Hepatitis C, Public Health & Politics: Screening Strategies

How to find those who are infected, but do not know it?

A LARGE PART of the infected are ‛silent carriers‛ showing no symptoms for years. And by the time they seek medical help it may be too late, because the disease have progressed too far for the treatment to be beneficial.

So there is a need to identify those, who do not know they are infected. But how? One solution could be to screen the entire population, but is that viable, not to mention fiscally sound? What if at most only 5 per cent of the population is infected? What if the prevalence is high like in Mongolia, with more than 10 per cent of citizens infected? What if the population is large like in China? The sheer number of people to be tested could easily be a logistical challenge.

Does availability of a test indicate screening? That was the question in Denmark in the mid 1990's, when a test for the virus HTLV-I/II became accessible. The scientific Danish Society of Clinical Immunology, had long argued that there was no basis for introducing screening in Denmark: the virus was almost exclusively found in the tropics; HTLV infection had not been detected in Scandinavia; transmission occurs only with great difficulty; and the clinical consequences of HTLV infection was limited, since the virus only in very rare cases and over a period of 20-30 years could lead to leukemia and tropical spastic paralysis.

In early 1994, the detection of a single case of HTLV-I in donor sera made neighbouring Sweden introduce HTLV screening for a trial period of one year. Soon after Denmark had its first case, also in donor sera. This made an opposition MP, himself a doctor, require screening introduced in Denmark, which the Health Minister did not dare challenge, even though it had been scientifically estimated that all Danish donor blood had to be tested for a period of between 30 and 60 years to prevent just one case of leukemia.

Yet, politically the Minister had no choice, because it was impossible to counter the politically cost-free view that blood had to be 100 per cent safe. After the first two years screening for HTLV was estimated to have cost around 30 million Danish kroner, equivalent to approximately 600 hip operations. Based on these high costs and the limited risk, a more selective screening has since been introduced, testing only new donors for HTLV and only once.

As illustrated by hepatitis C and HTLV-I/II, the lessons of HIV/AIDS appear to have made absolute security an indisputable political standard in Danish blood supply - whatever the cost.

One way to overcome this could be the development of a cheaper, simpler and more efficient method of screening. Instead of one serology test and another one to confirm the presence of the virus and quantify the viral load, it would be desirable to have only one test. Such a test would not necessarily require a fancy hospital setting but could be taken at the point of care. Not only would it be cheaper, it should also be easier to interpret and, aided by development of valid algorithms, determine the need for treatment.

If you do not want to test the whole population, the next question has to be: who would you then test?

In the USA and in Canada a systematic screening of all aging ‛baby boomers‛ once (without prior ascertainment of HCV risk factors) is recommended, since they are more at risk of having had a transfusion with blood that could not be screened at the time and because of the long latency for symptoms to develop. However, there is a little twist: in the USA it is recommended that everybody born between 1945 and 1965 be screened, whereas in Canada the age bracket is between 1945 and 1975.

Another more targeted approach screens those who are most at risk for HCV infection, for example people with a history of injection drug use or those who are rejected as blood donors because they have one or more risk factors. This is recommended in France.

But there are limitations to this strategy. Studies are showing that a significant proportion of individuals who have been identified carrying the virus appear to have no known risk factor, so this may not be as successful as originally hoped. Evidence has shown HCV to be more common among men than women; therefore it would make sense to focus more on the male population. Despite that, it could still be a good idea to add HCV to the current screening tests given to pregnant women, to get an indication of the spread of the virus in the population.

Jean-Michel Pawlotsky, Professor, University of Paris-Est.

It should be noted that Scandinavian countries do not have screening programmes as such. The reason for this decision is based on evidence that the incidence of HVC - the number of new cases - have 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 COMES with a number of ethical questions.

Based on present knowledge, roughly 70 per cent of those infected will probably never 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 life threatening liver diseases or not. Not to mention borderline cases. Also no one knows whether the 70/30 division will hold, simply because ‛present knowledge‛ only covers the 30 years or so HCV has been known. Current treatment protocols call for offering treatment first to the 30 per cent group. So what to tell an infected from the 70 per cent group, apart from they will have to be monitored, to see if they progress, for the rest of their lives?

An important question is whether to test, if the resources do not exist to treat and care for those patients who have been identified?

Jean-Michel Pawlotsky, Professor, University of Paris-Est.

But it could also be argued that even if there is no promise of treatment, it will still be valuable to know, if you are infected, because of the preventive steps you can take, like drinking less alcohol and thereby take a load off 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).

Charles Gore, president of WHA - World Hepatitis Alliance

Another argument for testing, regardless of treatment availability, is that should a person express the desire to know, whether she or he is infected with a virus that could potentially cause cancer; it is unethical to withhold the opportunity.

Once identified, what next?

HCV is a resource intensive disease that many health systems will find hard to manage, because not only is a very strong health system required there is also the question of the accumulated case load.

Jean-Michel Pawlotsky, Professor, University of Paris-Est.

HEALTH SYSTEMS are complicated and do not always perform as hoped. One way of overcoming this in low- and middle income countries, especially with HIV/AIDS, has been to establish a parallel health system, caring only for HIV/AIDS patient. Another name is a vertical programmes, because the deal with everything HIV/AIDS, and leaves the horizontal rest to the existing health system. But as the Ebola outbreak in West Africa (2014- ) has demonstrated, a vertical approach may not be adequate, if the existing health system is weak.

The countries that do have a hepatitis policy usually have well-functioning health systems in place to build on, to integrate hepatitis in what already exists.

Charles Gore, president of WHA - World Hepatitis Alliance

The lessons of HIV/AIDS vertical programmes are mixed. Because of the grave situation, many countries created parallel programmes with financial backing from international funds and NGO‛s. These programmes have been successful in bringing treatment to people who needed it, but have also been criticised for draining existing health systems of resources, particularly sparse human resources. An additional, negative consequence of this has been that individuals presenting other ailments cannot get care unless they are co-infected with HIV.

It is important to note that the expertise that has been built up in the HIV/AIDS programmes could also be used to manage viral hepatitis.

Karine Lacombe, Ass. Professor, Saint-Antoine Hospital (AP-HP), Paris

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 is again an 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 more developed 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 50-74 year old, the healthcare system in Denmark witnessed an unexpected increase in the waiting list for further tests. The assay used for screening turned out to be more sensitive than anticipated (e.g. finding too many 'positives'), requiring so many follow up coloscopies to sort out the the 'false positives' that a number of hospital units could not keep up. Despite having had years to prepare for the roll out of the screening programme.

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+ 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+ individuals have to wait?

The same question could be asked for statins that are readily given to prevent hearth attacks and strokes.

Next: Challenges around Treatment