Low-Birth Weight and Pre-Term Delivery in Relation to Lopinavir/Ritonavir Use in Pregnancy

Senise, Jorge Figueiredo; Cruz, Reisson; Palácios, Ricardo; Bonafé, Simone Martins; Vaz, Maria José Rodrigues; Lacerda, Ana P.; Ahmed, Abes; Castelo, Adauto

doi:10.3844/ajidsp.2008.209.214

Cited by 6 publications

(8 citation statements)

References 19 publications

(12 reference statements)

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“…Preterm and low birth weight were not observed as complications of HAART use during pregnancy, in agreement with findings of other studies [28-31], but as opposite to what was concluded by others [32-34]. Thus, our results confirm the safety of antiretroviral drugs during pregnancy.…”

Section: Discussionsupporting

confidence: 90%

Mother-to-child transmission of human immunodeficiency virus in aten years period

et al. 2011

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Objectivesto evaluate mother-to-child transmission (MTCT) rates and related factors in HIV-infected pregnant women from a tertiary hospital between 2000 and 2009.Subjects and methodcohort of 452 HIV-infected pregnant women and their newborns. Data was collected from recorded files and undiagnosed children were enrolled for investigation. Statistical analysis: qui-square test, Fisher exact test, Student t test, Mann-Whitney test, ANOVA, risk ratio and confidence intervals.ResultsMTCT occurred in 3.74%. The study population displayed a mean age of 27 years; 86.5% were found to have acquired HIV through sexual contact; 55% were aware of the diagnosis prior to the pregnancy; 62% were not using HAART. Mean CD4 cell-count was 474 cells/ml and 70.3% had undetectable viral loads in the third trimester. HAART included nevirapine in 35% of cases and protease inhibitors in 55%; Zidovudine monotherapy was used in 7.3%. Mean gestational age at delivery was 37.2 weeks and in 92% by caesarian section; 97.2% received intravenous zidovudine. Use of AZT to newborn occurred in 100% of them. Factors identified as associated to MTCT were: low CD4 cell counts, elevated viral loads, maternal AIDS, shorter periods receiving HAART, other conditions (anemia, IUGR (intra uterine growth restriction), oligohydramnium), coinfecctions (CMV and toxoplasmosis) and the occurrence of labor. Use of HAART for longer periods, caesarian and oral zidovudine for the newborns were associated with a decreased risk. Poor adhesion to treatment was present in 13 of the 15 cases of transmission; in 7, coinfecctions were diagnosed (CMV and toxoplasmosis).ConclusionUse of HAART and caesarian delivery are protective factors for mother-to-child transmission of HIV. Maternal coinfecctions and other conditions were risk factors for MTCT.

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Section: Discussionsupporting

confidence: 90%

Mother-to-child transmission of human immunodeficiency virus in aten years period

et al. 2011

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“…Conflicting reports on the fraction of LPV unbound during pregnancy have been reported. One study demonstrated no change in the fraction of LPV unbound, and four studies reported an increase in the fraction of LPV unbound (16,20,28,47,48). An increase in the fraction unbound may potentially offset at least part of the increase of the LPV clearance during pregnancy.…”

Section: Discussionmentioning

confidence: 99%

“…Several clinical studies have demonstrated LPV/r efficacy in achieving virologic suppression in mothers during pregnancy and preventing HIV transmission to their children (9)(10)(11)(12)(13)(14)(15)(16). Reports of higher LPV clearance during pregnancy have prompted some investigators to propose the use of a higher dose during the third trimester, while others advocated no adjustment to the standard 400/100-mg twice-daily (BID) regimen (17)(18)(19)(20).…”

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confidence: 99%

No Need for Lopinavir Dose Adjustment during Pregnancy: a Population Pharmacokinetic and Exposure-Response Analysis in Pregnant and Nonpregnant HIV-Infected Subjects

Salem

Jones

Santini-Oliveira

et al. 2016

Antimicrob Agents Chemother

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Lopinavir-ritonavir is frequently prescribed to HIV-1-infected women during pregnancy. Decreased lopinavir exposure has been reported during pregnancy, but the clinical significance of this reduction is uncertain. This analysis aimed to evaluate the need for lopinavir dose adjustment during pregnancy. We conducted a population pharmacokinetic analysis of lopinavir and ritonavir concentrations collected from 84 pregnant and 595 nonpregnant treatment-naive and -experienced HIV-1-infected subjects enrolled in six clinical studies. Lopinavir-ritonavir doses in the studies ranged between 400/100 and 600/150 mg twice daily. In addition, linear mixed-effect analysis was used to compare the area under the concentration-time curve from 0 to 12 h (AUC 0 -12 ) and concentration prior to dosing (C predose ) in pregnant women and nonpregnant subjects. The relationship between lopinavir exposure and virologic suppression in pregnant women and nonpregnant subjects was evaluated. Population pharmacokinetic analysis estimated 17% higher lopinavir clearance in pregnant women than in nonpregnant subjects. Lopinavir clearance values postpartum were 26.4% and 37.1% lower than in nonpregnant subjects and pregnant women, respectively. As the tablet formulation was estimated to be 20% more bioavailable than the capsule formulation, no statistically significant differences between lopinavir exposure in pregnant women receiving the tablet formulation and nonpregnant subjects receiving the capsule formulation were identified. In the range of lopinavir AUC 0 -12 or C predose values observed in the third trimester, there was no correlation between lopinavir exposure and viral load or proportion of subjects with virologic suppression. Similar efficacy was observed between pregnant women and nonpregnant subjects receiving lopinavir-ritonavir at 400/100 mg twice daily. The pharmacokinetic and pharmacodynamic results support the use of a lopinavir-ritonavir 400/100-mg twice-daily dose during pregnancy.T he use of combination antiretroviral therapy (cART) is recommended in all pregnant women with HIV infection for prevention of perinatal transmission as well as for maternal health. Such use has resulted in a significant reduction of perinatal transmission from 25% to 0 -3.6% (1, 2). Treatment guidelines include the use of protease inhibitors in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) (3-7).Lopinavir (LPV) is a peptidomimetic HIV type 1 (HIV-1) protease inhibitor. When LPV is coadministered with low-dose ritonavir (RTV), which acts as a pharmacokinetic enhancer by blocking the cytochrome P450 3A (CYP3A)-mediated metabolism of LPV, serum levels of LPV are significantly increased, and half-life is prolonged. The high LPV exposures achieved with coformulated lopinavir-ritonavir (LPV/r) have the advantage of providing a pharmacologic barrier to the emergence of HIV-1 viral resistance in patients with wild-type virus, as well as enhanced activity against some forms of drug-resistant HIV-1 (8).Because of the potency of ...

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“…Most Sexually Transmitted Infections (STIs) caused by bacteria have been declining in industrialized countries since 1980, but they are of major public health concern in developing countries (Senise et al, 2008).…”

Section: Introductionmentioning

confidence: 99%

<i>Chlamydia trachomatis</i> in Women with Ful-Term Deliveries and Women with Abortion

Jahromi¹

2010

American Journal of Infectious Diseases

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Problem statement: There are some documents which support the role of some certain infections such as Chlamydia trachomatis in spontaneous abortion. As there were not data about role this bacterium in abortion in this area of IRAN, this study was conducted to evaluate the prevalence of Chlamydia trachomatis in women with abortion and compare it with healthy women with no previous history of abortion. Approach: This case-control study was carried out in Shariatee hospital of Hormozgan University of medical sciences, during [2004][2005]. A number of 220 women with definite diagnosis of previous abortion and 200 matched women with normal full term delivery and negative history of miscarriage as controls were studied as case and control groups. All obtained PAP smears from the case and the control groups were then tested using Immunoflourescent method for detection of Chlamydia trachomatis. Data was analyzed, using SPSS software (chi square and t-test). Results: The prevalence of positive direct immunofluorescent test on PAP smears indicating the presence of Chlamydia trachomatis was 56 (25.45%) in women with abortion comparing to 13 (5.20%) in women in control group, the difference was significant (p = 0.0001). Conclusion: This study showed Chlamydia trachomatis is an important causative agent for abortion in this area of IRAN.

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Low-Birth Weight and Pre-Term Delivery in Relation to Lopinavir/Ritonavir Use in Pregnancy

Cited by 6 publications

References 19 publications

Mother-to-child transmission of human immunodeficiency virus in aten years period

Mother-to-child transmission of human immunodeficiency virus in aten years period

No Need for Lopinavir Dose Adjustment during Pregnancy: a Population Pharmacokinetic and Exposure-Response Analysis in Pregnant and Nonpregnant HIV-Infected Subjects

<i>Chlamydia trachomatis</i> in Women with Ful-Term Deliveries and Women with Abortion

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