Post on 05-Sep-2020
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Background • As access to HIV tes,ng and treatment expands throughout sub-‐
Saharan Africa, an increasing number of pregnant women with HIV are presen,ng to antenatal care already on an,retroviral therapy (ART).
• Uganda adopted Op,on B+ (lifelong ART for all pregnant and breasIeeding HIV-‐infected women, regardless of CD4 count) in 2012.
• Data are limited on viral suppression among pregnant women prescribed ART in public health se;ngs, par=cularly in rural clinics. • Many seQngs lack rou,ne viral load monitoring.
Study Design and Popula=on • We evaluated HIV-‐infected pregnant women enrolled in the
PROMOTE Birth Cohort 2 (BC2) study (NCT02282293) of HIV and malaria in Tororo, a municipality in rural eastern Uganda. • Par,cipants (N = 200) were enrolled between 12-‐28 weeks
gesta,on (confirmed by ultrasound) from 12/2014-‐10/2015. • Par,cipants had previously received care at area clinics per
Uganda Ministry of Health guidelines without viral load (VL) monitoring.
Study Procedures and Measurements • At enrollment, par,cipants were ART-‐naïve or receiving NNRTI-‐
based ART; all were started on or switched to efavirenz/tenofovir disoproxil fumarate/lamivudine (EFV/TDF/3TC).
• HIV-‐1 RNA tes,ng was performed at enrollment, 8 weeks acer enrollment, delivery, and addi,onally as clinically indicated.
• Par,cipants with confirmed virologic failure (at least two VL >1000 copies/ml acer >90 days on ART) were switched to protease inhibitors (lopinavir/ritonavir or atazanavir/ritonavir).
Analysis • Primary outcome: Viral suppression: HIV-‐1 RNA ≤400 copies/ml • Logis,c regression models were used to examine factors associated
with viral suppression at enrollment and delivery.
Acknowledgments: The authors thank the PROMOTE BC2 study par,cipants, the study staff, and the Infec,ous Diseases Research Collabora,on. This research was supported by funding from the Na,onal Ins,tutes of Health P01 HD059454 and K12 HD052163.
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Methods
Results
Discussion
Figure 1. Propor=on of Par=cipants with Viral Suppression at Enrollment and Delivery
• The majority of HIV-‐infected women already on ART at entry into antenatal care had previously achieved and were able to sustain viral suppression during pregnancy.
• Younger women had lower odds of viral suppression at enrollment, with a trend toward lower odds of viral suppression at delivery.
• Among all 200 enrolled women, 94% achieved VL ≤400 c/ml at delivery. • However, 15% of women already on ART for >90 days at enrollment were not virologically
suppressed. • Viral load monitoring in these asymptoma,c par,cipants triggered enhanced
adherence counseling and ART switch. • 81% of par,cipants not suppressed at enrollment achieved VL ≤1000 c/ml at delivery.
• Implementa,on of rou,ne viral load monitoring during pregnancy would allow for targeted adherence counseling and ART regimen switches, resul,ng in improved maternal and infant outcomes. Further studies are needed to iden,fy op,mal ,ming and frequency of monitoring.
Viral Suppression among HIV+ Pregnant Women Entering Antenatal Care on ART in Uganda Catherine A. Koss1,2, Paul Natureeba2, Deborah Cohan1,2, Teddy Ochieng2, Theodore Ruel1,2, Miriam Nakalembe2,3, Tamara D. Clark1,2, Edwin D. Charlebois1,2, Moses R. Kamya2,3, Diane V. Havlir1,2
1University of California, San Francisco, CA, United States; 2Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda; 3Makerere University College of Health Sciences, Kampala, Uganda
Catherine A. Koss, MD Division of HIV, Infectious Diseases, and Global Medicine San Francisco General Hospital University of California, San Francisco, catherine.koss@ucsf.edu
0%
20%
40%
60%
80%
100%
All par=cipants On ART at enrollment On ART >90 days at enrollment
All par=cipants
Enrollment (12-‐28 weeks gesta,on) Delivery
Table 1. Characteris=cs of Study Par=cipants at Enrollment, N = 200
Characteris=c n (%) or median (IQR)
Age, years 30.6 (24.9-‐35.0)
Educa=on, highest level achieved Less than primary Primary O Level or above
46 (23%) 111 (55.5%) 43 (21.5%)
Alcohol use, any 25 (12.5%)
Gravidity 4 (3-‐6)
Weeks gesta=on 19.4 (15.7-‐23.2)
HIV newly diagnosed during current pregnancy 39 (19.5%)
Years since HIV diagnosis 3.1 (0.7-‐6.4)
Currently taking ART Taking ART for >90 days prior to enrollment
161 (80.5%) 135 (67.5%)
Years since ART ini=a=on 2.0 (0.5-‐4.2) ART regimen (prior to enrollment) Efavirenz
Nevirapine None
125 (62.5%) 36 (18%) 39 (19.5%)
CD4 cell count, cells/mm3 503 (372-‐638) HIV-‐1 RNA, copies/ml 20 (20-‐5252)
Outcomes at Delivery and Switches to Protease Inhibitors • Of 135 par,cipants with viral
suppression at enrollment, 98.5% maintained viral suppression to delivery.
• Of 21 par,cipants with unsuppressed viral loads at enrollment despite >90 days on ART, 17 (80.9%) achieved viral load ≤1000 c/ml at delivery with switch to PI (n = 11) and adherence counseling.
Objec=ve To evaluate virologic outcomes during pregnancy in a cohort of HIV-‐infected women previously receiving HIV care per na,onal guidelines without viral load monitoring.
67.5% (135/200)
79.5% (128/161)
84.4% (114/135)
93.5% (187/200)
Table 2. Analysis of Factors Associated with Viral Suppression (HIV-‐1 RNA ≤400 copies/ml) at Enrollment and Delivery
Enrollment Delivery OR (95% CI) aOR (95% CI) P OR (95% CI) aOR (95% CI) P
Age, per 10 years 3.94 (2.27-‐6.85) 2.23 (1.05-‐4.75) 0.038 2.76 (1.06-‐7.18) 2.75 (0.87-‐8.75) 0.08
Years since ART ini=a=on, per year 1.41 (1.13-‐1.77) 1.41 (1.08-‐1.85) 0.012 1.21 (0.90-‐1.62) 1.17 (0.79-‐1.72) 0.44
ART regimen Efavirenz Nevirapine PI (ATV/r or LPV/r)
0.73 (0.27-‐1.92) Ref N/A
2.27 (0.66-‐7.75) Ref N/A
0.191 12.4 (3.36-‐45.5)
N/A Ref
16.3 (3.9-‐67.9) N/A Ref
0.001
Household wealth index Lowest Middle Highest
Ref 1.39 (0.64-‐2.99) 0.57 (0.28-‐1.16)
Ref 1.00 (0.19-‐5.14) 0.41 (0.10-‐1.65)
Alcohol use 0.84 (0.35-‐2.01) 0.45 (0.11-‐1.75)
HIV newly diagnosed during current pregnancy 0.14 (0.06-‐0.30)
Gesta=onal age at enrollment, per week 0.91 (0.80-‐1.04)