Background
It
has been proposed that initiation of antiretroviral treatment (ART) very soon
after establishment of HIV infection may be beneficial by improving host
control of HIV replication and delaying disease progression.
Methods
People
with documented HIV infection of less than 12 months’ duration in Baltimore MD
and seven Canadian sites were randomized to either a) observation and deferred
ART, or b) immediate treatment with ART for 12 months. All subjects not
receiving ART were followed quarterly and permanent ART was initiated according
to contemporaneous treatment guidelines. The endpoint of the trial was total
ART-free time from study entry until initiation of permanent ART.
Results
One
hundred thirteen people were randomized, 56 to the observation arm and 57 to
the immediate treatment arm. Twenty-three had acute (<2 months) infection
and 90 early (2–12 months) infection. Of those randomized to the immediate
treatment arm, 37 completed 12 months of ART according to protocol, 9 declined
to stop ART after 12 months, and 11 were nonadherent to the protocol or lost to
follow-up. Comparing those in the observation arm to either those who completed
12 months of ART or all 56 who were randomized to immediate ART, there was no
significant difference between the arms in treatment-free interval after study
entry, which was about 18 months in both arms.
Conclusions
This study did not find a benefit from administration of
a brief, time-limited (12-month) course of ART in acute or early HIV infection.
Below: Per-protocol survival analysis of time from randomization (Deferred Treatment arm) or cessation of immediate ART (Immediate Treatment arm) until permanent initiation of antiretroviral therapy (ART).
Results are stratified by study arm (Immediate ART vs. Deferred ART). The Immediate ART arm includes the 37 subjects who completed the study protocol, i.e., 12 months of ART followed by cessation of ART and continuation of clinical monitoring. Numbers of observations at 6-monthly time points are shown. (For the results of the same analysis including the 9 subjects in the Immediate arm who completed 12 months of ART but did not stop ART at that time, see S1 Fig).
Full article at: http://goo.gl/UkO6Xj
By:
Joseph B. Margolick, Linda Apuzzo
Department of Molecular Microbiology and Immunology, Johns
Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States
of America
Joel Singer, Hubert Wong, Terry Lee
CIHR Canadian HIV Trials Network, Vancouver, British
Columbia, Canada
Joel E. Gallant
Department of Medicine, Johns Hopkins School of Medicine,
Baltimore, Maryland, United States of America
Phillippe El-Helou
Department of Medicine, McMaster University, Hamilton,
Ontario Canada
Mona R. Loutfy
Maple Leaf Medical Clinic, Toronto, Ontario, Canada
Anita Rachlis
Sunnybrook Health Sciences, Toronto, Ontario, Canada
Christopher Fraser
Cool Aid Community Health Center, Victoria, British
Columbia, Canada
Kenneth Kasper
Department of Medical Microbiology, University of Manitoba,
Winnipeg, Manitoba, Canada
Cécile Tremblay
Centre de recherché du Centre Hospitalier de l’ Université
de Montréal, Montréal, Quebec, Canada
Harout Tossonian, Brian Conway
Vancouver Infectious Diseases Centre, Vancouver, British
Columbia, Canada
More at: https://twitter.com/hiv_insight
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