On Friday March 9, 2001, Health Canada granted permission to Abbott Laboratories for the sale of Kaletra (a combination of the protease inhibitors lopinavir/ritonavir), formerly known as ABT-378/r, for the treatment of HIV infection in adults and children six months or older. Kaletra was approved for sale in the U.S. in September 2000.
The approval of Kaletra is based partly on results from a Phase III study. In that study, subjects received one of two protease inhibitors — Kaletra or nelfinavir (Viracept) — as well as d4T (Zerit) and 3TC (lamivudine). According to the data analysis, Kaletra reduced viral load and raised CD4+ cell counts in significantly more people than did nelfinavir. Regulatory authorities also reviewed data from several small studies. These studies were designed to assess the effect of different doses of Kaletra. Currently there is no data in the public domain about the ability of Kaletra to delay the onset of symptoms of AIDS.
The recommended adult dose of Kaletra is 400 mg (3 capsules) twice daily with food. In children the dose is adjusted depending on the child's weight.
Apart from enrolling in a clinical trial, access to Kaletra in Canada has occurred via an expanded access programme. Since Kaletra is now available for sale, the expanded access programme will no longer be recruiting people.
There are currently more than 1,400 people with HIV/AIDS (PHAs) receiving Kaletra in the expanded access programme. Abbott Labs has said that it will continue to provide the drug at no charge to these people until such time as payment for Kaletra is covered by provincial/territorial formularies. One month's supply of Kaletra is expected to cost about $600.
At home, Kaletra capsules do not need to be refrigerated if they are used within two months and stored at temperatures not higher than 25°C (77°F). The liquid formulation of Kaletra can be stored at room temperature if used within two months. Refrigerated liquid Kaletra remains effective until the expiration date.
Side effects that can occur in some people who use Kaletra include the following:
Pancreatitis — a painfully swollen pancreas gland — has occurred in people using Kaletra. In some cases, this complication has been fatal. According to the manufacturer, pancreatitis should be considered if the following signs/symptoms occur:
Kaletra should not be used with the following drugs:
A CATIE Fact Sheet on Kaletra, listing further drug interactions and side effects, will be available at www.catie.ca in April 2001.
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Copyright © 2001 - TreatmentUpdate. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Editor, The Canadian AIDS Treatment Information Exchange, 555 Richmond St. West, Suite 505, Box 1104, Toronto, ON, M5V 3B1 • Phone: 416-203-7122 • Toll Free: 1-800-263-1638 • Fax: 416-203-8284 http://www.catie.ca.
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