Dataset Information

"Real life" use of raltegravir during pregnancy in France: The Coferal-IMEA048 cohort study.

ABSTRACT:

Introduction

Limited "real life" data on raltegravir (RAL) use during pregnancy are available. Thus, we aimed at describing effectiveness and safety of RAL-based combined antiretroviral therapy (cART) in this setting.

Methods

HIV-1-infected women receiving RAL during pregnancy between 2008 and 2014 in ten French centers were retrospectively analysed for: (1) proportion of women receiving RAL anytime during pregnancy who achieved a plasma HIV-RNA (pVL) < 50 copies/mL at delivery, and (2) description of demographics, immuno-virological parameters and safety in women and new-borns.

Results

We included 94 women (median age, 33 years) of which 85% originated from Sub-Saharan Africa and 16% did not have regular health insurance coverage. Sixteen women were cART-naïve (median HIV diagnosis at 30 weeks of gestation), whereas 78 were already on cART before pregnancy (40% with pVL < 50 copies/mL). RAL was initiated before pregnancy (n = 33), during the second trimester (n = 11) and the third trimester of pregnancy (n = 50). No RAL discontinuations due to adverse events were observed. Overall, at the time of delivery, pVL was < 50 copies/mL in 70% and < 400 copies/mL in 84% of women. Specifically, pVL at delivery was < 50 copies/mL in 82%, 55% and 56% of cases when RAL was started before pregnancy, during the second or third trimester of pregnancy, respectively. Median term was 38 weeks of gestation, no defect was reported and all new-borns were HIV non-infected at Month 6.

Conclusions

RAL appears safe and effective in this "real-life" study. No defect and no HIV transmission was reported in new-borns.

SUBMITTER: Gantner P

PROVIDER: S-EPMC6481866 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

"Real life" use of raltegravir during pregnancy in France: The Coferal-IMEA048 cohort study.

Gantner Pierre P Sylla Babacar B Morand-Joubert Laurence L Frange Pierre P Lacombe Karine K Khuong Marie-Aude MA Duvivier Claudine C Launay Odile O Karmochkine Marina M Arvieux Cédric C Ménard Amélie A Piroth Lionel L Canestri Ana A Trias Dominique D Peytavin Gilles G Landman Roland R Ghosn Jade J

PloS one 20190424 4

<h4>Introduction</h4>Limited "real life" data on raltegravir (RAL) use during pregnancy are available. Thus, we aimed at describing effectiveness and safety of RAL-based combined antiretroviral therapy (cART) in this setting.<h4>Methods</h4>HIV-1-infected women receiving RAL during pregnancy between 2008 and 2014 in ten French centers were retrospectively analysed for: (1) proportion of women receiving RAL anytime during pregnancy who achieved a plasma HIV-RNA (pVL) < 50 copies/mL at delivery, a ...[more]

PMID: 31017957

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Project description:IntroductionWomen frequently report pain associated with medical termination of pregnancy (MToP), and its management can differ largely between centres. This study aimed at evaluating in real-life settings pain related to MToP and its management in France.MethodsThis was a non-interventional prospective, longitudinal study run in 23 centres between 2015 and 2016 that included 893 pregnant women. Pain was reported by women prior any curative analgesic intake (CAI) through a five-level Likert scale (absence, mild, moderated, severe, extreme). Modalities of analgesic prophylaxis prescription (APP) and intake (API) and CAI were collected. Risk factors were investigated using ordinal logistic regression (for pain) or logistic regression (for CAI) with stepwise selection of variables.ResultsAPP was prescribed to 657 (73.7%) women irrespective of the gestational age, among whom 386 (73.7%) took the treatment. Out of 740 women who documented their pain symptoms prior to any CAI, few declared no pain (n = 94, 12.7%) or intense pain (n = 88, 11.9%). The majority reported mild or moderate pain (n = 558, 75.4%). On multivariate analysis adjusted on gestational age, increasing initial [odds ratio (OR) 1.25, 95% confidence interval (CI) 1.06-1.47] or total dose (OR 1.15, 95% CI 1.05-1.26) of misoprostol taken were independent factors associated with risk of more pain. When adjusting for gestational age, initial dose of misoprostol (OR 1.69, 95% CI 1.45-2.66) and pain experienced (OR 3.58, 95% CI 2.82-4.55) were significantly associated with higher risk of CAI while API (OR 0.52, 95% CI 0.36; 0.75) was negatively associated.ConclusionsMost of the women received an APP, but not all used it. API and gestational age were not related to different risks of more pain following MToP, whereas history of at least one child showed a negative association. Higher doses of misoprostol were strongly associated with both pain and CAI. API was associated with a decreased risk of CAI.

Project description:BackgroundRecent studies show a rapid growth among pregnant women using high potency opioids for common pain management during their pregnancy. No study has examined the duration of treatment among strong opioid users and weak opioid users during pregnancy. We aimed to investigate the prevalence of prescribed opioid use during pregnancy, in Quebec; and to compare the duration of opioid treatment between strong opioid users and weak opioid users.MethodsUsing the Quebec Pregnancy Cohort (1998-2015), we included all pregnancies covered by the Quebec Public Prescription Drug Insurance Program. Opioid exposure was defined as filled at least one prescription for any opioid during pregnancy or before pregnancy but with a duration that overlapped the beginning of pregnancy. Prevalence of opioids use was calculated for all pregnancies, according to pregnancy outcome, trimester of exposure, and individual opioids. The duration of opioid use during pregnancy was analyzed according to 8 categories based on cumulative duration (< 90 days vs. ≥90 days), duration of action (short-acting vs. long-acting) and strength of the opioid (weak vs. strong).ResultsOf 442,079 eligible pregnancies, 20,921 (4.7%) were exposed to opioids. Among pregnancies ending with deliveries (n = 249,234), 5.4% were exposed to opioids; the prevalence increased by 40.3% from 3.9% in 1998 to 5.5% in 2015, more specifically a significant increase in the second and third trimesters of pregnancy. Weak opioid, codeine was the most commonly dispensed opioid (70% of all dispensed opioids), followed by strong opioid, hydromorphone (11%), morphine (10%), and oxycodone (5%). The prevalence of codeine use decreased by 47% from 4.3% in 2005 to 2.3% in 2015, accompanied by an increased use of strong opioid, morphine (0.029 to 1.41%), hydromorphone (0.115 to 1.08%) and oxycodone (0.022 to 0.44%), from 1998 to 2015. The average durations of opioid exposure were significantly longer among pregnancies exposed to strong opioid as compared to weak opioid regardless of the cumulative duration or duration of action (P < 0.05).ConclusionsGiven the differences in the safety profile between strong opioids and the major weak opioid codeine, the increased use of strong opioids during pregnancy with longer treatment duration raises public health concerns.

Project description:ObjectiveThe aim of this study is to estimate the association between marijuana use during pregnancy and total, spontaneous and indicated preterm birth.Study designProspective cohort study of women receiving antenatal care at The Ohio State University from 2010 to 2015. Marijuana use was assessed by questionnaire, record abstraction, and urine toxicology. Women were followed through the end of pregnancy. Relative risks were assessed with Poisson regression and time to delivery with proportional hazard models.ResultsOf 363 eligible women, 119 (33%) used marijuana in pregnancy by at least one measure. In this high-risk cohort, preterm birth occurred to 36.0% of users and 34.6% of nonusers (p = 0.81). The unadjusted relative risk of all preterm birth was 1.06 (95% confidence interval [CI]: 0.76-1.47); the adjusted relative risk was similar 1.04 (95% CI: 0.72-1.50). Spontaneous preterm birth was nonsignificantly elevated among users before 1.32 (95% CI: 0.89-1.96), and after 1.21 (95% CI: 0.76-1.94) adjustment. Indicated preterm birth was nonsignificantly reduced before 0.52 (95% CI: 0.22-1.23) and after 0.75 (95% CI: 0.29-2.15) adjustment. The unadjusted hazard ratio (HR) for time to preterm birth was 1.26 (95% CI: 0.84-2.00); the adjusted HR was 1.32 (95% CI: 0.80-2.07). Both unadjusted 1.77 (95% CI: 1.06-2.93) and adjusted 2.16 (95% CI: 1.16-4.02) HRs for spontaneous preterm birth were significantly elevated, primarily due to an increased risk of spontaneous birth <28 weeks among users. The unadjusted and adjusted HRs for time to indicated preterm birth were 0.69 (95% CI: 0.33-1.43) and 0.58 (95% CI: 0.23-1.46).ConclusionMarijuana use was not associated with total preterm birth in this cohort, suggesting that among women already at high risk of preterm birth, marijuana does not increase risk further. However, there was a suggestion that pregnant women who use marijuana may deliver earlier, particularly from spontaneous preterm birth, than women who do not use marijuana.Key points· Marijuana was not associated with risk of all preterm birth.. · Marijuana was not associated with reduced time to delivery.. · However, users had reduced time to spontaneous preterm birth..

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Dataset Information

"Real life" use of raltegravir during pregnancy in France: The Coferal-IMEA048 cohort study.

Introduction

Methods

Results

Conclusions

Publications

"Real life" use of raltegravir during pregnancy in France: The Coferal-IMEA048 cohort study.

Similar Datasets

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