HEPATITIS C AUDIO SCRIPT
August 23,  1999
21 MINUTES

MULLINS: THIS IS LISA MULLINS. THIS TAPE HAS BEEN PRODUCED BY THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH TO INFORM PRIMARY CARE PHYSICIANS ABOUT HEPATITIS C--A DISEASE THAT AFFECTS SOME 4 MILLION AMERICANS. WHILE NEW CASES ON ARE ON THE DECLINE, MANY PEOPLE WHO CONTRACTED THE DISEASE YEARS AGO HAVE NOT YET BEEN DIAGNOSED. MOST HAVE NO SYMPTOMS AND DON’T EVEN  KNOW THEY'RE  ILL. MANY PEOPLE ARE NOT EVEN AWARE THEY WERE EVER AT RISK.

THIS YEAR, UNDER A FEDERAL MANDATE, BLOOD BANKS AND HOSPITALS WILL BEGIN TO NOTIFY FORMER PATIENTS WHO MIGHT HAVE BEEN EXPOSED TO HEPATITIS C THROUGH BLOOD TRANSFUSIONS. AS A RESULT OF THIS "LOOK-BACK" PROGRAM, MANY PEOPLE ARE LIKELY TO CONTACT THEIR PRIMARY CARE PHYSICIANS, SEEKING MORE INFORMATION OR REFERRALS.

IN THIS TAPE WE WILL DISCUSS: WHAT IS HEPATITIS C? WHAT ARE ITS SYMPTOMS? WHAT DO WE KNOW ABOUT ITS EPIDEMIOLOGY AND NATURAL HISTORY? WHAT SHOULD BE THE ROLE OF PRIMARY CARE PROVIDERS IN MANAGING AND TREATING THIS DEVASTATING DISEASE? AND HOW CAN PRIMARY CARE PROVIDERS ASSURE THAT THEIR PATIENTS RECEIVE ADEQUATE CARE.

MULLINS: FIRST--WHAT IS HEPATITIS C? DR MARGARET KOZIEL IS AN INFECTIOUS DISEASE SPECIALIST AND AN ASSISTANT PROFESSOR AT HARVARD MEDICAL SCHOOL.

KOZIEL: Hepatitis C is a virus infection that predominantly infects the liver, although it can infect other parts of the body as well...In virologic terms, it's a member of the family of viruses that include things like yellow fever

MULLINS: HEPATITIS C HAS AN ACUTE PHASE, WHICH GENERALLY LASTS UP TO SIX MONTHS. IT IS USUALLY FOLLOWED BY A CHRONIC PHASE, WHICH CAN LAST A LIFETIME. IN EITHER PHASE, THE ILLNESS OFTEN SHOWS NO SYMPTOMS. DR. AL DEMARIA, AN INFECTIOUS DISEASE PHYSICIAN, IS ASSISTANT COMMISSIONER OF THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH.

DEMARIA: It's very difficult to make the diagnosis of acute hepatitis C, because only about 20 to 30 percent of people have symptoms related to acute hepatitis C. So people with a new hepatitis C infection often and usually don't present with symptoms. When they do present with symptoms, the symptoms are suggestive of hepatitis. In other words, they have nausea, vomiting, malaise. They may be jaundiced, and they have abnormal liver function tests, abnormal liver enzymes.

The disease then progresses over time, and there's a very broad spectrum of progression in hepatitis C. And about 15 to 25% of people who get acute hepatitis C seem to resolve the infection.

MULLINS: DR. DEMARIA SAYS THAT THE MAJORITY OF PEOPLE WITH ACUTE HEPATITIS C--75 TO 85 PER CENT OF THEM--DEVELOP CHRONIC INFECTION. ABOUT HALF OF THOSE WITH CHRONIC HEPATITIS C SHOW NO SYMPTOMS OR EVIDENCE OF ACTIVE LIVER DISEASE FOR TWENTY TO THIRTY YEARS. DR. RAYMOND KOFF, PROFESSOR OF MEDICINE AT THE UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL, ELABORATES ON THE COURSE OF CHRONIC HEPATITIS C.

KOFF: Of 100 individuals who are infected by this virus, 85 will develop persistent infection, and of that group the bulk of them will actually have chronic hepatitis, an inflammatory disease of the liver, reflected in elevated liver enzymes and if they were to have a liver biopsy, abnormal finding including inflammation and necrosis of liver cells.

MULLINS: DR. KOFF SAYS THAT OF INDIVIDUALS WITH CHRONIC HEPATITIS C, BETWEEN TEN AND TWENTY PER CENT DEVELOP CIRRHOSIS WITHIN THE FIRST TEN TO TWENTY YEARS AFTER INFECTION. THOSE WITH CIRRHOSIS ARE LIKELY TO EXPERIENCE ADDITIONAL LIVER PROBLEMS. BETWEEN ONE AND FOUR PERCENT OF THOSE WITH CIRRHOSSIS CAN BE EXPECTED TO DEVELOP HEPATOCELLULAR CARCINOMA. EVERY YEAR, AN ESTIMATED EIGHT TO NINE THOUSAND PEOPLE NATIONWIDE DIE OF LIVER DISEASE RELATED TO HEPATITIS C.

MULLINS: NOW THAT WE HAVE DISCUSSED THE COURSE OF HEPATITIS C, WE ADDRESS THE QUESTION: HOW DO PEOPLE CONTRACT IT? STUDIES SHOW THAT BEFORE 1992, THERE WERE ABOUT 200 THOUSAND NEW CASES A YEAR--MANY OF THEM CAUSED BY TRANSFUSIONS OF CONTAMINATED BLOOD. ABOUT ONE MILLION PEOPLE IN THE UNITED STATES ARE ESTIMATED TO HAVE BEEN INFECTED THROUGH   TRANSFUSIONS. HOWEVER, IN THE LAST SEVEN YEARS, THE RISK OF GETTING HEPATITIS C HAS GONE DOWN DRAMATICALLY--LARGELY DUE TO NEW TECHNIQUES FOR SCREENING DONATED BLOOD. SO THAT TODAY, MOST NEW INFECTIONS--ABOUT 30 THOUSAND A YEAR-- COME FROM NEEDLE SHARING BY INJECTION DRUG USERS. NEEDLE SHARING IS BELIEVED RESPONSIBLE FOR HALF OF ALL PREVALENT CASES --THAT’S TWO MILLION CASES. WHAT OF THE REMAINING MILLION? DR. DEMARIA.

DEMARIA: There may be a significant proportion that’s due to the small but recognized sexual risk of hepatitis C transmission. A small proportion of these cases are related to vertical transmission from pregnant women to their babies, but this risk seems to be below 5% of births to hepatitis C positive mothers. And then there are some cases that are related to exposures, in the dialysis setting, to tissue and organ transplantation, and to blood product use other than transfusion, such as clotting factors and hemophilia.

MULLINS: STUDIES SHOW THAT THE RISK OF VERTICAL TRANSMISSION FROM WOMEN TO THEIR BABIES INCREASES THREE- FOLD IF THE WOMEN ARE ALSO INFECTED WITH HIV. DR. DEMARIA EMPHASIZES THAT HEPATITIS C IS NOT TRANSMITTED THROUGH CASUAL CONTACT. LIKE HEPATITIS B, HEPATITIS C IS NOT SPREAD THROUGH BREAST FEEDING. IT RARELY SPREADS FROM HEALTH CARE WORKERS TO PATIENTS. AND UNLIKE HEPATITIS A, HEPATITIS C IS NOT SPREAD THROUGH THE FECAL ORAL ROUTE. IT IS NOT TRANSMITTED BY SALIVA, OR IN FOOD. AND THE RISK TO HEALTH CARE WORKERS IF THEY ARE STUCK BY CONTAMINATED NEEDLES IS BETWEEN ONE AND A HALF AND THREE PERCENT. WHAT ABOUT SEXUAL ACTIVITY? ACCORDING TO THE CENTERS FOR DISEASE CONTROL AND PREVENTION, HEPATITIS C IS NOT EFFICIENTLY SPREAD THROUGH SEXUAL CONTACT UNLESS THERE IS EXPOSURE TO INFECTED BLOOD. THE CDC ADVISES USING CONDOMS FOR ANYONE ENGAGING IN HIGH-RISK SEXUAL PRACTICES.

WE NOW TURN TO THE QUESTION OF DIAGNOSIS, WHICH CAN BE DIFFICULT, BECAUSE SYMPTOMS MAY TAKE DECADES TO APPEAR, AND, EVEN THEN, THEY ARE EASY TO MISS. IN ITS CHRONIC FORM, DR. KOZIEL SAYS, HEPATITIS C EXHIBITS A SPECTRUM OF SYMPTOMS.

KOZIEL: Primarily, a fatigue is actually the first symptom. Then there are various laboratory abnormalities that develop, and that would be a low albumin, and the PT starts to elevate. On physical exam, you can look for skin manifestations such as spider angiomatous. You can look for jaundice or icterus. And then you can look for the classic signs of cirrhosis, which would be ascites and splenomegaly, as well as peripheral edema.

MULLINS: BUT BY AND LARGE , MOST PATIENTS SHOW NO OBVIOUS SYMPTOMS UNTIL THE ILLNESS IS WELL ADVANCED. THIS MEANS THAT IN TAKING A HISTORY, IT IS IMPORTANT TO ASK ABOUT EVERY POSSIBLE RISK FACTOR. ONCE AGAIN, THIS INCLUDES ANY INJECTION DRUG USE, PAST OR PRESENT.

KOZIEL: It’s actually not the habitual drug user. It’s drug use, even once. It’s remarkably efficiently transmitted when people use needles. And again, that’s a very difficult history to pull out of somebody. They don’t want to remember that when they were 20 and drunk, they used needles once. But it’s very important to try to get that history if you can.

MULLINS: DR. KOZIEL SAYS IT IS ALSO IMPORTANT TO ASK ABOUT RISKS LIKE INTRANASAL COCAINE USE, AND TO BE AWARE OF OTHER RISK GROUPS SUCH AS PATIENTS ON DIALYSIS, THOSE WITH A HISTORY OF MULTIPLE SEX PARTNERS, CHILDREN BORN TO INFECTED MOTHERS, AND ANYONE WITH UNEXPLAINED ELEVATIONS IN THEIR LIVER FUNCTION STUDIES.

IF YOU SUSPECT A PATIENT HAS HEPATITIS C, HOW SHOULD YOU DETERMINE IF THEY ARE INFECTED? DR. KOFF SAYS THIS CAN INVOLVE THREE POSSIBLE COMPONENTS. ONE: AN "E.I.A" OR "ELIZA" TEST AND A CONFIRMATORY TEST TO SEE IF THE PATIENT’S BLOOD CONTAINS ANTIBODIES FOR HEPATITIS C. TWO: A POLYMERASE CHAIN REACTION TEST, OR PCR, WHICH SHOWS IF THE BLOOD CONTAINS THE RNA OF THE HEPATITIS C VIRUS. AND THREE: AN ASSAY TO DETERMINE WHETHER THE LIVER ENZYMES ARE NORMAL. SOME PATIENTS MAY ELECT TO USE A HOME TEST KIT, RECENTLY APPROVED BY THE FOOD AND DRUG ADMINISTRATION, FOR THE INITIAL ANTIBODY TESTING.

WHICH TESTS YOU ORDER MAY DEPEND ON A PATIENT’S CIRCUMSTANCES--WHETHER THE PATIENT HAS ANY SYMPTOMS OR RISK FACTORS FOR HEPATITIS C--OR RECENT EXPOSURE TO THE VIRUS. IT IS IMPORTANT TO BEAR IN MIND THAT SOME 15 PERCENT OF PEOPLE CLEAR THE VIRUS WITHOUT THERAPY. THIS MEANS THAT SOME PEOPLE WHO ARE TESTED WILL HAVE ANTIBODIES BUT NO ACTIVE VIRUS, AND THEY SHOULD HAVE NORMAL LIVER ENZYMES.

BUT  IN SOME ACUTE INFECTIONS, ANTIBODIES TAKE TIME TO APPEAR. SO IF THE ANTIBODY TEST IS NEGATIVE, DR. KOFF SAYS, YOU SHOULD MAKE SURE THERE IS NO ACTIVE VIRUS BY REPEATING THE TEST AFTER THREE TO SIX MONTHS, OR BY TESTING FOR HEPATITIS C RNA.

ANOTHER DIFFICULTY IN DIAGNOSING HEPATITIS C IS THE POSSIBILITY OF FALSE POSITIVES.

KOFF: To sort that out, the next best thing to do is to measure the antibody using a recombinant immuno blot assay, or RIBA. If that test is negative, then the initially positive test was in fact a false positive. If the RIBA is positive, then the initial test was a true positive and now one wants to know whether or not this individual is actively infected and in order to do that one needs to measure the virus in the circulation.

MULLINS: PHYSICIANS SHOULD BE AWARE THAT THE AMOUNT OF HEPATITIS C VIRUS IN A PATIENT’S BLOOD DOES NOT CORRELATE WITH LIVER DAMAGE. NOR DOES THE AMOUNT OF VIRUS IN THE BLOOD HAVE ANY BEARING ON WHETHER TREATMENT WILL BE SUCCESSFUL. EXPERTS ADVISE THAT ONCE A PRIMARY CARE PHYSICIAN HAS DIAGNOSED HEPATITIS C, MOST PATIENTS SHOULD BE REFERRED TO SPECIALISTS TO DETERMINE WHETHER THERAPY IS INDICATED. THAT IS BECAUSE THERAPY IS COMPLEX, CAN HAVE MAJOR SIDE EFFECTS, AND IT OFTEN DOESN’T WORK.

WHAT ARE THE OPTIONS FOR TREATMENT? HERE IS DR. KOFF.

KOFF: All of our current treatments are interferon based. That is, they use interferon which is an injectable that is given subcutaneously by injection with or without ribavirin. Ribavirin is a guanosine analog that is given orally and it, together with Interferon are one of our standard treatments now of previously untreated patients.

MULLINS: AND WHAT IS THE SUCCESS RATE?

KOFF: Of 100 patients treated with either Interferon monotherapy or combination therapy, approximately 20-40% will have a sustained virologic response, meaning that six months after ending therapy, the virus will be cleared from their blood. Of this small group of individuals, 20-40%, 95% of those will maintain this response year after year after year and our data now go up to ten years.

MULLINS: ONE IMPORTANT ASPECT OF THERAPY IS THE SIDE EFFECTS--WHICH CAN BE DAUNTING. DR. KOZIEL.

KOZIEL: Approximately 60 to 80% of people will have a flulike syndrome which persists for the entire course of interferon therapy, which is 12 months. This flulike syndrome consists of fevers, myalgias, and most importantly, depression, which in some cases can be severe. In people with a prior history of depression, it can actually make them be suicidal. So it actually is one of the few contraindications to therapy.

MULLINS: DR. KOZIEL ADDS THAT A SERIOUS SIDE EFFECT OF COMBINATION THERAPY IS HEMOLYTIC ANEMIA, WHICH OCCURS IN ABOUT 10 PER CENT OF CASES. SIDE EFFECTS LEAD TO DOSE REDUCTION OR THE HALTING OF TREATMENT FOR ABOUT TWENTY PER CENT OF PATIENTS IN COMBINATION THERAPY.

SOME PATIENTS SHOULD NOT BEGIN THERAPY AT ALL. AMONG THOSE WHO SHOULD NOT BE TREATED ARE PREGNANT WOMEN OR THOSE WHO ARE TRYING TO CONCEIVE, AND THEIR MALE PARTNERS. AND THERE ARE OTHERS WHO SHOULDN’T BE TREATED.

KOFF: Individuals who have serious depression, individuals who have important co-morbidity such as cardiovascular disease, individuals who are quite elderly are not good candidates for therapy. On the other hand, most individuals who are relatively young, who are not suffering from depression, who have no hematologic abnormalities, would be appropriate candidates for therapy.

MULLINS: SOME SPECIALISTS SUGGEST POSTPONING TREATMENT IF A PATIENT DOES NOT SHOW EVIDENCE OF EXTENSIVE LIVER DAMAGE IN HOPES THAT MORE EFFECTIVE TREATMENTS WILL BECOME AVAILABLE. BUT DR. KOFF AND OTHERS FAVOR AGGRESSIVELY TREATING NEARLY EVERY CASE. DR. KOFF SAYS THAT IT IS DIFFICULT TO TELL IN ADVANCE WHICH PATIENTS WILL RESPOND. AND WHILE THERE ARE NEW TREATMENTS ON THE HORIZON, IT IS NOT CLEAR WHEN THESE, OR A VACCINE, MIGHT BE AVAILABLE.

NOW THAT WE HAVE DISCUSSED THE LONG-TERM NATURE OF HEPATITIS C AND THE DIFFICULTIES OF TREATING IT, WE ASK, WHAT SHOULD BE THE ROLE OF PRIMARY CARE PHYSICIANS IN CARING FOR PATIENTS WITH THE DISEASE?

DR. KOFF SAYS THAT IT IS IMPORTANT FOR PRIMARY CARE PHYSICIANS TO WORK CLOSELY WITH BOTH PATIENTS AND SPECIALISTS. ONE IMPORTANT ROLE IS TO PROVIDE PSYCHOLOGICAL SUPPORT.

KOFF: I think it is important that the primary care physician not scare his or her patients. This is a slowly progressive disease and in fact a substantial proportion of patients with this disease will not die of Hepatitis C. They will live out their lives to their normal life expectancy. They will die with this virus in their blood, but not as a consequence of this infection.

MULLINS: ANOTHER ROLE IS IN HELPING TO MAKE SURE THERAPY IS AS SUCCESSFUL AS POSSIBLE.

KOFF: It is the primary care physician who might wish to start a patient who appears to be somewhat depressed or has a history of depression, on an antidepressant, even before they see the hepatologist or gastroenterologist, for a decision about treatment. It is also important for the primary care physician to be aware of the full spectrum of adverse events associated with interferon therapy, so that when patients call ...or have questions, they are comfortable in responding.

MULLINS: PRIMARY CARE PHYSICIANS SHOULD ALSO HELP PREVENT ADDED LIVER DAMAGE BY MAKING SURE PATIENTS ARE VACCINATED AGAINST HEPATITIS A, AND, FOR PATIENTS WHO ARE AT RISK AND SUSCEPTIBLE, AGAINST HEPATITIS B, AS WELL. PATIENTS SHOULD ALSO AVOID ANY SUBSTANCES THAT MIGHT FURTHER HARM THE LIVER. CHIEF AMONG THOSE IS ALCOHOL. DR. KOZIEL EXPLAINS.

KOZIEL: Alcohol and hepatitis C together are a very bad combination, and anyone who drinks is harming their liver. So in practice, I tell people not to drink, that perhaps one glass of wine at a family wedding is okay, but that any more than that, they have to think about the damage they're doing to their liver.

MULLINS: PRIMARY CARE PHYSICIANS SHOULD COUNSEL HEPATITIS C PATIENTS TO AVOID ANY DRUGS THAT COULD DAMAGE THE LIVER--SUCH AS HIGH DOSES OF TYLENOL. AND PHYSICIANS SHOULD CONTACT THE SPECIALIST BEFORE WRITING NEW PRESCRIPTIONS FOR PATIENTS WITH HEPATITIS C. IN ADDITION, DR. KOZIEL EMPHASIZES THE IMPORTANCE OF EDUCATING PATIENTS ABOUT HOW THE DISEASE IS SPREAD--ESPECIALLY REGARDING SEXUAL BEHAVIOR.

KOZIEL...this is a difficult issue, because of the lack of really good data. But in practice, we tell people not to do anything different. We talk to people about how it's spread, that any contact with blood is a potential risk. We talk to people about the issue of intranasal cocaine use, and the fact that partners share things other than sex, so that if there's a behavior that they're doing that might transmit blood, they need to stop that behavior, but that sexual intercourse as we know it does not per se spread hepatitis C.

MULLINS: ONCE AGAIN, THE CDC RECOMMENDS CONDOMS TO PREVENT THE POTENTIAL SEXUAL TRANSMISSION OF THE DISEASE, ESPECIALLY FOR THOSE ENGAGING IN HIGH RISK SEXUAL ACTIVITIES. IN EVERY DAY CASUAL CONTACT, THE RISKS OF CONTRACTING HEPATITIS C ARE CONSIDERED LOW.

KOZIEL: And it's not spread within the family. That's very important, to reassure people that they cannot give it to their children in the absence of blood contact. So I talk to people about simple precautions they can take. Don't share the razors. Don't share the toothbrushes. And keep some disposable gloves on hand, so in the event of a cut, where a family member wants to help the person, they can put on some latex gloves and do it. So simple things they can do. and that reassures people greatly that they're not going to give it to their loved ones.

MULLINS: DR. KOZIEL SAYS THAT THERE IS NO MEDICAL REASON FOR PATIENTS TO LIMIT MOST ACTIVITIES. THAT INCLUDES EXERCISE.

KOZIEL: There is absolutely no evidence that it harms them with respect to their HCV. In terms of occupation, there are no limitations on occupation, and this is even true for health care workers. There is very little evidence that there has been any spread of hepatitis C to patients.... nor has there really been substantial data that patients are at risk as a result of undergoing typical medical procedures.

MULLINS: IN THE NEXT FEW YEARS, MANY INDIVIDUALS WILL LEARN THROUGH THE NEW "LOOK BACK" PROGRAM THAT THEY MAY HAVE BEEN EXPOSED TO THE VIRUS THROUGH BLOOD TRANSFUSIONS THEY RECEIVED YEARS AGO. THEY AND OTHERS WHO ARE CONCERNED WILL TURN TO HEALTH CARE PROVIDERS FOR HELP. THIS INFLUX OF NEW HEPATITIS C PATIENTS IS EXPECTED TO PLACE A MAJOR BURDEN ON THE HEALTH CARE SYSTEM. DR. DEMARIA EXPLAINS.

DEMARIA: The costs of HCV infection are substantial if one just looks at the natural history of the disease, and one looks at the evolution of cirrhosis, and the requirement for transplantation. The cost of a liver transplantation is 193,000 dollars...And then there are all the costs associated with a chronic disease, and now the cost associated with treating hepatitis C.

MULLINS: NATIONALLY, THE COST OF CARING FOR ALL CURRENT CASES IS ESTIMATED AT 320 BILLION DOLLARS--PLUS THE COST OF LIVER TRANSPLANTS. THERE ARE ABOUT 1000 HEPATITIS C-RELATED TRANSPLANTS A YEAR AND THIS NUMBER IS EXPECTED TO TRIPLE OVER THE NEXT TEN YEARS.  IN MASSACHUSETTS ALONE, PUBLIC HEALTH OFFICIALS ESTIMATE THAT THERE ARE CURRENTLY ABOUT 100 THOUSAND CASES OF HEPATITIS C....AND 700 NEW CASES A YEAR. IN ORDER TO PREPARE THE HEALTH CARE SYSTEM FOR THE ANTICIPATED INFLUX OF NEW PATIENTS, DR. DEMARIA URGES PHYSICIANS TO REPORT ANY CASES THEY DIAGNOSE.

DEMARIA: Clinical laboratories report hepatitis C positive results to the health department. These reports come with very minimal information. We need clinicians to report hepatitis C cases, so that we can correlate these results and utilize this information for public health purposes, and to assist all of us with the management of hepatitis C.

MULLINS: THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH WILL BE MAILING REVISED HEPATITIS C REPORTING FORMS IN LATE 1999. THESE FORMS SHOULD BE SUBMITTED TO YOUR LOCAL HEALTH DEPARTMENT OR TO THE STATE DEPARTMENT OF PUBLIC HEALTH.

MULLINS: WE HOPE THAT YOU HAVE FOUND THIS TAPE USEFUL AND THAT YOU WILL EXAMINE THE OTHER MATERIALS CONTAINED IN THE ACCOMPANYING PACKET. THEY PROVIDE ADDITIONAL INFORMATION ON HEPATITIS C AND SUMMARIZE THE INFORMATION YOU HAVE JUST HEARD. WE WELCOME YOUR COMMENTS AND SUGGESTIONS ON THE ENCLOSED BUSINESS REPLY CARD.

THIS TAPE WAS PRODUCED BY THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH IN COLLABORATION WITH THE DEPARTMENT OF FAMILY MEDICINE AND COMMUNITY HEALTH AT THE TUFTS UNIVERSITY SCHOOL OF MEDICINE. IT WAS WRITTEN BY ANITA HARRIS, WITH AUDIO BY MICHAEL MOSS OF SOUNDSCAPE PRODUCTIONS, IN BOSTON. THIS IS LISA MULLINS.

End