Special Interview on HCV: Dr. S. Wiktor of WHO

Posted on May 9, 2015

Thank you for agreeing to participate in this special interview on HCV. What do you see as the biggest global challenges in the diagnosis, screening, and treatment of hepatitis C?

Dr. Wiktor: The landscape is changing very quickly and it is being driven by remarkable progress in the development of direct-acting antiviral therapies for hepatitis C. We hear excitement at conferences like EASL and also from the journals, but this excitement has not yet translated into real action at the country level. There are a number of challenges, think about what it takes to get somebody diagnosed, linked to care, initiated on treatment, and followed. These challenges are faced by all countries, but they are especially difficult to overcome in low- and middle-income countries, where the health infrastructure may be weak.

There is a real lack of hepatitis awareness among national policy leaders and in the general population. So I think that the first step is to raise the visibility of the problem in order to get more people diagnosed. Note that there are a number of technical challenges involved in diagnosis, and the diagnostic tests are expensive and of varying quality. Health systems in most countries aren’t set up for testing, and health care workers don’t always know what to do with a positive or a negative result.

In a number of countries, the healthcare work force isn’t really there to scale up treatment of hepatitis, and hepatitis treatment remains in the domain of subspecialists — hepatologists, gastroenterologists and infectious disease specialists. But if you want to get treatment to the millions of people who need it, treatment must be delivered at the primary care level. For this to happen, we must simplify and standardize treatment. This will be made easier by the fact that the newer treatment regimens are simpler, shorter, and safer.

An important additional challenge is the cost of treatment, and that’s the one that really gets the most attention, because the costs are so high. But we’ve already seen improvements regarding the cost of treatment. We now have generic formulations of hepatitis C treatments, and some of the direct-acting antivirals are becoming available. So I think that similar to what happened with HIV, the prices will come down quickly. As we saw with HIV, however, for prices to come down quickly we will need to put pressure on the pharmaceutical companies to make their medicines affordable and available. Then the previous barriers/challenges that I mentioned will become more important: the lack of awareness, the need for testing, and the health system requirements for simpler laboratory diagnostics.

What are some diagnostic challenges that are really prominently different between Europe and the United States?

Dr. Wiktor: The US has taken an age-based approach whereby persons between the ages of 45-60 should be tested. However, the HCV problem is different in different countries. In some countries, HCV is more focused in certain groups such as persons who inject drugs. Each country should determine which groups have a higher prevalence of infection so that testing policies are developed to reach these groups.

What do you think of birth-cohort screening for Hepatitis C?

Dr. Wiktor: Well I mentioned that one of the real barriers/challenges is that the epidemiology is very different from country to country. The US has provided us with an example of how to collect and use data to be able to make some sound policy decisions. On a national level, they’re making these policies based on data that gives policy makers the information they need. I think birth cohort testing in the US is a good example of how quality epidemiological data that identifies a US population in need of testing is used to develop a policy that targets them. However, it’s going to be much harder for us at the WHO to develop global testing guidelines with similar birth cohort recommendations, as the populations affected by the HCV epidemic vary so differently between countries.

In some countries, like the US, the epidemic is more focused to a target population/group, while in other countries, like Pakistan or Egypt, the epidemic is a generalized problem. In addition, while we would like to be able to make similar recommendations for most countries, the prevalence of HCV, together with the groups or age groups at high risk, is not known in most countries. This is why the WHO is promoting the collection of epidemiologic data on HCV, so that appropriate testing policies can be developed.

What is the role of primary care providers in the treatment of Hepatitis C in Europe, and also globally? You briefly touched upon this before, but I wanted to ask if you could please further elaborate.

Dr. Wiktor: It’s not really happening. While primary care providers would be more likely to prescribe the more effective and better tolerated therapies, a number of countries haven’t approved the increased payments required for these therapies. However, in those countries that the WHO focuses on, which are essentially lower income countries, there is hope for use of the new options in the future. But the current levels of HCV treatment in these countries are so low that the immediate priority, once new therapies become available, is to focus treatment on those people who have a high risk of dying, which are those who have fibrosis and cirrhosis. A test-and-treat approach will be something that’s feasible once HCV medicines become less expensive, and once health systems scale up to accommodate the anticipated increase in service volume. This isn’t realistic right now, and is not something that we would expect to happen immediately, as testing rates are currently so low and treatments are not available to all.

In your opinion, is the cost of the newer, oral agents and HCV regimens going to introduce socioeconomic and ethical considerations in the treatment of HCV?

Dr. Wiktor: I think that the high cost of treatment is a real challenge for countries with limited budgets who want to start addressing the issue of HCV infection. These countries are going to base their treatment decisions on who should be prioritized for therapy, which leads to difficult choices. The current WHO recommendation is that people with hepatitis C-associated advanced fibrosis and cirrhosis (stages 3 and 4) should be prioritized for treatment, but that doesn’t take into account the preventive benefit of treating persons such as those who inject drugs and have a high risk of infecting others. Ideally, they should be prioritized for treatment since they bear a high burden of HCV infection. In addition, modeling studies show that treating HCV-infected drug users can really reduce the rate of new infections.

Pharmaceutical companies have announced or are developing licensing agreements with manufacturers of generic therapies, which will lower the cost of therapy in those countries where these therapies are made available. For example, the first generic formulations of sofosbuvir are being produced in India, and we hope that the introduction of more generics by more companies will generate competition, which will result in much lower prices. There is already a hundred-fold price difference between the price of sofosbuvir in the US and in Egypt. That’s a trend which we hope will continue so healthcare disparities and ethical considerations will not be as prevalent throughout the world.

Can you please touch upon how the treatment of populations will be affected by the higher cost of oral regimens?

Dr. Wiktor: I think that high cost will be a real challenge in middle income countries. Licensing agreements from Gilead and BMS will make generics available in lower income countries. In those countries, drug costs should be below $1000 per regimen, which while still high, results in these regimens becoming available for a greater slice of the population. Unfortunately, middle income countries such as Ukraine and Georgia don’t have access to these generic drugs and will have to pay a much higher cost, which is going to place a huge strain on national health systems and the individual patients who will have to pay out-of-pocket. So this is the real question; how flexible will pharmaceutical companies be when it comes to really reducing costs in a dramatic way?

I think that strong advocacy is needed to encourage pharmaceutical companies to lower HCV drug costs, which is a similar scenario to what we saw with HIV therapies. So I think that cost is extremely important, and there is no question that costs will come down. However, as I mentioned earlier, we have to address the whole problem in a more holistic way starting with increased awareness and looking at how health systems can be scaled up to be able to really deliver these services.

What are your thoughts about targeting newer, oral HCV regimens to specific populations such as active injection users or incarcerated individuals?

Dr. Wiktor. First of all, in some of the countries that we work with, these newer regimens aren’t even approved, so that’s not even an option. Once these medicines are available, deciding upon who to treat is going to be a really important question. Modeling studies clearly show that if you target certain key populations, such as injection drug users, you can really drive the prevalence of HCV down. In many countries, most new infections occur in a small percentage of the community. The key is to make the newer treatments available to these populations, but they are hard to access. You have to find these people and get them on treatment. In addition, health systems aren’t really set up to provide care to these people. Identifying ways to integrate some key services into drug treatment centers, and then really simplifying treatment, may allow access to happen.

At WHO, we are starting the development of a global Hepatitis strategy with elimination goals for 2030 to dramatically reduce the incidence of hepatitis B and hepatitis C infections. To do that, we’re going to have to treat those people who are at highest risk of transmitting. To be successful, we will definitely have to take a look at the groups that you mentioned in your question.

What are your thoughts on restricting hepatitis C therapy to patients with advanced fibrosis or severe complications and/or symptoms?

Dr. Wiktor: Unfortunately, because of the high cost of new therapy many payors have put restrictions on who will be reimbursed for treatment. In the short-term, while the drugs are so expensive, restricting therapy to persons with advanced hepatitis C-associated disease makes sense because these are the people who will die if they don’t get treatment. Published utility analyses show that when provided with only a fixed number of treatments, treating those with advanced disease is an effective strategy that saves more lives than treating persons with less advanced disease.

Clearly, I think that the real solution is having the newer drugs available at a lower cost, so that you’re not forced to make decisions regarding treatment prioritization. So while I think treating advanced cases is a less than ideal situation, I think that within current economic confines it really is a reasonable strategy. But I’m sure that as the drugs become cheaper, we won’t have to make such restrictive decisions anymore.

What in your opinion are the biggest challenges with Hepatitis C therapy in India and Pakistan?

Dr. Wiktor: The health care systems in those countries are really stretched. They do not have diagnostic technologies such as Fibroscans, and the number of clinicians who are experienced in treating HCV is really low. Currently, HCV treatment is really in the domain of hepatologists, and in some of these countries, hepatologists are very few in number.

One additional challenge that I haven’t mentioned is prevention. In countries like Pakistan, studies have been done showing that the greatest risk of getting hepatitis C is through healthcare interventions and injections, and other invasive procedures where infection control is sub-standard. So while it’s fine to treat, unless you couple treatment with a really effective prevention strategy, you’ll never catch up with the epidemic. Finding new treatments is important, because people are dying and they need treatment, but you really have to balance that with a vigorous prevention measure, and that’s difficult because health systems are fragmented and there are huge, unregulated private health systems. In some countries, injections are unregulated, and many unnecessary injections are given. In these countries, you can get an injection from someone with no health-care training, and you have no idea where the injection is coming from. In addition, you have to make sure that blood is screened, and some countries don’t screen all their blood donations.

Thank you Dr. Wiktor. Is there anything else that you’d like to mention that I forgot to ask?

Dr. Wiktor: At WHO, we are working to try to get countries to deal with Hepatitis in a more comprehensive way, by raising awareness and advocacy, and trying to get policy makers and the general population to focus on hepatitis. Each year we observe World Hepatitis Day on July 28, which is a day that we use to raise more awareness, because it really is a neglected disease. We are working hard to obtain better data, because the lack of data about country-specific hepatitis C prevalence is really a barrier to getting attention from decision makers, as they won’t focus on a problem unless they are convinced that it’s a problem in their country based on data from their country. And I think that balancing prevention really is key. The strategy that we’re developing is really a tool to get people to try and see that while hepatitis kills about the same number of people as HIV, it really gets much less attention and investment.

Special Interview on HCV: Biography 

Dr. Stefan Wiktor is a public-health physician with more than twenty-years’ experience in epidemiologic research and in the implementation of public-health programs for the control of infectious diseases. Dr. Wiktor is currently the Team Lead of the World Health Organization’s Global Hepatitis Programme which works with WHO Regional and country officials to promote the implementation of comprehensive viral hepatitis prevention and control programs. While working for the U.S. Centers for Disease Control and Prevention, he conducted research studies of HIV-1 and HIV-2 in Ivory Coast, West Africa and, in Tanzania, led the implementation of a large-scale HIV/AIDS prevention and treatment program. He is the author of more than 90 peer-reviewed scientific publications.

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