Background
In 2016, WHO estimated that only 13% of persons diagnosed with HCV infection had initiated treatment (4). This chapter provides a summary of eight key good practice approaches to service delivery across the continuum of care to support implementation of the clinical recommendations for Treat All and use of pangenotypic regimens. These would help countries improve access to effective hepatitis services (Box 6.1).
Box 6.1Good practice principles for health service delivery
Comprehensive national planning for the elimination of HCV infection based on local epidemiological context, existing health-care infrastructure, current coverage of testing, treatment and prevention, and available financial or human resources
Simple and standardized algorithms across the continuum of care from testing, linkage to care and treatment
Strategies to strengthen linkage from testing to care, treatment and prevention
Integration of hepatitis testing, care and treatment with other services (e.g. HIV services) to increase the efficiency and reach of hepatitis services
Decentralized testing and treatment services at primary health facilities or harm reduction sites to promote access to care. This is facilitated by two approaches:
- 5a.
task-sharing, supported by training and mentoring of health-care workers and peer workers;
- 5b.
a differentiated care strategy to assess level-of-care needs, with specialist referral as appropriate for those with complex problems.
Community engagement and peer support to promote access to services and linkage to the continuum of care, which includes addressing stigma and discrimination
Strategies for more efficient procurement and supply management of quality-assured, affordable medicines and diagnostics
Data systems to monitor the quality of individual care and coverage at key steps along the continuum or cascade of care at the population level.
6.1. National planning for HCV elimination
In 2015, WHO published a manual to guide national programme managers in developing or strengthening national viral hepatitis plans (156). The manual is aligned with a health systems approach to disease planning and supports an evidence-based decision-making process. It includes a template for a national hepatitis plan that covers prevention, testing and treatment within the framework of universal health coverage principles and other planning tools. National stakeholders should also use the plan to agree on the service coverage targets for the interventions towards achievement of elimination.
6.2. Simple standardized algorithms
A simplified algorithm is given for testing, treatment and monitoring with five key steps that can be adapted for use at the national level (see summary algorithm in the Executive summary).
6.3. Strategies to strengthen linkage from testing to care
Multiple factors may hinder successful uptake of testing and linkage to care, treatment and prevention. These include patient-level factors (e.g. mental health issues, substance abuse, misinformation, depression, lack of social or family support, fear of disclosure and housing instability), as well as structural or economic factors (e.g. stigma and discrimination, high cost of care, distance from care sites, transportation costs and long waiting times at the facility) (157). Optimizing the impact of effective treatment and prevention will require interventions to both expand the uptake of testing and improve linkage to confirmatory viral load testing and uptake of treatment.
The 2017 WHO Guidelines on hepatitis B and C testing recommended that all facility- and community-based hepatitis testing services adopt and implement strategies to enhance uptake of testing and linkage to care (strong recommendation, moderate quality of evidence) (3). In particular, the following evidence-based interventions should be considered to promote uptake of hepatitis testing and linkage to care and treatment initiation (conditional recommendation):
trained peer and lay health worker support in community-based settings (moderate quality of evidence);
clinician reminders to prompt provider-initiated, facility-based HCV testing in settings that have electronic records or analogous reminder systems (very low quality of evidence);
provision of hepatitis testing as part of integrated services within a single facility, especially mental health/substance use (very low quality of evidence);
dried blood spot (DBS) specimens for NAT ± serology in some settings (low/ moderate quality of evidence).
Other approaches that may be considered to promote linkage include (8)
on-site single rapid diagnostic test (RDT) with same-day results;
reflex laboratory-based virological NAT of positive serology samples;
providing assistance with transport if the treatment centre is far from the testing site.
Specific policies can improve and monitor linkages between hepatitis testing and prevention, treatment and care services. Interventions that impact on multiple steps along the care continuum will generally be more resource efficient.
6.4. Integrated testing, care and treatment
The goal of programme collaboration is to create integrated delivery systems that can facilitate access to hepatitis testing, treatment and other health services. There are three types of potential service integration:
providing testing for HCV infection in different settings (e.g. in HIV/ART, TB, sexually transmitted infection [STI] or antenatal clinics);
integrating the diagnosis of hepatitis with diagnostic platforms and laboratory services used for other infections;
integrated service delivery of care, prevention and treatment (e.g. HCV care at harm reduction or HIV sites).
6.4.1. Providing testing for HCV infection in different settings
WHO already recommends integration of HIV testing into a range of other clinical services, such as services for TB, HIV/ART, maternal and child health, sexual and reproductive health (STI clinics), mental health and harm reduction programmes, migrant and refugee services, and in prisons (158). Integrating HCV and HIV testing will be particularly important in populations with high-risk behaviours for both infections, such as PWID, MSM and incarcerated persons who have a high prevalence of both HIV and HCV infection (159).
The primary purpose of integration is to make HBV, HCV and HIV testing more convenient for people coming to health facilities, and so expand the reach and uptake of viral hepatitis testing. For the HCV-infected person, integration of hepatitis testing into other health services may facilitate addressing other health needs at the same time, thereby saving time and money. For the health system, integration may reduce duplication of services and improve coordination (e.g. in stock management of diagnostic assays).
6.4.2. Integrating the diagnosis of hepatitis with diagnostic platforms and laboratory services used for other infections
Combination integrated multidisease serological tests
The use of combination integrated blood- or oral-based multidisease assays allow for integrated testing of HIV, HBV and HCV. Using a single specimen improves the efficiency of testing programmes, especially in populations with a high prevalence of HIV/HCV or HBV/HCV coinfection. While not yet fully validated, preliminary results of these combination assays appear promising (160).
Shared use of HIV or TB multidisease platforms for HCV viral load testing
The introduction of multidisease testing devices (also known as polyvalent testing platforms) brings new opportunities for collaboration and integration, and can both increase access as well as provide significant system efficiencies, with cost-savings. Countries with existing multidisease platforms for HIV viral load or TB testing or those that are planning for their introduction can consider collaboration and integration of HCV viral load testing (161). This includes both high-throughput laboratory-based instruments for HIV viral load measurement and point-of-care instruments such as GeneXpert for HIV and TB.
6.4.3. Integrated service delivery of care, prevention and treatment
Increased access and rapid scale up of HCV treatment and care will require a significant change in the way that services are delivered. Where possible, HCV services (testing and DAA treatment) can integrate the public health system. In many cases, this integration goes down to primary health-care facilities. It makes use of existing HIV and harm reduction services (OST and/or needle exchange programmes) or prison health services to increase access, especially for PWID. Existing WHO guidance on delivery of effective OST programmes is available (5). Continuity of prevention and care is needed to ensure ongoing harm reduction measures and avoid reinfection, especially among PWID and MSM. Integration of services means not only provision of related services at a single setting, but also linking reporting systems to share information between settings and providers.
6.5. Decentralized services
Decentralization of services refers to service delivery at peripheral health facilities, community-based venues and locations beyond hospital sites, bringing care nearer to patients’ homes. This may reduce transportation costs and waiting time experienced at central hospitals and, as a result, improve linkage to treatment and follow up. In high HIV-burden LMICs, the decentralization of HIV treatment services was a key factor in successful global scale up, improving uptake of both testing and treatment, and reducing loss to follow up (162, 163). In contrast, delivery of viral hepatitis testing and treatment has until recently generally relied on specialist-led centralized care models in hospital settings (164, 165). Decentralization of testing services will require access to quality-assured RDTs or collection and analysis of DBS specimens, good specimen referral networks, enhanced connectivity for return of results, and an electronic results system. Decentralized provision of care and treatment will be facilitated by use of a simplified algorithm (see summary algorithm in the Executive summary), access to pangenotypic regimens and a programme of staff training and supervision. There are now several examples of successful models of decentralized viral hepatitis testing and treatment services emerging in high-burden countries, including Mongolia and Egypt. Decentralization of services, however, may not always be appropriate for all settings, or acceptable to all clients, and the relative benefits should be assessed according to the context. Key requirements to deliver effective decentralized care are described below.
6.5.1. Task-sharing
Many countries affected by HCV infection face shortages of trained health workers and specialists in hepatitis management. Task-sharing is a pragmatic response to shortages of the health workforce to support decentralized care. It is strongly recommended by WHO in HIV care based on a comprehensive evidence base and has been widely adopted to expand access to HIV testing and treatment globally (91, 166). Effective task-sharing with non-specialists or nurses requires provision of appropriate training at the decentralized site, and access to additional support or referral to tertiary or specialist sites for more complex cases.
6.5.2. Differentiated HCV care and treatment
Currently, the majority of HCV care and treatment during this early phase of scale up is facility based, and not differentiated according to individual needs. Differentiated care is defined as a client-centred approach that simplifies and adapts services across the cascade, in ways that both serve the needs better of those with more complex problems requiring prompt or specialized clinical care but also relieves overburdened hepatitis clinics in central hospitals. Based on an evidence-based differentiated care framework recommended by WHO and widely adopted in HIV treatment and care programmes, a similar approach is proposed to support decentralized management of HCV infection.
Broadly, three groups of HCV-infected persons with specific needs can be identified. summarizes these three groups, their anticipated care needs, the most appropriate setting to deliver care and the type of provider needed. The majority of persons with HCV will have early-stage liver disease; they can be treated at facility level or potentially even in the community. Only a small proportion will require more intensive clinical or psychosocial support. However, this will vary considerably according to the epidemic profile of the country, and the maturity of the treatment response and diagnosis rate.
Potential differentiated care needs and approaches to viral hepatitis.
Persons clinically well and stable: this represents the majority of persons diagnosed, and includes those with no evidence of cirrhosis, serious comorbidities, mental health issues or active drug use; and the ability to comprehend issues of adherence and prevention messages.
Persons requiring more intensive clinical support: this includes persons presenting to care with advanced liver disease or serious comorbidities, previous treatment failure that requires either a more intensive or fast-tracked clinical and care package to manage life-threatening clinical problems and initiate treatment with more intensive monitoring.
Persons requiring more intensive psychosocial/mental health support, or intercultural or language support: this may include those with mental health issues, PWID, those with alcohol misuse, or adolescents requiring additional support and counselling. Migrant populations and Indigenous Peoples may also require more intensive intercultural or language support.
6.6. Community engagement and peer support, including addressing stigma and discrimination in the general population
Peer-led interventions have been effective in increasing access, care and treatment, and supporting adherence to treatment, for both hepatitis and other infectious diseases particularly for marginalized population groups such as PWID (3, 167). In addition to providing services, peers can act as role models and offer non-judgemental support that may contribute to reducing stigma and improving the acceptability of services.
6.7. Strategies for more efficient procurement and supply management of medicines and diagnostics
Access to DAAs for hepatitis C has improved since their initial registration in 2013 (). In 2017, 62% of those infected with HCV lived in countries where generic medicines could be procured. Countries that made use of this possibility and registered multiple medicines from different manufacturers managed to achieve a major reduction in prices (4). However, initial progress in access to DAAs has been mostly for the sofosbuvir/ledipasvir and sofosbuvir/daclatasvir combinations (). Of these, sofosbuvir/daclatasvir is a pangenotypic regimen. With respect to the other two pangenotypic regimens, the innovator company has announced an access programme for sofosbuvir/velpatasvir. No information is available for glecaprevir/pibrentasvir.
Characteristics of available pangenotypic and non-pangenotypic DAAs.
Key steps to increase the availability of DAA and diagnostics at country level include the following (4):
Determining whether generic medicines are available in the country: if DAAs are not protected by a patent or if the country is included in the respective license agreement, procurement of generic medicines from various sources is possible. Otherwise, the country needs to enter into price negotiations with the originator company or if this does not yield satisfactory results, use the flexibilities contained in the World Trade Organization (WTO) Agreement on Trade Related Intellectual Property Rights
(4).
Registration and inclusion in the national essential medicines list: DAAs need to be registered with the national regulatory authority and included in the national essential medicines list. If access to generic medicines is possible, registration of products from as many manufacturers as possible will increase competition and lower prices.
Quantification and forecasting of demand for commodities: to estimate the volume of products required to meet programme demand, managers need to estimate the size of the infected population in need of treatment and the expected rate of scale up for testing and treatment activities.
Procurement of commodities: procurement mechanisms can include (i) a competitive tendering process in case of registration of multiple manufacturers of generic medicines or (ii) price/volume negotiation with the originators if generic medicines cannot be procured. A pooled procurement mechanism (e.g. Strategic Fund of the Pan American Health Organization) is another option for economies of scale in procurement of commodities, including diagnostics.
WHO tools are also available to estimate the cost–effectiveness of HCV treatment in individual countries (http://tool.hepccalculator.org/) and to procure diagnostics. (http://www.who.int/diagnostics_laboratory/publications/procurement/en/).
6.8. Data systems for monitoring the quality and cascade of care
WHO has developed a monitoring and evaluation framework to enable Member States to report on hepatitis elimination (73). Three indicators address the cascade of care, including the proportion of infected persons diagnosed (core indicator C6b), treatment initiation rate (core indicator C7b) and the proportion of those treated who are cured (C8b). In an initial assessment phase, triangulation of data from different sources may be used to generate an initial estimate of the three core indicators of the cascade of care. In the longer term, estimating the indicators of the cascade of care requires a database of HCV-infected persons based on simple individuals’ records. Such databases can be integrated with those used to monitor HIV and/or TB treatment as appropriate.
