HEPATITIS C, PUBLIC HEALTH and POLITICS
by Poul Birch Eriksen
Table of contents
- The Unseen Epidemic: events behind the HCV crisis.
- P for Public Health: Protection – Prevention – Promotion – Prognosis – Provision
- The Unknowingly Infected
- Challenges around treatment
Hepatitis C (HCV) is a crisis that has crept up on us in slow motion. Doctors have known about HCV – or, as it was long known, non-A non-B hepatitis – for years, but it was believed to be less problematic than its better known viral cousins, hepatitis A and hepatitis B. Besides, there were other, more formidable, infectious disease challenges that came along, like AIDS, that pre-occupied public health officials and politicians. But quietly, over time, scientific knowledge of hepatitis C grew and, along with it, the sobering realization that it is one of the world’s biggest killers, claiming as many lives as hepatitis B, and even more than malaria.
But, unlike other forms of viral hepatitis, there are effective treatments for HCV, and that means many of the estimated 700,000 deaths the disease claims annually are preventable – at least in theory. These treatments come at a high price and good data are lacking on how many are truly infected on a global scale, and who would benefit most from treatment.
Medicine, however, is only part of the story. HCV is a political and public health challenge on a global scale and, to come to grips with it, we must address many questions:
- How HCV has become a public health crisis.
- What is the best public health response to the epidemic?
- Who should be screened, and how?
- The challenges around treatment beyond cost.
This section will focus on these issues and more, providing fodder for inquisitive journalists.
The role of public health is to protect and improve the health of the population, not just individuals. Prevention and health promotion initiatives help routine challenges, such as the spread of infectious diseases, from developing into crises. However, public health officials rarely have the final say on priority-setting, adoption of specific strategies, or how much money will be allocated to the response. That belongs to politicians, and they may accept, ignore, or even go against expert advice, for a host of economic or political reasons.
How to respond to hepatitis C proved to be a major challenge for public health experts and policy-makers. At first, they had little solid information to guide their response. While scientists had known since the mid-70s that there was a variant of hepatitis that was neither A nor B, they could not pinpoint it. There was no test to detect it and no vaccine to prevent it. They also assumed, quite reasonably that the virus was not that big of a deal because few people fell acutely ill. They would realize only later that the virus gnawed away slowly at the liver and caused grave conditions like liver cancer and cirrhosis decades later.
HCV was finally given a proper name in 1989, when the virus was discovered. Soon after, an antibody test was developed to screen blood for the virus, and public health officials and regulators began the process of creating blood screening strategies. It was believed that this would help contain the spread of the virus. However, at the time, whether this was necessary was a matter of debate. HCV was seen as a small-scale problem, causing only minor manifestations in relatively few patients, many of whom were believed to clear the infection after the initial symptoms. No one knew HCV caused chronic infections or that carriers of the virus were able to infect others even when they had no obvious signs of illness.
As the global impact of HCV has become apparent, the World Health Assembly – WHO’s governing body – has adopted a number of resolutions. In 2011, July 28 was officially recognized as World Hepatitis Day – to create awareness, strengthen prevention and coordinate a global response. A Global Hepatitis Program has also been set up within the WHO to set standards and issue guidelines to help countries formulate specific hepatitis policies for prevention and treatment.
Hepatitis C had little profile as a public health issue because was it was thought to be a problem mainly confined to intravenous drug users.
As screening increased, it was discovered that out of the approximately 150 million individuals living with chronic hepatitis C only some 10 million got it through injection drug use. The vast majority contracted the virus via contact with the health system, through blood transfusions, unsafe injections and other health care exposures with poor infection control practices.
Another factor contributing to the crisis might possibly be doctors themselves.
The role of public health
Public Health tools for handling HCV could include:
- Surveillance and patient screening: monitoring national prevalence (number of total cases) and incidence (number of new cases in a given period of time) of the virus, identifying asymptomatic chronic carriers, following these patients to determine when to provide treatment and making sure they adhere to the prescribed regimen
- Education: disseminating information to the public and health professionals about the disease, risk factors, how to avoid infection, etc. on a regular basis and with a special effort on national and community level to mark World Hepatitis Day on July 28 initiating health education and training to reduce risk of transmission during exposures in nonmedical (e.g., commercial barbering, body piercing, tattoos, and traditional circumcision) and occupational (e.g., health care and sanitation worker) settings.
- Testing Blood products: testing all blood used for transfusions and blood products virus inactivation (heat-treatment) of plasma-derived products encouraging the use of as little transfusion blood as possible
- Infection-Control: enforcing infection control practices encouraging the use of therapeutic syringes with features to prevent reuse and injuries as well as safe handling and disposal of sharps and waste encouraging adequate sterilization of reusable material such as surgical or dental instruments
- Counseling: people with chronic, asymptomatic HCV including teaching them not to share toothbrushes and razors with others and to let their dentist and other medical workers know of their infection status, giving these individuals the opportunity to protect themselves appropriately
- Harm Reduction: initiating harm reduction programs, with counseling, needle-syringe exchange and opiate substitution therapy for injection drug users
However resources are limited, and as a result, political prioritization guides public health decisions. Public health may make recommendations, but whether or not these recommendations will be acted upon is something that will be determined at the political level. Therefore it is important to understand that there is public health and there are politics and these are not always aligned.
This is also fertile ground for journalism: to document and explore the discrepancies between promises and action.
Preventing the spread of HCV does not require reinventing the wheel. Many of these strategies are already used to prevent transmission of HIV/AIDS: the screening of donor blood and blood products, universal infection control practices, education, and harm reduction. A number of the steps that have been used against HIV/AIDS likely helped curb the spread of HCV because they have similar routes of transmission and there is some co-infection.
However, HCV can stay active outside the human body much longer than HIV. Consequently, infection control practices (e.g., hand-washing, sterilization of reusable medical equipment, and cleaning of surfaces) have to be even stricter for HCV.
All the HIV/AIDS prevention efforts never managed to curtail one significant contributor to the spread of blood-borne infections in low- and middle-income countries: unnecessary injections. In Egypt, where there is a generalized HCV epidemic, the prevalence is highest in people with ongoing or a past history of medical injections. It will require determined education efforts to change the practice of re-using needles for vaccinations and other procedures.
Of course, what is needed most fundamentally to prevent the spread of infectious diseases like hepatitis C is a well-functioning and well-staffed healthcare system – something that does not exist in many countries – along with political will, a willingness to invest in safer healthcare.
Many countries have only applied a few of the public health tools against HCV. Is that an option?
As most chronic patients are asymptomatic it might seem easy to ignore the disease, but there can be serious impacts on a community or a country’s health care resources. If a large group of individuals begins to exhibit liver disease within the same time frame, as expected in this case, then governments will indeed be faced with an acute problem. What course of action politicians decide to take determines the outcome of this public health issue.
The cost of instituting sound health policies can slow their adoption. For example, when a blood test for HCV became available in the early 1990s, some countries were slow to incorporate it as part of the regular screening of blood in hospitals as they had already spent a considerable amount in the 1980s to set up screening for HIV/AIDS.
Even before HCV was identified in 1989 it was known that a non-A, non-B hepatitis was circulating in the blood supply. It is estimated that in the 1970s in the U.S., the risk of contracting hepatitis from blood-transfusion was as high as 30 per cent. Thanks to screening of donor blood, that risk dropped to almost zero by the year 2000.
Questions worth asking:
Overuse of (unnecessary) injections with unsterile equipment seems to be a driver in spreading the virus, seen not only in Egypt, but in many low- and middle-income countries.
- Can education counter the popular belief that injections works against most everything?
- How to make sure that the needle being used in a medical procedure was sterile?
- How to make sure that the needle being used for an injection in a market stall was sterile?
A key question that was asked in country after country with regard to tainted blood and HIV/AIDS could also be applied to HCV:
- Did public health do enough and in time to curb the spread of non-A, non-B hepatitis? Or did they opt to do nothing to save money?
Screening Strategies: How to find those who are infected and do not know it?
A large number of people infected with HCV are ‛silent carriers‛ – meaning they show no symptoms for years, even decades. How can they be identified? And should they be identified if the resources treat them are lacking?
Universal screening – testing everyone systematically for HCV – is one approach, at least in theory. But, in most countries that is not practical, nor fiscally responsible, given all the other health priorities. Besides, a screening test only confirms past exposure to the virus. That would need to be followed up with other more costly tests that 1) confirm the continued presence of the virus circulating in the blood, and in what amounts, and 2) determine the degree damage to the liver. It is a cascade of testing that can quickly become very costly.
Ideally, what researchers would like to see is a single, inexpensive blood or serology test that provides all the relevant information. But a test like that is currently only a dream.
If you rule out universal screening, you then move to selective screening of high-risk groups. But who do you target first?
In the U.S. and Canada, systematic screening of all Baby Boomers is recommended – specifically everyone born between 1945 and 1965 in the U.S. and 1945 to 1975 in Canada.
This demographic group is singled out because they are at significant risk of having been exposed to tainted blood through a transfusion, through the sharing of needles and unprotected sex. Because HCV infection often takes decades to have serious health impacts – like cirrhosis and liver cancer – this group is also most likely to suffer health impacts.
Injection drug users and prisoners are also obvious targets for screening, as are blood donors who are rejected because they have one or more risk factors. But it cannot be forgotten that a significant proportion of HCV carriers – as many as one in four – have no obvious risk factors. Many countries are also adding hepatitis C to the current panel of screening tests done on pregnant women, in the hope they can prevent the virus from being passed on from mother-to-child.
It should be noted, however, that a number of countries, such as the Scandinavian nations, have made a decision to not screen for hepatitis C. Their reasoning is that the incidence of HCV – the number of new cases – has been close to zero for the past 20 years and that the rare cases found are usually imported, i.e. they would not be found by screening residents of Denmark, Norway and Sweden.
Testing is fraught with ethical questions.
Based on present knowledge, roughly 70 per cent of those infected will probably not develop serious complications as a result of their infection. However, the test in itself cannot determine whether a patient will be among the 30 per cent who will develop a life-threatening liver disease. In addition, it is not known whether the 70/30 division will hold up over the long term. Only time will tell.
Current treatment protocols call for offering treatment first to patients showing the effects of chronic HCV infection, because it is believed they are most likely to develop cirrhosis or liver cancer. But how do you reassure the other 70 per cent, the people who know they are infected but have no obvious illness? Will they be satisfied with simply being monitored, knowing they too could fall ill down the road?
The key ethical question is whether you should actually test broadly if the resources do not exist to treat and care for everyone who has been identified as a carrier.
But it could also be argued that even if there is no promise of treatment, it would still be valuable to know whether you are infected. Because of the preventive steps you can take, like drinking less alcohol, and reducing the stress on the liver. Or being careful not to infect others (e.g., not sharing toothbrushes or razors with others, informing dentists and health care workers of infection status).
If treatment is unavailable, should people be informed that they are infected with a virus that could potentially cause cancer? Is it unethical to withhold that information?
Once identified, what next?
Hepatitis C is a resource-intensive disease that many health systems will find hard to manage. A strong health system is required, and the ever-growing case load can potentially overwhelm even well-endowed systems.
One way low- and middle income countries have dealt with the crush burden of HIV/AIDS, has been to establish a parallel health system, caring only for patient with that condition. Could that approach, called “vertical programs,” also work for hepatitis C? And does this offering of specialized care strengthen or weaken the overall health system? The experience that countries in West Africa lived with the 2014-15 Ebola outbreak is that this approach may be counter-productive, leaving the rest of the system weak and vulnerable to new challenges. Ideally, investing in programs to treat diseases like HIV/AIDS and hepatitis C should be done in a manner that bolsters the system overall.
The countries that do have a hepatitis policy usually have well-functioning health systems in place to build on, to integrate hepatitis into what already exists.
It is important to note, however, that the expertise that has been built up in the HIV/AIDS programs could also be used to manage viral hepatitis, especially given the fact that the burden of HIV/AIDS is falling, and that of HCV is growing.
Do countries need a specific hepatitis policy?
It depends, as often is the case, on the local settings.
If the health system has the capacity and the resources to treat and follow a patient with chronic hepatitis like they would treat and follow up any other patient, then probably not.
If the health system does not have that capacity, then a plan, based on know-how from WHO‛s Global Hepatitis Program may be a good idea, because it will tell what to do and in which order. Also it can be a tool for accountability, to make sure things are being done.
The accumulated case load is again the obstacle. Dealing with a crisis usually comes at a cost, financial and managerial, somewhere else in the system. Most, maybe all, health systems don’t run with funds and personnel to spare. Budgets and resources are limited, even in the strongest, most developed and well-resourced health systems. The Ebola epidemic in West Africa, so overwhelmed Guinea, Liberia and Sierra Leone, that even with foreign assistance, other serious health problems could not be addressed; maternal health, malaria, vaccinations, as well as many emergency rooms were severely affected. Even high income countries may run into problems caused by a surge in need for a particular treatment or test. After beginning to offer screening for colorectal cancers to all persons between the ages of 50-74 years, the healthcare system in Denmark witnessed an unexpected increase in waiting lists―so many more patients than anticipated needed follow-up colonoscopies that a number of hospital units could not keep up, despite having had years to prepare for the roll out of the screening program.
Other questions to ask:
Doctors decide, based on guidelines, which patients receive treatment first.
- How are patients told they are not yet eligible for treatment? How do ineligible patients feel?
- What do you do as a journalist when approached by an ineligible patient? Do you write their story, trying to make the doctor change his or her mind?
Current protocols for treating HIV-positive individuals recommend initiation of triple therapy as soon as infection is confirmed and not waiting several years for the immune system to be compromised.
- Why then do HCV-positive individuals have to wait?
- The same question could be asked for statins that are readily given to prevent heart attacks and strokes.
Drug Costs and Access to Treatment
Hepatitis C drugs are expensive – as much as $1,000 a pill. But they offer great promise – the real possibility of cure for many HCV carriers, and preventing a countless number of future infections.
How drugs are priced, the profits they generate and the benefits they confer are the subject of much debate, and nowhere more so than when it comes to hepatitis C, because of the tremendous numbers of people infected.
Some believe the price the pharmaceutical companies are asking for new drugs like Harvoni are based on what they can extract from governments and insurance companies rather than actual costs plus a reasonable return. Companies argue that the cost of research and development are astronomical and the drugs, while highly-priced, are a good investment because of the benefits to sufferers and the future HCV cases that will be prevented.
In reality, we often don’t know the actual price paid, because list prices vary by country, and insurance plans, private and public, negotiate discounts.
With HIV/AIDS drugs, these tiered pricing schemes, and agreements signed with generic companies have brought prices down markedly and made treatment available to millions.
Will the same thing happen with hepatitis C drugs?
We don’t know.
What is known is that strong advocacy and the involvement of high-profile global health groups like The Global Fund, the Bill and Melinda Gates Foundation and Clinton Foundation created tremendous pressure to find solutions. Hepatitis C does not have that profile and the backing of people with star power – at least not yet.
Who to treat and follow up?
Current European and American guidelines do not recommend treating all those who test positive as soon as they are found. Most infected are asymptomatic for years and considered in no urgent need of treatment. Giving the medication too early may cause more harm than benefit.
Based on the progression of disease, the physician will decide when to start the treatment. However, there is no universal agreement on when that time is.
Treatment rids the body of the hepatitis C virus, but it does not eliminate or reverse liver disease. So the word “cure” is a bit misleading. Still, if the progression of disease can be halted, there should be less liver disease in the future, and that holds out the promise of drastically reducing the need for liver transplants, a very costly procedure. But reaping those savings in some distant future comes with a heavy price in the here and now. Today, health care systems are hit twice – they have to pay for the treatment as well as for liver transplants for those who have had chronic infection. To those already in need of a new liver the cure has come too late.
Will lowering the price of the drugs solve all problems?
Not necessarily. Of course it will make the drugs more accessible, but some of the bottlenecks in the system will remain, even if the drugs were available for free.
One of the first hurdles to overcome is having the drug registered within every country in which it is going to be used. The pharmaceutical company holding the rights to a product may not want to register it, because it will be too costly compared to what they can expect to earn. A generic manufacturer may also have concerns, because a generic drug has to be prequalified by the WHO, which is also costly.
Treatment involves testing, and tests have a price as well, not to mention that laboratories and trained personnel are required. Even in the industrialized countries trained personnel are in short supply. There are few physicians who specialize in liver disease, and taking on an extra caseload will be a challenge for them. Health systems do not have the excess capacity.
Questions worth asking:
- Is there a limit to how many new, high priced drugs governments and insurance companies are willing to pay for?
- Will price be an (overruling) indicator for which patients will be given access to expensive drugs?
- Usually pharmaceutical companies use the argument of cost of research, clinical trials, approval, and drug candidates that turned out to be blind end, to justify prices. But once those costs have been recuperated, will prices come down?
Developing stories to keep in mind:
At the Millennium Summit at the United Nations in September 2000, world leaders committed to help achieve the eight Millennium Development Goals (MDGs) by 2015. The MDGs are to be replaced by Sustainable Development Goals (SDGs) that from 2016 and onwards will set targets for future international development.
- Will HCV be a specific SDG?
The Global Fund to Fight AIDS, Tuberculosis and Malaria is a public-private partnership that began operating in 2002 as an international financing organization that aims to »attract and disburse additional resources to prevent and treat HIV and AIDS, tuberculosis and malaria«.
- Recently The Fund simplified its logo to just: The Global Fund. Is The Global Fund about to embrace HCV?