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| |  DG DISPATCH - CROI: Once Daily Indinavir/Ritonavir Suppresses HIV, Increases CD4 Counts By Ed Susman Special to DG News
CHICAGO, IL -- February 7, 2001 -- A combination of the protease inhibitors, indinavir and ritonavir, as once daily treatment was as successful as standard indinavir treatment on reducing viral load of HIV-infected patients. Alfred Saah, MD, of Merck Research Labs, West Point, Penn., reported the preliminary results of a planned 48-week study of the use of the combination to simplify treatment regimens. "We are still in a dose finding phase of the study," Dr. Saah said at the 8th annual Conference on Retroviruses and Opportunistic Infections. He reported the 24-week data of the open label, phase II study in which 1,200 mg of indinavir and 200 mg of ritonavir were given to patients once a day. They also received stavudine and lamivudine twice a day. Dr. Saah and colleagues from the United States and at the Instituo de Infectologia Emilio Ribas, Sao Paolo, Brazil, enrolled 40 treatment-naïve patients ranging in age from 21 to 46 years, with a median age of 32. About half the subjects were men and 60 percent were white; 25 percent were African-American. The patients had a median CD4 cell count of 329, although the indicator of immune competence ranged from counts of 38 to 964. About 87.5 percent of the patients achieved an undetectable viral load by week 24 as measured by the Roche Amplicor assay with the 400-copy cutoff. Using the ultrasensitive 50-copy cutoff, 65.6 percent of patients achieved the undetectable level. Dr. Saah observed about a 100-cell increase in the average CD4 counts. "The once daily combination showed HIV suppression and CD4 cell increases that were generally similar to historical data with indinavir therapy after six months," he said, indicating that a once-a-day regimen appeared to be practical. Adding low doses of ritonavir to other protease inhibitors has been shown to enhance the bioavailability of the drugs. Dr. Saah said previous studies of pharmacokinetics in healthy volunteers had demonstrated a favorable profile in once-daily dosing, leading researchers to use the combination with infected individuals. He said the one serious adverse event in the 24-week portion of the study was development of pneumonia in one patient that required hospitalization. However, he said it was unlikely that the event was related to the therapy. Other side effects included five cases of alopecia, one case of fever and one case of gastric pain. Once case of nephrolithiasis occurred, although a stone was not identified.
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