Pediatric Antiretroviral Therapy: International Center For AIDS Care and Treatment Programs

Pediatric Antiretroviral
Therapy
International Center for AIDS Care

and Treatment Programs
Columbia University
Mailman School of Public Health
1
Learning Objectives
• Identify the ARV-eligible child
• Prepare the family for ARV initiation
• Choose an effective 1st line regimen
• Create an appropriate follow-up schedule
for the newly initiated child
• Identify and manage ARV toxicities
• Recognize treatment failure
2
International Center for AIDS Care and Treatment Programs, Columbia University
Unifying Concepts
• The primary goal of ARV therapy is to
prevent clinical complications of HIV and to
prolong survival
• Prescribing ARV regimens requires careful
assessment and preparation of the patient
followed by consistent support
• There are unique considerations for ARV
use in infants, children, and adolescents
3
Antiretroviral Therapy in Children
• Similarities to adults
– Pathogenesis of HIV infection
– General virologic and immunologic principles
• Unique to infants and children

– Diagnostic issues
– Pharmacokinetic changes with age/maturation
– Natural history differences in disease progression,
immune function, viral replication
– Adherence issues particular to children and adolescents
4
Children Are Not Small Adults
• Age-related differences between children &
adults
– Body composition
– Renal excretion
– Liver metabolism
– Gastrointestinal function
• Drug metabolism in children varies with age
and maturation leads to differences in:
– Drug distribution and clearance
– Drug dosing and drug toxicities
• Pharmacokinetic (PK) data not consistently available in
young children
• Variations in PK (between and within individuals) frequently
greater in children
5
ART Eligibility
6
New WHO Criteria for Starting ART
in Children
WHO Pediatric Availability of Age specific recommendation
Stage CD4 cell assay
<18months >18 months
CD4
IVa Treat All
No CD4
CD4 Treat all except those

IIIa Treat All with TBb, LIP,OHL,
thrombocytopenia, also
take into account CD4
value
No CD4 Treat allb
CD4 CD4 guided

II
No CD4 TLC -guided
CD4 CD4 guided

1
No CD4 Do not treat
a- Stabilize any opportunistic infection prior to initiation of ART
b- in children with TB the CD 4 level and clinical status should be used to 7
determine the need and timing for initiation of ART in relation to TB treatment
New WHO Age-Related CD4
Values for Starting ART in Children
Age specific recommendations to initiate ARTb
Immunological
markera <11mo 12-35mo 36-59mo >5 years
CD4%c 25 % 20% 15% 15%
CD4 countc 1500cells/mm3 750 cells/mm3 350cells/mm3 200cells/mm3
To Be used only in absence of CD4 assay:

Total 4000cells/mm3 3000cells/mm3 2500cells/mm3 1500cells/mm3
Lymphocyte
count
a- Immunological markers supplement clinical staging

b-ART should be initiated at these cut-off levels regardless pf clinical stage 8
c- CD4 is more accurate in children < 5 years
Children > 13 years of age eligible
for ART
• WHO stage 4 irrespective of CD4 cell
count
• WHO stage 3 HIV disease and CD4 < 350
• CD4 < 200 irrespective of WHO stage
9
Special Circumstances: The
Rapidly Progressing Infant
• In situations of rapidly deteriorating health status and lack
of virologic test availability, a presumptive diagnosis can
be made on the following criteria:
– HIV exposed/ antibody positive
– < 18 months of age
– Symptomatic with at least two of:
• Oral thrush
• Severe pneumonia
• Severe wasting/malnutrition
• Severe sepsis
– Recent HIV-related maternal death, advanced HIV disease in the
mother, and/or CD4<25% will also support this diagnosis
– It is important to confirm the diagnosis as soon as possible.
• A presumptive diagnosis then necessitates management
of presenting acute illnesses and management of the HIV
including the initiation of ART when indicated.
10
Initiating ART
11
Preparing for ART
• Complex adherence challenges for
children
– Requires collaboration of child, parent, and all
secondary caretakers
– Family needs support around long-term
therapy, changing regimens, and doses
– Issues of disclosure and multiple caretakers
complicate complete adherence
– Ongoing support for evolving adherence
needs as child develops with age
12
Promoting Adherence
1. Education
Support Education
2. Preparation
3. Monitoring
Monitoring Preparation
4. Support
13
Adherence Preparation
• ART should never be initiated without extensive
preparation of the child and the family
• ART is rarely an emergency and therefore
should only be started once the family is ready
• Adherence Counseling must address:
– WHO will administer the medications
– WHAT medications will be given
– WHEN will medications be given
– HOW will medications be given
• The multi-disciplinary team must work together
to identify any possible barriers to adherence
and address these before commencing
treatment 14
Assess Family Readiness
• Has the mother disclosed HIV status to anyone? Do the
other people in the household know about the child’s
diagnosis?
• Is there support in the household/family?
• Is the living situation stable?
• Does the mother understand ARV treatments, dosages,
expected outcomes, potential side effects?
• Does the mother appreciate the need for intensive
monitoring and follow-up?
• Does the mother understand the need for strict
adherence?
15
Assess Patient Readiness
• Has the child tasted the medications?

• How does the child’s developmental level
influence ability to take medications?
• Have the health providers observed
medication administration?
16
Initiating ART
• Never prescribe ARVs in the absence of
adherence preparation and support
• Pay attention to other medications and treatments
in order to avoid interactions with ARVs
• NEVER prescribe monotherapy or dual therapy
• Never add a single drug to a failing regimen
• If ARVs are to be discontinued, stop all treatments
as instructed
• Be attentive to the dosages as the child grows
and develops
17
Before ART
• Consider any medical contraindications to
first line regimens using
– Medical history
– Symptom checklist
– Physical examination
– Laboratory studies (renal function, liver
function, and CBC)
18
Medical Contraindications to ART
• Severe Anemia (Hb<6.9 gdl)- Contraindication to AZT,
replace with d4T
• Severe Neutropenia (ANC<250 mm3)- AZT use requires
close monitoring. Can substitute d4T if ANC falls
• Severe Renal Insufficiency (Creatinine > 3 times normal)
Contraindication to ARV use. Patient not eligible for ART
• Severe hepatic insufficiency (LFTs > 5 times normal)
Contraindication to NVP use. Use EFV in children older
than 3, PI treatment suggested for small children
• History of prior ARV use- Potential for ARV resistance,
Consult for expert management.
• Current use of rifampin containing TB regimen-
Interactions with NVP. If CD4 is high, consider deferring
ART or use ritonavir containing regimen for children under
3 and EFV containing regimen for children older than 3. 19
First Line Regimens
Preferred pediatric first line regimes:
• Children under the age of 3
AZT+3TC+NVP or
d4T+3TC+NVP or
ABC+3TC+NVP
• Children older than 3 years (>10kg)
AZT+3TC+NVP/EFV or
d4T+3TC+NVP/EFV or
ABC+3TC+NVP/EFV
Additional dual NRTI backbone include ABC+ AZT or ABC+d4T

20
Special Circumstances
• WHO recommends Triple NRTI as alternative
option for initial therapy under certain
circumstances
– AZT+3TC+ABC or d4T + 3TC +ABC
– Infants and children receiving TB treatment where
NVP or PI cannot be used because of interactions
with rifampin
– Pregnant adolescent with CD4 cell > 250/mm3 in
which both NVP and EFV are contraindicated and PI
based regimes are not available
21
Dosing for Pediatric ARVs
• Dosing is weight dependent and must be adjusted for
significant weight gain/loss
– Refer to ICAP pediatric dosing charts
• Check weight and height at each visit and adjust dosage
when necessary
– Failure to adjust for weight gain can lead to underdosage
and development of resistance
– Failure to adjust for weight loss can lead to overdosing
and toxicity
• Review dose changes and reasons for changes with family
22
ICAP Pediatric ARV Dosing Chart
23
Zidovudine (AZT)
• Formulation
– Syrup:10 mg/ml
– Capsules: 100 mg; 250mg
– Tablet: 300mg
• May be crushed and combined with food
• Light sensitive, needs to be stored in a
glass jar
• Should not be used with d4T because of
possible antagonism 24
Zidovudine Toxicity
• Hematologic toxicity: granulocytopenia
and anemia
– May require dose reduction or
interruption of therapy
• Gastrointestinal disturbance: anorexia,
nausea, vomiting
• Myositis, myopathy, mitochondrial disease
25
Lamivudine (3TC)
• Formulation
– Oral solution: 10 mg/ml
– Tablet:150 mg
• Generally well tolerated
• Store solution at room temperature
• Tablet can be mixed with water or food
and taken immediately
• Use within one month of opening the bottle
26
Lamivudine Toxicity
• Side effects are uncommon and include
headache, nausea, and abdominal pain
• Rarely neutropenia, pancreatitis, and
elevated LFTs
• In the case of life threatening pancreatitis
all drugs should be discontinued until
resolution of toxicity and restarted with
careful monitoring
27
Stavudine (d4T)
• Formulation
– Oral solution: 1mg/ml
– Capsules:15mg, 20mg, 30 mg
• Solution must be refrigerated
• Capsules may be opened and mixed with
small amount of food
• Should not be used with AZT because of
possible antagonism
28
Stavudine Toxicity
• Most frequent side effect is headache and GI
disturbance
• Lactic acidosis and severe hepatomegaly with
steatosis, including fatal cases, have been
reported with d4T use.
– Increased risk when used with ddI
– Discontinue treatment if suspected
• Peripheral neuropathy (less common in children)
• Increasingly associated with metabolic
abnormalities, particularly lipoatrophy
29
Abacavir (ABC)
• Formulation
– Oral solution: 20mg/ml
– Tablet: 300mg
• Can be given with food
• Tablet can be crushed and mixed with
small amount of water or food and
immediately ingested
30
Abacavir Toxicity
• Most common side effects are headache,
GI upset, and rash
• Potentially fatal hypersensitivity reaction
occurs in a small proportion of children
receiving the drug (3%)
– Symptoms include rash, fatigue, nausea,
vomiting, cough, pharyngitis, and dyspnea
– ABC must be stopped permanently if this
occurs and do not rechallenge
31
Nevirapine (NVP)
• Formulation
– Oral solution: 10 mg/ml
– Tablet: 200 mg
• Can be given with food
• Store suspension at room temperature;
must be shaken well
• NVP is initiated at a lower dose and
increased in a stepwise fashion
32
Nevirapine Toxicity
Nevirapine hepatotoxicity
• Liver toxicity can occur but is less common
than in adults, can be fatal
• Discontinue for grade 3 toxicity:
substitution with efavirenz has been
successful in adults, but little data is
available for children
33
Nevirapine Toxicity
• Nevirapine Rash
• Usually occurs during first 2 – 6 weeks of
therapy
• For mild to moderate rash without systemic
symptoms, continue treatment with close
observation
• For severe rash (2-5%) Stevens Johnson
Syndrome (fever, oral lesions, conjunctivitis,
blistering), discontinue drug
34
Efavirenz (EFV)
• Formulation
– Syrup:30mg/ml (for children > 3 years)
– Capsules- 50mg, 100mg, 200 mg
• Not indicated for children under 3 years of age
and less than 10 kg
• Capsules can be mixed with sweet foods or jam
to disguise peppery taste
• Can be given with food but avoid high-fat meals
which decrease absorption by 50%
• Best given at bedtime to reduce CNS side
effects
35
Efavirenz Toxicity
• Should not be prescribed for adolescent
females who are at risk for becoming
pregnant because of teratogenicity
• Associated with CNS side effects which
last approximately 10-14 days
• Rash is more frequent in children than
adults but it is generally milder
36
Special Considerations in
Prescribing First Line Regimens
• Never prescribe efavirenz to a child under the age of 3.
Proper dosing has not been determined for any child <3yrs
or <10kg.
• Stavudine (d4T) liquid requires refrigeration. Families can be
taught to open capsules but this may be complex.
Zidovudine may be preferable.
• In children who were previously exposed to NVP as a
pMTCT regimen, NNRTI resistance may develop. While this
resistance generally fades within the first year, this may
impact the efficacy of the NNRTI-based regimen
37
Monitoring Pediatric ART
38
How to Monitor ARV Therapy
• Clinical
• Laboratory
• Treatment adherence
• Program adherence: keeping visit
appointments
39
Clinical Monitoring
• Weekly visits for the first 8 weeks.
– Assess adherence, side effects/toxicity,
immune reconstitution and growth
– Symptom checklist and targeted physical
exam
– Review and recalculate dose, if needed, at
each visit based on weight
– Dispense one week of medication
– To decrease burden on the family, f/u visits
can be combined with other health care visits
40
Clinical Monitoring-Cont’d
• Monthly visits after the first 8 weeks if
adherence is excellent.
• At each visit:
– Interim history
– Symptom checklist
– Targeted physical exam
– Growth and nutritional assessment
– Developmental assessment
– Psychosocial assessment
– Adherence with caregiver and older child when appropriate
– ARV prescription (recalculate doses)
– Referral for support services as needed
41
Laboratory Monitoring
• Baseline labs should include renal
function, liver function, CBC, and CD4
• CD4 count and percent should be
obtained every 6 months to monitor ART
efficacy
• Abnormal findings on history or physical
may warrant additional laboratory testing
• Abnormal lab results may indicate ART
toxicities, intercurrent illnesses, and/or
advancing disease.
42
Defining ART Success
• Mild or no reported side effects
• Excellent adherence
• Improved clinical status in 6 months
– Improved growth
– Improvement in neurological symptoms and development
– No new AIDS defining illness
– Fewer intercurrent illnesses
• Improved or stabilized immune status in 6 months
43
ART Toxicities
44
ART Toxicities
• In general, ART is well tolerated
• The majority of patients tolerate ART with mild to
no side effects or toxicities
• Drug-related adverse events can be
– acute (occurring right after initiation)
– sub-acute (occurring 1-2 weeks after initiation)
– chronic (after prolonged use).
• It is important to differentiate between
complications of HIV disease and toxicities
related to medication
45
Possible causes of adverse
events among patients on ART
• ART toxicity
• Immune reconstitution
• Intercurrent illness
• Disease progression
• Drug interaction
• Other?
46
Distinguishing ART Toxicity
• Timing of the event
– When was ART initiated
• Some toxicities occur more frequently close to the time of
initiation while others are associated with chronic treatment
• Constellation of signs & symptoms
– Progressive vs. acute
– Single vs. multiple organ systems
• Three step process
– Clinical Formulation
– Systematic assessment
– Management
47
Step 1: Clinical Formulation
• What are the most likely causes of the new
symptoms or findings?
• How severe is the new symptom/finding, and
which potential diagnosis has the most serious
consequences?
• Is this symptom or finding compatible with the
side effect of an individual drug?
• What additional information do you need?
– Will laboratory studies be useful?
48
Step 2: Systematic Assessment
• Know the patient
• Know the drugs
• Know the timeframe
49
Know the Patient
• History of presenting signs and symptoms
• Is the patient adherent to ART? Has her
adherence changed recently?
• What other medicines has she been on?
• Has she stopped or started any other prescribed
or non-prescribed medicines or substances?
• Does she have any sick contacts?
• Are there any other changes in her life?
• Does she have access to food and clean water?
50
Know the Drugs
• What medicines/substances is the patient
taking?
• Know individual toxicities and drug
interaction profiles
– ART
– Medicines for OI prophylaxis (e.g. cotrimoxazole,
isoniazid, fluconazole):
– Medicines for other conditions (e.g. TB)
– Other medicine or substances taken regularly (e.g.
alcohol, hormonal contraceptives)
– Other remedies including herbal, natural, or traditional
treatments and teas
– Vitamins (including lack of vitamins)
51
Know the Timeframe
• Exactly when did the patient start ART?
– Discuss with parent medicine by medicine
– Review chart
– Check pharmacy records
• When did the patient begin or discontinue other
medications or therapies?
• What was the exact timing of onset of symptom
or findings?
52
Step 3: Managing Acute Drug
Toxicity
• Management should be based on
– Severity of event/potential for harm
– Implications for adherence
53
Assessing Severity
• Grade degree of severity using toxicity tables
and clinical judgment
– Potentially life threatening
• Requires immediate management
– Static or Progressive
• Rapid vs. chronic evolution
– Impact on adherence
• Mild toxicity/side effect may have significant impact on
adherence
54
After Severity is Assessed,
There are Three Options:
• Continue the medication and observe
closely
– Example: early nausea from zidovudine (AZT)
• Hold the medication

– Example: hepatitis from nevirapine (NVP)
• Switch the medication

– Example: severe peripheral neuropathy from
stavudine (d4T)
55
Overview of Toxicity Management
• For “mild” (Grades 1 and 2) toxicity
– Continue medication with close observation
– Symptomatic relief with other medications (anti-
emetics, anti-diarrheals)
– If symptoms are severe, hold regimen and re-
introduce once symptoms sufficiently subside.
– Ask the patient how severe they think the side effect
is – a “mild” side effect may decrease adherence
• For severe (Grade 3 or higher) toxicity
– HOLD ALL MEDICINES
– When ready to restart, the offending medication must
be SWITCHED, if convinced it caused the toxicity
– Toxicity guidelines/tables vary for adults and children
56
Clinical Symptoms Requiring
Medication Switch
57
Laboratory Results Requiring
Medication Switch
58
Symptomatic Lactic Acidosis
• Rare but potentially fatal complication of ARV use
– most often associated with NRTI (especially d4T
and the combination of d4T + DDI).
• No single diagnostic sign or symptom; often
presents as symptom complex.
– Fatigue, abdominal pain, nausea/vomiting, weight
loss, dyspnea, pancreatitis
• Specialized laboratory testing can confirm the
presence of lactic acidosis
– Anion gap, lactate level
• Symptomatic lactic acidosis – stop therapy
59
Remember:
• Clinical judgment is important:
– Something other than ART may be causing
the adverse effect
– Lab error might confound the assessment of
toxicity severity
– Every individual is unique and might not fit
precisely into a table or guideline
– Again, response to management may be the
only way to determine if symptoms/problems
are really a result of ART toxicity
60
Switching single drug for toxicity
First Line ARV Major potential toxicities Drug substitution
regime
d4T/3TC/NVP d4T-lactic acidosis Switch d4T AZT or
ABC
d4T-peripheral neuropathy Switch d4T AZT
d4T- lipoatrophy Switch d4T ABC
NVP-severe hepatotoxicity Switch NVP EFV
NVP-severe rash but not Switch NVP EFV

life threatening
NVP-severe life Switch NVP EFV
threatening rash ( Steven with close monitoring or
Johnson Syndrome) PI or Triple NRTI
61
regime
AZT/3TC/NVP AZT-anemia, gastro- Switch AZT d4T or
intestinal intolerance, ABC
neutropenia
ABC-hypersensitivity Switch ABC AZT
ABC/3TC/NVP
NVP-severe Switch NVP EFV
hepatotoxicity
NVP-severe rash but not Switch NVP EFV
life threatening
NVP-severe life Switch NVP EFV
threatening rash ( Steven with close monitoring
Johnson Syndrome) or Triple NRTI or PI
62
regime
d4T/3TC/EFV d4T-lactic acidosis Switch d4T AZT or
ABC
d4T-peripheral Switch d4T AZT
neuropathy
AZT/3TC/EFV
d4T-lipoatrophy Switch d4T ABC
AZT-anemia, GI Switch AZT d4T

ABC/3TC/EFV intolerance , neutropenia or ABC
ABC- hypersensitivity Switch ABC AZT
EFV-CNS toxicity and Switch EFV NVP

potential for
teratogenicity
63
Triple NRTI First Major potential toxicities Drug substitution

Line ARV regime
AZT/3TC/ABC AZT-anemia, gastro- Switch AZT d4T
intestinal intolerance,
neutropenia
ABC- hypersensitivity Switch ABC NNRTI
or PI based regime
d4T/3TC/ABC
d4T-lactic acidosis Switch d4T AZT
d4T-peripheral Switch d4T AZT

neuropathy or
pancreatitis
64
Nevirapine/Efavirenz: How to
Stop?
• Some experts suggest:
– If all drugs in a NNRTI-containing regimen are held
simultaneously, the longer half life of NVP and EFV
(NNRTIs) can inadvertently lead to unintentional
monotherapy and subsequent risk of resistance
• New ICAP recommendation:
– For life threatening toxicities
• Stop all medications at once
– If the toxicity is not life threatening
• Hold NVP or EFV roughly 7 days before discontinuing NRTIs.
• National and Local Guidelines take precedence

65
Recognizing Treatment
Failure
66
Why is the Regimen Failing?
• Inadequate adherence is the most common cause of
treatment failure in children
• Issues to consider with regard to adherence:
– Who administers drug?
– How is drug administered?
– Is it the drug?
• Resistance to specific agents may have a significant
impact on treatment efficacy.
– Resistance to specific drugs can develop secondary to
inadequate adherence, inadequate drug levels and selection of
pre-existing mutations with selective pressure of present
regimen.
67
Clinical indications of treatment
failure
• Lack of or decline in growth rate in children who
show an initial response to treatment (WHO
Stage III or IV)
• Loss of neurodevelopmental milestones or
development of encephalopathy (WHO Stage IV)
• Occurrence of new opportunistic infections or
malignancies or recurrence of infections , such as
oral candidiasis that is refractory to treatment or
esophageal candidiasis (WHO Stage III or IV)
68
Immunologic indicators of
treatment failure
• Lack of improvement in CD4 cell percentage
or absolute count
• Return of CD4 percent or absolute to pre-
therapy baseline or below, in the absence of
other concurrent infection explaining transient
CD4decrease
• > 50% fall from peak level on therapy of CD4
percentage or absolute in the absence of
other concurrent infection explaining transient
CD4 decrease, particularly if CD4 values
declines below age–related threshold for
initiating therapy
69
Early vs. Late Change to Second
Line Regimen
• Early changes to a second line regime leaves
fewer drug class options for treatment of
subsequent failure (a single NNRTI mutation
results in cross class resistance)
• Late change to a second line regime (using just
clinical and or CD4 criteria may provide a
greater opportunity for drug resistance
mutations to develop before regime change
• The advantage of the alternative triple NRTI first
line regime is that treatment failure can be
managed with a wider choice of drugs because
drugs from two classes will have been spared
70
Role of the Multidisciplinary
Team
71
Side Effects of Medicines
• Non-clinicians may be the first to hear about a
medication toxicity. They should be able to:
– recognize serious toxicities
– advise the patient to see a clinician promptly
– inform clinician directly of these toxicities
– discuss occurrence and management in the
multidisciplinary team meetings
• Providers should note patient symptoms/signs
in the medical record. Decisions and follow-up
should be discussed in multidisciplinary team
meetings.
72
Adherence Assessment and
Support
• Assess adherence at every visit and contact
(clinician, counselors etc)
• Determine if medicines are being taken correctly
(over or under-dosing)
• Evaluate timing of food intake and medication
• Determine whether vomiting, diarrhea, and
trouble swallowing are affecting medicine intake
• Identify social issues that may impact adherence
• Discuss adherence at multidisciplinary team
meetings
73
Patient Education
• The parent/patient should be aware of what to
expect when starting ART and while receiving
ART
• The parent/patient should be aware of possible

side effects
• The parent/patient should know what to do if she

believes she is experiencing a side effect
(especially if this happens when the clinic is
closed)
74
Documentation and Coordination of
Care
• A complete medication history and record should
exist for all patients.
• Careful documentation of toxicities should
appear in the medical record: presentation,
confirmation, management strategy,
response/resolution
• This documentation should be shared with other
providers (e.g., TB clinic, ANC)
75
Summary
• ART can provide life sustaining support for the HIV
infected child
• Using clinical staging and CD4 count can help identify
the eligible child
• In the case of rapidly progressing disease, clinical
judgment may identify the eligible child before diagnosis
is confirmed
• There are unique adherence challenges for children on
ART
• Families need additional support from the MDT around
adherence and frequently changing dosage
requirements
• A child on ART must be monitored carefully in order to
identify adverse events early and respond appropriately
• The multi-disciplinary team plays an important role in
assessing adherence and in monitoring the child on ART76

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Pediatric Antiretroviral

International Center for AIDS Care

• Unique to infants and children

CD4 Treat all except those

CD4 CD4 guided

CD4 CD4 guided

CD4%c 25 % 20% 15% 15%

CD4 countc 1500cells/mm3 750 cells/mm3 350cells/mm3 200cells/mm3

To Be used only in absence of CD4 assay:

a- Immunological markers supplement clinical staging

• Has the child tasted the medications?

Additional dual NRTI backbone include ABC+ AZT or ABC+d4T

• Know the patient

• Know the drugs

• Know the timeframe

• Management should be based on

– Severity of event/potential for harm

– Implications for adherence

• Hold the medication

• Switch the medication

d4T- lipoatrophy Switch d4T ABC

NVP-severe hepatotoxicity Switch NVP EFV

NVP-severe rash but not Switch NVP EFV

AZT-anemia, GI Switch AZT d4T

EFV-CNS toxicity and Switch EFV NVP

Triple NRTI First Major potential toxicities Drug substitution

d4T-peripheral Switch d4T AZT

• National and Local Guidelines take precedence

• The parent/patient should be aware of possible

• The parent/patient should know what to do if she

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