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

Ford, Nathan; Mofenson, Lynne; Kranzer, Katharina; Medu, Olanrewaju; Frigati, Lisa; Mills, Edward J.; Calmy, Alexandra

doi:10.1097/qad.0b013e32833a2a14

Cited by 138 publications

(112 citation statements)

References 23 publications

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“…Cost is an important factor in the choice of an efavirenzcontaining vs. a nevirapine-containing regimen [14]. There has very likely been reluctance to use efavirenz in women of child-bearing age because of concerns about teratogenicity, which can occur during the first trimester of pregnancy [15][16][17].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of treatment outcomes for patients on first‐line regimens in US President's Emergency Plan for AIDS Relief (PEPFAR) clinics in Uganda: predictors of virological and immunological response from RV288 analyses

et al. 2014

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ObjectivesViral load (VL) monitoring is recommended, but seldom performed, in resource-constrained countries. RV288 is a US President's Emergency Plan for AIDS Relief (PEPFAR) basic programme evaluation to determine the proportion of patients on treatment who are virologically suppressed and to identify predictors of virological suppression and recovery of CD4 cell count. Analyses from Uganda are presented here. MethodsIn this cross-sectional, observational study, patients on first-line antiretroviral therapy (ART) (efavirenz or nevirapine + zidovudine/lamivudine) from Kayunga District Hospital and Kagulamira Health Center were randomly selected for a study visit that included determination of viral load (HIV-1 RNA), CD4 cell count and clinical chemistry tests. Subjects were recruited by time on treatment: 6-12, 13-24 or > 24 months. Logistic regression modelling identified predictors of virological suppression. Linear regression modelling identified predictors of CD4 cell count recovery on ART. ResultsWe found that 85.2% of 325 subjects were virologically suppressed (viral load < 47 HIV-1 RNA copies/ml). There was no difference in the proportion of virologically suppressed subjects by time on treatment, yet CD4 counts were higher in each successive stratum. Women had higher median CD4 counts than men overall (406 vs. 294 cells/μL, respectively; P < 0.0001) and in each time-on-treatment stratum. In a multivariate logistic regression model, predictors of virological suppression included efavirenz use [odds ratio (OR) 0.47; 95% confidence interval (CI) 0.22-1.02; P = 0.057], lower cost of clinic visits (OR 0.815; 95% CI 0.66-1.00; P = 0.05), improvement in CD4 percentage (OR 1.06; 95% CI 1.014-1.107; P = 0.009), and care at Kayunga vs. Kangulamira (OR 0.47; 95% CI 0.23-0.92; P = 0.035). In a multivariate linear regression model of covariates associated with CD4 count recovery, time on highly active antiretroviral therapy (ART) (P < 0.0001), patient satisfaction with care (P = 0.038), improvements in total lymphocyte count (P < 0.0001) and haemoglobin concentration (P = 0.05) were positively associated, whereas age at start of ART (P = 0.0045) was negatively associated with this outcome. ConclusionsHigh virological suppression rates are achievable on first-line ART in Uganda. The odds of virological suppression were positively associated with efavirenz use and improvements in CD4 cell percentage and total lymphocyte count and negatively associated with the cost of travel to The US President's Emergency Plan for AIDS Relief (PEPFAR), launched in 2002, has played a major role in the rapid scale-up of and expanded access to ART in resourcelimited countries, particularly in sub-Saharan Africa. In the opening session of the 20th Conference on Retroviruses and Opportunistic Infections (CROI 2013), Dr Thomas Frieden, Director of the Centers for Disease Control and Prevention (CDC), articulated the goals of interventions in the global HIV epidemic, stating, 'the proportion of patients with viral suppression should be the p...

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Section: Discussionmentioning

confidence: 99%

Evaluation of treatment outcomes for patients on first‐line regimens in US President's Emergency Plan for AIDS Relief (PEPFAR) clinics in Uganda: predictors of virological and immunological response from RV288 analyses

et al. 2014

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“…7 Moreover, because of efavirenz's potential teratogenicity, use during the fi rst trimester of pregnancy is controversial. 1,8,9 For national HIV programmes, fi xed-dose combinations containing efavirenz (efavirenz-lamivudine-tenofovir and efavirenztenofovir-emtricitabine) are less aff ordable than are fi xeddose combinations based on nevirapine. 10 Assessment of the eff ects of giving rifampicin with nevirapine on virological outcome has yielded confl icting results in clinical studies of nevirapine given with a 2 week lead-in dose.…”

Section: Introductionmentioning

confidence: 99%

Nevirapine versus efavirenz for patients co-infected with HIV and tuberculosis: a randomised non-inferiority trial

Bonnet¹,

Bhatt

Baudin³

et al. 2013

The Lancet Infectious Diseases

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“…Ayrıca metadon ile ilaç etkileşimi de mevcuttur. Efavirenz ; nöral tüp defekti, fasiyal yarıklanma ve anoftalmi gibi problemlere yol açabildiğinden, fetal organogenezin gerçekleştiği ilk sekiz gestasyon haftası içinde kullanımı önerilmemektedir 42,22 .Efavirenz kullanan kadınların postpartum kontrasepsiyonu sağlanmalıdır.…”

Section: Non-nükleozidreverstranskriptaz İnhibitörleri (Nnrti)unclassified

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et al. 2016

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The management of Human Immunodeficiency Virus (HIV) infection is progressing rapidly. In developed countries, the perinatal transmission rates have decreased from 20-30% to 1-2% with the use of antiretroviral therapy and cesarean section. Interventions for the prevention of prenatal transmission has made the prenatal care of pregnant patients with HIV infection more complex. Rapid development of standard care and continuing increase in the distribution of HIV infection has required clinicians taking care of pregnants to have current information. Therefore, in our review we aimed to summarize the prenatal course, treatment and preventive methods for perinatal transmission of HIV.

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

Cited by 138 publications

References 23 publications

Evaluation of treatment outcomes for patients on first‐line regimens in US President's Emergency Plan for AIDS Relief (PEPFAR) clinics in Uganda: predictors of virological and immunological response from RV288 analyses

Evaluation of treatment outcomes for patients on first‐line regimens in US President's Emergency Plan for AIDS Relief (PEPFAR) clinics in Uganda: predictors of virological and immunological response from RV288 analyses

Nevirapine versus efavirenz for patients co-infected with HIV and tuberculosis: a randomised non-inferiority trial

Gebelik ve HIV enfeksiyonu

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