Abbott Laboratories Release: New Data Show A Kaletra(R) (Lopinavir/Ritonavir)-Based Regimen Demonstrated Continued Efficacy And Favorable Resistance Profile For Patients Through Seven Years Of Initial HIV Therapy
DUBLIN, Nov. 18 /PRNewswire-FirstCall/ -- The longest clinical study of any HIV treatment -- seven years (360 weeks) -- of Kaletra(R) (lopinavir/ritonavir)-based therapy study results demonstrated patients taking Kaletra 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. This data, presented at the 9th European AIDS Conference (EACS), demonstrated that most patients taking a Kaletra-based regimen as initial therapy for HIV infection showed sustained antiviral response. Of the 19 patients who met criteria for resistance testing and had resistance testing results available through week 360, none demonstrated primary protease inhibitor (PI) resistance.
"This impressive seven-year Kaletra data, which demonstrates sustainable treatment without resistance for most patients new to therapy, is a hallmark of the importance of research and development in the area of HIV," said Robert Murphy, M.D., practicing physician and professor, and director of clinical research in biodefense and infectious diseases, Division of Infectious Diseases, Northwestern University, Feinberg School of Medicine, Chicago, IL.
Study 720: Seven-Year Data
Data from the randomized, uncontrolled, open-label, prospective Phase II study of 100 treatment-naive patients taking Kaletra in combination with lamivudine (3TC) and stavudine (d4T) show that 59 percent of patients (59/100) had an undetectable viral load (HIV RNA less than 50 copies per milliliter) and 61 percent (61/100) 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 62 patients remaining on treatment at week 360, 98 percent (61/62) had HIV RNA less than 400 copies per milliliter.
A total of 33 samples from 29 subjects were submitted for resistance testing. Genotypic drug resistance testing failed for 10 subjects whose median HIV-1 RNA was 575 copies/mL. Of the 19 patients who had resistance data available through 360 weeks, none demonstrated evidence of resistance to lopinavir (0/19) or stavudine (0/19). Three patients (3/19) demonstrated lamivudine resistance. Correspondingly, no evidence of phenotypic resistance to any PI was observed.
Patients in this open-label study, in which there was no comparator group, were initially 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 360 weeks of therapy. The most frequent adverse events were diarrhea and nausea. At week 360, Grade 3 or Grade 4 cholesterol and triglyceride values were observed in 2 percent and 3 percent of patients, respectively.
The low viral loads were accompanied by increases in CD4 cell counts. Average CD4 cell count increase from baseline to week 360 was 501 cells per cubic millimeter for all patients remaining in the study.
"Over the years, this study has helped us better understand the benefit Kaletra brings to patients new to therapy," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "Abbott remains committed to conducting research that adds value to the understanding of HIV and its treatment for clinicians and patients."
Additional Data Presented at EACS
Fourteen abstracts based on Abbott's HIV antiretroviral products were accepted to EACS this year. Highlights include:
-- Data analyzed from four studies of Kaletra-based therapy in 654 antiretroviral-naive subjects showed that patients achieved CD4 cell increase regardless of baseline CD4 cell count and viral load, including patients with the most advanced disease (those with baseline CD4 cell count less than 50 cells per cubic millimeter), through 48 weeks of therapy. -- Kaletra was evaluated as monotherapy in a study of 42 patients, with no history of virologic failure while using a protease inhibitor, through 72 weeks of treatment. Patients with undetectable viral load after six months of standard therapy were randomized to continue on their initial Kaletra-based, triple drug regimen or switch to Kaletra monotherapy. Using an intent-to-treat analysis, 81 percent of patients who switched to Kaletra monotherapy achieved undetectable viral load through 72 weeks. Kaletra Safety Information
Kaletra (lopinavir/ritonavir) is always used in combination with other anti-HIV medicines to treat people with HIV infection. Kaletra should not be taken by patients who have had an allergic reaction to Kaletra or any of its ingredients, including lopinavir or ritonavir.
Taking certain medications with Kaletra could create the potential for serious side effects that could be life threatening. Kaletra should not be taken with astemizole, cisapride, dihydroergotamine, ergonovine, ergotamine, methylergonovine, midazolam, pimozide, terfenadine or triazolam.
In addition, Kaletra should not be taken with fluticasone propionate, lovastatin, rifampin, simvastatin, or products containing St. John's Wort (Hypericum perforatum). Particular caution should be used when taking Kaletra with sildenafil, tadalafil or vardenafil. Please consult your local prescribing information for country-specific recommendations. 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 Kaletra clinical trials, the most commonly reported side effects of moderate-to-severe intensity were abdominal pain, abnormal bowel movements, diarrhea, feeling weak or tired, headache, nausea and vomiting. Children taking Kaletra may sometimes get a skin rash. 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. For more information, including full prescribing information, please visit http://www.kaletra.com .
Additional Information about Abbott
Abbott has been a leader in HIV 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.
Abbott currently supports nearly 200 HIV-related studies worldwide that examine a broad range of clinically relevant research questions, representing the most clinical research the company has been involved with in its HIV program.
Abbott submitted a line extension Marketing Authorization Application to the European Medicines Agency for the approval of a new Kaletra tablet formulation in May 2005. The company received U.S. Food and Drug Administration approval on Oct. 28, 2005 for the new tablet formulation, which will allow patients to take fewer pills with or without food. Data from pharmacokinetic studies in healthy individuals demonstrated that Kaletra tablets provide similar drug plasma concentrations to those achieved with the capsule formulation.
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 60,000 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 .Abbott
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