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Updated Guidelines for
the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
On December 1, 2009, the Guidelines for the Use of Antiretroviral Agents in
HIV-1-Infected Adults and Adolescents were revised to reflect the following
changes. You can find the complete,
revised guidelines on the
AIDSinfo web site..
What’s New in the Adults and Adolescent Guidelines Document?
The following key changes were made to update the November 3, 2008, version of
the guidelines.
New Section
Based on interests and requests from HIV practitioners, a new section entitled
“Considerations in Managing Patients with HIV-2 Infection” has been added to the
guidelines. This new section briefly reviews the current knowledge on the
epidemiology and diagnosis of HIV-2 infection and the role of antiretroviral
therapy in the management of patients with HIV-2 mono-infection and HIV-1/HIV-2
coinfection.
Key Updates
Drug Resistance Testing
In this revision, the Panel provides more specific recommendations on when to
use genotypic versus phenotypic testing to guide therapy in
treatment-experienced patients with viremia while on treatment.
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Genotypic
testing is recommended as the preferred resistance testing to guide therapy
in patients with suboptimal virologic responses or virologic failure while
on first or second regimens (AIII).
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Addition of
phenotypic testing to genotypic testing is generally preferred for persons
with known or suspected complex drug resistance mutation patterns,
particularly to protease inhibitors (BIII).
Initiation of Antiretroviral Therapy
In this updated version of the guidelines, the Panel recommends earlier
initiation of antiretroviral therapy with the following specific
recommendations:
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Antiretroviral
therapy should be initiated in all patients with a history of an
AIDS-defining illness or with CD4 count < 350 cells/mm3 (AI).
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Antiretroviral
therapy should also be initiated, regardless of CD4 count, in patients with
the following conditions: pregnancy (AI), HIV-associated nephropathy (AII),
and hepatitis B virus (HBV) coinfection when treatment of HBV is indicated (AIII).
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Antiretroviral
therapy is recommended for patients with CD4 counts between 350 and 500
cells/mm3. The Panel was divided on the strength of this recommendation: 55%
of Panel members for strong recommendation (A) and 45% for moderate
recommendation (B) (A/B-II).
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For patients
with CD4 counts >500 cells/mm3, 50% of Panel members favor starting
antiretroviral therapy (B); the other 50% of members view treatment as
optional (C) in this setting (B/C-III).
Patients initiating antiretroviral therapy should be willing and able to commit
to lifelong treatment and should understand the benefits and risks of therapy
and the importance of adherence (AIII). Patients may choose to postpone therapy,
and providers may elect to defer therapy, based on clinical and/or psychosocial
factors on a case-by-case basis.
What to Start in Antiretroviral-Naïve Patients
Increasing
clinical trial data in the past few years have allowed for better distinction
between the virological efficacy and safety of different combination regimens.
Instead of providing recommendations for individual antiretroviral components to
use to make up a combination, the Panel now defines what regimens are
recommended in treatment naive patients.
·
Regimens are classified as “Preferred,” “Alternative,” “Acceptable,” “Regimens
that may be acceptable but more definitive data are needed,” and “Regimens to be
used with caution.
·
The following changes were made in the recommendations:
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Raltegravir +
tenofovir/emtricitabine” has been added as a “Preferred” regimen based on
the results of a Phase III randomized controlled trial (AI).
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Four regimens
are now listed as “Preferred” regimens for treatment-naïve patients. They
are:
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efavirenz/tenofovir/emtricitabine;
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ritonavir-boosted
atazanavir + tenofovir/emtricitabine;
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ritonavir-boosted
darunavir + tenofovir/emtricitabine; and
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raltegravir + tenofovir/emtricitabine.
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Lopinavir/ritonavir-based
regimens are now listed as "Alternative" (BI) instead of "Preferred"
regimens, except in pregnant women, where twice-daily lopinavir/ritonavir +
zidovudine/lamivudine remains a "Preferred" regimen (AI).
Additional Updates
The following sections and their relevant tables have been substantially
updated:
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What Not
to Use
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Management
of Treatment-Experienced Patients
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Treatment
Simplification
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Hepatitis
C Coinfection
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Antiretroviral-Associated Adverse Effects
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Antiretroviral Drug Interactions
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Preventing
Secondary Transmission of HIV
The significant updates are highlighted throughout the document at
http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf.
WHO Updates HIV
Guidelines
Physician's First Watch for December 1, 2009
The World Health
Organization is advocating an earlier start to HIV treatment in a set of updated
recommendations published online.
Among the new guidelines, last updated in 2006:
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Adolescents, adults, and pregnant women with HIV should be started on
antiretroviral treatment when their CD4 count is at or below 350 cells/mm3,
whether or not they have clinical symptoms. (The 2006 guidelines recommend
starting treatment at 200 cells/mm3.)
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All
patients should have access to CD4 testing and routine viral load
monitoring.
Countries should start phasing out stavudine (d4T) as a first-line therapy
because of its toxicity. Zidovudine (AZT)- or tenofovir (TDF)-based regimens
are preferred.
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Pregnant
women who do not need antiretroviral treatment for their own health should
be started on antiretroviral prophylaxis in the second trimester to reduce
the risk for transmission to their infant.
The guidelines also outline first-, second-, and third-line treatment
options.
WHO
guidelines for adults and adolescents (Free PDF)
WHO
guidelines for pregnant women and infants (Free PDF)
WHO
guidelines on infant feeding (Free PDF)
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