learning objectives - ias- · pdf filenew york, ny: september 9, 2015 1. slide 4 of 50...

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Lucas A. Hill, PharmD Clinical Instructor University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences San Diego, California Drug-Drug Interactions Between Antiretrovirals and the HCV Treatments in HIV/HCV Coinfection Management AU EDITED: 09/01/15 New York, NY: September 9, 2015 ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ Slide 2 of 50 Financial Relationships With Commercial Entities Dr Hill has no relevant financial affiliations to disclose. (Updated 09/01/15) ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ Slide 3 of 50 Learning Objectives After attending this presentation, participants will be able to describe: Available efficacy data for treatment of HCV in HIV/HCV coinfected patients Important drug interactions between HIV antiretrovirals and HCV direct acting antivirals Future therapies for the treatment of HCV in HIV/HCV coinfection ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ New York, NY: September 9, 2015 1

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Page 1: Learning Objectives - IAS- · PDF fileNew York, NY: September 9, 2015 1. Slide 4 of 50 Potential issues in treating HIV/HCV ... Efavirenz + FTC + TDF 160 (48) Raltegravir + FTC + TDF

Lucas A. Hill, PharmDClinical Instructor

University of California San Diego Skaggs School of Pharmacy and

Pharmaceutical SciencesSan Diego, California

Drug-Drug Interactions Between

Antiretrovirals and the HCV Treatments in

HIV/HCV Coinfection Management

AU EDITED: 09/01/15

New York, NY: September 9, 2015

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Slide 2 of 50

Financial Relationships With Commercial Entities

Dr Hill has no relevant financial affiliations to

disclose. (Updated 09/01/15)

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Slide 3 of 50

Learning Objectives

After attending this presentation, participants will be

able to describe:

Available efficacy data for treatment of HCV in

HIV/HCV coinfected patients

Important drug interactions between HIV

antiretrovirals and HCV direct acting antivirals

Future therapies for the treatment of HCV in

HIV/HCV coinfection

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New York, NY: September 9, 2015 1

Page 2: Learning Objectives - IAS- · PDF fileNew York, NY: September 9, 2015 1. Slide 4 of 50 Potential issues in treating HIV/HCV ... Efavirenz + FTC + TDF 160 (48) Raltegravir + FTC + TDF

Slide 4 of 50

Potential issues in treating HIV/HCV co-infection with new HCV antivirals

HCV Therapy in

HCV/HIV

Efficacy

ProvidersAccess

D-D-I

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Slide 5 of 50

MD (evaluation, assessment, treatment planning)

Clinic Pharmacist (treatment planning, follow-up)

Health Educator, Drug and Alcohol Counselor (rehab, lifestyle changes)

Psychiatrist

Family, Friends

HIV-HCV Management Team

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Slide 6 of 50

Patient Case #1• 64 yo African American male

• HIV-HCV coinfected

• DM2 diagnosed 2006 last A1c 6.0

– Glipizide 10 mg bid + metformin 1g bid + insulin glargine 50u hs

• Seizure disorder dx 2007

– Levetiracetam 1000 mg bid

• HTN dx 1990s

– Hydrochlorothiazide 50 mg + quinapril bid + amlodipine

• Dyslipidemia

– Simvastatin 20 mg/day

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New York, NY: September 9, 2015 2

Page 3: Learning Objectives - IAS- · PDF fileNew York, NY: September 9, 2015 1. Slide 4 of 50 Potential issues in treating HIV/HCV ... Efavirenz + FTC + TDF 160 (48) Raltegravir + FTC + TDF

Slide 7 of 50

HIV History• Most recent VL and CD4 (6/15)

– HIV RNA not detected– CD4 769 cells/µL (33%)

• ARV History– Zidovudine, didanosine, zalcitabine during 1980s– Stavudine, nelfinavir, ritonavir during 1990s– Tenofovir, lamivudine, efavirenz 12/2003 – 5/2007– Tenofovir/emtricitabine/efavirenz (FDC) since 5/2007 to

present• HIV-1 viral load undetectable since 2003

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Slide 8 of 50

HCV History• Treatment history:

Failed peginterferon/ribavirin x 2 (relapsed after 42 wks)

• Genotype 1A

• HCV RNA (6/2015) – 7,700,000 IU/mL (6.89 log10 IU/mL)

• Liver biopsy (2013):– Cirrhosis

• CTP A

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Slide 9 of 50

HCV Genotype NS3/4A

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New York, NY: September 9, 2015 3

Page 4: Learning Objectives - IAS- · PDF fileNew York, NY: September 9, 2015 1. Slide 4 of 50 Potential issues in treating HIV/HCV ... Efavirenz + FTC + TDF 160 (48) Raltegravir + FTC + TDF

Slide 10 of 50

Audience Response Question• Based on the patient’s ARV regimen of

tenofovir/emtricitabine/efavirenz, which treatment regimen would allow the patient to remain on his current ARVs and start HCV treatment.

1. Paritaprevir/ritonavir/ombitasvir + dasabuvir + ribavirin x 24 weeks

2. Sofosbuvir + daclatasvir + ribavirin x 24 weeks

3. Ledipasvir/sofosbuvir x 24 weeks

4. Sofosbuvir + simeprevir x 24 weeks

9%

30%

57%

4%

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Slide 11 of 50

Audience Response Question• Based on the patient’s ARV regimen of

tenofovir/emtricitabine/efavirenz, which treatment regimen would allow the patient to remain on his current ARVs and start HCV treatment.

1. Paritaprevir/ritonavir/ombitasvir + dasabuvir + ribavirin x 24 weeks

2. Sofosbuvir + daclatasvir + ribavirin x 24 weeks

3. Ledipasvir/sofosbuvir x 24 weeks

4. Sofosbuvir + simeprevir x 24 weeks

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Slide 12 of 50

Efficacy in HIV/HCV co-infection

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New York, NY: September 9, 2015 4

Page 5: Learning Objectives - IAS- · PDF fileNew York, NY: September 9, 2015 1. Slide 4 of 50 Potential issues in treating HIV/HCV ... Efavirenz + FTC + TDF 160 (48) Raltegravir + FTC + TDF

Slide 13 of 50

PHOTON: SOF/RBV FOR HIV/HCV

• Cirrhosis permitted • Most ART allowed– CD4>500 not on ART– CD4>200 on ART

SOF/RBV (n=114)

SOF/RBV (n=68)

SOF/RBV (n=41)

GT1 TN

GT 2,3 TN

GT 2,3 TE

SOF/RBV (n=19)

SOF/RBV (n=55)

SOF/RBV (n=200)

GT 2,3 TE

GT 1,3,4 TN

GT 2 TN

12 36Weeks

PH

OTO

N-1

PH

OTO

N-2

Naggie S. EASL 2014. Molina J-M. IAS 2014.

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Slide 14 of 50

7688

67

92 9485 89 91

83 86

0

20

40

60

80

100

GT1/4 GT2 TN GT3 TN GT2 TE GT3 TE

SVR

12

(%

)

PHO-1

PHO-2

Naggie S. EASL 2014. Molina J-M. IAS 2014.

PHOTON: SOF/RBV FOR HIV/HCV

PHOTON 2: 65% (11/17) GT1 cirrhosis; 78% (18/23) GT 3 TE, cirrhosis

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Slide 15 of 50

ION-4 – LDV/SOF

• Phase 3, multicenter, open-label study (NCT02073656)

• HCV GT 1 or 4 patients in US, Canada, and New Zealand

• Broad inclusion criteria

– HCV treatment-naïve or treatment-experienced

– 20% with compensated cirrhosis

– Platelets ≥50,000/mm3; hemoglobin ≥10 mg/dL, CrCl ≥60 mL/min

– HIV-1 positive, HIV RNA <50 copies/mL; CD4 cell count >100 cells/mm3

• ART regimens included emtricitabine and tenofovir disoproxil fumarate plus efavirenz, raltegravir, or rilpivirine

Wk 0 Wk 12 Wk 24

SVR12LDV/SOFN=335

Naggie S, Cooper C, Saag M, et al. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015; 373:705-713.

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New York, NY: September 9, 2015 5

Page 6: Learning Objectives - IAS- · PDF fileNew York, NY: September 9, 2015 1. Slide 4 of 50 Potential issues in treating HIV/HCV ... Efavirenz + FTC + TDF 160 (48) Raltegravir + FTC + TDF

Slide 16 of 50ION-4 Results: Demographics and Baseline Characteristics

LDV/SOF 12 weeksN=335

Mean age, y (range) 52 (26-72)

Male, n (%) 276 (82)

Black, n (%) 115 (34)

Hispanic or Latino, n (%) 56 (17)

Mean BMI, kg/m2 (range) 27 (18-66)

IL28B CC, n (%) 81 (24)

GT 1 327 (98)

HCV treatment experienced, n (%) 185 (55)

Cirrhosis, n (%) 67 (20)

Mean HCV RNA, log10 IU/mL ± SD 6.7 ± 0.6

Median CD4 cell count, cells/µL (range) 628 (106-2069)

HIV ARV Regimen

Efavirenz + FTC + TDF 160 (48)

Raltegravir + FTC + TDF 146 (44)

Rilpivirine + FTC + TDF 29 (9)

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Slide 17 of 50

96 95 97 96 94

0

20

40

60

80

100

Naïve vs ExperiencedOverall Cirrhosis Status

LDV/SOF 12 Weeks

ExperiencedNaïve No Cirrhosis Cirrhosis

321/335 142/150 179/185 63/67258/268

SV

R12 (

%)

Results: SVR12 by Prior TreatmentExperience and Cirrhosis Status

Overall

Error bars represent 95% confidence intervals.

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Slide 18 of 50

ION-4 Results: Renal FunctionEFV+FTC+TDF (n=160)

RAL+FTC+TDF (n=146)

RPV+FTC+TDF (n=29)

LDV/SOF +

60708090

100110120130140150

Cre

atin

ine

Cle

aran

ce(m

L/m

in),

mea

n

SD

WeekBL 1 2 4 6 8 10 12 FU-4

4 patients (1%) had change in creatinine ≥ 0.4 mg/dL

– 2 completed treatment with no ART change

– 1 had dose reduction of TDF, 1 discontinued TDF

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New York, NY: September 9, 2015 6

Page 7: Learning Objectives - IAS- · PDF fileNew York, NY: September 9, 2015 1. Slide 4 of 50 Potential issues in treating HIV/HCV ... Efavirenz + FTC + TDF 160 (48) Raltegravir + FTC + TDF

Slide 19 of 50

SVR12ABT450/r/267 + 333 + R

ABT450/r/267 + 333 + R

12 24Weeks

SVR12

N=31

N=32

• Stable ART

– ATV or RAL

– HIV RNA <40 copies/mL

– CD4 >200

Wyles. EASL 2014.

.

12 Week 24 Week

Male 94% 91%

Naïve 65% 69%

Null 16% 16%

1a 87% 91%

F4 19% 19%

CD4 633 625

TURQUOISE I: PrOD + RBV in HIV/HCV

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TURQUOISE I: PrOD + RBV in HIV/HCV

• In 12-week arm 1 patient withdrew consent• Two patients in 24-week arm were re-infected causing decrease to 90.6% at SVR12• Two virologic failures — both 1a cirrhotic null responders, both on raltegravir

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Slide 21 of 50Daclatasvir-ALLY-2

■ Primary endpoint: SVR12 in treatment-naive patients with GT 1 treated for 12 weeks

■ Standard DCV dose is 60 mg– Dose-adjusted for concomitant ARV therapy: 30 mg with ritonavir-boosted PIs, 90 mg with

NNRTIs except RPV* HCV RNA <LLOQ (TD or TND) at posttreatment Week 12, assessed using the Roche HCV COBAS TaqMan Test v2.0 (LLOQ 25 IU/mL).

DCV 30/60/90 mg +SOF 400 mg QD

24

DCV 30/60/90 mg +SOF 400 mg QD

12

NaiveRandomize 2:1

Experienced

DCV 30/60/90 mg + SOF 400 mg QD

Week 0 8

N

101

50

52

SVR12*

Wyles D, Ruane P, Sulkowski M, et al. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015;373:714-725.

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New York, NY: September 9, 2015 7

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Slide 22 of 50Slide 22 of 50

Demographic and HCV Disease CharacteristicsDemographic and HCV Disease Characteristics

ParameterNaive

12 WeekN = 101

Experienced12 Week

N = 52

Naive8 WeekN = 50

Age, median years (range) 52 (24–71) 57 (43–66) 50 (28–75)

Male, n (%) 92 (91) 43 (83) 42 (84)

Race, n (%)

White 66 (65) 31 (60) 28 (56)

Black 30 (30) 20 (38) 19 (38)

Other 5 (5) 1 (2) 3 (6)

HCV GT, n (%)

1a 71 (70) 33 (63) 35 (70)

1b 12 (12) 11 (21) 6 (12)

2 11 (11) 2 (4) 6 (12)

3 6 (6) 4 (8) 3 (6)

4 1 (1) 2 (4) 0

HCV RNA, mean log10 IU/mL (SD) 6.50 (0.76) 6.52 (0.79) 6.40 (0.71)

Cirrhosis, n (%)* 9 (9) 15 (29) 5 (10)

*Cirrhosis status determined by liver biopsy (METAVIR >F3), Fibroscan (>14.6 kPa), or Fibrotest >0.74 with APRI >2.

Slide 22 of 50

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Slide 23 of 50

0

20

40

60

80

100

SVR

12

, %

12-WeekNaive

12-WeekExperienced

8-WeekNaive

GT 1 (N = 168)

ALLY-2: SVR12

12-WeekNaive

0

20

40

60

80

100

12-WeekExperienced

8-WeekNaive

All Patients (N = 203)

96 98 76 97 98 76

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Slide 24 of 50

96 100 100 100 10097 100 100 100 100

0

20

40

60

80

100

1a 1b 2 3 4

SVR

12

, %

HCV genotype

Naive Experienced

SVR12 by HCV Genotype: 12-Week Groups

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New York, NY: September 9, 2015 8

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Slide 25 of 50

Efficacy Summary

• Treatment recommendations are the same for mono-infected patients and co-infected patients based on efficacy

–Not recommended to treat co-infected patient with 8 weeks of LDV/SOF

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Slide 26 of 50

Drug-Drug Interactions in HIV/HCV co-infection

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Slide 27 of 50SOF and -007 Pharmacokinetics with ARV

Kirby AASLD 2012

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New York, NY: September 9, 2015 9

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Slide 28 of 50

ARV Pharmacokinetics

Kirby AASLD 2012

• Avoid SOF and LDV with tipranavir/ritonavir due to P-gp induction

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Slide 29 of 50

• EFV: ~35% reduction in LDV exposure

– LDV: no impact of EFV

• LDV: 40-98% increase in TFV AUC

– 90-150% increase in Ctau

LDV/SOF DDIs with antiretrovirals

German P. 15th Inter Clin Pharm HIV and HCV 2014.

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Slide 30 of 50

LDV/SOF and Tenofovir

AUC of tenofovir 3000-3300 ng.hr/mL

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New York, NY: September 9, 2015 10

Page 11: Learning Objectives - IAS- · PDF fileNew York, NY: September 9, 2015 1. Slide 4 of 50 Potential issues in treating HIV/HCV ... Efavirenz + FTC + TDF 160 (48) Raltegravir + FTC + TDF

Slide 31 of 50

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Slide 32 of 50

LDV/SOF and Tenofovir

German et al. CROI 2015.

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Slide 33 of 50

LDV/SOF and Tenofovir

German et al. CROI 2015.

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New York, NY: September 9, 2015 11

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Slide 34 of 50

LDV/SOF and Tenofovir

German et al. CROI 2015.

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Slide 35 of 50Tenofovir alafenamide (TAF)Novel Prodrug of Tenofovir

Tenofovir (TFV)

Tenofovir disoproxil fumarate (TDF)

Tenofovir alafenamide (TAF)

GI Tract Blood Lymphoid Cell

TFV

TDF TFV

TAF TFV

TFV-MP = tenofovir monophosphateTFV-DP = tenofovir diphosphateCatA = Cathepsin A

TFV

TFV-MP

TFV-DP

esterase

CatAAMPK

AMPK

Modified from CROI 2015 - Sax et al. Abstract 143LB

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Slide 36 of 50

LDV/SOF and TAF

LDV Mean (%CV)

LDV/SOF + E/C/F/TAF

n=30LDV/SOF

n=30GMR

(90% CI)

AUC ng.h/mL 22,900 (35.7) 12,700 (36.3) 1.79 (1.63, 1.96)

Cmax ng/mL 1140 (32.1) 684 (32.3) 1.65 (1.53, 1.78)

Ctau ng/mL 896 (37.7) 459 (40.3) 1.93 (1.74, 2.15)

Garrison et al. 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy. 2015

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New York, NY: September 9, 2015 12

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Slide 37 of 50

LDV/SOF and TAF

LDV Mean (%CV)

LDV/SOF + DTG+FTC/TDF

n=29LDV/SOF

n=30GMR

(90% CI)

AUC ng.h/mL 8940 (35.1) 10,300 (37.4) 0.89 (0.84, 0.95)

Cmax ng/mL 523 (33.9) 626 (33.6) 0.85 (0.81, 0.90)

Ctau ng/mL 316 (39.2) 365 (41.2) 0.89 (0.84, 0.95)

Garrison et al. 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy. 2015

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Slide 38 of 50

LDV/SOF and TAF

Garrison et al. 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy. 2015

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Slide 39 of 50

LDV/SOF and TAF

Garrison et al. 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy. 2015

TFV Mean (%CV)

LDV/SOF + DTG+FTC/TDF

n=29DTG+FTC/TDF

n=30GMR

(90% CI)

AUC ng.h/mL 4900 (24.1) 3020 (26.6) 1.65 (1.59, 1.71)

Cmax ng/mL 495 (24.0) 310 (24.4) 1.61 (1.51, 1.72)

Ctau ng/mL 117 (23.2) 55.7 (28.7) 2.15 (2.05, 2.26)

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New York, NY: September 9, 2015 13

Page 14: Learning Objectives - IAS- · PDF fileNew York, NY: September 9, 2015 1. Slide 4 of 50 Potential issues in treating HIV/HCV ... Efavirenz + FTC + TDF 160 (48) Raltegravir + FTC + TDF

Slide 40 of 50

LDV/SOF and TAF

Conclusions• Safe to administer E/C/F/TAF with LDV/SOF – increases in COBI and EVG levels not considered

clinically significant• Monitor for TFV toxicity when using DTG-FTC/TDF with LDV/SOF

Garrison et al. 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy. 2015

LDV/SOF + E/C/F/TAF

n=30E/C/F/TAF

n=30GMR

(90% CI)

TFV Mean(%CV)

AUC ng.h/mL 397 (15.9) 315 (18.7) 1.27 (1.23, 1.31)

Cmax ng/mL 20.7 (16.1) 17.8 (20.4) 1.17 (1.12, 1.22)

Ctau ng/mL 15.5 (16.6) 11.7 (20.0) 1.33 (1.28, 1.38)

TAF Mean (%CV)

AUClast, ng.h/mL 195 (29.2) 239 (45.9) 0.86 (0.78, 0.95)

Ctaung/mL 148 (48.2) 166 (50.8) 0.90 (0.73, 1.11)

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Slide 41 of 50

PrOD D-D-I: RAL, RPV, EFV, DTG• Healthy volunteer study

– Studied with RAL, TDF/FTC, RPV 25mg, EFV

• EFV arm discontinued prematurely

• RPV exposure similar to 75mg (QTc 10s)

• Study with PrOD + DTG or ABC/3TC– No significant changes in ABC/3TC or DTG levels– Reduction in paritaprevir levels by 34% with DTG and 27% by

ABC/3TC• Not studied with FDC DTG/ABC/3TC

• Do not use PrOD for patients not on ARV regimenKatri A. ICAAC 2014.,

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Slide 42 of 50

• Healthy volunteer study of 3D regimen with:– ATV/r 300/100mg QAM or QPM

• rit omitted if given in AM with 3D regimen– DRV/r 800/100mg QAM or QPM or 600/100mg BID

• rit omitted if given in AM with 3D regimen– LPV/r 800/200mg QPM or 400/100mg BID

• DRV Cmin 43-48% lower– DRV/r BID with 3D comparable exposure to DRV/r QD– DRV/r QD and BID being evaluated in TURQUOISE I

• Dasabuvir Cmin 46% lower with DRV BID (AUC27%)

PrOD DDIs: LPV, ATV, DRV

Katri A. ICAAC 2014.

HIV PI LEVELS ABT-450 LEVELS

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New York, NY: September 9, 2015 14

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Slide 43 of 50

Daclatasvir drug interactions: Unique role in Co-infection?

• Substrate of Pgp and CYP3A4

– Moderate Pgp inhibitor

• ATV/r- DCV 20mg: AUCt: 0.70, C24: 1.21

– 30mg (est): AUCt: 1.05, C24: 1.83

• EFV- DCV 120mg: AUCt: 1.37, C24: 0.83

– 90mg (est): AUCt: 1.03, C24: 0.62

• TDF- DCV 60mg: AUCt: 01.10, C24: 1.17Bifano M. CROI 2012.

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Slide 44 of 50

Audience Response Question• Based on the patient’s ARV regimen of

tenofovir/emtricitabine/efavirenz, which treatment regimen would allow the patient to remain on his current ARVs and start HCV treatment.

1. Paritaprevir/ritonavir/ombitasvir + dasabuvir + ribavirin x 24 weeks

2. Sofosbuvir + daclatasvir + ribavirin x 24 weeks

3. Ledipasvir/sofosbuvir x 24 weeks

4. Sofosbuvir + simeprevir x 24 weeks

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Slide 45 of 50

Which DAA regimen with which HAART regimenSOF/RBV SOF/SMV SOF/LDV SOF/DCV PrOD/RBV

TDF

ABC, 3TC, FTC

DRV/RTVCaution only if with TDF

ATV/RTVCaution only if with TDF

Use 30mg dose

EFVCaution when using with TDF

Use 90mg dose

ETR No data Use 90mg dose No data

RPV

RAL

EVG/COBI/TDF/FTC

Can consider with TAF No data No data

DTG No data No data

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New York, NY: September 9, 2015 15

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Slide 46 of 50

Investigational Therapies

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Slide 47 of 50

C-EDGE• All patients treated with Grazoprevir (PI)/Elbasvir (NS5A)

fixed dose combination for 12 weeks

• Co-infected, genotype 1, 4, and 6 treatment naïve patients with and without cirrhosis

• Naïve to ART with CD4 > 500 cells/mm3 and HIV RNA < 50k copies/mL or on stable ART with undetectable viral load and CD4 >200

• ART allowed was tenofovir or abacavir + emtricitabine or lamivudine + rilpivirine, raltegravir, or dolutegravir

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Slide 48 of 50

Demographics

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New York, NY: September 9, 2015 16

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Slide 49 of 50

C-EDGE results

• Well tolerated, most common side effects were headache, nausea, and fatigue

• Anticipate will not be able to use with efavirenz- or ritonavir-boosted protease inhibitors

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Slide 50 of 50

Regimen Switching in the Setting of Viral Suppression Prior to Starting Hep

C Treatment• Cardinal principle of regimen switching

– Maintain viral suppression without jeopardizing future options

• Virologic failure with emergence of new resistance mutations

– Increases need for more complex, difficult-to-follow, or expensive regimens

DHHS. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Revision May 1, 2014.

Panel on Antiretroviral Guidelines for Adult and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. May 1, 2014;1-285. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf

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Slide 51 of 50Principles for Successful Regimen Switching

• Review ART history

– Virologic suppression, resistance test results, and past adverse events

– If resistance data are unavailable, resistance may often be inferred by treatment history

– Consult with an HIV specialist for patients with a history of resistance >1 drug classes

• During first 3 months after a regimen switch

– More intensive monitoring of tolerability, viral suppression, adherence, and laboratory changes is recommended

DHHS. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Revision May 1, 2014.

Panel on Antiretroviral Guidelines for Adult and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. May 1, 2014;1-285. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf

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New York, NY: September 9, 2015 17

Page 18: Learning Objectives - IAS- · PDF fileNew York, NY: September 9, 2015 1. Slide 4 of 50 Potential issues in treating HIV/HCV ... Efavirenz + FTC + TDF 160 (48) Raltegravir + FTC + TDF

Slide 52 of 50

Monitoring After Switching Regimens• Evaluate more closely for several months after a treatment switch

– 1 to 2 weeks post switch: a clinic visit or phone call

– 4 to 8 weeks post switch: viral load test (rebound viremia)

• Goal of the intensive monitoring

– Assess medication tolerance

– Conduct targeted laboratory testing within 3 months after the regimen switch (ie, pre-existing laboratory abnormalities or potential concerns with the new regimen)

• Absent any specific complaints, laboratory abnormalities, or evidence of viral rebound at this 3-month visit, clinical and laboratory monitoring of the patient may resume on a regularly scheduled basis

DHHS. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Revision May 1, 2014.

Panel on Antiretroviral Guidelines for Adult and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. May 1, 2014;1-285. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf

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Slide 53 of 50

Summary

• Efficacy in HIV/HCV co-infection patients treated with DAAs appears to mimic efficacy seen in mono-infected patients

• Drug interactions and management have become easier in HCV treatment but still exist

• Remains “unique” population due to frequent complex drug regimens and co-morbid conditions

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IAS–USA

An IAS–USA State-Of-The-Art Clinical Conference on the

Management of Hepatitis C

Virus in the New Era: Small

Molecules Bring Big Changes

September 9, 2015—New York, NY

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New York, NY: September 9, 2015 18