health-care delivery. Sourcing of medication and negotiation on pricing at a central level (using pooled procurement) may also minimize costs. Patent coverage and the availability of prequalified biosimilar agents or generic formulations is another central consideration – this is likely to be of key importance as new DAAs are licensed.
Clinical and laboratory facilities for screening and monitoring patients on treatment are an essential component of health-care provision. The development and implementation of simpler methods to assess HCV viral load and genotype as well as for the tests needed to monitor drug toxicity are important to increase accessibility of treatment in less well-resourced settings. Point-of-care HCV viral load testing may be required in some settings in order to facilitate appropriate treatment. Pharmacy facilities and drug storage space, including refrigeration space for IFN, should be included in the planning of new treatment centres. Sourcing and distribution planning is also required. The registration of new drugs in individual Member States may be time consuming and will require adequate planning.
10.2. Service delivery
The key programmatic components of service delivery are adequate clinic infrastructure, laboratory and diagnostic services, reliable drug supply, human resources (doctors, nurses, trained persons to provide psychological support), a referral system, monitoring and evaluation, and civil society participation. Improving access to treatment requires the identification of infected patients. Implementation of screening for HCV therefore needs to be prioritized and targeted screening of high-risk populations carried out. Subsequently, persons with HCV infection require access to medical facilities for treatment, with ongoing follow up and monitoring for toxicity and efficacy. Integration with pre-existing services such as those already established for HIV would be of added value.
Service delivery may be achieved more readily by providing standardized, simplified treatment regimens at a population level. Decentralized service delivery has already enabled the treatment of large numbers of people infected with HIV. Service delivery should make use of simplified operational guidelines, training materials and approaches to clinical decision-making, as well as limited formularies. An initial clinical assessment is essential prior to commencing therapy in order to assess the presence of pre-morbid conditions that may rule out or delay treatment such as severe intercurrent illnesses, for example, TB, decompensated cirrhosis or pregnancy. A psychological assessment at this time and evaluation of potential drug–drug interactions are also essential. Disease education, patient preparation for side-effects while on treatment, support and appropriate informed pre- and post-test counselling are required. Access to appropriate diagnostic facilities for toxicity and efficacy monitoring is of critical importance and could be facilitated by utilizing the same or similar platforms currently being rolled out for HIV.4
For treatment, standardized regimens should be used in combination with simplified clinical decision-making tools and standardized monitoring. Minimum packages for care and treatment require to be formulated locally, and treatment and monitoring algorithms (including algorithms for the use of first- and second-generation DAAs) developed. Such algorithms should include information on when to start therapy, when to stop, follow up, side-effects and management flow sheets. Management of drug–drug interactions is important, particularly in those infected with HIV. For example, drugs such as AZT, ddI and d4T used widely in low-income settings are not recommended in persons treated with IFN and RBV. Monitoring and evaluation of centres treating persons for HCV is an essential component of appropriate management. Implementation of standard registers for tracking progress such as those developed for use in TB treatment programmes will allow monitoring and evaluation of progress after roll-out of treatment for HCV. Increased supervision of sites is likely to be important during the early stages of treatment roll-out. Other guidance on the delivery of treatment for HCV to people in low- and middle-income countries has been developed by Médecins Sans Frontières.166
10.3. Future considerations
The treatment landscape for HCV is in a phase of rapid transformation, and adaptations will be required as soon as new drugs are approved. Curative treatments that are more efficacious and less toxic than ever before have the potential to dramatically reduce the health and economic burdens associated with HCV infection around the world. The opportunity to address the massive HCV pandemic is now within reach and a global movement is needed to create generalized access to HCV treatment in high-, middle- and low-income countries. This will require political will, financial investment, and support from pharmaceutical, medical and civil society organizations around the world.
10.4. Dissemination, monitoring and implementation of the Guidelines for the screening, care and treatment of persons with hepatitis C infection
The guidelines will be launched at the annual meeting of the European Society for the Study of the Liver (April 2014). The Secretariat will identify other international conference venues to present the recommendations. The Secretariat staff will work with the hepatitis points of contact in the WHO regional offices to ensure dissemination to WHO country offices and Ministries of Health as well as key international, regional and national collaborating centres (e.g. civil society, foundations, donors), and national programmes. In addition, the guidelines will be accessible on the WHO website with links to other UN/related websites.
The successful implementation of the recommendations in these guidelines will depend on a well-planned and appropriate process of adaptation and integration into relevant regional and national strategies. It is a process that will be determined by available resources, existing enabling policies and practices, and levels of support from partner agencies and organizations.
Implementation of these guidelines can be measured by the number of countries that have incorporated them in their national treatment guidelines. This will be monitored through the biannual survey that forms the basis for the WHO Global policy report on the prevention and control of viral hepatitis. Ideally, the impact of the guidelines would be measured by monitoring the number of persons treated for HCV and the number cured. Currently, no monitoring system exists that can collect this information on a national level.
