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PROGRAM MANDATE &
In accordance with our mandate
(CROI) took place in Boston from February
update of the STARTMRK study at CROI.
27 to March 2, 2011. CROI is a scientifically-
The study is comparing twice-daily raltegravir
researchers working to understand, prevent,
and treat HIV/AIDS and its complications.
science-packed days of lectures, symposia,
were slightly more drug-related side effects
and presentations, and was attended by 4,000
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regimens for people below 250 copies/ml, but instead
The QDMRK study, comparing once-daily versus twice-
testing again monthly to ensure that they’re stable.
daily raltegravir, found that the once-daily dosing wasless effective, with more resistance and more failures
t han twice-daily dosing. As a result, t his study was
The Berlin patient, described in issue 71 (March/April
discontinued and participants all went to the twice-daily
2011), is a 40-year-old HIV-positive man who received a
bone marrow transplant to treat acute myeloid leukemia.
Another study, Mono-PI: DRV/RT V, compared once-
During the procedure, his own immune system was
daily dosing versus twice-daily dosing of darunavir
destroyed and replaced with stem cells from a donor
(Prezista) with ritonavir (Nor vir) over 96 weeks. Treat-
who had the ver y rare CCR5-delta32 mutation. As a
ment failures occurred af ter participants were switched
result, he appears to be cured of HIV and currently has
from a twice-daily dose to a once-daily dose.
an undetectable viral load, even though he’s no longertaking HAART.
A US company is using a genetic engineering
The 48-week update of a trial comparing a three-drug
approach to disrupt the CCR5. Once CD4 cells are
antiretroviral therapy versus a f ive-drug hypertherapy
removed from people, the cells are treated to mimic the
revealed no difference between the two therapies. This
CCRD-delta32 mutation and are then put back into the
study def initively shows that triple therapy is as good as
same person. This new experimental therapy was success-
it gets—there’s no need to add the extra two drugs.
ful in the f irst few test subjects: the procedure was well
Several trials testing different roles for maraviroc
tolerated and CD4 counts increased. This is an exciting
(Celsentri) didn’t demonstrate strong evidence to add a
development, but still in the early stages.
fourth drug to the antiretroviral regimens.
To address the many concerns about cardiovascular
Dr. Montaner provided some of the latest results from
problems with abacavir (Ziagen), the US Food and Drug
the HPTN 052 study (www.hptn.org). This study examined
Administration conducted a detailed statistical analysis
HIV transmission in 1,750 sero-discordant couples. The
comparing the results from all abacavir trials. The
HIV-positive partner either received highly active anti-
results showed once and for all that there’s no increased
retroviral therapy (HAART) immediately or deferred
treatment. In the couples where the poz partnerreceived immediate HAART, the HIV transmission rate
was reduced by 96.3 percent. Because this group had
lower transmission than the group that received deferred
The 96-week update of the ANRS 139 TRIO study
demonstrates that the combination of raltegravir plus
Dr. Montaner emphasized again how treating ever y-
etravirine (Intelence) and darunavir (Prezista) boosted
one diagnosed with HIV reduces disease progression,
with ritonavir provides a high rate of virologic suppression
reduces death, and prevents transmission. He discussed
in treatment-experienced people with multiple-drug
additional results that support the treatment-as-prevention
resistant HIV. They maintained virologic suppression
approach. He also noted that the World Health Organization
is going to make an announcement recommending that treatment as prevention be offered regardless of a
Dr. Montaner is still not satisf ied with the TaqManAssay, which is being used to determine viral load, asit’s been giving inaccurate results. Using this assay, heconsiders the threshold of 250 copies/ml as the clinicalthreshold for failure. He recommends carefully monitor-ing patients with viral loads over 50 copies/ml, and
recommends repeating the test more frequently. Dr.
Montaner doesn’t recommend switching treatment
The Australian Sports Drug Medical Advisory Committee (ASDMAC) processes Therapeutic Use Exemptions (TUE). These exemptions give permission to athletes who, for medical (therapeutic) reasons, need to use medications or methods that are prohibited in sport. The World Anti-Doping Agency’s (WADA) 2010 List of Prohibited Substances includes a change of status to the therapeutic use of inhale
FOR IMMEDIATE RELEASE Contact: Kimberly Kraemer Corporate Communications 510-450-3500 ADAMAS PHARMACEUTICALS ANNOUNCES SUCCESSFUL END-OF-PHASE 2 MEETING WITH FDA FOR ARIMENDATM EMERYVILLE, CALIF., May 15, 2012 – Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has held an End-of-Phase 2 meeting with the FDA to discuss the proposed safety a