Johnson & Johnson Says Prezista Matches Kaletra in HIV Trial
September 19, 2007
Johnson & Johnson's Prezista was as effective as Abbott Laboratories Inc.'s Kaletra in reducing HIV to undetectable levels in a population of treatment-naïve patients, according to a new study. The results of the late-stage trial were presented Tuesday at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago.
Prezista was introduced last year as a treatment for adults whose HIV infections were not responding adequately to other HIV drugs. Based on the new data, the company plans to ask US regulators this year to approve it for patients just starting HIV drug therapy, said company spokesperson Pam Van Houten.
In the current trial, one group of patients received the protease inhibitor Prezista in an experimental 800-milligram once-daily dose, along with Abbott's older protease inhibitor Norvir (ritonavir) and Truvada. Manufactured by Gilead Sciences Inc., Truvada contains two nucleoside reverse transcriptase inhibitors. The other group of patients received Kaletra, which combines Norvir with the protease inhibitor lopinavir, plus Truvada.
The Johnson & Johnson researchers said 84 percent of the Prezista patients had achieved undetectable HIV levels after 48 weeks, compared with 78 percent of the Kaletra patients.
Ilke Arici, an Abbott spokesperson, said the trial "does not reflect a real-life scenario." She said the study's design was inconsistent with the way doctors prescribe treatment. Many study patients, she said, were given the soft gel formulation of Kaletra, which she said is not as effective as the tablet version usually prescribed in the United States. Van Houten responded that most of the Kaletra patients were switched to tablets after they became available.
Van Houten also noted that the Prezista dose administered, 800 milligrams once a day, was lower than the twice-daily 600 milligram dosage the label recommends. The lower dose was given, she said, on the theory that it would be adequate for treatment-naïve patients without resistance to HIV drugs.
9.18.2007; Ransdell Pierson
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.