7.2.1 First-line ART for adults

Consolidated ARV guidelines, June 2013

Rationale and supporting evidence: NVP in pregnant women

There are continued concerns about the higher risk of adverse events with NVP compared with EFV, and about the use of NVP in women with HIV with CD4 cell counts above 250 cells/mm3, with some studies showing an increased relative risk for severe hepatic and skin reactions in pregnant women using NVP at higher CD4 cell counts (124–126). A systematic review (127), updated in 2013 (134) of the risk of NVP-associated toxicity in pregnant women suggests that the frequency of adverse events is elevated but no higher than that observed in the general adult population.

The evidence supporting the theory that pregnant women with HIV who have high CD4 counts are at increased risk of adverse events compared with the general population with HIV is weak. The need for lead-in dosing for initial use of NVP and the fact that it is not available as a fixed-dose combination with TDF + 3TC (or FTC) are important considerations. NVP should therefore be used with caution in pregnant women and women who might be pregnant and only after considering the risk and benefits and available alternatives (see section 7.3.2).

Alternatives to NVP, such as ABC and boosted PIs, are acceptable but should only be used when NVP is not available.