Clinical Impact of Data From the CROI 2015,Seattle

February 23-26, 2015Seattle, Washington

HIV/AIDS Seattle UpdateCCO Independent Conference Coverageof the 2015 Conference on Retroviruses and Opportunistic Infections*

*CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.

This program is supported by an educational grant from

This program is supported by educational grants fromGilead Sciences, Merck, and ViiV.

clinicaloptions.com/hiv2015 Conference on Retroviruses and Opportunistic Infections

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Faculty

Joseph J. Eron, Jr., MDProfessor of Medicine and EpidemiologyUniversity of North Carolina School of MedicineDirector, AIDS Clinical Trials UnitUniversity of North CarolinaChapel Hill, North Carolina

Joel E. Gallant, MD, MPHMedical Director of Specialty Services Southwest CARE CenterSanta Fe, New MexicoAdjunct Professor of MedicineDivision of Infectious DiseasesJohns Hopkins University School of MedicineBaltimore, Maryland

Kathleen E. Squires, MDW. Paul and Ida H. Havens Professor of Infectious DiseasesDirector, Division of Infectious DiseasesSidney Kimmel Medical College of Thomas Jefferson UniversityPhiladelphia, Pennsylvania


Disclosures

Joseph J. Eron, Jr., MD, has disclosed that he has received consulting fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV, Merck, Tibotec/Janssen, and Tobira; and has received funds for research support from GlaxoSmithKline/ViiV.

Joel E. Gallant, MD, has disclosed that he has received consulting fees from Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, and ViiV and funds for research support from AbbVie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV, Janssen, Merck, and Sangamo Biosciences.

Kathleen E. Squires, MD, has disclosed that she has received funds for research support paid to Thomas Jefferson University from Gilead Sciences and has served on advisory boards for Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, and ViiV.

Prevention


PROUD: Immediate vs Deferred PrEP in High-Risk MSM in “Real World” Trial Randomized, open-label trial of daily

oral TDF/FTC PrEP in HIV- MSM in 13 clinics in London

– Immediate (n = 267) vs

– Deferred for 12 mos (n = 256)

Primary endpoint: HIV infection in first 12 mos

86% reduction in risk seen over 60 wks with immediate PrEP (90% CI: 58% to 96%, P = .0002)

– Rate difference: 7.6 (90% CI: 4.1-11.2)

– Number needed to treat to prevent 1 infection: 13 (90% CI: 9-25)

2 of 3 infected persons in immediate group seroconverting at study entry or shortly after first dose of PrEP

M184V/I observed in 3/6 patients who seroconverted

– No K65R observed

High rate of STIs seen in both groups

DMSB interrupted trial; recommended that all participants be offered PrEP

HIV Incidence

Group Infected, nIncidence/100 PY (90% CI)

Immediate 3 1.3 (0.4-3.0)

Deferred 19 8.9 (6.0-12.7)

McCormack S, et al. CROI 2015. Abstract 22LB.Reproduced with permission.


0.20

0.16

0.12

0.08

0.04

0.000 2 4 6 8 10 12 14 16 18 20 22 24 26

Mos

ANRS Ipergay: On-Demand Oral PrEP in High-Risk MSM Randomized double-blind trial of event-

driven oral TDF/FTC* (n = 199) vs placebo (n = 201) (both with prevention services) in France

– 2 tablets taken 2-24 hrs before sex

– 1 tablet 24 hrs after sex

– 1 tablet 48 hrs after first event-driven dose

Primary endpoint: HIV seroconversion

86% reduction in risk seen in PrEP arm (95% CI: 40% to 99%, P = .002)

– Number needed to treat for 1 yr to prevent 1 infection: 18

– Median of 16 pills taken per mo in each arm

In pts with infection, no TFV found in serum in last 2 visits

4 cases of acute HCV infection noted among lab abnormalities

DSMB stopped trial early and recommended all participants start PrEPMolina JM, et al. CROI 2015. Abstract 23LB.

Reproduced with permission.

*On-demand PrEP strategy not FDA approved.

2 infections; incidence 0.94/100 PY

14 infections; incidence 6.6/100 PY

201199

141140

7482

5558

4143

Pts at Risk, nPlaceboTDF/FTC

Placebo

TDF/FTC

P = .002

Pro

bab

ilit

y o

f H

IV

Infe

ctio

n

Kaplan-Meier Estimate of Time to HIV Infection


Oral PrEP + ART as Prevention in High-Risk Serodiscordant Couples Partners Demonstration Project in Africa

– Oral daily TDF/FTC PrEP for HIV-uninfected partner in serodiscordant couple continued 6 mos beyond initiation of ART for infected partner

– High-risk couples defined as younger age, fewer children, uncircumcised HIV-negative male, cohabitating, unprotected sex in past mo, high HIV-1 RNA in HIV-positive partner

Interim analysis

– > 95% of HIV-negative partners using PrEP

– 80% of HIV-positive partners have initiated ART; of these, > 90% with suppression

96% reduction in expected infections

‒ IRR, expected vs observed: 0.04 (95% CI: 0.01-0.19; P < .0001)

In pts with seroconversion, no TFV detectable in plasma at time of seroconversion

– HIV-positive partner in 1 couple not on ART (high CD4+ count)

– Other couple dissolved and HIV-negative partner in new relationship

Baeten J, et al. CROI 2015. Abstract 24. Reproduced with permission.

HIV Incidence, Actual vs Expected

Group Infected, nIncidence/100 PY

(95% CI)

Expected 39.7 5.2 (3.7-6.9)

Actual 2 0.2 (0-0.9)


Medical Cost Savings Associated With HIV Prevention in the United States Cost modeling analysis of the Medical Expenditure Panel

Survey

Investigators used Cost-Effectiveness of Preventing AIDS Complications Model to project discounted lifetime medical costs, assuming HIV infection at 35 yrs of age

The medical cost savings of averting 1 HIV infection was found to be $229,800

Cost savings are higher if taking secondary infections into account and lower if infection is delayed vs totally averted

Schackmann R, et al. CROI 2015. Abstract 1104.


PROMISE: Randomized Trial of PMTCT Strategies: Antepartum Component Multinational trial in HIV-positive pregnant women in India and Africa

Primary endpoint: HIV infection in infant

– MTCT through neonatal 14 days of age significantly lower in triple ART arms

– Difference: -1.28% (95% CI, -2.11% to -0.44%)

Fowler MG, et al. CROI 2015. Abstract 31LB.

ZDV + sdNVP + TDF/FTC tail

TDF/FTC + LPV/RTV*

ZDV/3TC + LPV/RTV

HIV-positive pregnant women Gestational age ≥ 14 wksNo triple ART in current

pregnancyDid not meet country

eligibility for ARTCD4+ ≥ 350 or country

threshold for ARTCrCl > 60

No active TB(N = 3529)

MTCT, % (infections/births)

1.8 (25/1326)

0.56 (9/1710)†

*In Version 2 of the protocol, only HBV-positive women in TDF/FTC arm. †Combined triple ARV arms.

Primary Endpoint ResultsAntepartum component14 days postdelivery


PROMISE: Less MTCT but Adverse Events Greater in Triple ART Arms Higher moderate, but not severe, adverse pregnancy outcome with triple ARV

– Severe outcomes less in ZDV/3TC arm vs TDF/FTC arm

– Lower risk of infant death with ZDV/3TC vs TDF/FTC: 0.6% (2/346) vs 4.4% (15/341), P = .001

– Primarily among deaths in infants < 34 wks of gestational age

Fowler MG, et al. CROI 2015. Abstract 31LB. Reproduced with permission.

ZDV (Arm A)ZDV/3TC + LPV/RTV (Arm B)TDF/FTC + LPV/RTV (Arm C)

40

30

20

10

0

Moderate Adverse Outcomes Severe Adverse Outcomes

27

3835

2017

9

20

9 7

4

19

13

63 3210

B vs CP = .02 B vs C

P = .04

A vs CP = .004

A vs CP = .04

% W

ith

Eve

nt

Any < 37 WkGest. Age

Any < 34 WkGest. Age

< 2500 gBirth Wt

< 1500 gBirth Wt

Antiretroviral Therapy


Studies 104/111: Tenofovir Alafenamide Fumarate vs TDF in Treatment-Naive Pts Parallel, randomized, double-blind, active-controlled phase III studies

Primary endpoint: HIV-1 RNA at Wk 48

TAF/FTC/EVG/COBI*single-tablet regimen

(n = 866)

TDF/FTC/EVG/COBI†

single-tablet regimen(n = 867)

Treatment-naive HIV-infected pts with

HIV-1 RNA ≥ 1000 copies/mL,eGFR ≥ 50 mL/min

(N = 1733)

Stratified by HIV-1 RNA, CD4+ cell count, geographic region

Wk 48Primary endpoint Wk 144

*10/200/150/150 mg once daily.†300/200/150/150 mg once daily.

Wohl DA, et al. CROI 2015. Abstract 113LB.


Virologic Success*

Virologic Failure

No Data

Studies 104/111: TAF Noninferior to TDF at Week 48

TAF also noninferior to TDF at Wk 48 in each study (104 and 111)

Results similar across all baseline virologic and demographic subgroups

7 pts in TAF arm and 5 pts in TDF arm with NRTI resistance at VF

– 1 in TAF arm and 2 in TDF arm with combined M184V/I + K65R

5 pts in TAF arm and 3 pts in TDF arm with INSTI resistance at VF

0.9% in TAF arm and 1.5% in TDF arm discontinued due to AE

CD4+ increases greater in TAF arm: 211 vs 181 (P = .024)

Pts

(%

)

9290

Δ +2.0%(95% CI: -0.7% to +4.7)

TAF/FTC/EVG/COBI (n = 866)TDF/FTC/EVG/COBI(n = 867)

0

20

40

60

80

100

4 4 4 6n =

*HIV-1 RNA < 50 c/mL as defined by FDA Snapshot algorithmDiscontinued for AE, death, or missing data.

800 784

Wohl DA, et al. CROI 2015. Abstract 113LB. Reproduced with permission.


Renal Markers With TAF and TDF at Wk 48

Smaller decreases in eGFR with TAF[1]

Smaller changes in proteinuria with TAF[1]

In separate single-arm trial of virologically suppressed pts with eGFR 30-69 mL/min switched to open-label TAF/FTC/EVG/COBI[2]

– 65% on TDF at BL

At Wk 48 after switch:

– 92% maintained virologic suppression

– No change in eGFR

– Reduction in proteinuria and markers of renal tubular function

– Improvement in hip and spine BMD

1. Sax P, et al. CROI 2015. Abstract 143. Reproduced with permission. 2. Pozniak A, et al. CROI 2015. Abstract 795.

P < .0012010

0-10-20

0 12 24 36 48

Time (Wks)

-6.6-11.2

Mea

n Δ

Fro

m B

L i

n e

GF

R,

mL

/min

(C

ock

cro

ft-G

ault

) TAF/FTC/EVG/COBI (n = 866)TDF/FTC/EVG/COBI (n = 867)

Median % Change From BL in Urine Protein:Creatinine Ratio

MarkerTAF

(n = 866)

TDF (n = 867)

P Value

Protein -3 +20 < .001

Albumin -5 +7 < .001

Retinol-binding protein +9 +51 < .001

β2-microglobulin -32 +24 < .001


Studies 104/111: Significantly Smaller Decline in Hip and Spine BMD With TAF Significantly smaller decline in hip and spine BMD with TAF

Higher lipid levels with TAF, but TC:HDL-C ratio same as TDF[1]

0 24 48 0 24 48-8

-6

-4

-2

0

2

Wk Wk

-8

-6

-4

-2

0

2

= 845= 850

797816

784773

836848

789815

780767

-1.30-2.86

-0.66

-2.95

P < .001 P < .001

Mea

n %

Ch

ang

e F

rom

BL

Sax P, et al. CROI 2015. Abstract 143. Reproduced with permission.

n n

TAF/FTC/EVG/COBI (n = 866)TDF/FTC/EVG/COBI (n = 867)

Change in Spine BMD Change in Hip BMD


LATTE: Cabotegravir (GSK1265744) + RPV as Maintenance ART: Wk 96 Results Cabotegravir, DTG analogue with long half-life, oral or injectable formulations

Randomized, dose-ranging phase IIb study of oral formulation

Primary endpoint: HIV-1 RNA < 50 c/mL at Wk 48

CAB 10 mg QD + RPV 25 mg QD

CAB 30 mg QD + RPV 25 mg QD

*Pts with HIV-1 RNA < 50 c/mL at Wk 24 continued to maintenance phase.TDF/FTC or ABC/3TC.

ART-naive pts,HIV-1 RNA ≥ 1000 c/mL

(N = 243) CAB 60 mg QD + RPV 25 mg QD

EFV 600 mg QD + 2 NRTIs QD (n = 62)

Margolis D, et al. CROI 2015. Abstract 554LB.

CAB 10 mg QD + 2 NRTIs

(n = 60)


(n = 60)


(n = 61)

Wk 48primary analysis

Stratified by HIV-1 RNA (≤ vs > 100,000 c/mL) and NRTI Wk 24

Induction Phase* Maintenance Phase

Wk 96


LATTE: Virologic Success Through Maintenance Wk 96

6 pts in CAB arms with PDVF at Wk 96; 4 additional pts since Wk 48

– 3 pts in CAB 10-mg arm with treatment-emergent NNRTI resistance; 1 of these with both NNRTI + INSTI RAMs but decreased ARV exposure in PK analysis

Margolis D, et al. CROI 2015. Abstract 554LB. Reproduced with permission.

HIV

-1 R

NA

< 5

0 c/

mL

by

Sn

apsh

ot

Alg

ori

thm

(%

)

100

80

60

40

20

0BL 4 12 24 28 36 48 72 96

Induction Phase Maintenance Phase

CAB 10 mg (n = 60)CAB 30 mg (n = 60)*CAB 60 mg (n = 61)EFV 600 mg (n = 62)

68%63%

84%

75%

Wks*CAB 30 mg selected for future development


BMS-955176: Investigational Second-Generation Maturation Inhibitor BMS-955176 binds tightly and

reversibly to HIV-1 Gag with greater potency and coverage of Gag polymorphs than first-generation maturation inhibitors

– Low-dose with half-life supportive of once-daily dosing

– Low serum binding

– No significant safety issues in early clinical studies

Antiviral activity measured over 10 days in placebo-controlled study

– HIV-infected treatment-naive and experienced pts with HIV-1 RNA ≥ 5000 and CD4+ count ≥ 200

All doses ≥ 10 mg associated with HIV-1 RNA declines over dosing period

– Median change in HIV-1 RNA from BL to Day 11: 1.4 log10 c/mL

No serious AEs; no discontinuations due to AEs over study period

Hwang C, et al. CROI 2015. Abstract 114LB. Reproduced with permission.

1 2 3 4 5 6 7 8 91011 13 25

Dosing period

Study Days

1

0

-1

-1.8

BMS-955176: Median Δ in HIV-1 RNA Over Time

Placebo5 mg10 mg20 mg40 mg80 mg120 mg

Me

dia

n Δ

in

HIV

-1 R

NA

F

rom

B

L (

log

10 c

/mL

)

Comorbidity


NA-ACCORD: Recent Abacavir Use and Risk of MI Retrospective analysis of pts in 7

clinical cohorts with recent ABC use from 1/1/1995 to 12/31/2010

“Recent” ABC initiation: prescribed within previous 6 mos

ABC initiators (n = 1948) vs non-ABC initiators (n = 14,785):

– “Full” study population: all ART users excluding persons on ABC at study entry

– “Restricted” population: ART-naive persons who initiated ART in the cohort

Endpoint of incident MIs: presence of clinical diagnosis or elevation of cardiac enzymes

– All MIs independently adjudicatedPalella F, et al. CROI 2015. Abstract 749LB. Reproduced with permission.

0.00 2.001.00 4.003.00

Full Study

Restricted Study

D:A:DReplication

1.95

1.33

Recent ABC use significant in restricted population and D:A:D replication

Association diminished after adjusting for additional CVD risk factors in multivariate analysis

Significant factors

– Both: age 60+ yrs, HTN, eGFR < 30, AIDS

– Full: smoking, DM

Adjusted HRs for MI in Those With Recent ABC Use


A5260: Changes in Limb and Trunk Fat With INSTI vs PI/RTV First-line Regimens Metabolic substudy of A5257,

comparison of first-line TDF/FTC +

– RAL (n = 106)

– ATV/RTV (n = 109)

– DRV/RTV (n = 113)

Endpoints: change from BL to Wk 96 in peripheral fat, central adiposity, lean mass

– ATV/RTV vs DRV/RTV

– Combined PIs vs RAL

Trend toward greater % change in lean mass in ATV/RTV vs DRV/RTV

– Combined PIs similar to RAL

Similar changes in limb and trunk fat (SAT and VAT) among regimens

Greater gains in VAT and SAT in BL VL stratum HIV-1 RNA ≥ 100,000 c/mL vs < 100,000 c/mL, regardless of regimen

McComsey G, et al. CROI 2015. Abstract 140. Reproduced with permission.

ATV/RTV 31%RAL 33%DRV/RTV 29%

NATV/RTV 108 97RAL 105 95DRV/RTV 112 94

Wk 96BL

504030

2010

0

VAT Change

Mea

n %

Ch

an

ge

Fro

m

Bas

elin

e ATV/RTV vs DRV/RTV (P = .54)PI/RTV vs RAL (P = .72)


Randomized Trial of Statin Therapy and Coronary Plaque Progression Randomized 12-mo trial in HIV+ pts

on stable ART with LDL-C < 130 and ≥ 1 coronary plaque

– Atorvastatin 20 mg ( to 40 mg at 3 mos) (n = 19) vs

– Placebo (n = 21)

Statin therapy reduced progression of coronary plaques

– Reduced overall plaque volume, including lipid-laden plaques

– Reduced high-risk morphology plaques

Statin therapy safe and well tolerated

Lo J, et al. CROI 2015. Abstract 136. Reproduced with permission.

Plaque Progression in Proximal Left Anterior Descending Coronary

Artery With Atorvastatin or Placebo

BL

12 mos

PlaceboAtorvastatin


D:A:D: ARV Exposure and Risk of CKD

Retrospective analysis of pts with BL eGFR > 90/mL/min (N = 23,560)

– Evaluated cumulative exposure to TDF, ABC, ATV/RTV, LPV/RTV, other PIs and risk of CKD

– 210 pts developed CKD

Multivariate analysis: exposure to TDF, ATV/RTV, and LPV/RTV significantly associated with CKD development

– Risk greatly over 5 yrs

Association with TDF or LPV/RTV and CKD remains when excluding those who stopped drugs during or before study entry

When TDF exposure censored, CKD risk per yr of ATV/RTV or LPV/RTV exposure increased substantially

CKD risk with time after stopping TDF

CKD Risk by Yrs of ARV Exposure, IRR (95% CI)

Drug 1 Yr 2 Yrs 5 Yrs

TDF1.12 (1.06-1.18)

1.25 (1.12-1.39)

1.74 (1.33-2.27)

ATV/RTV

1.27 (1.18-1.36)

1.61 (1.40-1.84)

3.27(2.32-4.61)

LPV/RTV

1.16 (1.10-1.22)

1.35 (1.21-1.50)

2.11(1.62-2.75)Mocroft A, et al. CROI 2015. Abstract 142. Reproduced with permission.

Relationship Between Increasing Exposure to ARVS and CKD

1.80

1.60

1.40

1.20

1.00

0.00ATV/RTV LPV/RTV TDF

Univariate

Multivariate

On treatment

TDF censored

HCV Coinfection


ION-4: LDV/SOF for 12 Wks in GT1/4 HCV/HIV-Coinfected Pts Phase III open-label study in HIV

virologically suppressed HIV/HCV coinfected pts (N = 335)

– 20% with compensated cirrhosis

– n = 8 with HCV GT4

ART regimens

– TDF/FTC/EFV (n = 160)

– TDF/FTC + RAL (n = 146)

– TDF/FTC/RPV (n = 29)

HCV treatment experienced, 55%

– Previous HCV PI therapy: 29%

– n = 13 previously failed SOF + RBV

Very high rate of SVR12

– No difference in SVR rates based on HCV treatment experience or cirrhosis status

SV

R12

(%

)

96

0

20

40

60

80

95 97 96 94

Overall No Yes

n/N =321/335

142/150

100

179/185

258/268

63/67

No Yes

Naggie S, et al. CROI 2015. Abstract 152LB. Reproduced with permission.

SVR Rates According to BL Characteristics

CirrhosisPrevious HCV Tx


ION-4: LDV/SOF Effective Across All Pt Demographic and Disease Subgroups

10 relapses all in black pts

No pt with HIV virologic rebound

No discontinuation of therapy due to adverse events

4 pts experienced increase in creatinine > 0.4 mg/dL

– 2 completed treatment without change in ART

– 1 pt changed TDF to new NRTI

– TDF dose reduced in 1 pt

Naggie S, et al. CROI 2015. Abstract 152LB. Reproduced with permission.

BlackNonblack

1a1b4

< 800,000≥ 800,000

< 30≥ 30

CCCTTT

TDF/FTC/EFVTDF/FTC + RALTDF/FTC/RPV

< 350≥ 350

HCV Genotype

Baseline HCV RNA (IU/mL)

Baseline BMI (kg/m2)

Race

IL28B

ARV Regimen

Baseline CD4 (cells/mm³)

Overall

60 70 80 90 100

SVR12, % (95% CI)

Statistically significant in multivariate analysis


ION-4: Resistance Analysis and LDV/SOF Drug–Drug Interactions With bPIs Deep sequencing at BL

identified 67 (20%) pts with NS5A RAVs[1]

– 63 (94%) of these pts achieved SVR12

RAVs in NS5A found in 10/12 pts with virologic failure

No S282T mutation in NS5B found in any pt at BL or virologic failure

In drug–drug interaction studies with LDV/SOF and boosted PIs and TFV[2]

– LDV/SOF increases ATV, RTV, and TFV exposure

– ATV/RTV + TDF/FTC increases LDV

– DRV/RTV + TDF/FTC decreases SOF

Staggered administration did not mitigate interactions but interactions not deemed clinically relevant

1. Naggie S, et al. CROI 2015. Abstract 152LB. 2. German P, et al. CROI 2015. Abstract 82.


ALLY-2: SOF + DCV in GT1-6 HCV/HIV-Coinfected Pts Phase III open-label study

– Non GT1 < 20% in each cohort; compensated cirrhosis < 50% overall; HIV-1 RNA < 50 c/mL and CD4+ ≥ 100 in pts on ART; CD4 ≥ 350 in pts not on ART

– ART allowed: PI/RTV, NRTIs, NNRTIs, INSTIs, MVC, ENF

Primary endpoint: SVR12 in GT1 naive pts treated for 12 wks

Wyles DL, et al. CROI 2015. Abstract 151LB.

Treatment-naive pts(N = 151)

SOF 400 mg QD + DCV 30/60/90* mg QD

(n = 101)


(n = 52)

Treatment-experienced pts(N = 52)

Wk 12

Pts followed to Wk 36


(n = 50)

Wk 8

*Standard dose of 60 mg adjusted for ART: 30 mg with RTV; 90 mg with NNRTIs except RPV.


High SVR12 rates with 12 wks SOF + DCV

– Large decline in SVR rate with shortening to 8 wks

12-Wk 12-Wk8-Wk 12-Wk 12-Wk8-Wk

ALLY-2: Virologic Outcomes With SOF + DCV in HIV/HCV-Coinfected Pts

In 12-wk groups analyzed by GT, 100% with SVR12 except GT1a

– GT1a naive: 96%; exp’d: 97%

Similar SVR12 rates in pts with or without baseline NS5A RAVs

12 pts with relapse, 10 in 8-wk arm

– 1 in 8-wk arm had emergent NS5A RAVs

No NS5B RAVs at BL or time of failure

No discontinuation of therapy due to AEs

10 pts with HIV-1 RNA > 50 at EOT

– 8 with repeat testing; 7 with suppression without change in ART; 1 with HIV-1 RNA of 59; 2 LTFU

2 with HIV VF = HIV-1 RNA ≥ 400 c/mL

SV

R12

, %

96

0

20

40

60

80

98

76

97 98

n/N =80/83

43/44

100

31/41

98/101

51/52

76

38/50

Wyles DL, et al. CROI 2015. Abstract 151LB. Reproduced with permission.

Naive Exp’d Naive Exp’d

GT1 Overall

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Clinical Impact of Data From the CROI 2015,Seattle

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