Birth defects following exposure to efavirenz-based antiretroviral therapy during pregnancy: a study at a regional South African hospital

Bera, E; McCausland, Katrin; Nonkwelo, R; Mgudlwa, Batembu; Chacko, Saji; Majeke, Busiwe

doi:10.1097/qad.0b013e328333af32

Cited by 22 publications

(24 citation statements)

References 15 publications

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“…Efavirenz, which is found in regimen IA, is a teratogen and is thus not recommended for women who are pregnant or who are planning to conceive. [19] Nevirapine has a wide toxicity profile, consisting of hepatotoxicity and Stevens-Johnson syndrome. [20] Stavudine is a thymidine nucleoside analogue that is phosphorylated intracellularly to the active metabolite, stavudine 5′-triphosphate.…”

Section: Discussionmentioning

confidence: 99%

Fatal Toxicity from Symptomatic Hyperlactataemia

Leung¹,

Wilson

Manini

2011

Drug Safety

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Background In many Sub-Saharan African countries, first-line therapy for HIV may include a nucleoside reverse transcriptase inhibitor (NRTI). Long-term NRTI use is associated with symptomatic hyperlactataemia due to inhibition of mitochondrial DNA polymerase γ, a potentially fatal complication. Objective The purpose of the study was to evaluate the factors associated with inhospital fatality for HIV inpatients prescribed NRTIs long term who presented with symptomatic hyperlactataemia. Methods We performed a retrospective cohort study at a 900-bed university hospital in South Africa over 4 years (2005–2008). We included HIV inpatients prescribed NRTIs long term who presented with symptomatic hyperlactataemia (long-term NRTI use; lactate >4.0 mmol/L; absence of infectious source; symptoms requiring admission). Data included demographics, medical history, NRTI duration, blood pressure, symptom duration and relevant laboratory data. Results Of 79 patients who met inclusion criteria (mean age 38.2 ± 10.5 years, 97% female) there were 46 fatalities (58%). Factors significantly associated with fatality were presence of diabetes mellitus (p = 0.04), lactate ≥10 mmol/L (p = 0.003), pH <7.2 (p = 0.002), creatinine ≥200 μmol/L (p = 0.03) and altered mental status (p = 0.03). Conclusions In this study, NRTI-related symptomatic hyperlactataemia occurred predominantly in females. Mortality was associated with severely elevated lactate (≥10 mmol/L), the degree of acidosis, elevated creatinine, history of diabetes and altered mental status on presentation.

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Section: Discussionmentioning

confidence: 99%

Fatal Toxicity from Symptomatic Hyperlactataemia

Leung¹,

Wilson

Manini

2011

Drug Safety

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“…Intention to conceive on the ART drug efavirenz (EFV) would indicate inadequate patient-provider communication around fertility plans, as EFV is contraindicated for women at risk of pregnancy under both former and current South African national treatment guidelines due to teratogenicity concerns [15]. While recent research suggests that these concerns may be unwarranted [16,17], these safety data were not available to providers at the time of study enrollment and have not yet prompted a change in South African national guidelines.…”

Section: Introductionmentioning

confidence: 94%

High Pregnancy Intentions and Missed Opportunities for Patient–Provider Communication About Fertility in a South African Cohort of HIV-Positive Women on Antiretroviral Therapy

et al. 2011

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High fertility intentions amongst HIV-positive women have been reported elsewhere. Less is known about how clinical and HIV treatment characteristics correlate with fertility intentions. We use cross-sectional baseline data from a prospective cohort study to assess pregnancy intentions and patient-provider communication around fertility. Non-pregnant, HIV-positive women aged 18-35 on ART were recruited through convenience sampling at Johannesburg antiretroviral (ART) treatment facilities. Among the 850 women in this analysis, those on efavirenz had similar fertility intentions over the next year as women on nevirapine-based regimens (33% vs. 38%). In multivariate analysis, recent ART initiation was associated with higher current fertility intentions; there was no association with CD4 cell count. Forty-one percent of women had communicated with providers about future pregnancy options. Women on ART may choose to conceive at times that are sub-optimal for maternal, child and partner health outcomes and should be routinely counseled around safer pregnancy options.

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“…Reports consider efavirenz (20) as the most frequent cause for congenital malformatoins, however other studies have infirmed this (21), and this was noted in the APRegistry (17).…”

Section: Discussionmentioning

confidence: 90%