Welcome to the Clinical Center Grand Rounds, a weekly series of educational lectures for physicians and health care professionals broadcast from the Clinical Center at the National Institutes of Health in Bethesda, MD. The NIH Clinical Center is the world's largest hospital totally dedicated to investigational research and leads the global effort in training today's investigators and discovering tomorrow's cures. Learn more by visiting us online at http://clinicalcenter.nih.gov GOOD AFTERNOON. WELCOME TO TODAY'S CLINICAL GRAND ROUNDS. WE HAVE 3 COLLEAGUES DISCUSSING PROBLEMS AND PARADIGMS. THE FIRST SPEAKER, DR. HENRY MASUR SENIOR INVESTIGATOR, PRESENTING DATA ON THE EPIDEMIOLOGY OF HEPATITIS C. HE EARNED HIS UNDER GRADUATE DEGREE FROM DARTMOUTH AND MEDICAL DEGREE FROM CORNELL MEDICAL COLLEGE. SUBSEQUENTLY DID INTERNAL INTERNSHIP IN RESIDENCY, NEW YORK HOSPITAL AND SENIOR RESIDENCY AT JOHNS HOPKINS. FOLLOWING A FELLOWSHIP IN INFECTIOUS DISEASE AND INTERNATIONAL MEDICINER HE SERVED AS INSTRUCTOR IN THE INFECTIOUS DISEASE DIVISION OF THE DEPARTMENT OF MEDICINE FROM 1978 UNTIL 1982. IN 1982 RECRUITED TO THE NIH TO JOINTLY FOUND A NEW DEPARTMENT OF CRITICAL CARE MEDICINE IN THE CLINICAL CENTER WHERE HE SERVED AS FIRST DEPUTY CHIEF, AND I HAD THE GOOD FORTUNATE OF BEING RECRUITED AS ONE OF YOUR FIRST FELLOWS IN THE DEPARTMENT IN 1982. HE WAS ALSO PART OF THE CLINICAL AND RESEARCH TEAM THAT STARTED THE HIV-AIDS PROGRAM WITH THE NIAID. AND IN 1989 HE BECAME CHIEF OF THE CRITICAL CARE MEDICINE DEPARTMENT. DURING THE PAST 25 YEARS AS CHIEF THE CRITICAL CARE MEDICINE DEPARTMENT HAS ATTAINED NATIONAL INTERNATIONAL CLAIM FOR LEADERSHIP AND INDEPENDENT RESEARCH AND TRAINING MANY OF THE NATIONAL LEADERS IN CRITICAL CARE IN PULMONARY MEDICINE. EXPANDED CLINICAL SERVICES IN THE CLINICAL CENTER, SERVES A PIVOTAL ROLE IN THE CARE OF ALL PATIENTS WITH COMPLEX LIFE THREATENING MEDICAL DISORDERS. HE IS WELL-KNOWN FOR EXPERTISE IN HIV RELATED OPPORTUNITYISTIC INFECTIONS. HE'S PUBLISHED MANY HIGH IMPACT STUDIES PARTICULARLY NEW MA CYSTIS PNEUMONIA. COULD EDITOR OF THE GUIDELINES FOR MANAGEMENT OF OPPORTUNISTIC INFECTIONS IN ADULTS AND ADOLESCENCES. COEDITOR OF THE TEXTBOOK AIDS THERAPY AND A PAST PRESIDENT OF THE INFECTIOUS DISEASE SOCIETY OF AMERICA. DR. MASUR LEADS THE DISTRICT OF COLUMBIA PARTNERSHIP FOR AIDS PROGRESS, AND THIS PROGRAM IS A UNIQUE COLLABORATION BETWEEN NIH AND THE WASHINGTON DC GOVERNMENT WHICH AIMS TO CREATE AND URBAN MOD FOR DECREASING THE IMPACT OF HIV-AIDS ON UNDER-SERVED POPULATIONS. I WELCOME DR. MASUR AS OUR FIRST SPEAKER. [APPLAUSE] >> THANK YOU VERY MUCH, FRED. MUCH OF THE WORK THAT THAT WE'RE GOING TO TALK ABOUT IS WORK THAT THE DISTRICT OF COLUMBIA PARTNERSHIP FOR AIDS PROGRESS IS DONE IN THE DISTRICT WITH A SPECIAL FOCUS ON THE CO-MORBIDITY HEPATITIS C. THIS IS A UNIQUE PARTNERSHIP INVOLVING INTRAMURAL AND EXTRAMURAL, INVOLVES THE DISTRICT OF COLUMBIA DEPARTMENT OF HEALTH, THE GEORGE WASHINGTON SCHOOL OF PUBLIC HEALTH AND A NUMBER OF INSTITUTES HERE. WHICH I CAN IS A PROGRAM DESIGNED TO SHOW THAT INTRAMURAL CAN HAVE AN IMPACT ON THE COMMUNITY BOTH IN TERMS OF IMPROVING HEALTH IN THE CITY, AND IN TERMS OF DOING WHAT IS POINTER AT NIH, WHICH IS TO PRODUCE RESEARCH. IN TERMS OF THE SPEAKS, DR. KATTAKUZHY HIGHLY INTRODUCE IN A MOMENT HAS RECEIVED AND INSTITUTIONAL GRANT FOR GILEAD. WHAT WE'RE GOING TO TALK ABOUT TODAY ARE 3 ISSUES. ONE, WE'LL TALK ABOUT CURRENT CONCEPTS ABOUT THE EPIDEMIOLOGY OF HEPATITIS C. BOTH NATIONAL AND GLOBALLY. BARRIERS TO GLOBAL ERADICATATION, AND TALK ABOUT OPPORTUNITIES IN THE FUTURE FOR HOW TO SOLVE THE PROBLEMS OF HEPATITIS C. SARAH KATTAKUZHY IS GOING TO TALK ABOUT BARRIERS, SHE CAME TO CLINIC 8 TO SEE WHAT CLINICAL RESEARCH WAS LIKE AND SHE HAS SINCE STAYED WITH DC PARTNERSHIP FOR HIV AND WADES FOCUSING ON HEPATITIS C. SHE HAS AN APPOINTMENT AT THE UNIVERSITY OF MARYLAND WHERE SHE WORKS WITH SEAN COREAL, OUR THIRD SPEAKER. HE WORKED FOR 134 YEARS WITH ANTHONY FAUCI, NIAID. HE'S MOVED TO THE MARYLAND, THE ASSISTANT DIRECTOR OF INFECTIOUS DISEASE. HE CONTINUES TO BE INVOLVED IN THE DC PARTNERSHIP SERVING AS A SCIENTIFIC DIRECTOR AND LEADER FOR HEPATITIS C PROGRAM. YOU'LL HEAR FROM EACH OF THEM SEQUENTIALLY. ONE OF THE ISSUES I'D LIKE TO EMPHASIZE ABOUT THIS PARTNERSHIP BETWEEN THE DC GOVERNMENT AND ACADEMICS, THIS IS A PRODUCTIVE PARTNERSHIP. IF YOU LOOK AT WHAT'S IMPORTANT AT NIH, I THINK THE NUMBER OF PUBLICATIONS THAT SEAN HAS BEEN ABLE TO GET FROM THIS HAS BEEN ASTONISHING, SHOWN HERE. I THINK IT'S ALSO IMPORTANT TO POINT OUT THAT IF YOU LOOKED IN TERMS OF BENEFIT TO THE DISTRICT OF COLUMBIA, NOT ONLY HAS IT BEEN MORE ACCESS TO HEPATITIS C CARE BUT ALSO THE AMOUNT OF DRUG CONTRIBUTE BY THE PHARMACEUTICAL SPONSORS APPROACHES $60 MILLION, AND OVER 1,000 PATIENTS HAVE BEEN TREATED BY DC IN THE DISTRICT. LASTLY, THIS PROGRAM HAS REALLY BEEN A MAGNET FOR TALENT. YOUNGER INVESTIGATORS LIKE SARAH AND OTHERS HAVE COME TO THE PROGRAM AND REALLY A MARVELOUS WAY THROUGH PATIENTS AND TO RECRUIT UNDER INVESTIGATORS TO TO TO WORK WITH THE INTRAMURAL PROGRAM. IT'S IMPORTANT TO REMIND YOU WHO ARE NOT AWARE, HEPATITIS C HAS A SPECIAL RELATIONSHIP TO INTRAMURAL HIV. HARRY ALTER, PICTURED HERE -- ARE YOU HERE, HARVEY? HE WON THE LASKER AWARD FOR BEING THE CODISCOVERER OF HEPATITIS C. THIS IS A DISEASE, THE ETIOLOGIC AGENT WHICH WAS DISCOVERED AT NIH. WHAT WE'VE ALL WITNESSED IN OUR MEDICAL CAREERS IN THE LAST 20 YEARS IS A CITIES IN WHICH WE HAD -- DISEASE IN WHICH WE FIRST DIDN'T KNOW THE CAUSE, WHERE WE RECOGNIZED THE CAUSE, WE HAD SILOGIC TESTS. NOW WE'VE GONE FROM BEING ABLE TO TREAT IT ONLY WITH DIFFICULTY TO HAVING A VERY HIGH CURE RATE AS YOU'LL SEE. THIS IS REALLY A DISEASE, INTRAMURAL HIV SHOULD BE PROUD THIS HAD AN IMPORTANT ROLE IN. AS WE TALK ABOUT HEPATITIS C TODAY, WE HAVE TO REMEMBER THIS IS AN RNA VIRUS, MUCH LIKE DENYINGY, YELLOW FEVER OR ZIKA. IT'S VERY AIR PRONE. THIS GIVES YOU A PICTURE OF THE VIRAL EPIDEMIOLOGY. IF YOU LOOK AT THE NATURAL HISTORY IN TERMS OF WHAT DISEASES IN HUMANS, MOST ARE AWARE ALMOST EVERYBODY EFFECTED, ABOUT 85% BECOME CHRONICALLY INFECTED. ONLY ABOUT 15% OF PEOPLE SPONTANEOUSLY CLEAR THIS. THIS IS RELATED TO IL28B GENOTYPE AS WELL AS OTHER FACTORS. 85% OF INDIVIDUALS ARE CLONALLY INFECTED. OF THOSE, A FIFTH GO ON TO DEVELOP SEER ROSIS. 5-10% DEVELOP HE PAT CELLULAR CARCINOMA. HEPATITIS IS A MAJOR CAUSE OF DEATH, AND MAJOR CAUSE OF LIVER TRANSPLANTATION IN THE UNITED STATES. THIS EVOLUTION OCCURS OVER 10-30 YEARS SO THIS IS A SILENT KILLER, AS THEY SAY. SLOWLY PROGRESSIVE. ONE THAT IS CLEARLY CAUSING MORBIDITY OR MORTALITY IN THIS COUNTRY. IF YOU LOOK GLOBALLY THERE ARE ABOUT 170 MILLION PEOPLE WHO ARE INFECTED WITH THIS VIRUS, ABOUT 3-4000000 NEW INDIVIDUALS ARE INFECTED EACH YEAR. YOU'RE GOING TO SEE HERE BY THE DARKNESS OF THE COLOR, WHERE THIS IS MOST PRESSURE LIBERTY, ESPECIALLY IN -- PREVALENT, ESPECIALLY IN SOUTH AMERICA, ASIA AND AFRICA. IF YOU LOOK AT THE EPIDEMIOLOGY IN THE UNITED STATES, THESE DATA PROBABLY UNDER-REPRESENT THE PREVALENCE IN THE U.S., EXCLUDE PRISONERS AND HOMELESS. BUT YOU CAN SEE THAT FROM 1988 TO 2010, ALTHOUGH THE INCIDENCES OR PREVALENCE DECLINED A LITTLE BIT, THERE IS STILL ABOUT 1.3% OF INDIVIDUALS IN THE UNITED STATES WHO HAVE BEEN INFECTED, AND AGAIN, ABOUT 85% OF THOSE ARE ACTIVELY INFECTED AND LIKELY TO PROGRESS TO CIRRHOSIS AND OTHER FORMS OF END STAGE LIVER DISEASE. IT'S ALSO REMARKABLE TO LOOK AT WHAT'S HAPPENED IN TERMS OF MORTALITY DUE TO HEPATITIS C COMPARED TO HIV. THERE IS A LOT OF FOCUS IN THIS COUNTRY ON THE NUMBER OF DEATHS DUE TO HIV. ABOUT 2006 OR 2007, THE NUMBER OF DEATHS DUE TO HEPATITIS C EXCEEDED THAT OF HIV. I THINK THAT'S SOMETHING THAT NOT EVERYBODY RECOGNIZES, BUT IT'S IMPORTANT TO BE AWARE OF. IF YOU LOOK AT NOT JUST THE PEAK INCIDENCE OF DISEASE, IN THIS COUNTRY, BUT ALSO THE PEAK INCIDENCE OF THE MORBIDITIES, NAMELY CIRRHOSIS, YOU CAN SIGH THAT AROUND 2000 WE HAD WHAT IS LIKELY TO BE THE HIGHEST INCIDENCE GIVEN THE IMPACT OF THOSE INFECTED THROUGH 1945 AND 1965 WHICH IS THE PEAK BIRTH COHORT FOR HAVING HEPATITIS C. PROBABLY DUE TO IV DRUG USE. YOU CAN SEE THAT CIRRHOSIS WILL LAG BEHIND THAT A LITTLE BIT. FROM 2015 TO 2030, WE'RE LIKELY TO SEE SIGNIFICANT MORBIDITY DUE TO CIRRHOSIS AND IS HE QUILLI IN THIS COUNTRY. SOMETHING WE HAVE TO CONSIDER HOW WE CAN PRO VENT THE PROGNOSIS OF DISEASE AND WHAT WE CAN DO WITHOUT IT. IT'S ALSO IMPORTANT TO REMEMBER THAT IN THE DISTRICT OF COLUMBIA, THIS IS A MAJOR ISSUE. PROBABLY 16 TO 24,000 INDIVIDUALS IN THE DISTRICT ALONE. IF YOU LOOK LIT OCCURS IN THE CITY AND COMPARE IT TO WHERE HIV OCCURS THEY'RE IN SIMILAR, NOT IDEA CALL PARTS OF THE CITY. WORDS 6 USER 7, 8th WE HAVE OUR CLINICS AND SEE MANY PATIENTS. THIS IS THE HIGHEST INCIDENCE FOR HEPATITIS C AND HIV. LASTLY, IT IS REALLY BREATHTAKING TO LOOK AT WHAT HAS HAPPENED IN TERMS OF TREATMENT FOR HEPATITIS C. WHEN THIS DISEASE WAS FIRST RECOGNIZED, A DIFFICULT REGIMEN IN TERMS OF SIDE EFFECTS AND VERY POOR CURE RATES AS YOU CAN SEE ON THE LEFT, WE WENT PROGRESSIVELY FROM INTERRIEN, AROUND ONLY WITH THAT, ABOUT 50% OF PATIENTS WERE CURED. THE SEQUELI FOR INTERFERON, THE TOXICITIES, THE MALAISE, FEVER, WERE VERY DIFFICULT FOR PATIENTS TO TOLERATE. ASTONISHING AS YOU WILL SEE LATER, DIRECTLY ACTING AGENTS, THE AGENTS WE HAVE BEEN TESTING AND PILOTING IN THE DISTRICT OF COLUMBIA, OVER 95% OF PATIENTS IN ALMOST EVERY COHORT ARE CURED BY AN 8-24 WEEK REGIMENT. THIS INCLUDES PATIENTS IN THE DISTRICT WHO ARE CONSIDERED DIFFICULT TO TREAT, WARDS 6, 7, 8, SAUDI SASUBSTANCE ABUSE PROBLEMS, IT'S REMARKABLE HOW TOLERATED THESE DRUGS ARE. THIS IS OSTON NICHING, GOING FROM NOT UNDERSTANDING THE CAUSE OF HEPATITIS TO BEING ABLE TO CURE IT IN ALMOST EVERYBODY. SO THAT IS AN INTRODUCTION. SARAH KATTAKUZHY IS GOING TO COME AND TALK ABOUT BARRIERS TO HEPATITIS C CARE. >> WE'VE JUST WITNESSED THE WONDERFUL EVOLUTION OF THERAPY FROM THE 90s TO TODAY. AND YET WHILE WE HAVE THIS EFFICACIOUS DIRECTLY ACTING AIRPORT VIRAL AGENTS THERE EXISTS A NUMBER OF BARRIERS TO TREATMENT TO GLOBAL ERADIATION. WE WANT TO OUTLINE THESE. SO IN TALKING ABOUT BARRIERS TO CARE, THE HEPATITIS C CARE CASCADE IN THE UNITED STATES IS A GOOD FRAMEWORK FOR THIS DISCUSSION. WHAT WE HAVE HERE IS DATA FROM 2014 IN THE UNITED STATES. ON THE LEFT YOU HAVE THE NUMBER, THE PERCENTAGE OF PEOPLE WHO INFECTED WITH HEPATITIS C. AND THIS IDENTIFIES EACH STEP IN THE CARE CASCADE DOWN TO THE PERCENTAGE OF PATIENTS ON THE RIGHT WHO ARE CURED OF HEPATITIS. SO AS YOU CAN SEE, THERE ARE A NUMBER OF SIGNIFICANT DROP OFFS. IN THIS CASCADE. AND THAT'S WHAT WE HOPE TO TALK THROUGH. AND NOT ONLY ARE THEY BARRIERS, BUT THEY ALSO REPRESENT A PLATFORM FOR CHANGE, OPPORTUNITIES TO CLOSE THESE GAPS AND LEAD TO ERADIATION OF HEPATITIS. SO YOU'LL SEE HA THE FIRST STEP IN THE CARE CASCADE IS SCREENING FOR HEPATITIS C. THIS IS WHERE WE SEE THE HIGHEST DROP OFF IN LOSS OF PATIENTS. ONLY 50% OF PATIENTS INFECTED WITH HEPATITIS C ARE AWARE THAT THEY HAVE THE DIAGNOSIS. AND WE'LL DISCUSS WHY THIS POTENTIAL REASONS FOR THIS. SO ACCORDING TO THE CENTERS FOR DISEASE CONTROL, THERE ARE SEVERAL CHARACTERISTICS OF PATIENTS WHEN WE ENCOUNTER THAT SHOULD PROMPT HEPATITIS C SCREENING. AS DR. MASUR ALLUDED TO, THE BIRTH COHORT, PATIENTS WHO ARE BORN BETWEEN 1945 AND 1965, SHOULD HAVE A ONCE LIFETIME TEST FOR HEPATITIS C. THERE ARE ALSO A PLETHORA OF RISK BEHAVIORS, INJECTION DRUG USE, INTRANASAL DRUG I DON'T IMAGINE SO AS WELL AS RISK EXPOSURES, PEOPLE ON LONG TERM HEMODIALYSIS, INCARCERATED PATIENTS, UNCLEAN TATTOOS, AS WELL AS CONCOMITANT DISEASES SUCH AS HIV, WHERE THERE ARE ALSO RECOMMENDATIONS FOR SCREENING. BUT THERE ARE 2 ISSUES. ONE, THERE IS A LENGTHY RISK SCREENING PROCESS THAT'S REQUIRED TO PROMPT HEPATITIS C TESTING. SO ONE PROVIDERS MAY HAVE BIAS AND MAY NOT APPROPRIATELY CHARACTERIZE THE RISK OF THEIR PATIENTS. TWO, IN ORDER TO FIND OUT WHICH SPECIFIC RISK CATEGORIES PATIENTS MEET, IT TAKES TIME WHICH IS ONE THING WE KNOW PROVIDERS DO NOT HAVE IN THIS DAY AND AGE. SO THOSE ARE SEVERAL REASONS WHY SCREENING, ACCORDING TO THE GUIDELINES, MAY BE DIFFICULT. THE TECHED REASON IS THAT -- SECOND REASON IS CURRENTLY HEPATITIS C DIAGNOSIS REQUIRED A MULTIPLE STEP PROCESS. HEPATITIS C ANTIBODY IS INITIAL TEST FOR HEPATITIS C SCREENING. AS WE DISCUSSED WITH DR. MASUR ABOUT 15% OF PATIENTS WHO COME IN CONTACT WITH HEPATITIS C ELIMINATE THE VIRUS, HOWEVER, THEY RETAIN POSITIVE ANTIBODY FOR LIFE. THIS IS ALSO TRUE OF PATIENTS WHO ARE CURATIVE HEPATITIS C THROUGH TREATMENT. SO THE SECOND STEP IN THE SCREENING PROCESS IS CONFIRMATION OF ACTIVE DISEASE THROUGH TESTING OF HEPATITIS C RNA. ONCE IT RETURNS POSITIVE THIS IS WHEN WE CAN DIAGNOSIS THE PATIENT WITH HEPATITIS C INFECTION. SO AS YOU CAN SEE, AS YOU CAN IMAGINE, IN THE COMMUNITY, THIS REQUIRES THE PATIENT POTENTIALLY TO RETURN AT LEAST 3 TIMES BEFORE BEGINNING A CONVERSATION ABOUT THEIR HEPATITIS C DIAGNOSIS. WHICH TRANSLATED IN THE REAL WORLD HELPS CONTRIBUTE TO THE MISSING 50% OF PATIENTS. ANOTHER KEY ISSUE IS THAT AS EVIDENCED BY THE RISK CATEGORIES, OUTLINED BY THE CDC, HIGH HIVING POPULATIONS ARE REALLY THE -- HIGH RISK POPULATIONS ARE THE PRO GENDERS OF THE EPIDEMIOLOGY AND IMPORTANT GROUP WITH WHICH TO HAVE ROBUST SCREENING. THESE ARE ALSO THE GROUPS THAT USUALLY HAVE THE LOWEST INTERACTIONS WITH THE HEALTHCARE SYSTEM. SO WE HAVE A CYCLE OF PATIENCE WHO ARE UNTIMTIM DIAGNOSED WITH HEPATITIS C, ENGAGING IN HIGH RISK BEHAVIORS AND TRANSMITTING THE DISEASE. WHEN WE DISCUSS HIGH RISK POPULATIONS, SPECIFICALLY WE'RE REFERRING TO PERSONS WHO INJECT DRUGS, THOSE ARE HIGH RISK SEXUAL PRACTICES, HOMELESS PERSONS AND INCARCERATED INDIVIDUALS. AS WE CAN -- AS THIS CHEERLY LAYS OUT THERE ARE SOCIAL AND ECONOMIC FACTORS THAT LIMIT OUR ABILITY TO ACCESS THESE POPULATIONS AND THEREFORE HAVE ROBUST SCREENING. SO MOVING ON TO ACCESS AND TREATMENT. SO YOU CAN SEE THE NEXT STEP IN THE HEPATITIS C CARE CASCADE IS THAT ALTHOUGH THERE ARE 43% OF PATIENTS WHO HAVE ACCESS TO OUTPATIENT CARE, MEANING THEY'RE COMING TO A CLINIC, THEY'RE SEEING A PROVIDER, ONLY 16% ARE ACTUALLY PRESCRIBED HEPATITIS C THERAPY. WHY IS THAT? SO ONE OF THE MAIN LIMITATIONS IS THAT THERE ARE NOT NURTURE PROVIDERS TO -- ENOUGH PROVIDERS TO SEE THE 2.7 MILLION AMERICANS WITH HEPATITIS C. AT MAXIMAL ESTIMATE, THERE ARE AROUND 20,000 PRACTICING INFECTIOUS DISEASE AND GASTRO INTERROLLING SPECIALISTS IN THE UNITED STATES. THIS IS AN UPPER ESTIMATE WHICH TRANSRATES TO A VERY LARGE NUMBER OF PATIENCE PER PROVIDER. SECOND THING TO CONSIDER IS THAT SPECIALISTS ARE NOT DISTRIBUTED EQUALLY IN THE UNITED STATES. THEY'RE CONCENTRATED IN CITY LOCATIONS. AS SUCH, RURAL PATIENCE, URBAN PATIENTS SUCH AS OUR PATIENTS IN APCOSTIA IN WARD 8, HAVE DIFFICULTY WITH ACCESS TO SPECIALIST CARE, RESULTING IN LENGTHY WAIT TYPES TO BE EVALUATED FOR THEIR HEPATITIS C, OR LONG DISTANCE TRAVEL WHICH ALL CONTRIBUTE TO LOSS TO FOLLOW UP. SO THERE WAS A STUDY PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE IN 2010 THAT LOOKED AT THE POSSIBLE CARE MODEL TO BRIDGE THIS GAP. AND THEY DID THIS USING PRIMARY PROVIDERS. NURSE PRACTITIONERS AND PRIMARY CARE PHYSICIANS. AND THE ECHO STUDY WHICH STANDS FOR A FORM OF TELEMEDICINE COMMUNICATE, IN THE ECHO SITES WERE DISTRIBUTED IN RURAL AREAS IN NEW MEXICO AND ARIZONA. AND THE UNIVERSITY SITES WERE ALL SPECIALISTS LED THERAPY BASED IN THE UNIVERSITY CITY. AS YOU CAN SEE, WITH INTERFERON BASED THERAPY, THERE WERE VARYING RATES OF RESPONSE, BETTER THAN THE STANDARD. YET WHAT WAS REQUIRED WAS ONGOING TELEMEDICINE MENTORSHIP BETWEEN THE SPECIALIST PROVIDERS AND NURSE PRACTITIONERS AND PRIMARY CARE PHYSICIANS IN THE COMMUNITY. AND AS SUCH, THIS LIMITS POTENTIAL APPLICATION OF THIS, PARTICULARLY TO INTERNATIONAL AREAS WHO MAY NOT HAVE THIS TECHNOLOGY. NEXT WE GO ON TO CARE. A PATIENT IS ABLE TO GET TO SEE A PROVIDER WHAT HAPPENS NEXT? IT REQUIRES AN EXTENSIVE WORKUP TO INITIATIVE HEPATITIS C MEDICATIONS. THESE INCLUDE GENOTYPE, FAMILY OF HEPATITIS C WHICH HAS AN IMPACT ON WHICH DIRECT ACTING AGENT TO UTILIZE. THE VIRAL LOAD, WHICH HAS AN IMPACT ON LENGTH OF TREATMENT. ASSESSMENT OF LIVER ENZYMES, INR AROUND PLATELETS FOR SAFETY MONITORING, STAGING IN THE FORM OF ANY APPROVED ASLD APPROVED STAGING MECHANISM, FIBROTEST, OR LIVER BIOPSY. IF THE PATIENT IS CEROTIC, HAVING ADVANCED FIBROSIS, SCARRING OF THE LIVER, WE HAVE TO OBTAIN HEPATOCELLULAR CARS CASTER SCREENING AND THE FORM OF MAJORS THROUGH ULTRASOUND, CT OR MRI. THERE HAS TO BE DOCUMENTATION OF THE STATUS OF A SIRE ROTIC PATIENCE. IS THE PATIENT DECOMPENSATED? FINALLY, THERE HAS TO BE EXTENSIVE DOCUMENTATION OF BOTH DRUG AND ALCOHOL USE. THIS EXTENS EVEN TO ELDERLY PATIENCE, PATIENTS WHO HAVE NEVER USED DRUG OR ALCOHOL IN THEIR LIFETIME. ONE BARRIER WIDELY DISCUSSED IN THE MEDIA IS COST. SO I WANT TO JUST SPEND A FEW MOMENTS ON COST BECAUSE IT'S A LARGER CONVERSATION THAN PERHAPS THE MEDIA MAY IMPLY, BUT A VERY IMPORTANT ONE. THIS HAS BEEN EXTENSIVELY COVERED IN THE NEWS, AND THE REASON WHY MANY PEOPLE ARE AWARE OF NEW MEDICATIONS FOR HEPATITIS C. HEPATITIS C MEDICATIONS ARE EXPENSIVE. AND THE COSTS HAVE EVEN RESULTED IN CONGRESSIONAL HEARINGS OF -- AS RECENTLY OCCURRED IN 2015. SO HERE WE HAVE A LIST OF THE WHOLE ACQUISITION COSTS FOR ONE DAY. DAYS WORTH OF MEDICATION. AND ON THE LEFT COLUMN, WE HAVE THE RECENTLY APPROVED DIRECT ACTING ANTIVIRAL AGENTS THAT ARE UTILIZED FOR TREATMENT OF HEPATITIS C CURRENTLY. ONE IMPORTANT THING TO NOTE IS THAT WHOLE ACQUISITION COSTS IS RARELY WHAT PAYERS, INSURANCE COMPANIES ARE ACTUALLY PAYING. IN ONE ANALYSIS THERE IS UP TO A 46% DISCOUNT ON THE WHOLE ACQUISITION COST TO WHAT PAYERS OR INSURERS -- INSURANCE PROVIDERS ACTUALLY PAY FOR THE MEDICATION. BUT THE TRUTH IS THAT THERE IS A CLOSEED DOOR POLICY IN MEDICATION COSTS. WE REALLY DO NOT UNDERSTAND THE TRUE COST TO EACH INDIVIDUAL PAYER AND IT IS DIFFERENT FOR EACH INDIVIDUAL PAYER. AND THAT IS A PRODUCT OF OUR SYSTEM. BUT ONE THING TO KEEP IN MIND IS THAT COST ALSO HAS TO BE CONSIDERED RELATIVE TO THE DEGREE OF CURE. AND HERE WE HAVE THE COST PER CURE OF THE VARIOUS HEPATITIS C REGIMENTS. YOU CAN SEE THAT PEGASYD INTERFERON BASED THERAPY WAS $100,000, SIMILAR TO OTHERS FOR 12 WEEKS. THE ASTERISKS OR QUESTION MARKS INDICATE POTENTIAL DISCOUNTS BY SOME PAYERS, AGAIN, WE'RE NOT SURE OF. YOU CAN SEE THAT THERE ARE EQUIVALENT COSTS PER CURE OF SVR. BUT THE ISSUE IS THAT THERE ARE NOW -- THERAPY IS SAFE, TOLERABLE AND EFFECTIVE, AND POPULARIZED IN THE MEDIA. MORE PEOPLE ARE AWARE OF MEDICATION AND MORE PEOPLE COMING FORWARD. SO NOW WE HAVE AN ISSUE OF A HIGH COST MEDICINE WITH A HIGHLY PREVALENT DISEASE HAVING HIGH DEMAND, SOMETHING THAT WAS NOT THE CASE WITH INTERFERON BASED THERAPY. AS WELL AS MEDIA COVERAGE PROPELLING THIS CYCLE. AND THEREFORE, WHILE DIRECTLY ACTING AGENTS MAY HAVE AN APPROPRIATE PRICE PER CURE AND MAY BE COST EFFECTIVE, THEY'RE CURRENTLY NOT AFFORDABLE. AND THIS IS LEADING TO PAYER RESTRICTIONS AND RATIONING OF CARE. SO HERE WE HAVE A MAP FROM A STUDY CONDUCTED IN THE ANNUALS OF INTERNAL MEDICINE LAST YEAR. IN THIS MAP, THE DARKER COLORS, THE VARIATIONS IN COLOR, REFER TO THE RESTRICTIONS AROUND FIBROSIS STAGING. SO MOST STATE BASED MEDICAID, MOST PUBLIC STATE BASED INSURERS HAVE RESTRICTIONS AROUND FIBROSIS. YOU CAN SEE HERE IN THE DISTRICT OF COLUMBIA, THE PATIENT IS REQUIRED TO HAVE IN SOME CASES F2 OR F3 OR F4, MEANING ADVANCED STAGE FIBROSIS BEFORE THEY WILL BE APPROVED FOR HEPATITIS C MEDICATION. YOU CAN SEE THAT THIS RANGES FROM ONLY CEROTIC PATIENTS BEING TREATED TO SOME STATES LIKE MASSACHUSETTS WHERE THERE IS VERY FEW LIMITATIONS ON HEPATITIS C THERAPY. SECOND WE HAVE RESTRICTIONS AROUND ELICIT DRUG USE. IN THE DISTRICT OF COLUMBIA, THERE IS ACTUALLY INDIVIDUAL VARIATIONS BETWEEN EACH MANAGED CARE ORGANIZATION OF THE PUBLIC INSURERS. IT RANGES EVERYWHERE FROM COMPLETE DRUG ABSTINENCE FOR 3 MONTHS THAT'S DO YOU WANTED BY A MEDICAL PROVIDER, OR UP UP TO A YEAR'S WORTH OF DRUG AND ALCOHOL ABCTENCE. SO YOU CAN SEE ESPECIALLY CONSIDERING THE TARGET POPULATION, THIS IS EXTREMELY PROHIBITIVE FOR MEDICATION ACCESS FOR THE HEPATITIS C POPULATION AT LARGE. SO WHAT'S IMPORTANT TO KNOW IS THAT STATE INSURE RESTRICTIONS ARE NOT CONSISTENT WITH EITHER NATIONAL POLICY, NOR MEDICAL GUIDELINES. SO CMF ACTUAL LEANED A REPORT IN NOVEMBER OF LAST YEAR BECAUSE THEY WERE CONCERNED ABOUT THE DEGREE OF RESTRICTION THAT THE STATE BASED INSURANCE WAS PROVIDING AROUND BOTH FIBROSIS AND SUBSTANCE USE. SECONDLY, THIS BOX WAS TAKEN FROM THE HCV GUIDELINES.ORG, A JOINT EFFORT BETWEEN THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES AND THE INFECTIOUS DISEASE SOCIETY OF AMERICA OF WHICH DR. KOTTILIL IS A MEMBER OF. THESE GUIDELINES HELP REALLY CARVE OUT THE CHANGING LANDSCAPE OF HEPATITIS C THERAPY IN THE UNITED STATES, AND NOW THE MAIN FORM OF GUIDANCE THAT MOST PROVIDERS USE FOR HEPATITIS C CARE. AND CLEARLY, THE TREATMENT IS RECOMMENDED FOR ALL PATIENTS WITH HEPATITIS C EXCEPT FOR THOSE WITH SHORT LIFE EXPECTANCY IES. FROM ARE NO RESTRICTIONS BASED ON SUBSTANCE USE, CLEARLY DELINEATED IN THE GUIDELINE. INFECTIOUS RESTRICTIONS ARE NOT EVIDENCE BASED. THERE ARE CLEAR STUDIES TO INDICATE PERSONS THAT INJECT DRUGS, WHETHER IT'S PREVIOUS OR ON OPIOID THERAPY IS SUCCESSFULLY COME TO APPOINTMENTS, HAVE COMPARATIVE ADHERENCE AND COMPARATIVE SUSTAINED VIROLOGIC RESPONSE RATES TO THOSE WHO DO NOT HAVE ABSENCE SUBSTANCE USE. WHILE THIS ARE LIMITED NUMBER OF PATIENCE WHO SEE A PROVIDER, ARE ABLE TO BE PRESCRIBED TREATMENT, THERE ARE STILL GAPS IN THE NUMBER OF PATIENCE ACHIEVIS VCR, DESPITE DIRECT LAY DIRECTING ANTIVIRAL AGENT. THERE ARE CERTAIN TREATMENT GAPS. THESE INCLUDE 3 DISEASE WHICH IS NOT MUCH OF AN ISSUE IN TUNES. CERTAINLY PLACES ABROAD, INDIA, PAKISTAN, AND SOUTHEAST ASIA, PARTICULARLY FOR GENOTYPE 3 PATIENTS WITH CIRRHOSIS. FOR DECOMPENSATED SIR ROTICS, TRANSPLANT AND PERSONS THAT FAIL INITIAL DAA THERAPY, THERE IS REALLY UNCLEAR GUIDELINES BUT HEAVILY EVOLVING, CHANGING ALMOST EVERY 2 TO 3 MONTHS, AS TO WHAT IS THE BEST STRATEGY IN THESE POPULATIONS. RESISTANCE ASSOCIATED VARIANCE OR RAVs IS ALSO EMERGING UNCLEAR TREATMENT URN. SO AS DR. MASUR ALLUDED TO, HEPATITIS C IS AN RNA VIRUS, HIGH RATES OF VIRAL REPLICATION. HAS AN ERROR PRONE RNA ROW LIMEROUS. THERE IS A WAYS BASELINE RESISTANCE, PARTICULAR HEY TO NS3 OR NS5A INHIBITERS THAT ARE VERY PREVALENT BASELINE IN UP TO 20% OF PATIENTS WITH NATURALLY OCCURRING HEPATITIS C. RAVs ARE PERSISTENT IN ONE STUDY CONDUCTED UP TO 96 WEEKS LATER, RAVs WERE DEATHED. ON THE OTHER HAND, HEPATITIS C THERE IS NO DNA INTERMEDIATE, NO VIRAL RESERVOIR. WE HAVE HIGHLY EFFICACIOUS DIRECTLY ACTING AGENTS THAT PERHAPS MAY OVERCOME ANY IMPACT THAT RAVs DO CARRY. SO THIS IS AN ONGOING TREATMENT ISSUE THAT AS MORE PATIENTS ARE EXPOSED TO THERAPY, WE EXPECT TO BECOME OF GREATER SIGNIFICANCE. RE-INFECTION IS CONSIST PROPORTIONATE. PERSONS THAT INJECT DRUGS AND INCARCERATED INDIVIDUALS DUE TO THEIR SOCIAL SURROUNDINGS, IN ONE STUDY 10% OF PATIENTS WHO INITIALLY ENTERED PRISON BEING CURED OF HEPATITIS C, 10% WERE REINFECTED. THIS IS DUE TO MULTIPLE ENVIRONMENTAL AND SOCIAL FACTORS THAT THE INCARCERATED PATIENT FACES. ALSO SIGNIFICANCE, META-ANALYSIS CONDUCTED RECENTLY, PUBLISHED IN CID. HERE WE ARE DIGNITY THAT HIGH RISK INDIVIDUALS IN THE CENTER, THESE ARE PERSON WHOSE INJECT DRUGS WITH HIGH RISK SEXUAL PRACTICES, HAVE HIGH RATES OF FIVE YEAR RECURRENCE WITH REINFECTION. PARTICULARLY, WE SEE THAT COINFECTED POMS AT AN EVEN HIGHER RISK. THIS MAY BE SECONDARY TO IMPAIRED IMMUNITY WHEN EXPOSED TO REINFECTION. LASTLY, IT'S IMPORTANT TO REMEMBER THAT MARGINALIZED PATIENT POPULATIONS ARE DISPROPORTIONATELY EFFECTED AT EACH BARRIER THAT IS IN THE HEPATITIS C CARE CASCADE, PARTICULARLY THOSE PATIENTS WHO ARE PUBLICLY INSURED, WHO FACE GREATER RESTRICTIONS, A LARGER NUMBER OF MEDICATION DENIAL, AND HAVE LIMITED ACCESS TO SPECIALIST CARE. THESE ARE IMPORTANT POPULATIONS TO KEEP IN MIND IN OUR QUEST FOR GLOBAL ERADIATION OF HEPATITIS C. WHAT NEEDS TO BE DONE? WITH SCREENING WE NEED TO SIMPLIFY IT, TARGET TO THE HIGHEST RISK POPULATION. FOR TREATMENT, WE NEED TO SCALE UP PROVIDER CAPACITY. REDUCE THE FREQUENCY OF VISITS AND LABORATORY REQUIREMENTS. WE NEED TO ELIMINATE NON EVIDENCE BASED PAYOR RESTRICTIONS FOREHOCK THERAPY AND REDUCE THE COST. WE NEED A HIGH BARRIER OF RESISTANCE TO AVOID FUTURE ISSUE. LASTLY, WE NEED INTERVENTIONS TO REDUCE REINFECTION AND HAVE MONITORING FOR LONG TERM OUTCOMES. WITH THAT, I'LL TOSS IT TO TALKING ABOUT OPPORTUNITIES AHEAD. >> I'M GO BACK TO THE CASCADE OF HEPATITIS C CARE IN TUNES. TWO POINTS ON THIS SLIDE. ONE, 50% OF THE PEOPLE INFECTED DON'T EVEN KNOW THEY'RE INFECTED WITH HEPATITIS C, GIVE THAN WE CAN CURE THIS DISEASE. THAT'S A TERRIBLE FACT. SECOND, WE NOW ABLE TO TREAT AND CURE MOST OF THE TREATED PATIENTS WITH HEPATITIS C WITH THERAPEUTICS. HOWEVER, WE ARE NOT TREATING ENOUGH PEOPLE. IF YOU'RE TREATING ONLY 10% OF THE PEOPLE, WE CANNOT IMPACT THE GLOBAL PUBLIC HEALTH BURDEN OF THE DISEASE WHICH IS TREMENDOUS. TEN TIMES MORE THAN WHAT WE HAVE FOR HIV. SO HOW DO WE ACTUALLY ACCOMPLISH A MASSIVE ELIMINATION OF HEPATITIS C GLOBALLY? WE HAVE TO LOOK AT WHAT WE HAVE LEARNED FROM OTHER PANDEMICS. AS AN EXAMPLE, I WILL SHOW YOU WHAT HAS HAPPENED WITH HIV CARE MODEL IN RWANDA. YOU KNOW THAT IN 1994, THEY HAD A TERRIBLE GENOCIDE AND THE RECOVERY WAS IMPACTED BY THE HIV PANDEMIC THAT WAS IN THE AFRICAN SUBCONTINUANT. SO RWANDA STARTED HIV CARE AND THESE RED DOTS ARE THE HIV CLINICS THAT EXISTED IN 2004 BEFORE THE IMPLEMENTATION OF THE PEPFAR PROGRAM. SO THEY WERE ABLE TO TREAT PATIENTS IN THESE CLINICS, PROBABLY AROUND [INDISCERNIBLE], THE CAPITAL CITY. LOOK WHAT HAPPENED IN 2014. HIV CARE HAS EXPANDED IN EVERY NOOK AND CORNER OF RWANDA. THIS HAS RESULTED -- PEOPLE CAN ACCESS CARE WITHOUT TRAVELING, GO TO THESE CENTERS AND GET HIV CARE. WHAT THIS TRANSLATES TO EXACTLY WHAT YOU SEE HERE. THE MARKED DIAGRAMMED ARE THE NUMBER OF PEOPLE RECEIVING ANTIVIRALS FROM 2004 TO 2015. 80 TO 90% OF THE PEOPLE INFECTED WITH HIV ARE NOW RECEIVING ANTIVIRAL TREATMENT. THIS HAS RESULTED IN REDUCING THE NEW CASES OF HIV INFECTION OVER TIME, EXACTLY WHAT THEY HAVE ACCOMPLISHED IN HIV. MOST CITIES IN THE UNITED STATES WERE REALLY -- WOULD LIKE TO REPLICATE THE RESULTS OF WHAT WAS IN RWANDA. THIS SHOULD BE EASIER WITH HEPATITIS C, YOU HAVE A SHORT DURATION TREATMENT, YOU HAVE A CURE. SO THAT SHOULD BE TRANSLATED TO EASEILY. WHAT IS REQUIRED FOR US? WHAT IS REQUIRED FOR US? BASICALLY 4 ASPECTS. ONE, YOU NEED TO SIMPLIFY TESTING AND SCREENING AS DR. KATTAKUZHY MENTIONED. YOU HAVE TO HAVE A POINT OF CARE TESTING THAT YOU CAN DO IN THE FIELD OR IN A DOCTOR'S OFFICE. YOU NEED TO BE ABLE TO PROVIDE -- TRAIN AND NEW PROVIDERS ARE NOT ACCUSTOMED TO TREATING HEPATITIS C. WE HAVE TO HAVE -- TO BE ABLE TO TACKLE AND UNDERSTAND WHAT WORKS, WHAT DRIVES THE EPIDEMIC IN DIFFERENT PARTS OF THE WORLD AND BE ABLE TO ADDRESS THESE ISSUES AND BLOCK THE TRANSMISSION NETWORKS. YOU ALSO HAVE TO SIMPLIFY TREATMENT. WHEN I SAY SIMPLIFY TREATMENT, PEOPLE SAY HOW SIMPLE CAN YOU GET. ONE PILL ONCE A DAY. BUT THERE ARE THINGS WE CAN DO. WE CAN MAKE [INDISCERNIBLE] AVAILABLE TO REDUCE COST. MEDICATION TO ALLOW YOU TO TRUST ALL GENOTYPES, SAVES YOU MONEY FOR TESTING. YOU CAN LOOK AT INTRODUCING STUDIES WITH LESS MONITORING, GIVEN A REGIMENT IS SAFE AND EFFECTIVE IN ALL PEOPLE. SO TACKLING THESE ONE BY ONE. EVERY ONE KNOWS THIS IS THE SOUGHT AFTER THING, THAT WE NEED A POINT OF CARE TESTING. WHEN YOU TEST, THERE ARE MULTIPLE LAYER TESTING. IF YOU HAVE A TESTING THAT LOOK FOR SIROLOGY, YOU LOSE PEOPLE FROM FIRST TO SECOND TEST. ESPECIALLY WITH DAYS TO GIVE RESULTS. IF YOU HAVE A TEST AVAILABLE YOU CAN DO THE TEST, IMMEDIATELY GIVE THE RESULTS IN 15-30 MINUTES. THAT ENHANCES THE NUMBER OF COMPLIANCE OF PEOPLE GETTING TESTED. SO THERE ARE A VARIETY OF DIFFERENT COMPOUNDS DEVELOPED. WHAT YOU REALLY NEED IN THE IDEAL -- IT HAS TO BE CHEAP. SO IT HAS TO BE OF A CHEAP TEST. YOU CANNOT BE AFFORDABLE. SOMETIMES TESTS IS CHEAP BUT THE TREATMENT OR IMPLEMENTATION ARE NOT CHEAP. IT HAS TO BE EASY TO CARRY THOSE, FROM ONE PLACE TO ANOTHER. IT ALSO HAS TO BE ACCURATE, WE HAVE TO BE ABLE TO VALIDATE IT. IT HAS TO BE TRUE. STEPS HAS TO BE DONE IN A SETTING THAT ELECTRICITY PROBLEMS ARE NOT THERE SO YOU CAN RELY ON THIS MATERIAL TO TEST THEM. WHAT IS REQUIRED? THIS POINT OF CARE TESTING IS WHAT WE'RE TESTING IN THE DISTRICT OF COLUMBIA AND BALTIMORE. WE HAVE PLATFORM WHICH USES A SMALL FINGER STICK LIKE THEY DO FOR BLOOD SUGAR. THEN YOU DO A PCR REACTION WITHIN THIS PARTICULAR CHAMBER, ONLY 2 POUNDS. IT WILL GENERATE A COLOR, DETECTED BY THE CAMERA OF THE SMART PHONE. THAT WILL GIVE YOU, A YES OR NO ANSWER. OOF THESE PLATFORMS, EITHER THIS OR SOME OF THE ONES WILL BE AVAILABLE TO PROVIDERS MAINLY THE UNITED STATES IN THE NEXT FEW YEARS. AND THIS WILL TRANSFORM HOW THESE SCREENING PATIENTS -- YOU CAN SCREEN PATIENTS IN ONE STEP. IN AN OFFICE SETTING AND ENHANCE THE LINKAGE TO CARE OF MOST OF THESE PATIENTS. DR. KATTAKUZHY MENTIONED WE DON'T HAVE ENOUGH DOCTORS TO TREATMENT HEPATITIS C. WHO TREATS HEPATITIS C IN THE UNITED STATES? USUALLY HEPATOLOGIES AND A FEW INEFFICIENCY DISEASE DOCTORS. THERE ARE NOT THAT MANY OF US AROUND TO TREATMENT 2.7 MILLION PEOPLE. THE MAJORITIES ARE NEWLY DESIGNATED, SO YOU HAVE AN ANGRY GROUP OF PEOPLE WHO DON'T HAVE A DOCTOR, THEY KNOW THEY HAVE A DISEASE. THERE IS A CURE BUT YOU'RE GOING TO DIE OF LIVER DISEASE AND [INDISCERNIBLE]. THIS IS MAJOR PROBLEM HERE. MAJOR PROBLEM IN THE GLOBALLY. FEWER PROVIDERS EXIST GLOBALLY TO TACKLE HEPATITIS C INFECTION. SO DR. KATTAKUZHY CONDUCT ADD LANDMARK STUDY IN THE DISTRICT OF COLUMBIA. SHE ASKED PATIENTS WHO DEVELOPED -- PROVID ERS IN 3 GROUPS. SPECIALISTS, AND THEN THE SECOND GROUP, GENERAL INTERNISTS, THE THIRD GROUP OF PATIENTS, PEOPLE WERE NURSE PRACTITIONERS AND PAs. EVERYBODY GOT A STANDARD TRAINING OF HEPATITIS C TREATMENT. GROUP A WAS ABLE TO CURE 3 -- PROVIDED 3 DRUGS. THEY TREATED PATIENTS. WE LOOKED AT WHAT IS OUTCOME. SO OUTCOME WAS SURPRISINGLY GREAT. THIS IS PRESENTED A COUPLE YEARS AGO -- MONTHS AGO. EFFICACY WAS 95%. SPECIALISTS, 93%, YOU HAVE GEM INTERNISTS, 97%, AND YOU HAVE NURSE PRACTITIONERS, 95%. NOW YOU HAVE A PROOF OF PRINCIPAL AND CLEAR STUDY THAT TELLS YOU THAT YOU CAN CLEARLY TOSS TO NEW PROVIDERS TO TREAT HEPATITIS C. THAT'S REALLY INSTRUMENTAL IN ENHANCING CARE. WHAT MAY WORK IN DC MAY NOT WORK IN OTHER PLACES, SOME OTHER PLACES YOU PROBABLY LEAD A LOT MOTHER SUPPORT SYSTEM IN PLACE -- MORE SUPPORT SYSTEM IN PLACE TO GET TRAINED. IF YOU'RE IN AN AFRICA VILLAGE -- YOU MAY HAVE TO DO -- DOWN HERE, THIS IS A COMPLETE TOSS SHIFTING. WE DID NOT GIVE SUPPORT, ONGOING SUPPORT TO PROVIDERS. WE TOLD THEM HOW TO TREAT AND THEY ACTUALLY TREATED. BUT THAT MAY BE WORKED FOR DC. IN OTHER PLACES YOU MAY NEED TO HAVE SOME KIND OF ONGOING SUPPORT, LIKE THE TELEMEDICINE SUPPORT ALONG WITH POINT OF CARE TESTING THAT WILL ALLOW OTHER PLACES IN REMOTE CENTERS TO TAKE UP HEPATITIS C CARE. THOSE STUDIES NEED TO BE DONE. ONCE THEY'RE DONE YOU CAN REALLY ENHANCE THE CARE. GLOBALLY IN MANY MORE REMOTE PLACES MOOCH DR. KATTAKUZHY MENTIONED THAT THE EPIDEMIC EPIDEMIC IS DRIVEN BY PEOPLE WHO INJECT DRUGS. YOU HAVE 25,000 NEW INEFFICIENCIES THAT HAPPEN IN THE UNITED STATES -- NEVERTHELESS THAT HAPPEN IN THE -- INFECTIOUS THAT HAPPEN IN THE UNITED STATES EVERY YEAR. IF YOU'RE NOT ABLE TO TACKLE THE SITUATION WE CANNOT TACKLE THE EPIDEMIC. THIS IS THE STATISTIC IN THE UNITED STATES, NOT GLOBAL. SO MOST OF THESE PATIENTS ARE AT THE MOMENT EXCLUDED FROM THIRD PARTY INSURANCES GETTING TREATED. WHY? NOT BECAUSE THE MEDICATION ARE NOT EFFICACIOUS. SEVERAL STUDIES THESE PEOPLE CAN'T TAKE MEDICATION AND THEY WILL HAVE A HIGH RATE OVERCURE. THE PROBLEM IS IF YOU CONTINUALLY INJECT DRUGS YOU CAN GET REINFECTED WITH HEPATITIS C. IF YOU'RE GETTING REINFECTED, OBVIOUSLY, THE QUESTION, WHY YOU SHOULD TREAT THESE PEOPLE. THE QUESTION IS, WE HAVE TO TACKLE MARGINALIZED PATIENT POPULATIONS CLEATLY DIFFERENTLY. WE ARE CONDUCTING THE INITIATIVE IN BALTIMORE, ANCHOR STUDY. WHAT WE'RE TRYING TO DO HERE IS LOOK AT SUBSTANCE ABUSE DISEASE AS A DISEASE IS. HEPATITIS C IS PART OF THE QUESTION. YOU HAVE TO DEAL WITH MULTIPLE DIFFERENT ASPECTS OF SAUDI ARABIA. AND REALLY -- SUBSTANCE ABUSE, MAKE PEOPLE COMFORTABLE SO YOU CAN REDUCE THE RISK OF ACTIVATION OVER THE LONG RUN. SO YOU OVER HEPATITIS C TREATMENT IN THIS CLINIC. YOU INCORPORATE WITHIN A SUBSTANCE ABUSE CLINIC AND WE PROVIDE HEPATITIS C CARE. MAKE SURE THEY'RE TREATED. AT THE SAME TIME, YOU ALSO INTRODUCE HARM REDUCTION STUDIES. OPIATE SUBSTITUTION TREATMENT AND MAKE SURE THESE PEOPLE ARE DRUG FREE. THESE PEOPLE ARE AT RISK OF HIV INFECTION IF YOU DON'T HAVE THAT. THESE PATIENCE ARE PROVIDED COUNSELING. SO THE OBJECTIVE IS BY INTRODUCING HEPATITIS C CARE IN THESE CONTEXTS, YOU CAN KEEP PEOPLE DRUG-FREE. HIV-FREE. ONCE THIS DEMONSTRATION PROJECT IS DONE WE CAN TRANSLATE THAT INTO MANY OTHER SITES WHERE INTRAVENOUS DRUG USE A MAJOR PROBLEM AROUND HAVE LIMITED ACCESS TO THE CARE TODAY. YOU HAVE TO TALK ABOUT GENETICS, EVEN THOUGH THESE MEDICATIONS ARE NOT AVAILABLE TODAY IN UNITED STATES. I WOULD LIKE TO MAKE FOUR POINTS. IT TOOK TEN YEARS, FIRST POINT, TOOK TEN YEARS FOR US TO GET GENETIC MEDICATIONS FOR HIV. NOW TODAY, 8 MILLION PEOPLE RECEIVE ANTIVIRAL TREATMENT FOR HIV. 7 MILLION ARE USING GENETIC PRODUCTION. IF YOU WANT TO EXCALCULATE THE CARE YOU HAVE TO INCLUDE [INDISCERNIBLE]. IT'S NOT POSSIBLE WITHOUT HAVING [INDISCERNIBLE]. 2, ONLY TOOK ONE YEAR SINCE -- WITHIN ONE YEAR, GENETIC PILLS POSSIBLE OR AVAILABLE. DIDN'T HAVE TO WAIT FOR TEN YEARS. SO GENETIC -- 700,000 PEOPLE HAVE TREAT -- RECEIVED [INDISCERNIBLE] SINCE IT WAS APPROVED IN 2013. 500 OF THOSE, 500,000 PEOPLE CAME FROM 2 COUNTRIES, ONE FROM EGYPT, ONE PAKISTAN. NOBODY WOULD HAVE GUESSED INCLUDING MYSELF THAT EGYPT AND PAKISTAN WOULD LEAD -- TREAT MORE HEPATITIS C PATIENTS THAN THE EUROPEAN JUNE AND THE UNITED STATES. THE AVAILABILITY OF GENETICS. THE CURRENT ASPECT IS COST. $84,000 FOR 3 MONTHS. THE GENETIC LICENSED [INDISCERNIBLE] THAT SCIENCES HAS -- SUPPORTED MANUFACTURING IN INDIA, PRICED AT $900 FOR THE ENTIRE 3 MONTHS COURSE. MUCH CHEAPER THAN WHAT'S AVAILABLE. THERE ARE OTHER GENETIC COMPANIES THAT MAKE GENETIC PART FDA MANUFACTURING GUIDELINES. THAT MEANS THEY MAKE IT ON THEIR OWN. BUT CLONING -- THEY MAKE IT AVAILABLE MUCH CHEAPER WITH $500 FOR THE E NTIRE COURSE. YOU CAN ALSO FROM ALBABA.COM FOR $250. SO THERE ARE A VARIETY AVAILABLE. 4, NOT ALL ARE ET CETERAD EQUAL. WE HAVE LEARNED FROM OUR MISTAKES THERE THE HIV ESCALATION OF CARE WE HAVE TO PICK THE RIGHT ONES. WE HAVE TO MAKE SURE THEY CAN BE USED IN ESCALATING HEPATITIS C CARE. 2 STUDIES HAVE BEEN CONDUCTED. ONE OURS, ONE WAS AUSTRALIA. ALL TREATED A SMALL NUMBER OF PEOPLE DEMONSTRATEING THESE BRANDS TESTED WERE EQUALLY EFFICACIOUS. THESE STUDIES NEED TO BE DONE BEFORE WE PICK ONE BRAND AND USE IT. THAT DOESN'T MEAN THEY'RE THE SAME BUT THAT'S AN IMPORTANT PART OF HEPATITIS C CARE. THIS IS SOMETHING -- ANOTHER INTERESTING -- DR. KATTAKUZHY MENTIONED THE COST OF HEPATITIS C CARE, HOW IT HAS IMPACTED PEOPLE. HEPATITIS CARE IS FUNDED 3 WAYS. ONE, THIRD PARTY INSURANCE, 2, GOVERNMENTS. LIKE COUNTRIES IN EQUIP. EVERYBODY IS TREATED BY THE GOVERNMENT SPONSORED PROGRAM. THIRD, THE MOST PART OF THE WORLD IS SELF-FINANCING. SO IT'S AN IMPORTANT PART. YOU MAY HAVE THESE DRUGS AVAILABLE, SOMEONE WHO MAY HAVE A JOB IN A MIDDLE INCOME COUNTRY MAY NOT BE ABLE TO AFFORD HEPATITIS C CARE, EVEN $900. IT'S A SUBSTANTIAL AMOUNT OF MONEY. AN EXAMPLE IS IN KENYA, THEY JUST STARTED LAST WEEK. SUCH PROGRAMS WILL COME UP SOON, MANY OF THESE COUNTRIES, MOST OF THESE ARE MIDDLE INCOME COUNTRIES WITH MOST POPULATIONS WITH JOBS, AND NOT ABLE TO AFFORD HEPATITIS C CARE. YOU'LL HAVE THESE NEGOTIATING SMALL RATES. GOVERNMENT SPONSORED BANKS ARE PROVIDING FINANCING FOR LOWER INTEREST RATE. INTEREST RATE IS MUCH HIGHER, 9%. YOU CAN OVER THESE RATES THAT ALLOW THEM TO ESCALATE THE CARE. THESE ARE INITIATIVES PEOPLE ARE USING SO MORE AND MORE PEOPLE CAN BE TREATED WITH HEPATITIS C TREATMENT. WE HAVE TO IMPROVE HEPATITIS C CARE. WE KNOW IT'S ALREADY GREAT. BUT WHAT WE NEED TO IMPROVE HEPATITIS C IS WE NOW DON'T HAVE A REGIMENT THAT WORKS, SAME WAY ON ALL DIFFERENT GENOTYPES. SO COMBINATION IS A FORMULATION, THIS IS THE NEXT GENERATION. SO YOU HAVE [INDISCERNIBLE]. SERIES OF STUDIES CONDUCTED, LOOKED AT THE EFFICACY OF THIS COMBINATION, GENOTYPE 1, 2, 4, 5, 6 AND GENOTYPE 3 PATIENT POPULATION. THE NUMBERS ARE ASTOUNDING. IF YOU THINK THE 99% ONLY HANDFUL OF PATIENTS HAVE FAILED THIS REGIMENT. OVERALL, THESE REGIMENT -- THIS IS APPROVED BY THE FDA IN THE COMING WEEKS, YOU HAVE A REGIMENT THAT IS PROBABLY EQUALLY EFFICACIOUS. THERE ARE EXCEPTIONS, PEOPLE WITH CIRRHOSIS BUT ALL IN ALL, MOST PATIENTS HAVE A REGIMENT THAT WILL BE EQUALLY EFFICACIOUS IN MOST GENOTYPES. THERE ARE GOING TO BE COMPOUNDS LIKE THIS APPROVED IN THE NEXT YEAR. THE NEXT MARKET IS TO HAVE GENETIC MEDICATIONS THOROUGH WORKING AGAINST ALL DIFFERENT GENOTYPES. THIS WILL HELP US TO REDUCE THE COST OF SCREENING. IT'S HELPFUL BECAUSE HEPATITIS C CARE WE TALK ABOUT COST OF TREATMENT. THERE IS ALSO COST OF TESTING, COST OF ENGAGING IN CARE. THE COST OF [INDISCERNIBLE]. FREQUENT TESTS THAT WE HAVE TO DO. THEY ARE EXPENSIVE. GENO DEEP TESTING, THE SAFETY LABS, ALL THESE THINGS, SOMEONE HAS TO PAY FOR IT. IT CAN BECOME SUBSTANTIAL COST. SO WHAT DO WE REALLY NEED TO TREAT HEPATITIS C? THIS IS ONE AMBITIOUS WAY OF LOOKING AT IT. THIS IS NOT NORMAL BUT THE EXTREME. I'M IN MY OFFICE, I HAVE A PATIENT, WANT TO MAKE SURE HE HAS CHRONIC HEPATITIS C. BLOOD TEST, RNA, THAT TELLS ME HE HAS VIRAL LOAD. I CAN PRESCRIBE HIM MEDICATION, ASK HIM TO COME BACK IN 6 MONTHS. I CAN LOOK AT HIS BLOOD, SAY HE HAS NO HEPATITIS C. YOU CAN DO THAT IN A POINT OF CARE TESTING, OR PART OF AN RNA MODEL LOAD. THIS IS BY TWO TESTING ELIMINATING ALL THE REQUIREMENTS, PROVIDED YOU HAVE A REGIMENT THAT WORKS IN ALIENO TYPES, RELATIVELY SAFE WITHOUT SIDE EFFECTS. THAT'S ONE AMBITIOUS VIEW OF HOW HEPATITIS C LOOKS IN THE FUTURE. THERE ARE 3 STUDIES INCLUDING A LARGE STUDY THAT WILL START LATER THIS YEAR LOOKING AT A VARIETY OF MODELS. THEY WON'T ALL BE EXACTLY LIKE THIS. TO BUILD IN 7 ARMS TO EXPLORE SOME DEGREE OF LIMITED MONITORING FOR A VARIETY OF COMBINATIONS, INCLUDING THE [INDISCERNIBLE]. SO HEPATITIS C CARE IS IMPORTANT ASPECT. WHAT WE HAVE IS THAT WE HAVE HEPATITIS C TREATMENT, THAT WE KNOW WE CAN TREAT. IT'S NOT WE STANDING ALONE, NOT GOING TO BE POSSIBLE TO ELIMINATE OR TACKLE EVEN IN A SMALL CITY LIKE DISTRICT OF COLUMBIA. YOU REALLY HAVE TO BUILD IN OTHER INFRASTRUCTURE MEASUREMENTS. MULTIPLE LABORATORY CAPACITY HAS TO BE ROUTINE. YOU HAVE TO BUILD AND TRAIN OTHER PROVIDERS WHO ARE NOT TREATING HEPATITIS C BUT CAN WE QUICKLY TRAINED AND EFFECTIVE IN MANAGING PATIENTS AND TREATING THEM. YOU HAVE TO REALLY NORMAL HEALTHCARE FINANCING STRATEGIES, AND ADVOCACY GROUPS THAT ALLOW US TO EXPAND HEPATITIS C TREATMENT. YOU NEED TO HAVE BUILD UP -- INFRASTRUCTURE, AND WE HAVE TO DEMONSTRATE THAT WE CAN, IF YOU DO THESE THINGS, YOU CAN REDUCE -- YOU CAN REDUCE HOSPITALIZATION, TRANSPLANTATION WITH LONG TERM FOLLOW UP OF THESE PATIENTS. IF YOU DO THAT, THEN YOU'RE ACTUALLY IMPROVING NOT ONLY THE HEPATITIS C CONTINUUM OF CARE BUT YOU'RE IMPROVING THE HEALTHCARE SYSTEMS GENERALLY THAT EXIST IN MOST OF THESE COUNTRIES. SO IN CONCLUSION, THE NEWER DA IS HOPEFUL AND THEY OFFER -- FOR MOST PATIENTS WE NEED. THERE ARE VALUES IN EXPANSION OF CARE. EXPANSION OF TREATMENT REQUIRES PROGRAMS AND HAVE TO TARGET THE HIGH RISK TARGET POPULATIONS, SUCH AS PATIENTS IN PER SEEN AND PATIENTS USING DRUGS, THEY ARE NOT ENGAGED IN THE PATIENT CARE AT THE MOMENT. THE POINT OF CARE TESTING, GREATLY HELPFUL, HELPING US TO REDUCE MONITORING AND REDUCE OVERALL COST OF CARE AND MANAGEMENT. WE HAVE TO TRAIN NEW PROVIDERS, HAVE TO BE WILLING TO TRAIN NEW POSSIBLE AND TOSS SHIFT TO OTHERS RATHER THAN SAY WE'RE THE ONLY PEOPLE THAT CAN TREAT HEPATITIS C. POLICY CHANGES HAPPEN WHEN THERE IS ADVOCACY, AND THERE ARE DEMONSTRATION PROJECTS LIKE SOME OF THE PROJECTS WE HAVE DONE. WE'RE HOPEFUL AS WE CONTINUE TO DO THIS WITH ADVOCACY, WE CAN CHANGE POLICIES. AND EXPAND THE CARE OF HEPATITIS C FOR MOST PEOPLE. FOR ALL THE SPEAKERS, WE HAVE TO THANK PEOPLE WHO MADE THIS HAPPEN. A LOT OF PEOPLE ARE HERE TODAY. MANY ARE NOT. WE HAVE A PARTNER TEAM INBALTIMORE AND PARTNERSHIP IN DC, GROUP HERE. WE HAVE LEADERSHIP OF NIAID, EXTREMELY HELPFUL AND SUPPORTIVE FOR US, INCLUDING DR. [INDISCERNIBLE]. WE HAVE PARTNERSHIP IN DC. I DO SEE MEMBERS IN THE AUDIENCE. [LIST OF NAMES]. HAPPY TO TAKE QUESTIONS. [APPLAUSE] >> THERE ARE PEOPLE IN THE AUDIENCE WHO PROBABLY LIVED THROUGH ALL THE REVOLUTION OF HEPATITIS C WHO MAY HAVE COMMENT. THE KIND OF RESEARCH IS A LITTLE BIT DIFFERENT THAN WHAT NIH DOES. THERE IS BASIC SCIENCE, PUBLISHED IN JCI, ALTHOUGH THERE ARE FIRST IN HUMAN TRIALS, ALMOST ALL OF THESE TRIALS DONE IN THE DISTRICT WERE THE FIRST TIME THE COMBINATIONS HAVE BEEN USED IN INDIVIDUALS, SO DISTRICT REALLY IS ON THE MAP. SOME OF THE FEW TRIALS DONE WITH UNDER-REPRESENTED MINORITIES WERE INCLUDED WITH TRIALS BUT THIS IS OPERATIONAL RESEARCH WHICH I THINK NIH CAN GET INVOLVED IN. THIS STARTED IN CLINIC 8, [LIST OF NAMES] PROVIDED A HOME FOR THESE STUDIES. THESE MUCH EMNATED, GONE INTO THE COMMUNITY. I THINK WORKING IN THE COMMUNITY IS CLEARLY SHOWING THAT YOU CAN RECRUIT QUICKLY, THE PATIENTS ARE VERY EAGER TO BE ON STUDIES, THE PROVIDERS, ALTHOUGH THEIR TIME IS LIMITED RA VERY EAGER TO HELP. THIS, I THINK, IS A DIRECTION THAT NIH SHOULD GO AND COULD GO IN MANY AREAS IN ORDER TO BE ATTRACTIVE TO YOUNG INVESTIGATORS IN TERMS OF GETTING OUT IN THE COMMUNITY TO SEE WHAT THE REAL PROBLEMS ARE AND RECRUIT QUICKLY. WITH THAT WE'RE HAPPY TO TAKE QUESTIONS OR COMMENTS FROM ANYBODY IN THE AUDIENCE. >> AGAIN, WE'RE PLEASED TO GET A GOOD AUDIENCE TODAY. I HOPE DR. [INDISCERNIBLE] WILL GIVE US A GOOD GRADE FOR FINISHING ON TIME.