Baseline samples for CD4 cell count, VL and resistance should be taken. Treatment should be commenced immediately as per Recommendation 5.4.3 above. Triple therapy should be given to the neonate (see Section 8: Neonatal management). 5.5.1 Untreated women with a CD4 cell count ≥350 cells/μL and a VL <50 HIV RNA copies/mL (confirmed on a separate assay): Can be treated with zidovudine monotherapy

or with HAART (including abacavir/lamivudine/zidovudine). E7080 purchase Grading: 1D Can aim for a vaginal delivery. Grading: 1C Should exclusively formula feed their infant. Grading: 1D Elite controllers are defined as the very small proportion of HIV-positive individuals who, without treatment, have undetectable HIV RNA in plasma as assessed by more than one different VL assay on more than one occasion. It is estimated that 1-in-300 HIV-positive individuals are elite controllers [95]. In the absence of data from RCTs on elite controllers, recommendations are based on RCT and observational data on all pregnant HIV-positive women. In the original zidovudine monotherapy study (ACTG 076) the transmission rate if maternal VL was <1000 HIV RNA copies/mL was 1% (range 0–7%) [16]. Treatment reduced transmission even among women with low or undetectable HIV VL, suggesting that the effects of treatment Sotrastaurin were not all related

to decreasing maternal viraemia but may also be related to reducing HIV in the genital tract and/or peri-exposure prophylaxis of the infant by placental transfer of zidovudine. A meta analysis of transmission outcomes in several major USA and European studies MG-132 mouse also demonstrated that an HIV VL <1000 HIV RNA copies/mL at delivery was associated with a relatively low risk of transmission and that ARV prophylaxis offered additional clinically significant protection [96]. Zidovudine has been shown to reduce cervicovaginal shedding of HIV [2] and there are no data to suggest that HAART is more effective than zidovudine at reducing cervicovaginal shedding in women with a plasma HIV

VL <50 copies/mL. Therefore, zidovudine monotherapy is an option in this setting. There are no data to support the use of intravenous zidovudine infusion during labour in elite controllers. HAART may provide more reassurance about prevention of MTCT but will also expose both mother and infant to more potential drug toxicities. The choice of HAART is as per Recommendation 5.3.3. Data on the mode of delivery in elite controllers are sparse and limited to case reports [97]. The benefits of PLCS at various levels of viraemia are discussed in Section 7.2 (Mode of delivery). There are no data to support the use of PLCS for PMTCT when the VL is <50 HIV RNA copies/mL in women on ART. The Writing Group therefore recommends vaginal delivery for all elite controllers on ART. 5.6.