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15th Annual Retrovirus Conference (CROI), Boston, February 3–6, 2008
Antiretroviral Therapy Roundup from CROI
Report on newer drugs in development and some already approved drugs
by Jeff Berry
Editor’s Note: For access to webcast s, audio presentations,
slides, and abst ract s from the conference,
visit www.retroconference.org.
Encouraging results were presented at this year’s 15th Conference
on Retroviruses and Opportunistic Infections (CROI)
on many of the newer drugs which have recently been
approved in the last year or two, including drugs from new classes.
Much of it confi rms what we already know about these newer drugs,
that they are much more potent, easier to take, with fewer side
eff ects, and they off er hope for many individuals who have never
been able to achieve undetectable viral load up until now.
Sharon Walmsley, M.D., Professor of Medicine from the University
of Toronto, Canada, gave an excellent oral presentation
on Wednesday morning entitled “Management of the Treatment
Experienced Patient: Th e Second Wave of HAART.” In her opening
remarks she pointed out that “we all know that 60 is the new 40; in
HIV, what I hope to convince you of today is that the treatmentexperienced
patient is the new antiretroviral naïve patient.”
By looking at results from recent trials over the last few years,
and subdividing the trials and comparing the treatment naïve individuals
to those who were treatment-experienced, for those with
two or three active drugs, the percentage achieving undetectable
viral load was roughly the same.
“We treat the experienced patient now exactly the same way
that we treat the naïve patient, and it’s funny that it took us this
long to learn that.”
Vicriviroc, newest CCR5 inhibitor in development
Barry Zingman of Montefi ori Medical Center in Bronx, New
York presented data on the Phase 2 48-week trial of vicriviroc
(VCV) in treatment-experienced adults. VCV is a small-molecule
oral CCR5 receptor antagonist whose plasma levels are markedly
increased by CYP3A4 inhibitors (requiring Norvir boosting),
resulting in prolonged half-life, once-daily dosing without regard
to food, and potent activity in ART (antiretroviral therapy)-experienced,
CCR5-tropic patients. (See “Continued Challenges for CCR5
inhibitors” below.)
VICTORI-1 was a multinational trial with 37 sites in 12 countries.
116 individuals were randomized to receive either 20 or 30 mg
of VCV or a placebo, plus optimized background therapy (OBT).
20
Everyone received a ritonavir-boosted protease inhibitor (PI) in
this study.
Key eligibility requirements for this study included R5 tropism
at screening, triple-class experience with at least one NNRTI and
one PI mutation, and viral load greater than 1,000. Individuals were
stratifi ed to greater than or less than 100,000 VL and T-20 (Fuzeon)
use. Th is study was largely enrolled outside of the U.S. and Europe,
in an advanced population with CD4 counts of around 200 and, a
viral load of 4.5 log, with 30% having over 100,000 viral load. A
minority of individuals in the study had some T-20 or Prezista use.
Among the three groups, 23%, 25% and 14% were new to T-20, and
31%, 23% and 16% were new to Prezista in the 30 mg, 20 mg and
placebo groups respectively. Th e majority (82-85%) had less than
PA • May / June 2008 • tpan.com • positivelyaware.com
Positively Aware
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