Four weeks of antiretroviral prophylaxis is sufficient for HIV-exposed infants

A study conducted at three Dublin Hospitals looked at 4 vs 6 weeks ARV prophylaxis for HIV-exposed infants.

US guidelines currently recommend 6 weeks ARV prophylaxis for infants, but this is not evidence based. The investigators suggest that the potential benefits of the shorter duration include greater acceptability, adherence, reduced toxicity and cost.

The investigators performed an audit of the Irish PMTCT programme between January 1999 and December 2007. In this programme, prophylaxis is given according to infant risk: AZT (4mg/kg BD) or NVP (2mg/kg x 2 doses) plus AZT/3TC, for 4 weeks rather than 6 weeks.

In this programme, infants received AZT unless mothers had received <4 weeks ART in pregnancy, were non adherent, had detectable viral load, had prolonged rupture of membranes or other transmission risks were identified. Infants were categorised HIV-negative if, post prophylaxis, they have two negative DNA PCR tests, the second at =3 months of age. The investigators found, there were 868 pregnancies, during the study period, which included 9 twin pregnancies. The women in the study were 79% African, 20% Irish and 1% other nationalities. There were 874 live births, including 5 neonatal deaths = 48 hrs (1 preterm, 2 birth asphyxia, 1 dysmorphic and1 sepsis) and 3 infant deaths (2 SIDS, 1 structural heart defect).

ARV prophylaxis was given to 869 infants and they all completed the 4-week course. 9/869 infants were HIV-positive, 826 HIV-negative and 34 of indeterminate status, including 2 late infant deaths; 1SIDS at 2 months and 1cardiac. 32 infants with at least one negative HIV PCR at = 6 weeks of age, including 23 at six weeks, were lost to follow up prior to 3 month testing.

Based on data for 835 infants with known HIV status, the investigators found a TR of 1% (95% CI 0.98-1.019). Of these 8/9 HIV-positive infants were born to women who presented late to antenatal care; 6/8 women had <6 weeks ART and 2/8 were non adherent.

The investigators wrote: “Four weeks neonatal ART component has comparable efficacy to 6 weeks treatment with potential for less toxicity and cost savings.”

Ferguson W, Goode M, Walsh A et al. Four weeks neonatal antiretroviral therapy (ART) is sufficient to optimally prevent mother to child transmission (PMTCT) of HIV. 48th ICAAC, 25-28 October 2008. Washington. Abstract H-459.