Anrs c05 hiv 2 cohort clinical case management
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ANRS C05 HIV-2 Cohort Clinical case management . S Matheron Hopital Bichat – Claude Bernard Université Denis Diderot Paris 7. Open, multi-centric national cohort - since 1994- 121 investigating centers - 847 patients included (June, 2011) - + 155 since 2007. Year of HIV-2 diagnosis.

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ANRS C05 HIV-2 Cohort Clinical case management

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Anrs c05 hiv 2 cohort clinical case management

ANRS C05 HIV-2 CohortClinical case management

S Matheron

Hopital Bichat – Claude Bernard

Université Denis Diderot Paris 7


Anrs c05 hiv 2 cohort clinical case management

Open, multi-centric national cohort - since 1994- 121 investigating centers

- 847 patients included (June, 2011)

- + 155 since 2007

Year of HIV-2 diagnosis

ANRS HIV-2 cohort

  • Inclusion criteria

  • HIV-2 Infection only

  • ≥ 18 years old,

  • > 1 year in France

  • 60% women

  • 50% > 40 years

  • 75% fromsubsaharanAfrica

  • (WA)

  • 24% previouslygivencART

  • Clinical, epidemiological, biological and therapeutic follow-up

    • / 6 months*

  • Virological follow-up

    • untreated patients

      • / 6 months *

      • / 3 months if plasma VL>100copies/ml

    • treated patients

      • M1, / 3 months

  • * + in case of intermediate event

IAS 2011, ANRS satellite, HIV-2, 19th July


Anrs co5 patients characteristics

ANRS CO5: Patients’ characteristics

C

(Tuberculosis 44 %)

B

A

  • At inclusion

  • CDC stage (n=719)

    • A

  • B

  • C

N

600

31

88

87

345

132

264

(%)

83.3%

4.4%

12.3%

37%

47%

18%

35%

516

302

138

CD4 counts (median)

18%

30%

51%

27%

26%

95%

70%

IAS 2011, ANRS satellite, HIV-2, 19th July


Anrs co5 patients characteristics1

ANRS CO5: Patients’ characteristics

  • At inclusion

  • CDC stage (n=719)

    • A

  • B

  • C

  • Plasma RNA >100 copies/ml (n=235)

  • CD4+ T lymphocytes

  • >500/mm3

  • [300-500]/mm3

  • <300/mm3

  • Follow-up (n=702)

  • Lost of follow-up

  • cART initiation (n=488)

  • Survival at 5 years

  • Non progression to AIDS at 5 years

N

600

31

88

87

345

132

264

(%)

83.3%

4.4%

12.3%

37%

47%

18%

35%

516

302

138

CD4 counts (median)

Median : 2.8 log

18%

30%

51%

Detectable plasma RNA

27%

26%

95%

70%

IAS 2011, ANRS satellite, HIV-2, 19th July


Anrs co5 patients characteristics2

ANRS CO5: Patients’ characteristics

  • At inclusion

  • CDC stage (n=719)

    • A

  • B

  • C

  • Plasma RNA >100 copies/ml (n=235)

  • CD4+ T lymphocytes

  • >500/mm3

  • [300-500]/mm3

  • <300/mm3

  • Follow-up (n=702)

  • Lost of follow-up

  • cART initiation (n=488)

  • Survival at 5 years

  • Non progression to AIDS at 5 years

N

600

31

88

87

345

132

264

(%)

84%

4%

12%

38%

47%

18%

35%

516

302

138

CD4 counts (median)

Median : 2.8 log

18%

30%

51%

Detectable plasma RNA

27%

26%

95%

90%


Anrs co5 patients characteristics3

ANRS CO5: Patients’ characteristics

  • At inclusion

  • CDC stage (n=719)

    • A

  • B

  • C

  • Plasma RNA >100 copies/ml (n=235)

  • CD4+ T lymphocytes

  • >500/mm3

  • [300-500]/mm3

  • <300/mm3

  • Follow-up (n=702)

  • Lost of follow-up

  • cART initiation (n=488)

  • Survival at 5 years

  • Non progression to AIDS at 5 years

N

600

31

88

87

345

132

264

(%)

84%

4%

12%

38%

47%

18%

35%

516

302

138

CD4 counts (median)

Median : 2.8 log

18%

30%

51%

Detectable plasma RNA

27%

26%

95%

90%

  • Natural history

  • Response to cART


Drylewicz j et al aids 2008

Comparison of viro-immunological marker changes between HIV-1 and HIV-2-infected patients

(n= 6707/ 592)

Drylewicz J et al, AIDS, 2008

_9 cells/ml PY

_0.04%/year

HIV-2

HIV-1

_49 cells/ml PY

_1.01%/year

IAS 2011, ANRS satellite, HIV-2, 19th July


Drylewicz j et al aids 20081

Comparison of viro-immunological marker changes between HIV-1 and HIV-2-infected patients

Drylewicz J et al, AIDS, 2008

HIV-2

_11 cells/ml PY

_49 cells/ml PY

HIV-1

IAS 2011, ANRS satellite, HIV-2, 19th July


Anrs c05 hiv 2 cohort clinical case management

ANRS CO5 HIV-2

HIV-2 patients with at least one follow-up available since 2009 with known date of HIV diagnosis

n=357

HIV-2 infection ≥ 8 years

n=221

Non progressor

and

HIV controllers patients

At least 3 plasma viral loads and CD4 in the last five years

n=176

Asymptomatic patients

n=119

Antiretroviral naïve patients

n=60

CD4 nadir ≥ 500 cells/µl

n=36 « LTNP* »

HIV infection ≥ 10 years

n=44

6%

CD4 nadir ≥ 600 cells/µl

n=26 « LTNP** »

90% of pVL ≤ 500 copies/ml

n=40 « HIV controlers » 9%

CD4 slope ≥ 0 over the last 5 years

n=8 « Elite-LTNP » 1,5%

Among which 5 HIV controlers

and 5 Elite controlers

Last pVL ≤ 100 copies/ml

n=37 « Elite-controlers » 8;8%

Among which 23 LTNP

and 5 Elite LTNP


Treatment

Treatment

  • Clinical case management in the setting of cohortstudy

    • features and specificities of HIV-2 infection

      • Fewer patients

      • Slower infection

        • Fewer clinical events

        • Slower CD4 decrease

      • Lower viral replication

      • Viral load quantification

        • Threshold 100 cp/ml

      • Fewer potent drugs

      • Resistance pathway

  • data throughretrospectivestudies

    • currentlyhigherevidence-basedlevel of knowledge on treatment

  •  Viral load can’t be used as primary endpoint

  •  Limited options for second and further lines


Anrs co5 response to cart

ANRS CO5: Response to cART

  • lopinavir/r - containingcART(29 naïve patients, 2002-2007)

    • Responseat W24 : + ≥ 50 CD4 at M6, and VL < 100 cp/ml

      = 59%

    • Median CD4 gain

      • W24+71(28)

      • W48+122(19)

      • W96+132(13)

  • Estimated CD4 slope

    • W0-W12 : +23 CD4/mm3/mth

    • W13-W96: +8 CD4/mm3/mth

  • A Benard , AIDS, 2008

IAS 2011, ANRS satellite, HIV-2, 19th July


Drylewicz aids 2008

Comparison of viro-immunological marker changes between HIV-1 and HIV-2-infected patients

Drylewicz, AIDS, 2008

+ 46/y

+59/mth

match according to VL at D0

(>3.5 versus 3.5 log10 cp/ml)

+24/mth

- 2,88/y

- 1.56 log/m

- 0,62 log/m

IAS 2011, ANRS satellite, HIV-2, 19th July


Anrs c05 hiv 2 cohort clinical case management

ACHIeV2e : 3 INTI vs 2 INTI+PI/r as 1st line

M4-M12

+76/mm3/year

- 60/mm3/year

p=0.002

M0-M3

+12/mm3/month

+ 6/mm3/month

p=0.24

N=44

N=126

Estimated CD4 cell count changes (n=158)

Bénard, CID, 2011

IAS 2011, ANRS satellite, HIV-2, 19th July


Achiev2e 3 inti vs 2 inti pi r as 1 st line

ACHIeV2e : 3 INTI vs 2 INTI+PI/r as 1st line

M0-M3

-0.2 log10 cp/month

-0.4 log10 cp/month

p=0.02

M4-M12

+1.2 log10 cp/ml/year

-0.12 log10 cp/ml/year

p=0.19

Estimated HIV-2 RNA changes in patients with detectable values at treatment initiation (n=67)

Bénard, CID, 2011

IAS 2011, ANRS satellite, HIV-2, 19th July


Anrs co5 raltegravir including cart

ANRS CO5 raltegravirincludingcART

  • Case reports

    • Experienced patients (several cART failures)


Anrs c05 hiv 2 cohort clinical case management

Clinical case management

Recommendations

  • First line

    • 2 INTI + PI/r : LPV, or DRV/r or SQV/r

  • 2nd line ?

    • Samestrategy as for HIV-1

      • Tolerance, observance, PK, and genotype

    • Integraseinhibitors

    • Anti CCR5


Anrs c05 hiv 2 cohort clinical case management

Clinical case management

Questions :

  • Start earlier ?

  • Start stronger ?

    • impact on tolerance, observance ?

    • which options for 2nd line ?

  • Clinicalresearch

    • Evaluation of new treatmentstrategies

  • International network

    • Randomized trial


Hiv 2 cohort

Laboratories

Belgium: Patrick GOUBAU *, Jean RUELLE

Canada: Marc WAINBERG

France: BrigitteAUTRAN

Françoise BRUN-VEZINET *

Florence DAMOND*, Diane DESCAMPS *

François SIMON *

Gambia: AkumAVEIKA, MatthewCOTTEN

Sarah ROWLAND-JONES

Germany: BerndKUPFER

Italy: ClaudiaBALOTTA *

CarloTORTI

Netherlands: Martin SCHUTTEN

Portugal: Vitor DUQUE, Joao VAZ

RicardoCAMACHO *, Perpetua GOMES *

Sweden: JanALBERT

USA: GeoffreyGOTTLIEB

UK: Deenan PILLAY, Bridget FERNS, Jeremy GARSON

HIV-2 cohort

Clinical centres

Germany: Jürgen ROCKSTROH,

Carolynne SCHWARZE-ZANDER

Netherlands: Frank DE WOLF *,

Ard van SIGHEM *, PeterREISS

Maarten SCHIM VAN DER LOEFF

Portugal: Francisco ANTUNES*

Emilia VALADAS *

Kamal MANSINHO *

Spain: Vicente SORIANO*

Ana TREVINO *

Carlos TORO *

Berta RODES *

Switzerland: Jürg BÖNI *

Martin RICKENBACH *

Alexandra CALMY *

UK: JaneANDERSON

JenniferTOSSWILL

Investigateur coordonnateur

Sophie Matheron SMIT, Bichat-Claude Bernard

Coordination virologique

Francoise Brun-Vézinet ,

Laboratoire de Virologie, Bichat-Claude Bernard

Florence Damond

Coordination immunologique

Brigitte Autran,

Laboratoire d’immunologie cellulaire, Pitié-Salpétrière

Coordination méthodologique

Genevieve Chêne ,

NSERM U593, Bordeaux

Antoine Bénard

  • Monitorage

    • Dien Le, SMIT, Bichatt

  • Statistique et informatique

    • Audrey Taïeb, INSERM U593


Anrs co5 hiv 2 cohort

ANRS CO5 HIV-2 cohort

  • Acknowledgments

  • Patients

  • Investigators

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