 We want to welcome our online audience. This program is being live webcasted and will be available at csis.org following the event as a digital video recording. Everything okay? Good. I just got the thumbs up. So thank you for your patience. And again, welcome to CSIS this morning. Today's program will begin with an announcement of a partnership between the Republic of Georgia and Gilead Sciences. Gilead Sciences is an innovative biotechnology company located in Foster City, California. The goal of this partnership is to completely eradicate hepatitis C from the population of the Republic of Georgia. Until recently, there was no cure for hepatitis C and many of the treatment options were both expensive and limited in effect. Beyond this important announcement, we will examine the nature and operation of an innovative approach to public health. What is happening? Okay, ready to go? Okay, the feedback loops are amazing in this digital era. But we will examine the nature and operation of this innovative approach to public health which combines a technological breakthrough for a cure with the collaboration of the United States and Georgian public health officials to eradicate this debilitating disease. Today, we welcome officials here in Washington and are connecting via the Blue Jeans Network, I believe it's called, to people, the team on the ground in Tbilisi. We'll begin here in Washington and I'd like to introduce the two people here on stage with me, Dr. Arquill, Gekazita, Ambassador of the Republic of Georgia to the United States and Ambassador Jimmy Kolker, Assistant Secretary for Global Affairs of the U.S. Department of Health and Human Services. Their biographical statements are in the papers on your seat and so we'll dispense with the reading of these bios but we're delighted to welcome them both to CSIS and have asked the Ambassador and the Assistant Secretary to in turn make opening remarks. Mr. Ambassador. Thank you. Dear distinguished audience, ladies and gentlemen, and dear distinguished panel members, let me welcome you all and thank the CSIS team for hosting this event here, especially Mr. Scott Miller for your efforts to host us here as we are marking the launch of an outstanding exceptional program in Georgia in that absolute elimination of hepatitis C, this very dangerous disease in our country and in the wider region. And to my knowledge, this is a very acute problem here in the United States as well. And also I would like to thank AJ Jones and Pauli Fields from Gillett Sciences for their efforts to put together this event. I took several months of purposeful work of the government of Georgia, its Ministry of Health, Healthcare, the Embassy of Georgia here, and of course our US partners, US Centers for Disease Control and Prevention and Gillett Sciences to make this day. And today, Ministry of Health of Georgia has just signed a memorandum on understanding with Gillett Sciences, a renowned leader in the industry, to start the program. The Minister Sergenko and the Gillett leadership will join us soon alive and they will tell us more about the background and details of the program so I will not go into the specifics of this important undertaking. I just wanted to underline that this program does not come from nowhere over the years of fruitful cooperation between the US and Georgian partners in many areas of public health. Serious backlog has been made both in terms of research and medical treatment. And now we can proudly boast many outstanding achievements and I would single out a few of them. Let me start with the Public Health Research Center named after Senator Luger, which is a shining example of a US-Georgian cooperation towards combating biological threats. And this state-of-the-art facility which is located in Tbilisi, in the capital of Georgia, is the largest US investment projects in the country and currently Luger Center's BSL3 Lab is a center of especially dangerous pathogen related research in Georgia, supporting scientists from not only the National Center for Disease and Control, but from the Ministry of Agriculture and also from the relevant agencies from neighboring countries. The second thing I would like to also point out is that Georgia has been playing an active role as a key leader and partner in the US Global Health Security Initiative to strengthen the health preparedness and the global response to threats and as we witnessed recently, the Ebola outbreak in Africa. So it does not need additional explanation how important it is to really be prepared for this global response for the similar events. Third, I would like to outline to mention to know the collaboration with the US Centers for Disease Control and Prevention and as the agenda of partnership with the CDC grew over time, CDC decided to establish a representation in Georgia and the CDC is now involved in many projects on the ground but in this particular case, in relation with this program that we are talking about today, CDC is a key partner and it will provide technical assistance and guidance throughout the project. Last but not least is the collaboration with the National Institute of Health, particularly with the National Institute of Infectious Diseases and Immunology and I would like to take the opportunity and personally thank Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases for his consideration and effort to help Georgia address some of the most acute problems related to healthcare including by the way, Hepatitis C and the NIH has recently launched a collaborative workshop in Georgia which resulted in funding seven research projects in the field of communicable diseases including TB, HIV, AIDS and of course Hepatitis C. So the program on elimination of Hepatitis C we are about to start in Georgia is a pilot project and if successful it also be replicated in other countries and regions. Therefore I urge you to benefit from this panel and I think it's a good opportunity to learn about the origins and prospects of this program in Georgia. Thank you very much. Thank you, Mr. Rasser. Thank you, Scott. Good morning and good afternoon in Tbilisi. Jimmy Kolker from the Department of Health and Human Services and it's pleasure to be here to recognize the important collaboration to combat Hepatitis C in Georgia. As most of you know, viral hepatitis is a major burden on the health of people and economies throughout the world. There are about almost 150 million people globally who have chronic Hepatitis C infection. A degree of severity varies from being asymptomatic to mild illness to chronic liver cirrhosis, cancer and death. So as this illnesses, hepatitis illness occurs in all regions of the world but is particularly problematic where HIV co-infection or injecting drug use add to the problem and the vulnerability of the populations who are affected. US government through the Department of Health and Human Services and agencies that the ambassador mentioned, the US Centers for Disease Control and Prevention and the US National Institutes of Health address viral hepatitis disease including Hepatitis C all over the globe. We've developed multiple initiatives on hepatitis focusing on greater awareness and identification of those infected, improved public health measures to prevent the spread of Hep C, work with the WHO and the development of new therapies to combat the disease and that's really why we're gathered here today. First to build on what the ambassador has rightly said the government of Georgia has been a close international partner of the United States on many health issues. The center named for Senator Lugar is a state of the art example but Georgia's commitment to public health is impressive. Even the field epidemiology training program which is centered in Georgia also has brought epidemiologists and comparable programs in Africa have been very important in turning around the Ebola epidemic. So the training of Ministry of Health Epidemiologists in collaboration with CDC is one of our most important partnerships. But we're especially proud of CDC's active technical presence and partnership with Georgia and this is one example of the fruits of that partnership. Together we're tackling global health security, HIV and AIDS, tuberculosis, maternal and child health and notably as you mentioned ambassador the Georgia's lead role in the global health security agenda which President Obama himself launched in February 2014 and Minister Sergei Enko was president in Washington for that launch on a very snowy day. Through the global health security agenda we're addressing the abilities of many countries around the world to prevent, detect and respond to infectious diseases whether naturally occurring, accidental or deliberate as acts of bioterrorism. We're grateful to the Ministry of Health of Georgia and the multi-sector approach that you're taking to be important partners on these endeavors. The research and development has been ongoing for both vaccinations and treatments for hepatitis C but progress had been slow. Now through the hard work of both public and private sectors especially companies such as Gilead we've realized breakthroughs and therapies and combined efforts in the public and private sectors such as this initiative in Georgia will change the lives of many people who may have given up hope because the treatments were out of reach or ineffective. This turning point will be when hepatitis C and other diseases are seen to be dramatically reduced and it takes combined efforts and expertise of multiple actors some of today's greatest and most widespread health challenges. It's a pleasure to be part of an example of scaling up with CDC, with the government of Georgia and with Gilead's commitment to an innovative program which isn't just a pilot program or a center of excellence but there's a national response which will mean that everyone who needs the help will be able to get it. So thanks to all the partners from this much needed undertaking. Thanks very much. Thank you Jimmy. Now let me have the dramatic moment or what I hope won't be a dramatic moment of today's event which is to connect and turn the program for comments over to the people in Tbilisi. We have Dr. David Ciergenko who is the Minister of Labor Health and Social Affairs for the Republic of Georgia. With him in the room are Dr. John Ward and Juliet Morgan of the US Centers for Disease Control and Prevention and Greg Alton, Executive Vice President of Gilead Sciences. Let's see if this works. Good afternoon. Please go ahead. Please. We share with you our impression and excitement. One moment please. There we go. We're trying to get the volume correct here but please proceed. We share with you with great pleasure our excitement with signature for so important documents that happened just a couple of hours ago that used to my country gave so few new chances but I believe that these chances wouldn't be unique for Georgia only but it would be shared for other countries also because this is a literary new part to how new vision to this disease because this is not only improved access to treatment of hepatitis C but also comprehensive approach that includes prevention to provide the scientific survey and even before launching we are getting immediately after launching we are getting additional benefits knowing more and to explain to people how to reduce the steam of disease because this is very important to improve access before the treatment of this and with this team approach and I'm very thankful to the U.S.C.D. and Iliad Sciences that are doing literally revolutionary job in this direction and it gives to us absolutely new possibilities and opportunities. I think that within the nearest days we will get first patients and regarding prevention component we already started this project and we are already getting in the culture of let's say complex approach and I cannot mention new episodes of new opportunity in face of Google laboratory it gave to us new basement new new resources for laboratory control because we do qualified laboratory control even having resources in face of appropriate medication appropriate medical staff we the ex-competition of laboratory and without state of quality of testing of disease we would be are on a spot with not only hepatitis but other diseases also and I'm very happy in my vision that I would share with you this is some kind of important part of also global health security agenda because we are all recognizing that health is not managed with a force of isolated country even the strongest country the most developed country but this requires literally global approach I really will be very happy as minister of health in the country that we are launching this program and finally let me present my thanksfulness to our partners and thank you very much for this great attention thank you very much thank you Dr. Ward or Juliette, do you care to make comments? It's areas in the room there in Washington as well as my HHS colleague Jimmy Copa it's my privilege to represent the the Atlanta portion of the U.S. Centers for Disease Control and joined here by Dr. Juliette Morgan who is the lead of the office here in Tbilisi we feel very privileged to be asked to participate in this novel and a pioneering effort in the world to set a national goal for the elimination of H.C.B. transmission and disease this is a first and I think it's very very courageous for Georgia to embark upon this effort but also one that they see is very necessary given a large burden in the country and we would like to begin to lend some of our technical assistance and work with our colleagues here in Georgia to to make sure that they're successful as was mentioned by the health minister a few weeks will be setting off on the international survey to provide some current estimates of how many people are living with this infection something about their modes of transmission and about the different types of viruses of hepatitis C circulating in the country that are important to know for treatment we also will be looking at laboratory quality using the Luger lab that was built as a U.S. Georgian partnerships some years ago Keston is very important for this disease known as the silent killer most people can live unknowing the few symptoms of this but their virus is slowly and progressively happening with the need to liver damage and liver cancer so the testing has to be of high quality to get the diagnosis you need and unfortunately in Georgia as is true most countries around the world as a result of this silent nature most people are unaware of their infection so testing is very important and then lastly we're looking at the helping them develop their policy for elimination the first order of business to identify those persons already ill with this disease and get them into care then we can start out on reaching the goal of eliminating death from this virus and then move into a second phase we're going to to expand testing increase the number of people being treated and then magnify the management efforts in the Department of Transmission and healthcare settings through behavior such as injection drug use and sexual trans along the way we're going to be developing information systems to see what's working and what's not working so that we can improve the program here but also because this program is the first of its kind the lessons learned here in Georgia will be helpful for other countries recognizing this is a public health problem for their people and seeking to eliminate it and Georgia will be paving the way and shining the light as the virus do in this regard so Georgia will be going to become a leader in hepatitis C prevention and I think this partnership exemplifies that there's no one part of a health system or an international agency or a company can do this alone you have to pull together so we're very appreciative of CDC be working with ministry of health and also strong partners by Gilead Science who come here and are helping provide a life-saving therapist which is a critical part of the elimination plan so this is a very ambitious goal but I feel like if we work together we pull together and we can be successful thank you I'm turning over to Gilead to see if she has any other questions the launch of the program was led by the highest levels of government the prime minister we had the patriarch present as well many ministers from different ministries and I think it's a demonstration of the commitment that Georgia has put forward to make this happen and without that clearly this wouldn't be possible it's extremely exciting from a public health perspective to be able to participate something like this very exciting and I think also the fact that we have a partnership stepped up to as John said provide the critical elements just everything seemed to come together to be able to do this we have very high expectations and I think I think we'll be successful thank you Dr. Ward Dr. Morgan Greg would you like to make some comments please first I want to thank CSIS for hosting the event in Washington D.C. I'm sorry I can't be there but I had a sign of OU today so I just want to thank the embassy of Georgia in Washington D.C. as well as here that George is here for the hospitality that we've had and the support that we've had and put this program together this is a very exciting moment for Gilead you know we've we're very excited about the breakthrough therapy that I think has been discussed before and the potential that it offers to do something we've never been able to do in hepatitis C before which is not just cure the cure of the disease but cure it in large numbers of patients and really roll it out in a way that we could not have done with the prior therapies so we're very excited about the opportunity to show how that can be done and there's a lot of components that go into this let me just I think we want to try try to say how did we get to where we are today you know I think this started you know certainly in Georgia with a recognition of the science and seeing the science that was developing and seeing about the science that could really benefit patients here in Georgia which then resulted in conversations which initially started not around this particular project in this in the grand scheme that it is today but really you know talking with the minister of health about how they get access of Sevaldi and then Harvoni at an affordable cost for Georgia so that they could use it within their program and what we learned and the and in these conversations the questions were getting to understand what is the what are the patients in Georgia what is the prevalence what kind of capabilities are there in Georgia to do the treatment we've learned very quickly that there was incredibly strong commitment of the governor of Georgia to do something and and really be something big around hepatitis C for the people of Georgia and not just treat patients who are infected as the minister said also work on prevention to stop new infections in the country in Georgia that was very strong came through quite clearly the other thing we learned you know related to that commitment is that the significant investment have already been made in Georgia in the United States we were able to see some of that today in some of the hospitals laboratories but some really a comprehensive investment in infrastructure and diagnostic to treat patients that was there as well a couple other things we learned is that Georgia actually there's there's multiple modes of transmission of hepatitis C so you're not just dealing with a country that you know is all IU or is all hospital setting there's multiple modes of transmission as well as multiple genotypes of other diseases those of you who are familiar with it has six different genotypes and there are three predominant genotypes in in Georgia which are very interesting to us as well the other thing that's very unique about Georgia is the oh well there's a very high prevalence in Georgia it's one of the highest in the world but also a relatively small manageable population so hearing all this from the minister of health we kind of took this back again and said this is a real opportunity to see what could be done by the government that has the has the investment and not just the drug but all the other components that go into it and if we're able to really scale up treatment could we see the ability to eliminate hepatitis C in an in an entire practice in a subpopulation so and so that's really how it started and then the conversation turned to that with the minister of health and then the other key component there was CDC having the US CDC on the ground obviously part of this as well gave us a lot of comfort but also a lot of resources to do the type of work we need to do to demonstrate what what can be done not just here in Georgia but elsewhere let's keep in mind we're talking about an eradication program but this is actually a hypothesis but now that we can do this we don't know if this is important or we think it will work we know it will treat lots of people we hear lots of disease but the real the proof of being in you know several years from now we can see that that would have estimated 6.7% is coming down that is really and then I know that there's a number of other delegates in the room at CSIS from other countries and that would be very important to us to make the case globally of the value in better treatment of hepatitis C the value of the line of treatment the value in being able to cure and prevent disease for long-term benefits not going to people and for the government so for Gilead this is a signing opportunity about the patient she's she's working to develop on this little lot of similar programs all the way thank you and it's an exciting very comprehensive program that you've heard described what I'd like to do is now move to your questions here what it would ask you to do two things first once you're recognized wait for the microphone because all the experts are in Tbilisi and they won't be able to hear you unless you have the microphone and second let us know your name and organization or affiliation before you ask your question so Senator Daschle I'm Tom Daschle I work with the Daschle group and with Gilead but let me just first thank you Scott and CSIS for hosting this important event and let me congratulate the people of Georgia the leadership of Gilead and of HHS in arriving at this momentous moment for all of us it is clear that hepatitis C is one of the most devastating diseases and is certainly a death sentence for so many people not only here in the United States but around the world and I think what you've accomplished in this new level of cooperation is a recognition that we are actually going to save lives and improve the quality of life for literally millions of people I think we will also demonstrate the importance of public-private partnership and a recognition that if this works it could serve as a model for other countries as well it seems to me whether we're successful will be determined in part by our resilience certainly by our innovation by the level of collaboration and certainly by our engagement at all levels and so my question would be what are your expectations in the timeframe that you've laid out how quickly do you believe we began to see some results and how might we begin to anticipate the progress that you've just described this morning thank you Greg you may be the best person to answer that you describe this as a hypothesis that we can eradicate the disease how does this play out over time in Georgia to that question the estimation of the total all of the required treatment and we will have particular exact date a new year to August and based on these latest results we are planning with preliminary calculations that it could take more than three years and approximately five but final the figures we will know at August after knowing the exact date thank you please I will just chime in just a little bit I think one of the things that also that makes this program very unique and exciting is that we will have data and some populations that are going to be really have them have very limited data as people who inject drugs we will have data not population also a big commitment to a prison population in Georgia I think we'll have results back very quickly to see not only the cure rates which we believe based on the clinical data we will receive very high cure rates for these populations and what's going to be very important to see is what's the reinfection like what's the prevention aspect of this and I think we will get that data some preliminary data short very quickly on this that'll be extremely helpful what we're doing globally in the U.S. and Europe and everywhere just a follow-up question for Dr. Ward or Dr. Morgan you mentioned the difficulty of actually identifying patients people who carry the hep C disease but don't know they're ill how will that how do you expect that to progress as this test goes on first order of business that we're already hard to hard about is looking at the laboratory quality so that the testing that is done is a it is a high quality and so you're getting accurate diagnosis and then we want to begin to bring more laboratories in the country into that quality assurance program we also need to follow that up with what we call policy development who needs to be tested Greg mentioned two important populations prisoners persons who inject drugs it's well known they have a very high prevalence of infection it's a very common infection many people don't have those characteristics and so we'll probably have to move to more broad based testing in the United States we've adopted a year of birth recommendation because of a high prevalence among the so-called baby boom population here it may be some other type of recommendation but we'll have to be a fairly broad to capture the large number of people who are living in this infection and don't know it Julia and as has been mentioned we launched the National Survey next week and this will take a few months to conduct but at the end of that we will have a national estimate of the burden of disease and the transmission of the disease so we'll understand the risk factors and then this will lead us to the implement to the to the prevention implementations in the in the areas that have been identified where the transmission is taking place so not only in the IV drug users and the prison population where we know transmission takes place but in the other people that don't know that they've been exposed through different different risk factors and haven't been clearly identified yet so I mean the launch is taking place while we are also launching National Survey which will really give us the evidence and really point where we need to invest our prevention efforts so okay let me you know the other critical element here is what's called health systems strengthening the treatment for hepatitis C used to be actively done by specialists because of these complex had a lot of side effects one of the big advantages that these new curative treatments is that they are safe they have very few side effects and they require much shorter durations of treatment so you can begin to move treatment out of the specialist I'm gonna into a more of a primary care setting of some other setting that is a lot more widely available than a hepatologist or a gastroenterologist or infectious disease person so I think over the phase two try to train primary care providers to become providers of hepatitis C treatment which should be very possible with these new curative treatments that have been produced thank you thank you yes here in the hall thank you Kelly Miman with McClarty Associates I have a question for the the minister I'm just curious and it's kind of a good follow-up to yours I think Scott on testing what modes are you considering given that there are different ways that that hep C is transmitted in Georgia what modes of education are you considering in Georgia public education both from a hey have you been tested perspective but also from a prevention perspective what do you think will be most effective in the Georgian population thank you it includes literally comprehensive action plan that includes not only treatment not only prevention and infection control but enhancement and improvement of patient society education because we already started implementation kind of labs who went experienced and already treated patients that are well-known faces in our experience of all these so we are trying to bring it through this kind of if I may say artists that they this is some stigmatized in our country and by sharing experience from other countries who went patient societies are much well developed and in in Georgia we are thinking that we very intensive information campaign that we already started a couple of months ago with establishment of these patient societies or let's say patient clubs and with announcement maybe not announcement but with showing already treated patients that have just no chance before implementation of this program we will give us question here and then one in the back Hi, Paul Wolfwoods from the American Enterprise Institute just around the corner first of all I want to associate myself very strongly with Senator Daschle's comments and I would underscore that I think the pioneering nature of this program is particularly important because it's being done by a European country and it's true that many people in Europe don't know very much about Georgia but I think the fact that Georgia has pioneered quite a few innovations over the last decade or more I think this is another opportunity to do the same thing and it takes I think some political courage because as the minister said this is a disease that carries a good deal of stigma and admitting that your population is infected is an essential first step to doing anything about it and as you said this is a disease that people can have it without realizing they have it and so therefore it would be easier to just skate along and pretend it doesn't exist but my impression from data on Southern Europe at least in Southern Europe this disease has a prevalence that extends far beyond intravenous drug users and is partly the result of insufficient awareness of the risk in medical practice so I also have a political question related to this which is it's true that people don't know that they're infected but presumably they will know that they've been cured and it seems to me that is a very positive impact that can be had here and so I'm curious if it's possible to make any estimate of how many people in Georgia not how many have the disease not what is the prevalence of the disease but how many people have relatives or close friends who are candidates for this program because I suspect the number is actually quite large in the political impact the positive political impact could be quite large here and sort of related to that same question I'm curious to know whether anyone in Tbilisi or here in Washington has insights into what is the prevalence of hepatitis C not in Georgia but in some of the surrounding countries some of which is we are more extremely important these days thank you Mr. Minister do you have a comment on that regarding data for the neighborhood countries we have different different data let's say for Georgia we have the last data from 2002 and for our neighborhood to neighborhood countries with different states but I think much more important as you mentioned the recognition that yes we have health care problem in our country and we are not trying to somehow paint and keep it somewhere to rise our countries ranking up to some ratings but to recognize and describe the ways to deal with and to manage with so I think political will will is leading one that this is absolutely mandatory but of course not sufficient factor for successfulness of the project and the people are representing our partners I think with in support we will be we will be unique at least data makers for other countries also and just and it go to Lee I think just to address you mentioned the impact more generally beyond just the absolute number by time here in Tbilisi in almost two years I'm always impressed with the amount of people that I meet that they're either their brother their cousin there somebody in their immediate family is impacted by this almost on a daily basis I think the the population is is very excited about this opportunity as I think the impact is very big if you're part of the question regarding problems in other parts of Europe as we've already mentioned several times we're going to be doing a very high quality survey to really get precise estimates many countries lack that type of information so we don't really know and have a have a good idea and to the other part of your question you're saying it's sort of easy to skate on by I think that's what you know people are doing through ignorance of the problems burden of this disease I mean we with the data that are available we we believe that in countries such as Ukraine have a have a substantial problem perhaps a country like Romania Portugal Spain Italy and some areas like that but I think all of those areas could benefit from some additional after doing watching data so that they would have information that perhaps just make one comment because I visited Ukraine when I was working at UNICEF four years ago to look at the HIV hepatitis C co-infection among adolescents which was a huge problem by far the leading cause of death of HIV positive people in Ukraine but also in all of Europe the hepatitis C is the you don't die of age your immune system doesn't work so you die of something else and hepatitis C was the biggest threat but some of the things we've heard this morning are really important because in many societies especially those in the former Soviet Union any kind of drug use was criminalized it wasn't seen as a public health problem you're identifying this as a public health problem where people need interventions not to be put in jail also talking about patient organizations and the role of civil society the word is going to spread when people get cured and if those organizations aren't able to be part of the coalition that's bringing this program and it's great here that they are also that's a real limit on its effectiveness so there are a number of aspects of this program that I think really have lessons far wider than just Georgia great point great point thank you question in the back my name is Manos Harrison and I'm from Last Mile 4D the question is probably most to everybody and I want to echo Senator Daschle's comments as well are you using as you do this survey will you be using a national registry of disease prevalence are you actually setting up a national registry for that how would this data be some place that other health issues then can be either compiled or driven out of this for other matters that matters health matters that are in Georgia thank you to see how they progress and the outcome so we envision many opportunities building on these platforms we have time for one more question if it exists not seeing one let me bring us to a close by first congratulating the government of the Republic of Georgia the U.S. officials involved and the people from Gilead in this amazing partnership that is going to make an important difference in people's lives but also thank you so much for for giving us some insight into this test market that you're running and we look forward to following the progress of this initiative and seeing it not only succeed in Georgia but replicated beyond this thank you to those in the room who have joined us here at CSIS this morning and have a great day