High Virological Efficacy Rates in GT1 Patients Regardless ... · renal impairment compared to subjects with normal renal function. Paper presented at: 65th Annual Meeting of the

BECAUSE EVERY PATIENT MATTERS

High Virological Efficacy Rates in GT1 Patients Regardless of Baseline NS5A Resistance

These products are subject to additional monitoring. The report of the adverse events related to this medicine is a priority.

15% detection thresholdviekirax + exviera + RBV

Recommended regimen by patient type

Class RAVs present

No class RAVs present

OBV-speci�c RAVs present

No OBV-speci�c RAVs present(n=48/50) (n=271/280)

96%(n=36/38)95%

(n=283/292)97% 97%

SVR 48

%

100 -

80 -

60 -

40 -

20 -

0 -

At a 15% detection threshold in GT1a, NS5A

baseline OBV-specific RAVs were detected in 12% (11% 1 NS5A RAV and

1% 2 or more NS5A RAVs)1

IMPACT OF BASELINE RAVs ON SVR48 RATE IN GT1a PATIENTS*

Adapted from Sulkowski 2016.

Similar SVR rates were achieved irrespective of the presence or absence of baseline NS5A class and ombitasvir-specific variants1

IN GT1 PATIENTS Given the low virologic failure rates observed with recommended treatment regimens for HCV GT1a- and GT1b-infected subjects, the presence of baseline variants appears to have little impact on the likelihood of achieving SVR.2,3

IN GT1b PATIENTS All patients in this analysis who received viekirax + exviera without RBV (n=143)‡ achieved SVR48, including 8% of patients with NS5A Y93 variants.1

©AbbVie 2016 GBL/VIEX/0116/0110c ES/HCV/0316/0389

References: 1. Sulkowski M, Krishnan P, Tripathi R, et al. Effect of baseline resistance-associated variants on SVR with the 3D regimen plus RBV. Poster presented at: 23rd Annual Conference on Retroviruses and Opportunistic Infections; February 22-25, 2016; Boston, MA. 2. VIEKIRAX [SmPC]. Maidenhead, United Kingdom; AbbVie Ltd; 2016. 3. EXVIERA [SmPC]. Maidenhead, United Kingdom; AbbVie Ltd; 2016.

OBV=ombitasvir; RAV=resistance-associated variants; RBV=ribavirin; SVR48=sustained virologic response 48 weeks post-treatment.

* The study included GT1a patients with compensated cirrhosis (n=118) from arm B of TURQUOISE-II, and without cirrhosis (n=214) from arms A and B of SAPPHIRE-II, treated with viekirax + exviera label-recommended regimens. The study excluded GT1a patients (n=9) who did not achieve SVR for reasons other than virologic failure (breakthrough or relapse).1

†At the 15% detection threshold in GT1a, NS5A baseline RAVs, M28T/V, Q30E/R, H58D, or Y93C/F/H/L/N were detected in 11% of the samples; M28T/V was most prevalent (7.3%).1

‡ The study included GT1b patients with compensated cirrhosis (n=60) from TURQUOISE-lll, and without cirrhosis (n=91) from arm B of PEARL-II, treated with viekirax + exviera without RBV. Of the 151 patients included in the study, 143 patients were included in the final analysis.1

For the indication and summary of Important Safety Information, see the viekirax and exviera SmPCs located at this booth.

ombitasvir/ paritaprevir/ritonavir tablets

viekirax® exviera®

dasabuvir tablets



dasabuvir tablets



Viekirax + exviera elimination mainly occurs via the non-renal route and can be used in patients with mild, moderate, or severe

renal impairment, or end-stage renal disease on dialysis1,2

Renal Functional Group—Mild renal impairment: 60-89 mL/min; moderate renal impairment 30-59 mL/min; severe renal impairment 15-29 mL/min.

* SVR was the primary endpoint to determine the HCV cure rate in the Phase 3 studies and was defined as unquantiable or undetectable HCV RNA 12 weeks after the end of treatment (SVR12).1,2

†No dose adjustment of viekirax or exviera is required for patients with mild, moderate, or severe renal impairment.1,2

‡Changes in exposure with mild, moderate, and severe renal impairment are not clinically significant.1,2,5

For summary of Important Safety Information, see the viekirax and exviera SmPCs located at this booth.

©AbbVie 2016 GBL/VIEX/0116/0110e ES/HCV/XXXX/XXXX

References: 1. VIEKIRAX [SmPC]. Maidenhead, United Kingdom; AbbVie Ltd; 2016. 2. EXVIERA [SmPC]. Maidenhead, United Kingdom; AbbVie Ltd; 2016. 3. Pockros PJ, Reddy KR, Mantry PS, et al. RUBY-I: Ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin in non-cirrhotic HCV genotype 1-infected patients with severe renal impairment or end-stage renal disease. Paper presented at: 66th Annual Meeting of the American Association for the Study of Liver Diseases; November 13-17, 2015; Boston, MA. 4. Khatri A, Dutta S, Marbury T, et al. The pharmacokinetics and safety of the direct acting antiviral regimen of ABT-450/r, ombitasvir with/without dasabuvir in subjects with mild, moderate and severe renal impairment compared to subjects with normal renal function. Paper presented at: 65th Annual Meeting of the American Association for the Study of Liver Diseases; November 7-11, 2014; Boston, MA. 5. European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol. 2015;63:199-236.

RBV=ribavirin; SVR12=sustained virologic response 12 weeks post-treatment.1,2

Increase in AUC %

AUC

(ng*

h/m

L)

451%350%250%150%50%

Paritaprevir

Dasabuvir

PHARMACOKINETICS OF VIEKIRAX + EXVIERA IN PATIENTS WITH RENAL IMPAIRMENT VS PATIENTS WITH NORMAL RENAL FUNCTION1,2,4‡

Ritonavir

Ombitasvir

33%

19%

45%

37%

21%

50%

42%

COMPARABLE

Mild Moderate Severe

114%

80%

IN AN ALL-ORAL APPROVED REGIMEN

Overall safety profile in patients with severe renal impairment was similar to that seen in prior Phase 3 studies in patients without severe renal impairment1-3

Safety

Now for Patients on HaemodialysisViekirax + exviera is now approved for use in patients with

end-stage renal disease on dialysis1,2

NO DOSE ADJUSTMENT OF VIEKIRAX OR EXVIERA REQUIRED1,2†

HIGH SVR RATES* IN PATIENTS WITH RENAL IMPAIRMENT

EfficacySVR12

(n=18/19)

95%

In non-cirrhotic GT1 patients with severe renal impairment or end-stage renal disease, including those on dialysis, with 12 weeks of treatment (viekirax + exviera ± RBV)3


NEW for Your GT1b PatientsWithout cirrhosis or with compensated cirrhosis and regardless of prior P/R treatment experience

viekirax + exviera

SVR12 ACHIEVED IN GT1b PATIENTS

WITH 12 WEEKS OF TREATMENT (IN A POOLED ANALYSIS)1,2

(N=361/361)



dasabuvir tablets

SVR12 was the primary endpoint to determine the HCV virological efficacy rate in the Phase 3 studies and was defined as unquantifiable or undetectable HCV RNA 12 weeks after the end of treatment.1,2


©AbbVie 2016 GBL/VIEX/XXXX/XXXX ES/HCV/XXXX/XXXX

References: 1. VIEKIRAX [SmPC]. Maidenhead, United Kingdom; AbbVie Ltd; 2016. 2. EXVIERA [SmPC]. Maidenhead, United Kingdom; AbbVie Ltd; 2016.

P/R=pegylated interferon with ribavirin; RBV=ribavirin; SVR12=sustained virologic response 12 weeks post treatment.

RBV FREE 12-WEEKVIEKIRAX + EXVIERA

REGIMEN


Phone Charging Station





dasabuvir tablets







RBV FREE, 12-WEEK VIEKIRAX + EXVIERA REGIMENNEW FOR GT1b PATIENTS WITH COMPENSATED CIRRHOSIS

High SVR12 RatesIn GT1 patients with compensated cirrhosis

ACHIEVED IN GT1a PATIENTS WITH COMPENSATED CIRRHOSISWHO RECEIVED VIEKIRAX + EXVIERA + RBV FOR 24 WEEKS1,2

95%SVR12

(N=115/121)

SVR12 ACHIEVED IN GT1b PATIENTS WITH

COMPENSATED CIRRHOSIS WHO RECEIVED 12 WEEKS OF TREATMENT

(N=60/60)Regardless of prior P/R treatment experience1,2





dasabuvir tablets


High Virological Efficacy Rates in GT1 Patients Regardless of

Baseline NS5A ResistanceSimilar SVR rates were achieved irrespective of the presence or absence of baseline NS5A class and ombitasvir-specific variants1

15% detection thresholdviekirax + exviera + RBV Recommended regimen by patient type

Class RAVs present

No class RAVs present

OBV-speci�c RAVs present

No OBV-speci�c RAVs present

(n=48/50) (n=271/280)96%

(n=36/38)95%

(n=283/292)97%97%

SVR 4

8%

100 -

80 -

60 -

40 -

20 -

0 -

At a 15% detection threshold in GT1a,

NS5A baseline RAVs were detected in 12%

(11% 1 NS5A RAV and 1% 2 or more

NS5A RAVs)3

IMPACT OF BASELINE RAVs ON SVR48 RATE IN GT1a PATIENTS*

Adapted from Sulkowski 2016.

IN GT1 PATIENTS Given the low virologic failure rates observed with recommended treatment regimens for HCV GT1a- and GT1b-infected subjects, the presence of baseline variants appears to have little impact on the likelihood of achieving SVR.2,3

IN GT1b PATIENTS All patients in this analysis who received viekirax + exviera without RBV (n=143)‡ achieved SVR48, including 11 patients (8%) with NS5A Y93 variants.1


References: 1. Sulkowski M, Krishnan P, Tripathi R, et al. Effect of baseline resistance-associated variants on SVR with the 3D regimen plus RBV. Poster presented at: 23rd Annual Conference on Retroviruses and Opportunistic Infections; February 22-25, 2016; Boston, MA. 2. VIEKIRAX [SmPC]. Maidenhead, United Kingdom; AbbVie Ltd; 2016. 3. EXVIERA [SmPC]. Maidenhead, United Kingdom; AbbVie Ltd; 2016.

OBV=ombitasvir; RAV=resistance-associated variants; RBV=ribavirin; SVR48=sustained virologic response 48 weeks post-treatment.

* The study included GT1a patients with compensated cirrhosis (n=118) from arm B of TURQUOISE-II, and without cirrhosis (n=214) from arms A and B of SAPPHIRE-II, treated with viekirax + exviera label-recommended regimens. The study excluded GT1a patients (n=9) who did not achieve SVR for reasons other than virologic failure (breakthrough or relapse).1

†At the 15% detection threshold in GT1a, NS5A baseline RAVs, M28T/V, Q30E/R, H58D, or Y93C/F/H/L/N were detected in 11% of the samples; M28T/V was most prevalent (7.3%).1

‡ The study included GT1b patients with compensated cirrhosis (n=60) from TURQUOISE-lll, and without cirrhosis (n=91) from arm B of PEARL-II, treated with viekirax + exviera without RBV. Of the 151 patients included in the study, 143 patients were included in the final analysis.1



NEW forAll GT1b Patients WithCompensated Cirrhosis



dasabuvir tablets


©AbbVie 2016 GBL/VIEX/0116/0110v ES/HCV/0416/0482




(n=60/60) (IN A SINGLE STUDY)

CURE

%RBV FREE 12-WEEK

VIEKIRAX + EXVIERA REGIMEN

1,2*

*Sustained virologic response (SVR) was the primary endpoint to determine the HCV virological efficacy rate in the Phase 3 studies and was defined as unquantifiable or undetectable HCV RNA 12 weeks after the end of treatment (SVR12).

1,2





dasabuvir tablets

NEW for Your GT1b PatientsWithout cirrhosis or with compensated cirrhosis and regardless of prior P/R treatment experience



©AbbVie 2016 GBL/VIEX/0116/0110g ES/HCV/XXXX/XXXX



SVR12 ACHIEVED IN GT1b PATIENTS

WITH 12 WEEKS OF TREATMENT (IN A POOLED ANALYSIS)1,2

(N=361/361)

RBV FREE

12-WEEKVIEKIRAX + EXVIERA

REGIMEN

viekirax + exviera





dasabuvir tablets



SVR12 ACHIEVED IN GT1b PATIENTS WITH

COMPENSATED CIRRHOSIS WHO RECEIVED 12 WEEKS OF TREATMENT

(N=60/60)Regardless of prior P/R treatment experience1,2

ACHIEVED IN GT1a PATIENTS WITH COMPENSATED CIRRHOSISWHO RECEIVED VIEKIRAX + EXVIERA + RBV FOR 24 WEEKS1,2

95%SVR12(N=115/121)

RBV FREE, 12-WEEK VIEKIRAX + EXVIERA REGIMENNEW FOR GT1b PATIENTS WITH COMPENSATED CIRRHOSIS

High SVR12 RatesIn GT1 patients with compensated cirrhosis

©AbbVie 2016 GBL/VIEX/0116/0110b ES/HCV/0316/0388



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High Virological Efficacy Rates in GT1 Patients Regardless ... · renal impairment compared to subjects with normal renal function. Paper presented at: 65th Annual Meeting of the