Priorities in Adult HIV Outcomes Low Income Countries

1
Priorities in Adult HIV OutcomesLow Income
Countries

• Chairs Kumar, Serge, Xavier, Robin
• Co-conspirators Charlotte, Julian, Diana,
  Carlie, Bob, Bridgette, Ava, Suely, Fabrice,
  Antoine, Jeff, Mar, Catherine

2
Title Impact of facility and resource
characteristics on early mortality Objective Fact
ors of facility level related to early mortality
(3, 6 months after initiation of combination
treatment) Design Prospective cohort
study Outcomes 1) Primary Death, loss to
follow-up, death and/or loss to follow-up 2)
Secondary WHO III or IV (or AIDS diagnosis
bacteria infection) and/or hospitalisation IRIS
(TB) Inclusion criteria/patients All patients
(above 14 years) starting cART sites to
provide criteria to start cART Entry
point/date The date of starting
cART Endpoint/date Composite of death, lost to
follow-up and end of 3 or 6 months.
3
Statistics Main factors 1) Community
level Private/public/NGO Staffing (tracing
procedure) Lab monitoring Fee for
services Space, distance, waiting time Day
care Other facility and procedures Etc. 2)
Patient a. Demographic Age, sex, etc b.
Clinical CD4, CD4, HIV viral load, disease
staging haemoglobin, OI, BMI, initial cART c.
Adherence (or other instruments) Number of days
the medication given to the patient / follow-up
time d. Social-economic level Income,
education, marital status Statistic
analysis Survival analysis
4
Title The predictive value of CD4 count and CD4
in predicting mortality 6 months after initiation
of combination treatment Objective The
predictive value of CD4 count and CD4 in
predicting mortality 6 months after initiation of
combination treatment Design Prospective cohort
study Outcomes 1) Primary Death, loss to
follow-up, death and/or loss to follow-up 2)
Secondary WHO III or IV (or AIDS diagnosis
bacteria infection) and/or hospitalisation IRIS
(TB) Inclusion criteria/patients All patients
(above 14 years) starting cART sites to
provide criteria to start cART Entry
point/date The date of starting
cART Endpoint/date Composite of death, lost to
follow-up and end of 3 or 6 months.
5
Statistics Main factors 1) Control of sites 2)
Patient a. Demographic Age, sex, etc b.
Clinical CD4, CD4, HIV viral load, disease
staging haemoglobin, OI, BMI, initial cART c.
Adherence (or other instruments) Number of days
the medication given to the patient /
follow-up time d. Social-economic
level Income, education, marital
status Statistic analysis Survival analysis
6
International epidemiological Database to
evaluate AIDS (IeDEA)

• Inter-regional research proposal
• The characteristics and proportion of elderly
  HIV-infected patients over time in the IeDEA
  cohorts

7

• Background
• Elderly population high risk population for non
  Aids Events
• In low incoming countries available data on
  elderly
• HIV-infected population is scarce
• Accelerated aging hypothesis for HIV-infected
  population
• Objective
• Describe clinical, epidemiological and
  therapeutic
• characteristics of elderly HIV-infected patients
  over time
• Design
• Retrospective observational cohort

8

• Inclusion Criterions
• HIV- infected patients at 40 and over
• Attending an HIV clinic
• Outcome
• Descriptive characteristics of patients 40 and
  over in each
• calendar year
• - Gender
• - BMI
• - CD4
• - ART treatment
• - ART duration

9
Incidence and determinants of treatment
modification
10
Objectives

• Estimate incidence of treatment change overall,
  type-specific change (treatment failure, toxicity
  (type-specific toxicity), simplification, TB,
  pregnancy, stock-out, etc) frequency within
  person
• Investigate determinants of type-specific change

11

• Study design cohort analysis
• Outcome Overall and cause-specific change
• Inclusion criteria
• Adults (16)
• Started on ART
• ARV naïve at ART start

12

• Entry point date of ART start
• Variables needed at baseline ART regimen, age,
  sex, weight, BMI, CD4 count, hemoglobin, OI,
  programmatic characteristics (public vs private,
  monitoring)
• Endpoint cause-specific change
• Statistics
• Survival analyse
• Multivariable proportional hazard regression

13
Future follow-up planned analyses

• Outcome following treatment modification
• Eg (consequences of simplification, outcomes
  following anaemia, outcomes following changes for
  TB / pregnancy, other toxicities)

14
Adult Agenda

• Extensive list of projects were discussed!
• Several could be moved forward regionally or
  globally

15
Tuberculosis

• Best screening methods (diagnostic perfection)
  extending to programmatic characteristics versus
  rates of incident TB, unmasked TB, IRIS in 1st 4
  months (early)
• Does it matter when you get your TB - do we
  need to have diagnostic perfection?
• Smear
• X-ray
• Cough
• IPT

16
Tuberculosis

• When to start ARVs to improve TB/IRIS outcomes
• Description of regional TB practices
• ARV changes due to TB (Rifampin and NVP)
• Mortality, Lost to follow-up, Switch or no, VL,TB
  cure/completion (smear ?), ARV/pregnancy/TB
• Long term outcome of IRIS (could it indicate a
  robust response to ARVs?)
• Long term HIV outcomes in people with TB

17
Tuberculosis

• Incident TB in patients on ARVs by CD4 cell count
• MDR/XDR TB
• Linkages to TB registries

Anything that doesnt go away with antibiotics is
TB
18
When to start

• Do we have the diversity of CD4 start times to
  say something here? Maybe not.
• Pre-ARV, care outcomes prior to HAART - data
  availability survey

on the way back
Studies on the way down
Mortality, OIs, Morbidity
Start ARVs
19
Loss to follow-up

• Describe, document lost to follow-up,
• Sentinel sites with intensive evaluation of those
  lost to follow-up
• Determine one year mortality in select sites

Define L-T-F-Up can we say when they are really
lost?
20
Early Mortality

• Usual suspects CD4/CD8, VL, BMI, age, sex,
  anemia, IRIS, costs
• New suspects Access to dx of OIs, Tx of OIs, AE
  management/Diagnosis, subtypes, experience of
  doctors, nurses, task shifting, adherence,
  NVP/EFV/all drugs
• Kitchen sink Disclosure, social support, malaria
  care, water quality
• The independent predictive power of CD4

21
Causes of Death

• CoDE
• Sebastian Lucas study
• Bring in pathologists to do this with us
• We have the clinical data on treatment
• They can do the autopsies
• Relative low event rate - need multiple sites

22
Late Mortality

• Non-AIDS death
• Treatment failure - the patient without options
• Switch and survival
• Long term treated patients - cohort or calendar
  period analysis

23
Special PopulationsTreated History Descriptions
Older Patients gt40?, gt50?

• Case series, CD4, outcomes
• Management of the older patients

Perinatally infected adolescents - adults

• The transitioning patients - descriptive
  epidemiology
• LINKAGES between care providers
• Outcomes in these very long treated people.

24
Addiction etc

• Tobacco, EtOH
• Descriptive epidemiology by country
• Impact on outcomes

25
Cancer

• KS survival, epidemiology
• KS IRIS
• Cervical cancer - 1 cancer in women in Africa
• SIR analysis

26
Toxicities I

• Treatment limiting
• Predictors of
• Treatment failures
• Mortality
• Understanding treatment changes in general
• Do we know what drugs a patient is on?

27
Toxicities II

• Peripheral neuropathy
• 40 d4t versus 30 d4t - calendar time analysis
• Co-factors of neuropathy (maybe it is d4t at any
  dose)
• Hepatitis B
• Side effects of Hepatitis
• Tenofovir switches
• Cost effectiveness
• Tenofovir
• Hepatitis improvement versus renal problems

28
Toxicities III

• Weight loss
• Patients who respond to ARVs for some time
• Weight goes up, CD4 goes up
• Later they have severe weight loss
• Fatigue
• Anorexia
• Lipoatrophy, Lipohypertrophy
• Specialized studies - hard to do in the large
  cohort

29
Resistance

• Incidence, Prevalence, Outcomes
• Select group of sites can participate
• Impact of delayed switch on future outcomes