Real World Management of HCV in HIV: Approach to Initial ... · Real World Management of HCV in...

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Real World Management of HCV in HIV: Approach to Initial Therapy with focus on new DAAs Kristen M. Marks, MD Assistant Professor Weill Cornell Medical College New York, New York

Transcript of Real World Management of HCV in HIV: Approach to Initial ... · Real World Management of HCV in...

Page 1: Real World Management of HCV in HIV: Approach to Initial ... · Real World Management of HCV in HIV: Approach to Initial Therapy with focus on new DAAs Kristen M. Marks, MD Assistant

RealWorldManagementofHCVinHIV:ApproachtoInitialTherapywithfocus

onnewDAAsKristenM.Marks,MD

AssistantProfessorWeillCornellMedicalCollege

NewYork,NewYork

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FinancialRelationshipsWithCommercialEntities

• DrMarkswasawardedresearchgrants,paidtoherinstitution,fromBristol-MyersSquibb,GileadSciences,Inc,andMerck.

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LearningObjectives

Afterattendingthispresentation,learnerswillbebetterableto:

� Describe regimens recommended for initial treatment of HCV infection in HIV-infected persons

� Recognize when to do testing for HCV resistance� Identify the advantages and limitations of newly approved HCV

treatment regimens

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IDSA/AASLDwww.hcvguidelines.org

EASLhttp://www.easl.eu/research/our-contributions/clinical-practice-guidelines/detail/easl-recommendations-on-treatment-of-hepatitis-c-2016

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NewerstrategyforHCVtherapy:Directactingantiviralstargetlifecycle

---PREVIRProteaseinhibitors

e.g.telaprevir,boceprevir,faldaprevir,simeprevir,danoprevir,asunaprevir,paritaprevir,grazoprevir,voxilaprevir,glecaprevir

---BUVIRPolymeraseinhibitors– Nucleos(t)ideanalogs:e.g.

tegobuvir,sofosbuvir,– Non-nucs:e.g.deleobuvir,

dasabuvir---ASVIR

NS5A inhibitorse.g.daclatasvir,ledipasvir,ombitasvir,elbasvir,velpatasvir,pibrentasvir

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NUC PI+

NUC NS5A+

PI NS5A+

PI NS5A+ nonNuc+NUC-SPARINGHCVRenalinsufficiencyDrug-druginteractionsDurationAffordability/AccessToxicityResistance

+/-RBV

+/-RBV

+/-RBV

CurrentlyusedcombinationsofDAAclasses

NUC-SPARINGHIVToxicityResistanceRenalinsufficiencyDrug-druginteractionsAffordability

NUC + NS5A+/-RBVPI +

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PEGRBVSOF

RBVSOF SOF

RBVSMV

+/-

SOF

RBV+/-

LDV OMVDAS

Interferon PegIFN

Ribavirin ribavirin ribavirin +/-ribavirin +/-ribavirin

Nucs sofosbuvir sofosbuvir sofosbuvir sofosbuvir sofosbuvir sofosbuvir

Proteaseinhibitors

simeprevir Paritaprevir/ritonavir

grazoprevir velpatasvir glecaprevir

NS5A ledipasvir daclatasvir ombitasvir elbasvir pibrentasvir

Non-Nucs dasabuvir

SOFDAC

PTV/r

+/-

G1 X X X X X X X X X

G2 X X X X X

G3 X X X X X

G4 X X X X X X X X X

GZREBV SOF

VEL

ApprovedDrugRegimensforInitialTreatment

GLEPBV

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TeamApproachtoHCVTreatmentPre-treatment,Pre-approval

MyContribution• Workwithpatienttopickregimen

• ClearlydescribeinplanANYindicationsfortreatment• E.g.HCVst2fibrosis,womanofchildbearingpotential,

cryoglobulins,DM,etc.

• ClearlydescribeinmyplantheindicationsforthisSPECIFICregimen

• E.g.G1a,Tx-naïve,cirrhosis– LDV/SOFx12wks• Ifunusualchoice- citestudyorguidancedocument

• ClearlydescribeinmyplanthereasonsotherregimensNOTagoodoption

• E.g.currentdarunavir/ruseprecludesuseofPrOD

• Confirmdiscussedmedicationinteractionsandaddressanyspecificones

• DocumentnobarrierstoadherenceevidencedbyHIVcontrol,etc

ContributionofHepatitisNurses+/orPharmacy• Completespecialtypharmacyreferral• Printanyrelevantlab/imagingdocumentation• Faxtospecialtypharmacy

• FileandTrackprogress• HelpdraftlettersforAppeals

• FileandTrackprogress• Stayincommunicationwithpatient• Patientassistanceconnectionswhenneeded

• Copayprograms• Charity

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TeamApproachtoHCVTreatmentPre-treatment,Post-approval

MeetwithHepatitisNursesonly• Drugsusuallydeliveredtoourclinic• Reviewanynewmedications• Educationaboutmedications• Discussionofsideeffectsandmanagement

• Createmonitoringplanschedule• Bookappointmentsformonitoringvisits

• Localcommerciallabifcannotmaketoourclinic

• Reviewhowtotakeandusuallytakefirstdose

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Which of the following represents the BEST strategy for treating HCV?

1. 3drugsfor8weeks2. 2drugsfor8weeks3. 2drugsfor12weeks4. 3drugsfor12weeks

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CASE1– Treatmentduration:whentouse8v.12wks

26y.o.CaucasianWomanwithHCVGeno1b,nocirrhosis,HCVRNA1.2milIU/mL

• HCVHx:• Diagnosedduringlastpregnancy• RiskfactorIVDlastuse26mosago• Treatmentnaïve• FibrosureF0

• OthermedHxincludes:• SeizuredisorderonLevetiracetam(Keppra)

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Which of the following regimens would NOT be recommended for this patient with HCV g1b and no cirrhosis?

1. Sofosbuvir/velpatasvir/voxilaprevirx8wks2. Sofosbuvir/velpatasvirx12wks3. Sofosbuvir/ledipasvirx8wks4. Glecaprevir/pibrentasvirx8wks

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MinimumtoKnowPre-Treatment• HCVgenotype/subtype• HCVresistance(sometimes)• Stageoffibrosis

• Cirrhosis- yes/no• Ifyes,decompensated?(e.g.,ascites,encephalopathy,etc)

• Ifyes,don’tusePIs!• Method?

• Liverbiopsy• Transientelastography• Laboratorybiomarkers• Imaging

• PriorHCVtreatment?• Response?• DAAused?

HIV/Hepatitis C helpline

1-866-637-2342

• Medications• Tocheckfordruginteractions

• Comorbidities• Renalfunction• HIVstatus• Lifeexpectancy<1yrnon-livercauses?

• Patientpreference• Child-bearingpotentialofpatient/partner

• Ribavirinisateratogen

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IDSA/AASLDwww.hcvguidelines.org

NOCIRRHOSIS:• Elbasvir/grazoprevirx12w• Glecaprevir/pibrentasvirx8w• Ledipasvir/sofosbuvirx8*or12w• Sofosbuvir/velpatasvirx12w• Paritaprevir/ritonavir/ombitasvir+dasabuvirx

12w• Simeprevirxsofosbuvir12w• Daclatasvir+sofosbuvirx12w

*8wknotrecommendedforBlackpatientsorHIV-infected.OnlyrecommendedwhenRNA<6millionIU/ml

CIRRHOSIS:

• Elbasvir/grazoprevirx12w• Glecaprevir/pibrentasvirx12w• Ledipasvir/sofosbuvirx12w• Sofosbuvir/velpatasvirx12w• Paritaprevir/ritonavir/ombitasvir+

dasabuvirx12w*

G1b Initial Treatment Recommended Regimens

(BOLDED areregimensapprovedsincelastyear!)

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IDSA/AASLDwww.hcvguidelines.org

NOCIRRHOSIS:

• Elbasvir/grazoprevirx12wifnohilevelNS5Aresistance

• Glecaprevir/pibrentasvirx8w

• Ledipasvir/sofosbuvirx8*or12w• Sofosbuvir/velpatasvirx12w

• Paritaprevir/ritonavir/ombitasvir+dasabuvirx12w

• Simeprevirxsofosbuvir12w

• Daclatasvir+sofosbuvirx12w

*8wknotrecommendedforBlackpatientsorHIV-infected

CIRRHOSIS:

• Elbasvir/grazoprevirx12wifnohilevelNS5Aresistance

• Glecaprevir/pibrentasvirx12w• Ledipasvir/sofosbuvirx12w• Sofosbuvir/velpatasvirx12w

G1a Initial Treatment Recommended Regimens

(BOLDED areregimensapprovedsincelastyear!)

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PangenotypicGlecaprevir/pibrentasvir Slide 30 of 52

DAA combo naive (TN, PEG/RBV, SOF) & special pops

► ENDURANCE (Phase 3)– GT 1 no cirrhosis (8 vs 12W)– GT 2 no cirrhosis (12W)– GT 3 no cirrhosis (8 and 12W)– GT 4-6 (12W)

► EXPEDITION (Phase 3)– GT 1, 2, 4-6 cirrhosis– GT 1-6 HIV– GT 1-6 Renal impairment

► SURVEYOR (Phase 2)– GT 2, 4-6 no cirrhosis 8 weeks– GT 3 cirrhosis/TE 12 vs 16 W

► Co-formulated – 3 pills once daily► Pangenotypic► Next generation

– Active vs NS3 RAS at 80, 155, 168 and NS5A RAS at 28, Q30, 31, 93

– A30K associated with failure in GT3 infection

► Negligible renal excretion► Contains a protease inhibitor► Has interaction with acid suppressing

meds

G/PSlidescourtesyofS.Naggie

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Glecaprevir/pibrentasvir: No Cirrhosis

► 8 (N=828) vs 12 (N=1076) weeks

► TN and TE– PEG, RBV, SOF

– No DAA otherwise

► Relapse <1%

► Tx emergent RAS

99 99 9997

100 100 10099 100 10098

100 100 100

0

10

20

30

40

50

60

70

80

90

100

All GT1 GT2 GT3 GT4 GT5 GT6

8weeks 12weeks

Puoti et al. EASL 2017

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Glecaprevir/pibrentasvir:CirrhosisSlide 34 of 52

Forns et al. EASL 2017

► 12 weeks in N=146

►Compensated cirrhosis

► TN or TE (25%) with IFN, P/R or SOF+P/R

► GT1a 33%, GT1b 27%, GT2 23%, GT4 11%, GT5 1%, GT6 5%

► 1 relapse- GT1a

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Sofosbuvir/velpatasvirx12wksinHIV/HCVG1-6,Naïve+Rx-exp

Wyles,ClinInfectDis,2017.

N=10629%Rx-exp18%cirrhosis12%NS5aRAVs

Of2relapses:1rx-exp,0cirrhosis,0baselineRAVS

RenalfxnlookedunchangedinptsonboostedTDF

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POLARIS-2:8-WkSOF/VEL/Voxilaprevirvs.12-WkSOF/VELNot Non-inferiorforDAA-naïve

8-wkSOF/VEL/VOXdidnotmeetcriteriafornoninferiorityvs12-wkSOF/VEL

Treatmentdifference:-3.4%(95%CI:-6.2%to-0.6%)

Jacobson IM, et al. Gastroenterology. 2017. Slide credit: clinicaloptions.com

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InitialTreatmentAlgorithmAlgorithm• HCVgenotype/subtype&resistance• HIVstatus• Cirrhosis- yes/no- duration

• Ifyes,decompensated?(e.g.,ascites,encephalopathy,etc)

– Ifyes,don’tusePIs!• Renalfunction

– AvoidSofifCrCl<30• Medications

– Addressdruginteractions– Ribavirinisateratogen

• Patientpreference(8or12w,#pills,packaging)

OurCasePatient• 1a,startwith4recommendedregimens

• resistancetestingifelbasvir/grazoprevironly• HIVneg• Cirrhosis– no

• Potentiallyeligiblefor 8wkregimens• Renalfunctionnormalsoeligibleall4regimens

• Medications:• ChildbearingpotentialsoavoidRBV• Anti-epilepticsoftenhaveinteractions

• Pillsandpackaging• Elbasvir/grazoprevir– 1pill/dx12wks• Glecaprevir/pibrentasvir3pills/dx8wks• Sofosbuvir/ledipasvirx8wks• Sofosbuvir/velpatasvirx12wks

• (WHATPAYERCOVERS)TestallpregnantwomanforHCV.Remembertodopregnancytestingpriortotreatmentinwomenofchildbearingpotential

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CASE2– WhentodoresistancetestingandwhattouseinpatientswithESRD

55y.o.AfricanAmericanMwithHIV(wellcontrolled),HCVGeno1bandcirrhosis,HCVRNA221,000IU/mL,ESRDonhemodialysis

• HCVHx:• Treatmentnaïve• Cirrhoticbasedontransientelastographymeasurementof 17kpa

• Nodecompensationevents• EGDnovarices• SononoHCC

• OthermedHxincludes:• HIV-infectiononTDF,3TC,andDOL• HTN,highcholesterol,ESRDonhemodialysis• MildGERDonPPIqD• HBVsAg- cAb+sAb-,HBVDNAnegative

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v

(Slidetobeupdatedlaterthismonthwithguidelinesrelease)

HCVguidlines.orgaccessed9/29/17

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Glecaprevir/pibrentasvir:RenalImpairmentSlide 35 of 52

Gane et al. EASL 2017

► GT 1-6 for 12 weeks

► Stage 4 or 5 CKD

– GFR<30 including HD

– 82% on HD

► TN or TE (42%) with IFN, P/R or SOF+P/R

► Including compensated cirrhosis (19%)

► GT1a 22%, GT1b 28%, GT2 16%, GT3 11%, GT4 19%, GT5 1, GT6 11

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Testing for HCV resistance (RASs) would be indicated in this patient with HCV geno 1b if…

1. HehadfailedPegIFN+RBVinthepast2. Youplantotreatwith8weeksofglecaprevir/pibrentasvir3. Youplantotreatwith12weeksofgrazoprevir/elbasvir4. Nope!Resistancetestingisnotnecessaryhere5. Hmmm…What’saRAS?

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RASTestingpriortoTreatment• NS5ARASsarerelativelycommon(10-15%)• SignificanceofNS5ARASsmaydependontheRAS,thegenotype,theregimenusedandwhetherpriorNS5Atreatment

• Ininitialtreatment,useresistancetestingpriorto:• Treatmentwithgrazoprevir/elbasvirfor1a• TreatmentofG3ifcirrhosis

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ImpactofBaselineNS5ARAVs:SV

R12

(%)

GT1a GT1b GT1a, No BL NS5A RAVs

94 99 9990

144/154

129/130

133/135

9/10n/N =

SVR12 With 12 Wks of Grazoprevir/Elbasvir for initial treatment

10080604020

0GT1a, BL

NS5A RAVs With ≤ 5-Fold Shift to EBR

29

GT1a, BL NS5A RAVs

With > 5-Fold Shift to EBR

2/9

Slide credit: clinicaloptions.comZeuzem S, et al. Ann Intern Med. 2015;163:1-13.

IfNS5ARAVsingenotype1a,treatwithEBR/GZR+RBVfor16wks(alternative)

NobaselineRAVtestingneededingenotype1bpts

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InitialTreatmentAlgorithmAlgorithm• HCVgenotype/subtype&resistance

• HIVstatus• Cirrhosis- yes/no- duration

• Ifyes,decompensated?(e.g.,ascites,encephalopathy,etc)

• Ifyes,don’tusePIs!• Renalfunction

• AvoidSofifCrCl<30• Medications

• Addressdruginteractions• Ribavirinisateratogen

• Patientpreference(8or12w,#pills,packaging)

Ourcasepatient• 1b,noneedforresistancetesting,startwith4recommendedregimens

• HIVposbutnodrug/druginteractions• Cirrhosis– yes

• No8wkregimens• CompensatedsooktousePIs

• Hemodialysis,noregimensw/sofosbuvir,so2remainingregimens

• Medications:ARVs,PPIqd• Elbasvir/grazoprevir– nointeraction• Glecaprevir/pibrentasvir(limitdoseofPPI)

• Pillsandpackaging• Elbasvir/grazoprevir– 1pill/d• Glecaprevir/pibrentasvir – 3pills/d

• (WHATPAYERCOVERS)HBVtestingpriortotreatmentforallpatients.MonitorforHBVreactivationduringtreatmentifcAb+(withDNAforsAg+orDNA+,lfts/sxforothers)ContinuecirrhosismanagementandHCCscreeningaftercure

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CASE3– TreatmentanddruginteractionsinpatientswithHIV

49y.o.MwithHIVandHCVGeno2,HCVRNA120,000IU/mL

•HIVHx:•WellcontrolledonTDF/FTC+BIDdarunavir/ritonavirx10years

•HCVHx:• Treatmentnaïve• Fibroscan6.1kPa• AcquiredHCV2yearsago– RFMSM

• OthermedHxincludes:• HTN,renalinsufficiency(CrCl50)• GERDonPPI

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Which of the following regimens are recommended for genotype 2 infection in a person without cirrhosis?

1. Sofosbuvir/velpatasvirx12wks2. Glecaprevir/pibrentasvirx8wks3. Both1and24. Neither1or2

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IDSA/AASLD/IAS-USAwww.hcvguidelines.org

NOCIRRHOSIS:• Glecaprevir/pibrentasvirx8w• Sofosbuvir/velpatasvirx12wks

G2 INITIAL TREATMENT RECOMMENDED REGIMENS

CIRRHOSIS:• Glecaprevir/pibrentasvirx12w• Sofosbuvir/velpatasvirx12wks

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HCVguidlines.orgaccessed9/29/17

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Before administering sofosbuvir/velpatasvir in a patient with renal insufficiency (CrCl 50) on TDF/FTC + darunavir/ritonavir, which of the following should be considered?

1. Changedarunavir/rdosingfromBIDtoQD2. ChangeTDFtoTAF3. Changedarunavir/rtoefavirenz4. NoARVadjustmentneeded

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HCVguidelines.org

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RTV-BoostedPIsWithout WithLDV/SOF4-9LDV/SOF10

WithSOF/LDVTDFexposuresarehighinthoseonPIs

EFV RPV ATRCPA

NNRTIsWithout With

LDV/SOF1,2LDV/SOF3

• TFVexposuresarehigherwhenTDFiscoadministeredwithLDV/SOFcomparedtowithoutLDV/SOF,but• ComparedtotherangeofTFVexposureswithavailablesafetydata

• ForEFVorRPV:TFVexposuresfallwithintherange1• ForRTV-boostedPIs:TFVexposurespartiallyexceedtherange2

RangeofTFVexposureswithavailablesafety

data

1,DataonFile,GileadSciences.2.HoetelmansRMW,etal.6th IWCPHT2005.QuebecCity,Canada.Poster#2.113.GermanP,etal.ICPHHT2014.#O64.LuberAD,etal.HIVMedicine.2010;11:193-9(FPV+RTV)5.ChittickGE,etal.AAC.2006;50(4):1304-10(SQV+RTV)

6.Zhu.9thIWCPHT.2008.#023(ATV+RTV&LPV/r)7.KearneyB,etal.JAIDS. 2006;43(3):278-83(LPV/r)8.AgarwalaS,etal.6thIWCPHT2005.#16.(ATV+RTV)9.HoetelmansRMW,etal.BJCP. 2007;64(5):655-61(DRV+RTV)10.GermanP,etal.CROI2015

N=3015 1714FPVSQVLPV/rATVDRVATVDRV153519*2417*14122423

SlidecourtesyofJKiser

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GuidelinesRecommendationaboutuseofLDVorVELwithTDFSOF/LDV+TDFCrCl<60mL/min:AVOIDCrCl>60:MONITOR

SOF/LDV+TDF+cobi- orritonavir-boostedPIAnyCrCl:AVOIDifpossible,ConsiderTAF

SOF/VEL+TDFCrCl<60mL/min:AVOIDCrCl>60:MONITOR

SOF/VEL+TDF+cobi- orritonavir-boostedPICrCl<60mL/min:AVOIDCrCl>60:MONITORorconsiderTAF

HCVguidlines.orgaccessed9/29/17

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10093

0

10

20

30

40

50

60

70

80

90

100

8weeknocirrhosis 12weekcirhosis

Glecaprevir/pibrentasvir:HIV Slide 36 of 52

136/13614/15

Rockstroh et al. EASL 2017

► GT 1-6► Primarily an 8 week study► 12 weeks in 16 patients with

cirrhosis► TN or TE (19%) with IFN,

P/R or SOF+P/R► VBT on treatment – GT3

with cirrhosis

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HCVguidelines.org

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Drug-Drug Interactions with DAAS

•Acid-reducingdrugs

•Anti-epileptics

•Antiretrovirals

•Amiodarone

•Lipid-loweringdrugs

http://www.hep-druginteractions.org/https://www.hep-druginteractions.org/

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Marks,CROI,2018 Marks,CROI,2018

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InitialTreatmentAlgorithmAlgorithm• HCVgenotype/subtype&resistance

• HIVstatus• Cirrhosis- yes/no- duration

• Ifyes,decompensated?(e.g.,ascites,encephalopathy,etc)

• Ifyes,don’tusePIs!• Renalfunction

• AvoidSofifCrCl<30• Medications

• Addressdruginteractions• Ribavirinisateratogen

• Patientpreference(8or12w,#pills,packaging)

Ourcasepatient• 2,noneedforresistancetesting,startwith2recommendedregimens

• HIVpos– watchfordruginteractions• Cirrhosis– no• CrCl50,sofosbuvirokbutCrCl>30butassessifTDF

• Medications:TDF,HIVPI,PPIqdneedtobeaddressed

• ARVadjustmentneeded

• Pillsandpackaging• Sofosbuvir/velpatasvir– 1pill/d• Glecaprevir/pibrentasvir3pills/d

• (WHATPAYERCOVERS)MonitorMSMforreinfectionatleastannually.ConceptofHCVtreatmentaspreventionhasbeenprovenforHIV+MSMinNetherlands&Switzerland.

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CASE4– Genotype3management

71y.o.WwithHCVGeno3,HCVRNA950,000IU/mL

HCVHx:• Treatmentnaïve• Fibroscan14.2kPa(c/w)cirrhosis• Nosymptomsdecompensation• RAStesting:nomutations

• OthermedHxincludes:• DM• CrCL55

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Which of the following is recommended for initial treatment of HCV G3 in a patient with cirrhosis?

1. Sofosbuvir/ledipasvirx12wks2. Sofosbuvir/velpatasvirx12wks3. Elbasvir/grazoprevirx12wks4. Glecaprevir/pibrentasvirx8wks

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Page 50: Real World Management of HCV in HIV: Approach to Initial ... · Real World Management of HCV in HIV: Approach to Initial Therapy with focus on new DAAs Kristen M. Marks, MD Assistant

IDSA/AASLD/IAS-USAwww.hcvguidelines.org

NOCIRRHOSIS:• Glecaprevir/pibrentasvirx8w• Sofosbuvir/velpatasvirx12w• Sofosbuvir+daclatasvirx12w

G3 INITIAL TREAMENT RECOMMENDED REGIMENS

CIRRHOSIS:• Glecaprevir/pibrentasvirx12w• Sofosbuvir/velpatasvirx12w*• Sofosbuvir+daclatasvir+/-RBVx24w*

*RAVtestingforY93HandaddRBVifpresentorusesofosbuvir/velpatasvir/voxilaprevir

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Glecaprevir/pibrentasvirinGT3Treatment-naïvewithoutCirrhosis

Foster et al. EASL 2017

Slide 32 of 52

►Non-inferiority– 12W vs DAC/SOF X12W– 12W vs 8W

►Viral Failure 3% G/P– 4 in 12W (3 relapse, 1 VBT)– 1 in DAC/SOF– 6 in 8W (5 relapse, 1 VBT)

►BL Y93H: 5/5 SVR►BL dual NS3/NS5A

– 71-86% SVR►Tx emergent RAS

– 50% failures with A30K BL– A30K+Y93 (69-fold R

SURVEYOR-II– G3withCirrhosis48patientsreceivedG/P+/- RBVx12w=100%SVR

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Glecaprevir/pibrentasvirandRASs-- A30Keffect?

Foster et al. EASL 2017 Krishnan et al. EASL 2017

Slide 32 of 52

►Non-inferiority– 12W vs DAC/SOF X12W– 12W vs 8W

►Viral Failure 3% G/P– 4 in 12W (3 relapse, 1 VBT)– 1 in DAC/SOF– 6 in 8W (5 relapse, 1 VBT)

►Tx emergent RAS– 50% failures with A30K BL

• 6% patients overall had a BL A30K

SURVEYOR-II– G3withCirrhosis48patientsreceivedG/P+/- RBVx12w=100%SVR

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Sofosbuvir/velpatasvirx12wksforG3(ASTRAL-2)

Foster,NEJM,2015,hcvguidelines.org

Mostofthis3%w/failurehadcirrhosis

Page 54: Real World Management of HCV in HIV: Approach to Initial ... · Real World Management of HCV in HIV: Approach to Initial Therapy with focus on new DAAs Kristen M. Marks, MD Assistant

InitialTreatmentAlgorithmAlgorithm

• HCVgenotype/subtype&resistance

• HIVstatus

• Cirrhosis- yes/no- duration• Ifyes,decompensated?(e.g.,ascites,encephalopathy,etc)

• Ifyes,don’tusePIs!

• Renalfunction• AvoidSofifCrCl<30

• Medications• Addressdruginteractions• Ribavirinisateratogen

• Patientpreference(8or12w,#pills,packaging)

Ourcasepatient• Geno3,2regimens,noA30KorY93Hpresent

• HIVneg• Cirrhosis– yes

• CompensatedsoPIsok

• CrCl55,sofosbuvirok• Medications:nodruginteractions• Pillsandpackaging

• Sofosbuvir/velpatasvir– 1pill/dx12wks

• Glecaprevir/pibrentasvir3pills/dx12wks

• (WHATPAYERCOVERS)

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• RemarkableadvancesintermsofHCVtreatmenttolerability&efficacyforpatientswithHIV

• RecentadvancesinG2,G3,ESRD

• SVRsforHIV/HCVveryclosetomonoinfection

• Stilldruginteractionissues,butvaluableresourcestohelpmanage

• RAStestingpriortoinitialtreatmentif:• G1aandplannedgrazoprevir/elbasvir• G3&cirrhosisandplannedsofosbuvir/velpatasvir

• Successfultreatmentpreventscirrhosis,endstageliverdisease,andhepatocellularcancer

• PostSVR– continueliverdiseasemanagement/HCCscreening,monitorHBVreactivation,andprovideHCVRNAtestingifongoingrisk

It’stime!CureEveryonewithHCV

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• HCVguidelines.org• nynjaetc.org• http://www.hep-druginteractions.org

THANK YOU

Thankyou

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