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妊産婦における Lopinavir/ritonavir(カレトラ)の使用経験―特定使用成績調査―
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JPY
Abstract
Background Since its approval in 2000, lopinavir boosted with ritonavir(LPV/r, Kaletra)has been widely used to treat HIV infection. This post-marketing 10-year observational study was conducted to evaluate the safety of LPV/r in pregnant women who are HIV+ and their infants. Methods Twenty-four pregnant women were enrolled. Safety variables included adverse drug reactions(ADRs)including laboratory abnormalities. The babies were followed up for one year after birth. Results Twenty-one of the 24 women gave birth, all of them by caesarean section. There were no cases of vertical transmission of HIV. The efficacy of LPV/r therapy was evaluated in 19 women whose laboratory data at childbirth were available. ADRs developed in 37.50% of the mothers(9/24). The incidence of ADRs in infants was 28.57%(6/21). Conclusions All 21 infants were born through caesarean section. No case of vertical transmission of HIV was observed. Its established safety profile warrants the use of LPV/r in pregnant women.(ClinicalTrials. gov number, NCT01076985.)
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