PPT - International AIDS Society-USA

Report
Antiretrovirals in the
Management of HIV Infection:
Case-Based, Panel Discussion
Eric S. Daar, MD
Professor of Medicine
David Geffen School of Medicine
at University of California Los Angeles
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
IAS–USA
Slide 2 of 42
When to Start: Case 1
– 30 yo white man
– Diagnosed on routine insurance
examination
– PMHx remarkable for HTN, diet controlled
– No medications
– Understands treatment issues and wants
to begin therapy if you think it is
appropriate
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA. Adapted from Mike Saag
Slide 3 of 42
When to Start: Case 1b
– 30 yo white man
– Diagnosed on admission to jail for
disorderly conduct
– PMHx remarkable for HTN, diet controlled
and paranoid schizophrenia
– Doesn’t take any medications and doesn’t
want to
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 4 of 42
Effect on inflammation in predicting mortality higher in
HIV disease than the general population (SOCA/SCOPE)
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Hunt et al CROI 12
Slide 5 of 42
T cell “activation” is lower in treated than untreated
adults, but consistently higher than “normal”
P < 0.001
80
% CD38+HLADR+
CD8+ T Cells
P < 0.001
60
40
20
0
HIV +
HIV
Negative
Untreated
(n=82)
(n=82)
NonHIV +
Controller
ART
(n=65)
(n=65)
HAART
HIV –
(n=132)
(n=132)
Hunt et al JID 2003, PLoS ONE 2011 and unpublished
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 6 of 42
Permanent Loss of CD4 if Wait to Start
– >350
CD4 counts return
to near-normal levels
– ≤350 cells/mm3: CD4 counts
significantly increased but
plateau after 4 years below
normal range
cells/mm3:
• Differences in CD4 counts
associated with differences
in morbidity and mortality
Median CD4 Counts Over 6 Years
Stratified by Baseline CD 4 Count
CD4 Count (cells/mm3)
• CD4 count increases on
sustained suppressive
(<400 c/mL) ARV treatment
(n=655) by baseline count
900
800
700
740
500
400
300
200
<200
100
201–350
>350
0
0
1
2
3
4
5
6
Years After Starting HAART
Moore RD, Keruly JC. Clin Infect Dis 2007;44:441-446.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 7 of 42
Reasons to Start Early:
• The Biology
• Association of Inflammation and Disease
• Better Tolerated/Easier to Take
Medications
• Randomized Controlled Trial Data
• Cohort Data
• Irreversible Damage
• Public Health
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 8 of 42
Most New Infections Transmitted by
Persons Who Do Not Know Their
Status
~25%
Unaware
of
Infection
account for…
~42%
Aware
of
Infection
Source: G. Marks et al. AIDS 2006
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
~54%
New
Infections
~46%
of New
Infections
Slide 9 of 42
HPTN 052
1763 HIV discordant couples
(HIV+ partner CD4 350-550)
886 immediate
HAART
874 delayed
HAART (CD4 250)
All receiving HIV prevention services
1 transmission*
& 3 cases of
extrapulmonary TB
27 transmissions*
& 17 cases of
extrapulmonary TB
*96% reduction in HIV transmission to HIV-negative
partner median follow-up 2 years
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 10 of 42
So ….what is the harm?
•
•
•
•
Destruction of lymphoid tissue
Inflammation
Increased cardiovascular events
Increased incidence of certain
malignancies
• Increased ‘aging’
• Accelerated cognitive decline
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 11 of 42
When to Start Treatment
2/13/13
DHHS
Guidelines
CD4 Count
HIV RNA
Clinical Category
(cells/mm3)
(copies/mL)
AIDS-defining illness
or severe symptoms
Any value
Any value
Treat
<500
Any value
Treat
>500
Any value
Treat
Pregnant women
Any value
Any value
Treat
HIV-associated
nephropathy
Any value
Any value
Treat
HIV/HBV coinfection
when HBV treatment
is indicated
Any value
Any value
Treat
Asymptomatic
2012
IAS-USA
Guidelines
*Unless elite controller (HIV RNA <50 copies/mL) or has stable CD4 cell count and low-level viremia in absence of
therapy. The IAS-USA guidelines also recommend initiating antiretroviral therapy in HIV-infected patients with
active hepatitis C virus infection, active or high risk for cardiovascular disease, and symptomatic primary HIV
infection.
DHHS. Available at: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
Revision February 2013; Thompson MA, et al. JAMA. 2012;308:387-402.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 12 of 42
When to Start: Case 2
• 34 yo woman is diagnosed with TB
• As part of evaluation she is found to be HIV+
• Initial lab values
– CD4 82 cells/µL
– VL 76,000 c/mL
• No other significant medical condition
• She is started on 4-drug anti-TB therapy
(including INH and rifabutin)
• Virus is wild-type virus
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 13 of 42
When to Start ARV with Complications
• ARVs within 0-2 weeks of diagnosis
– Infections for which there is no specific treatment (e.g.
dementia, cryptosporidium, microsporidium, PML) (AIII)
– Other OIs, e.g. PCP (AI)
• Consider deferring therapy for crypto meningitis
• Tuberculosis
– Within 2 weeks for CD4 <50 cells/uL (AI)
– Within 2-4 weeks for severe symptoms with CD4 50-200
(BI) and >200 cells/uL (BIII)
– Within 8-12 weeks for mild symptoms and 50-500
cells/uL (AI) and >500 cells/uL (BIII)
– Meningitis 2 months (AI) in RLS, perhaps earlier in other
settings (CIII)
DHHS. Available at: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
Revision February 2013; Thompson MA, et al. JAMA. 2012;308:387-402.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 14 of 42
A 49 year old asymptomatic man
presents to your clinic after recently
being diagnosed with HIV
•
•
•
•
•
History of HTN with CrCl ~42 mL/min
HBsAb+, HCV antibody negative
CD4 cells repeatedly 700-420 cells/uL
Plasma HIV RNA 30-50,000 copies/mL
Not anxious to start antiretrovirals but willing
if you think it is necessary
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 15 of 42
Factors to consider in choosing
first-line therapy
•
•
•
•
•
•
•
•
Patient’s willingness to commit to therapy
Baseline resistance
Efficacy data
Tolerability
Convenience
Comorbid conditions
Consequences of failure (resistance)
Since the introduction of potent ARV therapy
preferred regimens all include NRTIs + third drug
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 16 of 42
Boosted-Protease Inhibitors
KLEAN1
(ITT-E, TLOVR)
48 weeks
100
100
80
66
65
CASTLE3
(ITT, NC=F)
96 weeks
ARTEMIS2
(ITT, TLOVR)
96 weeks
80
100
79
71
80
74
74
74
40
40
40
20
20
20
0
n=434 N=444
LPV/r
FPV/r
400/100 700/100
BID
BID
0
n=346 n=343
LPV/r DRV/r
QD or 800/100
BID
QD
0
68
74
n=443 n=440
LPV/r
ATV/r
400/100 300/100
BID
QD
Adapted from: 1. Eron J, et al. Lancet 2006; 368:476-482; 2. Mills A, et al. AIDS May 29, 2009
3. Molina J-M, et al. 48th ICAAC/46th IDSA , Washington, DC, 2008. Abst. H-1250d
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 17 of 42
ATV/r vs. EFV
Primary Endpoint
Daar ES, et al. Ann Intern Med 2011; 154:445-456.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 18 of 42
STARTMRK: RAL vs. EFV
ITT, NC=F
Percentage of Patients with
HIV RNA Levels <50 Copies/mL
100
86
81
42
76
69
67
71
80
82
79
74
61
40
CD4 Change: RAL +374 vs. EFV +312
20
0
Weeks
0
12 24
48
72
96
120
144
168
192
216
240
280
281
281
282
281
282
274
281
280
281
281
282
281
282
274
282
279
279
Number of Contributing Patients
Raltegravir 400 mg BID
Efavirenz 740 mg QHS
281 278 279
282 282 282
Rockstroh J, et al, 19th IAC; Washington, DC; July 22-27, 2012; Abst. LBPE19.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 19 of 42
Pooled ECHO and THRIVE: Virologic
Response (ITT-TLOVR)
84.3%
82.3%
Rimsky L, et al. 50th ICAAC 2010, Boston, MA. Abst. H-1810
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 20 of 42
Pooled ECHO and THRIVE:
Virologic Response (ITT-TLOVR)
Rimsky L, et al. 50th ICAAC 2010, Boston, MA. Abst. H-1810
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 21 of 42
GS102 & GS103: EVG/COBI/TDF/FTC vs.
EFV/TDF/FTC or ATV/RTV + TDF/FTC
Randomized, Phase III, Double-blind, Double Dummy,
Active-controlled, International Studies
GS 102
Quad QD
~89% men
33% >105 c/mL
CD4= ~385 c/uL
EFV/FTC/TDF Placebo QD
EFV/FTC/TDF QD
Treatment Naïve
Quad Placebo QD
HIV-1 RNA ≥5,000 c/mL
Any CD4 cell count
eGFR ≥70 mL/min
Quad QD
ATV/r +TDF/FTC Placebo QD
GS 103
~90% men
~41% >105 c/mL
CD4= ~370 c/uL
QUAD Placebo QD
ATV/r +TD/FTC QD
48 weeks
Sax P, et al, Lancet 2012: 379::2439-48; DeJesus E, et al, Lancet 2012; 379: 2429-38
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
192 weeks
Slide 22 of 42
Study 236-102: Primary Endpoint:
HIV-1 RNA < 50 copies/mL
+3.6%, 95% CI 3.6 (-1.6% to +8.8%)
CD4+ change: Quad +239 vs. EFV +206 c/mm3 (p=0.009)
No difference by baseline characteristics
Sax P, et al. 19th CROI; Seattle, WA; March 5-8, 2012. Abst. 101.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 23 of 42
Study 236-102:
Common Adverse Events
Quad
(n=348)
Treatment Emergent Adverse Events in ≥ 10% of subjects (%)
Diarrhea
23%
Nausea *
21%
Abnormal Dreams ^
15%
Upper Respiratory Infection
14%
Headache
14%
Fatigue
12%
Insomnia *
9%
EFV/FTC/TDF
(n=352)
19%
14%
27%
11%
9%
13%
14%
Depression
9%
11%
Dizziness ^
7%
24%
Rash #
6%
12%
* p<0.05; ^ p<0.001; # p=0.009
Sax P, et al, Lancet 2012: 379::2439-48
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 24 of 42
Percent with HIV RNA <50 c/mL (ITT, M=F)
Study 236-103: ATV/r vs.
TDF/FTC/COBI/EVG HIV-1 RNA < 50 c/mL
100
92%
90
88%
80
Diff: 3.5% (95% CI: -1.0 to 8.0)
70
74
QUAD
ATV/r
50
40
30
20
10
0
BL 2
4
8
12
16
24
32
40
48
Week
Changes in CD4+ count: Quad +207 vs. ATV/r +211 cells/mm3 (p=0.61)
No difference by baseline characteristics
DeJesus E, et al, Lancet 2012; 379: 2429-38
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 25 of 42
Study 236-103:
Adverse Events
Adverse Events > 10%
in Either Group
Quad
(n=353)
ATV/r + FTC/TDF
(n=355)
Diarrhea
22%
27%
Nausea
20%
19%
Upper respiratory infection
15%
16%
Headache
15%
12%
Fatigue
14%
13%
Ocular icterus
1%
14%
Discontinuation rates due to renal events were identical in
both arms (0.3%)
DeJesus E, et al, Lancet 2012; 379: 2429-38
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 26 of 42
TDF/FTC/EVG/COBI vs. EFV or
ATV/r: Lipid changes
P <0.001
P= 0.001
P =0.001
P =0.44
P =0.006
Conclusion: While some lipid fractions better with Quad than EFV or ATV/r, overall
differences were modest and unlikely to be of clinical significance.
Sax P, et al, Lancet 2012: 379::2439-48; DeJesus E, et al, Lancet 2012; 379: 2429-38
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 27 of 42
EVG/COBI/TDF/FTC vs. EFV or ATV/r:
Creatinine Changes
Conclusion: Cobicistat is associated with reduced active secretion of
creatinine in the renal tubules leading to initial rises in creatinine levels.
Sax P, et al, Lancet 2012: 379::2439-48; DeJesus E, et al, Lancet 2012; 379: 2429-38
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 28 of 42
A5202: Study Design
TDF/FTC QD
Arm
A
HIV-1 RNA ≥1000 c/mL
Any CD4+ count
> 16 years of age
ART-naïve
1857
N=1858
enrolled
B
ABC/3TC Placebo QD
ABC/3TC QD
TDF/FTC Placebo QD
Randomized
Randomized 1:1:1:1
1:1:1:1
C
Stratified by screening HIV-1 RNA
(< or ≥ 100,000 c/mL)
Enrolled 2005-2007
D
Followed through Sept 2009, 96 wks after
last pt enrolled
TDF/FTC QD
ABC/3TC Placebo QD
ABC/3TC QD
TDF/FTC Placebo QD
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
EFV
QD
EFV
QD
ATV/r
QD
ATV/r
QD
Slide 29 of 42
A5202: Time to Virologic Failure in
Patients with HIV RNA >100,000 c/mL
Probability of No Virologic Failure
Probability of No Virologic
Failure (%)
100
TDF-FTC (26 events)
80
ABC-3TC (57 events)
60
40
P<0.001, log-rank test
Hazard ratio, 2.33 (95% CI, 1.46-3.72)
20
0
0
12
24
No. at Risk
36
48
60
72
84
Weeks since Randomization
96
108
ABC-3TC
398
363
313
267
222
188
137
87
49
20
TDF-FTC
399
361
321
284
236
204
174
104
65
23
Sax PE, et al. NEJM 2009;361:2230-2240.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
ABC/3TC vs. TDF/FTC
Low Viral Load Stratum
Sax PE, et al. JID 2011: 204:1191-1201.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 30 of 42
Slide 31 of 42
HEAT: Virologic Failure by Baseline
HIV-1 RNA (A5202 Efficacy Endpoint)
90
87
87
80
60
40
20
0
n=
100%
90
Proportion of Subjects with VF
Percent without Virologic Failure
100
15%
22%
4%
80%
18%
~59%
~37%
19%
74%
18%
40%
63%
41%
20%
0%
<100,000
≥100,000
188
155
205
ABC/3TC
140
ABC/3TC
≥500,000 c/mL
250,000 - <500,000 c/mL
Pappa K, et al. 17th IAC, Mexico City, 2008. Abst. THAB0304.
Young B, et al. 48th ICAAC/46th IDSA, Washington, DC, 2008. Abst. H-1233.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
TDF/FTC
100,000 - <250,000 c/mL
<100,000 c/mL
Slide 32 of 42
Concerns regarding NRTIs
• Conflicting results regarding relationship
between ABC and CV events
• TDF-associated with greater decline in bone
mineral density
• TDF-associated with variable decline in
renal function
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 33 of 42
DHHS Guidelines for Adolescents/Adults:What to Start
Preferred
Regimens
• EFV/TDF/FTC
• ATV/r + TDF/FTC
• DRV/r (once daily) + TDF/FTC
• RAL + TDF/FTC
[Pregnant Women Only: LPV/r (twice daily) + ZDV/3TC]
Alternative
Regimens
• EFV + ABC/3TC
• RPV + (TDF or ABC)/(FTC or 3TC)
• ATV/r or DRV/r + ABC/3TC
• FPV/r or LPV/r (qd or bid) ABC/3TC or TDF/FTC
• RAL + ABC/3TC
• EVG/COBI/TDF/FTC (9/18/12)
Acceptable
Regimens
• EFV or RPV + ZDV/3TC
• NVP + TDF/FTC or ZDV/3TC or ABC/3TC
• ATV + (ABC or ZDV)/3TC
• ATV/r, DRV/r, LPV/r, FPV/r , RAL + ZDV/3TC
• MVC + ZDV or ABC/3TC
• SQV/r + TDF/FTC or ABC/3TC or ZDV/3TC (with caution)
DHHS Guidelines. Available at:
http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Revision March 27, 2012.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 34 of 42
ART: What to Start
IAS–USA Recommendations, 2012
Component
Recommended Regimens
NNRTI plus nRTIs
• Efavirenz/tenofovir/emtricitabine (AIa)
• Efavirenz plus abacavir/lamivudine (AIa)
in HLA-B*5701-negative patients with baseline
plasma HIV-1 RNA <100,000 copies/mL
PI/r plus nRTIs
• Darunavir/r plus tenofovir/emtricitabine (AIa)
• Atazanavir/r plus tenofovir/emtricitabine (AIa)
• Atazanavir/r plus abacavir/lamivudine (AIa)
in patients with plasma HIV-1 RNA <100,000
copies/mL
InSTI plus nRTIs
• Raltegravir plus tenofovir/emtricitabine (AIa)
Thompson MA, et al. JAMA. 2012;308(4):387-402
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 35 of 42
A 45 year old African American woman presents to
your clinic having been diagnosed with HIV and
severe thrush/onychomycosis
• Clinically stable on fluconazole
• History mild depression, diabetes, HTN and
dyslipidemia on ACE, metformin, atorvastatin
• Laboratories
– HBsAg and HCV antibody negative
– AST/ALT- 42/82 IU/mL, CrCl~70 mL/min (relatively stable),
HgbA1C=7.1%, UA- 3+ proteinuria
– CD4= 78 cells/uL, HIV-RNA= 219,000 copies/mL
– HIV genotype- WT
• Ready to start antiretrovirals if recommended with no
specific concerns regarding various adverse events
but would prefer simple regimen
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 36 of 42
Patient starts TDF/FTC/EFV, TMP/SMX and
continues other meds. At 2 months CD4 190
cells/uL, HIV RNA 220 copies/mL, but patient
has increasing depression and persistent
neurologic symptoms thought to be associated
with EFV. CrCl is repeatedly ~70 mL/min. She
is seeing psych and on antidepressants.
A 45 year old African American woman
• H/O depression, DM, HTN, dyslipidemia, CKD
• CrCl- 70 mL/min with proteinuria
• CD4 nadir= 78 cells/uL and BL HIV RNA 212,000 copies/mL
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 37 of 42
Switch TDF/FTC + EFV to RPV
(N=49)
RPV mean Ctrough
in ECHO/THRIVE
Mills A, et al. 51st ICAAC; Chicago, IL; September 17-20, 2011. Abst. H2-794c.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 38 of 42
Patient switched to TDF/FTC + ATV/r and
continued other meds. After 4 months
neurologic symptoms resolved, CD4 250
cells/uL, HIV RNA <40 copies/mL but patient
CrCl has gradually declined (now off TMP/SMX)
to 40-45 mL/min with no change in other labs or
UA (glucosuria and proteinuria).
A 45 year old African American woman
• H/O depression, DM, HTN, dyslipidemia, CKD
• CrCl- 40-45 mL/min with proteinuria (HLA-B5701-negative)
• CD4 nadir= 78 cells/uL and BL HIV RNA 212,000 copies/mL
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 39 of 42
Relative Risk of MI (95% CI)
D:A:D Study: NRTIs and Risk of MI
1.9
1.5
1.2
1
**
0.8
Recent Exposure*: yes/no
Cumulative Exposure: per year
0.6
#PYFU:
#MI:
ZDV
138,109
533
ddI
74,407
331
ddC
29,676
148
d4T
95,320
405
3TC
153,009
554
ABC
53,300
221
TDF
39,157
139
Adjusting for eGFR does not change ABC MI finding:
Adjusted RR 1.89; 95% CI (1.46 – 2.44; P=0.0001)
* Recent use=current or within the last 6 months.
**Not shown (low number of patients currently on ddC)
Lundgren J, et al. 16th CROI, Montreal, Canada, 2009. Abst. 44LB. Sabin C, et al. Lancet
2008;371:1417-26.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 40 of 42
VA Case Registry: Use of ABC or
TDF in Last Regimen and Risk of MI
2.2
Unadjusted HR of AMI for each PY of exposure to each one of the categories
Adjusted for estimated GFR prior to regimen onset (by MDRD method)
2.0
Hazard ratio
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
ABC
TDF
Both ABC and TDF
NRTI in Last Regimen During Observation Period
Bedimo R, et al. Clin Inf Dis. 2011;53:84-91.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 41 of 42
Cumulative Exposure to ARVs and Risk
of CKD
Tenofovir
Cockcroft-Gault (n=225)
MDRD (n=274)
CKD-EPI (n=258)
INSIGHT def (n=129)
Censoring ATV
Censoring TDF
Censoring boosted PI
Indinavir
Atazanavir
Lopinavir/r
0.9
Mocroft A, et al. AIDS. 2010; 53:1667-78
1.4
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
Slide 42 of 42
A5202: ABC/3TC vs. TDF/FTC
Median Change in Creatinine Clearance
p-values: ABC/3TC vs.
TDF/FTC
Change in Calculated
Creatinine Clearance, (mL/min)
Wk 48, p=0.83
Wk 96, p=0.14
Week 48
Wk 48, p<0.001
Wk 96, p<0.001
Week 96
TDF/FTC
ABC/3TC
ATV/r
N= 191
>25% decr(%):
3
173
2
TDF/FTC
ABC/3TC
EFV
217
191
7
6
186 157
2
Daar ES, et al. Ann Intern Med 2011; 154:445-456.
From ES Daar, MD, at Los Angeles, Ca: April 22, 2013, IAS-USA.
3
200
178
1
3

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