Publications: A Guide to the Clinical Care of Women with HIV/AIDS, 2005 edition

 

Table 7-10: Comparison of Intrapartum/Postpartum Regimens for HIV-1-infected Women in Labor
Who Have Had No Prior Antiretroviral Therapy (Scenario #3)
Drug Regimen Source of Evidence Maternal Intrapartum Infant Postpartum Data on Transmission Advantages Disadvantages
ZDV Epidemiologic data, U.S.; compared to no ZDV treatment 2 mg/kg intravenous bolus, followed by continuous infusion of 1 mg/kg/hr until delivery 2 mg/kg orally every six hours for six weeks* Transmission 10% with ZDV compared to 27% with no ZDV treatment, a 62% reduction (95% CI, 19–82%) Has been standard recommendation Requires intravenous administration and availability of ZDV intravenous formulation
Adherence to six week infant regimen
Reversible, mild anemia with 6 week infant ZDV regimen
ZDV/3TC Clinical trial, Africa; compared to placebo ZDV 600 mg orally at onset of labor, followed by 300 mg orally every three hours until delivery AND 3TC 150 mg orally at onset of labor, followed by 150 mg orally every 12 hours until delivery ZDV 4 mg/kg orally every 12 hours
AND
3TC 2 mg/kg orally every 12 hours for seven days
Transmission at six weeks 9% with ZDV-3TC vs. 15% with placebo, a 42% reduction Oral regimen Adherence easier than six weeks of ZDV Requires administration of two drugs
Nevirapine Clinical trial, Africa; compared to oral ZDV given intrapartum and for one week to the infant Single 200 mg oral dose at onset of labor Single 2 mg/kg oral dose at age 48–72 hours** Transmission at six weeks 12% with nevirapine compared to 21% with ZDV, a 47% reduction (95% CI*, 20– 64%) Inexpensive
Oral regimen
Simple, easy to administer
Can give directly observed treatment
Unknown efficacy if mother has nevirapine-resistant virus
Transient nevirapine resistance mutations detected at 6 weeks postpartum in 19% of women receiving single-dose intrapartum nevirapine, and 46% of infants who became infected despite receiving nevirapine
ZDV-Nevirapine Theoretical ZDV 2 mg/kg intravenous bolus, followed by continuous infusion of 1 mg/kg/hr until delivery
AND
Nevirapine single 200 mg oral dose at onset of labor
ZDV 2 mg/kg orally every six hours for six weeks
AND
Nevirapine single 2 mg/kg oral dose at age 48–72 hours**
No data Potential benefit if maternal virus is resistant to either nevirapine or ZDV
Synergistic inhibition of HIV replication with combination in vitro
Requires intravenous administration and availability of ZDV intravenous formulation
Adherence to six week infant ZDV regimen
Unknown if additive efficacy with combination
Transient nevirapine resistance mutations detected at 6 weeks postpartum in 15% of women receiving single-dose intrapartum nevirapine with ZDV or other antiretroviral drugs
ZDV, zidovudine; CI, confidence interval; 3TC, lamivudine
* ZDV dosing for infants <35 weeks gestation at birth is 1.5 mg/kg/dose intravenously, or 2.0 mg/kg/dose orally, every 12 hours, advancing to every 8 hours at 2 weeks of age if >30 weeks gestation at birth or at 4 weeks of age if <30 weeks gestation at birth [121].
** If the mother received nevirapine less than one hour prior to delivery, the infant should be given 2 mg/kg oral nevirapine as soon as possible after birth and again at 48-72 hours.