PARIS -- HIV patients
experiencing moderate side effects on their antiretroviral (ARV)
drug regimen reported an improvement in symptoms of depression
and in overall tolerability when they substituted Abbott
Laboratories' Kaletra(R) (lopinavir/ritonavir) for their current
protease inhibitor (PI) or non-nucleoside reverse transcriptase
inhibitor (NNRTI) in their treatment program. The data were
presented today at the International AIDS Society (IAS) 2nd
Conference on Pathogenesis and Treatment.
The data were gathered in the international PLATO (Performance of
Lopinavir/ritonavir as an Alternative Treatment Option) trial, an
open-label, randomized eight-week study. The study looked at the
impact of substitution with Kaletra in the treatment regimen of
patients experiencing a Grade 2 side effect on their current
PI/NNRTI. Grade 2 side effects are those that result in moderate
limitation in activity with no or minimal intervention/therapy
Patients enrolled in the PLATO study were randomized (4:1) to
immediately substitute their PI/NNRTI with Kaletra at baseline
(immediate substitution group), or defer the change until week
four of the study (deferred substitution group). All patients
remained on their original NRTIs.
These data looked at symptoms of depression, which was available
for 588 patients in the study, as measured using the Center for
Epidemiologic Studies Depression Scale (CES-D), a validated
self-report questionnaire. Scores of 16 or higher on the CES-D
have been correlated with depression.
A statistically significant (p=<0.001) mean reduction in
depression score was seen by week eight in patients who
substituted Kaletra for their PI/NNRTI at baseline. The
prevalence of CES-D depression scores of 16 or greater at week
eight ranged from 26 percent to 41 percent after substitution
with Kaletra compared to a range of 41 percent to 51 percent on
the baseline PI/NNRTI (nelfinavir, indinavir,
indinavir/ritonavir, efavirenz, or another PI/NNRTI).
PLATO was conducted by 169 investigators in 14 countries,
including Argentina, Brazil, England, Germany, Greece, Spain and
the United States.
As many as one in three people with HIV may suffer from
depression, according to the U.S. National Institute of Mental
Health. Depression should be appropriately diagnosed and treated.
"Research shows that depression can decrease a patient's energy
and may even contribute to the progression of HIV/AIDS. It is
important to consider HIV drug regimens that help keep the virus
undetectable and help minimize the barriers to treatment success
that depression can create," said Jurgen Rockstroh, M.D., HIV
Outpatient Clinic, Department of Medicine, University of Bonn,
The PLATO study also evaluated whether switching to Kaletra would
positively impact tolerability while maintaining viral control
(HIV RNA <400 copies/mL). Results show that at baseline, 91
percent of patients included in this analysis had plasma HIV RNA
below 400 copies/mL. At week eight, 91 percent (intent-to-treat)
to 97 percent (on-study) of patients who received Kaletra at
baseline maintained and possibly improved their virologic
Patient reported data on overall tolerability to HIV treatment
was measured using an augmented ACTG (AIDS Clinical Trials Group)
Symptoms Distress Module and showed a statistically significant
difference at week eight compared to baseline. No adverse events
leading to discontinuation of study drug were observed in more
than two percent of patients switched to Kaletra.
In the United States, Kaletra is indicated in combination with
other antiretroviral agents for the treatment of HIV infection.
This indication is based on analyses of plasma HIV RNA levels and
CD4 cell counts in controlled studies of Kaletra of 48 weeks
duration and in smaller, uncontrolled dose-ranging studies of
Kaletra of 72 weeks duration.
Kaletra should not be used with certain medications. Taking
certain other drugs with Kaletra could create the potential for
serious side effects that could be life threatening. Patients
should always talk to their physician or health care provider
before starting new medicines, including those without a
prescription and herbal preparations.
Kaletra should not be taken if a patient has had an allergic
reaction to Kaletra or any of its ingredients. Various degrees of
cross-resistance among protease inhibitors have been observed. In
patients with hemophilia, increased bleeding has occurred with PI
use. Diabetes and high blood sugar have also occurred in some
patients when taking protease inhibitors. Changes in body fat
have been seen in some patients receiving antiretroviral therapy.
Some patients receiving Kaletra have had large increases in
triglycerides and cholesterol, which should be monitored before
and during therapy. Pancreatitis and liver problems including
death have been reported in some patients taking Kaletra. It is
unclear if Kaletra caused these problems because some patients
had other illnesses or were taking other medications. Monitoring
of liver enzymes in some patients should be considered,
especially during the first several months of therapy.
Kaletra is not a cure for HIV infection. People treated with
Kaletra may continue to develop illnesses associated with
advanced HIV infection, including opportunistic infections.
Kaletra has not been shown to reduce the risk of passing HIV to
others through sexual contact or blood contamination. Patients
should continue to practice safe sex and should not use or share
dirty needles. In adults, the most commonly reported,
Kaletra-related side effects of moderate to severe intensity are:
abdominal pain, abnormal bowel movements, diarrhea, feeling
weak/tired, headache and nausea.
Under accelerated review, the U.S. Food and Drug Administration
approved Kaletra for marketing on September 15, 2000. Kaletra
received full FDA approval on November 27, 2002. Abbott also
obtained marketing approval for Kaletra in Canada, Japan, the
European Union, throughout Latin America and in additional
countries around the world.
Kaletra is now the most prescribed protease inhibitor in the
Abbott Laboratories (NYSE:ABT) has been a leader in HIV/AIDS
research since the early years of the epidemic. In 1985, the
company developed the first licensed test to detect HIV
antibodies in the blood, and remains a leader in HIV diagnostics.
Abbott retroviral and hepatitis tests are used to screen more
than half of the world's donated blood supply. To treat those
with HIV, Abbott scientists have developed two protease
inhibitors, Norvir(R) and Kaletra(R).
Abbott Laboratories is a global, broad-based health care company
devoted to the discovery, development, manufacture and marketing
of pharmaceuticals, nutritionals, and medical products, including
devices and diagnostics. The company employs more than 70,000
people and markets its products in more than 130 countries.
Abbott news releases and other information, including Kaletra
(lopinavir/ritonavir) full prescribing information, are available
on the company's Web site at www.abbott.com .
Source: Abbott Laboratories
CONTACT: U.S. Media, Laureen Cassidy, +1-847-938-7743, or Media
the U.S., Brian Kyhos, +1-847-936-7988, or Financial Community,
+1-847-938-2655, all of Abbott Laboratories
Web site: http://www.abbott.com/
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