Safety of efavirenz in first-trimester of pregnancy: a systematic review and meta-analysis of outcomes from observational cohorts

Médecins Sans Frontières, University of Cape Town, Cape Town, South Africa.
AIDS (London, England) (Impact Factor: 6.56). 06/2010; 24(10):1461-70. DOI: 10.1097/QAD.0b013e32833a2a14
Source: PubMed

ABSTRACT Data on efavirenz safety in first trimester pregnancy are conflicting. We conducted a systematic review and meta-analysis of the available evidence from observational cohorts.
We ran duplicate searches of databases (up to 02 January, 2010) and searchable websites of major HIV conferences (up to February, 2010) to identify observational cohorts reporting birth outcomes among women exposed to efavirenz during the first trimester of pregnancy. Our primary endpoint was birth defects of any kind; secondary outcomes were spontaneous abortions, termination of pregnancy, stillbirths, and preterm delivery.
Sixteen studies met our inclusion criteria, comprising 11 prospective cohorts and five retrospective reviews. Nine prospective studies reported on rates for birth defects both among women exposed to efavirenz-containing regimens (1132 live births) and non-efavirenz-containing regimens (7163 live births) during first trimester, giving a pooled, nonsignificant relative risk of 0.87 [95% confidence interval (CI) 0.61-1.24%, P = 0.45]. Low heterogeneity was observed between studies (I = 0, 95% CI 0-56.3%, P = 0.85). Across all studies (1256 live births), one neural tube defect (meningomyelocele) was observed with first trimester efavirenz exposure, giving a prevalence of 0.08% (95% CI 0.002-0.44%).
We found no increased risk of overall birth defects among women exposed to efavirenz during the first trimester of pregnancy compared with exposure to other antiretroviral drugs. Prevalence of overall birth defects with first trimester efavirenz exposure was similar to the ranges reported in the general population. However, the limited sample size for detection of rare outcomes such as neural tube defects prevents a definitive conclusion.

  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Prescribing, adherence, and adverse drug events to HAART in a large antiretroviral programme in Lagos was evaluated. A retrospective 5 year open cohort study. The AIDS Prevention Initiative in Nigeria (APIN) clinic at LUTH is one of the United States Presidential Emergency Plan for AIDS Relief (PEP-FAR) funded centers for HIV relief program in Nigeria Participants The case files of 390 patients on HAART and attending the APIN clinic were reviewed sequel to random selection. Demographics of the patients and pattern of antiretroviral (ARV) combination drugs prescribed were extracted from their case files. The details of the adverse drug events (ADEs) were extracted from drug toxicity forms regularly filled for each patient. A Chi-square test with Yates correction was used to determine the association between adherence and therapeutic outcome. A total of 2944 prescriptions were assessed. Zidovudine + lamivudine + nevirapine (35.87%) and stavudine + lamivudine + nevirapine (35.63%) were the most frequently prescribed combinations. Over 2000 ADEs were reported with cough (13.3%), fever (8.75%) and skin rashes (8.01%) being the most frequently reported. Drug adherence was associated with good therapeutic outcome (χ(2) = 115.60, p<0.0001). Zidovudine + lamivudine + nevirapine was the most frequently prescribed ARV combination. Cough was the most frequently reported ADE. Interventions aimed at rational prescribing of ARV drugs and improving adherence to antiretroviral drugs is essential for good therapeutic outcome in the treatment of HIV infection.
    Ghana medical journal 12/2014; 48(4):194-203. DOI:10.4314/gmj.v48i4.5
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The epidemic of human immunodeficiency virus continues impacting negatively health of women and children worldwide. Currently, the course of the entity can be modified through programs that provide antiretroviral prophylaxis and treatment. Preconception counseling and family planning are tools that still have low presence in the general population and especially in couples who are HIV positive. One of the objectives of management of the pregnant woman with HIV is the prevention of perinatal transmission. National and international guidelines address the management of different clinical scenarios in which you can find a woman of childbearing age with HIV. These guidelines should be permanently available in clinics, emergency rooms, delivery rooms and operating rooms, to be applied properly and promptly. Health professionals should be aware of drugs and dosages. The management of HIV positive pregnant women should be multidisciplinary. Rev.cienc. biomed. 2011; 1(2): 135-143
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: ART brings a complex series of choices; when to initiate therapy, what regimen to use, which class of drugs to use, when to change therapy, and which alternative drugs to use. Therefore, this study aims to assess reasons for initial ART regimen change in Nekemt Hospital. A retrospective cross sectional study was done by reviewing patient information sheet recorded from January 1, 2006 to December 31, 2010. Patients who changed their regimen were included in the study to identify the reasons for change and descriptive statistics were generated using SPSS version 16. Out of 142 patients, 57.7% were females and 57.7% were inthe age group 20-34. 61.2% were WHO clinical stage III patients and 69.7% of patients had a CD4 count below 350 cells/mm 3 . The most common initial regimens were D4T/3TC/NVP (42.2%), D4T/3TC/EFV (27.5%) and AZT/3TC/EFV (12.7%). The main reasons for modification of therapy were toxicity (80.3%), pregnancy (6.3%), new TB (5.6%), stock out (4.9%) and treatment failure (2.8%). The main toxicity observed was lipoatrophy (58.8%) followed by rash (12.3%) and CNS toxicity (11.4%). Toxicity was the main reason for initial regimen modification. D4T based regimens had high incidence of lipoatrophy.
    Journal of Applied Pharmaceutical Science 08/2013; 3(8):36-40. DOI:10.7324/JAPS.2013.3807

Full-text (2 Sources)

Available from
Jun 4, 2014