infectious hepatitis drug

hello this is dr. david spach at the university ofwashington and hepatitis c infection is an extremely important health issue inthe correction setting. and with the widespread availability of highlyeffective but very expensive new therapies a number of issues haveemerged in efforts to treat hepatitis c and corrections. to discuss a number ofthese issues were joined today by dr. lara strick, who is an infectious diseasephysician who works at the washington state department of corrections andlara has extensive experience and practical experience in managinghepatitis c in the correction setting. so we'll kick this off by starting off withasking the question: what's the basic

difference between a jail and a prisonsetting? i think many providers are actually confused about that. [dr strick] so often inthe media these terms are used interchangeably but in the world ofcorrections they're actually quite different jail is where you go when you areinitially arrested and therefore jails by their nature house both innocentpeople as well as people who have committed a crime, either a misdemeanoror felony, and then once people are sentenced it kind of depends on how longtheir sentence is: if their sentenced for over a year in most states that is thecutoff to move on to go to a prison and

given the length of sentence that meansthat prisons mainly house only felons and this directly impacts hepatitis ctreatment because of timing in that the average stay in jail really is only acouple of days for the most part and often is not long enough to complete anentire course of treatment for hepatitis c and therefore jailed in general havereally different hepatitis c treatment to the community jails, i mean prisons on the other hand,are longer sentences and therefore it is possible to complete an entire course oftreatment and it often is medically necessary to do that while they areincarcerated. prison systems are also

larger entities, they are either state orfederal and they get larger budgets and therefore are better equipped toafford treatment for at least some patients although with the cost oftherapies that's getting more difficult [dr. spach] now i think one of the things we oftenthink about is the individuals who go in in the correction setting do have anumber of risk factors for hepatitis c but from a practical standpoint youknow how big a problem really is this? what's the general ballpark for thepercentage of people that are in a correctional setting who are actuallyinfected with hepatitis c? [dr. strick] ya so the prevalence of hepatitis c andcorrections is way more than in the

community setting in the community it'sthought that there probably is about one to two percent prevalence rates ofhepatitis c and that's based on nhanes estimates. the problems with thenhanes estimates are that initially they said that there probably are about 3.7million people in the united states living with hepatitis c but thesesurveys don't include people who are incarcerated and homeless and in otherfacilities and therefore the true estimates of hcv are thought to bemuch higher probably closer to five million or more and that based on theseestimates of people living in prison now the problem is that most prison systemsdo not routinely test for hepatitis c

and there is a limited amount of datafrom those states that do do routine testing but from the data that we haveit is estimated that about 17.4% of people living in correctional facilities across the united states have at least a positive antibody and thatthere's a huge range though and so some states like new mexico have rates ashigh as 41% and over the thing with corrections is that it's a revolvingdoor and so people go in and people go out and so over a given the year howeverit's thought that up to about a third of people living with hcv in the united states potentially passthrough a correctional system. [dr. spach] that's

pretty amazing statistic: approximately athird of people with hepatitis c passed through a correction setting that's areally very high number now you mention the testing in corrections and you knowwhat is the general procedure in terms of routine testing and hepatitis c youmentioned that's not uniform but but where does this happen and how oftendoes this happen that routine testing occurs? [dr strick] yeah so i mean corrections is aplace where you have a very high risk population as you mentioned and so it isa place where case finding is a crucial place to do testing. unfortunately manycorrectional facilities do not routinely do testing and practices really very from state facility to facility some places

to testing based on risk factors someplaces do testing based on whether the patient coming in asks for testing otherplaces do offer opt-out testing i think there have been several studies thatreally looked at this idea of taking the risk factor based testing in thecommunity and moving it into the correctional setting and the problemthere is that the number of risk factors in the setting of corrections is so highand patients are not always a hundred percent truthful about those riskfactors but also there's been a huge push more recently to really concentrateon the baby boomer birth cohort those people born between 1945 and 1965and really what the studies have shown

is that when you try to translate thatto a correctional setting although it is true that the prevalence of hcvantibodies is higher in those birth cohorts that because the majority ofpeople who are incarcerated often fall outside of those birth cohorts thatyou actually only pick up a minority of cases because the number of peopleusually people who are incarcerated tend to be in earlier ages and thereforeyou'll miss the majority of people with hepatitis c if you only focus on thatage group. the other problem with testing and corruptions unfortunately is aliability issue is that there often is a concern or you can say disincentive totest particularly in jail settings in

that you will wind up diagnosing all ofthese people with the disease that you then don't have the resources toadequately treat all of them and sometimes unfortunately it may be betternot to know that the person has hepatitis c although i would argue thatthere are an enormous number of benefits of knowing you have hepatitis c shortof treating them which includes things like harm reduction strategies andcounseling and a lot of the data does show that although sometimes it doesn'tfeel like it that people truly do change their behavior based on knowing thatthey're infected and decreased transmission rates. [dr spach] given the veryhigh prevalence rate of people moving through

corrections with hepatitis c ifresources were unlimited would it be reasonable to, if you had unlimitedresources, to try and actually do hepatitis c testing on everyone moving through thesystem? [dr strick] sure i mean we know that the prevalencerates and corrections are so high that if you were going to focus on a groupthat you would pick up the most number of cases corrections would be an idealplace to do that. [dr spach] now let's actually move into the correctional setting and thinkabout hepatitis c within the system. is a really significant problem withtransmission of hepatitis c from person to person in the correction setting?[dr strick] that's a really good question

unfortunately it's probably one of thehardest questions to answer in that prison setting we know has a lot of riskfactors related to the the acquisition of hepatitis c and weknow that those risk factors don't stop at the time people enter into thecorrectional facility. the problem is is many of those behaviors are actuallymost of those behaviors are against the rules of correctional facilities andthose would include intravenous drug use or drug use in general tattooing as well as sex and thereforeit's very difficult to collect really good data about those risk behaviors. theother problem in estimating incidence

behind the walls is the fact that acutehepatitis c usually is asymptomatic and they don't come to medical attention andso really the only way to get this data would to be do serial testing overpeople over time and a lot of those studies haven't been done in the unitedstates i think partly due to the ramifications that if somebody does comeup hepatitis c positive how does that impact their custody status. there havebeen some smaller studies in australia looking at this that clearly have shownthat transmission rates are pretty prevalent and that risk behaviors docontinue at a pretty high rates but most of the data in the united states isanecdotal. [dr spach] so i would imagine then trying to

really devise effective preventionstrategies may vary be very difficult when you're in thissetting where people certainly don't want to disclose these things areagainst the rules? [dr strick] yeah so harm reduction strategies inprison are a little bit tricky and particularly the philosophically harmreduction in a prison setting has kind of lagged behind a little bit because theassumption is that none of these risk behaviors will ever happen again whetherit's behind the walls or after people get out but i think it is very possibleto do harm reduction strategies without having to ask people to admit to all oftheir risk behaviors but to just assume

i'm not necessarily to assume that eachindividual has risk but if they don't have risk they have the potential toeducate all of their peers about harm reduction and what safe, safer strategies are in the community andcorrections to help protect themselves their others and their family. [dr spach] nowthinking a little bit about approaching treatment in the correction setting youyou've been in the trenches for years doing this you've been in the trenchesbefore the newly effective direct acting antiviral agents become available andnow in this current era what do you see are some of the major challenges tryingto approach treatment on a system wide

basis and correction setting? [dr strick] it is adefined population that gets a set budget and given the high prevalencethat we've already talked about you multiply that by the cost of the currentdrugs and you're in the tens of billions of dollar range and even for any givenfacility most have a prevalence that will at least get them to the millionrange and so for most facilities that is beyond the realm of feasible and itwould be impossible for them to treat all of the people that is are confinedwithin their walls. there also is a philosophical issue in that we oftentalk about cost effectiveness but many of cost effectiveness is based on risksand benefits to the payer and

correctional facilities often will windup being the payer but the benefits to their health in the long term healthconsequences that are avoided are a benefit to the community payers,community systems, and the public by reducing both cost and transmissiononce the patient releases. you get into this philosophical argument of whoshould be responsible for making sure that everyone getshepatitis c treatments. on top of that given how many patients have hepatitis cin many systems is that it becomes a capacity issue, in that, they are responsiblefor all of the other health problems that these patients have, hep c beingonly one of many, and therefore you often

would need providers solely there totreat hep c in order to accomplish and treat as many patients that wouldneed it in any one given time. the models used to treat people in the correctionalsetting also vary significantly i think you have the ability to both usecorrectional providers as your actual treaters. some facilities use correctional providers as the assessors but when it comes to the point of actual treatment they send them outto some person in the community that may have more expertise. other correctionalfacility invite people who are the experts into the facility to doboth the assessment and/or treatment from the outside or from the communitythrough contracts. so i think the models

vary. there also is a unique model thatis becoming more commonly used to avoid moving inmates out into the communitybut still getting them access to those experts by implementing telemedicine andspecifically project echo has been used in the correctional setting to helpincrease the expertise of the prison providers while still having acollaborative relationship with community experts. [dr spach] along those lines can you tell us a little about your own experience in the state of washington interms of your educational role in the system and having other people involvedin the management because as you're saying that capacity requirements to tryand deal with the number of people

infected with hepatitis c initiatetreatment is very large especially for one individual so what have you done inthe system here to work with that? [dr strick] yes so i quickly recognized that actually seeing every patient with hepatitis c would bean unfeasible way to go about it so our system is setup so that we have eight major facilitieseach of those major facilities has a physician and a nurse that is the hepctreaters, or team, and they join a conference call weekly to kind ofdiscuss cases both patients who were on treatment but also patients who they'reconsidering treatment to talk about their eligibility criteria as a group[dr spach] and this is a call that you lead every

week? [dr strick] this is a call that i chair andhelp guide practitioners and making sure that we follow protocols and the mostup-to-date standard of care. [dr spach] and you address issues and problems that maycome up during the treatment course is that right? [dr strick] correct so one of the things that we start out the call by actually reviewing all of the patients who arecurrently on treatment to address any side effects or issues or operationalissues or other facility-related barriers that may come into play related to corrections. so for example ifa patient is on treatment and winds up going to segregation and therefore needsto be transferred how do we arrange that

transfer and smoothly transition thepatient from one facility to another without them missing medications. [dr spach] so given the huge burden of trying to manage hepatitis c in the correction settingand given the cost constraints, how do you go about trying to prioritize inthe system who to initiate treatment for? [dr strick] i think that's the key question and i think it's a hard one to answer correctional systems have gone the sameroute that a lot of community payers have done which is looking at theseverity of disease and prioritizing those that are at higher risk ofcomplications of the disease and basing it on both the how advanced fibrosisof the liver is but also if they have

extra hepatic manifestations or if youhave another infection that potentially would cause your disease to advance morerapidly like hiv or hepatitis b the natural history of hepatitis coften allows for the deferral of treatment although i will say that thereis some data that's now coming out that says that treating earlier may have someclinical benefit to patients but i think what's really unique about working incorrections that's different than the community is that you are not just a physician for a single patient you're a physician for the entire community andyou have a fixed budget and therefore it would make sense that you would want totreat all of the people with more

advanced disease before expandingtreatment to others in order to have equity across the population that isyour responsibility and i think what corrections can do which the communityreally doesn't have the capability of doing is that if you are screeningeveryone upon entry you have the ability to actually divide your entirepopulation and estimate advanced fibrosis so that rather than addressing eachpatient as an individual as they walk through your door in your clinic in somerandom order you actually can go out and find those patients with more advanceddisease and seek them out rather than waiting for them to come to you so thatyou're treating people in the best

priority order that's possible. [dr spach] in this setting are the resourcesgenerally pretty good for actually assessing the fibrosis of individualsonce they're diagnosed with hepatitis c and corrections or once you know they'rein the system and they have hepatitis c and are you predominately usingnon-invasive methods to estimate hepatic fibrosis? [dr strick] i think that's a goodquestion again it really varies from facility to facility a lot of times theguidelines that are put out by the federal bureau of prisons are used asthe standard of care that a lot of other correctional facilities look towards tofigure out what the standard is in

corrections versus what the standard isin the community and the bureau of prisons really has moved away from doingbiopsies i think some systems still rely on biopsies mainly because things likefiber scans are not as readily accessible in that correctionalfacilities often are built in more remote places that don't have as muchaccess to more advanced technology but there are also a lot of systems areusing more simplified assessment using whether it be the apri score or afiber shorts to kind of just get a general idea of how advanced somebody'sdisease is. [dr spach] in the correction setting given the very high prevalence of individualswhat are some of the unique features to

think about this is a great place to tryand actually treat people versus treating them out in the community? [dr strick] yeah so there are definitely advantages this is a place potentially where their lives are much more stable, they're in avery structured environment some of the competing priorities areremoved, they have guaranteed housing, guaranteed food, there still is drug usebut hopefully at least left that it is in the community and drug use oftencauses treatment plans to go slightly awry and there is a lot more ability tomonitor and oversee treatment and so therefore treatment is at leastas successful if not more successful in

corrections than in thecommunity because once returning to the community a lot of this population are people whodon't regularly access health care i think in states where that have expandedmedicaid you now have the ability to potentially transitions some of thosepatients to hepatitis c treatments in the community but in states that havenot that still often is a they don't have access to adequatehealth care in the community that would allow them to be treated and theadvantage to the community is that this is a population that holds the brunt ofthe burden of the disease and therefore

because 98 percent or more of people incorrections return to the community to stop transmission and really impact theepidemic it's gonna be really important to address the issue in corruption andprobably start to address it in jails as well as prisons particularly astreatment get shorter and shorter and as people are able to complete a course oftreatment even within a jail setting. [dr spach] once you've decided that you're going to actually initiate treatment in the correction setting do you generally usethe same regimens and strategy that is used out in the community outside of thecorrection settings for the specific genotypes or are there some uniquefactors that would cause you to use

different regiments? [dr strick] that's acomplicated question and i'm not sure i actually can answer it for everycorrectional facility because each correctional facility creates their ownprotocols and guidelines i think many facilities now do follow the aasldguidelines but some don't for different reasons and i think one of the mainreason is cost in particularly for example for genotype 2 there was arecent paper that showed that for genotype 2 even though peginterferonand ribavirin has a fair number of side effect that it still might be more costeffective than using the newer treatments because it remains relativelyefficacious compared to say for

genotype 1 where a lot of the olderregimens the difference in efficacy is so extreme that even though these newerregimens are much much more costly they remain cost effective. [dr spach] now out in the community there a number of issues that come up with payment for medications but in the correction settingi think it would be very useful to hear where does the payment come from?what are the different systems that are utilized once the decision is made toactually access to medications? [dr strick] yes that's one of the big problems and whythe cost of these medications is so extreme in corrections becauseunfortunately as soon as a person walks

through the door of the correctionalfacility that correctional facility takes jurisdiction and is responsiblefor payment of all of the medications and when that happens not only does theperson lose their insurance but they also lose the ability to have anyfederal discounts or some of the other programs that are available in thecommunity to help improve pricing and that also would include patientassistance programs from the drug companies. docs and jails, if they areinterested, do still have the ability to contract directly with the drugcompanies to make their own negotiations although usually each facility acting onits own so they don't have a lot of

bargaining power or they also have theability to get some of the federal discounts by collaborating with anotheragency like an academic center that is eligible for these discounts in order tokind of funnel the medications through a different system but that system has tobe the provider of the health care in order to be eligible for those federaldiscounts and so in general most correctional facilities are kind ofstuck just negotiating with the drug companies as their only source ofpricing savings. the other issue which we kind of already touched upon is thesilos of funding when comes to patient care and in correctionsas i said is that as soon as they walk

through those doors is that as thesystem currently stands the correctional facility is solely responsible forpayments. one could argue that the mission forhealth services in corrections, their main mission, is for the health of theindividual and that's really the constitutional standard that they areheld by. they certainly play a huge role for public health but they're notnecessarily funded for that role and i think that really to impact thisepidemic and to really treat people as a prevention measure to decreasetransmission and improve the public health of society we really have torethink those silos and decide whether

this is an area that is worth placingpublic health dollars towards in order to really combat this epidemic. [dr spach] so lara we've heard that treatment of hcv in correction setting can be very effectivethan the svr 12 rates are nearly as good if not perhaps better in thecorrection setting that our community but in that raises the issue whathappens after the person is released? what what sort of concerns and effortsneed to be out there once they are outside of the correction setting? [dr strick] yeah i think this is another one of the big questions right now for which we havevery little data we know that people can get re-infected with hepatitis c afterthey clear the infection from treatment

and so there is this kind of whiteelephant in the room of how many people upon release go back to similarbehaviour and get re-infected after they had just been successfully treated andtruthfully we don't know there are several studies right now that i thinkare being geared up to kind of look at this question but i think it brings upthe point of how important it is to really marry treatment with some sort ofharm reduction program and i think in the past there has been ahesitancy to do harm reduction both because of costs but also because ofphilosophically the idea that people are gonna go back to doing behaviors thatthey did prior to incarceration was

kind of what we were trying to preventand so we lived in this utopia that no one would ever use drugs again or tattoo and so i think it's really really important to recognize that oneof our goals for health services is to make sure that even if they do return tosome of these behaviors that they have the knowledge of how to do it safely andgiven the cost and expense of treatment in this day and age the costof harm reduction or prevention programs are a drop in the bucket and reallyshould be part of any treatment program and frequently they are most effectiveif you include the use of peers in order to do some of that education in oursystem we modified project shield which

was actually a cdc hiv prevention program that we've modified specifically to include both hepatitis c but also tomake it applicable to the correctional setting with the idea that you educate anumber of peers on accurate information which they really are desperate for andthen to take that information and know how to then educate others in theirsocial networks both within the facility but also upon release when they go hometo give them the best chance that they would not get re-infected and keep theirbenefit of their svr. [dr spach] so lara we appreciate you sharing your experience and thoughtsabout some of the intricacies of trying to manage hepatitis c in the correctionsetting i think for clinicians out there

are there are few summary thoughtsthat you'd leave us with about this issue. [dr strick] i think the main thing to understand is that the prevalence of hepatitis c in a correctional setting is much higherthan it is in the community and that most of these people return to thecommunity and so corrections really is a funnel or a time where we can probablybetter impact every level of the hep c treatment cascade starting with testing,to counseling, to harm reduction, to treatment but in order to do that giventhe fact that correctional facilities are kind of isolated and solelyresponsible for the care of these patients that we probably really needto think from a public standpoint of the

importance of treating and getting itdone while they're incarcerated before they go back to the streets and areback to the chaotic lives that many come from thinking of funding streams insilos and really rethinking how we would pay for expanding treatment as a publichealth measure in the correctional setting. [dr spach] again thank you for sharing your experience with us about trying to manage hepatitis c in the correctionsetting we've obviously heard there are a number of very unique features andchallenges and we hope that they'll be continued to be advances for managing hepatitis c in this setting. thank you very much. [dr strick] thank you david.