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The UC San Diego AntiViral Research Center sponsors weekly presentations by infectious disease clinicians, physicians and researchers. The goal of these presentations is to provide the most current research, clinical practices and trends in HIV, HBV, HCV, TB and other infectious diseases of global significance. The slides from the AIDS Clinical Rounds presentation that you are about to view are intended for the educational purposes of our audience. They may not be used for other purposes without the presenter’s express permission. AIDS CLINICAL ROUNDS
58

A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Jan 27, 2017

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Page 1: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

The UC San Diego AntiViral Research Center sponsors weekly presentations by infectious disease clinicians, physicians and researchers. The goal of these presentations is to provide the most current research, clinical practices and trends in HIV, HBV, HCV, TB and other infectious diseases of global significance. The slides from the AIDS Clinical Rounds presentation that you are about to view are intended for the educational purposes of our audience. They may not be used for other purposes without the presenter’s express permission.

AIDS CLINICAL ROUNDS

Page 2: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

A"Decade"of"Trea,ng"HCV"in"Pa,ents"with"Ongoing"Barriers"to"Care

Edward&Cachay&MD,&MAS&

Associate&Professor&of&Clinical&Medicine&

October&16,&2015&&

Page 3: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

HCV"is"a"disease"of"the"disenfranchised"

2&

14&17& 19&

29&35&

50&

90&

0&

10&

20&

30&

40&

50&

60&

70&

80&

90&

100&

1&

%"HCV

"an(

body"posi(ve"

US&populaHon&

&AA&born&in&1950s&

Hospitalized&paHents&

Severely&mentally&ill&

Prisoners&Homeless&people&

People&IDU&≤&10&yrs&

People&IDU&>&10&yrs&

Page 4: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

February"2008

• Rates&of&hepaHHs&C&were&increasing&in&the&general&populaHon&and&~&10&Hmes&higher&among&HIV&infected&paHents.&

• HIV&coUinfected&paHents&with&hospital&inpaHent&care&consHtuted&7.5&Hmes&as&many&hospitalizaHons&and&incurred&2.9&Hmes&the&charges&in&1995,&relaHve&to&all&HIV&hospitalizaHons&and&charges.&&

•  In&contrast&to&the&general&populaHon,&rates&in&HIV&infecHon&represented&incident&cases.&

&

Hepatology:"2005,"42:"1406J13"

Page 5: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

HCV&incidence&in&HIV&MSM&in&relaHonship&to&calendar&year&

Rate/&100UPY&

MetaUregression&Polynomial&fit&&&&&&&&&&(with&95%&CI)&

Year&of&esHmate&

Page 6: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Tim"who"was"32yo"was"admiMed"to"our"ICU"in"April"2007

•  Tim"suffered"a"massive"myocardial"infarc,on"resul,ng"in"severe"conges,ve"heart"failure.

•  "Suspected"induced"by"intravenous"methamphetamine"use. •  Tim"was"diagnosed"with"HIV"and"also"HCV. •  Tim"had"history"of"bipolar""disorder,"he"acknowledged"a""prior"suicidal"aMempt"at"age"21"while"‘under"the"influence’.

• CD4:"450,""HIV"VL"load">750,000"copies/ml"(at"diagnosis) &&

Page 7: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

March"2008":"Referred"for"HCV"treatment"considera,on:

• HCV"genotype"3""and"HCV"viral"load"HCV"RNA"9’000,000 • He"had"started"HAART"2"months"prior • Grade"I"liver"enzyme"eleva,on,"albumin"4.6,"INR:"1.0"and"had"‘a#normal#looking#liver#on#a#CT#scan’"while"in"the"ICU.

•  Tim"said"“my"liver"is"fine"and"does"not"bother"me"all”."

• Nick"has"Ryan"White"insurance

•  Tim"was"at"the",me"on"a"rehabilita,on"program"in"San"Marcos."

&

Page 8: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Thinking&of&HCV&treatment&opHons&in&2007,&was&Tim&a&good&candidate&for&HCV&therapy?&&

1. Yes&2. No&&

Page 9: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

The"conven,onal"approach:

• HCV&GT&3&considered&to&have&more&favorable&responses&to&PegUIFN&and&ribavarin&(&~50%).&

• CoUmorbidiHes&could&be&exacerbated&during&HCV&therapy.&

• Psychiatry&issues&would&likely&become&too&challenging.&

“&No&major&evidence&of&liver&fibrosis,&conHnue&rehabilitaHon,&treat&your&HIV,&follow&closely&with&your&PMD,&remain&absHnent&and&RTC&in&1&year…”&

Page 10: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Survival&by&HCV&AnHbody&Status&at&Clinic&Entry,&adjusted&for&Entry&CD4.&Owen&Clinic,&n&=,&5,978&

Page 11: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

What"propor,on"of"HIV"pa,ents"with"known"HCV"and"in"HIV"care"were""treated"for"HCV"in"the"United"States"at"the"end"of"2010?

1.&Less&than&3%&

2.&5%&

3.&8%&

4.&15%&

5.&30%&

Page 12: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

In"average"in"less"than"2.5%"of"pa,ents"coJinfected"with"HIV/HCV"were"cured"of"HCV""at"the"end"of"2012

100%&paHent&with&known&HIV/HCV&

&

never&treated&

25%&adverse&events&

10%&lost&to&followUup&

35%&sustained&viral&response&

30%&virological&failure&

Page 13: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Factors"that"contribute"to"low"HCV"treatment"uptake"among"HIV"coJinfected"pa,ent"s

Pa(ent"" &Provider"

Medical"system"

Limited&tesHng&centers&

Low&№&providers&confident&delivering&HCV&

treatment&

Too&complex&percepHon:&A.  PaHents&B.  Management&

Depend&on&subUspecialty&clinic&

Too&much&paper&work:&A.  PaHent&access&&B.  Underinsured&

Low&reimbursement&incenHve&

Adapted from Grebely et al. 2013. JID; 207 (Suppl 1)

Page 14: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

The"problem"is"not"limited"to"the"USA

From 1947 HIV-infected patients included, with a median follow-up time of 107 months (IQR: 57–156), only 23% received treatment for HCV (456 patients)

Grint D et al. HIV Med. 2013;14:614-23

0.00"

1.00"2.00"

3.00"

4.00"

5.00"6.00"7.00"8.00"

9.00"

Incide

nce&pe

r&100&PYFU

&

1998" 2000" 2002" 2004" 2006" 2008" 2010"

Incidence&rate&of&uptake&of&HCV&treatment&in&EuroSIDA&by&region&

South&

North&

West&

East&C&

East&&

Copyright © Edward Cachay MD, MAS.

Page 15: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

April"2008:"Shortage"in"staff"and"reimbursement"became"major"disincen,ves"for"on"site"subJspecialty"care"for"our"HCV/HIV"pa,ents."

HIV&provider&

Pharmacist&

Psychiatrist&

Substance&counselor&

UCSDGOwen"Hepa((s"Clinic"

is"born..."

Copyright © Edward Cachay MD, MAS.

Page 16: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Our&Goal:&To&improve&the&efficiency&of&the&HCV&staging&process&of&paHents&coUinfected&with&HIV/HCV&and&to&increase&the&absolute&number&of&paHents&&who&start&and&complete&treatment&&for&HCV&at&any&given&Hme&point.&

Page 17: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Owen"coJinfec,on"hepa,,s"clinic

Page 18: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

HIV/HCV"coJinfected"pa,ents"had"more"coJmorbid"condi,ons"

The&median&№&of&comorbid&condiHons&was&greater&for&persons&with&HCV&coUinfecHon&(p<0.0001)&

0%"

10%"

20%"

30%"

40%"

50%"

0" 1" 2" 3+"№"of"comorbid"condi(ons"

Percen

tage"with

"con

di(o

ns"

HIV&monoinfected&

HIV/HCV&

Goulet'et'al.'AIDS'2005;'19'(suppl'3):'S99:S105'Copyright © Edward Cachay MD, MAS.

n=&25,116&&

Page 19: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Among"HIV/HCV"coJinfected"pa,ents"there"is"a"high"prevalent"of"low"health"literacy,"ongoing"substance"dependences,"neuropsychiatry""disorder"and"unstable"housing

Illegal&substance&use&

Neuropsychiatry&disease&Alcohol&dependence&

Poverty&

Cachay et al. AIDS Res Ther 2011, 8:e29

Page 20: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

HIV

control

BA

RR

IER

S

LIV

ER

status

Co-m

orbidities The Owen Hepatitis Co-Infection staging table of HCV among HIV-infected patients

Lesson"#1:"More"than"assessing"liver"fibrosis…

Copyright © Edward Cachay MD, MAS.

Page 21: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

The"‘CCR’"rule"and"prospec,ve"engagement"in"care:

• Commitment:&HIV&viral&load&undetectable&

• Consistency:&Follow&through&with&medical&&&&&

&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&recommendaHons&and&or&appointment&

• Reliability:&Avoid&‘no&shows’&,call&to&‘reschedule’.&

Copyright © Edward Cachay MD, MAS.

Page 22: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Key"prac,cal"points

• No&reUschedule&penalty&for&late&arrivals&• Always&it&is&a&good&Hme&to&start&over&again&

•  ‘Cutback’&as&much&as&you&can&but&‘come&back’&no&maqer&what&

•  SD&needle&exchange&program&/&methadone&clinics&

Page 23: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Clinic"visit"schedule"for"HIV"pa,ents"on"HCV"treatment"based"on"their"specific"barriers"and/or"medical"coJmorbidi,es"(in"weeks)

! 0! 1! 2! 3! 4! 5! 6! 7! 8! 9! 10! 11! 12! 14! 16! 18! 20! 22! 24! 26! 28! 30! 32! 34! 36! 40! 44! 48!

Group&1& ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !

Pharmacists!! X! !!!!!!!!!X! !!!!!!!!!!X! ! ! ! X! ! ! ! X! ! X! ! X! ! X! ! X! ! X! ! X! X! ! X!

Providers! X! ! ! ! X! ! ! ! X! ! ! ! X! ! X! ! X! ! X! ! X! ! X! ! X! X! X! X!

Group&2& ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !

Pharmacists! X! X! X! X! X! ! X! ! X! ! X! ! X! X! ! X! ! X! ! X! ! X! ! X! ! X! ! X!

Providers! X! ! ! ! X! ! ! ! X! ! ! ! X! ! X! ! X! ! X! ! X! ! X! ! X! ! X! X!

Group&3& ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !

Pharmacists! X! X! ! X! ! X! ! X! ! X! ! X! ! ! X! X! X! X! X! ! X! ! X! ! X! ! X! X!

Providers! X! X! X! X! X! ! X! ! X! ! X! ! X! X! X! X! X! X! X! X! X! X! X! X! X! X! X! X!

!

Homeless1!

Group 1: patients without major significant medical comorbidity, social barriers and no ongoing illicit substance use Group 2: patients with ongoing substance use (including intravenous) and/or homelessness Group 3: patients with severe neuropsychiatry disease (including prior suicidal attempts) and/or medical comorbidity

Cachay et al, AIDS Res Ther. 2013 Mar 28;10(1):9

Lesson&#2:&One&size&does&not&fit&all&

Copyright © Edward Cachay MD, MAS.

Page 24: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

What"happened"with"Tim?

05/2008&

No"show"

"Completed"Echocardiogram"

HCV&Treatment&iniHaHon&

1&2&

4&

5& SVR&

3.&HIV&VL&UD&

End&HCV&therapy&

Psych"

“ProspecHve&engagement&in&care”&

Copyright © Edward Cachay MD, MAS.

06/2008& 06/2008& 07/2008&07/2008&

Call"to"reGschedule"

07/2008& 08/2008& 08/2009&09/2008&

02/2010&

Page 25: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

‘Valida,on"of"the"HCV/HIV"primary"care"model"’

SubGspecialty"model (January"2005GMarch"2008)

N&=152

N&=&22

N&=&199

Ini(al" evalua(on

study inclusion

Received"HCV"treatment

N&=146

N&=39

Primary"care"Model (April"2008"–"June"2010)

N&=&195

Excluded"pa(ents"(n"="47) UEntered&on&HCV&treatment:&9 UUndetectable&HCV&viral&load:&13& UPursued&clinical&trial:&11 UIncomplete&staging:&10 UTreatment&beyond&3/08:&4

Excluded"pa(ents"(n"="49) UEntered&on&HCV&treatment:&7 UUndetectable&HCV&viral&load:&6 UPursued&clinical&trial:&2 UIncomplete&staging:&12 UTreatment&beyond&8/11:&22

Untreated"pa(ents"(n=130) UAdvanced&cirrhosis:&13&UU&Uncontrolled&AIDS:&9& UPaHent&choice:&19 UPrior&nonUresponse:&6 ULost&to&followUup:&45&U&Drug/alcohol:&8 UUnstable&psych:&12 U&Homelessness&/language&literacy:&18

Untreated"pa(ents"(n=107) UAdvanced&cirrhosis:&17&UUncontrolled&AIDS:&22& U&&PaHent&Choice:&29 U&&&Prior&nonUresponse:10 U&&&Lost&to&follow&up:&22 U&&&Unstable&psych:&5 U&&&&Drug/alcohol&use&&&U  Homelessness&/language&literacy:& 1

U  The&referral&rate&did&not&differ&during&the&two&periods&(0.10&vs.&0.12/paHentUyr,&p = 0.18).&

&U  Similar&treatment&disconHnuaHon&rates&due&to&

adverse&events&(29%&vs.&16%),&loss&to&followUup&(8&vs.&8%),&Owen&vs&subUspecialty,&respecHvely.&

&U  Increase&trend&to&higher&HCV&SVR&(44&vs.&35%)&

for&Owen&vs.&&SubUspecialty&model,&respecHvely.&

Cachay&et&al.&AIDS&Res&Ther.&2013&

Page 26: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Clinic"Model HighGrisk"(n="17)

NonGhighGrisk""(n=31)

P"value

№&PaHents&with&Sustained&viral&response&(%) 5(29) 16(52) 0.14

№&PaHents&who&disconHnued&HCV&therapy&due&to&nonUviral&response&(%)

2(12) 7(23) 0.36

№&PaHents&who&disconHnued&HCV&therapy&due&to&treatmentUrelated&side&effects&(%)

6(35) 8(26) 0.49

№&PaHents&lost&to&followUup&(%) 3(18) 1(3) 0.08

Cachay et al, AIDS Res Ther. 2013 Mar 28;10(1):9

Early"preliminary"observa(ons:""Successful"HCV"treatment"of"HIV"pa(ents"with"ongoing"barrier"to"care"is"possible"

There&were&no&differences&between&groups&in&age,&ethnicity,&liver&fibrosis,&proporHon&of&HCV&genotype,&baseline&laboratory&exams&,&HCV&RNA&,&CD&and&HIV&VL.&&

Page 27: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Cure"of"HCV"means"a"lot"to"our"pa,ents

Cachay"et"al."2011,"AIDS"Res"Ther.;8:29"

0" 5" 10" 15" 20" 25"1" 4"3"2" 5" 6"

40"

60"

80"

100"

120"

40"

60"

80"

100"

120"

Page 28: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

2011:"HRSA""‘UCSD"CoJinfec,on"Clinic"a"model"to"replicate’

PegUIFN&+&&RBV&

PegUIFN&+&RBV&+&DAA&

DAA&combinaHon&

2016&2011& 2013&2012& 2014& 2015&2010&

Treatment"complexity"

HIV"primary"care/ID"clinics"to"treat"HCV""

2005&

Page 29: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Lesson"#3:"Do"not"do"harm

• Use&of&triple&therapy&with&pegylatedUInterferon&+&Ribavirin&+&Telaprevir&promised&~&75%&chance&of&HCV&cure&

•  Following&treatment&of&our&first&25&paHents&with&triple&therapy,&we&observed&something&different:&&

&&‘&One&of&two&paHents&treated&with&HCV&triple&therapy&could&be&cure&of&HCV&…but&at&&the&cost&of&one&in&two&developing&serious&adverse&reacHons&(Grade&III&or&IV)&that&required&hospitalizaHon’.&

Cachay&et&al.&AIDS.&2013;27(18):2893U7.&

Page 30: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

HCV"treatment"uptake"at"UCSD"Owen"Clinic"

Cachay et et al. Plos One 2014

2008& 2009& 2010& 2011& 2012&0&

1&

3&

2&

4&

5&

6&

7&

8&

HCV

&treatm

ent&u

ptake&pe

r&100P

YFU&

Copyright © Edward Cachay MD, MAS.

2013&

Mean&

95%&&CI&

2014&

Page 31: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

May"2013:

&

• We&advocated&for&IFNUfree&DAA&combinaHons&for&our&paHents,&before&any&professional&guideline&was&available.&

Page 32: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Sofosbuvir:"HCV"vs"HCV/HIV,"in"genotype"1,2"and"3

SOF/P/R&& SOF/R& GT2&naive&

89& 89&

68&

95& 94&90&

93& 91&

0&

10&

20&

30&

40&

50&

60&

70&

80&

90&

100&SV

R"rate"HCV& HIV/HCV&

AnHviral&Drugs&Advisory&Commiqee&MeeHng,&FDA&review,&10/24/13&&C208,&C216,&C206,&C212,&HPC3007,&Dieterich,&14th&European&AIDS&Conference,&2013;&&

Lawitz&et&al.&NEJM&2013&

81&89&

79&88&

GT2&experienced&

GT3&naive& GT3&experienced&

Lesion&#4:&‘HIV&is&no&longer&a&poor&prognosHc&factor&for&response&to&HCV&treatment’&

Page 33: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

We"were"looking"forward"to"the"exci,ng",mes"coming"ahead!

IFN& pegIFNURBV& Triple& All&oral&DAA&

Sustaine

d&viral&respo

nse&(cure)&&

1990s& 2000s& 2011& 2014&

10%&

35%&

65%&

>&90%&

No.&

Adapted from Expert Opin Pharmacother. 2013;14:1161-70

Copyright © Edward Cachay MD, MAS.

Page 34: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Treatment"only"helps"those"who"receive"it

100&%& 100&%&& 100&%&

20&%& 20&%&

10&%& 19&%&

90&%&

85&%&

All&HCV&PaHents&

Diagnosis&and&therapy&

Cure&

PegUIFN/RBV& 95%&SVR&95%&SVR,&increase&diagnosis&and&

linkage&to&treatment&

Page 35: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

1"pill"of"Sofosbuvir"~"1,000$

Page 36: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Consequences"of"high"price"of"HCV"medica,ons

0&

1&

2&

3&

4&

5&

6&

7&

8&

1& 2& 3& 4&2013&Q4&

Q2& Q3& Q4& 2015&Q1&

2014&

$&Billions&per&month& Sales&>&$&2.5&

billion/month&

Profits&&>&$&1.4&billion/month&

Source:&Gilead&sales,&adapted&from&IDWeeK&2015.&Sunday&11&

Page 37: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

• U.S.&is&the&only&country&that&places&no&limit&to&drug&prices&

• Government&grants&drug&patents&under&HatchUWaxman&Act&

• Purpose:&to&incenHvize&development&of&the&drugs&the&public&needs&

• When&these&drugs&are&placed&out&of&reach&of&the&public,&government&needs&to&weight&preventable&morbidity&and&mortality&vs.&company&monopoly&pricing&rights.&

•  Federal&law&28&U.S.C.&§&1498&(a)&allows&government&to&use&patent&invenHon&without&permission&of&the&owner.&

Page 38: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

The"HCV"market"running"and"their"impact"on"lowering"the"prices"

Gilead"

AbbVie"

BMS"

Janssen"

Merck"

&&&&&&&&&

Roche&Boehringer&

Page 39: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Consequences"of"high"price"in"2014

• Conflict&&between&provider,&paHent&and&payer&over&raHoning&&UU&&“you&must&wait&unHl&you&have&severe&liver&damage&to&g&t&treated”&

&UU&“&You&need&to&be&clean&and&sober&to&be&treated”&&

&UU&“&I&am&not&worth&the&treatment”&

Page 40: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

2014:"Payer"restric,ons"(Public"and"private)..aka..

Alcohol&and&substance&use&&

Fibrosis:&Most&state&Medicaid&required&F3/4&&&&&&&&&&&&&&&&6&States&required&liver&biopsies&&

Prescriber&specialtyU&monopoly&&&

Onerous&preUauthorizaHon&procedures:&&&&&&&&&&&&&&&&&&~&12&hours&per&paHent&&

U  Contradict&medical&specialty&guidance&

&U  Purely&for&financial&reasons&&&U  Discriminatory&&U  Illegal&&

Page 41: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

HCV is the only disease where there has to be significant organ damage to treat.

Ann Intern Med. 2013;158(9):658-666.

Persons with HIV had liver fibrosis measurements equal to those of persons without HIV, who were, on average, 9.2 years older

Page 42: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

REVEALJHCV:"‘HCV"is"a"systemic"infec,on’"

Lee"et"al."J"Infect"Dis"2012;"206:"469J77.""

2.8

1.5

1.3

1.4

5.4

21.6

12.5

1.9

//

All causes death Liver-related

Liver cancer

Cirrhosis

Extrahepatic Cancers*

Cardiovascular

Kidney

Adjusted hazard ratios

HCV Ab-pos vs HCV Ab-neg

U  23,820"adults"followed"for"a"mean"of"16.2"years"U  1095"HCV"Ab+"(4%)"U  69%"of"HCV"Ab+"were"HCVGRNA"pos"U  2394"deaths"during"the"study"period"

*esophagus, prostate & thyroid

Page 43: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

""Hepa,,s"C"surpasses"HIV"as"a"cause"of"death"in"the"US"

Rate"per""100"000"Persons"

2000"1999" 2001" 2002" 2003" 2004" 2005" 2006" 2007"

Hepa((s"B"

Hepa((s"C"

HIV"

adapted from Ann Intern Med. 2012, 156:271-8

0&1&

2&

3&

4&

5&

6&

7&

HIV" Chronic"liver"disease"

Alcohol"related"condi(ons" Hepa((s"B"

&1.8&(1.6&U2.0)& 32.1&(31.0U33.3)& 4.6&(4.4&U4.8)& 29.9&(26.5U33.6)&

Why&do&we&have&to&exclude&people&who&use&drugs&or&alcohol?&

Page 44: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

The"most"frequent"reason"for"not"ini,a,ng"HCV"therapy"is"the"presence"of"ongoing"barriers"to"care"in"the"IFNJera

Known"HCV"infec,on"with"established"HIV"care 100%"(n=751)"

Referred"for"HCV"treatment" 40%"(n=301)"

AMended"≥"1"clinic"visit"for"HCV"evalua,on" 37%"(n=281)"

Final"decision"is"made"regarding" HCV"therapy"ini,a,on

33%"(n=248)"

Start"HCV"treatment "12%"(n=88)"

""""HCV"cure" """""5%(n=41)"

Cachay"et"al."PLoS"One."2014";9:e102883

&&&&&&&&U&Barriers&to&care:&78&of&195&(40%)&U&PaHent&did&not&want&IFNUbased&regimens:&45&of&195&(23%)&U&Advanced&liver&disease:&34&of&195(18%)&&U&Prior&null&response&:&16&of&195(8%)&U&Spontaneous&clearance:&16&of&195(8%)&U&ContraindicaHon&to&IFN/or&RBV:&6&of&195(3%)&

Reasons&for&not&starHng&HCV&treatment:&

Page 45: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Where"do"we"stand"in"this"fight?" MedicaHon&manufacturer& InsurancesU&

Health&payees&

Page 46: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Nothing"speaks"beMer"than"data"and"that"is"the"best"way"to"advocate"for"our"pa,ents

Page 47: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

HCV"treatment"regimens"used"in"HIV"coJinfected"pa,ents"in"2014"at"UCSD

Genotype" N"="30" Regimens"1a& &23& &&&RBV&+&SOFU24&weeks&&&&&&&&&&&&&&&&&&&&&&&&&&&&(&2)&

&&&SIM&+&SOFU12&weeks&&&&&&&&&&&&&&&&&&&&&&&&&&&&(12)&&&&SIM&+&SOFU24&weeks&&&&&&&&&&&&&&&&&&&&&&&&&&&&(&4)&&&&SIM&+&SOF&+&RBVU24&&weeks&&&&&&&&&&&&&&&&(&1)&&&&LDV&+&SOFU12&weeks&&&&&&&&&&&&&&&&&&&&&&&&&&&&(&2)&&&&LDV&+&SOFU24&&weeks&&&&&&&&&&&&&&&&&&&&&&&&&&&(&2)&

2& &3& &&&SOF+RBVU12&weeks&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&(&3)&

3& &2& &&&SOF+RBVU24&weeks&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&(&2)&

4& &2& &&&SIMF+SOF&+&RBVU12&weeks&&&&&&&&&&&&&&&&&(&1)&&&&SIM&+&SOFU24&weeks&&&&&&&&&&&&&&&&&&&&&&&&&&&&&(&1)&

Cachay et et al. OFID under review

Page 48: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Characteris,cs"of"pa,ents"with"cirrhosis"("n=22)

Genotype&"""X""&

&&&&&&&&&&1a&&&&&&&&&&&2&&&&&&&&&&&4&

&&&&19&(86%)&&&&&&1&(5%)&&&&&&&2&(9%)&

Median&&MELD&score&&(range)& &&&11&(6U20)&Prior"liver"decompensa(on""&&Ascites&&&&HepaHc&encephalopathy&&&&Esophageal&varices&bleeding&&

10"&9&&7&&&3&

Cachay et et al. OFID under review

Page 49: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

"90%"of"our"treated"pa,ents"will"not"fulffil"clinical"trial"enrollment""

5&

2& 2& 2&

4&

2&

Comorbilidad& Barreras&de&salud&

TARGA&compleja&+&comorbilidad&

comorbilidad&+&barreras&de&

salud&

TARGA&compleja&+&barreras&+&

comorbilidad&

Child&CUcirrosis&

Cirrho(cs"pa(ents"with"GT"1a"(n=17)"

Comorbidity&& Barriers&to&care&

Complex&ART&&+&

&comorbidity&

Comorbidity&+&&

Barriers&to&care&

Complex&ART&&+&

Barriers&+&

&comorbidity&

Child&C&Cirrhosis&&

Cachay et et al. OFID under review

Page 50: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

0

75 83.34

SMV + SOF± RBV x 12 Wks

Real"world

. 1Dieterich D, et al. AASLD 2014. Abstract 46.

n =

UCSD

SV

R 4

(%)

100

80

60

40

20

COSMOS F3/F4

N=&145& N=&30&N=&13&

93 89.6

N=&29&

TRIO&

Mt"Sinai

81.08

N=&37&

"Penns."/"New"Jersey

N=33&

83.03

Northwest

HIV&cohorts&

90

80

Cachay et et al. OFID under review

Page 51: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

What"is"the"impact"of"barriers"to"care"on"HCV"treatment"response?"

•  Ongoing&barriers&to&care&&definiHon:&drug/alcohol&use,&homelessness&,&poverty&and&neuropsychiatry&disease.&

•  RetrospecHve&comparison&of&all&paHents&treated&an&Owen&HCV&clinic&

•  Our&treatment&protocol&for&treaHng&HCV&among&paHents&with&barriers&to&care&has&been&unchanged&since&clinic&incepHon&(2008),&we&compared&treatment&outcomes&across&HCV&treatment&era&:&

&&&&U&Dual&therapy&(pegylated&interferon&plus&ribavirin,&2008U2011);&&

&&&&U&Triple&therapy&(pegUIFN&plus&ribavirin&and&telaprevir,&2011U2013);&&

&&&&U&IFNUfree&DAA&therapy&(2014&)&

Page 52: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Cachay et et al. IDweek 2015- abstract 1672

Page 53: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Cachay et et al. IDweek 2015- abstract 1672

Page 54: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Results:"

• HCV&eradicaHon&among&paHents&with&ongoing&barriers&to&care&improved&from&40%&(95%&CI:&21U61)&to&75%&(95%&CI:&48U93)&in&the&dual&and&DAA&eras,&respecHvely.&

• Using&DAA&and&an&inclusive&HCV&treatment&protocol&75%&of&HIV/HCV&treated&paHents&with&ongoing&barriers&to&care&achieved&HCV&eradicaHon.&

Page 55: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

S,ll"much"remains"to"be"done

Page 56: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Conclusions:

• A&HIV&primary&care&model&is&a&effecHve&way&to&increase&HCV&treatment&uptake&among&HIVUinfected&paHents.&

• Our&data&supports&that&HIVUinfected&paHents&with&ongoing&barriers&to&care&(e.g.&drug/alcohol&use)&achieve&similar&proporHons&of&HCV&cure&than&paHents&without&barriers&to&care&&if&they&seek&voluntarily&HCV&treatment.&

• We&need&collaboraHons&of&all&fronts&in&our&society&to&effecHvely&treat&HCV&in&our&paHents:&Pharma,&Public&payers,&Local&&&federal&government.&&

Page 57: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

Acknowledgements

U  Christopher&Mathews&

U  Chuck&Hicks&U  Robert&Schooley&U  Alex&Kuo&&U My&Owen&colleagues&

U  Jerry&Collins&U  Susan&McQuillen&

&&

• Owen&HCV&team&U&Craig&Ballard&

U&David&Wyles&

U  Bradford&Colwell&U  Francesca&Torriani&U Miguel&Goicoechea&(2008U2011)&

U  Lucas&Hill&

Page 58: A Decade of Treating HCV in Patients with Ongoing Barriers to Care

People&with&ongoing&barriers&to&care&are&a&reflecHon&of&us&as&society.&They&provide&us&the&opportunity&to&look&at&the&place&where&we&live&from&a&different&perspecHve.&Working&together&with&tolerance&and&inclusion&are&key&to&promote&the&common&good&of&everyone&in&our&society.&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&Edward&Cachay&