Antiretroviral therapy for prevention of mother-to-child HIV transmission: Focus on single-dose nevirapine

Clinical Drug Investigation

Volumn 26, Issue 11, 2006, Pages 611-627

  Giaquinto, Carlo ^a   Rampon, Osvalda ^a   De Rossi, Anita ^a  

^a UNIVERSITY OF PADOVA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

LAMIVUDINE; NEVIRAPINE; RNA DIRECTED DNA POLYMERASE INHIBITOR; ZIDOVUDINE;

ARTIFICIAL MILK; CLINICAL TRIAL; DELIVERY; DOSE RESPONSE; DRUG EFFICACY; GENE MUTATION; GESTATIONAL AGE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; META ANALYSIS; MOTHER CHILD RELATION; PREGNANCY; PRENATAL CARE; PRIORITY JOURNAL; REVIEW; RISK FACTOR; SYSTEMATIC REVIEW; TREATMENT OUTCOME; VERTICAL TRANSMISSION; VIRUS REPLICATION; VIRUS RESISTANCE;

ANTI-HIV AGENTS; DISEASE TRANSMISSION, VERTICAL; DRUG RESISTANCE, VIRAL; FEMALE; HIV INFECTIONS; HUMANS; INFANT, NEWBORN; LAMIVUDINE; NEVIRAPINE; PREGNANCY;

EID: 33750351449     PISSN: 11732563     EISSN: 11732563     Source Type: Journal    
DOI: 10.2165/00044011-200626110-00001     Document Type: Review

References (75)

1. WHO/UNAIDS. AIDS epidemic update. December 2005 [online]. Available from URL: http://www.unaids.org/epi/2005/doc/report_pdf.asp [Accessed 2006 Aug 1]
2. De Cock K, Fowler MG, Mercier E, et al. Prevention of mother to child HIV transmission in resource poor countries: translating research into policy and practice. JAMA 2000; 283: 1175-82
3. John-Stewart G, Mbori-Ngacha D, Ekpini R, et al. Breastfeeding and transmission of HIV-1. J Acquir Immune Defic Syndr 2004; 35: 196-202
4. Connor E, Sperling R, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med 1994; 331: 1173-80
5. World Health Organization. HIV transmission through breastfeeding: a review of available evidence: 2004 [online]. Available from URL: http://www.who.int/reproductive-health/docs/hiv_infantfeeding/breastfeeding.pdf [Accessed 2006 Oct 9]
6. PHSTF/CDC. Recommendations for use of antiretroviral drugs in pregnant HIV 1 infected women for maternal health and intervention to reduce perinatal HIV transmission in the United States. AIDS info website [online]. Available from URL: http://www.AIDSinfo.nih.gov [Accessed 2005 Nov 1]
7. Mofenson LM, Lambert JS, Stihem R, et al. Risk factors for perinatal transmission of HIV [abstract no. 1229]. In: Proceedings of the XIII AIDS Conference; 2000 Jul 9-14; Durban, South Africa
8. Dorenbaum A, Cunningham CK, Gelber RD, et al. Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission: a randomized trial. JAMA 2002; 288: 189-98
9. Ioannidis JPA, Abrams EJ, Ammann A, et al. Perinatal transmission of human immunodeficiency virus type 1 by pregnant women with RNA virus loads <1000 copies/mL. J Infect Dis 2001; 183: 539-45
10. Wiktor SZ, Ekpini E, Karon JM, et al. Short-course oral zidovudine for prevention of mother-to-child transmission of HIV-1 in Abidjan, Côte d'Ivoire: a randomised trial. Lancet 1999; 353: 781-5
11. Dabis F, Msellati P, Meda N, et al. 6-month efficacy, tolerance, and acceptability of a short regimen of oral zidovudine to reduce vertical transmission of HIV in breastfed children in Côte d'Ivoire and Burkina Faso: a double-blind placebo-controlled multicentre trial. DITRAME Study Group. Diminution de la Transmission Mere-Enfant. Lancet 1999; 353 (9155): 786-92
12. The Petra study team. Efficacy of three short-course regimens of zidovudine and lamivudine in preventing early and late transmission of HIV-1 from mother to child in Tanzania, South Africa, and Uganda (Petra study): a randomized, double-blind, placebo-controlled trial. Lancet 2002; 359: 1178-86
13. Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet 1999; 354: 795-802
14. Moodley D, Moodley J, Coovadia H, et al. A multicenter randomized controlled trial of nevirapine versus a combination of zidovudine and lamivudine to reduce intrapartum and early post-partum mother-to-child transmission of human immunodeficiency virus type 1. J Infect Dis 2003; 187: 725-35
15. Dabis F, Bequet L, Ekouevi DK, et al. ANRS 1201/1202 DITRAME PLUS Study Group. Field efficacy of zidovudine, lamivudine and single-dose nevirapine to prevent peripartum HIV transmission. AIDS 2005; 19: 309-18
16. Shaffer N, Chuachoowong R, Mock PA, et al. Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomized controlled trial. Lancet 1999; 353: 773-80
17. Lallemant M, Jourdain G, Le Coeur S, et al. A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Perinatal HIV Prevention Trial (Thailand) Investigators. N Engl J Med 2000; 343 (14): 982-91
18. Lallemant M, Jourdain G, Le Coeur S, et al. A randomized, double-blind trial assessing the efficacy of single-dose perinatal nevirapine added to a standard zidovudine regimen for the prevention of mother-to-child transmission of HIV-1 in Thailand. N Engl J Med 2004; 351: 217-28
19. Lallemant M. Prevention of mother to child transmission of HIV [online]. Available from URL: http://www.pentatrials.org [Accessed 2005 Aug 1]
20. Quaghebeur A, Mutunga L, Mwanyumba F, et al. Low efficacy of nevirapine (HIVNET012) in preventing perinatal HIV-1 transmission in a real-life situation. AIDS 2004; 18: 1854-6
21. Cressey TR, Jourdain G, Lallemant MJ, et al. Persistence of nevirapine exposure during the post-partum period after intrapartum single dose nevirapine in addition to zidovudine prophylaxis for prevention of mother-to-child transmission of HIV-1. J Acquir Immune Defic Syndr 2005; 38: 283-8
22. Chung MH, Kiarie JN, Richardson BA, et al. Breast milk HIV-1 suppression and decreased transmission: a randomised trial comparing HIVNET 012 nevirapine versus short course zidovudine. AIDS 2005; 19: 1415-22
23. Leroy V, Sakarovitch C, Cortina-Borja M, et al. Is there a difference in the efficacy of peripartum antiretroviral regimens in reducing mother-to-child transmission of HIV in Africa? AIDS 2005; 19: 1865-75
24. UNAIDS. Available from URL: http://www.womenandaids.unaids.org/ issues_access.html [Accessed 2006 Sep 11]
25. Chi BH, Wang L, Read JS, et al. Timing of maternal and neonatal dosing of nevirapine and the risk of mother-to-child transmission of HIV-1: HIVNET 024. AIDS 2005; 19: 1857-64
26. Jackson JB, Parsons T, Musoke P, et al. Association of cord blood nevirapine concentration with reported timing of dose and HIV-1 transmission. AIDS 2006; 20: 217-22
27. 25. Eure C, Bakaki P, McConnell M, et al. Effectiveness of repeat single-dose nevirapine in subsequent pregnancies among Ugandan women [abstract no. 125]. 13th Conference on Retroviruses and Opportunistic Infections; 2006; Denver, USA
28. 26. Martinson N, Ekouevi D, Gray G, et al. Effectiveness of single-dose nevirapine in consecutive pregnancies in Soweto and Abidjan [abstract no. 722]. 13th Conference on Retroviruses and Opportunistic Infections; 2006; Denver, USA
29. Eastman PS, Shapiro DE, Coombs RW, et al. Maternal viral genotypic zidovudine resistance and infrequent failure of zidovudine therapy to prevent perinatal transmission of human immunodeficiency virus type 1 in paediatric AIDS Clinical Trials Group Protocol 076. J Infect Dis 1998; 177: 557-64
30. Welles SL, Pitt J, Colgrove R, et al. HIV-1 genotypic ZDV drug resistance and the risk of maternal-infant transmission in the Women and Infants Transmission Group. AIDS 2000; 14: 263-71
31. Mofenson LM, Lambert JS, Stihem R, et al. Risk factors for perinatal transmission of HIV [abstract no. 1229]. In: Proceedings of the XIII AIDS Conference; 2000 Jul 9-14; Durban, South Africa
32. Kully C, Yerly S, Erb P, et al. Codon 215 mutations in HIV infected pregnant women. J Infect Dis 1999; 179: 705-8
33. Sitniskaya Y, Rochford G, Rigaud M, et al. Prevalence of T215Y mutation in HIV-1 infected pregnant women in a New York cohort, 1995-1999. Clin Infect Dis 2001; 33: e3-7
34. Palumbo P, Holland B, Dobbs T, et al. Antiretroviral resistance mutations among pregnant HIV-1 infected women and their newborns in the United States: vertical transmission and clades. J Infect Dis 2001; 184: 1120-6
35. Ekpini RA, Nkengasong JN, Sibailly T, et al. Changes in plasma HIV-1-RNA viral load and CD4+ cell counts, and lack of zidovudine resistance among pregnant women receiving short-course zidovudine. AIDS 2002; 16: 625-30
36. Giuliano M, Palmisano L, Galluzza C, et al. Selection of resitance mutations in pregnant women receiving zidovudine and lamivudine to prevent HIV perinatal transmission. AIDS 2003; 17: 1570-3
37. Colgrove RC, Pitt J, Chung PH, et al. Selective vertical transmission of HIV-1 antiretroviral resistance mutations AIDS 1998; 12: 2281-8
38. Mandelbrot L, Landreau-Mascaro A, Rekacewicz C, et al. Lamivudine and zidovudine combination for prevention of maternal-infant transmission of HIV-1. JAMA 2001; 285: 2083-93
39. WHO. Scaling up ART in resource-limited settings: treatment guidelines for a public health approach; 2003 revision. Geneva, Switzerland: 2004
40. Jackson JB, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18 months of follow up of the HIVNET 012 randomised trial. Lancet 2003; 362: 859-68
41. Eshleman SH, Guay LA, Mwatha A, et al. Characterisation of nevirapine (NVP) resistance mutations in women with subtype A vs D in HIV-1, 6-8 weeks after single dose NVP (HIVNET 012). J Acquir Immune Defic Syndr 2004; 35: 126-30
42. Eshleman SH, Guay LA, Mwatha A, et al. Comparison of NVP resistance in Ugandan women 7 days vs. 6-8 weeks after single dose NVP prophylaxis: HIVNET 012. AIDS Res Hum Retroviruses 2004; 20: 595-9
43. Eshleman SH, Mwatha A, Guay LA, et al. Selection and fading of resistance mutations in women and infants receiving nevirapine to prevent HIV-1 vertical transmission (HIVNET 012). AIDS 2001; 15: 1951-7
44. Loubser S, Balfe P, Sherman G, et al. Sensitive real-time PCR quantification of 103N resistance mutants following single dose treatment with nevirapine [abstract no. 102]. In: Proceedings of the 12th Retrovirus Conference; 2005; Boston, USA
45. Johnson J, Li JF, Morris L, et al. Emergence of drug resistance HIV-1 after intrapartum administration of single-dose nevirapine is substantially underestimated J Infect Dis 2005; 192: 16-23
46. Flys T, Nissley DV, Claesen CW, et al. Sensitive drug-resistance assay reveals long-term persistence of HIV-1 variants with the K103N nevirapine (NVP) resistance mutation in some women and infants after the administration of single dose NVP: HIVNET 012. J Infect Dis 2005; 192: 24-9
47. Eshleman SH, Hoover DR, Chen S, et al. Nevirapine resistance in women with HIV-1 subtype C compared with subtype A and D after the administration of single-dose nevirapine. J Infect Dis 2005; 192: 30-6
48. Lee EJ, Kantor R, Zijenah L, et al. Breast milk shedding of drug-resistant HIV-1 subtype C in women exposed to single-dose nevirapine. J Infect Dis 2005; 192: 1260-4
49. Sullivan J. South African Intrapartum Nevirapine Trial: selection of resistance mutations [abstract no. LbPeB9024]. XVI International Conference on AIDS; 2002 Jul 7-12; Barcelona, Spain
50. Shapiro R, Thior I, Gilbert P, et al. Maternal single dose nevirapine may not be needed to reduce mother-to-child HIV transmission in the setting of maternal and infant zidovudine and infant single dose nevirapine: results of a randomised clinical trial in Botswana [abstract no. 74LB]. In: Proceedings of the 12th Retrovirus Conference; 2005; Boston, USA
51. McIntyre JA, Martinson N, Gray G, et al. Addition of short course Combivir (CBV) to single dose Viramune (SD-NVP) for the prevention of mother-to-child transmission (pMTCT) of HIV-1 can significantly decrease the subsequent development of maternal and paediatric NNRTI resistant virus [abstract no. TuFo0204]. In: Proceedings of the 3rd IAS Conference; 2005; Rio de Janeiro, Brazil
52. Chaix ML, Dabis F, Ekouevi D, et al. Addition of ZDV+3TC post-partum to short course of ZDV+3TC and single dose nevirapine provides low rate of NVP resistance mutations and high efficacy in preventing HIV-1 transmission: ANRS DITRAME Plus. Abidjan, Cote d'Ivoire [abstract no. 72LB]. In: Proceedings of the 12th Retrovirus Conference; 2005; Boston, USA
53. Palombi L, Germano P, Liotta G, et al. HAART in pregnancy: safety, effectiveness and protection from viral resistance: results from the DREAM cohort [abstract no. 67]. 12th Retrovirus Conference; 2005; Boston, USA
54. Lyons F, Coughlan S, Byrne CM, et al. Emergence of antiretroviral resistance in HIV positive women receiving combination antiretroviral therapy in pregnancy. AIDS 2005; 19: 63-7
55. Martinson N, Morris L, Gray G, et al. HIV resistance following single-dose nevirapine in pMTCT cohort [abstract no. 38]. In: Proceedings of the 11th Retrovirus Conference; 2004; San Francisco, USA
56. Arrivè E, Dabis F, Newell ML, et al. Frequency of nevirapine resistance (NVPR) after single dose nevirapine (SD-NVP) use to prevent HIV-1 vertical transmission: a meta-analysis [abstract no. TuPe5.2P15]. In: Proceedings of the 3rd IAS Conference; 2005; Rio de Janeiro, Brazil
57. Jourdain G, Ngo-Giang-Huong N, Le Coeur S, et al. Intrapartum exposure to nevirapine and subsequent maternal responses to nevirapine-based antiretroviral therapy. N Engl J Med 2004; 351: 229-40
58. Taha TE, Kumwenda NI, Hoover DR, et al. Nevirapine and zidovudine at birth to reduce perinatal transmission of HIV in an African setting: a randomised controlled trial. JAMA 2004; 292: 202-9
59. Mironchnick M, Fenton T, Gagnier P, et al. Pharmacokinetics of nevirapine in HIV type 1 infected pregnant women and their neonates. PACTG 250 team. J Infect Dis 1998; 178: 368-74
60. Musoke P, Guay LA, Beganda D, et al. A phase I/II study of the safety and pharmacokinetics of nevirapine in HIV-1 infected pregnant Ugandan women and their neonates. AIDS 1999; 13: 479-86
61. Brenner B, Turner D, Oliveira M, et al. V106M mutation in HIV-1 clade C viruses exposed to efavirenz confers cross-resistance to non nucleoside reverse transcriptase inhibitors. AIDS 2003; 8: F1-5
62. Eshleman SH, Becker-Pergola G, Deseyve M, et al. Impact on HIV-1 subtype in women receiving single dose NVP prophylaxis to prevent HIV vertical transmission (HIVNET 012). J Infect Dis 2001; 184: 914-7
63. Eshleman SH, Guay LA, Mwatha A, et al. Comparison of mother-to-child transmission rates in Ugandan women with subtype A versus D HIV-1 who received single-dose nevirapine prophylaxis: HIV Network For Prevention Trials 012. J Acquir Immune Defic Syndr 2005; 39 (5): 593-7
64. Gray G, McIntyre J, Hopley M, et al. NNRTI-resistant mutations in HIV-1 infected infants following single dose nevirapine (SD-NVP) are reduced by addition of short course zidovudine and 3TC [abstract no. TuPe5.4P01]. In: Proceedings of the 3rd IAS Conference; 2005; Rio de Janeiro, Brazil
65. Ngo-Giang-Huong, Jourdain G, Tungyai P, et al. Infant zidovudine prophylaxis and emergence of nevirapine resistance at 6 weeks in perinatally HIV-infected infants exposed to intrapartum or newborn nevirapine [abstract no. 802]. In: Proceedings of the 12th Retrovirus Conference; 2005; Boston, USA
66. Eshelman SH, Hoover DR, Chen S, et al. Resistance after single dose nevirapine prophylaxis emerges in high proportion of Malawian newborn. AIDS 2005; 19: 2167-9
67. Hammer SM. Single-dose nevirapine and drug resistance: the more you look, the more you find. J Infect Dis 2005; 192: 1-3
68. Lallemant M. Response to therapy after prior exposure to nevirapine [abstract no. TuFo0205]. In: Proceedings of the 3rd IAS Conference; 2005; Rio de Janeiro, Brazil
69. Bedikou G, Viho I, Tonwe-Gold B, et al. 6-months immunological response with HAART containing nevirapine in HIV-infected women post exposure to single dose nevirapine for PMTCT. The MTCT Plus Initiative in Abidjan, Cote d'Ivoire (2003-2005) [abstract no. MaOa0203]. In: Proceedings of the 3rd IAS Conference; 2005; Rio de Janeiro, Brazil
70. Lockman S, Smeaton L, Shapiro R, et al. Maternal and infant response to nevirapine (NVP) based ART following peripartum single-dose NVP [abstract no. LB5]. In: Proceedings of the 43rd IDSA; 2005; San Francisco, USA
71. Coovadia A, Marais B, Abrams E, et al. Virologic response to NNRTI treatment among women who took single dose nevirapine 18 to 36 months earlier [abstract no. 641]. In: Proceedings of the 13th Conference on Retroviruses and Opportunistic Infections; 2006; Denver, USA
72. Chi B, Sinkala M, Levy J, et al. Maternal immune response and clinical outcomes on NNRTI-based antiretroviral therapy (ART) following exposure to single dose Nevirapine (NVP) for prevention of mother to child transmission (PMTCT) [abstract no. WEAB0104]. In: Proceedings of the XVI International AIDS Conference; 2006 Aug; Toronto
73. MacKie NE, Fidler S, Tamm N, et al. Clinical implications of stopping nevirapine-based antiretroviral therapy: relative pharmacokinetics and avoidance of drug resistance. HIV Med 2004; 5: 180-4
74. Palmer S, Boltz V, Maldarelli F, et al. Short-course Combivir (CBV) single dose nevirapine reduces but does not eliminate the selection of nevirapine-resistant HIV-1: improved detection by allele-specific PCR [abstract no. 3]. Antiviral Ther 2005; 10: S5
75. WHO. Guidelines on the use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants. Geneva, Switzerland, 2006 [online]. Available from URL: hhttp://www.who.int/hiv/pub/guidelines/pmtct/en/ index.html [Accessed 2006 Sep 30]