ANRS highlights results of EDCTP-cofunded PROMISE-PEP study

08 March 2013

Today – following on from the Conference on Retroviruses and Opportunistic Infections (CROI 2013) in Atlanta, USA – the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) held a press conference in Paris to highlight several studies, including the EDCTP-cofunded PROMISE-PEP study. The preliminary findings of this antiretroviral treatment trial in infants to prevent mother to child transmission of HIV are very encouraging.

This trial presents the first data on the efficacy of a treatment strategy to prevent mother-child transmission of HIV-1 during 12 months of breastfeeding. The transmission rate of the disease from mother to child was reported as 1.1% at 12 months, the lowest rate ever reported during breastfeeding according to Professor Philippe Van de Perre (University of Montpellier 1, France). Moreover, the survival rate was 96% among infants who remained uninfected for a period of 50 weeks, which is the highest rate ever reported, corroborating the health benefits of ART prophylactic treatment during breastfeeding.

The PROMISE-PEP clinical trial, coordinated by Prof. Van de Perre, compares two prophylactic treatment regimens to prevent transmission of HIV from mother to child during 12 months of breastfeeding. To compare the efficacy of infant Lopinavir/Ritonavir (LPV/r, 40/10mg twice daily if 2-4kg and 80/20mg twice daily if >4kg) vs. Lamivudine 7,5mg twice daily if 2-4kg, 25mg twice daily if 4-8kg and 50mg twice daily if >8kg) from day 7 until 4 weeks after cessation of breastfeeding (maximum duration of prophylaxis: 50 weeks for a recommended maximum duration of breastfeeding of 49 weeks) to prevent postnatal HIV-1 acquisition between 7 days and 50 weeks of age. Data analyses for the comparative efficacy and tolerance of the two regimens will be available in September 2013.

More information