Maternal or infant antiretroviral drugs to reduce HIV-1 transmission.
BACKGROUND
We evaluated the efficacy of a maternal triple-drug antiretroviral regimen or infant nevirapine prophylaxis for 28 weeks during breast-feeding to reduce postnatal transmission of human immunodeficiency virus type 1 (HIV-1) in Malawi.


METHODS
We randomly assigned 2369 HIV-1-positive, breast-feeding mothers with a CD4+ lymphocyte count of at least 250 cells per cubic millimeter and their infants to receive a maternal antiretroviral regimen, infant nevirapine, or no extended postnatal antiretroviral regimen (control group). All mothers and infants received perinatal prophylaxis with single-dose nevirapine and 1 week of zidovudine plus lamivudine. We used the Kaplan-Meier method to estimate the cumulative risk of HIV-1 transmission or death by 28 weeks among infants who were HIV-1-negative 2 weeks after birth. Rates were compared with the use of the log-rank test.


RESULTS
Among mother-infant pairs, 5.0% of infants were HIV-1-positive at 2 weeks of life. The estimated risk of HIV-1 transmission between 2 and 28 weeks was higher in the control group (5.7%) than in either the maternal-regimen group (2.9%, P=0.009) or the infant-regimen group (1.7%, P<0.001). The estimated risk of infant HIV-1 infection or death between 2 and 28 weeks was 7.0% in the control group, 4.1% in the maternal-regimen group (P=0.02), and 2.6% in the infant-regimen group (P<0.001). The proportion of women with neutropenia was higher among those receiving the antiretroviral regimen (6.2%) than among those in either the nevirapine group (2.6%) or the control group (2.3%). Among infants receiving nevirapine, 1.9% had a hypersensitivity reaction.


CONCLUSIONS
The use of either a maternal antiretroviral regimen or infant nevirapine for 28 weeks was effective in reducing HIV-1 transmission during breast-feeding. (ClinicalTrials.gov number, NCT00164736.)
Chasela
Charles S
CS
University of North Carolina Project, Lilongwe, Malawi.
Hudgens
Michael G
MG
Jamieson
Denise J
DJ
Kayira
Dumbani
D
Hosseinipour
Mina C
MC
Kourtis
Athena P
AP
Martinson
Francis
F
Tegha
Gerald
G
Knight
Rodney J
RJ
Ahmed
Yusuf I
YI
Kamwendo
Deborah D
DD
Hoffman
Irving F
IF
Ellington
Sascha R
SR
Kacheche
Zebrone
Z
Soko
Alice
A
Wiener
Jeffrey B
JB
Fiscus
Susan A
SA
Kazembe
Peter
P
Mofolo
Innocent A
IA
Chigwenembe
Maggie
M
Sichali
Dorothy S
DS
van der Horst
Charles M
CM
D000328:Adult; D044966:Anti-Retroviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001942:Breast Feeding; D018791:CD4 Lymphocyte Count; D004342:Drug Hypersensitivity / Q000209:etiology; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000635:transmission*; D018023:HIV Seronegativity; D015497:HIV-1; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D053208:Kaplan-Meier Estimate; D019259:Lamivudine / Q000627:therapeutic use; D008297:Male; D009503:Neutropenia / Q000139:chemically induced; D019829:Nevirapine / Q000009:adverse effects / Q000627:therapeutic use; D011247:Pregnancy; D012307:Risk Factors; D013262:Stevens-Johnson Syndrome / Q000139:chemically induced; D055815:Young Adult; D015215:Zidovudine / Q000627:therapeutic use
D044966:Anti-Retroviral Agents; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine