Brief Report: Surveillance of Congenital Anomalies After Exposure to Raltegravir or Elvitegravir During Pregnancy in the United Kingdom and Ireland, 2008–2018

Rasi, Virginia; Cortina‐Borja, Mario; Peters, Helen; Sconza, Rebecca; Thorne, Claire

doi:10.1097/qai.0000000000001924

Cited by 21 publications

(22 citation statements)

References 20 publications

(20 reference statements)

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“…Rasi et al 40 evaluated data collected prospectively for pregnant women receiving elvitegravir/cobicistat or raltegravir. Data were extracted from the National Study of HIV in Pregnancy and Childhood in the UK and Ireland.…”

Section: Resultsmentioning

confidence: 99%

“…Data thus far do not suggest a signal for birth defects with raltegravir use during pregnancy either. 13,14,40…”

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 99%

“…Data thus far do not suggest a signal for birth defects with raltegravir use during pregnancy either. 13,14,40 The Department of Health and Human Services Antiretroviral Guidelines Panels suggest to not initiate dolutegravir in women who are planning to become pregnant or those who are sexually active and not using effective contraception. 7,28 Dolutegravir may be considered in women who are not planning pregnancy; however, pregnancy testing is recommended prior to starting dolutegravir, and women should be using effective contraception.…”

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 99%

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Pharmacokinetics and Safety of the Integrase Inhibitors Elvitegravir and Dolutegravir in Pregnant Women With HIV

2019

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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. Additional reports were identified from conference abstracts and review of reference lists. Study Selection and Data Extraction: English-language studies reporting pharmacokinetic and/or safety data in pregnant women receiving dolutegravir or elvitegravir/cobicistat were included. Data Synthesis: A total of 17 studies were selected. Studies demonstrated a modest decrease in dolutegravir concentrations in pregnancy. Preliminary data suggest an increased risk of neural tube defects when dolutegravir is used at the time of conception. Available pharmacokinetic data in pregnant women showed significantly reduced plasma concentrations of elvitegravir/cobicistat which may increase the risk of virological failure. Current guidelines recommend that dolutegravir should not be initiated in women who have the potential to become pregnant or women in their first trimester of pregnancy and elvitegravir/cobicistat should be avoided during pregnancy. Relevance to Patient Care and Clinical Practice: This review highlights pharmacokinetic and safety data for dolutegravir and elvitegravir/cobicistat in pregnant women. Clinicians need to be aware of these data to convey the risks and benefits of using these agents in women of child-bearing potential. Conclusions: Changes in guideline recommendations reflect emerging data regarding the use of dolutegravir and elvitegravir/cobicistat in pregnancy. Until further information is available, raltegravir or other first-line agents are recommended for women with HIV planning to become pregnant.

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Section: Resultsmentioning

confidence: 99%

“…Data thus far do not suggest a signal for birth defects with raltegravir use during pregnancy either. 13,14,40…”

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 99%

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 99%

See 1 more Smart Citation

Pharmacokinetics and Safety of the Integrase Inhibitors Elvitegravir and Dolutegravir in Pregnant Women With HIV

2019

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“…Bictegravir has only recently been FDA approved 6 , thus investigations are needed to see whether this INSTI, a close relative of dolutegravir, is safe to use during pregnancy. For now, raltegravir is the recommended INSTI to suppress viral load in HIV-1 pregnant women and prevent mother-to-child transmission, and no adverse effects have been found (Chouchana et al, 2019; Rasi et al, 2019; van der Galien et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

Inhibition of HTLV-1 Infection by HIV-1 First- and Second-Generation Integrase Strand Transfer Inhibitors

2019

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More than 10 million people worldwide are infected with the retrovirus human T-cell lymphotropic virus type 1 (HTLV-1). Infection phenotypes can range from asymptomatic to severe adult T-cell leukemia/lymphoma (ATLL) and HTLV-1-associated myelopathy. HTLV-1, like human immunodeficiency virus type 1 (HIV-1), is a blood-borne pathogen and viral infection happens in a similar fashion, with the major mode of transmission through breastfeeding. There is a strong correlation between time of infection and disease development, with a higher incidence of ATLL in patients infected during childhood. There is no successful therapeutic or preventative regimen for HTLV-1. It is therefore essential to develop therapies to inhibit transmission or block the onset/development of HTLV-1 associated diseases. Recently, we have seen the overwhelming success of integrase strand transfer inhibitors (INSTIs) in the treatment of HIV-1. Previously, raltegravir was shown to inhibit HTLV-1 infection. Here, we tested FDA-approved and two Phase II HIV-1 INSTIs in vitro and in a cell-to-cell infection model and show that they are highly active in blocking HTLV-1 infection, with bictegravir (EC 50 = 0.30 ± 0.17 nM) performing best overall. INSTIs, in particular bictegravir, are more potent in blocking HTLV-1 transmission than tenofovir disproxil fumarate (TDF), an RT inhibitor. Our data suggest that HIV-1 INSTIs could present a good clinical strategy in HTLV-1 management and justifies the inclusion of INSTIs in clinical trials.

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“…Antiretroviral therapy, specifically protease inhibitors, use during pregnancy has been associated with increased risk of preterm birth in some studies [ 51 – 59 ], as antiretroviral therapy produces immunologic changes [ 60 ], and interfering with maintenance of pregnancy [ 61 ]. A potential safety signal for an increased rate of neural tube defects in association with dolutegravir use in pregnancy has been identified in the surveillance study in Botswana [ 62 ], but not in other studies [ 63 – 65 ].…”

Section: Introductionmentioning

confidence: 99%

Available medications used as potential therapeutics for COVID-19: What are the known safety profiles in pregnancy

et al. 2021

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Background Medications already available to treat other conditions are presently being studied in clinical trials as potential treatments for COVID-19. Given that pregnant women are excluded from these trials, we aimed to investigate their safety when used during pregnancy within a unique population source. Methods Using the population-based Quebec Pregnancy Cohort, we identified women who delivered a singleton liveborn (1998–2015). Taking potential confounders into account including indications for use, the risk of prematurity, low birth weight (LBW), small for gestational age (SGA), and major congenital malformation (MCM) associated with COVID-19 repurposed drug use during pregnancy were quantified using generalized estimation equations. Results Of the 231,075 eligible pregnancies, 107 were exposed to dexamethasone (0.05%), 31 to interferons (0.01%), 1,398 to heparins (0.60%), 24 to angiotensin-receptor blockers (ARB) (0.01%), 182 to chloroquine (0.08%), 103 to hydroxychloroquine (0.05%), 6,206 to azithromycin (2.70%), 230 to oseltamivir (0.10%), and 114 to HIV medications (0.05%). Adjusting for potential confounders, we observed an increased risk of prematurity related to dexamethasone (aOR 1.92, 95%CI 1.11–3.33; 15 exposed cases), anti-thrombotics (aOR 1.58, 95%CI 1.31–1.91; 177 exposed cases), and HIV medications (aOR 2.04, 95%CI 1.01–4.11; 20 exposed cases) use. An increased risk for LBW associated with anti-thrombotics (aOR 1.72, 95%CI 1.41–2.11; 152 exposed cases), and HIV medications (aOR 2.48, 95%CI 1.25–4.90; 21 exposed cases) use were also found. Gestational exposure to anti-thrombotics (aOR 1.20, 95%CI 1.00–1.44; 176 exposed cases), and HIV medications (aOR 2.61, 95%CI 1.51–4.51; 30 exposed cases) were associated with SGA. First-trimester dexamethasone (aOR 1.66, 95%CI 1.02–2.69; 20 exposed cases) and azithromycin (aOR 1.10, 95%CI 1.02–1.19; 747 exposed cases) exposures were associated with MCM. Conclusions Many available medications considered as treatments for COVID-19 are associated with adverse pregnancy outcomes. Caution is warranted when considering these medications during the gestational period.

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Brief Report: Surveillance of Congenital Anomalies After Exposure to Raltegravir or Elvitegravir During Pregnancy in the United Kingdom and Ireland, 2008–2018

Cited by 21 publications

References 20 publications

Pharmacokinetics and Safety of the Integrase Inhibitors Elvitegravir and Dolutegravir in Pregnant Women With HIV

Pharmacokinetics and Safety of the Integrase Inhibitors Elvitegravir and Dolutegravir in Pregnant Women With HIV

Inhibition of HTLV-1 Infection by HIV-1 First- and Second-Generation Integrase Strand Transfer Inhibitors

Available medications used as potential therapeutics for COVID-19: What are the known safety profiles in pregnancy

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