Effect Of Prevention Of Mother To Child Transmission Of HIV With Triple-antiretroviral Regimen

Objective: To evaluate the effectiveness, safety, and feasibility of preventing mother to child transmission of HIV (PMTCT) with two triple-antiretroviarl regimens in high prevalence regions of AIDS in Yunnan Province and to explore the correlates of the two triple-antiretroviarl regimens to prevent mother to child transmission of HIV, so as to provide the scientific basis for making current effective and appropriate intervention in high prevalence regions of AIDS in Yunnan Province.Methods:The study was conducted by clinical trial. HIV-infected pregnant women and their infants from11counties in high prevalence regions of AIDS in Yunnan were cruited as subjectives. Well trained medical staff provided one-to-one follow-up and PMTCT services to them. HIV infected pregnant women were randomized into two groups and received antiretroviral therapy by either Lopinavir/ritonavir (LPV/r) or Efavirenz(EFV)/Nevirapine (NVP) and with Zidovudine (AZT) and Lamivudine(3TC), respectively. At the same time, all of the women deliveried in hospital, and all of their infants were feeded with formula milk. CD4+T lymphocytes count and plasma HIV viral load were detected to HIV infected pregnant women before therapy, at36weeks gestation,3months postpartum, and HIV viral was also measured to the women in delivery period as well. Blood routine and hepatic function were detected before therapy and at the2nd, the4th, the8th, the12th, the24th weeks and delivery after therapy. Infants received HIV-DNA polymerase chain reaction (PCR) tested at age of6weeks old, and each3month after the first test to one year old. A questionnaire survey were conducted to HIV-infected pregnant women to get information including socialdemographic, knowledge, attitude and behavior on AIDS. All the women and their infants were followed up and recorded the information regarding antenatal and postpartum health care, drug taken, deliveries, infants birth, feeding, etc.Results:A total of152HIV-infected pregnant women were enrolled with82cases in AZT+3TC+LPV/r group (LPV/r group) and70cases in AZT+3TC+EFV/NVP group (EFV/NVP group).144women have already deliveried with143live births and one stillbirth. Among the deliveried,56.3%were normal vaginal deliveries,11.1%had episiotomy, and4.9%had artificial rupture of membranes. Premature birth rate and LBW rate was5.6%and14.6%, respectively. Except for one infant dead of asphyxia, all other babies received formula-feeding. HIV DNA-PCR test had been done to121live babies. The total HIV infection rate of infants was1.65%, with2HIV positive cases in LPV/r group and none HIV positive in EFV/NVP group. There was no significant difference in HIV infection rate of infants between the two groups.Before therapy, the median of CD4+cells was399/mm3, and the median of viral load was3.88log10copies/mL. The median of CD4+cells increased to500/mm3and the median of viral load decrease of3.88log10copies/mL at36weeks gestation after therapy. There was increasing trend of CD4+cell after therapy and CD4+cell count topped at3months postpartum in two groups. Both the medians of HIV viral load in two groups were the lowest at36weeks gestation. There were no significant differences in changes of viral load and CD4+cell after therapy between the two groups. Viral load was below50copies/ml at onset of labour for68%(68/100). Multiple logistic regression showed that initiate gestation week of antiretroviarl therapy was negative associated with the viral load below50copies/ml at delivery.The prevenlance of Anemia was11.2%in all HIV-infected pregnant women before therapy. The prevenlances of Anemia at the week of eight and the week of twelve after therapy in LPV/r group and at the week of four and the week of eight after therapy in EFV/NVP group were higher than those before the therapy (P<0.05). After therapy, there were only a few maternity abnormal cases occurred in Leukopenia, Thrombocytopenia and Neutropenia, the rate had no significant difference before therapy and after in the same group. There were no significant difference in accident of Anemia, Leukopenia, Thrombocytopenia, Neutropenia at the same stage of6detections after therapy between the two groups.ALT, AST, TBIL in same cases increased out of normal at each stage of6detections after therapy.However, there was mild or moderate hepatic toxicity happened to26.3%women cases with ALT or/and AST or/and TBIL increasing at each stage of6detections after therapy.There were no significant differences in accident of ALT, AST, TBIL before therapy and after in the same group. The accident of ALT abnormal in EFV/NVP group at the week of eight after therapy was higher than that in LPV/r group(P<0.05). The accident of TBIL abnormal at the week of fourth and eight after therapy in LPV/r group were higher than those in EFV/NVP group(P<0.05).The total adherence rate of antiretroviarl therapy in women was96.05%(146/152).Both the two triple-antiretroviarl regimens were higher than95%, with no significant difference between the two regimens.Conclusion:Both the two triple-antiretroviarl regimens can significantly reduce HIV viral and improve immune function for HIV positve women. The tolerance and adherence of the two regimens to HIV positve women are good. The intervention measure of preventing mother to child transmission of HIV containing triple-antiretroviarl regimen showed good effectiveness, safety, and feasibility in high prevalence regions of AIDS in Yunnan Province. The effects of the two triple-antiretroviarl regimens to prenventing mother to child transmission had no significant difference.This study strongly suggests that HIV positve pregnant women should receive triple-antiretroviarl regimen therapy as early as possible after14weeks gestation, and should continue therapy regularly after delivery.