By Sonjelle Shilton, Deputy Head of HCV Access at FIND
Though little talked about, hepatitis C is one of the world’s most common infectious diseases. More than 70 million people worldwide are estimated to be living with chronic hepatitis C, and every year, close to 400,000 people die from it.
Hepatitis C virus (HCV) is also a common co-infection for people living with HIV (of the 38 million people living with HIV worldwide, 2.3 million are also living with HCV) and is a major cause of liver cancer. Hepatitis C is a preventable disease and, since 2013, highly effective treatment for it has been available in the form of direct-acting antivirals (DAAs), which have a more than 90% cure rate and few side-effects.
So why are so many people still dying from HCV? The answer is tragically simple: most people living with HCV – four out of five – go undiagnosed and therefore untreated. Approximately 80% of new HCV infections are asymptomatic, which means that people usually have no obvious trigger to seek a test. Compounding the problem is that the tests available for HCV have historically been expensive and complex to carry out. This makes them unworkable in point-of-care settings, especially in low- and middle-income countries (LMICs), where the vast majority of people living with HCV reside and where rates of diagnosis and treatment are particularly low.
People who inject drugs – who make up 23% of the global total of people living with HCV and 33% of global mortality from HCV – are especially hard to reach because drug use is criminalized in many countries, which often excludes people who inject drugs from national responses to HCV. This means that many people living with HCV go untested and untreated, and unknowingly continue to infect others (HCV is blood borne, transmitted through unsafe healthcare practices or shared needles during injection drug use).
Though several rapid diagnostic tests (RDTs) have recently become available for HCV serological screening, proper testing for HCV also involves – for those who initially test antibody positive – a second, laboratory-based test to confirm viraemic infection. At the moment, the second test, aviral ribonucleic acid (RNA) test, still requires laboratory expertise and equipment, which in LMICs is often scarce, costly and geographically centralized.
If more people were tested for HCV, more people would be treated, reducing the spread of infection, and hundreds of thousands of lives could be saved and cancers avoided every year. It is therefore critical that we decentralize and integrate HCV screening using RDTs at primary healthcare sites as part of the standard of care.
One of the challenges for managing HCV and HIV co-infections is the typically siloed approach to disease management that still prevails in many LMICs. One consequence of this is that HCV infection can be easily missed in people living with HIV. If HCV and HIV services were better integrated (just as TB services have been integrated into HIV services in many settings in the past five or so years), recipients of care would have the opportunity to test for both in one place at one time. This would better identify instances of co-infection, minimize the recipient of care’s time and cost burdens in accessing care, and optimize treatment for both conditions. Additionally, it would improve convenience, compliance and treatment outcomes for those affected.
Hepatitis C Elimination through Access to Diagnostics (HEAD-Start) is a project that aims to do just that: overcome the major obstacles to scaled-up HCV testing by improving the options for HCV diagnosis and making testing more easily available for patients by demonstrating the integration of HCV testing into HIV programmes. HEAD-Start is running demonstration projects in four countries: Georgia, India, Malaysia and Myanmar.
In India, the Punjab state hepatitis programme has been a trailblazer for the delivery of HCV treatment among the general population, having put almost 82,000 people on treatment since its launch in 2015. The Punjab government teamed up with the Foundation for Innovative New Diagnostics (FIND) to ensure that the state programme could reach other key populations, such as people living with HIV, through the HEAD-Start Punjab programme. HEAD-Start Punjab integrated HCV services into existing HIV care pathways. In Punjab, HCV treatment for people living with HCV and with HIV is now available through anti-retroviral treatment (ART) centres, and RNA (second-step to confirm active HCV infection) diagnostic facilities have been decentralized to four Integrated Disease Surveillance Programme laboratories at local hospitals. The HEAD-Start Punjab project has tested more than 80% of those attending ART centres for HCV.
Using a “hub-and-spoke” model, this is the first state programme in India that is systematically reaching people living with HIV in its HCV response, and its success could provide a roadmap for other states. HCV counselling and screening is integrated into ART and opioid substitution treatment centres, and is offered to each person who comes to a clinic. If someone screens positive for HCV, blood is taken immediately for the RNA test. This has resulted in 98% of all those who screened positive having the RNA test done. This is an extraordinarily high linkage success rate, made possible by the screening and blood draw taking place in the same visit, drastically simplifying the process for each client. When a client returns to the clinic for their next appointment, their RNA test results are waiting; if those are positive, the client continues with the next steps to obtain treatment.
The Punjab government is committed to sustaining and expanding the HEAD-Start HCV model in the state which could help inform other programmes nationally, and has catalysed consultation between India’s National Viral Hepatitis and National AIDS programmes.
In the presence of COVID-19, HEAD-Start might also provide lessons for the potential integration of testing and streamlining of services for multiple conditions, so that clients’ contact with healthcare services is minimized, reducing their risk of infection with the coronavirus.
The need for easier and scaled-up HCV testing is driven by the moral imperative to save lives and prevent illness among millions of people. If we are to prevent hundreds of thousands of additional deaths – and meet the WHO target for the elimination of viral hepatitis as a public health threat by 2030 – the number of people with HCV who know their status must move from 20% to 90%. Expanding access to HCV testing is non-negotiable.
HEAD-Start is a project funded by Unitaid.