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A randomized trial of two postexposure prophylaxis regimens to reduce mother-to-child HIV-1 transmission in infants of untreated mothers

Gray, Glenda Ea; Urban, Michaelb; Chersich, Matthew Fa; Bolton, Carolyna; van Niekerk, Ronellea; Violari, Avya; Stevens, Wendyc; McIntyre, James Aa; for the PEP Study Group

Clinical Science

Background: Single-dose nevirapine (NVP) prophylaxis to mother and infant is widely used in resource-constrained settings for preventing mother-to-child transmission (MTCT) of HIV-1. Where women do not access antenatal care or HIV testing, postexposure prophylaxis to the infant may be an important preventative strategy.

Methods: This multicentre, randomized, open-label clinical trial (October 2000 to September 2002) in South Africa compared single-dose NVP with 6 weeks of zidovudine (ZDV), commenced within 24 h of delivery among 1051 infants whose mothers had no prior antiretroviral therapy. HIV-1 infection rates were ascertained at birth, and at 6 and 12 weeks of age. Kaplan–Meier survival methods were used to estimate HIV-1 infection rates in an intention-to-treat analysis.

Results: Overall, 6 week and 12 week MTCT probability was 12.8% [95% confidence interval (CI),10.5–15.0] and 16.3% (95% CI,13.4–19.2), respectively. At 12 weeks, among infants who were not infected at birth, 24 (7.9%) infections occurred in the NVP arm and 41 (13.1%) in the ZDV arm (log rank P = 0.06). Using multivariate analysis, factors associated with infection following birth were ZDV use [odds ratio (OR), 1.8; 95% CI,1.1–3.2; P = 0.032), maternal CD4 cell count < 500 × 106 cells/l (OR, 2.5; 95% CI,1.3–5.0; P = 0.007), maternal viral load > 50 000 copies/ml (OR, 3.6; 95% CI,2.0–6.2; P < 0.0001) and breastfeeding (OR, 2.2; 95% CI,1.3–3.8; P = 0.006).

Conclusion: A single-dose of NVP given to infants offers protection against HIV-1 infection and should be a strategy used in infants of mothers with untreated HIV infection.

From the aPerinatal HIV Research Unit

bCoronation Hospital Department of Pediatrics

cDepartment of Molecular Medicine and Haematology, University of the Witwatersrand, Johannesburg South Africa.

*See Appendix for study members.

Received 9 November, 2004

Revised 8 April, 2005

Accepted 13 April, 2005

Correspondance to Dr G. Gray, Perinatal HIV Research Unit, University of the Witwatersrand, Chris Hani Baragwanath Hospital, PO Box 114, Diepkloof, Johannesburg 1864, South Africa. E-mail: gray@pixie.co.za

© 2005 Lippincott Williams & Wilkins, Inc.