Antiretroviral Therapy at GHESKIO

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Antiretroviral Therapy at GHESKIO

• Patrice Sevère, Paul Denis Léger, Estere Michel,
  Sabine Prince, Jean W. Pape

Centres GHESKIO, Port-au-Prince, Haïti Weill
Medical College of Cornell University, NewYork,
NY, USA Sponsored by GLOBAL FUNDS
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Introduction

• Data is provided on first 96 adults treated with
  ART at GHESKIO
• We initiated therapy between1999-2002
• We have shown that ART dramatically improved
  survival.
• With the support of the Global Fund for AIDS,
  TB,and Malaria we started to increase the number
  of patients on ART in February 2003

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ENROLLMENT PROCEDURE

• Medical visit
• Screening for opportunistic infections
• Prophylaxis and treatment of OI
• Initial lab exams
• Verify clinical and lab criteria for ART
• IEC Three sessions
• Information on ART
• GHESKIO and patient responsibilities
• Behavioral and Family Planning
• Adherence and Retention

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When to Start?

• Endorsed WHO Guidelines Treat if
• WHO stage IV (clinical AIDS), regardless of CD4
  cell count
• CD4 cell count available, WHO stages I, II, III
  with CD4 cell count lt200 (or lt15)
• CD4 cell count not available, WHO stages II and
  III (symptomatic HIV disease) with TLC (total
  lymphocyte count) lt1200
• Addition to WHO Guidelines
• HIV symptoms defined locally
• Also treat WHO stages II and III (symptomatic
  HIV disease) with CD4 200-350
• All patients should be evaluated for TB prior to
  starting ART if active TB infection is present,
  it should be treated first.

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What treatment regimen to start?

• Endorsed WHO Guidelines
• Based on convenience, tolerability, cost, and
  second-line treatment options, first-line therapy
  should be
• D4T 3TC NVP or EFV
• AZT 3TC NVP or EFV
• This regimen should be modified, depending on
  concomitant conditions
• TB or hepatoxicity substitute EFV for NVP
• Pregnancy or D4T-related peripheral neuropathy
  substitute D4T for AZT

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Improving adherence and retention

• FACILITATE COMMUNICATION WITH THE PATIENT
• VISIT MONITORING
• INCENTIVES
• CONTINGENCY PLAN
• EDUCATIONAL BROCHURE

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Educational Brochure

• Written in native Creole.
• Covers all aspects of ART
• Illustrated for illiterate patients

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Preliminary Results of ART at GHESKIOFebruary-Oct
ober 2003

• N 800 (100 Patients per month)
• Active 721 (90)
• Lost to follow-up 33 (4)
• Deceased 46 (6)
• Long term N751
• Short term (PEP) N49
• Regimens used AZT/3TC/EFV 447 (60)
• AZT/3TC/NVP 241 (32)
• OTHERS 63 ( 8.3)
  

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Characteristics Of ART PatientsFebruary
October 2003 N 800
Median age, years 37
Female 56
Median CD4 count, cells/?l 114 cells/mm3
Clinical AIDS 90
O I TB, candida esophagitis Wasting Syndrome
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How to monitor therapy?

• Clinical evaluations at 1or 2 weeks, 1month, then
  every 3 months.
• Monthly evaluations (e.g., by nurse, pharmacist,
  social worker, PLWAs, field workers).
• Lab monitoring at start of therapy and every 6
  months thereafter.

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Table of events
IEC1General information about ARV,
patient/GHESKIO responsibility, guardian/contact
identification , contact update IEC2Signature
of at home visit authorization form, evaluation
of HIV reinfection risk level, risk reduction
planning FP method proposal - ARV counceling
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How to assess treatment failure

• Adherence should be assessed carefully first.
• Clinical definition of treatment failure
  Chronic signs/symptoms of HIV disease (e.g.,
  candidal or refractory/recurrent bacterial
  infections, including salmonellosis chronic
  enteropathy anemia neutropenia) that either
  fail to resolve, or resolve and then recur.

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How to assess treatment failure, cont.

• At a minimum, clinical criteria should be used to
  assess treatment failure. CD4 (and HIV RNA)
  should be used, if available.
• If CD4 cell count available, check every 3 to 6
  months.
• Failure gt30 decrease from baseline CD4 cell
  count (or gt3 decrease of CD4 percent).

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What treatment to change to?

• If changing for toxicity, can substitute a single
  drug
• D4T ? AZT
• NVP ? EFV
• If changing for treatment failure, depends on
  prior regimen
• D4T 3TC NVP (or EFV) ? ZDV DDI PI
• ZDV 3TC NVP (or EFV) ? D4T DDI PI
• PI choices
• IDV (q8h, fasting/water requirements, difficulty
  with DDI coadministration)
• LPV/RTV (necessary to keep cool)
• NFV (diarrhea, ?less effective)

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What about drug resistance?

• If possible, samples should be collected at
  baseline (prior to starting therapy) to assess
  (later) drug resistance in the community. (AACTG
  5175)
• If possible, samples should be collected at each
  visit and particularly at the time of treatment
  failure to assess (later) drug resistance in the
  patient.

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Antiretroviral Adverse ReactionsN17

• Anemia 10 (lt7,5 g/dl)
• Severe Rash 5
• Steven Johnson 3
• CNS (dizziness, bad dreams) seen in 65 of
  patients on EFV with spontaneous improvement in
  nearly all.

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Risk factor for deathN46

• Wasting syndrome 46
• Tuberculosis 25
• Wasting synd/TB 4
• Poor adherence 11
• Others 14
• Death occurs early after ART initiation (average
  23 days)for a majority of patients 85

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Summary

• Excellent response to ARV
• Rapid enrollment of patients
• Patient retention is good
• Future efforts will extend the benefit of ART to
  larger population of patients