VIH. novedades terapéuticas

X

Avances del tratamiento antirretroviralAvances del tratamiento antirretroviral


Antirretrovirales disponibles en la actualidad

Nucleoside RTIs• Zidovudine (ZDV)• Didanosine (ddI)• Zalcitabine (ddC)• Stavudine (d4T)• Lamivudine (3TC)• Abacavir (ABC)• Emtricitabine (FTC)• Tenofovir DF (TDF)

Nonnucleos(t)ide RTIs• Nevirapine (NVP)• Rilpivirina (RPV)• Efavirenz (EFV)• Etravirine (ETR)

Protease Inhibitors• Saquinavir (SQV)• Ritonavir (RTV)• Indinavir (IDV)• Nelfinavir (NFV)• Amprenavir (APV)• Lopinavir/r (LPV/r)• Atazanavir (ATV)• Fosamprenavir (Fos-APV)• Tipranavir (TPV)• Darunavir (DRV)Boosters

• Ritonavir (RTV)Fusion Inhibitor• Enfuvirtide (T-20)

CCR5 Antagonist• Maraviroc (MVC)

Integrase Inhibitors• Raltegravir (RAL)• Elvitegravir

Antirretrovirales acutales y futuros

Nucleoside RTIs• Zidovudine (ZDV)• Didanosine (ddI)• Zalcitabine (ddC)• Stavudine (d4T)• Lamivudine (3TC)• Abacavir (ABC)• Emtricitabine (FTC)• Tenofovir DF (TDF)• Tenofovir AF (TAF)

Nonnucleos(t)ide RTIs• Nevirapine (NVP)• Rilpivirina (RPV)• Efavirenz (EFV)• Etravirine (ETR)• Doravirine (DRV)

Protease Inhibitors• Saquinavir (SQV)• Ritonavir (RTV)• Indinavir (IDV)• Nelfinavir (NFV)• Amprenavir (APV)• Lopinavir/r (LPV/r)• Atazanavir (ATV)• Fosamprenavir (Fos-APV)• Tipranavir (TPV)• Darunavir (DRV)Boosters

• Ritonavir (RTV)• Cobicistat* (cobi) Fusion Inhibitor

• Enfuvirtide (T-20)

CCR5 Antagonist• Maraviroc (MVC)

Integrase Inhibitors• Raltegravir (RAL)• Elvitegravir•Dolutegravir*

MK-1439 (Doravirine): A New NNRTI

� <3-fold potency shift vs. common NNRTI-resistance mutants K103N, Y181C, G190A, E138K(4)

� Low potential for CNS effects, drug-drug interactions; lower protein-binding vs. other NNRTIs

Morales-Ramirez J, et al. 21st CROI; Boston, MA; March 3-6, 2014. Abst. 92LB.

EfavirenzEfavirenz

MK-1439 200 mgMK-1439 200 mg

EfavirenzEfavirenz

96 Week End of Study Treatment

for Part 1

96 Week End of Study Treatment

for Part 1

MK-1439 Selected Dose

MK-1439 Selected Dose

PART 1 Dose-Ranging ~200 patients (~40/group)

PART 1 Dose-Ranging ~200 patients (~40/group)

MK-1439 50 mgMK-1439 50 mg

MK-1439 100 mgMK-1439 100 mg

MK-1439 25 mgMK-1439 25 mg

24 Week Primary Time Point for Dose Selection

24 Week Primary Time Point for Dose Selection

Dose-Ranging Trial in Treatment-naïve Patients

Virologic Response by Screening RNAAd hoc analysis (Week 24), Observed Failure

≤100,000 c/mL >100,000 c/mL

27 12 13 1211

Copyright © 2014 Merck & Co. Inc. All Rights Reserved.

All MK = 86% All MK = 92% All MK = 66% All MK = 94%

Virologic Response by Screening RNAAd hoc analysis (Week 24), Observed Failure

≤100,000 c/mL >100,000 c/mL

27 12 13 1211

Copyright © 2014 Merck & Co. Inc. All Rights Reserved.

All MK = 86% All MK = 92% All MK = 66% All MK = 94%

La coformulación de Darunavir pronto seráposible


� HIV-1 integrase inhibitor, dolutegravir analogue

� Oral drug (t½ = 40 hours)

� Long-acting SC or IM injection (apparent t½ ≈ 40 days)

� Good virologic response at 5 and 30 mg/day as oral 10-day monotherapy

GSK1265744 (744)

Margolis et al. CROI 2014; Boston, MA. Abstract 91LB.

Spreen et al. HIV Clin Trials. 2013;14:192-203.

� Phase IIb, randomized, multicenter, partially blind , dose-ranging study

� 744 + NRTI subjects with a W20 HIV-1 RNA <50 c/mL s implified to 744 + RPV at W24

� Primary endpoint: % HIV-1 RNA <50 c/mL at 48 weeks (FDA “Snapshot”) – Intent-to-treat exposed (ITT-E) – received at least one dose of Investigational Product (IP)

– Intent-to-treat maintenance exposed (ITT-ME) – recei ved at least one maintenance dose

LATTE Study Design

*ABC/3TC or TDF/FTC

HIV ART-naive

HIV-1 RNA ≥≥≥≥1000 c/mL

CD4 ≥≥≥≥200 cells/mm3

1:1:1:1 Randomization

Stratified by VL

and NRTI

744 30 mg + 2 NRTIs

744 10 mg + 2 NRTIs*

Oral Induction Phase

744 60 mg + 2 NRTIs

EFV 600 mg + 2 NRTIs

Oral Maintenance Phase

744 10 mg + RPV 25 mg

744 30 mg + RPV 25 mg

744 60 mg + RPV 25 mg

Week

Primary Endpoint Virologic Success: HIV-1 RNA <50 c/mL by FDA Snapsh ot (ITT-E)

Week

744 overall response W4882%

EFV response W4871%

744 overall response W2487%

EFV response W2474%

Median (IQR) change from baseline CD4+ cell count

(cells/mm 3)Week 48

744 overall +219 (141,343)

EFV +227 (134,369)

Pro

po

rtio

n, %

242 4 8 12 16 4032 483626 28BL

Induction Phase Maintenance Phase

Margolis et al. CROI 2014; Boston, MA. Abstract 91LB.


Choice of Initial Regimen

Tenofovir/emtricitabine (TDF/FTC) ORAbacavir/lamivudine (ABC/3TC)

WITH

Third agent (NNRTI, boosted PI, or InSTI):

• Efavirenz OR

• Atazanavir/r OR

• Darunavir/r OR

• RaltegravirThompson et al, JAMA, 2012.

A5257 Study Design*

RAL 400 mg BID + RAL 400 mg BID +

FTC/TDFFTC/TDF 200/300200/300 mgmg QDQDDRV 800DRV 800 mgmg QDQD ++ RTV 100RTV 100 mgmg QD QD

+ FTC/TDF 200/300 mg QD+ FTC/TDF 200/300 mg QDATV 300ATV 300 mg QD + RTV 100mgmg QD + RTV 100mg QDQD

+ FTC/TDF 200/300 mg QD+ FTC/TDF 200/300 mg QD

Study Conclusion 96 weeks after final participant enrolled

Follow-up continued for 96 weeks after randomization of last subject (range 2-4 years) regardless of status on randomized ART

HIV-infected patients, ≥18 yr, with no previous ART, VL ≥ 1000 c/mL at US Sites

Randomized 1:1:1 to Open Label TherapyStratified by screening HIV-1 RNA level (≥ vs < 100,000 c/mL), A5260s

metabolic substudy participation, cardiovascular risk

*With the exception of RTV, all ART drugs were provided by the study

600 PACIENTES POR RAMA

Virologic Failure

Arms Difference 97.5% CI Favors

ATV/r vs. RAL 3.4% -0.7%, 7.4% Equivalent

DRV/r vs. RAL 5.6% 1.3%, 9.9% Equivalent

ATV/r vs. DRV/r -2.2% -6.7%, 2.3% Equivalent

ACTG 5257: Failure Comparisons at 96 Weeks

Virologic Failure





Tolerability Failure


ATV/r vs. RAL 13% 9.4%, 16% RAL Superior

DRV/r vs. RAL 3.6% 1.4%, 5.8% RAL Superior

ATV/r vs. DRV/r 9.2% 5.5%, 13% DRV/r Superior


Virologic Failure





Tolerability Failure


ATV/r vs. RAL 13% 9.4%, 16% RAL Superior

DRV/r vs. RAL 3.6% 1.4%, 5.8% RAL Superior


Cumulative Failure


ATV/r vs. RAL 15% 10%, 20% RAL Superior

DRV/r vs. RAL 7.5% 3.2%, 12% RAL Superior




Elvitegravir/c: Eficacia y seguridad en los estudios 102 y 103

en semana 96

• Subgrupo de CD4 < 50 (n=30).

• 11/19 EVGc con éxito virológico. 8 fueron fracasos (todos con CV > 100 K c/mL, 4 con adherencia subóptima.

• 5/6 EFV con éxito virológico; 1 fracaso (CV > 100 K c/mL, con adherencia subóptima).

• 5/5 ATV/r + TDF/FTC con éxito virológico.

Zolopa A. et al. 20th CROI. Atlanta, 3 – 6 Marzo 2013. #553

78 84 86

80 80 82 85 81 82

0

20

40

60

80

100

>50 a ≤200 >200 a ≤350 >350

TDF/FTC/EVG/c (n=701) EFV/TDF/FTC (n=352) ATV/r + FTC/TDF (n=355)

CD4 (cels/mm 3)

Éxi

to v

iroló

gico

en

sem

ana

96 (

%)

Dolutegravir (estudio SPRING-2). Análisis de eficacia a 48 semanas

• DTG es no-inferior a RAL con un margen del 10%: Diferencia: 2,5%; IC95% (-2,2% a 7,1%).• No-inferioridad demostrada con > 100.000 c/mL 7,5 (-3,1 a 18).• No-inferioridad demostrada con TDF/FTC: 4,6 (-1,3 a 10,6) y con ABC/3TC -0,8 (-8,2 a 6,6).• Similar recuperación de CD4 entre DTG y RAL (+230 CD4 a las 48 semanas).• Fallo virológico a 48 semanas: DTG 20 (5%; 1 con CV>400); RAL: 28 (7%; 5 con CV>400). • Resistencias: con DTG: 0 a integrasa, 0 a nucleósidos; RAL: 1 a integrasa, 4 a nucleósidos.• Efectos adversos grado 2-4: 6% DTG vs 7% RAL. Abandonos por EA: 2% DTG, vs 2% RAL.• Incremento de creatinina (grado 1/2): 2%/0,6% para DTG vs 2%/0% para RAL.

Raffi F, et al. IAS 2012. Washington DC. 19 - 27 Julio. #THLBB04

100

90

80

70

60

50

40

30

20

10

0

BL Sem 4 Sem 8 Sem 12 Sem 16 Sem 24 Sem 32 Sem 40 Sem 48

Semana

Pro

porc

ión

<50

c/m

L (%

)

DTG 50 mg QD

RAL 400 mg BID

DTG 88%

RAL 85%

DTG

50 mg QD

DRV/r

800 mg/

100 mg QD

Globala n=484 90% 83%

HIV-1 RNA

basalb

≤100.000 c/mL

>100.000 c/mL

n=362

n=122

88%

93%

87%

70%

Nucleósidosb

ABC/3TC

TDF/FTC

n=159

n=325

90%

90%

85%

81%

Estudio FLAMINGO: DTG vs DRV/r en pacientes naïve

Feinberg J. et al. ICAAC. Denver, 10-13 Septiembre 2013. #1464a

Proporción (IC 95%) de individuos con RNA VIH-1 <50 c/mL en el tiempo-snapshot

Snapshot por estrato de randomizaciónen la semana 48

*Diferencia ajustada (DTG-DRV/r) basada en un análisis estratificado CMH ajustando por HIV RNA basal y los nucleósidos acompañantes. Resultados confirmados en el análisis por protocolo : 91% DTG vs. 84% DRV/r, ∆∆∆∆ (IC): 7,4 (1,4 – 13,3).

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Pro

porc

ión

(%)

BL 4 8 12 16 24Semanas

36 48

DTG 50 mg QD

DRV/r 800 mg/100 mg QD

DRV/r: 83%

DTG: 90%

95% IC para la diferencia *

A favor DRV/r

A favorDTG

0 20%-12%-20%

Test de superioriad: P=0,025

0,9 7,113,2

Se demostró superioridad global

aDiferencia ajustada (DTG-DRV/r) basada en un análisis estratificado Cochran-Mantel-Haenszel ajustando por HIV RNA basal y los nucleósidos acompañantes. .bLas diferencias no ajustadas apoyan la no-inferioridad de DTG vs DRV/r en los estratos de HIV-1 RNA basal y de nucleósidos acompañantes.

A favor DRV/r

A favor DTG

60

Diferencia en la proporción (DGT – DRV/r)

50403020100-10-20-30-40

SINGLE Study. Virologic Suppression (HIV-1 RNA <50

c/mL; FDA Snapshot)

Walmsley et al. CROI 2014; Boston, MA. Poster 543.

24 32 40 48 60 8472 96161284

Week 96 adjusted difference in response (95% CI): +8.0% (+2.3% to +13.8%); P=0.006

DTG: 80%

EFV: 72%

Resistance Mutations in Individuals Who Met PDVF

Criteria

Walmsley et al. CROI 2014; Boston, MA. Poster 543.

TE = treatment emergent

*n=1 with K101E, n=1 with K103N, n=2 with K103K/N, n=1 with G190A and n=1 with

K103N + G190A

**E157Q/P polymorphism detected with no significant change in IN phenotypic

susceptibility

MutationDTG + ABC/3TC QD

(n=414)EFV/TDF/FTC QD

(n=419)

NRTI TE major mutations 0 1 (K65R)

NNRTI TE major mutations 0 6 (K101E, K103N,

G190A)*

INI-r TE major substitution 0** 0


Evolución del tratamiento antirretroviral de inicio

DualNRTIsDual

NRTIs

• IP/r + NRTI• IP/r + NNRTI• IP/r + CCR5 inh• IP/r + II

1987Zidovudine:•First NRTI

1987Zidovudine:•First NRTI

1991–2ddI and ddC approved

1991–2ddI and ddC approved

1994Dual NRTIs better than monotherapy

1994Dual NRTIs better than monotherapy

• NNRTI + 2NRTIs• IP/r + 2NRTIs• II + 2NRTIs • CCR5 i + 2 NRTIs

Triple

combination

therapy

Triple

combination

therapy

Dual

therapy

Dual

therapySequential

monotherapySequential

monotherapy

NEAT 001/ANRS 143 study design

• Phase III, randomised, open-label, multicenter, parallel-group, non-inferiority, strategic trial

• 78 sites, 15 countries (Austria, Belgium, Denmark, France, Germany, Great Britain, Greece, Hungary,

Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden)

DRV+r 800+100 mg QD + TDF/FTC FDC QD

DRV+r 800+100 mg QD + RAL 400 mg BID

Minimum

Week 96• Randomisation 1:1 • stratified by country and participation in virology/immunology substudy

HIV-1 ART-naïve≥≥≥≥ 18 years

HIV-1 RNA > 1000 c/mlCD4 ≤≤≤≤ 500/mm3

HBs Ag negativeNo major IAS-USA resistance mutations

• Composite virological and clinical primary endpoint (6 components)

NEAT 001/ANRS 143

0

0 4 8 12 18 24 32 48 64 80 96

401404

385389

377385

382387

376388

356374

RAL + DRV/r

TDF/FTC + DRV/r

20

40

60

80

100

Weeks

Percentage of participants with available data

89 %

91 % 93 %

89 %

HIV-1 RNA < 50 c/ml

n

Mean (95% CI) Change From Baseline CD4+ Cell Count (cells/mm3)

W48 W96

RAL + DRV/r + 197 (184, 210) + 267 (250, 285)

TDF/FTC + DRV/r + 193 (180, 206) + 266 (249, 283)

NEAT 001/ANRS 143

Creatinine clearance (eGFR, ml/min [Cockroft-Gault formula]Mean (95% CI) change from baseline

No grade 2-4 creatinine elevation in either arm

-15

-10

-5

0

5

0 4 8 12 18 24 3232 48 64 80 96

Weeks

RAL + DRV/r TDF/FTC + DRV/r

- 3.8

+ 0.9

p=0.02

NEAT 001/ANRS 143Renal safety

– Phase III, randomized, international , controlled, open-label study

– Study included adult patients from Argentina, Chile, Mexico, Peru, Spain, US.

GARDEL: DesignGARDEL: Design

Cahn P, et al. EACS, 2013. Brussels, Belgium.

DT:

LPV/r 400/100mg BID

+ 3TC 150 mg BID

(n=217)

TT:LPV/r 400/100mg BID+ 3TC or FTC and a third investigator-selected NRTI in fixed-dose combination(n=209)

ARV- naive patients,

≥18 years

HIV-1 RNA

>1000 copies/ml

No IAS-USA defined NRTI

or PI resistance at

screening*

HB(s)Ag negative

(N = 426)

Stratified by screening

HIV-1 RNA

(≤ or > 100,000 copies/mL)

Wk 48

primary endpoint

*Defined as > 1 major or > 2 minor LPV/r mutations)

LPV major mutations include the following mutations: V32I; I47V/A; L76V; V82A/F/T/S

Wk 24

interim analysis

Estudio Gardel: LPV/r + 3TC

GARDEL: GARDEL: Viral load <50 copies/mL at week 48 (ITTe)Viral load <50 copies/mL at week 48 (ITTe)


(p= 0.171, difference +4.6%

[CI95%:-2.2% to +11.8%])


(p= 0.145, difference +9.3%

[CI95%:-2.8% to +21.5%])

GARDEL: Viral load <50 copies/mL at week 48 (ITTe), baseline VL >

100.000 copies/mL)




Multicenter, randomized, open-label, 96-week study

n =293

n =140• HIV-1 RNA <50 c/mL for ≥≥≥≥6 months• ≤≤≤≤ 2 prior ARV regimens• No resistance to FTC or TDF• eGFRCG ≥≥≥≥70 mL/min

2:1

PI + RTV + FTC/TDF

E/C/F/TDF (Stribild®)PI + RTV + FTC/TDF

Week 96Week 48

Primary endpoint : HIV-1 RNA <50 c/mL at Week 48 by Snapshot (noninferiority margin of 12%). If noninferiority is established, then superiority will be tested.

Secondary endpoint: Safety and tolerability at Week 48 & 96

Other endpoints : Patient reported outcomes*

STRATEGY-PI

*HIV Symptom Index and HIV Treatment Satisfaction questionnairesE/C/F/TDF: single-tablet regimen elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir DF 300mg; Stribild®

PI + RTV + FTC/TDF: ritonavir-boosted protease inhibitor and emtricitabine/tenofovir DFStudy GS-US-236-0115 is registered with ClinicalTrials.gov, number NCT01475838.

STRATEGY - PI

Study Design

ATV, atazanavir, DRV, darunavir; FPV, fosamprenavir; LPV, lopinavir; SQV, saquinavir

STRATEGY - PI

PI and Number of Prior Regimens at Randomization

Reasons subject choose to enroll in study

Desire to simplify current regimen 86%

Concerned about long-term side effects of current regimen 12%

95% CI for Difference

12%

0.4 13.7

FavorsPI + RTV + FTC/TDF

6.7

FavorsE/C/F/TDF

0 -12%

Per

cent

age

of S

ubje

cts

(%)

94%

<1%6%

87%

1%

12%

0

10

20

30

40

50

60

70

80

90

100

Virologic SuccessW48

Virologic FailureW48

No Virologic DataW48

E/C/F/TDF (n=290) PI + RTV + FTC/TDF (n=139)

Prespecified sequential testing Statistical superiority (p = 0.025)

CD4 Cell Count (cells/mm 3) Baseline(mean)

ΔΔΔΔWeek 48(mean)

P-value(ΔΔΔΔ W48 - BL)

E/C/F/TDF 603 +40 <0.001

PI + RTV + FTC/TDF 625 +32 =0.025

STRATEGY - PI

Primary Endpoint: HIV-1 RNA < 50 c/mL

Full analysis set excluded subjects with protocol-prohibited mutations on historical genotype and those not on PI at randomization.

*P <0.04 & **P <0.001 (comparison with baseline within each treatment group). Decreases noted at week 4 & sustained to week 48.P <0.001, diarrhea & P=0.019, bloating (comparison of changes from baseline at week 48 between treatment group).^ HIV Treatment Satisfaction questionnaire, score range: -30 to 30

% o

f Sub

ject

Rep

ortin

g S

ympt

oms

HIV Symptom Index

� Subjects who switched to E/C/F/TDF from PI + RTV + FTC/TDF had� Lower rates of diarrhea and bloating at Week 48 compared to baseline� Higher treatment satisfaction scores at Week 24 (mean: 23 vs. 15, p <0.001)^

STRATEGY – PI

Patient Reported Outcomes

Diarrhea100

132222

68211

63102

5387

84223

41208

32101

3887

34100

Baseline

E/C/F/TDFPI + RTV + FTC/TDF

Week 48

E/C/F/TDF

** *

86264

48118

108283

44134

126284

56133

77260

53116

BL W48 BL W48 BL W48 BL W48

Bloating

PI + RTV + FTC/TDF

Multicenter, randomized, open-label, 96-week study

n =291

n =143• HIV-1 RNA <50 c/mL for ≥≥≥≥6 months• ≤≤≤≤ 2 prior ARV regimens• No resistance to FTC or TDF• eGFRCG ≥≥≥≥70 mL/min

2:1

NNRTI + FTC/TDF

E/C/F/TDF (Stribild®)NNRTI + FTC/TDF

Week 96Week 48

Primary endpoint : HIV-1 RNA <50 c/mL at Week 48 by Snapshot (noninferiority margin of 12%). If noninferiority established, test for superiority

Secondary endpoint: Safety and tolerability at Week 48 & 96

Other endpoints : Patient reported outcomes*

STRATEGY-NNRTI

*Expanded HIV Symptom Index and HIV Treatment Satisfaction questionnairesE/C/F/TDF: single-tablet regimen elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir DF 300mg; Stribild®

NNRTI + FTC/TDF: non-nucleoside reverse transcriptase inhibitor and emtricitabine/tenofovir DFStudy GS-US-236-0121 is registered with ClinicalTrials.gov, number NCT01495702.

STRATEGY - NNRTI

Study Design

EFV, efavirenz; ETR, etravirine; NNRTI, non-nucleoside reverse transcriptase inhibitors; NVP, nevirapine; RPV, rilpivirine

Single-tablet Regimen(n =338; 78%)

Atripla (n =322; 74%)

Complera (n =16; 4%)

STRATEGY - NNRTI

NNRTI and Number of Prior Regimens

95% CI for Difference

12%

-0.5 12.0

FavorsNNRTI + FTC/TDF

5.3

FavorsE/C/F/TDF

0 -12%

Per

cent

age

of S

ubje

cts

(%)

93%

1%6%

88%

<1%

11%

0

10

20

30

40

50

60

70

80

90

100

Virologic SuccessW48

Virologic FailureW48

No Virologic DataW48

E/C/F/TDF (n=290) NNRTI + FTC/TDF (n=143)

CD4 Cell Count (cells/mm 3) Baseline(mean)

ΔΔΔΔWeek 48(mean)

P-value(ΔΔΔΔ W48 - BL)

E/C/F/TDF 586 +56 <0.001

NNRTI + FTC/TDF 593 +58 <0.001

STRATEGY - NNRTI

Primary Endpoint: HIV-1 RNA < 50 c/mL

The full analysis set excluded subjects with prohibited mutations on historical genotype and those not on NNRTI at randomization.

* P <0.01 & **P <0.001 (comparison with baseline within treatment group). Decreases noted at week 4 & sustained through week 48.P <0.001, vivid dreams & P <0.01, dizziness (comparison of changes from baseline at week 48 between treatment group).^ HIV Treatment Satisfaction questionnaire, score range: -30 to 30

% o

f Sub

ject

Rep

ortin

g S

ympt

oms

HIV Symptom Index

� Subjects who switched to E/C/F/TDF from EFV + FTC/TDF had� Lower rates of neuropsychiatric symptoms at Week 48 compared to baseline� Higher treatment satisfaction scores at Week 24 (mean: 21 vs. 14, p <0.001)^

STRATEGY – NNRTI: Efavirenz Subgroup

Patient Reported Outcomes

Vivid Dreams Insomnia Anxiety Dizziness100

136224

75212

65101

5687

119224

84209

48100

4187

103222

71208

40100

3487

90225

49211

3799

3287

BL W48 BL W48 BL W48 BL W48 BL W48 BL W48 BL W48 BL W48

****

**

BaselineE/C/FTDFNNRTI + FTC/TDF

Week 48E/C/FTDFNNRTI + FTC/TDF


StudyEffect size (CI)

Medical male circumcision (MMC) (Orange Farm, Rakai, Kisumu)

57% (42, 68)

Prime-boost HIV Vaccine (Thai RV144)

31% (1, 51)

Efficacy0% 10 20 30 40 50 60 70 80 90 100%

TDF/FTC oral-PrEP in MSM (iPrEx, Grant et al 2010)

44% (15, 63)

1% tenofovir gel (Caprisa 004, Karim et al.)

39% (6, 60)

*Provisional

Immediate ART for positivePartners (HPTN052)

96% (82, 99)*

TDF/FTC oral-PrEP in heterosexuals (TDF2, CDC)

TDF oral-PrEP in serodiscordant Partner (Partners PrEP)

63% (22, 83)*

TDF/FTC oral-PrEP in serodiscordant Partner (Partners PrEP)

62% (34, 78)*

73% (49, 85)*

Profilaxis pre-exposición al VIH

Partner Cohort Study

� Estudio en 1.140 parejas serodiscordantes, 40% HSH.

� Criterios para incluir en el estudio– Manifestar que realizaban relaciones sexuales sin preservativo

– No seguir estrategias de profilaxis pre-exposición o postexposición

� Análisis a 767 parejas

� Al inicio del estudio– Los VIH de las parejas HSH llevan TAR con una media de 5 años

– Los VIH de las parejas HTS llevaban TAR entre 7-10 años

� Se realizaron: 16.400 RS entre los HSH y 28.000 en los HTS– No transmisión del virus dentro de la pareja

� Riesgo de transmisión con un IC95% del 0,45% anual general y 1% en el caso de las RS anales

� No son datos definitivos: el estudio finaliza en el año 2017

Author’s Last Name, Conference Name, Year, Presentation # 45


Consenso sobre el inicio del tratamiento: Recomendaciones de GESIDA 2014

Consenso sobre el inicio del tratamiento: Recomendaciones de la DHHS

Recuento de CD4

(cél/mm 3)DHHS 2013

<350 TAR recomendado (AI)

>350 a <500 TAR recomendado (AII)

>500 TAR recomendado (BIII)



OBJETIVOS

o Analizar la valoración que los pacientes con VIH en España hacen de las diferentes características del tratamiento antirretroviral (TARV)

o Estudiar el perfil de los pacientes, sus necesidades de información, la relación médico-paciente y su bienestar.

MÉTODO

DISEÑO Encuesta transversal

MUESTRA 370 personas con VIH

PROCEDIMIENTO

Recogida datos en 6 hospitales:

-Mutua Terrassa (BCN), Miguel Servet (ZGZ),

Reina Sofía (Córdoba), Xeral (Vigo), Universitario

(La Coruña)

VARIABLES (a)Datos socio-demográficos , (b) Datos sanitarios

(c) Información sobre el VIH, (d) características

TARV, (e) Relación médico-paciente, (f) Bienestar

DATOS SANITARIOS

MEDIANA 12 AÑOS

IMPORTANCIA CARACTERISTICAS TRATAMIENTO PARA ADHERENCIA



IMPORTANCIA CARACTERISTICAS TRATAMIENTO PARA ADHERENCIA (FACTORES)


LIMITACIONES PARA ESTOS AVANCES

61

Health & Medicine

VIH. novedades terapéuticas