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PROMISE consortium published in Nature

The PROMISE consortium has published the results of their long-term study showing similar long-term clinical outcomes from early use of two different HIV prophylactic drugs in Nature.

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CIH Professors Ingunn M. S. Engebretsen and Thorkild Tylleskär are the UiB participants in the consortium’s project: PROMISE M & S: Infant Peri-Exposure Prophylaxis to Prevent HIV-1 Transmission by Breastfeeding: Mechanisms & Safety. The Promise consortium has had and continues to have a number of projects. Learn more.

The paper summarises the conclusion of their work:

“It provides reassuring data on clinical outcomes for all HIV-infected children treated with this antiretroviral drug in early life.”


PROMISE M&S first assessed the long-term safety and efficacy of one-year infant prophylaxis using lamivudine (3TC) or lopinavir/ritonavir (LPV/r) to prevent post-natal transmission through breastfeeding. Infants on both treatments exhibited slower growth from birth to week 50.

The project’s second research question was to evaluate whether this difference in growth persisted over time, and whether it was accompanied by differences in neuropsychological and clinical outcomes. The researchers were able to re-enrol 1101 of the 1273 children initially enrolled in the study at ages 5-7 years. They used these children to conduct a cross-sectional clinical evaluation of these former trial participants who both completed the initial 50-week follow-up and who were not HIV-infected.

The researchers concluded that the impact of 1 year of LPV/r prophylaxis on growth did not persist over time after drug withdrawal. At school age, children exposed to LPV/r or 3TC regimens during their first year of life had comparable growth and neuropsychological outcomes without evidence of long-term deleterious effects of LPV/r on health status. This study provides reassuring data regarding the use of this antiretroviral drug in early life.

Read the Nature article.