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Article Dans Une Revue AIDS. Official journal of the international AIDS Society Année : 2015

Randomized noninferiority trial of two maternal single-dose nevirapine-sparing regimens to prevent perinatal HIV in Thailand

Marc Lallemant
  • Fonction : Auteur
Wasna Sirirungsi
  • Fonction : Auteur
Timothy Cressey
  • Fonction : Auteur
Nicole Ngo-Giang-Huong
  • Fonction : Auteur
Patrinee Traisathit
  • Fonction : Auteur
Virat Klinbuayaem
  • Fonction : Auteur
Prapan Sabsanong
  • Fonction : Auteur
Prateep Kanjanavikai
  • Fonction : Auteur
Gonzague Jourdain
Kenneth Mcintosh
  • Fonction : Auteur
Suporn Koetsawang
  • Fonction : Auteur
Phpt Study Investigators
  • Fonction : Auteur

Résumé

OBJECTIVES: Perinatal single-dose nevirapine (sdNVP) selects for resistance mutations. The objective of this trial was to compare two maternal sdNVP-sparing regimens with standard zidovudine (ZDV)/sdNVP prophylaxis. DESIGN: PHPT-5 was a randomized, partially double-blind placebo-controlled, noninferiority trial in Thailand (NCT00409591). Study participants were women with CD4 of at least 250 cells/mul and their infants. METHODS: All women received ZDV from 28 weeks' gestation and their newborn infants for one week. Women were also randomized to receive NVP-NVP (reference): maternal intrapartum sdNVP with a 7-day 'tail' of ZDV along with lamivudine, and infant NVP (one dose immediately, another 48 h later); infant-only NVP: maternal placebos for sdNVP and the 'tail', with infant NVP; LPV/r: maternal LPV/r starting at 28 weeks. Infants were formula-fed. HIV-diagnosis was determined by DNA-PCR. RESULTS: Four-hundred and thirty-five women were randomized between January 2009 and September 2010. Accrual was terminated prematurely following a change in Thai guidelines recommending antiretroviral combination therapy for all pregnant women. Data on 405 mothers and 407 live-born children were analyzed. Baseline characteristics were similar between arms. Intent-to-treat transmission rates were 3.8% (95% confidence interval: 1.2-8.6) in NVP-NVP, 1.6% (0.2-5.6) in infant-only NVP, and 1.4% (0.4-5.1) in LPV/r arms. As-treated rates were 2.2% (0.5-6.4), 3.2% (0.9-7.9), and 1.5% (0.2-5.2), respectively. Factors independently associated with transmission were prophylaxis duration less than 8 weeks (adjusted odds ratio 15.5; 3.6-66.1) and viral load at baseline at least 4 log10copies/ml (adjusted odds ratio 10.9; 1.3-91.5). Regimens appeared well tolerated. CONCLUSION: Transmission rates in all arms were low but noninferiority was not proven. Antiretroviral prophylaxis for at least 8 weeks before delivery is necessary to minimize transmission risk.

Dates et versions

hal-02087687 , version 1 (02-04-2019)

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Citer

Marc Lallemant, Sophie Le Coeur, Wasna Sirirungsi, Timothy Cressey, Nicole Ngo-Giang-Huong, et al.. Randomized noninferiority trial of two maternal single-dose nevirapine-sparing regimens to prevent perinatal HIV in Thailand. AIDS. Official journal of the international AIDS Society, 2015, 29 (18), pp.2497-2507. ⟨10.1097/QAD.0000000000000865⟩. ⟨hal-02087687⟩
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