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Preparing for HAART

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Oral Hairy Leucoplakia. Pulmonary TB. Severe Bacterial infections e.g. pneumonia ... Considerations for the pregnant women. Timing, medications to be avoided ... – PowerPoint PPT presentation

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Title: Preparing for HAART


1
Preparing for HAART
  • Cyril Goshima, M. D.
  • Monday
  • April 4, 2005

2
Prior to Considering HAART for Your Communities
  • HIV Testing with Confirmatory Tests must be
    available.
  • Certain Minimal Tests must be available e.g. CBC
  • At least two Classes of Antiviral Medications
    must be available on an ongoing basis.
  • Providers trained in HIV Care

3
Indications for ART
  • World Health Organization
  • DHHS Guidelines
  • IAS-USA Guidelines

4
WHO Staging System for HIV Infection Disease in
Adults Adolescents
  • Clinical Stage I
  • Asymptomatic
  • Generalized Lymphadenopathy
  • Clinical Stage II
  • Wt. loss
  • Minor mucocutaneous manifestations e.g.
    onychomycosis, seb. derm., prurigo, angular
    cheilitis
  • Herpes Zoster within the last 5 yrs.
  • Recurrent URI e.g. bacterial sinusitis
  • And/or performance scale 2 symptomatic, normal
    activity

5
WHO Staging System
  • Clinical Stage III
  • Wt. loss 10 of BW
  • Unexplained chronic diarrhea 1 mo.
  • Unexplained prolonged fever (intermittent or
    chronic) 1 mo.
  • Oral Candidiasis
  • Oral Hairy Leucoplakia
  • Pulmonary TB
  • Severe Bacterial infections e.g. pneumonia
  • And/or performance scale 3 bedridden the day during last month

6
WHO Staging System
  • Clinical Stage IV
  • HIV Wasting Syndrome
  • Opportunistic Infections
  • Any disseminated endemic mycosis
  • Non-typhoid Salmonella Septicemia
  • Extra-pulmonary TB
  • Lymphoma
  • Kaposis Sarcoma
  • HIV encephalopathy
  • And/or performance scale 4 bedridden 50 of
    the day during last mo.

7
WHO Recommendations for Starting ART in Adults
and Adolescents
  • Documented HIV Infection
  • If CD4 testing is available
  • WHO Stage IV disease, irrespective of CD4
  • WHO Stage III disease, CD4
  • WHO Stage I or II disease, CD4

8
WHO Recommendations for Starting ART in Adults
Adolescents
  • CD4 Testing Unavailable
  • WHO Stage IV disease, irrespective of TLC
  • WHO Stage III disease, irrespective of TLC
  • WHO Stage II disease with TLC
  • WHO Stage I, ART not recommended
  • Viral Load is considered not necessary
  • TLC is a useful marker of prognosis survival in
    combination with clinical staging

9
DHHS Guidelines for Initiating ART in Adults and
Adolescents
10
DHHS Guidelines for Initiating ART in Adults
Adolescents
  • Guidelines for initiating ART in pregnant women
    are different depending on the stage of
    pregnancy.
  • If a pregnant woman needs ART for her health
    then, ART should be started irregardless of the
    trimester. EFV should be avoided and NVP should
    be used with caution or avoided in women with CD4
    250.
  • Delaying ART until after 10-12 wks. gestation.

11
IAS-USA Guidelines-2004 for Initiating ART in
Adults/Adoles.
12
IAS-USA Guidelines 2004Initiating Therapy
  • other criteria for considering therapy is a
    more rapid decline in CD4 by 100 in a year

13
Comparison of the Guidelines for Initiating ART
  • Clinical staging important
  • Severe symptoms or AIDS Defining Conditions
  • Evidence of significant immunological suppression
  • CD4 cut off around 350
  • Considerations for the pregnant women
  • Timing, medications to be avoided

14
Initial ART Regimens
  • WHO for Resource Limited Settings
  • Usage in Pregnancy NVP3TCd4T or AZT, avoid EFV
  • Usage with TB Co-Infection EFV3TCd4T or AZT,
    avoid NVP with incr. LFT
  • AZT use more costly with the addition of Hct
    monitoring.
  • NVP3TCd4T and NVP3TCAZT available in fixed
    dose combination

15
Initial ART
  • DHHS Guidelines 2004
  • Preferred NNRTI-Based Regimens
  • EFV(3TC or FTC)(AZT or TDF), except in pregnant
    women or women with pregnancy potential
  • 3TCAZT is in a fixed combination pill, Epzicom
  • FTCTDF is in a fixed combination pill, Truvada
  • Preferred PI-Based Regimens
  • LPVr(3TC or FTC)AZT

16
Initial ART
  • DHHS Guidelines 2004 contd
  • Alternative NNRTI-Based Regimens
  • EFV(3TC or FTC)other NRTI
  • NVP(3TC or FTC)other NRTI
  • Alternative PI-Based Regimens
  • Other PI(3TC or FTC)other NRTI
  • Many PI are boosted with RTV, except NFV

17
Initial ART
  • IAS-USA Guidelines 2004
  • NNRTI Component
  • EFV, NVP for selected pts.
  • NNRTI Component to be used with NRTI component
  • PI Component
  • ATZr, SQVr, LPVr, IDVr (rboosted with RTV)
  • PI Component to be used with NRTI Component
  • NRTI Component
  • (AZT or TDF)(3TC or FTC)
  • ddIFTC

18
Initial ART
  • IAS-USA Guidelines 2004
  • Alternative PI Components FAPr, ATZ, NFV
  • Alternative NRTI Components ABC3TC, ddI3TC,
    AZTABC, d4T3TC
  • Both DHHS and IAS-USA Guidelines list AZT3TCABC
    in a fixed combination as an alternative in
    special circumstances

19
Regimens or Components of ART That Are Not
Recommended
  • Monotherapy
  • Two-Agent Drug Combinations
  • TDF3TCABC or TDF3TCddI
  • AZT3TCABC (Trizivir)
  • ATVIDV (hyperbilirubinemia)
  • AZTd4T (antagonistic)
  • Combination of d drugs

20
Regimens or Components of ART That Are Not
Recommended
  • EFV in Pregnancy (teratogenic in non-human
    primates)
  • d4TddI in Pregnancy (lactic acidosis)
  • FTC3TC (no benefit)
  • 2 NNRTI (increase in side effects)

21
Adherence
  • Adherence is the most important factor in the
    success of ART.
  • Barriers to achieving adherence
  • Readiness to beginning treatment
  • Pill burden
  • Side Effects
  • Dosing Schedule, Storage Food Requirements

22
Adherence
  • Barriers to Achieving Adherence
  • Co-Morbid Conditions e.g. TB, Hepatitis, Mental
    Illness, Active Substance Use
  • Specific Cultural Issues
  • Lack of Family, Community, Country Support

23
When to Change Therapy
  • Clinical Failure HIV-related event 3 or more
    months after start of ART excluding
    reconstitution syndromes. WHO Stg. III, IV.
  • Immunologic Failure Failure to increase CD4
    25-50 cells during the first year of ART. WHO
    return to pre-treatment baseline or fall 50.
  • Virologic Failure Failure to achieve VL 24 wks. or
  • Criteria for children are different.

24
What to Change to?
  • Change at least 2 and at best all 3 ARV.
  • Try to avoid the use of 3 classes of ARV
    together, i.e. NRTI NNRTI PI.
  • Dual PI therapy is an option.
  • Mega-HAART whatever the patient can tolerate.
  • Better to be on ART than not.

25
What to Change to?
  • Special Considerations
  • Women of child bearing age
  • Pts. on TB therapy
  • Hepatitis B Co-Infection hepatitis flare if stop
    3TC, FTC, TDF
  • Resistance Testing
  • Where available

26
Any Questions?
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