Laboratory Abnormalities Among HIV-Exposed, Uninfected Infants: IMPAACT Protocol P1025

Read, Jennifer S.; Huo, Yanling; Patel, Kunjal; Mitchell, Marcia; Scott, Gwendolyn B.

doi:10.1093/jpids/pis036

Cited by 8 publications

(4 citation statements)

References 39 publications

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“…Pacheco et al reported significantly decreased infant hemoglobin and neutrophil values, and Mussi-Pinhata et al described anemia at hospital discharge in 24% of ARV-exposed infants, although in both studies nearly all AE were of grade 1 or 2 [ 17 , 23 ]. Read et al described grade ≥3 anemia or neutropenia in less than 10% of ARV-exposed infants in the first six weeks of life [ 19 ]. Four infants in our study required a blood transfusion due to anemia, all of whom were born at ≤32 weeks of gestation.…”

Section: Discussionmentioning

confidence: 99%

Maternal Lopinavir/Ritonavir Is Associated with Fewer Adverse Events in Infants than Nelfinavir or Atazanavir

Smith

Weinberg

Forster

et al. 2016

Infectious Diseases in Obstetrics and Gynecology

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Combination antiretroviral therapy (cART) is successfully used for prevention of perinatal HIV transmission. To investigate safety, we compared adverse events (AE) among infants exposed to different maternal cART regimens. We reviewed 158 HIV-uninfected infants born between 1997 and 2009, using logistic regression to model grade ≥1 AE and grade ≥3 AE as a function of maternal cART and confounding variables (preterm, C-section, illicit drug use, race, ethnicity, infant antiretrovirals, and maternal viremia). Frequently used cART regimens included zidovudine (63%), lamivudine (80%), ritonavir-boosted lopinavir (37%), nelfinavir (26%), and atazanavir (10%). At birth, anemia occurred in 13/140 infants (9%), neutropenia in 27/107 (25%), thrombocytopenia in 5/133 (4%), and liver enzyme elevation in 21/130 (16%). Corresponding rates of AE at 4 weeks were 59/141 (42%), 54/130 (42%), 3/137 (2%), and 3/104 (3%), respectively. Serious AE (grade ≥ 3) exceeded 2% only for neutropenia (13% at birth; 9% at 4 weeks). Compared with infants exposed to maternal lopinavir/ritonavir, infants exposed to nelfinavir and atazanavir had a 5-fold and 4-fold higher incidence of AE at birth, respectively. In conclusion, hematologic and hepatic AE were frequent, but rarely serious. In this predominantly protease inhibitor-treated population, lopinavir/ritonavir was associated with the lowest rate of infant AE.

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Section: Discussionmentioning

confidence: 99%

Maternal Lopinavir/Ritonavir Is Associated with Fewer Adverse Events in Infants than Nelfinavir or Atazanavir

Smith

Weinberg

Forster

et al. 2016

Infectious Diseases in Obstetrics and Gynecology

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“…The SMARTT arm of the Pediatric HIV/AIDS Cohort Study (PHACS) is currently ongoing and aims to estimate the incidence of conditions and diagnoses potentially related to in utero exposure to ARVs or exposure in the first 2 months of life among children born of HIV-infected mothers. Another recent study of over 1500 HIV-exposed infants and uninfected infants exposed to ARVs and to trimethoprimin-sulfamethoxazole in utero and in early infancy demonstrated that serious adverse events related to hemoglobin, absolute neutrophil count, total lymphocyte count, and glucose were experienced by fewer than 10% of infants in the first 6 months of life [12]. Although these results are encouraging, it is clear that further pharmacokinetic, efficacy, and safety data are needed for these medications in pregnancy as well as for exposed infants.…”

Section: Discussionmentioning

confidence: 99%

Salvage Regimens Containing Darunavir, Etravirine, Raltegravir, or Enfuvirtide in Highly Treatment-Experienced Perinatally Infected Pregnant Women

Shust¹,

Jao²,

Rodriguez-Caprio³

et al. 2013

Journal of the Pediatric Infectious Diseases Society

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Combination antiretroviral therapy in pregnant women with human immunodeficiency virus has dramatically decreased maternal-to-child transmission. Highly treatment-experienced pregnant patients have limited effective treatment options due to past toxicities and viral resistance. We present 8 pregnancies in 7 perinatally infected women successfully treated with salvage regimens containing darunavir, etravirine, raltegravir, or enfuvirtide.

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“…Our findings were similar to those reported for the IMPAACT P1025 study, where 91% of infants received ZDV alone as neonatal prophylaxis, 3% also received SD NVP, and 6% received other combination ARV prophylaxis. 22 However, infants in the United States are much less likely to receive combination prophylaxis than their European counterparts, where up to 14% receive combination prophylaxis. 5,8 In addition, only about 2% of infants in our evaluation received a three-drug combination prophylaxis regimen, while use of triple-ARV prophylaxis is relatively common in Europe and Canada.…”

Section: Discussionmentioning

confidence: 99%

Trends in Neonatal Prophylaxis and Predictors of Combination Antiretroviral Prophylaxis in US Infants from 1990 to 2015

Williams

Huo

Rutstein

et al. 2018

AIDS Patient Care and STDs

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Postnatal antiretroviral (ARV) prophylaxis for infants born to women with HIV is a critical component of perinatal HIV transmission prevention. However, variability in prophylaxis regimens remains and consistency with guidelines has not been evaluated in the United States. We evaluated trends over time in prophylaxis regimens among 6386 HIV-exposed uninfected (HEU) infants using pooled data spanning two decades from three US-based cohorts: the Women and Infants Transmission Study (WITS, 1990-2007), Pediatric AIDS Clinical Trials Group (PACTG) 219C (1993-2007), and the PHACS Surveillance Monitoring of ART Toxicities (SMARTT) study (2007-2015). We also identified maternal and infant risk factors for use of combination prophylaxis regimens (‡2 ARVs) and examined consistency with US perinatal guidelines. We found that receipt of combination prophylaxis between 1996 and 2015 ranged from 2% to 15%, with a consistent median duration of 6 weeks. Infants whose mothers had lower CD4 T-cell counts, higher viral load (VL), no antepartum ARVs, age <20 years at delivery, and Cesarean delivery had significantly higher rates of combination prophylaxis, while infants born 2006-2010 (vs. 2011-2015), who were Hispanic or with lower maternal education levels, had significantly lower rates. Predictors for combination prophylaxis varied over time, with the strongest associations of maternal VL in later birth cohorts. While use of combination prophylaxis increased over time, only 50% of high-risk infants received such regimens in 2011-2015. In conclusion, HEU infants at higher risk of HIV acquisition are more likely to receive combination neonatal prophylaxis, consistent with US guidelines. However, substantial variability remains, and infants at higher risk often fail to receive combination prophylaxis.

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Laboratory Abnormalities Among HIV-Exposed, Uninfected Infants: IMPAACT Protocol P1025

Abstract: The overall frequency of laboratory SAEs was low and decreased with age. Preterm infants are at higher risk of hemoglobin- and total lymphocyte count-related SAEs.

Cited by 8 publications

References 39 publications

Maternal Lopinavir/Ritonavir Is Associated with Fewer Adverse Events in Infants than Nelfinavir or Atazanavir

Maternal Lopinavir/Ritonavir Is Associated with Fewer Adverse Events in Infants than Nelfinavir or Atazanavir

Salvage Regimens Containing Darunavir, Etravirine, Raltegravir, or Enfuvirtide in Highly Treatment-Experienced Perinatally Infected Pregnant Women

Trends in Neonatal Prophylaxis and Predictors of Combination Antiretroviral Prophylaxis in US Infants from 1990 to 2015

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