Dolutegravir should be considered an appropriate treatment option for women living with HIV who are pregnant or considering pregnancy if they are carefully engaged and involved in decision making about their antiretroviral treatment For more information on the use of dolutegravir during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States. If you are breastfeeding or plan to breastfeed
, pregnant women, adolescents and paediatric clients, and as a job aide for healthcare workers and implemen ng partners Information on dolutegravir in pregnancy to date: Data was released on May 18, 2018 based on an interim analysis of an NIH funded birth surveillance study, the Tsepamo study, based in Botswana. At that time, they found that in 11,558 women living with HIV in Botswana who became pregnant, 0.9% of babies (4 of 426 In May 2018, the BHIVA HIV in Pregnancy Guidelines Committee released a statement advising on dolutegravir (DTG) use at the time of conception and in pregnancy, based on a preliminary unscheduled analysis of an ongoing birth surveillance study in Botswana In the updated 2019 guidelines, WHO recommends: Dolutegravir in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) for first-line treatment of all adults and adolescents. Efavirenz 400mg plus two NRTIs as an alternative first-line regimen for adults and adolescents Dolutegravir has been widely available in Brazil since 2017. Following the signal that infants born to women with dolutegravir exposure at conception in Botswana had a higher risk of neural tube defects (NTDs), public health leaders initiated a national investigation to evaluate periconception dolutegravir exposure among all pregnant Brazilian women with HIV and its potential association with.
According to the Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission, dolutegravir is recommended as a preferred antiretroviral drug throughout pregnancy and as an alternative antiretroviral drug in patients who are trying to conceive during pregnancy. However, information on DTG safety in women who started ART before pregnancy is limited and further studies are still needed. - Antiviral Pregnancy Registry (APR) : As of January 2017, pregnancy outcomes and birth defects were analysed from 142 pregnancies with reported exposure to DTG during pregnancy Interim Statement Regarding Potential Fetal Harm from Exposure to Dolutegravir - Implications for HIV Post-exposure Prophylaxis (PEP) • Pregnant women early in pregnancy since the risk of an unborn infant developing a iii The Panel on Antiretroviral Guidelines for Adults and Adolescents,. In 2020, U.S. guidelines did the same, moving dolutegravir from alternative to preferred status for people trying to conceive. U=U and Breast Feeding The updated guidelines continue to discourage people with HIV from breast-feeding their infants
The 2019 HIV clinical guidelines have been revised to include a new formulation of the fixed dose combination (FDC) of Tenofovir (TDF) 300 mg + Lamivudine (3TC) 300 mg + Dolutegravir (DTG) 50 mg (TLD) for all eligible adults, adolescents and children over the age of 10 years and weighing 20 kg or more
The Department of Health and Human Services Antiretroviral Guidelines Panels provide the following interim recommendations regarding use of dolutegravir in adults and adolescents with HIV who are pregnant or of reproductive potential:-Females not known to be pregnant should have a negative pregnancy test before starting dolutegravir
A preliminary unscheduled analysis of an ongoing birth surveillance study in Botswana has reported an increased risk of neural tube defects amongst infants of women who become pregnant whilst taking dolutegravir (DTG)-based regimens Dolutegravir in pregnant mothers and newborns (Image: pexels.com) Preventing mother-to-child transmission of HIV in late pregnancy. Challenges. In sub-Saharan Africa more than one in five HIV-infected pregnant women are diagnosed in late pregnancy each year In late May 2018, the DHHS guidelines added a warning regarding dolutegravir use in the first trimester of pregnancy secondary to data from a surveillance study in Botswana Dolutegravir (DTG) appears to be safe if started in pregnancy; however, there are concerns of preconception safety signal
Uncertainty about dolutegravir use in pregnancy. A major challenge to developing ART guidelines for the transition in both countries was uncertainty about dolutegravir use in pregnancy (and among women of childbearing potential) due to potential association with neural tube defects The 2016 guidelines for antiretroviral postexposure prophylaxis for nonoccupational exposure to HIV recommend either raltegravir (RAL) 400 mg twice daily or dolutegravir (DTG) 50 mg daily in.. The antiretroviral drugs dolutegravir and emtricitabine/tenofovir alafenamide fumarate (DTG+FTC/TAF) may comprise the safest and most effective HIV treatment regimen currently available during pregnancy, researchers announced today. Their findings come from a multinational study of more than 640 pregnant women with HIV across four continents Key updates to the guidelines include the following: The Panel has updated the recommendations on the use of dolutegravir (DTG) in pregnant women and women who are trying to conceive based on data available as of August 2019. Restrictions on the use of DTG during the first trimester and in women who are trying to conceive have been removed
Therefore, dolutegravir is not included as a first-line recommended regimen in pregnancy by WHO or by HIV guideline committees in the USA or Europe. Unavailability of pregnancy safety data has also hampered use of dolutegravir for all adults in low-income and middle-income countries where women of reproductive age make up a large proportion of. WEB ANNEX C. SAFETY OF DOLUTEGRAVIR IN PREGNANCY AND BREAST FEEDING LYNNE MOFENSON In: Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV: interim guidelines. Supplement to the 2016 consolidated guidelines The World Health Organization (WHO) has issued new antiretroviral treatment guidelines recommending dolutegravir-based treatment as the preferred first-line treatment option for all adults, adolescents and children, including women and adolescent girls who have access to consistent and reliable contraception.. The decision highlights the huge gap in access to reliable contraception and its. Indications for Antiretroviral Therapy in Pregnancy. The Perinatal Guidelines recommend using combination antiretroviral therapy for all pregnant women with HIV, regardless of CD4 count or HIV RNA level, to decrease the risk of perinatal HIV transmission and to benefit the mother's health. [21,22,23] All instances of antiretroviral exposure during pregnancy, should be reported online to the.
Non-dolutegravir @ time of conception 11,300 14 0.12% Dolutegravir initiated during pregnancy 2,812 0 - HIV-uninfected mothers 66,057 61 0.09% Zashet al. 2018 Zashet al. 2019 15 Guidelines 16 •Patients of childbearing potential: •Perform a pregnancy test •Recommended therapy for individuals attempting to conceive/are pregnant: Raltegravir. For women in the 2nd or 3rd trimester of pregnancy, guidelines recommend use of abacavir; dolutegravir; lamivudine as a preferred regimen; however, use of the drug should be avoided during the 1st trimester of pregnancy, and in non-pregnant women of childbearing potential who desire pregnancy or who are not using effective contraception Objective: To synthesize data on the pharmacokinetics and safety of dolutegravir and elvitegravir in pregnant women living with HIV. Data Sources: A PubMed, EMBASE, Web of Science, and Google Scholar literature search (January 2010 to December 2018) was performed using the search terms dolutegravir, elvitegravir, women, pregnant*, and HIV Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Preconception counseling and care for women of childbearing age living with HIV. Naver L. Dolutegravir in pregnancy — effects on HIV-positive women and their infants. Eur J Clin Microbiol Infect Dis. 2018 Mar;37(3):495-500. doi: 10.1007/s10096-018. of dolutegravir for use in HIV treatment during pregnancy to the National Core Formulary (NCF). This modification aligns the NCF with current recommendations from recent HHS treatment guidelines for HIV. Discussion: Dolutegravir, an integrase strand transfer inhibitor, was added as the preferred backbone for HI
Background: The integrase inhibitor dolutegravir is being considered in several countries in sub-Saharan Africa instead of efavirenz for people initiating antiretroviral therapy (ART) because of superior tolerability and a lower risk of resistance emergence. WHO requested updated modelling results for its 2019 Antiretroviral Guidelines update, which was restricted to the choice of dolutegravir. found in women who start dolutegravir during pregnancy Summary: Risk of dolutegravir use is small, benefits of dolutegravir include once-daily dosing, generally wel The WHO said it had changed its guidelines to strongly recommend dolutegravir (DTG) as the preferred first- and second-line treatment for all populations living with the disease, including pregnant women and those of childbearing potential
The HIV perinatal treatment guidelines of the U.S. Department of Health and Human Services (DHHS) also support dolutegravir for conception and pregnancy. There were three infant transmissions in utero for the dolutegravir group compared to one in the efavirenz group, which occurred postpartum to the baby of a breastfeeding mom • See BHIVA pregnancy guidelines for full guidance • Folic Acid o All HIV positive women who are trying to conceive or are pregnant should take folic acid until end of 13 weeks gestation. Dose depends on patient factors. Recommend folic acid 5mg daily if the woman is:: • taking dolutegravir • has diabete
In this context, the 2018 announcement that preconception use of dolutegravir was associated with four NTDs in a population-based surveillance study in Botswana generated immediate and massive concern.2 Dolutegravir was at that time poised to become the preferred first-line antiretroviral agent throughout international guidelines; the. Five countries recommend dolutegravir - except for pregnant women - which is in keeping with the superseded 2018 WHO guidelines. Between them, Côte d'Ivoire, Ethiopia, Kenya, Malawi and Namibia have 15% of HIV-positive people in the region Despite concerns about dolutegravir use in pregnancy, most low- and middle-income countries are accelerating the introduction of dolutegravir-based regimens into national antiretroviral treatment programmes. Questions remain about the acceptability of dolutegravir use in women due to the potential risks in pregnancy. This study from South Africa and Uganda explored community values. Dolutegravir (Tivicay) OK'd for pregnancy. The latest update essentially completes a rehabilitation of dolutegavir's safety profile in cases where the patient is or may become pregnant. In 2018, the Tsepamo study, an observational study of pregnant women in Botswana, initially appeared to find a link between dolutegravir exposure in the.
Dolutegravir-based antiretroviral treatment was associated with a higher rate of undetectable viral load at delivery in pregnant women, results of the IMPAACT 2010 trial show. A regimen containing both dolutegravir and tenofovir alafenamide was associated with fewer pre-term births and neonatal deaths than efavirenz-based treatment World Health Organization & Mofenson, L. (2018). Web annex C: safety of dolutegravir in pregnancy and breastfeeding: updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV: interim guidelines The effects on the pharmacokinetics of dolutegravir in pregnant women and the wash-out times in infants are not fully known. Few reports of dolutegravir use in pregnancy are published [ 6, 7 ]. The placenta transfer rate is high, and the half-life of DTG in infants is reported to be double that of adults [ 8, 9 ] A preliminary analysis of an independent observational study in Botswana has identified a potential safety issue with dolutegravir (DTG) -- a commonly used antiretroviral (ARV) drug for HIV. The preliminary findings identified 4 cases of neural tube defects out of 426 women who became pregnant while taking DTG
Three infant HIV infections were detected, all in the dolutegravir group, and were considered likely to be in-utero transmissions. Interpretation: Our data support the revision to WHO guidelines recommending the transition to dolutegravir in first-line ART for all adults, regardless of pregnancy or child-bearing potential Until April 2018, safety data on dolutegravir (DTG) antiretroviral therapy (ART) in pregnancy were reassuring. A systematic review on the safety of DTG during pregnancy reported no evidence for increased risk of adverse birth outcomes or congenital anomalies Introduction: Recent data on the 2-drug regimen (2DR) with dolutegravir (DTG) plus lamivudine (3TC) have shown high efficacy and tolerability both in treatment-naïve and experienced HIV-positive patients.Current guidelines recommend DTG+3TC as an alternative to triple antiretroviral therapy (ART) in selected patients to reduce long-term toxicity and costs
For 15 months preceding the update, however, following findings in Botswana of four babies born with defects to the brain, spine or spinal cord, among 426 women taking dolutegravir at conception - a rate of 0.9% — WHO guidelines cautioning against the use of dolutegravir among pregnant women led to policies withholding the preferred drug. Last week, in response to newly available surveillance data, multiple agencies issued a warning about the HIV integrase inhibitor dolutegravir (DTG) and pregnancy. The warnings cite an increased risk of neural tube defects in babies born to women who became pregnant while receiving the drug. From the U.S. Department of Health and Human Services: The concern stems from [ Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil . fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, randomised, controlled, phase 3 tria During pregnancy, atazanavir/ritonavir, darunavir/ritonavir, dolutegravir, efavirenz, raltegravir, and rilpivirine are recommended. Before any treatment changes, the patient's ART regimen, regimen tolerability, co-medications, food requirements, cost, and results from prior resistance tests should be reviewed PEP Quick Guide for Occupational Exposures. These NCCC post-exposure prophylaxis (PEP) recommendations will help you with urgent decision-making for occupational exposures to HIV and hepatitis B and C. Consultation can be obtained from Occupational Health or Employee Health Services, local experts, or the NCCC's PEPline
Pauline Bollen, Jolien Freriksen, Deborah Konopnicki, Katharina Weizsäcker, Carmen Hidalgo Tenorio, José Moltó, Graham Taylor, Irene Alba-Alejandre, Reinout van Crevel, Angela Colbers, David Burger, Pharmacokinetics of ANtiretroviral agents in HIV-infected pregNAnt women Network, The Effect of Pregnancy on the Pharmacokinetics of Total and Unbound Dolutegravir and Its Main Metabolite in. At that time, they found that in 11,558 women living with HIV in Botswana who became pregnant, 0.9% of babies (4 of 426) whose mothers became pregnant while taking dolutegravir had a NTD, compared with 0.1% of babies (14 of 11,173) whose mothers took other antiretroviral combinations (1,2) For this reason, newer guidelines recommend the use of dolutegravir in pregnancy as a preferred agent and consider it a reasonable alternative agent in women contemplating conception. References Rates of mother-to-child transmission of HIV-1 in Africa, America, and Europe: results from 13 perinatal studies Tivicay risk revised: The last update to the guidelines recommended that dolutegravir (Tivicay) not be prescribed to women who want to become pregnant or are pregnant, because of a low potential risk of birth defects. Recent data have shown that the rate of such concerns was lower than previously reported, and the guideline around this issue.
Dolutegravir. As part of the IMPAACT protocol P1026s, researchers looked at the effect of pregnancy on dolutegravir pharmacokinetics in 22 HIV-infected pregnant women. Data were available for 15 women in the third trimester and for 9 women postpartum who completed intensive PK studies A pregnancy test should be performed for those of childbearing potential prior to initiation of ART (AIII). Preliminary data suggest there may be an increased risk of neural tube defects (NTDs) (0.9%) in infants born to women who were receiving dolutegravir (DTG) at the time of conception 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 pregnan Animal Data: Dolutegravir: Dolutegravir was administered orally at up to 1,000 mg per kg daily to pregnant rats and rabbits on gestation Days 6 to 17 and 6 to 18, respectively, and to rats on gestation Day 6 to lactation/post-partum Day 20. No adverse effects on embryo-fetal (rats and rabbits) development were observed at up to the highest dose. If pregnancy is confirmed in the first trimester during treatment, the benefits and risks of continuing dolutegravir versus switching to another antiretroviral regimen should also be discussed, considering the gestational age and the critical time period of neural tube defect development The dolutegravir, emtricitabine, and tenofovir alafenamide fumarate regimen (A) had the lowest frequency of adverse pregnancy outcomes and neonatal deaths The authors conclude When started at 14-28 weeks of pregnancy, all three ART regimens studied in this trial led to high rates of virological suppressio