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BACKGROUND: A single intrapartum dose of nevirapine for the prevention of moth er-to-child transmission of human immunodeficiency virus (HIV) leads to the se lection of resistance mutations. Whether there are clinically significant conseq uences in mothers who are subsequently treated with a nevirapine-containing reg imen is unknown. METHODS: We randomly assigned 1844 women in Thailand who receiv ed zidovudine during the third trimester of pregnancy to receive intrapartum nev irapine or placebo. In the postpartum period, 269 of the women with a CD4 count below 250 cells per cubic millimeter began a nevirapine-containing antiretrovir al regimen.Plasma samples were obtained 10 days post partum and analyzed for res istance mutations. Plasma HIV type 1(HIV-1) RNA was measured before the initiat ion of therapy and three and six months thereafter. RESULTS: After six months of therapy, the HIV-1 RNA level was less than 50 copies per milliliter in 49 perc ent of the women who had received intrapartum nevirapine, as compared with 68 pe rcent of the women who had not received intrapartum nevirapine (P=0.03 ). Resist ance mutations to nonnucleoside reverse-transcriptase inhibitors were detectabl e in blood samples obtained 10 days post partum from 32 percent of the women who had received intrapartum nevirapine; the most frequent mutations were K103N,G19 0A, and Y181C. Among the women who had received intrapartum nevirapine, viral su ppression was achieved at six months in 38 percent of those with resistance muta tions and 52 percent of those without resistancemutations(P=0.08). An HIV-1 RNA level at or above the median of 4.53 log10 copies per milliliter be fore therapy and intrapartum exposure to nevirapine were independently associate d with virologic failure. After six months of therapy,there was no significant d ifference between groups in the CD4 count (P=0.65). CONCLUSIONS: Women who recei ved intrapartum nevirapine were less likely to have virologic suppression after six months of postpartum treatment with a nevirapine-containing regimen. Our da ta suggest the need for strategies to maximize the benefits of both antiretrovir al prophylaxis against mother-to-child transmission of HIV and antiretroviral therapy for mothers.
BACKGROUND: A single intrapartum dose of nevirapine for the prevention of moth er-to-child transmission of human immunodeficiency virus (HIV) leads to the selection of resistance mutations. If there are clinically significant conseq uences in mothers who are subsequently treated with a METHODS: We randomly assigned 1844 women in Thailand who receiv ed zidovudine during the third trimester of pregnancy to receive intrapartum nev irapine or placebo. In the postpartum period, 269 of the women with a CD4 count below 250 Cells per cubic millimeter began a nevirapine-containing antiretrovir al regimen. Plasmids were obtained 10 days post partum and analyzed for res istance mutations. Plasma HIV type 1 (HIV-1) RNA was measured before the initiation of therapy and three and six months thereafter. RESULTS: After six months of therapy, the HIV-1 RNA level was less than 50 copies per milliliter in 49 per cent of the women who had received i ntrapartum nevirapine, as compared with 68 pe rcent of the women who had not received intrapartum nevirapine (p = 0.03). Resist ance mutations to nonnucleoside reverse-transcriptase inhibitors were detected ab l e in blood samples obtained 10 days post partum from 32 percent of the women Among the women who had received intrapartum nevirapine, viral supression had achieved at six months in 38 percent of those with resistance muta tions and 52 percent of those who had received intrapartum nevirapine; the most frequent mutations were K103N, G19 0A, and Y181C. without resistance motions (P = 0.08). An HIV-1 RNA level at or above the median of 4.53 log 10 copies per milliliter be fore therapy and intrapartum exposure to nevirapine were independent associate d with virologic failure. After six months of therapy, there was no significant difference between groups in the CD4 count (P = 0.65). CONCLUSIONS: Women who recei ved intrapartum nevirapine were less likely to have virologic suppression after six months of postpartum treatment with a nevirapine-containing regimen. Our da ta suggest the need for strategies to maximize the benefits of both antiretrovir al prophylaxis against mother-to-child transmission of HIV and antiretroviral therapy for mothers.