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Less frequent CD4 and viral load monitoring safe for people doing well on ART
Michael Carter, 2016-06-13 10:30:00
The frequency of
routine monitoring for people treated with antiretrovirals with viral suppression
can be safely reduced from every three months, to every six months, investigators from Europe and the United States
report in the June 1st edition of the Journal of Acquired Immune Deficiency Syndromes. However, people followed-up every nine to twelve months were more
likely to experience virologic failure and also had lower CD4 count increases
compared to patients monitored every three months.
“We found little
evidence of an effect of monitoring frequency on death or AIDS-defining illness
or death in the short term among individuals who achieve virologic suppression
within 12 months of cART [combination antiretroviral therapy] initiation”,
comment the authors. “Our findings suggest that monitoring every 9-12 months
increases the risk of virologic failure…this might reflect intermittent
adherence among individuals monitored less frequently.”
The benefits of immunologic
and virologic monitoring for patients with HIV is well known. However, there
are few data to inform the frequency of follow-up for patients doing well on
guidelines recommend frequent CD4 and viral load monitoring following the
initiation of antiretrovirals, with check-ups every three-to-six months once
viral load is suppressed to below 50 copies/ml and CD4 count has increased to
over 500 cells/mm3. In contrast, US guidelines viral load monitoring
every one-to-two months after treatment initiation, with frequency reduced to
every three-to-four months once viral load is undetectable and after two years
of viral suppression, the frequency of monitoring is further reduced to every
six months. These guidelines also recommend CD4 count monitoring every
three-to-six months in the period after starting treatment, with a decrease in frequency
to every twelve months for patients for patients with an undetectable viral
load and CD4 count above 300 cells/mm3 for two years.
uncertainty, investigators from the HIV-CAUSAL Collaboration used data from six
large observational cohort studies in Europe and the US to assess differences
between three CD4 and viral load monitoring strategies.
Data were available
for approximately 39,000 adult patients who started HIV therapy after 2000 and
who achieved viral suppression within twelve months of treatment initiation.
monitored according to one of three strategies:
- Every nine-to-twelve months.
Two main outcomes
were compared between these three strategies:
- Clinical – all cause mortality
and a combined end-point of AIDS or death within 24 months of follow-up.
- Virologic failure (sustained
increase in viral load above 200 copies/ml) and CD4 cell increase within 18
months of follow-up.
there were 265 deaths and 690 AIDS-defining illness or deaths.
Compared with the
three-month monitoring strategy, the mortality hazard ratio (HR) was 0.86 (95%
CI, 0.42-1.78) for six-month monitoring and 0.82 (0.46-1.47) for monitoring
every nine-to-twelve months.
survival was 99% for monitoring every three months, 100% for monitoring every
six months and 99% for monitoring every six-to-nine months.
AIDS-free survival was 99% for all monitoring strategies.
virologic failure, patients monitored every six months were somewhat less
likely to experience a sustained rebound in viral load to above 200 copies/ml
(HR, 0.74; 95% CI, 0.46-1.19) compared to patients with three-monthly follow-up.
However, patients monitored every nine-twelve months were significantly more
likely than those monitored every three month to experience virologic failure
(HR, 2.35; 95% CI, 1.56-3.54). Using a viral load threshold of 50 copies/ml
altered the results somewhat, but patients with nine-to-twelve month monitoring
were still more likely to have virologic failure compared to patients with the
most frequent follow-up, though the difference was no longer significant (HR,
The mean baseline
CD4 count was 397 cells/mm3. After 18 months of treatment, this had
increased to 506 cells/mm3 for patients who had check-ups every
three months, compared to 501 for patients followed-up every six months and 475
cells/mm3 for those monitored every nine-to-twelve months.
“The mean CD4
count at 18 months was greater than 400 cells/mm3 for all of the
monitoring strategies, and so the clinical relevance of these differences could
be debated,” suggest the investigators.
suggest that less frequent monitoring of individuals on cART with confirmed
virologic suppression has little effect on clinical outcomes by 18 months of
follow-up,” conclude the investigators. “Because effects of different
monitoring strategies could take years to materialize, longer follow-up is
needed to fully evaluate this question.”