 Efficacy of Nevirapine Administration on the Mother to Child Transmission of HIV using a modified HIVNET 012 regimen. M. A St John*, Alok Kumar*, Kelly Carmichael**, Clyde Cave*, Akin Abayomi**. *Department of Paediatrics, Queen Elizabeth Hospital, ** Ladymeade Reference Unit (LRU) Laboratory, Ministry of Health, Barbados.

 Status of HIV/AIDS in the Caribbean? Caribbean region 2nd highest in prevalence to Sub-Saharan region (UNAIDS) In 2001, 3 million lives claimed 580,000 deaths paediatric cases (CAREC) In 2000, estimated 3000 children born to infected mothers, 1000 infants newly infected

 ( CAREC ) Prevalence of new HIV infected paediatric cases No. per /1000 live births Guyana Belize Trinidad &Tobago Jamaica Barbados (‘96-’00) 1.5

 >90% paediatric HIV/AIDS cases result through mother to child transmission Pre ART era: MTCT 15%-30%, without breast- feeding With breast-feeding: transmission 43%-50%

 Effect of ART regimens on MTCT Significant % reduction depending on protocol depending on breast-feeding compliance

 In the last decade….. NEJM 1994 : Pediatric AIDS Clinical Trial Group (ACTG) 076 protocol collaborative study Long course ZDV Rx of pregnant women and non breast-fed infants : reduced transmission of 25.5% to 8.3% (RR 67.5%) J. Pediatrics Infectious Diseases 2003: Barbados study ‘ Modified ACTG protocol :reduced transmission of 27.1% to 5.5%--non breast fed infants (RR 79.7%)

 Alternative regimens Trial with oral nevirapine HIVNET 012 protocol In Kampala Uganda ( Lancet 1999) Single dose nevirapine for mother in labour and Rx breast-fed infants < 72 hours after birth Results: Mother to child transmission nevirapine Rx % intrapartum ZDV Rx %

 Study objective To evaluate the efficacy of single dose nevirapine (NVP) on mother to child transmission of HIV using a HIVNET 012 protocol.

 Methods Approval of Ethics Committee, Min. of Health Written consent from infected pregnant women ART treated pregnant women excluded From Sept. 2000, single dose oral Nevirapine--HIVNET 012 to: pregnant woman 200mg at onset of labour : infant 2mg/Kg orally at < 72 hr, no breast feeding Infant: examination, clinic visits 6wk, 3m,6m, 12,18m Blood samples: viral loads HIV-RNA PCR (Roche), ELISA

Target sample: 37 pregnant women 2 samples 6 mths) by Ultrasensitive method, where <50 copies/mL = undetectable virus Data analysis: incidence rate of HIV transmission : 95% Confidence Intervals (CI) : Chi Square Test, Vassar Statistical calculator for statistical significance and CI.

 Results. One mother (2nd pregnancy in study period) 35 infants had VL testing Gender distribution: 22 male (63%): 13 female (37%) 2 (5%) > 4 Kg 37 (95%) >2.5 Kg 2 deaths ---at ages 2 months and 16 months

 Results. Transmission rate in Nevirapine treated mother infant pairs 8.8% (95% CI=2.2%-24.2%) 68.6% reduction in transmission rate Statistically significant (p=0.03) 2 deaths (5.7%) (95% CI=1.0%-20.5%)

 Conclusions 2 year study: nevirapine protocol less efficacious than zidovudine protocol in reducing MTCT NVP transmission rate 8.3%; ZDV rate 5.5% in previous study.

 Study limitations.. Small number of mother-infant pairs Not a placebo controlled study …..ethical considerations Precise timing of administration and receipt of NVP could have adversely affected the results

 Recommendations Need to review protocol used for reducing MTCT of HIV, whether ZDV protocol re-adopted, NVP reserved for late /undiagnosed pregnant women and infants, effort to optimise a reduction in MTCT.

 Acknowledgments Support of Dr Arthur Amman, President, and Natasha Martin, Consultant, Global Strategies Fund, USA Global Strategies Fund for supplying nevirapine treament for patients in this study.