Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
PR Newswire - December 6, 1995
"Ritonavir monotherapy appears to be well-tolerated and is associated with potent antiviral effects and immunologic benefit in AIDS patients. Expanded clinical trials of ritonavir are needed," said Martin Markowitz, M.D., staff investigator at New York's Aaron Diamond AIDS Research Center and principal author of the Journal article.
The study was a 12-week trial consisting of a four-week randomized, placebo controlled, double-blinded phase followed by an eight-week, dose-blinded phase. In the trial, 62 patients were randomized to receive ritonavir at one of four doses -- a three times a day dosing of ritonavir at either 200 or 300 milligrams, or four times a day dosing at either 200 or 300 milligrams -- or placebo.
Fifty-two patients completed the trial. In these patients, the antiviral effect of ritonavir was rapid and pronounced, with a mean maximal reduction from baseline in HIV-1 RNA copies in blood plasma of approximately 90 percent in the four dosing groups. After 12 weeks of treatment, the antiviral effect was partially sustained as a mean viral reduction of plasma viremia of approximately 50 percent.
A more sensitive assay for HIV-1 RNA in plasma used with a subset of 20 patients documented a mean reduction of 99 percent in plasma viremia. This antiviral effect was partially sustained with a mean reduction of approximately 93 percent after 12 weeks of treatment.
Concurrently with the reduction in viral load, CD4 lymphocyte counts rose in patients receiving ritonavir at all four dosing schedules, with median increases of 74 cells per microliter after four weeks of treatment and 99 cells per microliter after 12 weeks of treatment.
The most common clinical side effects associated with ritonavir were diarrhea and nausea. Reversible elevations in serum triglycerides and gamma-glutamyl transferase were the most frequent laboratory abnormalities.
"Ritonavir appears to be a safe and effective antiretroviral agent," said Dr. Markowitz. "A novel mechanism of action as a protease inhibitor and an apparent lack of toxicity in combination with existing AIDS therapies make it an ideal candidate for combination therapy with inhibitors of HIV reverse transcriptase."
Ritonavir is in clinical development at Abbott Laboratories (NYSE: ABT) for the treatment of AIDS/HIV infection.
CONTACT: Mary Wagner of Bozell Public Relations, 312-988-2356/ 16:26 EST
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