title: Field efficacy of zidovudine, lamivudine and single-dose nevirapine to prevent peripartum HIV transmission.
abstract: OBJECTIVE
  In Africa, single-dose nevirapine (NVPsd), short regimens of zidovudine (ZDV) or ZDV + lamivudine (3TC) are recommended to prevent peripartum mother-to-child HIV transmission (PMTCT). We evaluated the 6-week field efficacy of two more PMTCT drug combinations.
  
  
  METHODS
  An open-label intervention cohort in Abidjan.
  
  
  METHODS
  In 2001-2002, consenting women started oral ZDV 300 mg twice daily (bid) at > or =36 weeks of gestation, with 600 mg of ZDV + 200 mg NVPsd orally at beginning of labour. In 2002-2003, the antepartum regimen at > or =32 weeks comprised ZDV as previously + 3TC 150 mg bid; the labour dose comprised ZDV + NVPsd as previously + 300 mg 3TC orally. Neonates received ZDV syrup (2 mg/kg per 6 h) for 7 days + NVPsd syrup (2 mg/kg) on day 2 in both periods. Each woman was assisted to either use breast milk substitutes or breastfeed exclusively. Paediatric HIV infection was diagnosed by plasma HIV RNA viral load at 4 weeks, confirmed at 6 weeks. The reference group was a cohort receiving a short regimen of ZDV > or = 36-38 weeks in 1995-2000 in the same population.
  
  
  RESULTS
  A total of 1144 HIV-infected pregnant women were included: 351 with ZDV, 420 with ZDV + NVPsd and 373 with ZDV + 3TC + NVPsd; 1010 livebirths were eligible for analysis; 79 children were HIV-infected peripartum. Six-week transmission probability was 6.5% [95% confidence interval (CI), 3.9-9.1%) with ZDV + NVPsd, a 72% reduction compared with ZDV alone (95% CI, 52-88%; P = 0.0002 adjusted on maternal CD4, clinical stage and breastfeeding). It was 4.7% (95% CI, 2.4-7.0%) with ZDV + 3TC + NVPsd (P = 0.34 compared with ZDV + NVPsd).
  
  
  CONCLUSIONS
  A short-course of ZDV + NVPsd prevents most peripartum HIV transmission in Africa. This regimen could be added to international guidelines.
authors.affiliation: Unité INSERM 593, Institut de Santé Publique, Epidémiologie et Développement (ISPED), Université Victor Segalen, 146 Rue Léo Saignat, 33076 Bordeaux, France. francois.dabis@isped.u-bordeaux2.fr
authors.forename: François
authors.initials: F
authors.lastname: Dabis
authors.forename: Laurence
authors.initials: L
authors.lastname: Bequet
authors.forename: Didier Koumavi
authors.initials: DK
authors.lastname: Ekouevi
authors.forename: Ida
authors.initials: I
authors.lastname: Viho
authors.forename: François
authors.initials: F
authors.lastname: Rouet
authors.forename: Apollinaire
authors.initials: A
authors.lastname: Horo
authors.forename: Charlotte
authors.initials: C
authors.lastname: Sakarovitch
authors.forename: Renaud
authors.initials: R
authors.lastname: Becquet
authors.forename: Patricia
authors.initials: P
authors.lastname: Fassinou
authors.forename: Laurence
authors.initials: L
authors.lastname: Dequae-Merchadou
authors.forename: Christiane
authors.initials: C
authors.lastname: Welffens-Ekra
authors.forename: Chrisitine
authors.initials: C
authors.lastname: Rouzioux
authors.forename: Valériane
authors.initials: V
authors.lastname: Leroy
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D007560:Cote d'Ivoire; D003906:Developing Countries; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D015497:HIV-1; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D019259:Lamivudine / Q000627:therapeutic use; D019829:Nevirapine / Q000627:therapeutic use; D018743:Perinatal Care / Q000379:methods; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011295:Prenatal Care / Q000379:methods; D012367:RNA, Viral / Q000032:analysis; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load; D015215:Zidovudine / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine
references.citation: AIDS. 2002 Mar 8;16(4):631-41
references.pmid: 11873008
references.citation: Lancet. 2002 Apr 6;359(9313):1178-86
references.pmid: 11955535
references.citation: Lancet. 2002 Jun 15;359(9323):2097-104
references.pmid: 12086778
references.citation: JAMA. 2002 Jul 10;288(2):189-98
references.pmid: 12095383
references.citation: J Infect Dis. 2002 Jul 15;186(2):181-8
references.pmid: 12134253
references.citation: AIDS. 2002 Nov 22;16(17):2323-8
references.pmid: 12441805
references.citation: J Infect Dis. 2003 Mar 1;187(5):725-35
references.pmid: 12599045
references.citation: AIDS. 2003 Jun 13;17(9):1377-82
references.pmid: 12799559
references.citation: AIDS. 2003 May 23;17(8):1239-42
references.pmid: 12819526
references.citation: AIDS. 2003 Jul 4;17(10):1570-2
references.pmid: 12824800
references.citation: Lancet. 2003 Sep 13;362(9387):842-3
references.pmid: 13678965
references.citation: Lancet. 2003 Sep 13;362(9387):859-68
references.pmid: 13678973
references.citation: AIDS. 2002 Mar 8;16(4):625-30
references.pmid: 11873007
references.citation: Stat Med. 2001 Dec 15;20(23):3539-56
references.pmid: 11746336
references.citation: AIDS. 2001 Oct 19;15(15):1951-7
references.pmid: 11600822
references.citation: Lancet. 2003 Oct 11;362(9391):1171-7
references.pmid: 14568737
references.citation: JAMA. 2000 Mar 1;283(9):1167-74
references.pmid: 10703779
references.citation: AIDS. 2000 Jul 28;14(11):F111-5
references.pmid: 10983633
references.citation: J Acquir Immune Defic Syndr. 2004 Feb 1;35(2):178-87
references.pmid: 14722452
references.citation: AIDS. 2004 Mar 5;18(4):697-700
references.pmid: 15090779
references.citation: JAMA. 2004 Jun 2;291(21):2639-41
references.pmid: 15173158
references.citation: JAMA. 2004 Jul 14;292(2):202-9
references.pmid: 15249569
references.citation: N Engl J Med. 2004 Jul 15;351(3):217-28
references.pmid: 15247338
references.citation: N Engl J Med. 2004 Jul 15;351(3):229-40
references.pmid: 15247339
references.citation: J Clin Microbiol. 2004 Sep;42(9):4147-53
references.pmid: 15365003
references.citation: Lancet. 1999 Mar 6;353(9155):781-5
references.pmid: 10459958
references.citation: Lancet. 1999 Mar 6;353(9155):786-92
references.pmid: 10459959
references.citation: Lancet. 1999 Aug 7;354(9177):471-6
references.pmid: 10465172
references.citation: AIDS. 2001 Sep 28;15(14):1849-56
references.pmid: 11579248
references.citation: Bull World Health Organ. 2001;79(7):641-7
references.pmid: 11477967
references.citation: JAMA. 2001 Apr 25;285(16):2083-93
references.pmid: 11311097
references.citation: AIDS. 2001 Apr 13;15(6):761-70
references.pmid: 11371691