René Ekpini

1. Towards Universal Access Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants in Resource-Limited Settings Recommendations for a Public Health Approach René Ekpini

2. Global inequities in the prevention of mother-to-child transmission of HIV • More than 90% of paediatric HIV infections occurs in resource-limited settings • Virtual elimination of HIV infection in infants with MTCT rates <2% in developed countries bearing only 0.6% of global paediatric burden • Low coverage and uptake in resource-limited settings: • Less than 15% of pregnant women tested for HIV • Less than 10% are offered ARV prophylaxis • less than 5% of HIV-infected women in need of treatment are offered ART

3. The UNAIDS universal access initiative " …with the aim of an AIDS-free generation in Africa, significantly reducing HIV infections and working with WHO, UNAIDS and other international bodies to develop and implement a package for prevention, treatment and care, with the aim of as close as possible to universal access to treatment for all those who need it by 2010". The Abuja call to action: towards an HIV-free and AIDS-free generation Called upon governments, development partners, civil society and private sector to join this Call to Action, and move swiftly towards supporting measures needed to eliminate HIV in infants and young children and clear the way for a worldwide HIV-free and AIDS-free generation Goal:elimination of HIV infection in infant and young children to pave the way towards an HIV-free and AIDS-free generation International commitments to re-energize the PMTCT agenda

4. Objective of the Guidelines • Provide guidance to assist national ministries of health in the selection and the provision of ART and ARV prophylaxis for women and their infants in the context of PMTCT

5. Evidence-based recommendations taking into account scientific evidence and programmatic experiences • Recommendations based on evidence from randomized controlled trials, high-quality scientific studies for non-treatment-related options, observational cohort data, or expert opinion where evidence is lacking or inconclusive

6. Recommendations for initiating ARV treatment in pregnant women based on clinical stage and availability of immunological markers

7. WHO Guidelines implementation: Cote d’Ivorie results - Tonwe-Gold B et al, 12th CROI, Boston, MA 2005 (abs 785) p=0.70

8. Conclusions from short-course ARV prophylaxis studies -1- • Efficacy of AZT alone or AZT/3TC regimens decreases with breastfeeding, particularly with prolonged breastfeeding • In contrast, efficacy of Sd NVP less affected by breastfeeding • A combination regimen of AZT plus SD NVP is more effective than single drug regimens in formula-fed and breastfeeding populations • AZT plus SD NVP is equally effective as a more complex regimen of AZT/3TC + SD NVP and an AP-IP-PP AZT/3TC regimen

9. Conclusions from short-course ARV prophylaxis studies -2- • Estimated 20-30% of pregnant women meet WHO criteria for initiating ART for their own health • Advanced disease, low CD4 associated with higher MTCT, even in women receiving short-course ARV prophylaxis • Risk of NVP resistance after Sd-NVP, given alone or with other ARVs, significantly higher in women with indication of ART • An AZT/3TC “tail” given at the time of Sd-NVP and for a short time in the postpartum reduces development of NVP resistance

10. Recommended regimens for treating pregnant women and prophylactic regimen for infants • Women, including pregnant women, who need ART for their own health should receive it • Women who do not need ART should be offered ARV prophylaxis for MTCT prevention • The recommended prophylactic regimen is: • Mother: • Antepartum: AZT starting at 28 wks of pregnancy • or as soon as thereafter • Intrapartum: Sd-NVP + AZT/3TC • Postpartum: AZT/3TC for 7 days • Infant: single dose NVP plus one week AZT

11. Recommended first-line ARV regimens for treating pregnant women and prophylactic regimen for infants *If the mother receives < 4 wks of ART during pregnancy, give 4 wks of infant AZT

12. Different approaches for using ARV prophylaxis to prevent HIV infection in infants *1 If the woman receives at least 4 wks of AZT during pregnancy, omission of maternal NVP dose may be considered; the infant NVP dose must be given immediately at birth; Infant: 4 wks of AZT instead of 1 wk; and women do not require 7-day tail of AZT and 3TC. 2 If the mother receives < 4 wks of AZT during pregnancy, 4 weeks of infant AZT recommended

13. ARV prophylaxis for MTCT prevention among pregnant women who have not received antenatal ART or prophylaxis

14. ARV prophylactic regimens for infants born to HIV-positive women who have not received antepartum or intrapartum ART or ARV prophylaxis NVP administered immediately after birth, if possible within 12 hours after delivery, is likely to result in a larger reduction in transmission than later initiation. Data on added efficacy of 4 weeks of infant AZT in this situation limited

15. Special considerations • Pregnant women living with HIV who have anaemia • Pregnant women living with HIV who have active tuberculosis • Management of injecting drug-using pregnant women living with HIV • Pregnant women with HIV-2 infection • Women with primary HIV infection during pregnancy

16. Antiretroviral drugs for preventing HIV postnatal transmission through breastfeeding • Current UN recommendations on HIV and infant feeding remain valid, irrespective of whether a woman is receiving ART • Women receiving ART who are breastfeeding should continue their ARV regimen • The use of ARV drugs in the mother and/or infant solely to prevent MTCT through breastfeeding is currently not recommended

17. Integrated delivery of PMTCT interventions within MCH services WHO comprehensive strategic approach to the prevention of HIV in infants and young children Guiding principles of the Guidelines A public health approach for increasing access to PMTCT services Women's health as the overarching priority in decisions about ARV treatment during pregnancy Necessity for highly effective ARV regimens for eliminating HIV infection in infants and young children

18. Scaling up national PMTCT programmes • Government leadership and commitment to mobilizing and allocating resources • A national scale up plan built around decentralization and integration • Adoption of standards and simplification of approaches to service delivery • Health system strengthening for effective delivery of services • Engaging and supporting communities to alleviate stigma and discrimination

19. A glimmer of hope for an HIV-free and AIDS-free Generation