Dr. Ward reviews the prevention, treatment, and goals for elimination of Hepatitis C.
our first speaker today, I'm delighted to introduce as dr john Ward who was the director of the Coalition for global Hepatitis elimination at the Task force for Global Health. Um he currently is in Atlanta Georgia. Most of you know dr Ward as he was a senior scientist and the head of viral hepatitis At the c. d. c. for a number of years for 13 years. And um he was very influential in his recommendations for viral hepatitis vaccinations and for linkage of care and testing for hepatitis C. So we all know dR Ward through his many efforts That way. He's also very prolific, is published over 150 papers and he's currently faculty um at the um Rollins School of Public Health at Emory University. So I'd like to take this opportunity and I cordially welcome um Dr Ward who's going to talk to us today about hepatitis C elimination john thanks paul. Thanks Carrie, it's great to be on the faculty today and to give you an update about our progress toward goals for hepatitis C elimination. Yeah, these are my disclosures of support for the coalition at the task force and today we'll be going over what are our goals for hepatitis C elimination. Give you an update of the burden of disease of hepatitis C around the world and in the United States, our success and prevention of transmission and disease innovations in testing care and treatment and what is our progress toward elimination. Those? You know, I think it's really important when we start our discussions about hepatitis C, we really need to take note of, you know, the noting the remarkable contributions of our colleagues, harvey alter michael Hylton and charlie rice For their scientific work, leading to the discovery of Hepatitis C virus that was first recorded in 1989. And for their work there was they were awarded the 2020 Nobel Prize in Medicine and Physiology. And I think it just really, you know, it's just really signifies the truly remarkable achievement uh in medicine to for this viral discovery that made the development of reliable test for diagnosis and the curative treatments that we now have available to us possible. And I think it's really, you know, I see it as a real call to action that you really want to take these remarkable scientific discoveries and fully apply them around the world so you can maximize the benefit uh and improved health really for everyone, and that's what elimination those are all about. Yeah, you develop elimination goes, it's process. First of all, the disease has to meet criteria that make it feasible for elimination, you know, lack of an animal co host uh test to diagnose it, an intervention to to rid the body of the infection or prevented through vaccination. So this effort really began in earnest globally with the World Health Assembly in 2010 passing a resolution endorsed by all the ministries health in the world, calling them the W. H. O. To do more to improve prevention, hepatitis transmission and disease. At about the same time we stimulated the Institute of Medicine in the US to look at the situation in our country and they made a similar call for improved action for the U. S. Government, leading to the first action plan for hepatitis that was issued by the US government about one year. About one year later. Um Several global resolutions followed that first one, including the Assembly calling on W. H. O. To develop elimination goals for hepatitis, which they proceeded to do, which were endorsed by W. H. A. N. Uh 2016 with the benchmark year of 2015 of where progress could be made. We then with that we then return back to Iowa am now called the National Academies to for them to look at the situation again. And the national Academies uh called on development of elimination goals for the U. S. And uh the Department of Health and Human Services proceeded to respond to that after the latest action plan expired. And the we now have a roadmap towards hepatitis. The elimination which was published in january of this year. And what are their elimination goals? Its elimination of hepatitis C as a public health threat As well as hepatitis B defined as a 65% reduction in mortality, 90% reduction in incidence by 2030. With with interim smaller targets for 2020 and then targets for implementing the key interventions essential to achieve those goals such as preventing blood born expo exposures to these blood borne viruses um including uh through community uh interventions for people who inject drugs and then testing and linkage to care. Now you can have a tremendous uh impact as you can see there on the far right. And that's actually for both Hepatitis B and Hepatitis C. But you can actually have a total of 17 million deaths averted Both before and after 2030 from Hepatitis C alone. If we are successful in reaching these elimination goes globally. So truly a huge health impact. And the latest roadmap really brings the US plan very much into alignment with that global plan to encourage you to read that. And I just started those uh those goals now for the U. S. That are very similar that are similar to the ones for for the world. So what is the prevalence of hepatitis C uh globally? These estimates just were developed by W. H. O. Last month. They estimate now that to the far upper left as you see here on the slide about 58 million people are living with hepatitis C. There's about 290,000 deaths Per year. And they estimate by 1.5 million new chronic infections per year. Uh those numbers are a little smaller than the ones five years ago. Um it's about 71 million prevalence. It was about 400,000 deaths. So there is trending down globally although because of the really lack of precision of the data you really can't say for certain. So you really have to look at it at a country by country level you can see it's a fairly dispersed distribution of the burden around the world regionally. Although I'll show you a moment is concentrated in a few area in a few countries and indeed um reaching elimination goes for the U. S. Will obviously improve the health of our country. But also really helped advanced progress towards these global goals. Because the U. S. Has a substantial burden, a substantial fraction of the global burden as you can. As you can see here of the other countries that also have a large burden is representing the great overall burden of hepatitis C globally. Uh W. H. O. U. Two has developed testing recommendations based on risk but also based recognizing the prevalence and there are certain countries recommending everyone be tested for hepatitis C. And then if you are found to be infected too that all persons should be treated. So that's the global standard. Now as as was suggested by that trend in global prevalence and mortality. Uh There are more people getting diagnosed and cured of hepatitis C, Estimated about 26% of that original burden has been diagnosed. We've had about 90 million persons treated. So that's trending toward reaching those interim global goals for hepatitis C, which is great news and and to achieve those health benefits that are referenced there in that second box on the left. Now, one of the reasons for expanded treatment is because the treatment costs have fallen dramatically Since they were licensed in 2014, With 62% of persons living with hepatitis C, residing in countries with the cost of a cure is less than $150. So hepatitis C is very much a cost effective and not cost saving intervention for most countries now globally. Just to give you some examples, hepatitis C was was a huge large problem in the country of Egypt. Indeed, they probably had the largest prevalence uh in the in the world. As a as a nation With about 7% of people uh in that country chronically infected with hepatitis C, they had developed a very good treatment program but I mean people were getting diagnosed and treated and then with the availability of curative treatments, uh the president uh decreed that every adult would be tested for hepatitis C. The national government took that to develop a very robust program with a very large component for media outreach and engaging the public in this large effort. They greatly expanded access to testing in their health care facilities that may testing and treatment available at no charge to the citizens of Egypt. They developed a robust information system. So we're literally in real time they can they can monitor the numbers of people getting tested and referring for testing and treatment. They developed a low cost um Well they didn't I'm sorry. They developed through negotiations. They made available very low cost high quality point of care test for A. C. P. Antibody. Uh and with those that were able to test 75 million people in less than two year, responding about 2.2 million who had evidence of having been infected with hepatitis C. Um And then they referred them to follow up with a by Pcr again with a very low cost high quality option. Uh identifying 1.16 million persons with chronically infected with hepatitis C, Treating over a million of those and achieving about cure for over 95%. And already are seeing declines in the in the country's burden of disease. So truly a remarkable program. A country like Rwanda had much less resources than Egypt, also found to have a high prevalence but with that. But the uh the policymakers, the president became engaged and became a big supporter of developing a national program with treatment guidelines training for health care providers. Uh developing again access to low cost high quality diagnostics and treatments. Building HCB program on the infrastructure of the HIV programmes supported by the Global Fund and and then achieving this cascade of carrot and shown here on the upper right Um and decreasing their prevalence over about five years from 4% to 1.8%. Uh Really looking at that important uh political engagement, public engagement, affordable diagnostics and treatments, scaling up capacity to deliver those and then making testing and treatment widely available through task shifting and moving from specialist. Only two non specialist care other countries are in progress. Uh developing Hepatitis C programs. Georgia has was one of the very first countries to do so with a gift of of therapeutics from Gilead sciences and C. D. C. When I was there it was involved in that. It continues to be so. But they have uh continued to develop out this program and approaching or exceeding their targets that they had set for 2020 and they have just moved their targets to 2025 but still are very much committed to this effort. India has developed a national hepatitis elimination plan with state of punjab being a model program. So that work is underway. Country of Mexico just developed a C. V elimination program just about the last 1 to 2 years again making a point of care testing available. Uh moving from specialist and non specialist care developing a case registry so they can track of the progress through the kare cascade as people are diagnosed and so they can provide navigation services as needed. And and and showing a remarkable increase in the number of persons found positive on antibiotic testing. Justin. That's really about an 18 month period compared to all total years prior to that time. So they have launched this even despite having to respond to the covid pandemic, Vietnam is much earlier in the process with a variety of pilot projects going on, you know, and revealing some issues regarding the continued high cost of diagnostics uh and treatments there that they are just now beginning to work through. And we need now the covid pandemic response had an impact on hepatitis C testing and treatment around the world. So the coalition uh we developed, we put out a survey between august and december of last year of clinicians and program managers in 44 countries who reported that most of whom reported that they were deferring large proportions of their Patients from in in person care 80% reporting disruptions and hepatitis c. Testing and treatment services. Unfortunately, as indicated by the green bars here over time, they reported improvements in the number of persons being tested and treated, although not yet reaching pre covid levels now. In the case of the United States. At the at the dawn of the curative treatment era for hepatitis C, We had a prevalence about 3.5 million persons. The prevalence uh was concentrated among the so called Baby Boom Population, persons born between 1945 and 1965, many of whom already had evidence of moderate to severe liver disease and mortality was rising indeed becoming the leading cause of mortality among diseases reported through a public health systems to C. D. C. So we opted for a recommendation for testing uh that birth cohort from C. D. C. And that was adopted by the US prevent U. S. Preventive services task force one year later and then health systems clinicians um public health put in place um testing programs using a variety of different strategies listed there in the box in the lab such as reflex testing after an HCV antibody test was found to be positive electronic prompts to remind people of testing and although it took a while to get going, there has been a large increase in testing of that population. You're looking at a variety of large data sets of clinical records. And then with that increased testing and diagnosis was followed by improved treatments when an estimated 1.5 million people treated between 2015 and 2019 and as a result prevalence has declined from 3.5 million to 2.4 million. Now another important metric illustrated here is the percent of antibiotic positives found to be very ironic And as you can see, that's dropped from 73% to 57%, indicative of that curative effect of treatment as people obviously remain antibody positive but are getting cleared of their infection. So that's a very important metric to follow. You know, it is important to point out that about 44% of the persons in the US continues to be unaware of their infection. So testing continues to be important as well. Pick up. I can't hear in a moment. Now there's been some remarkable programs put in place in the US uh for testing and treatment of hepatitis C. Probably the most remarkable has been the one for uh put in place by the V. A. Medical system where they recognized they had a large burden of hepatitis C among veterans particularly of the Vietnam War about 170,000. So they developed a program um and using a variety of Um different innovations to be implemented over time. And they had a great data dashboard. So the contract progress, identify problems and provide information for continual quality improvement to the point now where they only have about 10, about 10% of that burden remains to be treated. And we'll be outlining this program in more detail in an upcoming issue of clinical liver disease later in the month of july uh with that national road map. And with these global call for elimination uh states, cities, tribal nations of the U. S. Have been putting in place elimination programmes and their outlined here are the ones that are available. For example, the one in Louisiana was started. Uh They overcame the the issue of cost of therapies by adopting the subscription model um innovated by Australia whereby you you pay a one time fee to a pharmaceutical company for unlimited access to their hepatitis C treatments so that the more you diagnose and treat the cost per cure goes down and that's what they adopted in Louisiana. Again, they had a local political commitment put in different strategies to make treatments available. And they started their program targeting improved testing treatment for prisoners in their state correctional facilities who had never been offered testing and treatment prior. And those photographs shows how they are beginning to test and treat prisoners. How that has, how that increased in the early period of the program. And they had a decline As the COVID-19 pandemic emerged and hopefully those treatment rates will recover in the future. Another quick example is the Cherokee nation of Eastern Oklahoma. Again, they put in a variety of strategies to make testing and treatment available throughout their health system and into the community. They begin to uh track they're they're kare cascade showing very wide acceptance of testing. Um Good not excellent linkage to care which they're seeking to explore and then excellent cure rates of those who were treated. And as a result of all of those efforts, mortality from hepatitis C in the U. S. Is declining. Indeed 27% decline between 2015 and 2019 based on vital record data um published by C. D. C. So this is a big interim achievement and you you can view this as the US being on the road toward hepatitis C elimination of mortality Uh for the country to reach these 2030 goals. You know, and this this move toward simplification is reflected in the S. O. D. I. D. S. A. Guidelines which called for really a minimum of pre treatment assessment just to identify uh cirrhosis or not uh recommendations for the use of Panjin, a typical regiments very limited on treatment monitoring and then very little routine follow up except obviously for some specific clinical indications. So it's all about simplification and moving from a specialty model to a non specialty one. The coalition also develops national hepatitis elimination profiles to assess progress toward elimination goals. So we've done one for the U. S. Just to show that simplification is being reflected in these once owner estate restrictions for access to treatment. Most states no longer require that except for a few states that still require some fibrosis uh to have developed before they will approve Medicaid um to pay for a C. V. Treatment. And some member states to continue to be concerned about injection drug use, alcohol use um as uh and then delaying treatment in that regard as well. And that's those kind of restrictions we would like to um have dismissed. And this move towards simplification really continues with additional operational research. This is a remarkable study known as minimum that was presented A. S. So the last year where they gave all of the prescription prescription at one time to patients had very limited follow up in the interim when they should be taking their medications and found that they had excellent adherence and excellent treatment outcomes really comparable to persons followed more closely with more routine prescriptions. So you so it's just another example of how how really how remarkable these drugs are that they can be given in such a simple fashion and something we should be pushing for broader adoption on now. Covid did have a response. I did have an impact on testing in the United States as was recently published by C. D. C. About a 60% decline and testing in the first months of the pandemic Uh and the epidemic in the us. But that that that testing volume did return did did recover and it's about a 6% decline in July of 2020 suggesting that you know testing is getting back to pre covid levels with something that needs to be continued to be monitored. Health care related exposures is the most common mode of hepatitis C transmission globally and continues to be so about two thirds of the cases transmitted in that way because it is a blood borne virus and breaks in infection control lead to transmission. Now, fortunately there's been remarkable improvements in blood safety and infection control around the world Uh leading to large declines, about 83% decline in transmission in healthcare settings globally. Um and you know that's also true for the US. Even though we continue to get outbreaks and it's just a reminder that good strong infection control, particularly safe injection procedures continue to be critically important to avoid unnecessary transmission in health care settings. The major mode, the major population at risk for injection-related transmission are persons who inject drugs 52% globally, estimates in the US about 30-70% depending on the cohort. Uh It's related to the use of a non sterile equipment if you provide sterile equipment injection drug users um that that risk declines dramatically, particularly if it's coupled with Access to drug treatment so that they have an option of not using drugs and then further if you test and treat them, you can prevent over 90% of those infections by those combination of strategies unfortunately globally. Um And in the United States of the access to those preventive services are in very short supply. So only about the only about 33 syringes or exchange per person inject drugs per year globally. Uh its estimate you really need about 200 to get the the coverage to have effective prevention. So we have a long ways to go globally to protect this population. at highest risk of infection. Now this is an emerging problem for the US and has been for about 10 years now because of the increases in heroin use as a consequence of the opioid epidemic. And uh you know a certain proportion of persons who use heroin will be injectors. So the increased use of heroin has led to increased injection drug use, which leads to a CVT transmission. So there's been a several fold increase over the last 10 years. Uh so there's about 57,500 acute infections in 2019 estimated by C. D. C. is concentrated among young persons, including among pregnant women who uh posing a risk of mother to child transmission Of which there's about a 6-12% risk if the mother is HMB infected. You know interventions are highly cost effective, it's just trying to apply them. So what once we had a epidemic very much concentrated among older persons. We now have this by model situation where you have large numbers, a larger numbers of persons who are younger in age becoming infected. Uh to join that pre existing higher prevalence uh in older persons. Uh And as a result we have moved to a recommendation of testing for baby boomers only to a recommendation that all adults should be tested at least once for hepatitis C. In the United States. As recommended by C. D. C. And by the U. S. Preventive services task force including testing a pregnant women. Um And some of that is fueled by the models and the potential benefits of that and improved diagnosis treatments, cures and improved reductions in a CB related mortality. This really illustrates the work in front of us on the prevention side with the red dots representing young people less than 30 years of age living with hepatitis C and the black triangles representing where a syringe exchange program is. And you can see a large disconnect between that availability and and also just in terms of the number needed uh We estimated over 2000 new programs would be needed to match uh the prevention uh needs of this population and we have a long ways to go with that. Uh In addition, drug treatment programs are not doing a very good job providing testing and linkage to treatment. And as a result, a recent study looking at large primary care data sets that suggests that very very few persons who inject drugs are receiving HIV testing routinely. So a large body of work to do. Sorry, I missed that. Could you say sorry. Theory. Had something to say. Their apologies. Uh there has been an impact on the COVID-19 pandemic response on Syringe service programs with some interruptions and services. Uh so this is another another interruption that needs to be a monitored. It does appear that this is improving over time, but again, um we'll have to see how that moves along. Operational research is also improving this particular area. Um I was involved in a study has been going on for about six years and eight sites around the United States where they uh implemented to different treatment models for hepatitis C for persons who were in drug treatment but who had were either very recent injectors or were current injectors. Um Either directly observed treatment as they came in from methadone or more modified one where they were periodically checked in with through telephone and other telehealth means. Um And we showed that you know initiation was quite high. Uh There were some differences in adherence based on these two models with the D. O. T. Having more adherence better adherence than uh the the the the the modified Uh monitoring as I mentioned earlier. And uh but showing that the treatment outcomes were about the same about 90% did achieve a cure. Um So suggesting that you you know it's again it's a reminder even of the population that you would be perceived to be at highest risk of not remaining adherent to treatment and having little cure rates is actually not the case. And we're now looking at the data for reinfection rates to see uh you know, to see what what are the outcomes of that for this particular population. But we're very interested to see how we can promote these two models more broadly. So we can improve access to testing treatment for people who inject drugs, particularly those who are in drug treatment. Now, as I mentioned, we, you know, the coalition develops these profiles. So in summary the status of hepatitis C within the United States, Uh we're doing a good uh the best job uh when it comes to appetites, the elimination in providing testing and treatment. Although improvements are still needed, mortality is declining. The proportion of persons who have been diagnosed has gone up to about 60 Uh from uh from prior estimates and about 43% of persons have been cleared of HMV infection, which again is an improvement. Our greatest work is our high uh large increases in incidence, reflecting the poor access to preventive services, including testing and treatment for persons who inject drugs. Yeah, there have been some achievements. Uh You know, we do we do have an elimination plans. We have a government commitment to hepatitis elimination For the very first time. With the money going out for the American rescue plan. As in response to COVID-19. Federal money is available for state health departments and other organizations to purchase injection equipment to be distributed for persons who inject drugs that will say that was a never before possible. So that's a true improvement achievement. And this move to a policy for all adults testing for hepatitis C made available as a no copay preventive services for persons in primary care. Um. Uh huh. Um We have remarkable programs like the via an increasing number of states have dropped restrictions to treatment that said we have challenges. We still have racial and ethnic disparities in health. We have a rising HCB incidents. Uh We have limited access to safe injection equipment and HCV treatment for persons who inject drugs as I've been going over and you know, we still have work to do to make sure that we are scaling up testing now that we have this policy and in a way that people uh that treatment follows after diagnosis. And we have, you know, certain quirks in our health system. Like if you go to primary care your tests. Perhaps it is paid for by the insurer. If you get tested in emergency department, the patient may have to pay because of preventive services task force guidelines. It only relates to primary care not to other parts of the health system. So it's those kind of uh kind of barriers that we are looking to overcome. So the coalition put this uh together with uh this profile together with the community based organizations U. S. C. D. C. H. H. S. Uh expert clinicians um And so we you know to perform these immediate next steps which we really need to continue to build the database for hepatitis so that we can develop a registry um like the half of the V. A. But one more nationally to really help patients get the care they need. Um We definitely need to expand harm reduction including in correctional facilities. Um We need to um and then we need to take advantage of this new policy for hepatitis testing and scale it up for for young people including for pregnant women. Um and uh um um um there's also some other something I didn't really touch on but there's some other technical uh innovations that are not yet available in the U. S. Particularly a point of care testing for HCV uh diagnosis. Uh Those tests are widely available around the world but have not been licensed in the U. S. Such as the gene expert by seven is not licensed and that would provide another avenue of making testing more widely available. So it will be very be very important to see how those types of tests can be made available. So I think I'll stop there uh to say, I think I'll go in with the title of this talk was actually HCB eradication. So right now we have goals for HCV elimination as a public health threat which is sort of an interim, which is a less ambitious target than eradication, which is complete elimination of uh of an infection. Uh and it's related diseases of which we've only been successful uh smallpox and closing in on polio. So I think we I'd like to look at this uh as uh as elimination as an interim step and that we need to be successful in elimination. And then then from that achievement, then look forward toward, you know, eradication which is biologically feasible. But now then there will be upon us to see how how technically feasible is it uh to to marshal all the resources and services together to make that possible. But in summary we are making progress with hepatitis C elimination, particularly around testament treatment around mortality reduction. But we have a lot of work to do in that regard. Our biggest challenge in the US is uh increases in incidence and how to curb that reverse that and have those have those improvements In uh incident reduction, join our improvements in mortality reduction and so that we can be successful in in reaching our elimination goals by 2030. Um uh the full US profile is available on our website at Global Help dot org, as are other national profiles again, thank you for inviting me to be a part of this faculty and I look forward to the discussion of follow. Thank you. Thank you very much. Um john that was excellent. You know, we have just a couple of minutes before our next lecture and I'd like to take that time to ask you one or two questions and first I want to recognize A colleague of ours. You recognized our three colleagues who you and I have worked with for 30 years who won the Nobel Prize. But there's a another colleague who unfortunately passed away this year named john martin, who we both are very familiar with, who was the ceo of Gilead, I think he you just said something important, Which was 62% of people in the world that are being treated and cured are being treated and cured for less than $100. So virtually free therapy, it was because of john martin that I think that's really happened. His business plan was to charge a lot for the therapy in the United States, um and the Western world and in turn give the drug a ways to give the possible beer and the other key drugs away in the rest of the world and and I think he's been vindicated and he was criticized for that, but I think this has been vindicated because you could just pointed out that most of the people being cured in the world are getting the drugs for almost nothing. Um So mike I had uh two quick questions. One is we heard a lot about outbreaks of hepatitis C and dialysis centers. And the CDC started a number of um processes for testing etcetera and treating and dialysis centers. But you mentioned is that had any effect jOHn or not? Well I think over a time that particularly 15 years ago or so the you know, the prevalence of hepatitis c among uh mhm patients on dialysis was was quite high and CDC had hepatitis a hemodialysis surveillance system to monitor uh to monitor those trends. And then and then along along with that obviously with that information policy development to improve infection control for hepatitis uh in uh in hemodialysis centers and so that those those that prevalence did decline. Uh but you know outbreaks tend to continue to occur but they are much smaller now than they used to be because testing is more routine and so you capture them earlier. So uh so you know, so we would have 23 or outbreaks tend to uh can be quite frequent. Uh several years ago there were there were nine outbreaks in one state alone but they again they tend to be a little bit uh a small, large smaller in total number. But it's just again a reminder that because of the large risk for blood exposures and dialysis the infection control remains to be is critically important. So I'm not her kids because I remember when it was made the news and there are a number of these outbreaks but I haven't seen one of those in the last couple of years. So and hopefully those people are getting treated now. I know that's a certain dialysis companies he took on this elimination. Um but um and really began to seek to make testing treatment more available. I haven't seen the latest data how successful they were but uh but that would be good to see uh what progress has been made with some of those companies patients. And my second question is one that I'm sure everybody's thinking about but nobody's asking which is can covid be eradicated. I am going to put you on the spot at all. Uh Yeah thinking and when reading about other other pandemics like the one they want uh The big flu pandemic earlier in the 20th century. You know they say yeah that uh uh pandemic stone in with a bang they end with a sputter, they sort of like fade out and sort of become part of the background of other diseases that you may okay less, you know less frequently see than was the case during the pandemic. And so I think it will probably um sort of uh sort of go go along that path more than a Um complete eradication for COVID-19. Uh but let me just let me just share with you the acknowledgement of john martin. I uh think the world of him, we worked on a lot of projects together through the CBC Foundation. Um His Foundation supports the coalition, he was very much committed to global elimination and he really helped develop um you know those generic manufacturers to make his truly revolutionary drugs more widely available very, very quickly. Um and uh uh so yes, so I just wanted to just join you in acknowledging john's contribution. Thank you.
