Lopinavir and atazanavir
in pregnancy:
preterm delivery rates,
infant outcomes and
virological efficacy.
Dr Melissa Perry
Guy’s & St Thomas’ NHS Foundation Trust
London
United Kingdom
Townsend et al CROI 2013 poster 906
What we know?
 Excellent ART coverage
 Excellent PMTCT
Preterm delivery concerns
 Drug or drug class?
 Timing of ART?
Lorenzi P, Spicher VM, Laubereau B et al.
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Association between ART and PTD
Association
between PI-based ART and
Association between ART and PTD
PTD
No Association between ART and PTD
- particularly marked in patients on PI’s
Association between ART and PTD
Association between ART and PTD
-No
particularly
marked
in patients
PI’sPTD
No
Association
between
ARTonand
and
PTD
Association
between
ART
Association
between
and on
PTD
1.5-fold
increased
riskART
of PTD
ART
only
if ART included
a PIPTD and PI- -No
association
between
No Association between PTD and
containing
AssociationART
between ART and PTD
PI-containing ART
Association
- only if ARTbetween
includedART
a PIand PTD
www.bhiva.org
 As per HIV treatment guidelines for non pregnant
individuals - based on VL, CD4 & genotype
 Conceive on ART
 remain on the same ART*
 Commencing ART for maternal health
 start ART ASAP
 All women should commence ART by 24W*
 No recommended dose adjustments.
 Therapeutic drug monitoring - only consider.
In clinical practice:
 Two most commonly used PIs in pregnancy in
the UK are ritonavir-boosted lopinavir and
ritonavir-boosted atazanavir
Our Question?
Atazanavir or lopinavir in pregnancy?
Outcomes
 Pre term delivery
 Infant outcomes




transmission
birth weight
phototherapy requirement
birth defects
 Tolerability and viral response
 clinical and virological aspects
 Retrospective case note review
 9 London HIV specialist care centres
 All pregnancies
 commenced on atazanavir or lopinavir
or
 conceived on atazanavir or lopinavir
 delivered 1st Sept 2007 - 30th Aug 2012
Results
 n=493 pregnancies
 Median age 33 years
 Ethnicity
 81% Black African.
 HIV acquisition
 97% through heterosexual exposure
 0.6% from injecting drug use
 Hepatitis co-infection
 Hep B – 4%
 Hep C – 1%
Use of Lopinavir vs. AtazanavirAtazanavir
in Pregnant women overLopinavir
time
Total number of patients:
187
14
306
A t az anavir
Lo p inavir
Number of patients
12
10
8
6
4
2
0
S e pt 0 7 - A ugus t 12
NRTI Backbone
Lopinavir
Atazanavir
7%
Truvada
6%
8%
Com bivir
20%
24%
Kivexa
Other
3%
70%
62%
% on standard dose
Atazanavir
88%
Lopinavir
92%
Numbers of patients
Atazanavir
Lopinavir
Total
95
82
177
Post
conception
92
224
316
Total
187
306
493
Conceived on
% of women who delivered <37W
Atazanavir
Lopinavir
p-value
Overall:
19 (13%)
40 (14%)
ns
Conceived on
11 (15%)
8 (12%)
0.98
Post conception
16 (20%)
24 (12%)
0.12
*8 percent (1 in 13) of general population UK live births are born preterm
Infant outcomes
Transmissions
Atazanavir
Lopinavir
1 (0.7%)
1 (0.4%)
Overall MTCT rate: 0.5%
% requiring phototherapy
2 (2%)
2 (1%)
Birth defects
(Conceived on)
3 (3%)
2 (2%)
% <2500g birth weight
23 (15%)
40 (15%)
Tolerability / toxicity
Conceived on
Post conception
Atazanavir
Lopinavir
2 (2%)
5 (6%)
5 (5%)
24 (11%)
55% related to
nausea & vomiting
Viral load decay
Atazanavir
Lopinavir
Gestation
(at starting ART)
20w
22w
% VL<=50 cps/ml
at delivery
85%
81%
Median days
VL <= 50 cps/ml
56days
43days
0.61
0.52
(despite the majority of women on ATV/r receiving the standard 300/100mg
dose and co-prescribed tenofovir.)
Conclusions
 Both regimens were successful in preventing MTCT
 No significant difference between ATV/r and LPV/r
in
preterm delivery rates
infant outcomes
tolerability and toxicity
virological efficacy
 The PTD rates were comparable to those reported in
previous studies and more favourable than others
Limitations
•Retrospective case note review
•Small case numbers
•Lacks power
•Limited scope for multivariable logistic
regression analysis
Summary
 This is the first study comparing pregnancy
outcomes between these two PIs.
 This study suggests both PI regimens at
standard dosing are comparable in terms of
virological efficacy, preterm delivery rates and
infant outcomes.
Disclosure
 I have received travel grants from Abbott,
Boehringer Ingelheim, ViiV, Gilead.
Authors & Affiliations
 Melissa Perry1, Katie Conway1, Caroline Sabin2, Stuart
Flanaghan3, Ellen Dwyer4, Stevenson J4, Larissa Mulka5,
Anna McKendry6, Elizabeth Williams8, Alison Barbour10,
Sherie Roedling6, Rimi Shah7, Jane Anderson3, Mette
Rodgers4, Chris Wood8, Liat Sarner9, Phillip Hay10, Graham
Taylor5, Annemiek DeRuiter1.
1Guys
and St Thomas NHS Foundation Trust.
2Department
of Infection and Population Health, Division of Population Health, UCL Medical
School.
3Homerton
4Croydon
5Imperial
6Central
7Barnet
8The
University Hospital.
College Healthcare NHS Trust.
and North West London NHS Foundation Trust.
and Chase Farm hospital NHS trust.
North Middlesex University Hospital NHS Trust.
9Barts
10St
University Hospital NHS Foundation Trust.
Health NHS Trust.
Georges Healthcare NHS Trust
Questions?