J&J says Prezista matches Kaletra in HIV trial

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NEW YORK, Sep 19 (Reuters) Johnson&Johnson said its drug Prezista was as effective in a late-stage trial as Abbott Laboratories Inc's Kaletra in cutting HIV to undetectable levels among patients not previously treated with HIV drugs.

Prezista, a once-daily protease inhibitor recently introduced by J&J, was given to patients along with Abbott's older protease inhibitor Norvir (ritonavir) and Gilead Science Inc's widely used Truvada. Truvada itself contains two drugs belonging to a separate class of HIV treatments called nucleoside reverse transcriptase inhibitors.

Another group of patients was given Kaletra, a top-selling HIV pill that combines Norvir with the protease inhibitor lopinavir, as well as Truvada.

J&J said yesterday levels of HIV dropped to undetectable levels after 48 weeks among 84 per cent of patients taking experimental 800-milligram doses of Prezista, compared with undetectable virus levels in 78 percent of those receiving Kaletra.

Data from the so-called ARTEMIS trial -- the first study to test Prezista among patients never previously treated with other HIV medicines -- were presented in Chicago at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

Prezista was launched last year as a treatment for adults whose HIV infections have not been adequately controlled by prior treatment with other HIV drugs. Data from the new trial could eventually support its use as a first-line treatment.

Kaletra, approved for adults and children over 6 months of age both as a first-line treatment and for those who have failed to benefit from other drugs, is the world's best-selling HIV protease inhibitor product. It had global sales last year of 1.14 billion dollars.

Abbott spokeswoman Ilke Arici said Prezista's showing of ''non-inferiority'' to Kaletra in the trial was somewhat questionable because the trial design did not reflect how the drugs are given in real-world medical practice.

Patients were given 800-milligram daily doses of Prezista in the trial, although the J&J drug is only approved at daily doses of 600 milligrams, she said.

Moreover, Arici said many patients were given soft gel forms of Kaletra in the study, which she said are less effective than a new tablet formulation now widely used in the United States.

''So this trial does not reflect a real-life scenario since these are not the ways patients are given these drugs,'' Arici said.

Johnson&Johnson officials were not immediately available for comment.

Shares of J&J were up 22 cents to 63.16 dollars, while Abbott's rose 51 cents to 52.50 dollars, in early afternoon trading on the New York Stock Exchange amid broad stock market gains.


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