Controversies in the use of nevirapine for prevention of mother-to-child transmission of HIV

Expert Opinion on Pharmacotherapy

Volumn 7, Issue 6, 2006, Pages 677-685

  McIntyre, James A ^a  

^a UNIVERSITY OF THE WITWATERSRAND   (South Africa)

Author keywords

Antiretroviral therapy; HIV; Interventions; Mother to child transmission; Nevirapine; Pregnancy; Resistance

Indexed keywords

CD4 ANTIGEN; LAMIVUDINE; NELFINAVIR; NEVIRAPINE; PROTEINASE INHIBITOR; RNA DIRECTED DNA POLYMERASE; ZIDOVUDINE;

ANTIBIOTIC RESISTANCE; CLINICAL STUDY; CLINICAL TRIAL; DISEASE SEVERITY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ERUPTION; DRUG HALF LIFE; DRUG MECHANISM; DRUG USE; ENZYME ACTIVITY; GENE MUTATION; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION PREVENTION; LIVER FAILURE; LIVER TOXICITY; LONG TERM CARE; LYMPHOCYTE COUNT; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; STEVENS JOHNSON SYNDROME; T LYMPHOCYTE; VERTICAL TRANSMISSION;

ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; DISEASE TRANSMISSION, VERTICAL; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; INFANT; NEVIRAPINE; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS;

EID: 33645886076     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.7.6.677     Document Type: Review

References (77)

1. JOINT UNITED NATIONS PROGRAMME ON HIV/AIDS (UNAIDS), AND WORLD HEALTH ORGANIZATION: AIDS epidemic update (2004). World Health Organization Geneva, Switzerland (2004).
2. VERMUND SH: Prevention of mother-to-child transmission of HIV in Africa. Top. HIV Med. (2004) 12:130-134.
3. MOFENSON LM: Successes and challenges in the perinatal HIV-1 epidemic in the United States as illustrated by the HIV-1 serosurvey of childbearing women. Arch. Pediatr. Adolesc. Med. (2004) 158:422-425.
4. EUROPEAN COLLABORATIVE STUDY: Mother-to-child transmission of HIV infection in the era of highly active antiretroviral therapy. Clin. Infect. Dis. (2005) 40:458-465.
5. MAGDER LS, MOFENSON L, PAUL ME et al.: Risk factors for in utero and intrapartum transmission of HIV. J. Acquir. Immune Defic. Syndr. (2005) 38:87-95.
6. MCINTYRE J: Preventing mother-to-child transmission of HIV: successes and challenges. BJOG (2005) 112:1196-1203.
7. WORLD HEALTH ORGANIZATION: Prevention of mother-to-child transmission of HIV: Selection and use of nevirapine. WHO/HIV_AIDS/2001.3. WHO/RHR/ 01.21. World Health Organization, Geneva, Switzerland (2002).
8. WORLD HEALTH ORGANIZATION. Antiretroviral drugs and the prevention of mother-to-child transmission of HIV infection in resource-limited settings. Recommendations for a public health approach (2005 revision), Geneva, Switzerland (2005).
9. GUAY L, 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.
10. 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-month follow-up of the HIVNET 012 randomised trial. Lancet (2003) 362:859-868.
11. 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) 39:593-597.
12. Drug could slash rate of perinatal HIV. Nature (1999) 400:304.
13. LURIE P, WOLFE SM: HIVNET nevirapine trials. Lancet (1999) 354:1816-1817.
14. NUWAHA FN, KARLIN T, BUYSE DS, WILFERT C: Prevention of mother to child transmission of HIV: from research to action. XIII International AIDS Conference, Barcelona, Spain (2002) Abstract TuPeF5413.
15. SIDLEY P: HIV drug under review as firm withdraws FDA application. Br. Med. J. (2002) 324:807.
16. BALETA A: South African government threatens to ban nevirapine. Move would take away option for treating vertical HIV transmission. Lancet (2003) 362:451.
17. SIDLEY P: South African government to withdraw antiretrovirals for pregnant mothers. Br. Med. J. (2003) 327:306.
18. CULLINAN K: Court orders South Africa to treat pregnant HIV-positive women with nevirapine. Bull. World Health Organ. (2002) 80:335.
19. WORLD HEALTH ORGANIZATION: Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants. Guidelines on care, treatment and support for women living with HIV/AIDS and their children in resource-constrained settings. World Health Organization, Geneva, Switzerland (2004).
20. COHEN J: HIV transmission. Allegations raise fears of backlash against AIDS prevention strategy. Science (2004) 306:2168-2169.
21. INSTITUTE OF MEDICINE: Review of the HIVNET 012 Perinatal HIV Prevention Study. Institute of Medicine, Washington DC, USA (2005).
22. MIROCHNICK M, FENTON T, GAGNIER P et al.: Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Pediatric AIDS Clinical Trials Group Protocol 250 Team. J. Infect. Dis. (1998) 178:368-374.
23. MERLUZZI VJ, HARGRAVE KD, LABADIA M et al.: Inhibition of HIV-1 replication by a nonnucleoside reverse transcriptase inhibitor. Science (1990) 250:1411-1413.
24. HAVLIR D, CHEESEMAN SH, MCLAUGHLIN M et al.: High-dose nevirapine: safety, pharmacokinetics, and antiviral effect in patients with human immunodeficiency virus infection. J. Infect. Dis. (1995) 171:537-545.
25. MIROCHNICK M, CAPPARELLI E: Pharmacokinetics of antiretrovirals in pregnant women. Clin. Pharmacokinet. (2004) 43:1071-1087.
26. GROB PM, CAO Y, MUCHMORE E et al.: Prophylaxis against HIV-1 infection in chimpanzees by nevirapine, a nonnucleoside inhibitor of reverse transcriptase. Nat. Med. (1997) 3:665-670.
27. 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 postpartum mother-to-child transmission of human immunodeficiency virus type 1. J. Infect. Dis. (2003) 187:725-735.
28. SHERMAN GG, JONES SA, COOVADIA AH, URBAN MF, BOLTON KD: PMTCT from research to reality-results from a routine service. S. Afr. Med. J. (2004) 94:289-292.
29. MARTINSON N, MORRIS L, GREY G et al.: HIV resistance and transmission following single-dose nevirapine in a PMTCT cohort. 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, CA, USA (2004). (2004) Abstract 38.
30. QUAGHEBEUR A, MUTUNGA L, MWANYUMBA F, MANDALIYA K, VERHOFSTEDE C, TEMMERMAN M: Low efficacy of nevirapine (HIVNET012) in preventing perinatal HIV-1 transmission in a real-life situation. AIDS (2004) 18:1854-1856.
31. KIARIE JN, KREISS JK, RICHARDSON BA, JOHN-STEWART GC: Compliance with antiretroviral regimens to prevent perinatal HIV-1 transmission in Kenya. AIDS (2003) 17:65-71.
32. STRINGER JS, SINKALA M, CHAPMAN V et al.: Timing of the maternal drug dose and risk of perinatal HIV transmission in the setting of intrapartum and neonatal single-dose nevirapine. AIDS (2003) 17:1659-1665.
33. STRINGER JS, SINKALA M, GOLDENBERG RL et al.: Universal nevirapine upon presentation in labor to prevent mother-to-child HIV transmission in high prevalence settings. AIDS (2004) 18:939-943.
34. AYOUBA A, TENE G, CUNIN P et al.: Low rate of mother-to-child transmission of HIV-1 after nevirapine intervention in a pilot public health programme in Yaounde, Cameroon. J. Acquir. Immune Defic. Syndr. (2003) 34:274-280.
35. KAGAAYI J, DREYFUSS ML, KIGOZI G et al.: Maternal self-medication and provision of nevirapine to newborns by women in Rakai, Uganda. J. Acquir. Immune Defic. Syndr. (2005) 39:121-124.
36. GREY GE, URBAN M, CHERSICH MF et al.: A randomized trial of two postexposure prophylaxis regimens to reduce mother-to-child HIV-1 transmission in infants of untreated mothers. AIDS (2005) 19:1289-1297.
37. TAHA TE, KUMWENDA NI, HOOVER DR et al.: Nevirapine and zidovudine at birth to reduce perinatal transmission of HIV in an African setting: a randomized controlled trial. JAMA (2004) 292:202-209.
38. LALLEMANT M, JOURDAIN G, LE COEUR S et al.: Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. N. Engl. J. Med. (2004) 351:217-228.
39. 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. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, USA (2005) Abstract 74LB.
40. TAHA TE, KUMWENDA NI, GIBBONS A et al.: Short postexposure prophylaxis in newborn babies to reduce mother-to-child transmission of HIV-1: NVAZ randomised clinical trial. Lancet (2003) 362:1171-1177.
41. DABIS F, BEQUET L, EKOUEVI DK et al.: Field efficacy of zidovudine, lamivudine and single-dose nevirapine to prevent peripartum HIV transmission. AIDS (2005) 19:309-318.
42. CRESSEY TR, JOURDAIN G, LALLEMANT MJ et al.: Persistence of nevirapine exposure during the postpartum period after intrapartum single-dose nevirapine in addition to zidovudine prophylaxis for the prevention of mother-to-child transmission of HIV-1. J. Acquir. Immune Defic. Syndr. (2005) 38:283-288.
43. ESHLEMAN SH, JONES D, GUAY L et al.: HIV-1 variants with diverse nevirapine resistance mutations emerge rapidly after single dose nevirapine: HIVNET 012. XII International HIV Drug Resistance Workshop: Basic Principles and Clinical Implications. Cabo San Lucas, Mexico (2003).
44. ESHLEMAN SH, GUAY LA, MWATHA A et al.: Extended analysis of nevirapine (NVP) resistance in women with subtype A versus D 6-8 weeks after single dose NVP prophylaxis: HIVNET 012. 10th Conference on Retroviruses and Opportunistic Infections, Boston, MA, USA (2003) Abstract P40 (857).
45. ESHLEMAN SH, HOOVER DR, CHEN S et al.: Nevirapine (NVP) resistance in women with HIV-1 subtype C, compared with subtypes A and D, after the administration of single-dose NVP. J. Infect. Dis. (2005) 192:30-36.
46. CHAIX ML, MONTCHO C, EKOUEVI DK et al.: Genotypic resistance analysis in women who received intrapartum nevirapine associated to a short course of zidovudine to prevent perinatal HIV-1 transmission: the ditrame plus ANRS 1201/02 study, Abidjan, Côte d'Ivoire. 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, CA, USA (2004) Abstract 457.
47. ESHLEMAN SH, JACKSON JB: Nevirapine resistance after single dose prophylaxis. AIDS Rev. (2002) 4:59-63.
48. ESHLEMAN SH, HOOVER D, CHEN S et al.: Comparison of nevirapine resistance in women with subtype C compared with subtypes A and D after single-dose NVP. 12th Conference on Retroviruses and Oppotunistic Infections, Boston, MA, USA (2005) Abstract 799.
49. ESHLEMAN SH, GUAY LA, WANG J et al.: Distinct patterns of emergence and fading of K103N and Y181C in women with subtype A versus D after single-dose nevirapine: HIVNET 012. J. Acquir. Immune Defic. Syndr. (2005) 40:24-29.
50. MORRIS L, MARTINSON N, PILLAY C et al.: Persistence of nevirapine resistance mutations 6 months following single dose nevirapine. 15th International AIDS Conference, Bangkok, Thailand (2004).
51. 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) 192:1260-1264.
52. CHAIX ML, DABIS F, EKOUEVI D et al.: Addition of 3 days of ZDV+3TC postpartum to a short course of ZDV+3TC and single-dose NVP provides low rate of NVP resistance mutations and high efficacy in preventing peri-partum HIV-1 transmission: ANRS DITRAME Plus, Abidjan, Côte d'Ivoire. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, USA (2005) Abstract 72LB.
53. 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) 351:229-240.
54. LYONS FE, COUGHLAN S, BYRNE CM, HOPKINS SM, HALL WW, MULCAHY FM: Emergence of antiretroviral resistance in HIV-positive women receiving combination antiretroviral therapy in pregnancy. AIDS (2005) 19:63-67.
55. ESHLEMAN SH, MRACNA M, 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) 15:1951-1957.
56. SULLIVAN J, THE SAINT STUDY TEAM: South African Intrapartum Nevirapine Trial (SAINT): selection of resistant mutations. XIV International AIDS Conference, Barcelona, Spain (2002) Abstract LbPeB902.
57. HAMMER SM: Single-dose nevirapine and drug resistance: the more you look, the more you find. J. Infect. Dis. (2005) 192:1-3.
58. JOHNSON JA, LI JF, MORRIS L et al.: Emergence of drug-resistant HIV-1 after intrapartum administration of single-dose nevirapine is substantially underestimated. J. Infect. Dis. (2005) 192:16-23.
59. PALMER S, BOLTZ V, MALDARELLI F et al.: Persistence of NNRTI-r resistant variants after single-dose nevirapine in HIV-1 subtype-C-infected women. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, USA (2005) Abstract 101.
60. FLYS T, NISSLEY DV, CLAASEN CW et al.: Sensitive drug resistance assays reveal 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) 192:24-29.
61. MARTINSON N, LUPONDWANA P, MORRIS L et al.: Effectiveness of single dose nevirapine in a second pregnancy. 12th Conference on Retroviruses and Opportunbistic Infections, Boston, MA, USA (2005) Abstract 103.
62. ZIJENAH L, KADZIRANGE G, RUSAKANIKO S et al.: Community-based generic antiretroviral therapy following single-dose nevirapine or short-course AZT in Zimbabwe. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, USA (2005) Abstract 632.
63. BEDIKOU G, VIHO I, TONWE-GOLD B et al.: 6-Month immunological response with HAART containing nevirapine in HIV infected women post exposure to single dose of nevirapine for PMTCT. The MTCT-plus initiave in Abidjan, Côte d'Ivoire (2003-2005). 3rd IAS Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, Brazil (2005) Abstract MoOa0203.
64. LOCKMAN S, SMEATON L, SHAPIRO R et al.: Maternal and infant response to nevirapine (NVP)-based antiretroviral treatment (ART) following peripartum single-dose NVP or placebo (Plc). 43rd Annual Meeting of IDSA, San Francisco, CA, USA. (2005) Abstract LB5. Available at www.idsociety.org.
65. MCINTYRE JA, MARTINSON N, GREY GE et al.: Addition of short course combivir to single dose viramune for the prevention of mother to child transmission of HIV-1 can significantly decrease the subsequent development of maternal and paediatric NNRTI-resistant virus. 3rd IAS Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, Brazil (2005) Abstract TuFoO2O4.
66. PALMER S, BOLTZ V, MALDERELLI 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. XIV International HIV Drug Resistance Workshop: Basic Principles And Clinical Implications, Quebéc, Canada. (2005) Abstract 3. Antiviral therapy 10:S5 Available at http://www.intmedpress.com/files/PDF/Session1FINAL.pdf.
67. US PUBLIC HEALTH SERVICE: Public Health Service Task Force recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States. Washington DC, USA (2005).
68. THE BRITISH HIV ASSOCIATION: Guidelines for the management of HIV infection in pregnant women and the prevention of mother-to-child transmission of HIV. The British HIV Association, London, UK (2005).
69. HITTI J, FRENKEL LM, STEK AM et al.: Maternal toxicity with continuous nevirapine in pregnancy: results from PACTG 1022. J. Acquir. Immune Defic. Syndr. (2004) 36:772-776.
70. TIMMERMANS S, TEMPELMAN C, GODFRIED MH et al.: Nelfinavir and nevirapine side effects during pregnancy. AIDS (2005) 19:795-799.
71. MONEY D, KHOO D, MACDONALD G et al.: A comparison of toxicity in nevirapine-versus protease inhibitor-containing HAART regimens in pregnant women. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, USA (2005) Abstract 784.
72. NATARAJAN U, PYM A, ANDERSON J et al.: The side effect profile associated with use of nevirapine in a cohort of pregnant women in London. 7th Conference on HIV Drug Therapy, Glasgow, Scotland (2004) Abstract P190.
73. BERSHOFF-MATCHA SJ, MUNDY LM, HENRY JV: Adverse events to nevirapine therapy during pregnancy. 11th Conference on Retroviruses and Opportunisitc Infections, San Francisco, CA, USA (2004) Abstract 939.
74. PHANUPHAK N, APORNPONG T, INTARASUK S, TEERATAKULPISARN S, PHANUPHAK P: Toxicities from nevirapine in HIV-infected males and females, including pregnant females with various CD4 cell counts. 12th Conference on Retroviruses and Opprtunistic Infections, Boston, MA, USA (2005) Abstract 21.
75. THOMAS T, AMORNKUL P, MWIDAU J et al.: Preliminary findings: incidence of serious adverse events attributed to nevirapine among women enrolled in an ongoing trial using HAART to prevent mother-to-child HIV transmission. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, USA (2005) Abstract 809.
76. LEITH J, PILIERO P, STORFER S, MAYERS D, HINZMANN R: Appropriate use of nevirapine for long-term therapy. J. Infect. Dis. (2005) 192:545-546.
77. FDA: FDA Public Health Advisery for nevirapine (viramune). Washington DC, WA, USA (2005).