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The new guidelines

The new guidelines. Dr Francois Venter Reproductive Health and HIV Research Unit University of the Witwatersrand Feb 2010. History. 2002/2003 process – peer reviewed Annual pointless consultations End 2009 (Nov) – consultative meeting 2010 – confused revision Now a draft!.

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The new guidelines

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  1. The new guidelines Dr Francois Venter Reproductive Health and HIV Research Unit University of the Witwatersrand Feb 2010

  2. History • 2002/2003 process – peer reviewed • Annual pointless consultations • End 2009 (Nov) – consultative meeting • 2010 – confused revision • Now a draft!

  3. What informed the change?

  4. Increasing recognition of benefit of higher CD4 initiation • OI • Side effects • Impact on ‘non-AIDS’ diseases • PMTCT

  5. When Is Antiretroviral Therapy Started? • Review of data from 2003-2005 from 176 sites in 42 countries (N = 33,008) 164 200 179 187 163 192 123 157 206 102 86 95 53 103 125 134 122 100 72 97 97 239 87 181 Egger M, et al. CROI 2007. Abstract 62.

  6. Non-nuke 2 Nukes Efavirenz/ nevirapine d4T 3TC Toxic! Failure – VL>5000 Protease Kaletra AZT ddI

  7. Measurement of Generally Accepted Indicators Reveals that the South African Healthcare System is Functioning Poorly by International Standards 230 Trend Projection for Maternal Mortality Rate until 2015 Maternal Mortality Rates by Geography (2000 vs 2005) 1,900 Afghanistan South Africa 1,800 Brazil India Namibia South Africa Chile Iraq China MDG 2015 Target Namibia Brazil Chile United Kingdom 58 2000 Netherlands 2005 Note: MMR = Number of Maternal deaths per 100,000 *Public Sector deliveries estimated. Live births is used as a proxy for the number of pregnancies annually.MMR is an indicator of the quality of a health care system Source: WHO Maternal Mortality Report, 2007, StatsSA 2

  8. TB… Thanks: Braamie Variava

  9. In addition: Highest TB incident and prevalence Incidence of TB per 100,000 population 1,200 1,100 1,000 900 800 +13% 700 600 500 400 MDG 2015 Target 300 200 100 56 0 2000 2001 2002 2003 2004 2005 2006 • TB-HIV co-infection was approximately 55% in 2002 • The number of people diagnosed with TB trebled between 1996 and 2006 (from 269 to 720 cases of TB per 100 000) • 900 cases of Extensive Drug Resistant TB were reported between 2004 and 2007 Source: Health Systems Trust reported 722 number; WHO: Global Tuberculosis Control, Surveillance, Planning, Financing reported 940

  10. High death rate while waiting for ART Braitstein, P et al. High Risk Express Care: a novel care model to reduce early mortality among high risk HIV-infected patients initiating combination antiretroviral treatment. HIV Implementers Meeting, Namibia, abstract 1556, June 2009. Arch Intern Med 2008;1678:86 Expedited care decreased mortality by 60%

  11. In summary, what has changed: • CD4 350, qualified, for adults • Initiation of children immediately • New maternal health/ PMTCT • New 1st line drugs for adults, kids • Altered second line • Expedited referral with timelines • Decreased monitoring for adults • Nurse initiation focus

  12. When to start – CD4 (adults) • < 200 or • CD4 count <350cells/mm3 • in patients with TB/HIV • Pregnant women • Any CD4 – WHO 4 and XDR TB

  13. Expedited • Require fast track (i.e ART initiation within 2 weeks of being eligible • Pregnant women needing lifelong ART OR • Patients with very low CD4 (<100) OR • Stage 4, CD4 count not yet available OR • MDR/XDR TB

  14. 1st line adults • All new patients needing treatment, including pregnant women • TDF + 3TC/FTC +EFV/NVP • Contraindication to TDF: renal disease AZT+ 3TC +EFV/NVP • For those on existing d4T, remain, but vigilance urged • Now: Controversy re EFV!

  15. 2nd line • Failing on a d4T or AZT based 1st line regimen - TDF + 3TC/FTC + LPV/r • Failing on a TDF based 1st line regimen - AZT+3TC+ LPV/r • Beyond 2nd: refer

  16. Baseline • If eligible for ART • Serum Creatinine if starting on a TDF based regimen • ALT if starting on a NVP based regimen • Hb or FBC if available if starting on an AZT based regimen.

  17. Monitoring • Clinical stage • CD4 at month 6 and then every 12 months • VL at month 6 into ART, then every 12 months • ALT if on NVP and develops rash or symptoms of hepatitis • FBC at month 1,2, 3 and 6 if on AZT • Creatinine at month 3 and 6 then every 12 months if on TDF • Fasting cholesterol and triglycerides at month 3 if on LPV/r

  18. Children • All children less than 1 year of age • Children 1 – 5 years with clinical stage 3 or 4 or CD4 ≤ 25 % or absolute CD4 count < 750 cells/µl • Children ≥ 6 years to 15yrs with clinical stage 3 or 4 or CD4 < 350 cells/µl.

  19. Fast track kids • Child less than 1 year • Stage 4 and CD4 count not yet available • MDR or XDR TB

  20. 1st line kids • All infants and children under 3 years ABC + 3TC + LPV/r • Children 3 years or over ABC + 3TC + EFV • Currently on d4T based regimen with no side effects - Can continue

  21. 2nd line • Children above 3 years - Failed ABC +3TC + EFV get AZT + ddi +LPV/r • Failed on AZT or d4t based regimen: ABC + 3TC + LPV/r • Failed LPV/r OR less than 3 OR failed second line - refer

  22. Maternal health • Eligible for ART (i.e < 350 cell or clinical stage 4 ) - TDF + 3TC/FTC + NVP and start ART as soon possible • Not eligible for ART i.e. cd4 > 350 - AZT from 14 weeks, sdNVP at delivery TDF + FTC single dose after delivery • Unbooked and presents in labour - sdNVPTDF + 3TC/FTC one week

  23. Infant regimens • Mother on lifelong ART - NVP at birth and then daily for 6 weeks irrespective of infant feeding choice • Mother on AZT for MTCT prophylaxis - NVP at birth and then daily for 6 weeks continued as long as any breastfeeding • Mother did not get any ARV before or during delivery - NVP as soon as possible and daily for at least 6 weeks continued as long as any breastfeeding

  24. Reflections… • Strange consultation process • Tension between clinicians, public health, DoH and Treasury – lack of transparency • Hep B, nurses, PMTCT big tension points • FDCs still an issue

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