Antiretroviral regimens in pregnancy and breast-feeding in Botswana.
BACKGROUND
The most effective highly active antiretroviral therapy (HAART) to prevent mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) in pregnancy and its efficacy during breast-feeding are unknown.


METHODS
We randomly assigned 560 HIV-1-infected pregnant women (CD4+ count, > or = 200 cells per cubic millimeter) to receive coformulated abacavir, zidovudine, and lamivudine (the nucleoside reverse-transcriptase inhibitor [NRTI] group) or lopinavir-ritonavir plus zidovudine-lamivudine (the protease-inhibitor group) from 26 to 34 weeks' gestation through planned weaning by 6 months post partum. A total of 170 women with CD4+ counts of less than 200 cells per cubic millimeter received nevirapine plus zidovudine-lamivudine (the observational group). Infants received single-dose nevirapine and 4 weeks of zidovudine.


RESULTS
The rate of virologic suppression to less than 400 copies per milliliter was high and did not differ significantly among the three groups at delivery (96% in the NRTI group, 93% in the protease-inhibitor group, and 94% in the observational group) or throughout the breast-feeding period (92% in the NRTI group, 93% in the protease-inhibitor group, and 95% in the observational group). By 6 months of age, 8 of 709 live-born infants (1.1%) were infected (95% confidence interval [CI], 0.5 to 2.2): 6 were infected in utero (4 in the NRTI group, 1 in the protease-inhibitor group, and 1 in the observational group), and 2 were infected during the breast-feeding period (in the NRTI group). Treatment-limiting adverse events occurred in 2% of women in the NRTI group, 2% of women in the protease-inhibitor group, and 11% of women in the observational group.


CONCLUSIONS
All regimens of HAART from pregnancy through 6 months post partum resulted in high rates of virologic suppression, with an overall rate of mother-to-child transmission of 1.1%. (ClinicalTrials.gov number, NCT00270296.)
Shapiro
R L
RL
Division of Infectious Diseases, Beth Israel Deaconess Medical Center, 110 Francis St., Suite GB, Boston, MA 02215, USA. rshapiro@hsph.harvard.edu
Hughes
M D
MD
Ogwu
A
A
Kitch
D
D
Lockman
S
S
Moffat
C
C
Makhema
J
J
Moyo
S
S
Thior
I
I
McIntosh
K
K
van Widenfelt
E
E
Leidner
J
J
Powis
K
K
Asmelash
A
A
Tumbare
E
E
Zwerski
S
S
Sharma
U
U
Handelsman
E
E
Mburu
K
K
Jayeoba
O
O
Moko
E
E
Souda
S
S
Lubega
E
E
Akhtar
M
M
Wester
C
C
Tuomola
R
R
Snowden
W
W
Martinez-Tristani
M
M
Mazhani
L
L
Essex
M
M
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D001942:Breast Feeding; D018791:CD4 Lymphocyte Count; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy / Q000635:transmission*; D017320:HIV Protease Inhibitors / Q000627:therapeutic use; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D009503:Neutropenia / Q000139:chemically induced; D019829:Nevirapine / Q000627:therapeutic use; D010349:Patient Compliance; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D012367:RNA, Viral / Q000097:blood; D012307:Risk Factors; D019562:Viral Load / Q000187:drug effects; D055815:Young Adult; D015215:Zidovudine / Q000627:therapeutic use
D017320:HIV Protease Inhibitors; D012367:RNA, Viral; D015215:Zidovudine; D019829:Nevirapine