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Triple-antiretroviral (ARV) prophylaxis during pregnancy and breastfeeding compared to short-ARV prophylaxis to prevent mother-to-child transmission of HIV-1 (MTCT): the Kesho Bora randomized controlled clinical trial in five sites in Burkina Faso, Kenya
Presented by Isabelle de Vincenzi (Switzerland).
I. de Vincenzi, Kesho Bora Study Group
World Health Organization, Department of Reproductive Health and Research, Geneva, Switzerland
Background: ARV interventions to reduce MTCT during late pregnancy and delivery are well established, but no randomized trial has assessed safety and efficacy of continued maternal ARVs during breastfeeding.
Methods: Between June 2005 and August 2008, HIV-infected pregnant women with CD4 200-500 cells/mL were randomized between 28 and 36 weeks of pregnancy to triple-ARV (ZDV+3TC+LPV/r to 6.5 months post-delivery or breastfeeding cessation if earlier) or short-ARV (ZDV through delivery plus single-dose NVP in labour). Infants received single-dose NVP. From September 2007, 1 week maternal ZDV+3TC was added to short-ARV regimen postpartum and 1 week ZDV for all infants. 12-month cumulative lifetable rates were compared using logrank tests.
Results: 824 women (413 triple-ARV, 411 short-ARV) delivered 805 live, singleton or first-born infants. Median enrolment CD4 was 335; 56% had CD4 200-350. By May 2009 all infants had been born ≥ 6 and 87% ≥ 12 months previously. 77% were breastfed median duration 21 weeks in both arms. 12-month cumulative incidence of HIV infection or death was 10.4% (95% CI 7.7-14.9%) [40 endpoints] with triple-ARV and 16.3% (13.0-20.5%) [62 endpoints] with short-ARV (36% risk reduction, p=0.023). 56 infants were infected by 12 months, 37 born to mothers with CD4 200-350; another 46 died. Cumulative HIV infection rates (95% CI) [infections] were:
| Age | Birth | 6 weeks | 6 months | 12 months | | Triple-ARV | 1.8% (0.8-3.7) [7] | 3.3% (1.9-5.6) [13] | 4.9% (3.1-7.5) [19] | 5.6% (3.4-8.4) [21] | | Short-ARV | 2.0% (1.0-4.0) [8] | 4.5% (2.9-7.1) [18] | 8.2% (5.9-11.5) [32] | 9.3% (6.7-12.7) [35] |
Reduction in HIV infections by 12 months was 40% (p=0.052). There was no increase in adverse events with triple-ARV.
Conclusions: Twelve-month HIV-free survival was significantly better when mothers with CD4 200-500 received triple-ARV prophylaxis. Largest effect (HIV infections averted) was observed between 6 weeks and 6 months postpartum when ARV prophylaxis was received in triple-ARV but not short-ARV arm; and among women with CD4 200-350.
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