Kaletra (lopinavir/ritonavir) Is Most-prescribed Protease Inhibitor in US and Europe for Treatment of HIV

The protease inhibitor (PI) Kaletra (lopinavir/ritonavir) has become the most-prescribed PI as part of a treatment regimen for HIV in the United States and Europe, according to the drug’s manufacturer Abbott Laboratories. 

Following is the text of an announcement released by the company on 6/24/03:

“Based on the number of patients receiving therapy, Kaletra also has become the PI market share leader in Europe with a 29.5 percent share. Kaletra, which now holds a 28.0 percent share in the U.S. PI market, received accelerated approval in the US in September 2000, based on ongoing clinical studies. 

“The success of Kaletra-based regimens explains why Kaletra has become the most widely prescribed protease inhibitor,” said Eugene Sun, MD, vice president, Anti-infective and Antiviral Drug Development, Abbott Laboratories.  “In clinical trials conducted in treatment-naïve patients taking a Kaletra-based regimen, viral suppression has been maintained for as long as four years. No protease inhibitor resistance mutations have been detected in treatment-naïve patients in these studies. Abbott continues to monitor these patients.”

“In one clinical trial (M98-863), data were compared between treatment-naïve patients taking either Kaletra (n=326) or nelfinavir (n=327), in combination with stavudine (d4T) and lamivudine (3TC).  In this randomized, double-blind, Phase III study, patients with detectable HIV (>400 copies/mL) were monitored through 96 weeks, and of those with viruses that could be analyzed, none (0/40) in the Kaletra arm had developed protease inhibitor resistance, compared to 33 percent (28/84) of patients in the nelfinavir arm.  Additionally, resistance to 3TC was detected in only 38 percent of viruses (15/40) from patients in the Kaletra arm, compared to 82 percent of viruses (69/84) from patients in the nelfinavir arm. 

“In another clinical trial, data demonstrate that a drug regimen including Kaletra provided viral suppression (as measured by viral load) and immunologic response (as measured by CD4 levels) through four years.  This ongoing Phase II study (M97-720) of 100 antiretroviral (ARV)-naïve patients was specifically designed to evaluate different doses of Kaletra and had no comparator group.  Patients were randomized to one of three doses of Kaletra in addition to stavudine (d4T) and lamivudine (3TC).  After 48 weeks, all patients were converted to open-label 400/100 mg twice daily dosing of Kaletra with continued nucleoside reverse transcriptase inhibitors (NRTIs) twice daily.

“The Kaletra-based regimen provided viral suppression through four years (192 weeks of treatment).  In an intent-to-treat (ITT) analysis where non-completers were considered treatment failures, 72 percent of patients (from the original 100 enrolled) maintained undetectable viral levels (HIV RNA <400 copies/mL) through four years of therapy.  At 192 weeks, 72 of 100 patients remained on the study drug; of the 28 patients who discontinued, seven were due to Kaletra-related adverse events.

“Analysis of viral resistance to protease inhibitors was gathered after three years where viral samples were tested for genotypic resistance in patients with a detectable viral load.  Of the six patients with a detectable viral load (HIV RNA >400 copies/mL) and whose viral isolates could be analyzed, none were found to have mutations associated with PI resistance. 

“According to UNAIDS figures, approximately 40 million adults and children worldwide now are living with HIV/AIDS.  Unfortunately, many of those infected are unaware of their HIV status, which serves as an obstacle to proper care and treatment.  In addition, some patients develop resistance to their first HIV therapy within the first year of treatment.  Once this occurs, it becomes more difficult for patients to succeed on future regimens.  Consequently, minimizing the risk of developing resistance is of increasing concern to both physicians and patients.  With proper therapy, many people with HIV are managing their illness and leading productive and fulfilling lives.

“Kaletra is not a cure for HIV infection.  People treated with Kaletra may continue to acquire 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 stools, diarrhea, feeling weak/tired, headache, nausea and vomiting. 

“Under accelerated review, the U.S. Food and Drug Administration approved Kaletra for marketing in September 2000, and marketing authorization in the European Union was obtained in March 2001.  Abbott also has obtained marketing approval for Kaletra in Canada, Japan, throughout Latin America and in additional countries around the world.”

06/25/03

Source
Abbott Laboratories. www.kaletra.com

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