guidelines make no fundamental changes to the CD4 count criteria for starting
antiretroviral therapy (ART), retaining 350 cells/mm3 as the
threshold. But they extend the range of situations in which ART is recommended
for people with higher CD4 cell counts and also include a range of situations
in which ART should be 'considered'.
include a wider range of recommended initial regimens than national guidelines
such as those issued by the British HIV Association and the US Department of
Health and Human Services. They include either of the first-line non-nucleoside reverse transcriptase inhibitor (NNRTI) drugs
efavirenz and nevirapine, three boosted protease inhibitors (atazanavir,
darunavir and lopinavir) and the integrase inhibitor raltegravir.
(Truvada, or with efavirenz as Atripla) or abacavir/3TC (Kivexa)
are given equal weight as the nucleoside analogue (NRTI) 'backbone' of combination regimens, though
the guidelines note that abacavir 'should be used with caution' with a high viral load or cardiovascular disease risk and that patients should always be
advised on the possibility of a hypersensitivity reaction to abacavir, even if
they are negative for the B*5701 genetic variation that usually causes this. There
are new tables of the most common and serious HIV drug side effects, and also
of interactions with drugs commonly used for other illnesses.
Nathan Clumeck of St Pierre University Hospital
who chaired the group writing the HIV guidelines, said: “We have probably been
quite conservative in our approach. We have included a variety of first-line
treatments. The risk is that if you are too prescriptive it will create double standards.”
said that it was not realistic to be too prescriptive “for a region where some
countries have good access to treatment while others have poor access. For
instance in our host country Serbia,
no Truvada or raltegravir are available.”
addition to the CD4 count threshold, the guidelines recommend HIV
treatment at any CD4 count if there is HIV-related disease, including TB (with a recommendation to start within two weeks for patients with CD4 counts below 100 cells/mm3), cancer including Hodgkin's lymphoma and HPV-related cancer, symptomatic
hepatitis B infection, neurocognitive impairment and also in pregnancy. For pregnant women natural delivery is now preferred to Caesarean section if the mother
has a viral load below 50 copies/ml.
advise physicians to consider treatment for all patients with a CD4
count under 500, especially if they have hepatitis C, and at any CD4 count in patients with high
cardiovascular disease risk (greater than 20% 10-year risk), other cancers or primary HIV infection (within
eight weeks of infection).
Clumeck was asked if the 'consider' categories would give healthcare funders an
excuse to rule out these categories. He
said the intention was to leave as much room as possible for physician and
added that the 'consider' category had been the solution to situations where the
writing panel could not agree: “Now we have a variety of treatments that work
and less toxicity, there is a wider range of situations where there is clinical
equipoise, in other words where the evidence does not firmly point to one
strategy or other.”