New
Updates to U.S. HIV Treatment Guidelines
By
Liz Highleyman
On
January 29, 2008, the U.S. Food and drug Administration (FDA) announced new updates
to the Department of Health and Human Services (DHHS) Guidelines
for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. These updates supplement the last major revision of
the guidelines, issued December 1, 2007. A summary of the latest changes is presented
below.
Initial
Combination Regimens for the Antiretroviral-Naive Patients
- Abacavir
(Ziagen) + 3TC
(lamivudine; Epivir) -- also available together in the Epzicom
combination pill -- has been upgraded
from an “alternative” to a “preferred” nucleoside/nucleotide reverse transcriptase
inhibitor (NRTI) backbone for patients who test
negative for HLA-B*5701,
a genetic marker for susceptibility to abacavir hypersensitivity reactions.
- AZT
(zidovudine; Retrovir) + 3TC has
been downgraded from “preferred” to an
“alternative” NRTI background due to potential toxicities.
- Ritonavir-boosted saquinavir
(Invirase) was changed from “acceptable…but inferior to preferred or alternative components”
to an “alternative” protease inhibitor (PI).
- The PI nelfinavir
(Viracept), the 2-NRTI combination
of d4T (stavudine;
Zerit) + 3TC, and the NRTI-only triple regimen of abacavir + AZT
+ 3TC are no longer recommended for treatment-naive
individuals.
- The
panel added a section entitled “Other Treatment
Options Under Investigation: Insufficient Data to Recommend,” which includes
recent data from clinical trials of ritonavir-boosted darunavir
(Prezista), the newly approved CCR5 antagonist maraviroc
(Selzentry), and the new integrase inhibitor raltegravir
(Isentress) in treatment-naive patients.
Treatment
Interruption
- This
section was updated with recent data on short-term and long-term treatment interruption.
The panel reaffirmed that -- aside from unplanned or planned short-term interruption
due to illnesses -- long-term treatment interruption is not recommended
and should only be undertaken in a clinical trial.
Acute
HIV Infection
- The
new guidelines include a new table on “Identifying, diagnosing, and managing acute
HIV-1 infection,” replacing the old table of signs and symptoms of acute retroviral syndrome.
- The
panel now recommends that treatment-naive
patients who plan to start therapy before drug resistance test results are available
should consider using a PI-based regimen, since non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance is more
common in newly infected individuals.
Tuberculosis
- The
panel updated recommendations concerning
the timing of antiretroviral therapy
in patients with active tuberculosis (TB), emphasizing overlapping toxicities
and possible interactions between TB and HIV drugs, and
the potential for immune reconstitution
inflammatory syndrome. They also recommend
repeat testing for latent TB infection in people whose CD4 count rises above 200
cells/mm3.
Table
Updates
- Various tables were updated to
include information on the most recently approved antiretroviral drug, the second
generation NNRTI etravirine
(Intelence, formerly TMC125).
- Tables were changed to reflect
new
recommendations for
atazanavir
(Reyataz) dosing in combination
with proton pump inhibitors or H2 receptor antagonists.
- The table of “Antiretroviral components that are acceptable as initial antiretroviral
components but are inferior to preferred
or alternative components” has been
removed.
The complete new version of the treatment guidelines is
available on the federal
government’s AIDSInfo Web site. The latest changes are highlighted in yellow.
02/01/08
Sources
R
Klein and K Struble. Division of Antiviral Drug Products, U.S. Food and Drug Administration.
Updated Adult and Adolescent Treatment Guidelines.
Email announcement. January 29, 2008.
U.S.
Department of Health and Human Services. Guidelines
for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.
January 29, 2008.
