To review TDF interaction data Introduction

1

Introduction

Geraldine Reilly

Gilead Science

Objectives

® To review TDF interaction data

® To review triple nucleoside data

® To discuss the relevance of these data to clinicalpractice

® To present the EMTRIVA dataset

® To discuss questions regarding Emtriva andrequirements for additional data or information

® To review TDF safety data

® Nucleoside (cytosine)analogue

® One capsule, once daily,without food restrictions

® Long intracellular half-life

® Significant HIV RNA reductions

® Favorable safety profile

® Durable efficacy and safety intreatment-naïve and treatment-experienced patients

EMTRIVA™

(emtricitabine)Mean Steady-State Plasma EmtricitabineConcentration Following 200 mg QD Dose

0.001

0.01

0.1

1

10

0 24 48 72 96 120

Time (hrs post dose)

Pla

sma

Em

tric

itab

ine

Co

nc

(µg

/mL

)

Mean In Vitro IC90

Mean In Vitro IC50

Plasma half-life ~ 10 hours

Wang L, et al. XIV International AIDS Conference, Barcelona 2002, Poster #4546

Intracellular FTC-TP ConcentrationFollowing 200 mg QD Dose_

0.01

0.1

1

10

0 24 48 72 96 120

Time (hrs post dose)

FTC-TP mean half-life ~ 39 hours

1Wang L, et al. XIV International AIDS Conference, Barcelona 2002, Poster #45462Moore K., et al, AIDS 1999;13:2239-50

3TC-TP mean half-life ~ 16 hours_

FT

C-5

'-T

P C

on

c in

PB

MC

(p

mo

le/1

06ce

lls

Pharmacokinetic Considerations for Approvedand Investigational Once-daily NRTIs

0

5

10

15

2025

30

35

4045

50

ZDV d4T ABC 3TC FTC

Serum half-life Intracellular half-life

Hou

rs

Investigational Approved Approved Approved ApprovedQD as QD or BID as QD or BID as QD as QD

24 hours

12 hours

Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002;51(RR-7):1-64

TDFddI

* Piliero, et al. 43rd ICAAC, Chicago, 2003. ** Anderson, et al. AIDS 2003; 17(15):2159-2168.

Indicates range where available

* **

**

2

Forgiveness and Once-dailyAntiretroviral Therapy (ART)

0 24 483612

Time (hours)

QD long half-life

BID

Dru

g c

on

cen

trat

ion

Zone of potential replication

IC90

IC50

Missed Dose

Day 1 Day 2Hypothetical and not

representative of specificARV agents

QD short half-life

Emtricitabine Pharmacology

® Once-daily dosing– Serum t1/2 ª10 hours– Long intracellular half-life (FTC-TP); t1/2 ª 39 hours

® Can be taken without regard to food– 93% in fed or fasted state

® Renally cleared– 83% cleared through the kidneys

• Dosage reduction required in renally impaired patients

® Few drug interactions– Not a substrate or inhibitor of human CYP450 enzymes– No known clinically significant drug interactions

® Pregnancy Category B

3TC and ABC naiveMonotherapy10-day dosing vs3TC(n=81)

Study 102

3TC and ABC naiveMonotherapy14-day dosing(n=41)

Study 101

Patient PopulationDesign

EmtricitabineMonotherapy Studies

Study 101Emtricitabine Antiviral Activity DuringShort Term (14 days) Monotherapy

Mea

n C

han

ge

in H

IV-1

RN

A (

log

10)

25 mg bid (n = 9)

100 mg qd (n = 8)

100 mg bid (n = 8)

0.5

0.0

–0.5

–1.0

–1.5

–2.0

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Study Day

200 mg qd (n = 8)

200 mg bid (n = 8)

-1.92 log

F. Rousseau, et al. JAC(2001) 48, 507-513

Study 102Emtricitabine Antiviral Activity Compared to Lamivudine150 mg BID in Short Term (10 Days) Monotherapy

0

–0.5

–1.0

–1.5

–2.0

1 2 3 4 5 6 7 8 9 10 11 12

3TC 150 mg bid (n=20)FTC 25 mg qd (n=21)FTC 100 mg qd (n=19)FTC 200 mg qd (n=21)

Study Day

Mea

n C

han

ge

in

HIV

-1 R

NA

(L

og

10)

Delehanty J. et al, 6th CROI. Chicago 1999. Abstract #16

*p<0.05 for FTC 200 mg QD compared to each of the other treatment arms

-1.7 log

-1.5 logp<0.05*

Study 102Emtricitabine Antiviral Activity Compared to Lamivudine150 mg BID in Short Term (10 Days) Monotherapy

0

–0.5

–1.0

–1.5

–2.0

1 2 3 4 5 6 7 8 9 10 11 12

3TC 150 mg bid (n=20)

FTC 200 mg qd (n=21)

Study Day

Mea

n C

han

ge

in

HIV

-1 R

NA

(L

og

10)

Delehanty J. et al, 6th CROI. Chicago 1999. Abstract #16

*p<0.05 for FTC 200 mg QD compared to each of the other treatment arms

-1.7 log

-1.5 logp<0.05*

3

Summary: Preclinical and PK

u In vitro preclinical findings

– 10-fold greater relative substrate specificity for HIV-1 RT than3TC

– 24-fold less relative substrate specificity for mtDNA gammapolymerase

u Pharmacokinetics clearly support QD dosing

– Plasma half life of 10 hours with linear kinetics and plasmavalues > IC90 ~ 84 hrs

– Triphosphate intra-cellular half life ~ 39 hrs

u Potent antiviral activity

– 1.92 log10 reduction in plasma HIV-1 RNA after 14 days ofmonotherapy (FTC-101)

– Statistically greater reduction in plasma HIV-1 RNA after 10 daysof monotherapy compared to 3TC (FTC-102)

HIV RNA <400 copies/ml

CD4: no restriction

3TC switch to FTCin 3TC-stable patients(n=440)

Study 303

Patient PopulationDesign

Clinical Program Overview:Efficacy and Safety Studies

HIV RNA <400 copies/ml

CD4: no restriction

PI switch to FTC/ddI/EFV(n=355)

ANRS 099(Alize)

Treatment-Naïve Studies

Switch Studies

HIV RNA >5000 copies/ml

CD4: no restriction

FTC vs d4T [+ddI/EFV](n=571)

Study 301

HIV RNA >5000 copies/ml

CD4 >100 cells/mm_

FTC/ddI/EFV - Open Label(n=40)

ANRS 091(MONTANA)

Study 301

Study 301 Study Design

ART-naivepatients

(N = 571)randomized1:1, double-

blind

FTC 200 mg QDddI QDEFV QDd4T placebo BID

d4T BIDddI QDEFV QDFTC placebo QD

Week 48

Week 48

Cahn P, et al. 10th CROI, Boston, 2003, Poster #606.

Study 301Baseline Characteristics

4041HIV-1 RNA >100,000 (%)

324312Mean CD4 count (cells/mm3)

4.84.8Mean HIV-1 RNA (log10)

56%48%Caucasian

86%84%Male

3636Mean age (y)

d4T+ddI+EFV(n=285)

FTC+ddI+EFV(n=286)


Study 301

Patient Disposition at Week 48

*p<0.05

3 (1%)2 (<1%)Noncompliance

2 (<1%)7 (2%)Protocol Violation

4 (1%)5 (2%)Request for withdrawal

12 (4%)9 (3%)LTFU

23 (8%)25 (9%)Other

22 (8%)8 (3%)Treatment Failure*

33 (12%)16 (6%)D/C due to Adverse Event*

78 (27%)49 (17%)Patients Discontinued from Study *

FTC+ddI+EFV(n=286)

d4T+ddI+EFV(n=285)


4

0

20

40

60

80

100

0 4 8 12 16 20 24 28 32 36 40 44 48

Weeks

% P

atie

nts

wit

h H

IV-1

RN

A <

50

cop

ies/

mL

d4T+ddI+EFVFTC+ddI+EFV

BL

74%

58%

p = 0.0001

Intent to Treat (Missing = Failure)

Study 301% Patients < 50 copies/mL


0

20

40

60

80

100

0 4 8 12 16 20 24 28 32 36 40 44 48

Weeks

% P

atie

nts

wit

h H

IV-1

RN

A <

50

cop

ies/

mL

BL

91%

84%


As Treated (Missing = Excluded)

p<0.05

Data on file. Gilead Sciences, Inc. June 2003.

Study 301% Patients < 50 copies/mL

Study 301Mean Change From Baseline in Absolute CD4+

0

40

80

120

160

200

BL 4 8 12 16 20 24 28 32 36 40 44 48

Weeks

Mea

n C

han

ge

Fro

m B

asel

ine

- A

bso

lute

CD

4+ C

ell C

ou

nt


168

134

p = <0.05

Intent to Treat (Missing = Failure)

Data on file. Gilead Sciences, Inc. June 2003. * Reported in > 3% of FTC-treated patients in Study 301 or 303 Only events that occurred in > 10% in either arm were analyzed for statistical significance.

p<0.05* *

26%

21%

19%

13%

12%

13%

25%

16%

11%

4%

6%

9%

Dizziness

Insomnia

Abnormal dreams**

Neuropathy/Peripheral neuritis**

Paresthesia**

Depressive disorders

32%

23%

12%

12%

23%

13%

8%

9%

Diarrhea**

Nausea**

Dyspepsia

Vomiting

17%

25%

17%

14%

22%

12%

Abdominal Pain

Headache

Asthenia

D4T+ddI+EFV(n=285)

FTC + ddI + EFV(n=286)Adverse Events

Study 301Selected* Treatment-Emergent Adverse EventsThrough 48 Weeks (All Grades, Regardless of Causality)

p<0.05* *

3%6%

6%5%

MyalgiaArthralgia

10%8%

12%14%

RhinitisIncreased cough**

33%30%Rash event

D4T+ddI+EFV(n=285)

FTC + ddI + EFV(n=286)Adverse Events

Study 301Selected* Treatment-Emergent Adverse EventsThrough 48 Weeks (All Grades, Regardless of Causality)

* Reported in > 3% of FTC-treated patients in Study 301 or 303 Only events that occurred in > 10% in either arm were analyzed for statistical significance.

<1%<1%Bilirubin (>2.5 x ULN)

6%5%ALT (>5.0 x ULN)

9%6%AST (>5.0 x ULN)

11%12%Creatinine Kinase (>4.0 x ULN)

38%34%Percentage with Grade 3 orGrade 4 laboratory abnormality

D4T+ddI+EFV(n=285)

FTC + ddI + EFV(n=286)Number of Patients Treated

* Reported in > 1% of FTC-treated patients in Study 301 or 303** Only events that occurred in > 10% in either arm were analyzed for statistical significance.

Study 301Treatment-Emergent Grade 3/4 LaboratoryAbnormalities* Through 48 Weeks

5

7%5%Neutrophils (<750 mm3)

6%9%Triglycerides (>750 mg/dL)

3%2%Serum Glucose (<40 or >250mg/dL)

1%<1%Pancreatic amylase (>2.0 x ULN)

10%5%Serum amylase (>2.0 x ULN)**

2%1%Serum lipase (>2.0 x ULN)

D4T+ddI+EFV(n=285)

FTC + ddI + EFV(n=286)Number of Patients Treated

p<0.05* *

* Reported in > 1% of FTC-treated patients in Study 301 or 303 Only events that occurred in > 10% in either arm were analyzed for statistical significance.

Study 301Treatment-Emergent Grade 3/4 LaboratoryAbnormalities* Through 48 Weeks, Cont

Study 301Virology

® FTC-resistant isolates have been selected in vitro– Genotypic analyses demonstrated M184V or M184I mutation

® 37.5 % (6/16) of isolates from FTC-treatedpatients with virologic failure in study 301 showedreduced susceptibility to FTC associated with thedevelopment of the M184V/I mutation

® Interim Analysis:– After last enrolled patient completed 24-weeks of treatment

– Median duration of follow-up was 42-weeks– Efficacy and safety data

– Results presented at the 42nd ICAAC, September 2002

® DSMB Recommendation:– Termination of the double-blind comparative phase of study– d4T-treatment group discontinued and all patients offered open-label

access to the FTC-treatment group

® Study Completion:– After last enrolled patient completed 48-weeks of treatment

– Median duration of follow-up was 60-weeks– Update of efficacy and results

Study 301DSMB Interim Analysis Review

FTC in Treatment-naïvePatients: Conclusions

® FTC+ddI+EFV is a convenient, potent andwell- tolerated once-daily regimen in ARV-naïvepatients

– Durable efficacy reported to 3 years (MONTANA)

® Once-daily FTC demonstrated superior efficacyand safety as compared to twice-daily d4T(FTC 301)

Dose and Dose Interval Adjustments of NRTIs forPatients with Renal Impairment

Drug Renal Impairment

CBV Not recommended

TZV Not recommended

AZT Dose adjust per guidelines

3TC Dose adjust per guidelines

FTC Dose interval adjust per guidelines

TDF Dose interval adjust per guidelines

d4T Dose adjust per guidelines

ddI EC Dose adjust per guidelines

ABC Unknown

Emtricitabine:Dose Interval Adjustment in Renal Impairment

Creatinine Clearance (mL/min)

? 50 mL/min 30 – 49 mL/min 15 – 29 mL/min < 15 mL/min (including patients requiring

hemodialysis)* Recommended Dose and Dosing Interval

200 mg every 24 hours




*Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis.

6

ARV Pregnancy Categorization

Category B: TDF, FTC, ddI

- NFV, RTV, SQV, T-20

Category C: CBV, TRZ, 3TC, AZT, d4T, ABC, ddC

- DLV, NVP, EFV, APV, IDV, IDV/r, fos-APV/r

Category D: Hydroxyurea

FDA Pregnancy Categories –Definitions*

A: Controlled studies in women in first trimester show no risk

B: Animal studies do not indicate risk OR human studies show norisk to fetus (although animal studies may show adverseeffect)

C: Animal studies show adverse effects (teratogenic orembryocidal); no controlled studies in pregnant women; weighbenefits versus risks

D: Positive evidence of human risk; benefits may outweigh risksfor serious diseases where alternatives not available

X: Risk shown; risk outweighs benefit

*FDA Federal Register

Hyperpigmentation

u Hyperpigmentation was rare and generally mild and non-progressive– 3% (29/814) of patients in studies 301,302,303

– 28/29 Grade 1; 1/29 Grade 2

– Only 2 progressed from Grade 1 to 2

u Observed primarily on the palms/soles after 3 months– Median time to onset 88 days– Occurred at a higher rate in black patients (8%)

u Never required FTC discontinuation

u Resolved in some patients (5/29) while on treatment

Emtricitabine NDA filing June 2003

Hyperpigmentation of the Palms

Incidence of Hyperpigmentation in FTC-Treated Patients by Ethnic Group

FTC-301A FTC-302 FTC-303FTC-301A &

FTC-303

FTC-301AFTC-302FTC-303

Number of Patients on FTCTreatment

286 234 294 580 814

Number (%) of Patients withSkin Discoloration (Total)

10(3.5%)

14(6.0%)

5(1.7%)

15(2.6%)

29(3.6%)

Number (%) of Patients withSkin Discoloration byEthnicity or Race

Black7/52

(13.5%)13/186(7.0%)

4/59(6.8%)

11/111(9.9%)

24/297(8.1%)

Caucasian 1/136(0.7%)

0/24 0/193 1/3290.3%

1/353(0.3%)

Asian 0/3 0/2 0/3 0% 0%

Hispanic 2/77(2.6%)

0/0 1/34(2.9%)

3/1112.7%

3/1112.7%

Other 0/18 0/0 0/5 0% 0%

Mixed Race 0/0 1/22(4.6%)

0/0 0% 1/22(4.6%)

Emtricitabine NDA filing June 2003

Nail Discoloration Observed with AZT

u Observed primarily on fingernails and toenails1-3

– Color ranges from dark brown to purple1-3

u Onset: 4 months to 1 year after starting AZT1-4

u Incidence:

– In a study of Combivir (AZT/3TC) + ABC, theincidence of nail discoloration was 5.7%4

– In two retrospective studies, the incidence was 42%and 39%, respectively2,3

• Of those who developed it, 67-82% were AfricanAmerican2,3

1 Rahav et l. Scan J Infect Dis 1992; 24:557-612 Groark et al. J Am Acad Dermatol 1989; 21:1032-3

3 Don et al. Ann Intern Med 1990; 112-145-64 GlaxoWellcome Medical Information

7

Emtricitabine Virology

Triple NRTI ComparisonsIncidence of the M184V/I Mutation in Patients whoExperienced Virological Failure

52%

74%

78%

73%

67% 67%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

FTC +d4T+ABC

All 3TC +AZT+ABC

CNAAB3005 CNAA3003 EPV40001 QD EPV40001 BID

p < 0 .02

• Incidence of M184V/I mutation was significantly lower for FTC regimen compared to 3TC+ AZT+ ABCregimens (-21% treatment difference with a 95% CI [-37%, -5%]; p < 0.02)

Sanne I, et al. 43rd ICAAC, Chicago, 2003, #H-868.

Historical Studies of ABC/3TC/ZDV

Overview of Emtricitabine (FTC) inPediatric Program

Nathalie Adda, MD

Clinical Research

Once Daily Emtricitabine in HIV-Infected PediatricPatients with Other ART Agents: Study FTC-203

• Phase I/II study in ART naïve or stable 3TC-treated pediatric patients aged 3 mo to 17 yr

• N=82 patients; (51 ART naïve; 31 3TC-stable)

• FTC dosed at 6 mg/kg QD

• Median Baseline VL:87,096 cp/mL (naïve); 50 cp/mL (exp)

• Median Baseline CD4+:724 cells/mm3 (naïve); 1072 cells/mm3 (exp)

• Results Through Week 24:

SAE: 13/82 (15%)

Grade 3/4 labs: 5/82 (6%) CD4+ @ W24 ART-naive: 984 cells/mm3

stable 3TC: 971 cells/mm3

• PK studies demonstrated that dose of 6 mg/kgQD produced similar AUC as 200 mg in adults

• These results suggest that FTC in combinationtherapy is well tolerated with potent activity.

Saez-Llorens X, et al. 10nd CROI, Boston 2003, Poster 872, February 13, 1:30-3:30

Plasma HIV-1 RNA at Week 24 (NC=F)

0

20

40

60

80

100

% <400 % <50

naïve (n=51)

exp (n=31)

93%

71%

84%

%

63%

An Ongoing Phase I/II Study of Once-Daily Emtricitabine(FTC), Didanosine (ddI) and Efavirenz (EFV) in Therapy Naïveor Minimally Treated Pediatric Patients: Study PACTG-1021

• Phase I/II study in minimally treated or naïvepediatric patients aged 3 to 21 yrs at 15 sites

• Two age cohorts (3-12 yrs; 13-21yrs)

• N=37 patients; [FTC+ddI+EFV] once-daily

• FTC dosed at 6 mg/kg QD; ddI dosed at 240mg/m2; EFV adjusted for weight and age

• Median Baseline VL: 47,775 copies/mL

• Median Baseline CD4+ 310 cells/mm3

• Results Through Week 24:

Discontinuations: 7/37 (19%)

Grade 3/4 labs: 4/37 (11%) ÒCD4+ @ W24 (n=33): 254 cells/mm3

• PK studies at Week 2 demonstrated that FTCand ddI concentrations met threshold criteria

• FTC+ddI+EFV was easily administered withgood activity and tolerability through W24

McKinney R, et al. Statistical report of the Third Interim Analysis

Plasma HIV-1 RNA at Week 24

60

80

100

% <400 % <50

<=12 yrs

overall

86%

78%

81%

%

An Ongoing Open Label Study of Once-Daily Emtricitabinein combination with Other antiretroviral Agents in HIVPediatric Patients: FTC-211

• Phase II study in ART naïve or treatedpediatric patients aged 3 months to 17yrs at 2sites in Romania

• Three age cohorts (3-24 months; 7-12yrs; 13-17yrs)

• N=16 patients; [FTC+ddI+EFV] once-daily or[FTC+d4t+LPV/r]

• FTC dosed at 6 mg/kg QD; ddI dosed at 240mg/m2; EFV adjusted for weight and age orFTC dosed at 6 mg/kg QD; d4T dosed at1mg/kg bid; LPV/r dosed at 12/3 mg/kg bid.

• Mean duration of treatment : 164 days (range:55 to 273 days) as of the safety update datacut-off (October 03 , 2003).

• Preliminary results through W24:

0

20

40

60

80

100

% <400

overall

Plasma HIV-1 RNA at Week 2486%n=6/7

No Discontinuations

Grade 3/4 labs: 2/16 (12%)

ÒCD4+ @ W24 (n=8): 136 cells/mm3

8

Anti-HBV Activity of Emtricitabine(FTC) in Patients Co-Infected with

HIV and Hepatitis B Virus

F. Raffi1, A. Snow2, K. Borroto-Esoda2, A.Shaw2, J. Anderson2, J. Sorbel2, J.B. Quinn2,

E. Mondou2, and F. Rousseau2

1CHU de Nantes, Nantes, France; 2Gilead Sciences, Inc., USA

Introduction

® Emtricitabine (FTC) is a novel nucleosidereverse transcriptase inhibitor (NRTI) shown tobe a potent and selective inhibitor of HIV-1and Hepatitis B Virus (HBV) replication in vitro.

® Once daily FTC has demonstrated clinicalefficacy against HIV and activity againstchronic HBV infection in HIV-negative patients.

F. Raffi IAS Conference, July 13-16, 2003, Abstract # 215

HBsAg+ Patient Population

FTC treatedn=52 patients

total across studies

n=39 patients treated 6 months

15 with HBVDNA <4700 C/ml

at entry

n=24 FTC-treatedpatients with detectable HBV

DNA at entry

Comparatorn=22 patients

total across studies

n=18 patients treated 6 months

5 with HBV DNA < 4700 C/ml

at entry3 on 3TC; 2 on d4T

n=13 Comparator-treated withdetectable HBV DNA at entry

3 on 3TC; 10 on d4T


Baseline Characteristics

Emtricitabine Control

(n=39) (n=18)

Undetectable HBV DNA at entry (n) 15 5

No. patients with Entry HBV DNA > LOD 24 13

Mean age (years) 35 39

% male 92% 92%

Mean HBV DNA (log10copies/mL) 7.7 8.8

Mean HIV RNA (log10copies/mL) 4.6 4.8

Mean CD4 count (cells/mm3) 391 325

Mean ALT value (U/L) 107 50

Patients with ALT > ULN (n) 10 7


HBV DNA Suppression in PatientsTreated with FTC 200 mg QD

12 24 36 48

8/22 (36%)

9/20 (45%)

12/20 (60%)

10/17 (59%)

-2.23

-2.51

-3.03

-2.72

Metric N (%) < 4700 C/mL HBV DNA median change from baseline (log10 C/mL)

Week of Study


0

10

20

30

40

50

60

70

0 12 24 36 48

% H

BV

DN

A B

elo

w L

OD

FTC HBV+HIV FTC in Chronic HBV (FTCB-102)

Proportion of Patients with HBV DNA< 4700 copies/ml by Study Week

24 22 20 20 1733 33 33 33 33

FTC HBV+HIVFTC HBV


9

-4

-3

-2

-1

0

0 12 24 36 48

FTC HBV+HIV d4T HBV+HIV FTC in Chronic HBV (FTCB-102)

Lo

g10

HB

V D

NA

Median Log10 Change from Baseline inHBV DNA by Study Week

24 22 20 20 1733 33 33 33 3310 10 10 7 7

FTC HBV+HIVFTC HBVd4T HBV+HIV


9591

7883

0

20

40

60

80

100

0 12 24 36 48

% H

IV R

NA

< 4

00 C

/ml

FTC HBV+HIV Control HBV+HIV

Proportion of Patients with HIV RNA< 400 copies/ml by Study Week

24 24 23 22 2013 13 13 12 9

FTC HBV+HIVControl HBV+HIV


Conclusions

® FTC produced similar suppression of HBV DNAin patients co-infected with HIV as that observedin patients infected with HBV alone

® In HBV+HIV co-infected patients, the safetyprofile of FTC was similar to that of control


Future StudiesDiscussion

The Future: TDF/FTC Fixed DoseCombination Tablet

Tenofovir and Emtricitabine fixeddose combination

Study 934 in progressTDF/FTC/EFV vs COM/EFV

Bioequivalence and stability studiesin progress

Other Studies

® TDF + FTC backbone --– What other studies should be performed to better

characterize the clinical role of this NRTI backbone?

– Specific regimens or third agents?– Different patient populations?

– Other?

10

Other Studies

® EMTRIVA --– What other studies should be performed to better

characterize Emtriva and its place in clinical care?

– Comparative trials?– Different patient populations?

– Other?

Emtriva & VireadSummary of Similar Characteristics

® Durable efficacy in clinical trials– Both Emtriva and Viread have shown efficacy in both treatment-naïve

and treatment-experienced patients

® Tolerability and safety

® Convenience– Both one tablet dosed once-daily

® Pharmacokinetics– Both have long intracellular half-lives, true once-daily dosing– Both can be taken without regard to food

® Co-infection– Though not indicated for hepatitis B, both have demonstrated potency

against hepatitis B in co-infected patients

Thank you!

To review TDF interaction data Introduction

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