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Abstract
Quantifying the risks and benefits of efavirenz (EFV) use in HIV-infected women of childbearing age in the US
H. Hsu1, C. Rydzak2, K. Cotich2, B. Wang1, P. Sax3, E. Losina4, K. Freedberg1, S. Goldie2, Z. Lu1, R. Walensky1
Background: The US FDA has categorized EFV as pregnancy Category D, indicating possible evidence of fetal risk. We quantify the benefits (life expectancy [LE] gains) and harms (EFV-related teratogenicity) associated with using EFV in HIV-infected US women of childbearing age.
Methods: We used a computer simulation model of HIV disease and treatment to estimate LE and time on first-line ART in (1) women receiving an EFV-containing first-line ART regimen and (2) women receiving a non-EFV-containing first-line regimen.
Model input data were from the Women’s Interagency HIV Study (mean CD4: 520/µl; mean HIVRNA: 4.4 log10 copies/ml). Differences in survival with and without EFV were calculated using model-estimated LE. We then used the time on first-line ART along with CDC surveillance data, data from the ART Pregnancy Registry, and literature-based age-specific pregnancy rates to estimate the number of teratogenic events/1000 ART-receiving women per year with and without EFV. We used a CDC-reported US population risk of 3.1 teratogenic events/100 live births for women not receiving EFV and a risk range of 5.1-10.0/100 live births for women receiving EFV. We performed sensitivity analyses on model inputs and literature-based rates.
Results: Projected LE with and without EFV were 20.8 and 19.9 years, respectively. The resulting LE gain was 827 yrs/1000 EFV-treated women. Average per person time on EFV was 4.0 years. Over this time, we calculated a background rate of 0.34 teratogenic events/1000 HIV-infected women/year in the absence of EFV. Excess teratogenic events due to EFV ranged from 0.11 to 0.54/1000 EFV-treated women/year over the background rate. LE and teratogenicity rate estimates were sensitive to variations in ART efficacy, duration of EFV-based treatment, and substitution of nevirapine for EFV.
Conclusions: Limiting EFV use in HIV-infected women of childbearing age may decrease mean HIV-infected women’s life expectancy (0.8 years/person), but may also prevent rare teratogenic events.
AIDS 2008 - XVII International AIDS Conference
Abstract no.
TUPE0230
Suggested Citation
"H.Hsu, et al.
Quantifying the risks and benefits of efavirenz (EFV) use in HIV-infected women of childbearing age in the US.
:
AIDS 2008 - XVII International AIDS Conference:
Abstract no.
TUPE0230"
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