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Valacyclovir suppression reduces breast milk and plasma HIV-1 RNA postpartum: results of a randomized clinical trial. Alison Drake International AIDS Society Conference July 18, 2011. Abstracts at IAS 2011. Oral Abstract Session Maternal Health and Paediatric Outcomes

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slide1

Valacyclovir suppression reduces breast milk and plasma HIV-1 RNA postpartum: results of a randomized clinical trial

Alison Drake

International AIDS Society Conference

July 18, 2011

abstracts at ias 2011
Abstracts at IAS 2011
  • Oral Abstract Session

Maternal Health and Paediatric Outcomes

    • TUAB0202: Tuesday 2:30 – 4:00, MR 4
  • Poster Exhibitions
    • MOPE174: Monday 12:30 – 2:30
    • TUPE268: Tuesday 12:30 – 2:30
mtct in non breastfeeding populations
MTCT in non-breastfeeding populations

Postnatal Tx rate

(6 mo)

Maternal HAART

Maternal HAART

1 - 2%

sdNVP

Maternal ZDV + 3TC (1 wk)

ZDV

1 - 2%

Pregnancy

Delivery

Postpartum

mtct in breastfeeding populations
MTCT in breastfeeding populations

Cessation of BF

Postnatal Tx rate

(6 mo)

Maternal HAART

Maternal HAART or Infant NVP

3 - 5%

sdNVP

Maternal ZDV + 3TC (1 wk)

ZDV

8 - 10%

Pregnancy

Delivery

Postpartum

mtct in breastfeeding populations1
MTCT in breastfeeding populations
  • Access to ARVs for PMTCT not universal
    • 53% coverage in low- and middle- income countries (WHO 2010)
  • Alternative strategies needed to reduce postnatal transmission

Cessation of BF

Postnatal Tx rate

(6 mo)

Maternal HAART

Maternal HAART or Infant NVP

3 - 5%

sdNVP

Maternal ZDV + 3TC (1 wk)

ZDV

8 - 10%

Pregnancy

Delivery

Postpartum

hsv 2 infection in hiv 1 infected women
HSV-2 infection in HIV-1 infected women
  • Prevalence 75% to > 95%
  • Suppressive therapy
      • Reduces plasma HIV-1 RNA 0.25 - 0.5 log
      • 0.18 log greater reduction with valacyclovir (Ludema 2011)
      • Effect on breast milk HIV-1 RNA or MTCT unknown
slide7
Aims
  • To evaluate the effect of valacyclovir suppressive therapy administered during late pregnancy and for 12 months postpartum on:
    • Plasma HIV-1 RNA levels
    • Breast milk HIV-1 RNA detection and levels
study design
Study design
  • Inclusion criteria
  • Procedures
  • Double blind RCT
    • 500 mg valacyclovir
    • or placebo bid
  • PMTCT ARVs
    • ZDV + sdNVP
  • HIV-1/HSV-2 seropositive
  • ≥ 18 years of age
  • HAART ineligible
    • CD4 > 250 cells/mm3
  • Seeking ANC in Nairobi, Kenya
  • Deliver and remain in Nairobi 12 months postpartum
study design1
Study design
  • Inclusion criteria
  • Procedures
  • Double blind RCT
    • 500 mg valacyclovir
    • or placebo bid
  • PMTCT ARVs
    • ZDV + sdNVP
  • HIV-1/HSV-2 seropositive
  • ≥ 18 years of age
  • HAART ineligible
    • CD4 > 250 cells/mm3
  • Seeking ANC in Nairobi, Kenya
  • Deliver and remain in Nairobi 12 months postpartum

Screen

Enroll &

Randomize

Blood & breast milk

Delivery

Pregnancy

Postpartum

28-32wk

38wk

34wk

6wk

2wk

14wk

6mo

12mo

slide10
Screening, enrollment, and follow-up

April 2008 – June 2009

359 screened

Ineligible *

85 HSV-2

67 CD4

70 HAART

24 Residence

211 eligible

148 enrolled

74 placebo

74 valacyclovir

1 LTFU

73 included in analysis

1 LTFU

73 included in analysis

* not mutually exclusive

postpartum plasma hiv 1 rna levels3
Postpartum plasma HIV-1 RNA levels

Placebo

Valacyclovir

p

2wk PVL 2- 6 wk rate of ∆

3.102.08

2.83 1.48

0.11 <0.001

0.60 lower (95% CI 0.92 – 0.28)

postpartum plasma hiv 1 rna levels4
Postpartum plasma HIV-1 RNA levels

Placebo

Valacyclovir

p

6 wk – 12 mo rate of ∆ Mean (95% CI) difference

0.03

0.02 0.51 lower (0.73 – 0.30)

0.3 <0.001

breast milk hiv 1 rna levels
Breast milk HIV-1 RNA levels

Placebo

Valacyclovir

Breast milk

Plasma

Median (IQR)

6 wk 14 wk

2.42 (1.70 – 3.35)1.70 (1.70 – 2.96)

1.70 (1.70 – 2.57) 1.70 (1.70 – 1.70)

breast milk and plasma hiv 1 rna levels
Breast milk and plasma HIV-1 RNA levels

Placebo

Valacyclovir

Breast milk

Plasma

Median (IQR)

6 wk 14 wk

2.42 (1.70 – 3.35)1.70 (1.70 – 2.96)

1.70 (1.70 – 2.57) 1.70 (1.70 – 1.70)

conclusions
Conclusions
  • Valacyclovir reduced
    • Early breast milk HIV-1 RNA detection
    • Plasma HIV-1 RNA 0.51 log
  • Plasma results consistent with other trials
  • Impact of valacyclovir on MTCT may differ from heterosexual transmission
    • Prolonged exposure to bodily fluids
    • 0.4 log lower viral load associated with reduced risk of postnatal MTCT (Neveu 2011)
implications
Implications
  • Valacyclovir is an appealing intervention
  • Valacyclovir suppressive therapy, in conjunction with PMTCT ARVs, should be evaluated as an intervention to reduce postnatal MTCT and improve maternal health
slide23
Acknowledgments
  • Funding
  • NIH R03 5R03HD057773-02
  • NIH ARRA 5R03HD057773-02S1
  • University of Washington CFAR
  • P30 AI027757
  • CFAR STD Pre-doctoral Training Grant 5T32AI007140-33
  • Puget Sound Partners for Global Health
  • UW Royalty Research Fund

Study participants

Mathare staff

DSMB

GlaxoSmithKline

  • University of Washington
  • Carey Farquhar
  • Alison Roxby
  • Anna Wald
  • Grace John-Stewart
  • Barbra Richardson
  • Julie Overbaugh
  • Jane Hitti
  • Sandy Emery

University of Nairobi

  • James Kiarie
  • Francisca Ongecha-Owuor
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