Efficacy of Three Antiretroviral Regimens Initiated during Pregnancy: Clinical Experience in Rio de Janeiro

Teixeira, Maria de Lourdes Benamor; Fuller, Trevon; Gouvêa, Maria Isabel Fragoso da Silveira; Cruz, Maria Letícia Santos; Ceci, Loredana; Lattanzi, Fellipe Pinheiro; Sidi, Leon Claude; Mendes‐Silva, Wallace; Nielsen‐Saines, Karin; Joao, Esau Custodio

doi:10.1128/aac.01068-20

Cited by 8 publications

(4 citation statements)

References 18 publications

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“…We and Patel et al identified NNRTI and protease inhibitor alternatives with similar efficacy to dolutegravir, whereas other observational studies and randomized controlled trials have shown that INSTIs were superior to protease inhibitors or NNRTIs at achieving virologic suppression in pregnancy [3][4][5][6][7][8][9]17]. We suspect that the differences between those prior studies and our findings are a result of those studies using older and less potent anchors in the comparator groups and initiating ART late in pregnancy, leaving less time to achieve viral suppression prior to delivery.…”

Section: Discussionmentioning

confidence: 86%

“…Some INSTIs, in particular dolutegravir, also have a high genetic barrier to resistance. Several randomized controlled trials and observational studies have demonstrated superior virologic outcomes among pregnant women who received raltegravir compared with efavirenz, atazanavir/ritonavir, or lopinavir/ritonavir [3][4][5][6]. Three randomized controlled trials compared dolutegravir to efavirenz started in the second or third trimester and found that dolutegravir was superior at suppressing the viral load by delivery [7][8][9].…”

Section: Introductionmentioning

confidence: 99%

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Modern antiretroviral regimens in pregnant women: virologic outcomes and durability

Smith

Silveira

Crotteau

et al. 2023

Aids

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a,e , the CHIP Perinatal Team M Objectives: Data are lacking on the virologic efficacy and durability of modern antiretroviral treatment (ART) regimens during pregnancy. We compared virologic outcomes at delivery among women receiving dolutegravir versus other ART and the rate of change of the initial pregnancy regimen.Design: Single-site retrospective cohort between 2009 and 2019.Methods: We used univariable and multivariable generalized estimating equations to model the relationship between the maternal ART anchor and the proportion of women with a detectable viral load (greater than or equal to 20 HIV RNA copies/mL of plasma) closest to delivery (suboptimal virologic control) and with a detectable viral load at any time in the third trimester. We also compared changes in ART during pregnancy.Results: We evaluated 230 pregnancies in 173 mothers. Rates of optimal virologic control at delivery did not significantly differ in mothers who received dolutegravir (93.1%), rilpivirine (92.1%), boosted darunavir (82.6%), or efavirenz (76.9%) but were significantly lower among mothers receiving atazanavir (49.0%) or lopinavir (40.9%). The odds of having a detectable viral load at any time in the third trimester was also higher for atazanavir and lopinavir. Raltegravir, elvitegravir, or bictegravir were used in less than 10 mothers at delivery, which precluded statistical analyses. The frequency of change in ART was significantly higher in mothers who initially received elvitegravir (68%) or efavirenz (47%) than dolutegravir (18%).Conclusion: Dolutegravir-containing, rilpivirine-containing, and boosted darunavircontaining regimens conferred excellent virologic control in pregnancy. Atazanavir and lopinavir, elvitegravir, and efavirenz were associated with either high rates of virologic failure or regimen change during pregnancy.

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Section: Discussionmentioning

confidence: 86%

Section: Introductionmentioning

confidence: 99%

Modern antiretroviral regimens in pregnant women: virologic outcomes and durability

Smith

Silveira

Crotteau

et al. 2023

Aids

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“…The group involved in the current study also took part in the follow‐up of this cohort prospectively. A detailed description of our institution's cohort has been published previously [13]. From October 2014 to October 2021, all pregnant women living with HIV who were referred for prenatal care to our centre, which is a national reference for PMTCT in Rio de Janeiro (one of the epicentres of the HIV epidemic in Brazil) and who met the study inclusion criteria were included.…”

Section: Methodsmentioning

confidence: 99%

Real‐world experience with weight gain among pregnant women living with HIV who are using integrase inhibitors

et al. 2022

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Objectives We assessed real‐world weight change and pregnancy outcomes among pregnant women living with HIV who used integrase strand transferase inhibitor (INSTI)‐based combined antiretroviral therapy (cART). Methods In a retrospective cohort study from 2014 to 2021 for prevention of perinatal HIV infection, we evaluated changes in weight from the first prenatal visit to near delivery for two groups. The categories of change were: low (< 0.18 kg/week), normal (0.18–0.59 kg/week), and high (> 0.59 kg/week). The backbones were lamivudine + tenofovir disoproxil or lamivudine + zidovudine. The comparison groups were women with body mass index (BMI) < 25 kg/m2 versus BMI ≥ 25 kg/m2 and INSTI‐naïve versus INSTI‐experienced. Continuous variables were analysed with a Kruskal–Wallis test and count or categorical data with χ2 tests. Results We enrolled 198 pregnant women. At study entry, 74 had BMI < 25 kg/m2 and 124 had BMI ≥ 25 kg/m2. Excess gestational weight gain was more frequent among women who were INSTI‐naïve among both BMI groups (< 25 and ≥ 25). However, the proportion of participants per weight change category was only significantly different between INSTI‐naïve women with baseline BMI < 25 kg/m2 and INSTI‐experienced women with BMI < 25 kg/m2. In particular, INSTI‐naïve women with BMI < 25 kg/m2 had significantly higher rates of excess gestational weight gain (31.6%) compared with participants with BMI < 25 kg/m2 who conceived while on INSTIs (11.8%, p = 0.004). Rates of unfavourable pregnancy outcomes were low and did not differ significantly between groups. Conclusions INSTI‐naïve participants with BMI < 25 kg/m2 gained more weight during pregnancy than participants with BMI ≥ 25 kg/m2 who conceived while using INSTIs. Rates of adverse pregnancy outcomes did not differ between the groups.

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“…5 RAL is safe for pregnant women, and the most common adverse event is the presence of abnormal hemoglobin values when compared with average values during pregnancy. 5,6 A study from Brazil 7 did not find differences in the frequency of preterm birth, low birth weight, small for gestational age, stillbirths, or perinatal mortality between neonates whose mothers received RAL and those whose mothers received other evaluated treatments, including efavirenz, lopinavir/ritonavir, or atazanavir/ ritonavir. RAL pharmacokinetics are highly variable, 8 with secondary peaks often seen in plasma concentrations versus time profiles, probably due to enterohepatic recycling or delayed absorption.…”

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confidence: 99%

Total, Unbound, Renal, and Hepatic Clearances of Raltegravir and the Formation and Elimination Clearances of Raltegravir Glucuronide in Pregnant Women

Moreira

Paz

Melli

et al. 2023

The Journal of Clinical Pharma

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This work aimed to evaluate the total, unbound, renal, and hepatic clearances of raltegravir (RAL) and the formation and elimination clearances of raltegravir glucuronide (RAL GLU) in pregnant women living with HIV. The participants received RAL 400 mg twice daily during the third trimester (n = 15) of gestation, delivery (n = 15), and the postpartum period (n = 8). Pharmacokinetic parameter values were calculated on the basis of plasma and urine data using noncompartmental methods. RAL clearances for the third trimester of gestation were as follows: total clearance: geometric mean, 63.63 L/h (95% CI, 47.5–85.25); renal clearance: geometric mean, 2.56 L/h (95% CI, 1.96–3.34); hepatic clearance: geometric mean, 60.52 L/h (95% CI, 44.65–82.04); and unbound clearance: geometric mean, 281.14 L/h (95% CI, 203.68–388.05). RAL GLU formation and elimination clearances for the third trimester of gestation were 7.57 L/h (95% CI, 4.94–11.6) and 8.71 L/h (95% CI, 6.71‐11.32), respectively. No differences were observed in RAL GLU pharmacokinetic parameters between the third trimester of gestation and the postpartum period, except for higher formation (7.57 vs 4.03 L/h) and elimination (8.71 vs 4.92 L/h) clearances during the third trimester. The findings based on plasma and urine data are consistent with an increase in the hepatic uridine 5′ diphospho‐glucuronosyltransferase isoenzymes activities involved in RAL metabolism during pregnancy, and the formation of RAL GLU is a minor route of RAL elimination. Compared to the postpartum period, in the third trimester of gestation, the similar RAL plasma exposure in pregnant women reinforces the maintenance of an RAL regimen including a 400‐mg oral dose twice daily during pregnancy.

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Efficacy of Three Antiretroviral Regimens Initiated during Pregnancy: Clinical Experience in Rio de Janeiro

Cited by 8 publications

References 18 publications

Modern antiretroviral regimens in pregnant women: virologic outcomes and durability

Modern antiretroviral regimens in pregnant women: virologic outcomes and durability

Real‐world experience with weight gain among pregnant women living with HIV who are using integrase inhibitors

Total, Unbound, Renal, and Hepatic Clearances of Raltegravir and the Formation and Elimination Clearances of Raltegravir Glucuronide in Pregnant Women

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