CCO AU 2016 HCV Plenary 1 Slides

Genotype 1 HCV in 2016:
Clinical Decision Making in a

Time of Plenty
Ira M. Jacobson, MD
Chair,Department of Medicine
Mount Sinai Beth Israel
SeniorFacultyandVice-Chair,
Department of Medicine
Icahn School of Medicine at
Mount Sinai
New York, New York
Supported by educational grants from AbbVie, Bristol-Myers Squibb,
Gilead Sciences, Janssen Therapeutics, Merck, and ViiV Healthcare.
About These Slides

Please feel free to use, update, and share some or all
of these slides in your noncommercial presentations

to colleagues or patients
When using our slides, please retain the source

attribution:
Slide credit: clinicaloptions.com
These slides may not be published, posted online, or

used in commercial presentations without permission.
Please contact permissions@clinicaloptions.com for
details
Disclosures
Ira. M. Jacobson, MD, has disclosed that he has
received funds for research support from AbbVie,
Bristol-Myers Squibb, Gilead Sciences, Janssen, and
Merck; has served on speaker bureaus for AbbVie,
Bristol-Myers Squibb, Gilead Sciences, and Janssen;
and has received consulting fees from AbbVie, BristolMyers Squibb, Gilead Sciences, Intercept, Janssen,
Merck, and Trek.
New Regimens and Data for Genotype 1

HCV Infection
AASLD Guidance
Updated July 6, 2016
AASLD guidance stratifies regimens as
recommended and alternative
AASLD/IDSA. HCV guidelines. April 2016.
AASLD: Recommended and Alternative

Regimens for GT1 Without Cirrhosis
Nucleotide
Population
LDV/SOF
DCV
+ SOF
SMV
+ SOF
No nucleotide
SOF/VEL
GZR/EBR
12 wks + RBV
12 wks
GT1a
GT1b
12 wks
12 wks
12 wks
12 wks
12 wks
16 wks +
RBV
12 wks
12 wks
12 wks
12 wks
12 wks
If NS5A RAVs present.
AASLD/IDSA. HCV guidelines. July 2016.
Recommended
OBV/PTV/RTV
+ DSV
Alternative
AASLD: Recommended and Alternative

Regimens for GT1 With Compensated
Cirrhosis
Nucleotide
No nucleotide
Population
GT1a
Naive
PR exp
GT1b
Naive
PR exp
LDV/SOF
DCV
+ SOF
SMV
+ SOF
SOF/VEL
GZR/EBR
OBV/PTV/RTV
+ DSV
12 wks
24 wks
RBV
24 wks
RBV
24 wks
RBV*
24 wks
RBV*
12 wks
12 wks
16 wks + RBV
12 wks
16 wks + RBV
24 wks + RBV
24 wks
RBV
24 wks
RBV
24 wks
RBV
24 wks
RBV
12 wks
12 wks
12 wks
12 wks
12 wks
12 wks
12 wks +
RBV
or 24 wks
12 wks
12 wks
+ RBV
or 24 wks
*Not with Q80K.
If NS5A RAVs present.

AASLD/IDSA. HCV guidelines. July 2016.
12 wks
Recommended
24 wks + RBV
Alternative
Sofosbuvir/Velpatasvir: Approved June

2016
Genotype 1a or 1b, without cirrhosis or with
compensated cirrhosis (Child-Pugh A), treatment
naive or treatment experienced
12 weeks sofosbuvir/velpatasvir
Genotype 1a or 1b, with decompensated cirrhosis

(Child-Pugh B or C), treatment naive or treatment
experienced
12 weeks sofosbuvir/velpatasvir + ribavirin
Sofosbuvir/velpatasvir prescribing information.
ASTRAL-1: VEL/SOF FDC for 12 Wks in

GT1/2/4/5/6 With and Without Cirrhosis
Velpatasvir (GS-5816): pangenotypic HCV NS5A
inhibitor
GT3 pts evaluated in separate study
19% cirrhosis, 32% treatment experienced
SVR12* (%)
100
99
98
99
618/624
206/210
117/118
Overall
GT1a
GT1b
75
50
25
n/N =
0
*HCV RNA < 15 IU/mL
Feld JJ, et al. AASLD 2015. Abstract LB-2.
ASTRAL-4: VEL/SOF FDC for HCV in Pts

With Decompensated Liver Disease
Treatment-naive or treatment-experienced pts with
GT1-6 HCV infection and CTP B cirrhosis (N = 267)
55% treatment experienced; 95% MELD < 15; 75% to
83% ascites; 58% to 66% encephalopathy
GT1: 78%; GT3: 15%, GT2/4/6: 8%
Wk 0
Wk 12
n = 90 VEL/SOF*
n = 87 VEL/SOF* + RBV
n = 90 VEL/SOF*
Wk 24
Wk 36
SVR12
SVR12
SVR12
*100 mg/400mg
Charlton MR, et al. AASLD 2015. Abstract LB-13.
ASTRAL-4: VEL/SOF FDC for HCV in Pts

With Decompensated Liver Disease
SOF/VEL 12 wks
SVR12 (%)
100
n/N =
SOF/VEL + RBV 12 wks
94
83
86
88
77/90
60/68
SOF/VEL 24 wks
96
92
65/68
65/71
80
60
40
20
0
75/90
82/87
Overall
Breakthrough, n Relapse, n
11
LTFU, n
1
Death, n
3
1
2
2
D/c due to AE: 3% (n = 9)
Death due to AE: 3% (n = 9)
Fatigue (29%); nausea (23%); HA (22%);

anemia (13%; 31% in RBV arm)
AE more frequent with RBV
Genotype 1
1
7
3
2
Charlton MR, et al. AASLD 2015. Abstract LB-13
5
1
2
1
2
3
3
-
RBV arm: Hb < 10 mg/dL, 23%;

Hb < 8.5 mg/dL, 7%
RBV decreased in 37% and d/c in 17%
ASTRAL-5: VEL/SOF FDC for 12 Wks in

Pts Coinfected With HCV and HIV-1
N = 106
SVR12
VEL/SOF
Wk 0
SVR12 (%)
100
95
12
95
92
2 relapse
1 LTFU
1 LTFU
62/
65
GT1a
11/
12
GT1b
24
100
92
100
80
60
1 withdrew
consent
40
20
n/N =
0
99/
104
Total
Wyles D, et al. EASL 2016. Abstract PS104.
11/
11
GT2
11/
12
GT3
4/
4
GT4
Grazoprevir/Elbasvir: Approved Jan 2016

Genotype 1a, with/without compensated cirrhosis,
treatment naive or treatment experienced
Without NS5A RAVs: GZR/EBR, 12 wks
With NS5A RAVs: GZR/EBR + RBV, 16 wks*
RAVs at positions 28, 30, 31, 93
Genotype 1b, with/without compensated cirrhosis,

treatment naive or treatment experienced
GZR/EBR, 12 wks
RAV testing not indicated
*Listed as alternative regimen.
C-EDGE TN: 12 Wks of GZR/EBR in

Genotype 1, 4, or 6
94
97
231/
246
68/
70
92
99
100
80
80
60
3
1
9
1
0
1
18/
18
8/
10
GT
4
GT
6
129/
131
GT
1b
144/
157
GT
1a
rrh
ot
ic
Ci
299/
316
rh
ot
ics
20
40
No
nc
ir
n/N =
95
Al
lP
ts
SVR12 (%)
100
0
0
0
0
0
2
Non-VF
Breakthrough
Relapse
Good safety and tolerability profile
No drug-related serious AEs; 2 deaths unrelated to drug
No concurrent ALT/bilirubin increase
Lower SVR12 rates in pts with BL NS5A RAVs (2/9, 22%); associated with > 5-fold loss of
EBR susceptibility
Virologic failure only if baseline HCV RNA > 800,000 IU/mL
Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.
C-EDGE TE: 12 or 16 Wks of GZR/EBR

RBV in Treatment-Experienced GT1, 4, or 6
n/N =
SVR12 (%, 95% CI)
100
92
94
92
97
80
12 wks
60
16 wks
40
20
0
Breakthrough
Rebound
Relapse
LTFU/early d/c
97/
105
98/
104
97/
105
103/
106
No RBV
+ RBV
No RBV
+ RBV
0
0
6
2
0
0
6
0
1
2
4
1
0
0
0
3
*ITT population.
Virologic failures driven by RAVs
Analysis from AASLD 2015 shows that presence of baseline NS5A RAVs by population
sequencing or next-generation sequencing (with 10% to 20% cutoff) is predictive of failure
Kwo P, et al. EASL 2015. Abstract P0886. Jacobson I, et al.

AASLD 2015. Abstract LB22.
C-EDGE TE: Efficacy of 12 Wks of

GZR/EBR RBV by Baseline RAVs
SVR12, n/N (%)
GT1a
GT1b
GT1a
GT1b
Total
NS3 Variants Not

Detectable
NS3 RAVs
5-Fold Shift
NS3 RAVs
> 5-Fold Shift
95%
99%
107/112 (96)
133/135 (99)
104/111 (94)
9/9 (100)
0
1/1 (100%)
NS5A Variants Not

Detectable
NS5A RAVs
5-Fold Shift
NS5A RAVs
> 5-Fold Shift
190/192 (99)
127/127 (100)
10/10 (100)
0
11/21 (52)
16/18 (89)
95%
99%
Should baseline RAV testing be done with this regimen?

The NS5A RAVs that matter are in the 28, 30, 31, and 93 positions
Kwo P, et al. EASL 2015. Abstract P0886.
C-SURFER: Grazoprevir/Elbasvir in Pts

With GT1 HCV and Stage 4/5 CKD
Treatment
Wk 12
GT1 HCVinfected
pts with
stage 4/5 CKD
(n = 224)
Follow-up
Wk 4
Follow-up
Wk 16
Randomized period
SVR12*
Grazoprevir/Elbasvir
(n = 111)
99%
Placebo
(n = 113)
Open-label period
Grazoprevir/Elbasvir
(n = 113)
98%
Grazoprevir/elbasvir dosed orally 100 mg/50 mg once daily. This study also included a pharmacokinetic
analysis (n = 11) in which pts were treated as in the randomized grazoprevir/elbasvir study group.
76% on dialysis
34% with diabetes
52% GT1a, 48% GT1b
6% cirrhosis
Roth D, et al. Lancet. 2015;386:1537-1545

Roth D, et al. Kidney Week 2015. Abstract SA-PO1100.
*Modified full analysis set population.
Daclatasvir + Sofosbuvir
Genotype 1a or 1b, treatment naive or experienced,
without cirrhosis
DCV + SOF, 12 wks
Genotype 1a or 1b, treatment naive or experienced,

with compensated cirrhosis
DCV + SOF RBV, 24 wks*
*Listed as alternative regimen
DCV + SOF RBV for 24 Wks in GT1 Pts

With Advanced Liver Disease
SVR12 by Genotype
100
SVR12 (%)
80
98
98
92
91
98 100
96 96
97
97
89
90
60
40
20
0
All GT1
GT1a
GT1b
As observed
DCV + SOF
DCV + SOF + RBV
mITT
DCV + SOF
DCV + SOF + RBV
Welzel T, et al. EASL 2016. Abstract SAT-275.
Ombitasvir/Paritaprevir/Ritonavir +
Dasabuvir
Genotype 1a, treatment naive or experienced
No cirrhosis: OBV/PTV/RTV + DSV + RBV, 12 wks
With compensated cirrhosis: OBV/PTV/RTV + DSV +
RBV, 24wks*
Genotype 1b, with/without compensated cirrhosis,

treatment naive or experienced
OBV/PTV/RTV + DSV, 12 wks
*Listed as alternative regimen.
TURQUOISE III: 12 Wks of OBV/PTV/RTV +

DSV Without RBV in Cirrhotic GT1b Pts
Virologic Response
100
100
100
100
100
60/60
60/60
60/60
60/60
RVR
EOTR
SVR4
SVR12
Pts (%)
80
60
40
20
n/N =
AASLD guidance now recommends

OBV/PTV/RTV + DSV 12 wks
without RBV for GT1b cirrhotics
Still need 24 wks + RBV for GT1a cirrhotics, naive or experienced
Poordad F, et al. AASLD 2015. Abstract 1051.
AASLD/IDSA. HCV Guidance. April 2016.
Real-World Efficacy of OBV/PTV/RTV

DSV RBV: German HCV Registry Cohort
Efficacy population (complete follow-up): n = 543; safety population
(initiated treatment): n = 1017
GT1: 88%; GT4: 12%; cirrhosis: 22% (CTP B/C: 7%); tx experienced: 59%
97 96 97 100
95 93 96 100
96 98
96
80
*Includes 13 pts with
mixed or unknown GT1
subgenotype infection,
all of whom achieved
SVR.
60
Without Cirrhosis
2/
2
200/ 268/ 46/

208 274 48
Na
iv e
(pe
g)I
FN
TV RBV
peg R/B
IFN OC
+R +
BV
121/ 26/ 93/

127 28 97
G
Tot T1
a l*
GT
1a
GT
1b
n/N =
365/ 108/ 246/ 51/

378 113 254 51
GT
4
20
GT
4
40
G
Tot T1
a l*
GT
1a
GT
1b
SVR24 (%)
100
With Cirrhosis
Hinrichsen H, et al. EASL 2016. Abstract GS07.
Real-World Efficacy of OBV/PTV/RTV

DSV RBV: Israeli Cohort
Efficacy population (complete follow-up): n = 432; safety population
(initiated treatment): n = 661
Pts With Undetectable

HCV RNA (%)
GT1: 100%; cirrhosis: 62% (CTP A/B: 98.5%/1.5%); tx expd: 62%
Post LT: n = 22
100
99
99
80
No cirrhosis
Cirrhosis
60
40
20
n/N =
161/
161/
163
163
251/
251/
253
253
SVR12 (mITT*)
*Excludes pts who did not

achieve SVR12 for reasons
other than virologic failure.
SVR12 mITT/overall: 82%/86%; 4 discontinued due to serious AEs, one of

which achieved SVR
Zuckerman E, et al. EASL 2016. Abstract PS004.
Real-World Safety of OBV/PTV/RTV DSV

RBV: German and Israeli Cohorts
Most common AEs across both

cohorts[1,2]: fatigue, pruritus,
headache, insomnia, nausea,
diarrhea (Israeli), anemia (German)
Serious AE: 2.1% to 3.8%
D/c for AE: 1.5% to 3.0%
3 deaths deemed unrelated to HCV
therapy: stroke, MI, multiple organ
failure
In Israeli cohort, 20 pts

discontinued for AEs[2]
In Israeli cohort, several factors

identified as significant predictors of
hepatic decompensation[2]
Factor
P Value
Age older than 75 yrs
.005
Platelets < 90,000/mL
.03
Albumin < 3.5 g/dL
.048
CTP score 7
.07
MELD score > 10
.01
Previous decompensation
< .001
Serious AE: n = 12
Decompensation: n = 8
1. Hinrichsen H, et al. EASL 2016. Abstract GS07.
2. Zuckerman E, et al. EASL 2016. Abstract PS004.
Ledipasvir/Sofosbuvir for GT1 Tx-Naive

Noncirrhotics With HCV RNA < 6 M IU/mL:
Are8wkssufficient?Orare12wksbetter?
Established by retrospective analysis of ION-3
Many clinicians were initially uncomfortable
What do real-world data show?
8 vs 12 Wks of LDV/SOF in Pts With GT1

HCV: HCV-TARGET and TRIO Network
Treatment-naive, noncirrhotic pts with GT1 HCV
HCV RNA < 6 M IU/mL in HCV-TARGET
HCV-TARGET[1]
97
97
80
60
40
20
n/N =
100
SVR12 (%)
SVR12 (%)
100
TRIO Network[2]
127/131
187/192
8 Wks
8 Wks
1. Terrault N, et al. AASLD 2015. Abstract 94.

2. Curry M, et al. AASLD 2015. Abstract 1046.
95
96
251/263
604/632
80
60
40
20
0
8 Wks
12 Wks
8 Wks of LDV/SOF in Pts With GT1 HCV:

German Real-World Single-Center Study
Pts noncirrhotic (100%) and primarily treatment naive
(97%), GT1 (98%), and HCV RNA < 6 M IU/mL (96%)
99
SVR12 (%)
100
80
60
40
20
n/N =
127/128
Buggisch P et al, EASL 2016. Abstract SAT-242.
8 Wks
LDV/SOF: SVR12 by Treatment Regimen

and Duration in Pts Without Cirrhosis
Pooled data from multiple trials, HCV RNA < 6 M IU/mL in
8-wk arm
With RAVs
100
98
99
30/32
107/108
No RAVs
99
99
SVR12 (%)
80
60
40
20
n/N =
8 Wks
Zeuzem S, et al. AASLD 2015. Abstract 91.
187/189 504/509
12 Wks
PPIs and Ledipasvir:

Does Acid Suppression Matter?
HCV-TARGET: Effect of PPI Use?
Virologic outcome
known for 1074 pts
SVR12 According to Baseline

PPI Use
PPI: No
100
93
28/
30
456/
464
60
40
20
n/N =
Terrault N, et al. AASLD 2015. Abstract 94.
98
PPI: Yes
98
93
80
SVR12 (%)
Pts treated according

to local standards of
care at 44 academic/
17 community medical
centers in North
America/Europe
122/
124
151/
163
8-Wk LDV/SOF 12-Wk LDV/SOF
TRIO Network: No Effect of PPI Use?

Real-world data from 2034 pts with GT1 HCV receiving
LDV/SOF
A per protocol analysis (n = 1979) showed no effect of
PPIs on SVR
SVR12 According to Baseline PPI Use
98
100
98
97
99
97
SVR12 (%)
PPI: No
PPI: Yes
n/N =
230/
234
41/
41
Afdhal N, et al. EASL 2016. Abstract LBP519.
1024/
1045
287/
297
243/
246
113/
116
TRIO Network: Predictors of Response to

LDV/SOF by PPI Usage
Per protocol analysis
(n = 1979)
97%
n = 454
PPI drug
Dexlansoprazole (n = 10)
Esomeprazole (n = 48)
Lansoprazole (n = 26)
P= .799
Caution with
use of high
dose PPIs
with
LDV/SOF
Omeprazole (n = 288)
Pantoprazole (n = 77)
Rabeprazole (n = 5)
PPI dose
Low (n = 282)
P= .965
High (n = 172)
PPI frequency
Once daily (n = 420)
P= .030
Twice daily (n = 34)

80%
Afdhal N, et al. EASL 2016. Abstract LBP519.
90%
100%
New Regimens
VEL/SOF + GS-9857 for 6 or 8 Wks in

Treatment-Naive Pts With GT1-6 HCV
Genotype 1
Genotypes 1-6
100
96
100
79
60
40
20
n/N =
Cirrhosis
94
71
81
80
SVR (%)
SVR (%)
80
No Cirrhosis
100
53/67
95/99
No RBV
6 Wks
No RBV
8 Wks
60
40
20
0
25/35
36/36
31/33
25/31
No RBV
6 Wks
No RBV
8 Wks
No RBV
8 Wks
RBV
8 Wks
8 wks of VEL/SOF + GS9857 highly effective including pts with RAVs and cirrhosis
Single tablet QD in phase III
6 wks had high relapse
No benefit of RBV with 8 wks
Will the triplet be used as primary first-line treatment or as salvage treatment for persons
who fail current DAAs?
Gane EJ, et al. EASL 2016. Abstract SAT-138.
VEL/SOF + GS-9857 for 12 Wks in

Treatment-Experienced GT1-6 HCV
Cirrhosis, n (%)
Mean HCV RNA,
log10 IU/mL (range)
VEL/SOF +
GS-9857
61 (48)
6.3 (3.8-8.1)
HCV genotype, n (%)
1
2
3
4/6
63 (49)
21 (16)
35 (27)
9 (7)
DAA experience, n (%)
None (GT2-6 only)

1 DAA class
2 DAA classes
27 (21)
36 (28)
65 (51)
Lawitz E, et al. EASL 2016. Abstract PS008.
100
99
100
127/128
63/63
Overall
GT1
80
SVR12 (%)
BL Characteristics
(N = 128)
60
40
20
n/N =
0
1 pt relapsed at
posttreatment Wk 8
SURVEYOR-I/II: ABT-493 + ABT-530 for 8

or 12 Wks in Pts With GT1 or 2 HCV
Open-label, treatment naive or pegIFN/RBV experienced
SVR12 in Pts With GT1 HCV
8 wks
97
100
80
60
40
20
n/N =
0
100
SVR12 (%)
SVR12 (%)
100
12 wks
33/34
33/33
ITT
mITT
No Cirrhosis[1]
1. Poordad F, et al. EASL 2016. Abstract SAT-157.

2. Gane EJ, et al. EASL 2016. Abstract SAT-135.
96
80
60
40
20
0
26/27
Cirrhosis[2]
C-CREST 1 and 2: MK-3682/GZR/MK-8408

for 8 Wks in Tx-Naive Noncirrhotic Pts
GT1, 2, or 3 without cirrhosis (N = 240)
100
100
87
80
60
40
20
n/N =
0
MK-3682 (300 mg) + GZR + MK-8408

MK-3682 (450 mg) + GZR + MK-8408
24/24
20/23
Genotype 1
In GT1 arm, no impact of baseline NS5A, NS3, or

NS5B RAVs on SVR12
Gane EJ, et al. EASL 2016. Abstract 139.
Conclusions
5 highly effective regimens approved for GT1 HCV
Newest is GZR/EBR, which requires RAV testing in GT1a
Need for extended therapy and/or RBV in cirrhotics

depending on regimen, GT1 subtype, and prior treatment
status
Real-world data reflect efficacy in clinical trials
Data support 8 wks of LDV/SOF in GT1 treatment-naive
noncirrhotics with HCV RNA < 6 M IU/mL
High-dose PPIs should be avoided with LDV (same likely
to be the case with VEL based on clinical trial designs)
New Regimens in Development

Promising regimens
Second-generation 2-drug regimen of ABT-493/
ABT-530
Triplet regimens of PI/NS5A/Nuc
New regimens may offer 8-week option for

noncirrhotics
High SVR rates in DAA failures
Go Online for More CCO

Coverage of HCV!
Multimedia modules featuring video of expert faculty discussions of
challenging cases
Downloadable slidesets for your own study or presentations
clinicaloptions.com/hcv

CCO AU 2016 HCV Plenary 1 Slides

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

CCO AU 2016 HCV Plenary 1 Slides

Uploaded by

Copyright:

Available Formats

Genotype 1 HCV in 2016:

Clinical Decision Making in a

About These Slides

of these slides in your noncommercial presentations

When using our slides, please retain the source

These slides may not be published, posted online, or

New Regimens and Data for Genotype 1

AASLD/IDSA. HCV guidelines. April 2016.

Slide credit: clinicaloptions.com

AASLD: Recommended and Alternative

If NS5A RAVs present.

AASLD/IDSA. HCV guidelines. July 2016.

Slide credit: clinicaloptions.com

AASLD: Recommended and Alternative

*Not with Q80K.

If NS5A RAVs present.

Slide credit: clinicaloptions.com

Sofosbuvir/Velpatasvir: Approved June

Genotype 1a or 1b, with decompensated cirrhosis

Sofosbuvir/velpatasvir prescribing information.

Slide credit: clinicaloptions.com

ASTRAL-1: VEL/SOF FDC for 12 Wks in

Feld JJ, et al. AASLD 2015. Abstract LB-2.

Slide credit: clinicaloptions.com

ASTRAL-4: VEL/SOF FDC for HCV in Pts

Slide credit: clinicaloptions.com

ASTRAL-4: VEL/SOF FDC for HCV in Pts

SOF/VEL + RBV 12 wks

D/c due to AE: 3% (n = 9)

Death due to AE: 3% (n = 9)

Fatigue (29%); nausea (23%); HA (22%);

AE more frequent with RBV

Charlton MR, et al. AASLD 2015. Abstract LB-13

RBV arm: Hb < 10 mg/dL, 23%;

RBV decreased in 37% and d/c in 17%

Slide credit: clinicaloptions.com

ASTRAL-5: VEL/SOF FDC for 12 Wks in

Wyles D, et al. EASL 2016. Abstract PS104.

Slide credit: clinicaloptions.com

Grazoprevir/Elbasvir: Approved Jan 2016

Genotype 1b, with/without compensated cirrhosis,

Slide credit: clinicaloptions.com

C-EDGE TN: 12 Wks of GZR/EBR in

Good safety and tolerability profile

No drug-related serious AEs; 2 deaths unrelated to drug

No concurrent ALT/bilirubin increase

Virologic failure only if baseline HCV RNA > 800,000 IU/mL

Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.

Slide credit: clinicaloptions.com

C-EDGE TE: 12 or 16 Wks of GZR/EBR

SVR12 (%, 95% CI)

Virologic failures driven by RAVs

Kwo P, et al. EASL 2015. Abstract P0886. Jacobson I, et al.

Slide credit: clinicaloptions.com

C-EDGE TE: Efficacy of 12 Wks of

NS3 Variants Not

NS5A Variants Not

Should baseline RAV testing be done with this regimen?

Slide credit: clinicaloptions.com

C-SURFER: Grazoprevir/Elbasvir in Pts

34% with diabetes

52% GT1a, 48% GT1b

Roth D, et al. Lancet. 2015;386:1537-1545

*Modified full analysis set population.