AEGiS-Reuters: Once-daily HIV drug seen safe, well-tolerated

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Once-daily HIV drug seen safe, well-tolerated

Reuters NewMedia - Tuesday September 19, 2000


TORONTO (Reuters) - Scientists said an ongoing trial of an experimental anti-HIV drug from Bristol-Myers Squibb showed it continued to be safe and well- tolerated, although given just once a day, unlike other drugs in its class that must be taken several times daily.

The experimental drug, from the protease inhibitor class, is known as BMS 232632.

Scientists said an ongoing mid-stage, or Phase II, test showed the drug candidate also had no impact on cholesterol and levels of triglyceride, a type of fat in the blood, after 24 weeks of treatment in patients who had not taken other medications.

That was also a first for the protease class, they said.

"Based on the Phase II profile of this compound, BMS 232632 dosed once a day continues to demonstrate efficacy at 24 weeks, while maintaining a favorable safety and tolerability profile," said Ian Sanne, Head of the Clinical HIV Research Unit, University of Witswatersrand, Johannesburg, South Africa.

Under the study, 98 HIV-positive patients took three dose ranges of BMS 232632 and compared their safety and antiviral activity with another protease inhibitor, nelfinavir, in combination with didanosine and stavudine.

The 24-week results presented at the International Conference on Antimicrobial Agents and Chemotherapy (ICAAC) demonstrated that BMS 232632 reduced viral load to undetectable levels and boosted the count of CD4 cells, proteins the virus attacks, similarly to nelfinavir. Those results occurred even at doses 5-10 fold lower than nelfinavir.

Also presented were 12-week results from a group of more than 300 patients in the same Phase II protocol. In these patients, combination therapy with BMS 232632 also significantly decreased viral load levels and increased CD4 cell counts.
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