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synergistic toxic effects and so should not be combined. Expert opinion should always be sought.
Adequate viral suppression for most patients on therapy is defined as a reduction in viral load to
undetectable levels. There are cases in which adequate viral suppression may not be achieved
despite appreciable increases in CD4 cell count. Increases in CD4 cell count in people with good
virological control show an average increase of approximately 100 cells/mm3 per year for the
subsequent few years until a threshold is reached, which in many patients may be within the
normal range. However, successful outcomes have not been observed across all patients.
Problems encountered with HAART are medicine resistant virus, poor patient adherence,
interactions between medicines when treating co-infections like tuberculosis, and medicine
toxicity. In the beginning of the HAART era it was hoped that all HIV-seropositive persons
would benefit from antiretroviral therapy. Nowadays, clinicians have considerable reservations
about treating asymptomatic immunocompetent cases, because of the risk of adverse effects to
medication, the challenge of long-term adherence and development of virus resistance.
In asymptomatic patients with HIV, decisions on when to start treatment are based on an
assessment of the risk of disease progression over the medium term if treatment is not started (e.g.
using data from the CASCADE collaboration – see section on “Risk of Progression”) versus the
potential risks of starting treatment earlier (toxicity and resistance), and in any case always before
the CD4+ lymphocyte count has fallen to below 200 cells/mm3.
In 2004 the Panel on Clinical Practices for Treatment of HIV Infection (convened by the
Department of Health and Human Services, USA) published revised indications for antiretroviral
therapy, which are shown in table 2. Similar cut-off values are used in guidelines in other
ICAO Preliminary Unedited Version — November 2009 III-13-10
industrialized countries. WHO recommendations, adopted by many low and middle-income
countries are slightly more conservative and the debate about early treatment with HAART vs.
deferring until lower CD4+ counts are reached continues. The latest advice should therefore be
sought.
When assessing aeromedical certification of persons on HAART, consideration must be given to
aeromedically relevant adverse effects, and clinicians treating aviation personnel should be
asked to carefully design treatment regimens to minimize these. Medicines that are likely to
interfere with flight safety should be avoided e.g. indinavir, which causes nephrolithiasis (with
radiolucent stones), and with other medications specialist evaluation may be required before
deciding on certification, e.g. efavirenz, which may cause psychiatric symptoms.
Table 2.— Indications for antiretroviral therapy
(Panel on Clinical Practices for Treatment of HIV Infection, 2004, USA)
1
Antiretroviral therapy is recommended for all patients with history of an
AIDS-defining illness or severe symptoms of HIV infection regardless of
CD4+ T cell count.
2 Antiretroviral therapy is also recommended for asymptomatic patients with
< 200 CD4+ T cells/ μL.
3 Asymptomatic patients with CD4+ T cell counts of 201-350 cell/ μL should
be offered treatment.
4 For asymptomatic patients with CD4+ T cell of >350/ μL and plasma HIV
RNA >100.000 copies/mL most experienced clinicians defer therapy but
some clinicians may consider initiating treatment.
5 Therapy should be deferred for patients with CD4+ T cell counts of >350
cells/ μL and plasma HIV RNA < 100.000 copies/mL.
Only medicines that are licensed by national authorities will be acceptable. During the initiation
of therapy and when adjustments are made to the regimen used, applicants should be assessed as
temporarily unfit. Further assessment should then be made for side effects that are likely to be
disabling after treatment is stable for a period of months, before any decision on certification is
made.
Adverse effects of HAART include gastrointestinal intolerability, medicine hypersensitivity,
Stevens-Johnston syndrome, cytochrome P450 interactions, CNS effects, myopathy, neuropathy,
bone marrow depression, nausea, diarrhoea, fatigue, headache, hepatitis, hepatic steatosis, lactic
acidosis, pancreatitis, dilated cardiomyopathy, renal colic, nephrolithiasis, haematuria, abdominal
pain, metabolic syndrome and lipodystrophy. There is considerable variability in the occurrence
of adverse effects between medicines and between individuals. Noteworthy is the occurrence of a
lipodystrophy syndrome, characterized by a “buffalo hump” fat distribution, in 50 per cent of the
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Manual of Civil Aviation Medicine 2(96)
