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Technical Overview

ART Regimen Selection and Treatment Initiation for PMTCT Programs Lara Stabinski , MD, MPH Medical Officer Clinical Services S/GAC June 18, 2012. Technical Overview. 1. PMTCT Options and ART Regimens Recognized in WHO PMTCT Programmatic Update 2012 2 . Who needs ART? 3 . Benefits of ART

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Technical Overview

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  1. ART Regimen Selection and Treatment Initiation for PMTCT ProgramsLara Stabinski, MD, MPHMedical OfficerClinical ServicesS/GACJune 18, 2012

  2. Technical Overview 1. PMTCTOptions and ART Regimens Recognized in WHO PMTCT Programmatic Update 2012 2. Who needs ART? 3. Benefits of ART 4. New WHO Guidance on ART in Pregnancy

  3. WHO PMTCT Update 2012 http://www.who.int/hiv/pub/mtct/programmatic_update2012/en/index.html http://www.who.int/hiv/pub/mtct/programmatic_update2012/en/index.html

  4. Who needs ART? Women Eligible for ART Are At Highest Risk for Mother to Child HIV Transmission and Mortality • Cohort 1,025 pregnant women in Zambia prior to HAART availability • Analyzed MTCT/mortality by eligibility for ART with current WHO criteria (CD4 <350 or WHO Stage 3 or 4) Kuhn L et al. AIDS 2010;24:1374-7

  5. WHO Options A & B Who needs ART?

  6. Who needs ART? Transforming PMTCT: Option B+ Option B+ provides full antiretroviral treatment for life for all HIV-positive pregnant women, regardless of CD4 “Recent developments suggest that substantial clinical and programmatic advantages can come from adopting a single, universal regimen both to treat HIV-infected pregnant women and to prevent mother-to-child transmission of HIV.” -April 2012 WHO Programmatic Update on the use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants 10 PEPFAR countries are currently implementing, transitioning to, or considering Option B+

  7. .2 .15 Proportion pregnant at ART start .1 .05 0 2002 2004 2006 2008 Year of ART initiation Estimated proportion Observed proportion Who needs ART? Connecting PMTCT and Treatment PregnantWomen represent an increasing proportion of all patients initiating combination antiretroviral therapy at PEPFAR sites. A recent study of PEPFAR programs in Kenya, Uganda, and Tanzania found that between 2002 and 2008 the prevalence of pregnancy at cART start increased from 2.6% to 16.0%. Holmes, et al, CROI 2012

  8. National ARV Coverage for PMTCT, 2010 Who needs ART? % National ARV Coverage for PMTCT Source: Universal Access Report, 2011

  9. Linking Eligible Women with ART Who needs ART?

  10. Benefits of ART WHO 2010 Treatment Recommendations CD4<350 & for TB, ART initiation regardless of CD4 count 75% reduction in the rate of death 50% decrease in the incidence of tuberculosis Severe, P et al. NEJM, 2010. Starting Treatment Earlier in Resource Limited Settings Reduces Morbidity and Mortality(CD4 350 vs 200)

  11. Benefits of ART • Decreasing Morbidity & Mortality With Earlier Treatment • CD4 <500 (Mostly Cohort Studies, sub-analysis of RCCT) • NA-ACCORD 6,278 patients* • Delayed Treatment 70% increase progression to AIDS or Mortality • ART-CC 45,691 patients, 18 cohort studies# • Delayed Treatment 30% increased progression to AIDS or Mortality • HIV-CAUSAL 8,392 patients# • Delayed Treatment 38% increase progression to AIDS or Mortality • CASCADE 5,527 patients • Early treatment decreased mortality by half • SMART 249 patient subgroup • Deferred therapy were 4.6 times more likely to die or have an AIDS related event • HPTN 052 1,763 patients • Approximately 40% reduction in events/mortality, benefits driven by extrapulmonaryTB *Also showed mortality benefit >500 # Did not show morbidity or mortality benefit >500

  12. Benefits of ART ART Potential Benefits to Maternal Health • Maternal Mortality 24 months post-partum • Zambia study 2010 (n=14,110;ref group= HIV-) HIV+ Mortality higher all CD4 Counts • Cause specific mortality • higher TB, pneumonia, • meningitis, puerperal • sepsis, hemorrhage, PID <200 200-400 400-600 600-800 800-1K >1K Hargrove JW et al. AIDS.2010 Jan 28;24(3):F11-4.

  13. Benefits of ART HPTN 052:Treatment Prevents HIV Transmission

  14. Benefits of ART HPTN052: Linked HIV-1 Transmissions: 27 vs 1 Treatment as Prevention “A real game changer …” “People can say with a good deal more confidence that treatment is prevention.” - Dr. Tony Fauci, US National Institute of Allergy and Infectious Diseases Cohen et al, NEJM 2011

  15. Benefits of ART Validation: HIV Incidence and ART Coverage Every percentage point increase in ART coverage among all HIV+ adults in a community was associated with a 1.7% decline in the hazard of HIV acquisition (p <0.001) faced by an HIV– adult living in the same community Tanser, CROI 2012

  16. Benefits of ART ART and Maternal Health Services • Investigators assessed the effect of HIV programs on the utilization of maternal health services by HIV negative women over time: 257 PEPFAR-funded facilities in 9 countries (1907 quarters) • There was a 1.3% increase in facility deliveries for a 10% increase in HIV patients in care per quarter. • The number of facility deliveries was positively associated with the total number of ART patients in care in the past quarter, availability of HIV support groups, onsite CD4+ testing, and electronic HIV data systems. • Evidence that building systems to deliver ART and other services can have beneficial effects. Kruk et al, CROI 2012

  17. WHO 2010 Guidance on ART Regimens for Pregnant Women These guidelines also suggested that: Efavirenz (EFV) should not be used in the first trimester. Nevirapine (NVP) should not be used at CD4 counts >350

  18. WHO Updated Guidance June 2012 • Supports the use of EFV to Optimize and Simplify Treatment • EFV superior efficacy and tolerability compared to NVP • Substantial reduction in the price of EFV • Increasing availability as part of a once-daily FDC • Reassuring data on the risk of birth defects in pregnancy • Programmatic experience highlighting complications and misconceptions about switching EFV to NVP in pregnancy http://www.who.int/hiv/pub/treatment2/efavirenz/en/index.html

  19. http://www.who.int/hiv/pub/treatment2/efavirenz/en/index.htmlhttp://www.who.int/hiv/pub/treatment2/efavirenz/en/index.html

  20. PriceEvolution of NVP and EFV http://www.who.int/hiv/pub/treatment2/efavirenz/en/index.html

  21. TDF In Pregnancy • Concern in pregnancy for fetal growth based on animal data at high doses • PHACS Study (2012) • N=2,000 births women TDF in Pregnancy • No greater risk of low birth weight, small head circumference or reduced weight for gestational age • Found very small but significant difference in length for age at 1 year in infants • Should be viewed in the context of potential increased mitochondrial toxicity seen with infant AZT exposure and maternal anemia on AZT • May be especially useful where prevalence of HIV-HBV co-infection is high • Can be used in once daily FDC

  22. Acknowledgements • S/GAC Clinical Team • PEPFAR Technical Working Groups (Adult Treatment, PMTCT)

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