(Isentress), Etravirine (Intelence), and Boosted Darunavir
(Prezista) Is Highly Effective for Treatment-experienced
An antiretroviral therapy (ART) regimen
containing 3 recently approved anti-HIV
drugs -- the integrase inhibitor raltegravir
(Isentress), the next generation non-nucleoside
reverse transcriptase inhibitor (NNRTI)
(Intelence), and the ritonavir-boosted
protease inhibitor darunavir
(Prezista) -- was well tolerated and
produced good viral suppression and CD4
cell gains in heavily treatment-experienced
adolescents, according to a study published
in the November
13, 2009 issue of AIDS.
As previously reported, 2
recent studies demonstrated that a triple combination
regimen of raltegravir, etravirine, and darunavir/ritonavir
was well tolerated and produced high rates of virological
suppression in heavily treatment-experienced adult
HIV patients with extensively drug-resistant virus.
French researchers have reported that the same regimen
is also effective for older children and adolescents
Thuret and colleagues studies 12 highly treatment-experienced
patients with an average age of 15 years who contracted
HIV via perinatal transmission, and thus were infected
for their entire lives. At study entry, the group
had relatively advanced HIV disease, with a median
viral load of about 100,000 copies/mL and a median
CD4 cell count of 124 cells/mm3.
had a history of virological failure and resistance
to drugs in the first 3 antiretroviral classes (nucleoside/nucleotide
reverse transcriptase inhibitors, NNRTIs, and protease
inhibitors). All patients received raltegravir,
etravirine, and darunavir/ritonavir through an expanded
access program in France.
a median follow-up period of 12 months, 6 of the
12 patients (50%) had undetectable HIV viral load
< 50 copies/mL.
of the 12 (92%) had HIV RNA < 400 copies/mL.
12 months, the median CD4 cell count had increased
to 500 cells/mm3.
participants developed an AIDS-related illness
or died during follow-up.
clinical side effects or laboratory abnormalities
more serious than grade 2 (moderate) were reported.
1 participant discontinued therapy prematurely
due to adverse events.
Based on these findings, the investigators concluded
that "preliminary results in adolescents with
extensive multidrug resistant virus are encouraging,"
and characterized the tolerability and efficacy of
the regimen as "remarkable."
their discussion, the authors wrote, "the majority
of extensively treated adolescents can be virologically
controlled with by a salvage regimen consisting of
a combination of new drugs, despite a long record
of suboptimal treatment and viral multi-resistance."
I Thuret, M-L Chaix, C Tamalet, and others. Raltegravir,
etravirine and r-darunavir combination in adolescents
with multidrug-resistant virus. AIDS 23(17):
2364-2366. November 13, 2009. (Abstract).