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1. P.S. I’m HIV positive
It’s all about living, not living with HIV
Prescribing information and adverse event reporting can be found on last page

2. P.S. I’m HIV positive
Unbeaten virological
control?
Sustained virological
control?
Increasing CD4 count
over the long-term?
A favourable long-term
tolerability profile?
Reassuring MI data?
Minimal pill
burden?
What helps
put their HIV into
perspective?
Sustiva
inperspective

3. It’s all about living, not living with HIV
Longer virological control
than LPV/r1
EFV + LPV/r 250 215 189 181 149 73 17
LPV/r + 2 NRTIs 253 185 140 74 14210 168
EFV + 2 NRTIs 250 210 186 173 142 73 19
Weeks after Randomisation
Probabilityofnovirologicalfailure(%)
100
70
80
90
60
50
40
20
10
30
144120967248240
0
No. of patients
EFV + 2 NRTIs
LPV/r + 2 NRTIs
LPV/r+EFV
p=0.006
Primary endpoint: time to virological failure1
Adapted from Riddler SA, et al. NEJM 2008; 358: 2095-2106.
ACTG 5142 study design1
: Phase III, randomised, open-label study comparing outcomes of antiretroviral therapy with EFV + 2 NRTIs
[1st NRTI (all patients): 3TC (150mg bd or 300mg od): 2nd NRTI (investigator selection): ZDV 300mg bd or TDF 300mg od or
d4T XR od*]; LPV/r + 3TC (+ZDV, d4T XR or TDF) or LPV/r + EFV in 753 antiretroviral-naïve patients. Median follow-up was 112 weeks.
(*d4T XR was an investigational formulation of stavudine that is not commercially available. Dosing was 100mg od or 75mg if subject
weighed <60kg). Sustiva safety profile in these studies was in line with already known data.
● Sustiva + 2 NRTIs demonstrates a significantly longer time to virological
failure than LPV/r + 2 NRTIs (p=0.006)1
● Longer time to virological failure than LPV/r + 2 NRTIs in patients
with HIV-1 RNA ≥100,000 copies/mL at baseline (p=0.01)1
Stronger virological control than LPV/r in terms
of undetectable viral load1
● Higher proportion of patients with plasma HIV-1 RNA 50 copies/mL
at week 96 (89% for Sustiva + 2 NRTIs and 77% for LPV/r + 2 NRTIs)
(p=0.003)1
ITT analysis Missing = Ignored
Significantly reduced virological
failures compared to NVP2
NEW STUDY (2008): Designed to demonstrate non-inferiority of treatment
failure with nevirapine (NVP) twice daily vs. Sustiva at 48 weeks2
20
25
15
10
5
0
SUSTIVA + 2 NRTIs
(n=1,822)
13.8%
p0.001
NVP + 2 NRTIs
(n=995)
20.4%
%patientswithvirologicalfailure
HIV-1 RNA 400 copies/mL
Proportion of patients with virological failure
after 2 years’ follow-up2
Adapted from Nachega et al. AIDS 2008; 22: 2117–2125.
Nachega et al, study design2
: observational cohort study in 2,817 HIV-infected, HAART-naïve adults who began NVP- (n=995) or
SUSTIVA-based (n=1,822) therapy via a private-sector HIV/AIDS programme in nine countries of southern Africa. The primary outcome
was time to virological failure (two measurements of viral loads ≥ 400 copies/mL). Median follow-up period was 2 years. Sustiva safety
profile in these studies was in line with already known data.
Sustiva helps
give me unbeaten
virological control
Unbeaten
virologicalcontrol

4. It’s all about living, not living with HIV
7 year proven virological control
Undetectable virological control maintained3
Time (years)
PatientswithHIVRNA50copies/mL(%)
100
70
80%
(n=86)
90
80
60
50
40
20
10
0
30
0 1 764 532
Virological response (50 copies/mL) through 7 years (M=F)3
Adapted from Cassetti I, et al. IAC 2008, Abstract TUPE0057.
Study 903E3
is a Phase III trial with an ongoing 336-week open-label extension phase and a completed
144-week randomized, double-blind phase designed to evaluate TDF compared to stavudine (d4T) in
combination with 3TC and EFV in antiretroviral-naive patients (n=86). 15 patients discontinued from the
study prior to Year 7.
No. of patients 86 85 85 84 82 77 73 71
Time (years)
MeanchangeinCD4cells/mm3
0
500
350
450
400
300
250
200
100
50
0
150
1 764 532
+459
Mean change from baseline in CD4 count through 7 years3
Adapted from Cassetti I, et al. IAC 2008, Abstract TUPE0057.
Study 903E3
(n=86) is an ongoing 336-week open-label extension phase and a completed 144-week randomized, double-blind phase III
trial designed to evaluate TDF compared to stavudine (d4T) in combination with 3TC and EFV in antiretroviral-naïve patients. All patients in
Study 903E received EFV+3TC+TDF. Mean baseline CD4 count = 299 cells/mm3
. 15 patients discontinued from the study prior to Year 7.
● CD4 count rose by 459 cells/mm3
from a mean baseline CD4 count of
299 cells/mm3
.3
Sustiva helps give me
sustained virological control
Continuing improvement in CD4
count over 7 years3
Sustained
virologicalcontrol

5. Sustiva gives them the added
reassurance of long-term
tolerability
Favourable long-term
tolerability profile4,5,11
Lipid profile
In the STARTMRK Study,
● Sustiva + TDF/FTC exerted only modest effects on serum lipids over 96 weeks4
● The change from baseline in the T Chol:HDL-C ratio was similar for the Sustiva
and RAL arms over 48 weeks (-0.1 vs -0.3 respectively, p=0.292)5
Many studies show that the total cholesterol/HDL cholesterol ratio is a powerful
predictor of CHD risk6-10
Reassuring Myocardial Infarction (MI) data
Sustiva was not associated with increased relative risk
of MI unlike LPV/r11
1.2
1.15
1.05
0.95
1.1
0.9
IDV NFV LPV/r SAQ NVP EFV
1.0
PI NNRTI*
#PYFU (Person-
years of follow up):
#MI (Myocardial
Infarction):
68,469
298
56,529
197
37,136
150
44,657
221
61,855
228
58,946
221
RR/year95%CI
p=0.0009
PIs/NNRTIs and risk of MI: cumulative exposure to each drug11
Adapted from Lundgren JD, et al. CROI 2009; Presentation and Abst 44LB.
D:A:D study design11
: Multicentre, 11 cohort, 33,308 patient study examining the relative risk of Myocardial Infarction following exposure
to specific antiretroviral therapy from the PI, NNRTI, and NRTI Drug Classes. Approximate test for heterogeneity: p=0.02.
Atazanavir (ATZ) was not included in this study as it did not meet the number threshold.
Cumulative exposure
● No association with an increased relative risk of MI was seen with
cumulative exposure to Sustiva11
● Cumulative (but not recent) exposure to LPV/r was associated with
an increased relative risk of MI (relative rate [RR]: 1.13/year)11
And:
Increased risk of MI with LPV/r was only partly explained by dyslipidaemia11
Favourable long-term
tolerability profile3,5,12,13
Limb fat
● Although there were more patients with protocol-defined 20% loss
of peripheral fat in ACTG 5142, this was mainly associated with
thymidine analogue-containing regimens compared to TDF-containing
regimens12
10
8
12
6
4
2
0
0 1 2
69 69 65 61 59 58
3 4 5 6 7
MedianLimbFatinkg
Year
TDF+3TC+EFV n =
* p-value for change from year 2 using Wilxcoxon Signed Rank test
p0.001
6.7
8.0*
Study 903E: median total limb fat (IQR) years 2 - 73
Adapted from Cassetti I, et al. IAC 2008, Abstract TUPE0057.
● Study 903E3
showed significant and continued increases in limb fat
between years 2 and 7 with Sustiva +TDF/FTC3
● In the STARTMRK Study, both the Sustiva and RAL arms showed no
patterns of fat loss over 48 weeks5
Long-termtolerability

6. It’s all about living, not living with HIV
CNS symptoms in perspective
CNS symptoms generally resolve after the first 2-4 weeks14,15
non-SUSTIVA
EFV group, n = 191 186 185 176
Non-EFV group, n = 99 99 98 93
SUSTIVA
2412410
Weeks
EFVsymptomscorechanges
-2
0
2
4
6
8
Sustiva-associated neurologic symptoms (excluding depression
and anxiety) compared with non-Sustiva therapies15
Adapted from Clifford DB, et al. Ann Intern Med 2005; 143: 714–721.
A5097s study design15
: from the double-blind, randomised, controlled A5097 trial, a substudy compared neurological changes from
baseline in patients who received SUSTIVA (n=200) with non-SUSTIVA patients (n=103). Neuropsychological performance and patient
status was evaluated with a symptom questionnaire, which included SUSTIVA-focused score change and general symptoms. Mean
changes from baseline over time with 95% CIs were evaluated.
● CNS symptoms of moderate-to-severe intensity were experienced by 19.4%
of patients14
but resulted in a low number of discontinuations (2.1%)14
● CNS symptoms are generally mild, normally begin during
the first one or two days of therapy and usually resolve
after the first 2-4 weeks14
Because Sustiva offers…
Unbeaten virological control1,2
Sustained virological control3
Increasing CD4 count over
the long-term3
A favourable long-term
tolerability profile3-5,11-13
Reassuring MI data11
Minimal pill burden14
…and is the
recommended/preferred
NNRTI for treatment
initiation across many
international guidelines…
● EACS16
● DHHS17
● IAS18
● BHIVA19
● GESIDA20
● ANRS21
…Sustiva helps put
patients’ HIV into perspective
Sustivasummary

7. It’s all about living, not living with HIV
SUSTIVA®
600mg FILM-COATED TABLETS PRESCRIBING INFORMATION See Summary
of Product Characteristics prior to prescribing PRESENTATION: Film-coated tablets:
600mg efavirenz. INDICATIONS: Antiretroviral combination treatment of HIV-1 infected
adults, adolescents and children 3 years of age and older. Sustiva has not been
adequately studied in advanced HIV disease. DOSAGE AND ADMINISTRATION: Oral.
Sustiva must be given in combination with other antiretroviral medications. Adults and
adolescents over 40kg: 600mg once daily preferably at night and on an empty stomach.
CONTRAINDICATIONS: Hypersensitivity to contents. Severe hepatic impairment (Child
Pugh Grade C). Do not use in combination with St. John’s wort or products that are
substrates of CYP3A4 See SPC for details. WARNINGS AND PRECAUTIONS: Not for sole
use. Discontinue use if severe rash associated with blistering, desquamation, mucosal
involvement or fever develops. Advise immediate contact with doctor if experience
severe depression, psychosis or suicidal ideation. Nervous system symptoms generally
resolve after the first 2 - 4 weeks. Immune reactivation syndrome may arise with severe
immune deficiency. Given lipodystrophy association with combination antiretroviral
therapy, consider monitoring fasting serum lipids and blood glucose and manage as
appropriate. Patients with hereditary disorders of galactosaemia or glucose/galactose
malabsorption syndrome should not take Sustiva. Patients should be advised to seek
medical advice if they experience joint aches pain, joint stiffness of difficulty in
movement. Caution needed in mild to moderate liver disease or chronic Hepatitis B or C
infection. Where evidence of worsening liver disease, interruption or discontinuation of
treatment must be considered. Close safety monitoring is recommended in patients with
severe renal failure. Caution if history of seizures. Efavirenz should not be given to
patients below 3 years or weigh less than 13kg. DRUG INTERACTIONS: Efavirenz is an
inducer of CYP3A4 and an inhibitor of some CYP isozymes including CYP3A4. Other
compounds that are substrates of CYP3A4 may have decreased plasma
concentrations when co-administered with efavirenz. Efavirenz exposure may alter
when given with medicinal products or foods (e.g. grapefruit) which affect CYP3A4
activity (see Contraindications above). See SPC for full drug interaction details with
antiretrovirals, antimicrobials, anticonvulsants, lipid-lowering agents, antacids, opiods,
St. John’s Wort, antidepressants, hormonal contraceptives, calcium channel blockers,
immunosuppressants,the H1-antihistamine cetirizine,lorazepam,and antifungal agents,
(efavirenz dose should be reduced when co-administered with voriconazole).
PREGNANCY AND LACTATION: Avoid use in pregnancy and lactation. Barrier
contraceptionshouldalwaysbeusedincombinationwithothermethodsofcontraception.
UNDESIRABLE EFFECTS: Common: disturbance in attention, dizziness, headache,
somnolence, abdominal pain, diarrhoea, nausea, vomiting, rash, pruritus, fatigue,
abnormal dreams, anxiety, depression, insomnia. Serious: psychiatric adverse reactions,
immune reactivation syndrome, lipodystrophy and metabolic abnormalities,
osteonecrosis, acute hepatitis, acute pancreatitis. Laboratory abnormalities for liver
enzymes, amylase, lipids, and false positive cannabinoid test results. See SPC for full
details of side effects. LEGAL STATUS: POM. PACKAGE QUANTITIES AND BASIC NHS
PRICE: Blister packs of 30 tablets: £200.27. MARKETING AUTHORISATION NUMBERS:
EU/1/99/110/009.MARKETINGAUTHORISATION HOLDER:Bristol-Myers Squibb Pharma
EEIG, BMS House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex.
UB8 1DH Telephone: 0800-731-1736. DATE OF PI PREPARATION: July 2009
SUS/0709/2317
Date of preparation: October 2009
Adverse events should be reported. Reporting forms
and information can be found at www.yellowcard.gov.uk
Adverse events should also be reported to Bristol-Myers
Squibb Pharmaceuticals Ltd Medical Information on
0800 731 1736, medical.information@bms.com
References:
1. Riddler SA, et al. Class-sparing regimens for initial treatment of HIV-1 infection. NEJM 2008; 358: 2095-2106. 2. Nachega JB, et al. Efavirenz versus nevirapine-based initial
treatment of HIV infection: clinical and virological outcomes in Southern African adults. AIDS 2008; 22: 2117–2125. 3. Cassetti I, et al. IAC 2008, Abstract TUPE0057; Conference
reports for NATAP: www.natap.org/2008/IAS/IAS_66.htm. 4. Lennox J, et al. Raltegravir Demonstrates Durable Efficacy through 96 Weeks: Results from STARTMRK, A Phase III
Study of Raltegravir (RAL)-based vs Efavirenz (EFV)-based Therapy in Treatment-Naïve HIV+ Patients. September 2009. Poster #H924b, ICAAC, San Francisco, CA. 5. DeJesus E, et
al. Metabolic Profiles and Body Composition Changes in Treatment-HIV-Infected Patients Treated with Raltegravir 400 mg bid-based vs. Efavirenz 600 mg qhs-based combination
therapy: 48-week data. September 2009. Poster #H1571b, ICAAC, San Francisco, CA. 6. Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults
(Adult Treatment Panel III or ATP III). National Cholesterol Education Program (NCEP) Guidelines 2009. 7. Hong MK, Romm PA, Reagan K, Green CE, Rackley CE. Usefulness of the total
cholesterol to high-density lipoprotein cholesterol ratio in predicting angiographic coronary artery disease in women. Am J Cardiol 1991;68:1646-50. 8. Castelli WP, Anderson K,
Wilson PWF, Levy D. Lipids and risk of coronary heart disease: the Framingham Study.Ann Epidemiol 1992;2:23-8. 9. Kinosian B, Glick H, Preiss L, Puder KL. Cholesterol and coronary
heart disease: predicting risks in men by changes in levels and ratios. J Investig Med 1995;43:443-50. 10. Criqui MH, Golomb BA. Epidemiologic aspects of lipid abnormalities. Am
J Med 1998;105: 48S-57S. 11. Lundgren JD, et al. CROI 2009; Presentation and Abst 44LB. 12. Haubrich RH, Riddler SA, DiRienzo G, et al. Metabolic outcomes of ACTG 5142:
A prospective, randomized, phase III trial of NRTI-, PI-, and NNRTI sparing regimens for initial treatment of HIV-1 infection. 14th Conference on Retroviruses and Opportunistic
Infections, 2007; Oral Presentation 38. 13. Arribas JR, Pozniak AL, Gallant JE, et al. Three year Safety and Efficacy of Emtricitabine (FTC)/ Tenofovir DF (TDF) and Efavirenz (EFV)
Compared to Fixed Dose Zidovudine/Lamivudine (CBV) and EFV in Antiretroviral Treatment-Naïve Patients. 4th International AIDS Society Conference on HIV Pathogenesis,Treatment,
and Prevention, Sydney, Australia, 2007; Poster.] 14. Sustiva®
(efavirenz, Bristol-Myers Squibb Pharma EEIG). Summary of Product Characteristics: Last modification – September
2009. http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=11284 Accessed October 2009. 15. Clifford DB, et al. Impact of efavirenz on neuropsychological
performance and symptoms in HIV-infected individuals.Ann Intern Med 2005; 143: 714–721. 16. European AIDS Clinical Society (EACS) Guidelines for the clinical management and
treatment of HIV infected adults in Europe. 2008.http://www.eacs.eu/guide/index.htm. 17. DHHS guidelines, Nov 2008. http://AIDSinfo.nih.gov. 18. Hammer SM et al. Antiretroviral
treatment of adult HIV infection: 2008 Recommendations of the International AIDS Society USA Panel. JAMA 2008; 300(5): 555–570. 19. Gazzard B. British HIV Association (BHIVA)
Guidelines for the treatment of HIV-1-infected adults with antiretroviral therapy. HIV Medicine 2008;9: 563–608. 20. Recommendations of GESIDA/Spanish AIDS. Plan on antiretroviral
therapy in adults infected by the human immunodeficiency virus (updated January 2007). 21. Rapport du Groupe d’Experts 2008 sur la prise en charge médicale des patients
infectées par le VIH, sous la direction du Prof. Patrick Yeni.
Place
holder
for
PI