Pregnancy categories A, B, C, D, and X are being phased out. Because animal reproduction studies are not always predictive of human response, and dolutegravir was shown to cross the placenta in animal studies, this drug should be used during pregnancy only if clearly needed. Medical care of pregnant women with HIV requires coordination and communication between HIV specialists and obstetric providers. He has been covering HIV news since 1988.https://www.thebodypro.com/article/dolutegravir-and-the-fetus Embryofetal toxicity included increased postimplantation embryolethality (including total litter loss), decreased fetal weights, and increased rate of costal cartilage fusion in mice with maternal toxicity (clinical signs, reduced weight gain); decreased fetal weights, reduced sternebrae ossification, decreased pup survival, and mildly delayed maturation in rats with slight maternal toxicity (reduced weight gain); and reduced fetal weights in rabbits with maternal toxicity (clinical signs, reduced weight gain, reduced food intake). In studies with pregnant mice and rats, other researchers have not found "direct evidence" that exposure to dolutegravir resulted in birth defects or affected the development of the fetus.Most anti-HIV drugs are not formally tested in large randomized clinical trials of pregnant women. Dolutegravir pharmacokinetics in pregnant and postpartum women living with HIV. To monitor maternal-fetal outcomes of pregnant women that have used an antiretroviral, including Triumeq, an Antiretroviral Pregnancy Registry has been established. Animal studies have failed to reveal evidence of adverse developmental outcomes at up to the highest dose tested in rats and rabbits; systemic exposures to this drug were less than (rabbits) and about 27 times (rats) the exposure in humans at the maximum recommended human dose.
Risk summary: Insufficient data available on use of this drug in pregnant women to definitively inform a drug-related risk; possible increased risk of neural tube defects when used at time of conception (compared to … ARV drugs are important for maintaining maternal health because they decrease the rate of HIV disease progression, reduce the risk of opportunistic disease, and reduce the risk of maternal death.ARV drugs reduce the risk of perinatal transmission of HIV in all pregnant women, regardless of their CD4 counts and HIV RNA levels.
Pregnancy Category B. Dolutegravir EC 50 values against three HIV-2 clinical isolates in PBMC assays ranged from 0.09 nM to 0.61 nM. It is taken by mouth. Women should be screened for mental health conditions, assessed for the risk of intimate partner violence, counseled about disclosure of their HIV status when needed, and referred to the appropriate services.In addition, providers should counsel women with HIV about what to expect during labor, delivery, and the postnatal period. It is therefore important to study the movement of these drugs across the placenta so that researchers can assess the potential of medicines to protect the fetus from HIV.The most potent class of anti-HIV drugs is called integrase inhibitors. By driving the amount of HIV in the mother down to very low levels, ART plays a key role in protecting the fetus from infection.Anti-HIV drugs move from the mother's circulation to that of the fetus via a physical connection during pregnancy called the placenta. General counseling should include current knowledge about risk factors for perinatal HIV transmission. Placental transfer of this drug and/or its metabolites was observed in rats. Patients taking a dolutegravir-containing regimen at the time of becoming pregnant and during the first trimester of pregnancy, there is a potential risk of neural tube defects; neural tube defects happen early in pregnancy, before many women even know they are pregnant As some HIV-positive women who use dolutegravir-containing ART can become pregnant, it is important to begin to investigate how this drug can affect the fetus. Data on use of Dolutegravir before Conception and During Pregnancy: In May of 2018, an unplanned interim evaluation of the Botswana birth surveillance data revealed four NTDs among infants born to 426 women (0.94%) who conceived while taking DTG-based ART. We comply with the HONcode standard for trustworthy health information - Pre-exposure prophylaxis is achieved by administering ARV drugs to the mother that cross the placenta and produce adequate systemic drug levels in the fetus. If you take a dolutegravir-containing regimen at the time of becoming pregnant and during the first trimester of pregnancy, there is a risk that your baby may develop neural tube defects. However, reproduction studies with the components of Triumeq have been performed in animals.
To begin to explore this possibility, researchers in Nijmegen, the Netherlands, have developed a system in their lab, using donated placentas, to simulate the blood circulation between fetus and mother.Dolutegravir can cross the placenta and enter the blood supply of the fetus.The concentration of dolutegravir in the fetus' blood supply was considered "moderate to high" by the researchers.
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