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Mother And Child Medical Services |
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The information contained at the Jachabacha Web site
should not be used as a substitute for the medical care and advice of your physician. Information
provided here pertains to Medicine in general. There may be variations in treatment recommended by your physician based on
individual facts and circumstances. |
Anti Retroviral Therapy In The Children
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General Considerations:
q
Antiretroviral
therapy has provided substantial clinical benefit to HIV infected children with
immunologic or clinical symptoms of HIV infection
q
There is
substantial improvement in neurodevelopment, growth and immunological and / or
virologic status with use of antiretroviral drugs
Essential Classifications For Deciding
Antiretroviral Therapy
HIV Pediatric classification system : Immune
categories based on age specific CD4 T lymphocyte and percentage
|
Immune
Category |
<
12 months |
1-5
years |
6-12
years |
|||
|
No./micl |
% |
No./micl |
% |
No./micl |
% |
|
|
Category
1 (no
suppression) |
>=1500 |
>=25 |
>=1000 |
>=25 |
>=500 |
>=25 |
|
Category
2 (moderate
suppression) |
750-1499 |
15-24 |
500-999 |
15-24 |
200-499 |
15-24 |
|
Category
3 (severe
suppression) |
<750 |
<15 |
<500 |
<15 |
<200 |
<15 |
Reference : From CDC.
1994 revised classification system for human immunodeficiency virus infection in
children less than 13 years of age. MMWR
1994;43 (No. RR-12): 1-19
HIV
Pediatric classification : Clinical Categories
|
Category
N: Not Symptomatic Children who have no signs or symptoms considered
to be the result of HIV Infection or who have only one of the conditions
listed in category A Category
A: Mildly Symptomatic Children with 2 or more of the following
conditions but none of the ones listed in category B or C q
Lymphadenopathy
(>=0.5 cm at more than 2 sites; bilateral = one site) q
Hepatomegaly q
Splenomegaly q
Dermatitis q
Parotitis q
Recurrent
or persistent upper respiratory infections, sinusitis or otitis media Category
B: Moderately Symptomatic Children who have symptomatic conditions other than those listed for
category A or C that are attributed to HIV infection (HIV Positive).
Examples of conditions in clinical category B include but are not limited
to the following: q
Bacterial
Meningitis, pneumonia or sepsis (single episode) q
Candidiasis,
oropharyngeal (ie thrush) persisting for > 2 months in children aged
> 6 months q
Cardiomyopathy q
CMV
infection with onset before age 1 month q
Diarrhea,
recurrent or chronic q
Hepatitis q
HSV
stomatitis, recurrent (ie more than 2 episodes within 1 year) q
HSV
bronchitis, pneumonia or esophagitis with onset before age 1 month q
Herpes
Zoster (ie shingles) involving at least 2 distinct episodes or more than 1
dermatome q
Leiomyosarcoma q
Lymphoid
Interstitial Pneumonia (LIP) or pulmonary lymphoid hyperplasia complex q
Neuropathy q
Nocardiosis q
Fever
lasting > 1 month q
Toxoplasmosis
with onset before age 1 month q
Varicella,
disseminated (ie complicated chickenpox) Category
C: Severely Symptomatic Children Having The Following Conditions: q
Candidiasis
of esophagus or pulmonary (bronchi, trachea,
lungs) q
Coccidioidomycosis,
disseminated (at site other than or in addition to lungs or cervical or
hilar lymph nodes) q
Extrapulmonary
cryptococossis q
Cryptosporidiosis
with diarrhea persisting > 1 month q
CMV
infection of an organ other than liver, spleen or lymph nodes with onset
of symptoms > 1 month of age q
Progressive
multifocal leucoencephalopathy q
Mycobacterium
tuberculosis, disseminated or extrapulmonary q
Kaposi
Sarcoma q
Lymphoma,
primary in brain q
Histoplasmosis,
disseminated (at site other than or in addition to lungs or cervical or
hilar lymph nodes) q
Pneumocystis
carini pneumonia |
Reference : From CDC. 1994 revised classification system for human
immunodeficiency virus infection in children less than 13 years of age. MMWR
1994;43 (No. RR-12): 1-19
Indications For
Antiretroviral Therapy In Children With HIV Infection
q
Clinical
symptoms associated with HIV infection (i.e. clinical categories A, B, or C)
q
Evidence of
immune suppression, indicated by CD4, T- lymphocyte absolute number or
percentage (i.e., immune category 2 or 3
q
Age < 12
months - regardless of clinical, immunologic, or virologic status
q
For
asymptomatic children aged > 1 year with normal immune status two options can
be considered:
1.
Preferred
Approach
Initiate therapy - regardless of age or symptoms
|
Data From Prospective cohort studies, indicates
that by 1 year : ü
most
HIV infected infants will have clinical symptoms of infection and ü
most
asymptomatic infected children will have CD4 counts indicative of
immunosuppression |
2.
Alternative
Approach
o
Defer treatment
(in
situations in which the risk for clinical disease progression is low and other
factors (e.g., concern for the durability of response, safety, and adherence)
favor postponing treatment.In such cases, the health-care provider should
regularly monitor virologic, immunologic, and clinical status)
Risks
And Benefits Of Early Initiation Of Antiretroviral Therapy In Asymptomatic HIV +
Child
|
Potential Benefits |
Potential Risks |
|
|
|
|
Control of replication and mutation; reduction in
viral load |
Reduction in quality of life from adverse drug
effects |
|
|
|
|
Prevention of progressive immunodeficiency and
delayed progression to AIDS |
Earlier developmenmt of drug resistance |
Factors to be
considered in deciding to initiate therapy in the asymptomatic HIV + group
include the following:
q
High or
increasing HIV RNA copy number
(The level of HIV RNA considered indicative of of
increased risk of disease progression not known, but any value > 100,000
copies / ml warrants immediate treatment
Results for >30 months indicate levels between
10,000-20,000 copies / ml
Any increase more than 5 fold for age < 2 years
and more than 3 fold for >=2 year)
q
Rapidly
declining CD4; T-lymphocyte number or percentage to values approaching those
indicative of moderate immune suppression (i.e., immune category 2)
q
Development of
clinical symptoms
Recommended Antiretroviral Regimens for initial
therapy for HIV infection in Children
Strongly
Recommended
Clinical trial evidence of clinical benefit and / or
sustained suppression of HIV replication in children
(Most
trials are in adults however interim analysis from a clinical trial of children
PACTG protocol 338) has demonstrated that combination therapy which includes a
protease inhibitor is more effective than 2 NRTI in reducing viral levels to
undetectable levels
Another
trial : Impact Of New Antiretroviral Combination Therapies In HIV Infected
Patients In Switzerland : Prospective Multicentric Study Reveals Similar
Results)
q
One highly
active protease inhibitor plus two nucleoside analogue reverse transcriptase
inhibitors (NRTIs)
ü
Preferred protease inhibitor for infants and
children who cannot swallow pills or capsules: nelfinavir or ritonavir
Alternative for children who can swallow
pills or capsules : indinavir
ü
Recommended
dual NRTI combinations: the most data on use in children are available for
combinations of zidovudine (AZT) and Didanosine (ddl) and for AZT and Lamivudine
(3TC)
More limited data are
available for the combinations of stavudine
(d4T and ddl, Stavudine (d4T) and Lamivudine (3TC), and for AZT and Zalcitabine
(ddC)
q
Alternative for
children who can swallow capsules: Efavirenz (NNRTI)
(Sustiva) plus 2 NRTIs
Recommended
as an Alternative
Clinical trial evidence of suppression of HIV
replication, but
1)
durability may
be less in children than with strongly recommended regimens; or
2)
the durability
of suppression is not yet defined; or
3)
evidence of
efficacy may not outweigh potential adverse consequences (e.g, toxicity, drug
interactions, cost, ctc)
q
Nevirapine and
two NRTIs
q
Abacavir in
combination with ZDV and 3TC
Offer
only ln Special Circumstances
Clinical trial evidence of
1)
limited benefit
for patients; or
2)
data are
inconclusive, but may be reasonably offered in special circumstances
ü
Two NRTIs
ü
Amprenavir in
combination with 2 NRTIs or abacavir
Not
Recommended
Evidence against use because of
1.
Overlapping
toxicity and / or
2.
because
use may be virologically undesirable
ü
Any monotherapy
ü
Stavudine and AZT
ü
Zalcitabine and Didanosine
ü
Zalcitabine and Stavudine
ü
Zalcitabine and Lamivudine
Note: Except
for AZT chemoprophylaxis administered to HIV exposed infants during the first 6
weeks of life to prevent perinatal
HIV transmission; if an infant is identified as HIV infected while receiving AZT
prophylaxis, therapy should be changed to a combination antiretroviral drug
regimen
Thank You.
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