AEGiS-14IAC: Nevirapine (NVP) during labor and in the neonate significantly improves zidovudine (ZDV) prophylaxis for the prevention of perinatal HIV transmission: results of PHPT-2 first interim analysis.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Nevirapine (NVP) during labor and in the neonate significantly improves zidovudine (ZDV) prophylaxis for the prevention of perinatal HIV transmission: results of PHPT-2 first interim analysis.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbOr22)

Lallemant M, Jourdain G, Le Coeur S, Mary JY, Koetsawang S, McIntosh K, Ngo-Giang-Huong N, Kanshana S, Thaineua V
UR54 - Institut de Recherche pour le Developpement, Chiang Mai, Thailand

BACKGROUND: ZDV starting at 28 weeks? gestation decreases ?in utero? transmission to 1-2%, but 4-5% ?intrapartum? transmission still occurs. Adding NVP to ZDV during labor and in neonates may further reduce intrapartum transmission.

METHODS: Eligibility: ZDV prophylaxis from 28 wks?gestation or as soon as possible thereafter (at least 2 wks), oral loading dose during labor and 1 wk for infants (6 wks if mother <4 wks); formula feeding. Multicenter, randomized, double-blind, 3-arm study 1) NVP+ZDV mother/ NVP+ZDV infant; 2) NVP+ZDV mother/Placebo+ZDV infant; 3) Placebo+ZDV mother/Placebo+ZDV infant (Reference). Dosing: NVP mother = 200 mg po at onset of labor, NVP infant = 6 mg po 48-72 hours after birth. Endpoint: HIV-infected infants (2 PCR+ on 2 samples); vs. uninfected (2 PCR- after 1 month).

RESULTS: As of May 24, 2002, 1247 women have been enrolled, 1100 have delivered. At the first interim analysis based on the outcomes of the first 629 infants (May 2, 2002), the DSMB recommended that we stop enrollment in the ZDV alone arm because HIV transmission was significantly higher than in the NVP+ZDV mother/ NVP+ZDV infant (stopping boundary: P=0.00036), and that we continue the other 2 arms. Safety data did not raise concerns. 48% of the women started ZDV before/at 28 wks' gestation, 16% after 32 wks. ARV naïve: 99%. Median baseline CD4+: 371/mm³ (18%<200); median log viral load: 3.94. Median duration from study treatment intake to delivery: 7 hours (13%<2 hrs); C-sections (non-elective): 21%. Infants: median time from birth to study treatment intake: 48.5 hrs (98% <72 hrs).

CONCLUSION: Adding NVP during labor and in the neonate to oral ZDV prophylaxis starting at 28 weeks' gestation or as soon as possible thereafter significantly decreases the risk of HIV perinatal transmission. Sponsors: NIH R01 HD39615, USA; ANRS 1208 and IRD, France; Ministry of Public Health, Thailand; Boehringer-Ingelheim (study treatment), Glaxo-Smith-Kline (ZDV), Roche Diagnostics (DNA-PCR).

Keywords: AEGIS, Zidovudine, Nevirapine, HIV Infections, Labor, Obstetric, Parturition, HIV Seropositivity, Viral Load, Delivery, Obstetric, Antiretroviral Therapy, Highly Active, Thailand, France, Infant, Newborn, Infant, Human, Female, Pregnancy, transmission, prevention & control, surgery, therapy, drug therapy

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