Longest Study of Kaletra(R) (Lopinavir/Ritonavir) Based Regimen Demonstrated Favorable Resistance Profile for Patients Through S
01 Novembre 2004 - 3:00PM
PR Newswire (US)
Longest Study of Kaletra(R) (Lopinavir/Ritonavir) Based Regimen
Demonstrated Favorable Resistance Profile for Patients Through Six
Years of Initial HIV Therapy WASHINGTON, Nov. 1 /PRNewswire/ --
Study data presented showed no primary protease inhibitor (PI)
resistance was reported in anti-retroviral-naove patients taking a
Kaletra(R) (lopinavir/ritonavir)-based regimen through six years
(300 weeks) of therapy. The data, presented at the 44th
Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC), also showed the majority of patients taking Calera in
combination with other antiretroviral agents maintained an
undetectable viral load, (amount of virus in the blood) of less
than 50 copies per milliliter, as measured by HIV RNA, through six
years of therapy. "We have come a long way in treating HIV for many
individuals," said Constance Benson, M.D., professor of medicine,
University of Colorado Health Sciences Center, Division of
Infectious Diseases. "Kaletra, as part of an initial treatment
regimen, is a good example of how far we have come in being able to
provide patients with long-term HIV treatment options that include
durable viral suppression and a favorable resistance profile." Data
from the randomized, uncontrolled, prospective Phase II study of
100 treatment-naove patients taking Kaletra in combination with
lamivudine (3TC) and stavudine (d4T) show that of 18 patients out
of 28, who met the criteria for resistance testing and who had
resistance data available through 300 weeks, none demonstrated
evidence of resistance to lopinavir (0/18) or stavudine (0/18).
Three patients (3/18) demonstrated lamivudine resistance. In
addition, 61 percent of patients (61/100) had an undetectable viral
load (HIV RNA less than 50 copies per milliliter) and 63 percent
(63/100) had HIV RNA less than 400 copies per milliliter, using an
intent-to-treat analysis, which categorizes any patient who does
not complete the study as a treatment failure. Of the 63 patients
remaining on treatment at week 300, 100 percent (63/63) had HIV RNA
less than 400 copies per milliliter. The low viral loads were
accompanied by increases in CD4 cell counts. These data include
patients with the most advanced disease (those with baseline CD4
cell count less than 50 cells per cubic millimeter). CD4 cell
counts increased consistently over the 300-week period, with an
average increase, from baseline, of 595 cells per cubic millimeter
observed for all patients remaining in the study. Patients with the
most advanced disease (n=16) had an average CD4 cell count increase
of 568 cells per cubic millimeter. "There are few HIV clinical
trials with six years of data, and we are encouraged that no
primary protease resistance has been seen in patients taking
Kaletra as part of their initial treatment regimen over the
extended duration of this trial," said Scott Brun M.D., divisional
vice president, Infectious Disease Development, Abbott.
"Approaching six years of clinical study, a Kaletra-based regimen
demonstrated its ability to meet the pressing needs in HIV therapy,
long-term viral suppression, immunological benefit and
tolerability." Patients in this open-label study, in which there
was no comparator group, were given one of three doses of Kaletra
in addition to the nucleoside analogues stavudine and lamivudine.
After 48 weeks of therapy, all patients were converted to the same
dose of Kaletra (400/100 mg twice-daily) with stavudine and
lamivudine. Kaletra was generally well tolerated through 300 weeks
of therapy. The most frequent adverse events were diarrhea, nausea
and abnormal fat distribution. Non-fasting lipid elevations were
reported. At week 300, Grade 3 total cholesterol elevation was
observed in six percent of study patients. No Grade 4 total
cholesterol elevation was observed. Grade 3 or Grade 4 triglyceride
values were observed in 10 percent of patients. A minority of
patients in this study employed appropriate lipid lowering agents
to treat these elevations through week 300. A decrease in total
cholesterol and triglycerides were observed in these patients.
Additional Information About Kaletra Kaletra is always used in
combination with other anti-HIV medicines to treat people with
human immunodeficiency virus (HIV) infection. Kaletra should not be
taken if you have had an allergic reaction to Kaletra or any of its
ingredients, including lopinavir or ritonavir. Taking Kaletra with
certain drugs can cause serious problems or death. Kaletra should
not be taken with dihydroergotamine, ergonovine, ergotamine, and
methylergonovine such as Cafergot(R), Migranal(R), D.H.E. 45(R),
Ergotrate Maleate, and Methergine, as well as Halcion(R),
Hismanal(R), Orap(R), Propulsid(R), Seldane(R), Versed(R),
Rimactane(R), Rifadin(R), Rifater(R), Rifamate(R), Mevacor(R),
Zocor(R), or products containing St. John's wort (Hypericum
perforatum). Particular caution should be used when taking
Viagra(R), since the interaction with Kaletra may result in an
increase in Viagra-related side effects. Discuss all medicines,
including those without a prescription and herbal preparations you
are taking or plan to take, with your doctor or pharmacist.
Pancreatitis and liver problems, which can be fatal, have been
reported. Patients should tell their doctor if they have had liver
disease such as hepatitis. In patients taking protease inhibitors,
increased bleeding (in patients with hemophilia) and diabetes/high
blood sugar have occurred. 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. Varying degrees of cross-resistance among protease
inhibitors have been observed. In clinical trials, the most
commonly reported side effects of moderate or severe intensity
were: abdominal pain, abnormal bowel movements, diarrhea, feeling
weak or tired, headache and nausea. This is not a complete list of
reported side effects. Kaletra oral solution contains alcohol.
Kaletra does not cure HIV infection or AIDS and does not reduce the
risk of passing HIV to others. About Abbott Abbott 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. Today, 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. Kaletra is the protease inhibitor market share leader
in Europe, and is the most prescribed protease inhibitor in the
United States. Abbott is a global, broad-based health care company
devoted to the discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals,
devices and diagnostics. The company employs more than 55,000
people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com/. Outside of the U.S.,
health care professionals can access additional information on
Kaletra at http://www.kaletra.com/. DATASOURCE: Abbott Laboratories
CONTACT: Nicole Wesley, US Media, +1-847-935-9877, cell
+1-847-772-3209, Media Outside the U.S., Michelle Johnson, +1
847-935-0011, or cell +1-312-213-6140, Financial Community, Larry
Peepo, +1-847-935-6722 Web site: http://www.abbott.com/ Company
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